Consumer medicine information

Minulet

Gestodene; Ethinylestradiol

BRAND INFORMATION

Brand name

Minulet

Active ingredient

Gestodene; Ethinylestradiol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Minulet.

SUMMARY CMI

Minulet®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Minulet?

Minulet contains two active ingredients, gestodene and ethinylestradiol. Minulet is used to prevent pregnancy.

For more information, see Section 1. Why am I using Minulet? in the full CMI.

2. What should I know before I use Minulet?

Do not use if you have ever had an allergic reaction to gestodene or ethinylestradiol or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Minulet? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Minulet and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Minulet?

  • Take one tablet at the same time every day, regardless of how often you have sex.
  • See the full CMI for instructions on how to start taking Minulet for the first time or how to change to Minulet from a different contraceptive.

More instructions can be found in Section 4. How do I use Minulet? in the full CMI.

5. What should I know while using Minulet?

Things you should do
  • Remind any doctor or dentist and pharmacist you visit that you are using Minulet.
  • Tell your doctor immediately if you become pregnant while taking Minulet.
  • See your doctor if you have not taken your tablets correctly and have missed a period.
  • Have regular check-ups from your doctor, including a Pap smear.
  • Perform regular breast self-examination
Things you should not do
  • Do not stop using this medicine or change the dosage, without checking with your doctor. If you stop taking Minulet or do not take a tablet every day without using another form of contraception, you may become pregnant.
Driving or using machines
  • Make sure you know how Minulet affects you before you drive or use machines. Minulet may cause dizziness in some people.
Looking after your medicine
  • Keep Minulet in a cool, dry place where the temperate stays below 25°C, away from moisture, heat or sunlight.

For more information, see Section 5. What should I know while using Minulet? in the full CMI.

6. Are there any side effects?

Common side effects include changes to your bleeding patterns, painful periods, breast tenderness, changes in sex drive, abdominal pain, cramps or bloating, changes to your mood, headaches, weight changes, swelling of the hands, ankles or feet, acne, loss of scalp hair, increase in body hair. More serious side effects include blood clots, worsening or new onset of migraines/headaches, jaundice (yellowing of skin or eyes), increase in epileptic seizures or significant rise in blood pressure. For full list of side effects and further information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Minulet®

Active ingredient(s): gestodene and ethinylestradiol


Consumer Medicine Information (CMI)

This leaflet provides important information about using Minulet. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Minulet.

Where to find information in this leaflet:

1. Why am I using Minulet?
2. What should I know before I use Minulet?
3. What if I am taking other medicines?
4. How do I use Minulet?
5. What should I know while using Minulet?
6. Are there any side effects?
7. Product details

1. Why am I using Minulet?

Minulet contains two active ingredients, gestodene and ethinylestradiol, which are similar to the hormones that your body normally produces. Minulet is an oral contraceptive, commonly known as a "birth control pill" or "the Pill".

Minulet is used to prevent you from becoming pregnant in several ways, if taken correctly:

  • It inhibits the egg release by stopping it maturing
  • It changes the cervical mucus consistency making it difficult for the sperm to reach the egg
  • It changes the lining of the uterus making it less suitable for implantation.

Your doctor may have prescribed Minulet for another reason.

Ask your doctor if you have any questions about why Minulet has been prescribed for you.

2. What should I know before I use Minulet?

Warnings

Do not take Minulet if:

  1. You are allergic to gestodene or ethinylestradiol, or any other similar medicines (such as other oral contraceptives), or any of the ingredients listed at the end of this leaflet.
Some of the symptoms an allergic reaction may include:
  • Shortness of breath
  • Wheezing or difficulty breathing
  • Swelling of the face, lips, tongue or other parts of the body
  • Rash, itching or hives on the skin
Always check the ingredients to make sure you can use this medicine.
  1. You have, or have had, a blood clot in the:
  • legs (deep vein thrombosis (DVT))
  • lungs (pulmonary embolism (PE))
  • heart (heart attack)
  • brain (stroke)
  • other parts of the body
  1. You are at increased risk of a blood clot in the legs (DVT) or lungs (PE) due to any of the following:
  • A family history of blood clots (DVT or PE) or you have been advised that you have an increased risk of blood clots
  • Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma
  • Biochemical factors, such as Activated Protein C resistance (including Factor V Leiden), antithrombin-III deficiency, protein C deficiency, protein S deficiency
  • Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis)
  • Sickle cell disease
  • Obesity, age above 35 years, high cholesterol
  • Smoking, particularly if you are a heavy smoker (15 or more cigarettes per day) and are aged over 35 years
  1. You have, or have had, blood clots in the arteries (known as arterial thromboembolism (ATE)).
Examples of these include:
  • Stroke
  • Angina
  • Transient ischaemic attack or "mini stroke"
  1. You are at increased risk of arterial thromboembolism (ATE), including:
  • A family history of ATE or you have been advised that you have an increased risk of ATE
  • Multiple risk factors for ATE or a serious risk factor for ATE that include:
    - Uncontrolled high blood pressure
    - Diabetes with blood vessel damage
    - Severe lipid (fatty materials) disease, such as cholesterol or triglyceride issues
    - History of migraine, accompanied by blurred vision, difficulty in speaking, muscle weakness, or increased sensitivity to light, sound or noise.
    - Biochemical factors, such as hyperhomocysteinaemia and antiphospholipid antibodies (e.g. anticardiolipin antibodies and lupus anticoagulant)
  1. You have any of the following conditions
  • Disease in any blood vessel(s)
  • Inflammation of the pancreas, which is associated with very high blood levels of triglycerides (fatty substances)
  • Breast cancer or cancer of the lining of the womb, cervix or vagina, or you think you have these conditions
  • Unexplained vaginal bleeding
  • Liver tumour or liver disease
  • Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of an oral contraceptive
  • Severe skin itchiness during pregnancy
  • A history of herpes in pregnancy, known as herpes gestationis
  • A history of a hearing problem known as otosclerosis, which is worse during pregnancy
  1. You are pregnant or you think you are pregnant. Pregnancy must be excluded before you start taking Minulet.
  2. You are under 18 years of age or are post-menopausal.
  3. You are taking anti-viral hepatitis C virus (HCV) medicinal products such as those containing glecaprevir, pibrentasvir, ombitasvir, paritaprevir, ritonavir and dasabuvir with or without ribavirin.
If you are not sure about your anti-HCV medication, tell your doctor.

Check with your doctor if you:

  • Take any medicines for any other condition
  • Have any other medical conditions or health problems, such as:
    - Heart disease including heart valve disorders or certain heart rhythm disorders
    - High blood pressure, a history of high blood pressure or high blood pressure during pregnancy
    - High cholesterol
    - Hepatitis C
    - Diabetes
    - Migraine or other headaches
    - Hyperhomocysteinemia
    - Breast lumps, abnormal breast X-ray or mammogram
    - Epilepsy
    - Depression
    - Gallbladder disease
    - Fluid retention or kidney disease
    - Asthma
    - Fibroids
    - Hereditary angioedema
If you have any of these conditions you should have regular check-ups with your doctor to make sure that taking Minulet is not making the conditions worse. If you are not certain whether any of the above may apply to you, check with your doctor.
  • Are over 35 years of age or are overweight
  • Are intolerant to some sugars, or your doctor has told you so, speak to your doctor before taking it.
    Minulet contains lactose.
  • Are allergic to any foods, dyes, preservatives or any other medicines.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Minulet is not recommended during pregnancy. Pregnancy must be excluded before you start taking Minulet.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Minulet is not recommended while you are breastfeeding. Small amounts of oral contraceptives have been found in breast milk. It is not known what effect this may have on the baby. A decrease in milk supply may also occur.

Children

Do not give this medicine to a child under 18 years.

Blood clots

  • You must tell your doctor if you or anyone in your immediate family has, or has had blood clots in the legs or lungs.
  • Blood clots are a rare occurrence when taking an oral contraceptive.
  • The risk of a blood clot is highest during the first year of taking an oral contraceptive for the first time or if you are re-starting the "pill" after a break of 4 weeks or more.
  • The risk of having a blood clot is higher in oral contraceptive users than in non-users, but is not as high as during pregnancy.

Tell your doctor if you have, or have had, any of the following conditions as these are risk factors for developing blood clots:

  • Cancer
  • Systemic lupus erythematosus (SLE) - a type of inflammatory disease caused when the immune system attacks its own tissues
  • Haemolytic uraemic syndrome (HUS) - a disorder of blood coagulation causing failure of the kidneys
  • Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)
  • Sickle cell disease
  • Smoking particularly if you are a heavy smoker (15 or more cigarettes per day) and are aged over 35 years
  • Have had any recent surgery or trauma
  • Recently had a baby
  • Lost a baby in the second trimester
  • Are pregnant
  • Had major surgery and have been confined to bed for long periods of time

Also tell your doctor if you are planning a long-haul plane flight (greater than 4 hours).

Stroke

You must tell your doctor if you or anyone in your immediate family has, or has had, a stroke or heart attack.

Taking oral contraceptives is linked with an increased risk of having a heart attack, angina, stroke or a "mini stroke".

Medical check-ups

Before you start to take Minulet, you must have a thorough medical check-up, including a Pap smear, breast check, blood pressure check and urine test.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Minulet and affect how it or the other medicine works.

Some medicines may increase the levels of Minulet in your blood, which may lead to unwanted side effects. These medicines include:

  • Atorvastatin, used to treat high cholesterol
  • Indinavir, for the treatment of HIV infection
  • Anti-fungal agents such as itraconazole and fluconazole
  • Paracetamol
  • Ascorbic acid (Vitamin C)

Medicines that may reduce the effect of Minulet include:

  • Rifampicin and rifabutin for the treatment of infections, including tuberculosis
  • Antibiotics such as ampicillin, other penicillins and tetracyclines
  • Anti-fungal agents such as griseofulvin
  • Barbiturates (phenobarbitone)
  • Medicines for epilepsy (such as phenytoin, primidone, carbamazepine and topiramate)
  • Ritonavir for the treatment of HIV infection
  • Modafinil, used to treat excessive daytime sleepiness
  • St. John's wort, an ingredient in many medicines you can buy without a prescription from a pharmacy, health food shop or supermarket
  • Corticosteroids, such as dexamethasone.

While you are taking any of these medicines and for the next 7 days after stopping them, you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods). If you come to the end of the white tablets during these 7 days, start the next pack straight away. Skip the 7 red tablets.

If you take rifampicin and some other medicines, you may need to use additional non-hormonal contraception for four weeks after finishing the course of treatment.

Ask your doctor or pharmacist about how long you need to use additional non-hormonal contraception.

Minulet may also affect how well some other medicines work.

These medicines include:

  • Anti-viral hepatitis C virus (HCV) medicines such as glecaprevir, pibrentasvir, ombitasvir, paritaprevir, ritonavir and dasabuvir
  • Ciclosporin, used to prevent organ rejection
  • Theophylline, used for asthma and other breathing difficulties
  • Corticosteroids
  • Lamotrigine, used for seizures

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Minulet.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Minulet.

4. How do I use Minulet?

How much to take

  • Take one tablet every day.
  • Follow the instructions provided and use Minulet until your doctor tells you to stop.

When to take Minulet

  • Minulet should be taken at the same time every day, regardless of whether you have sex.
  • Minulet will work best if you do not miss any tablets and take it at the same time each day. Taking your tablet at the same time each day will also help you remember when to take the tablets.
  • It does not matter if you take Minulet before or after food.
  • If you are concerned about this, please speak to your doctor or pharmacist.

How to take Minulet

  • Swallow Minulet with a glass of water.

How to start taking Minulet for the first time

  1. On the first day of your menstrual bleed, take a white tablet that matches the day of the week from the purple shaded section of the blister pack.
  2. Then take one white tablet each day, following the arrows so that you are taking the correct tablet for the day of the week until all 21 white tablets have gone.
  3. Then take one red tablet each day for the next 7 days.
  4. You will have a 'withdrawal' bleed, similar to having a period, during the week of red tablets.

Minulet is effective from the first day of use if begun as instructed. Your first cycle is likely to be shorter than usual, approximately 23 to 24 days long. Thereafter, your cycles should be about 28 days long.

If you do not bleed and there is any chance that you have not followed all the instructions in this leaflet, contact your doctor to check if you are pregnant.

Going on to further blister packs

On the day after your last red tablet, begin the next pack with a white tablet from the purple shaded section of the blister pack that matches the day of the week. Do this even if you are still bleeding.

Each new pack is started with a white tablet on the same day as the first pack, so that you have 21 days on white tablets, then 7 days on red tablets. There is no break between packs.

If you start the new pack later than the day after your last red tablet, you may have started a normal fertile cycle.

If you start late, you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until a white tablet has been taken daily for 7 days without a break.

How to change to Minulet from a different combined oral contraceptive

Follow these steps if your current oral contraceptive contains an estrogen and a progestogen:

  1. Stop taking your current oral contraceptive after you have taken the last tablet in the pack.
  2. If your current oral contraceptive is a 28 day pack, start Minulet the next day by taking take the first white tablet from the purple shaded section that matches the day of the week. If your current oral contraceptive is a 21 day pack, wait 7 days from when the last tablet was taken. On the 8th day, start Minulet by taking take the first white tablet from the purple shaded section that matches the day of the week.
You must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until a white tablet has been taken daily for 7 days without a break.
  1. Then take one white tablet each day following the direction of the arrows until all 21 white tablets have gone.
  2. Then take one red tablet each day for the next 7 days.
  3. You will have a 'withdrawal' bleed, similar to having a period, during the week of red tablets.

If you do not bleed and there is any chance that you have not followed all the instructions in this leaflet, contact your doctor to check if you are pregnant.

How to change to Minulet from a progesterone-only contraceptive

You can stop taking a progestogen-only contraceptive tablet any day and start taking Minulet the next day, at the same time.

If you have been using a progestogen-only implant, start taking Minulet on the day the implant is removed.

If you have been using a progestogen-only injection, start taking Minulet on the day the next injection would be due.

In all cases start Minulet by taking a white tablet from the purple shaded section that matches the day of the week.

You must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until a white tablet has been taken daily for 7 days without a break.

After having a baby

If you have just had a baby, talk to your doctor before you start taking Minulet.

After a miscarriage or abortion

Your doctor will advise you how to take Minulet after a miscarriage or abortion.

How long to take Minulet

Your doctor may prescribe Minulet for long periods, until you no longer need or want contraception.

If you are not sure how long you should be taking Minulet, ask your doctor.

If you forget to use Minulet

Minulet should be used regularly at the same time each day. If you miss your dose at the usual time, it may not work as well in protecting you from becoming pregnant.

Do not take a double dose to make up for the dose you missed.

Forgetting one white tablet

  • If you forget one white tablet but it is less than 12 hours late, take the missed tablet immediately. Take the next tablet at your usual time, even if this means taking two tablets in one day.
    If you do not take the missed tablet within 12 hours, Minulet may not work as well in protecting you from becoming pregnant.
  • If one white tablet is missed and is more than 12 hours late, skip the missed white tablet and take the next white tablet at the usual time.
  • Continue to take tablets at your usual time but you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm but not the rhythm or temperature methods) until a white tablet has been taken daily for 7 days without a break. If you come to the end of the white tablets during the 7 days after a missed tablet, start the next pack straight away. Skip the 7 red tablets.

Forgetting more than one white tablet

Contact your doctor for advice on what to do.

Forgetting a red tablet

  • If you miss one or more red tablets, leave them in the pack and do not worry.
  • However, if you miss red tablets and then forget to start the next pack on time, start as soon as you remember by taking a white tablet that matches the day of the week from the purple shaded section.
    You must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm but not the rhythm or temperature methods) until a white tablet has been taken daily for 7 days without a break.

If you are not sure what to do, ask your doctor or pharmacist.

If you are having trouble remembering to take Minulet, ask your pharmacist for some hints.

If you vomit or have diarrhoea after taking Minulet

  • If you have vomiting or diarrhoea within 4 hours of taking a white tablet, you must use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until a white tablet has been taken daily for 7 days without a break. If you come to the end of the white tablets during these 7 days, start the next pack straight away. Skip the 7 red tablets.
  • The tablet may not have time to be absorbed properly and may not protect you from becoming pregnant.
  • If you have vomiting or diarrhoea after taking a red tablet, do not worry.

If you use too much Minulet

If you think that you have used too much Minulet, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too much Minulet, some of the symptoms you may have include:

  • Feeling sick or vomiting
  • Dizziness
  • Feeling sleepy or tired.

Women may also experience menstrual bleeding.

5. What should I know while using Minulet?

Things you should do

  • Tell all doctors, dentists and pharmacists who are treating you that you are taking Minulet.
  • If you are about to start taking any new medicines, tell the doctor or pharmacist that you are taking Minulet.
  • If you become pregnant while taking Minulet, see your doctor immediately.
  • Tell your doctor you are using Minulet at least 4 weeks before any planned hospitalisation or surgery.
    Your doctor may tell you to stop taking Minulet several weeks before surgery or at the time of immobilisation. Your doctor will tell you when you can start taking Minulet after you are back on your feet.
    To avoid pregnancy during this time you must use a non-hormonal method of contraception such as condoms or a diaphragm.
  • If you are scheduled for any laboratory tests, tell your doctor you are taking Minulet.
    Some blood tests may be affected by taking Minulet.

Missed periods

  • If you miss a period and you have taken your tablets correctly, continue taking your tablets as you would normally.
    Sometimes you might not have a menstrual period while taking Minulet.
  • If you miss a period and you have not taken your tablets correctly, keep taking your tablets and see your doctor immediately.
    Not taking your tablets correctly includes missing one or more tablets or starting a new pack later than you should have.
  • If you miss two menstrual periods, stop taking your tablets and see your doctor, even if you have taken the tablets correctly. You must use a non-hormonal method of contraception, (such as condoms or a diaphragm) during this time.
  • Your doctor should make sure you are not pregnant before you start taking Minulet again.

Pap smear

  • Have regular check-ups from your doctor, including a Pap smear.
  • Oral contraceptives should not be prescribed for longer than one year without your doctor carrying out a check-up. Your doctor will advise you how often you need a Pap smear.
  • A Pap smear can detect abnormal cells lining the cervix. Sometimes abnormal cells can progress to cervical cancer. The most important risk factor for cervical cancer is persistent human papillomavirus (HPV) infection. However, cervical cancer has been reported to occur more often in women using an oral contraceptive for a long time. This finding may not be caused by the oral contraceptive, but may be related to sexual behaviour and other reasons.

Breast cancer risk

  • Perform regular breast self-examination.
  • Risk factors for the development of breast cancer include increasing age, family history, obesity, never having had a baby, and late age for first full-term pregnancy.
  • Breast cancer has also been found slightly more often in women who use oral contraceptives than in women of the same age who do not use them. This slight increase in the number of breast cancer cases gradually disappears during the course of the 10 years after stopping use of oral contraceptives.
  • It is not known whether the oral contraceptive causes the difference. It may be that the women were examined more often, so that the breast cancer was noticed earlier.

Sexually transmitted disease (STD)

  • If you are concerned about contracting a sexually transmitted disease (STD), ask your partner to wear a condom when having sexual intercourse with you.
  • Minulet will not protect you from HIV-AIDS or any other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, human papilloma virus and syphilis. To help protect yourself from STDs, you need to use a barrier contraceptive such as a condom.

Things you should not do

  • Do not take this medicine if the expiry date (EXP) printed on the pack has passed.
    Minulet may have no effect at all, or worse, an entirely unexpected effect, if you take it after the expiry date.
  • Do not take this medicine if the packaging is torn or shows signs of tampering.
    If this is the case, take the tablets back to your pharmacist.
  • Do not give Minulet to anyone else.
  • Do not use Minulet to treat any other complaints unless your doctor tells you to.
  • Do not stop taking Minulet, or change the dosage, without checking with your doctor.
    If you stop taking Minulet or do not take a tablet every day, without using another form of contraception, you may become pregnant.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Minulet affects you.

Minulet may cause dizziness in some people.

Drinking alcohol

No information available.

Looking after your medicine

  • Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the pack they may not keep well.
  • Keep Minulet where the temperature stays below 25°C and is away from light.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

After stopping Minulet

  • If your periods do not return within 2 to 3 months of stopping Minulet, tell your doctor.
  • Some women have short-term problems getting pregnant after stopping Minulet, especially if they had irregular menstrual cycles before starting to use an oral contraceptive.
    If you are planning to become pregnant after stopping Minulet, use a non-hormonal method of contraception such as condoms or a diaphragm for 3 months before trying to get pregnant.
  • Ask your doctor or pharmacist for advice about taking folate if you plan to become pregnant.

When to discard your medicine

If your doctor tells you to stop taking Minulet, or the tablets have passed their expiry date, ask your pharmacist what to do with any left over.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Side effects

Common side effectsWhat to do
Reproductive or breast problems:
  • Changes in bleeding patterns, including breakthrough bleeding/spotting
  • Painful periods
  • Missed periods, but if you have not taken Minulet as directed you should check whether you are pregnant.
  • Changes in mucus from the vagina
  • Changes in the cervix
  • Vaginal thrush (candida)
  • Breast pain, tenderness, enlargement, possible milk secretion
  • Changes in sex drive
Stomach problems such as:
  • Nausea or vomiting
  • Abdominal pain, cramps or bloating.
Difficulties thinking or working because of:
  • Mood changes, including depression
  • Headache, including migraines
  • Nervousness
  • Dizziness
  • Contact lenses becoming uncomfortable to wear
Changes to your appearance such as:
  • Weight change (increase or decrease) or changes in appetite
  • Swelling of the hands, ankles or feet
  • Acne
  • Rash
  • Darkening of the skin, which may persist after stopping your medicine
  • Loss of scalp hair
  • Increase in body hair
Speak to your doctor if you have any of these common side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Worsening of your existing conditions, such as:
  • Chorea
  • Porphyria
  • Systemic lupus erythematosus
  • Varicose veins
  • Gallbladder disease
  • Hereditary angioedema
Pain or discomfort:
  • Fever
  • Unexplained or persistent pains in the head, chest, arm or below the breastbone
  • Severe pain, swelling or discolouration in either of your legs
  • Weakness or numbness in any part of your body
  • Discomfort radiating to the back, jaw, throat or stomach
  • Abdominal pain
Problems with your eyes or eyesight:
  • Blurred or double vision
  • Partial or complete loss of sight
  • Eye protrusion, swelling of the eye or eye lesions
  • Swelling around eyes or mouth
Migraines:
  • Migraine headaches for the first time
  • More frequent migraines if you already suffer from them
General feelings of unwellness, including:
  • Feeling tired
  • Shortness of breath
  • Rapid or irregular heartbeat
  • Dizziness or fainting, sometimes with loss of balance
  • Sweating, nausea or vomiting
  • An unusual cough
Changes to your body:
  • Confusion, trouble speaking or understanding
  • Breast lumps
  • Jaundice or a yellowing of the skin or eyeballs, often with fever, fatigue, loss of appetite, dark coloured urine or light coloured bowel movements.
    Taking oral contraceptives has been associated with an increased risk of having a benign liver tumour and, in very rare cases, liver cancer. The risk appears to increase the longer oral contraceptives are taken.
  • Rise in blood pressure. You may experience headache, blurred vision or palpitations.
    Sometimes your blood pressure may rise without you experiencing any of these symptoms. It is important to keep your routine doctor's appointments so that your blood pressure can be checked.
  • If you have epilepsy and your fits become more frequent
  • Itchy rash
Digestive system problems:
  • Feeling of indigestion or choking
  • Rectal bleeding, or blood on your underwear or when going to the bathroom.
  • Bloody diarrhoea
  • Loss of appetite or weight loss
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
You may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Minulet contains

Active ingredient
(main ingredient)

Each white active tablet contains:

  • 75 micrograms of gestodene
  • 30 micrograms of ethinylestradiol

The red tablets do not contain active ingredients.

Other ingredients
(inactive ingredients)
  • Lactose monohydrate
  • Maize starch
  • Povidone
  • Magnesium stearate
  • Sucrose
  • Calcium carbonate
  • Purified talc
  • Macrogol 6000
  • Glycol montanate

The white active tablets also contain:

  • Sodium calcium edetate

The red inactive tablets also contain:

  • Brilliant scarlet 4R CI 16255
  • Erythrosine CI 45430

Do not take this medicine if you are allergic to any of these ingredients.

Minulet does not contain gluten, tartrazine or any other azo dyes.

What Minulet looks like

Minulet comes in a 12 week box containing 3 blister packs. Each blister pack contains 21 white active tablets and 7 red inactive tablets. The white active tablets are round, biconvex tablets, approximately 6 mm in diameter. The red inactive tablets are round, biconvex coated tablets. The blister pack is marked with days of the week next to each tablet.

(AUST R 296803)

Who distributes Minulet

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedicalinformation.com.au

® = Registered Trademark

This leaflet was prepared in June 2023.

Published by MIMS August 2023

BRAND INFORMATION

Brand name

Minulet

Active ingredient

Gestodene; Ethinylestradiol

Schedule

S4

 

1 Name of Medicine

Gestodene and ethinylestradiol.

2 Qualitative and Quantitative Composition

Each white active tablet contains ethinylestradiol 30 microgram and gestodene 75 microgram.
Each red tablet is a placebo tablet.

Excipients with known effect.

Sucrose, lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablets.
Minulet calendar blister pack consists of 28 tablets: 21 white tablets and 7 red placebo tablets. The white active tablets are round, biconvex tablets, approximately 6 mm in diameter.
The red inert tablets are round, biconvex coated tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

Minulet is indicated for the prevention of pregnancy.

4.2 Dose and Method of Administration

How to take Minulet.

Each package of Minulet contains 21 active white tablets and 7 red inactive tablets.
To achieve maximum contraceptive effectiveness, Minulet must be taken as directed and at daily intervals not exceeding 24 hours. Women should be instructed to take the tablets at the same time every day, preferably at bedtime.

How to start Minulet.

No preceding hormonal contraceptive use (in the past month).

On the first day of the menstrual cycle, i.e. the first day of bleeding, the woman is instructed to take a white active tablet corresponding to that day of the week from the purple section of the Minulet pack. Thereafter, one white active tablet is taken daily, following the arrows marked on the package, until all 21 white active tablets have been taken from the pink section. The woman should be instructed then to take one red inactive tablet daily for the next seven days following the arrows marked on the Minulet pack. Withdrawal bleeding should usually occur within 2 to 4 days after the last white active tablet is taken. The woman should be advised that her first cycle after taking Minulet is likely to be shorter than usual, i.e. approximately 23 to 24 days in length. Thereafter, cycles should be approximately 28 days in length.
If withdrawal bleeding does not occur and Minulet has been taken according to directions, and conditions possibly impairing contraceptive effectiveness (see Section 4.2 Dose and Method of Administration, Vomiting or diarrhoea; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions) can be ruled out, it is unlikely that the woman has conceived. She should be instructed to begin a second course of Minulet on the usual day. If bleeding does not occur at the end of this second cycle, Minulet should not be taken until diagnostic procedures to exclude the possibility of pregnancy have been performed.
The next and all subsequent courses of Minulet will begin on the day after the last package was completed, even if withdrawal bleeding is still in progress. Each course of Minulet is thus begun on the same day of the week as the first course, always beginning with a white tablet.
If withdrawal bleeding does not occur and Minulet has been taken according to directions, and conditions possibly impairing contraceptive effectiveness (see Section 4.2 Dose and Method of Administration, Vomiting or diarrhoea; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions) can be ruled out, it is unlikely that the woman has conceived. She should be instructed to begin a second course of Minulet on the usual day. If bleeding does not occur at the end of this second cycle, Minulet should not be taken until diagnostic procedures to exclude the possibility of pregnancy have been performed.
Minulet is effective from the first day of therapy if the tablets are begun as described above.

Changing from another combined oral contraceptive.

If the woman is switching to Minulet from another 28 day oral contraceptive pack, then all tablets in the current 28 day pack should be finished and Minulet started on the next day by taking a white active tablet, which corresponds to that day of the week. During the first Minulet cycle, a nonhormonal contraceptive method (other than rhythm or temperature method) should be used until 7 consecutive daily white active tablets have been taken. During this changeover, a period of shortened duration or no period may occur.
If the woman is switching to Minulet from another 21 day oral contraceptive pack, then the woman should wait seven (7) days from when the last active tablet was taken from the old pack and start this new Minulet pack on the eighth day by taking a white active tablet, which corresponds to this day of the week from the purple section of the pack. A nonhormonal contraceptive method (other than rhythm or temperature method) should be used during the tablet free interval and during the first Minulet cycle until 7 consecutive daily active white tablets have been taken.
If transient spotting or breakthrough bleeding occurs, the woman is instructed to continue the regimen since such bleeding is usually without significance. If the bleeding is persistent or prolonged, the woman is advised to consult her physician.

Changing from a progestogen only method (progestogen only tablet, injection, implant).

The woman may switch any day from the progestogen only tablet and should begin Minulet the next day. She should start Minulet on the day of implant removal or, if using an injection, the day the next injection would be due. In all these situations, the woman should be advised to use a nonhormonal back-up method for the first 7 days of tablet taking.

Following first trimester abortion.

The woman may start Minulet immediately. Additional contraceptive measures are not needed.

Following delivery or second trimester abortion.

Since the immediate postpartum period is associated with an increased risk of thromboembolism, combined oral contraceptives should be started no earlier than day 28 after delivery in the nonlactating mother or second trimester abortion. The woman should be advised to use a nonhormonal back-up method for the first 7 days of tablet taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of Minulet use or the woman must wait for her first menstrual period.

Management of missed tablets.

Contraceptive efficacy may be reduced if active tablets are missed and particularly if the missed tablets extend the inactive tablet interval.
If one active white tablet is missed, but is less than 12 hours late, it should be taken as soon as it is remembered. Subsequent tablets should be taken at the usual time.
If one active white tablet is missed and is more than 12 hours late or if more than one active white tablet is missed, contraceptive protection may be reduced. The last missed tablet should be taken as soon as it is remembered, even if this means taking two active white tablets in one day. Any earlier missed tablets should be discarded. Subsequent tablets should be taken at the usual time. In addition, a nonhormonal back-up method of contraception (other than the rhythm or temperature methods) should be used until one active tablet has been taken for 7 consecutive days.
If these 7 days extend into the section containing the red inactive tablets, she should start a new pack on the next day after having taken the last active white tablet from the current pack (i.e. skip the 7 red inactive tablets). This will mean that the woman may not have a period until the end of two packs.
However, if the woman misses one or more red inactive tablets, she will still be protected against pregnancy provided she begins the active tablets on the appropriate day.
If the woman has not adhered to the prescribed regimen (missed one or more active tablets or started taking them on a day later than recommended), the probability of pregnancy should be considered at the time of the first missed period before Minulet is resumed. In the case of the continuous intake of active tablets from two packs of Minulet (see before), a period should occur at the end of the second pack. If it does not, pregnancy should be ruled out before Minulet is resumed.
If these 7 days extend into the section containing the red inactive tablets, she should start a new pack on the next day after having taken the last active white tablet from the current pack (i.e. skip the 7 red inactive tablets). This will mean that the woman may not have a period until the end of two packs.
However, if the woman misses one or more red inactive tablets, she will still be protected against pregnancy provided she begins the active tablets on the appropriate day.

Concurrent medication.

If the woman is taking other drugs that may interact with Minulet, then she should continue to take her tablets as usual but also employ a nonhormonal method of contraception (except the rhythm or temperature method) during the time she is taking the interacting medication and continued for 7 days after the medication is stopped. If these 7 days extend into the section containing the red inactive tablets, the woman should start a new pack on the next day after having taken the last active tablet from the current pack (i.e. skip the inactive tablets). This will mean that the woman may not have a period until the end of two packs. If the woman is taking interacting medications on a chronic basis, another method of contraception should be considered.

Vomiting or diarrhoea.

If vomiting or diarrhoea occurs during or shortly after the intake of Minulet, contraceptive reliability may be jeopardised. If vomiting occurs within 4 hours after tablet taking, absorption may not be complete. In such an event, the advice concerning management of missed tablets is applicable. The woman must take the extra active tablet(s) needed from a back up pack. Mild laxatives do not impair the effectiveness of Minulet. If the circumstance reducing the effectiveness of Minulet is protracted, other methods of contraception should be considered.

4.3 Contraindications

Minulet should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during Minulet use, the product should be stopped immediately.
Presence or risk of venous thromboembolism (VTE) (see Section 4.4 Special Warnings and Precautions for Use):
a history of, or current thromboembolic disorders, deep vein thrombosis and conditions that predispose to such diseases (e.g. disturbance of the clotting system with a tendency towards thrombosis);
known hereditary or acquired predisposition for venous thromboembolism, such as APC resistance (including factor V Leiden), antithrombin-III deficiency, protein C deficiency, protein S deficiency;
major surgery with prolonged immobilisation;
a high risk of venous thromboembolism due to the presence of multiple risk factors;
sickle cell anaemia.
Presence or risk of arterial thromboembolism (ATE) (see Section 4.4 Special Warnings and Precautions for Use):
current ATE or history of ATE (e.g. myocardial infarction or stroke) or prodromal condition (e.g. angina pectoris or transient ischaemic attack (TIA)) and conditions that predispose to such diseases (e.g. disturbance of the clotting system with a tendency towards thrombosis and certain heart diseases e.g. valvular heart disease, thrombogenic valvulopathies and thrombogenic rhythm disorders);
known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid antibodies (e.g. anticardiolipin antibodies and lupus anticoagulant);
headaches with focal neurological symptoms (such as aura) including hemiplegic migraine;
a high risk of arterial thromboembolism due to multiple risk factors or to the presence of one serious risk factor such as: diabetes mellitus with vascular symptoms, uncontrolled hypertension, abnormal lipid metabolism.
Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia.
Severe hepatic dysfunction or active liver disease, a history of cholestatic jaundice or pruritus of pregnancy or previous or existing liver tumours (adenomas or carcinomas), Dubin-Johnson syndrome or Rotor syndrome.
Presence or history of liver tumours (benign or malignant).
Known or suspected sex steroid influenced malignancies (e.g. of the genital organs or the breasts).
Undiagnosed vaginal bleeding.
Known or suspected pregnancy.
History of herpes gestationis, a history of otosclerosis with exacerbation in pregnancy.
Combined oral contraceptives (COCs) are contraindicated for concomitant use with certain anti-viral hepatitis C virus (HCV) medicinal products such as glecaprevir, pibrentasvir, ombitasvir, paritaprevir, ritonavir and dasabuvir (see Section 4.4 Special Warnings and Precautions for Use, Hepatic neoplasia/liver disease/hepatitis C; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Hypersensitivity to any of the ingredients contained in Minulet.
Due to the vague symptomatology of many venous thromboembolic events, discontinuation of oral contraceptives and the provision of alternative contraception should be considered in cases of suspected thrombosis in patients on oral contraceptives, while diagnostic tests are being conducted.
In cases of an uncertain diagnosis of venous thromboembolic events, alternative contraceptive strategies should be discussed with the patient, as the event may represent a first signal of a thrombotic tendency associated with the use of the oral contraceptive.

4.4 Special Warnings and Precautions for Use

In the absence of the above contraindications, if any of the conditions/risk factors mentioned below are present, the benefits of Minulet should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start taking it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her doctor. The doctor should then decide whether Minulet should be discontinued.

Reasons for immediate discontinuation of Minulet.

1. The occurrence for the first time of migrainous headaches or the more frequent occurrence of unusually severe headaches.
2. Acute disturbances of vision, hearing or other perceptual disorders.
3. First symptoms of thromboembolism.
4. Development of jaundice (cholestasis), anicteric hepatitis or generalised pruritus.
5. Increase in epileptic seizures.
6. Significant rise in blood pressure.
7. Pregnancy (known or suspected).

Circulatory disorders.

Epidemiological studies have suggested an association between the use of combined oral contraceptives (COCs) containing ethinylestradiol and an increased risk of venous and arterial thrombotic and thromboembolic events, such as myocardial infarction, stroke, deep venous thrombosis, and pulmonary embolism. These events occur rarely in average risk women.
For any particular estrogen/progestogen combination, the dosage regimen prescribed should be one which contains the least amount of estrogen and progestogen that is compatible with a low failure rate and the needs of the individual patient.
Venous thrombosis and thromboembolism. The physician should be alert to the earliest manifestations of venous thrombotic and thromboembolic events disorders (e.g. pulmonary embolism, cerebrovascular insufficiency, cerebral haemorrhage, cerebral thrombosis, coronary occlusion, retinal thrombosis, mesenteric thrombosis). Should any of these occur or be suspected; the medicine should be discontinued immediately.

Risk of venous thromboembolism (VTE).

The use of any COC increases the risk of VTE compared with no use. The women considering using Minulet should be advised that her VTE risk is highest in the first ever year of use and that there is some evidence that the risk is increased when a COC is restarted after a break in use of 4 weeks or more.
The risk of VTE with the COC is greatest for products containing over 50 microgram of ethinylestradiol. There is less risk for products such as Minulet containing less than 35 microgram ethinylestradiol.
The decision to use any product other than one with the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with COCs, and how her current risk factors influence this risk. (See Table 1).
It is important that women understand that VTE associated with COC use is rare in average risk women. The risk in pregnancy (5-20 per 10,000 women over 9 months) and the risk in the postpartum period (45-65 per 10,000 women over 12 weeks) is higher than that associated with COC use.
However VTE is a serious condition and may be fatal in 1-2% of cases. Extremely rarely, thrombosis has been reported to occur in COC users in other blood vessels, e.g. hepatic, cerebral, mesenteric, renal or retinal veins and arteries.
The risk for venous thromboembolic complications in COC users may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see list below).
Minulet is contraindicated if a woman has multiple risk factors that put her at high risk of venous thrombosis. If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors, in this case her total risk of VTE should be considered. If the balance of benefits and risks is considered to be negative a COC should not be prescribed.

Risk factors for VTE.

The risk of venous thrombotic and thromboembolic events is further increased in women with conditions predisposing for venous thrombosis and thromboembolism. Examples of predisposing conditions for venous thrombosis and thromboembolism are:
Obesity (body mass index over 30 kg/m2). Risk increases substantially as BMI rises.
Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma.
Temporary immobilisation including air travel > 4 hours can also be a risk factor for VTE, particularly in women with other risk factors.
Positive family history (venous thromboembolism ever in a sibling or parent especially at a relatively early age e.g. before 50).
Biochemical factors activated protein C (APC) resistance (including factor V Leiden), antithrombin-III deficiency, protein C deficiency, protein S deficiency.
Other medical conditions associated with VTE: cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis), sickle cell disease.
Increasing age, particularly above 35 years.
Smoking.
Recent delivery or second trimester abortion.
In women at risk of prolonged immobilisation (including major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma), it is advisable to discontinue use of Minulet (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation. Another method of contraception should be used to avoid unintentional pregnancy. Antithrombotic treatment should be considered if Minulet has not been discontinued in advance.
If a hereditary predisposition to VTE is suspected, the woman should be referred to a specialist for advice before deciding about any COC use.
The increased risk of VTE during the postpartum period should be considered if restarting Minulet. Since the immediate postpartum period is associated with an increased risk of thromboembolism, combined oral contraceptives should be started no earlier than day 28 after delivery in a non-lactating woman, or second trimester abortion.
There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism.

Symptoms of VTE (deep vein thrombosis and pulmonary embolism).

Women should be informed of the symptoms of VTE and be advised to seek urgent medical attention if VTE symptoms develop and to inform the healthcare professional that she is taking a COC.
Symptoms of deep vein thrombosis (DVT) can include:
unilateral swelling of the leg and/or foot or along a vein in the leg;
pain or tenderness in the leg which may be felt only when standing or walking;
increased warmth in the affected leg; red or discoloured skin on the leg.
Symptoms of pulmonary embolism (PE) can include:
sudden onset of unexplained shortness of breath or rapid breathing;
sudden coughing which may be associated with haemoptysis;
sharp chest pain;
severe light headedness or dizziness;
rapid or irregular heartbeat.
Some of these symptoms (e.g. shortness of breath, coughing) are nonspecific and might be misinterpreted as more common or less severe events (e.g. respiratory tract infections).
Other signs of vascular occlusion can include sudden pain, swelling and slight blue discoloration of an extremity.
If the occlusion occurs in the eye symptoms can range from painless blurring of vision which can progress to loss of vision. Sometimes loss of vision can occur almost immediately.
Arterial thrombosis and thromboembolism.

Risk of arterial thromboembolism (ATE).

Epidemiological studies have associated the use of COCs with an increased risk for arterial thrombotic and thromboembolic events (e.g. myocardial infarction, angina pectoris, and cerebrovascular events, such as ischaemic and haemorrhagic stroke or TIA). Arterial thromboembolic events may be fatal.
The risk of arterial thrombotic and thromboembolic complications in COC users further increases in women with risk factors. Minulet is contraindicated if a woman has one serious or multiple risk factors for ATE that puts her at high risk of arterial thrombosis. If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors, in this case her total risk should be considered. If the balance of benefits and risks is considered to be negative a COC should not be prescribed.

Risk factors for ATE.

Caution must be exercised when prescribing COCs for women with risk factors for arterial thrombotic and thromboembolic events, such as:
increasing age, particularly above 35 years;
smoking;
hypertension;
hyperlipidaemias;
obesity.
positive family history (arterial thromboembolism ever in a sibling or parent especially at relatively early age e.g. below 50);
biochemical factors: hyperhomocysteinaemia and antiphospholipid antibodies (e.g. anticardiolipin antibodies, and lupus anticoagulant);
migraine;
other medical conditions associated with adverse vascular events: diabetes mellitus, hyperhomocysteinaemia, valvular heart disease, atrial fibrillation, dyslipoproteinaemia, systemic lupus erythematosus, history of pre-eclamptic toxaemia.
Oral contraceptive use by cigarette smokers increases the risk of cardiovascular disease. This risk increases with heavy smoking and advancing age and is quite marked in women over the age of 35 years. Women should be advised not to smoke if they wish to use a COC. Women over 35 years of age who continue to smoke should be strongly advised to use a different method of contraception.
If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any COC use.
An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation.

Symptoms of ATE.

Women should be informed of the symptoms of ATE and be advised to seek urgent medical attention if ATE symptoms develop and to inform the healthcare professional that she is taking a COC.
Symptoms of a stroke can include:
sudden numbness or weakness of the face, arm or leg, especially on one side of the body;
sudden trouble walking, dizziness, loss of balance or coordination;
sudden confusion, trouble speaking or understanding;
sudden trouble seeing in one or both eyes;
sudden, severe or prolonged headache with no known cause;
loss of consciousness or fainting with or without seizure.
Temporary symptoms suggest the event is a transient ischaemic attack (TIA).
The onset or exacerbation of migraine or development of headache of a new pattern that is recurrent, persistent, or severe requires discontinuation of the medicine and evaluation of the cause.
Women with migraine (particularly migraine with aura) who take combined oral contraceptives may be at increased risk of stroke.
Symptoms of myocardial infarction (MI) can include:
pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone;
discomfort radiating to the back, jaw, throat, arm, stomach;
feeling of being full, having indigestion or choking;
sweating, nausea, vomiting or dizziness;
extreme weakness, anxiety, or shortness of breath;
rapid or irregular heartbeats.

Medical examination/consultation.

A complete medical history and physical examination should be taken prior to the initiation or reinstitution of COC use, guided by the contraindications and precautions, and should be repeated at least annually during the use of COCs. A Papanicolaou (Pap) smear should be performed if the patient has been sexually active or if it is otherwise indicated. Pregnancy should be ruled out before the start of therapy. Baseline and periodic blood glucose determinations should be performed in patients predisposed to diabetes mellitus. Periodic medical assessment is also of importance because contraindications (e.g. a transient ischaemic attack, etc.) or risk factors (e.g. a family history of venous or arterial thrombosis) may appear for the first time during the use of a COC. The frequency and nature of these assessments should be adapted to the individual woman but should generally include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests such as urinalysis.
The woman should also be instructed to carefully read the user leaflet and to adhere to the advice given.

Elevated blood pressure.

An increase in blood pressure has been reported in women receiving oral contraceptives. In some women, hypertension may be evident within a few months of beginning use and the incidence increases with the duration of use and the age of the woman. A significant rise in blood pressure is a reason for immediate discontinuation of use of oral contraceptives.
In women with hypertension, or a history of hypertension or hypertension related diseases, another method of contraception may be preferable. If combined oral contraceptives are used in such cases, they should be monitored closely and if a significant elevation of blood pressure occurs, the medicine should be discontinued.
For most women, elevated blood pressure will generally return to baseline after stopping combined oral contraceptives, and there appears to be no difference in the occurrence of hypertension among ever and never users.
Combined oral contraceptive use is contraindicated in women with uncontrolled hypertension (see Section 4.3 Contraindications).

Angioedema.

Exogenous estrogens may induce or exacerbate symptoms of angioedema, particularly in women with hereditary angioedema.

Carcinoma of the reproductive organs.

Cervical cancer.

The most important risk factor for cervical cancer is persistent human papillomavirus infection.
Several epidemiological studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia or invasive cervical cancer. The studies suggest that there is an "ever used" effect in addition to duration of use. These findings must be balanced against evidence of effects attributable to sexual behaviour, smoking and other factors. In cases of undiagnosed abnormal genital bleeding, adequate diagnostic measures are indicated.

Breast cancer.

A meta-analysis from 54 epidemiological studies showed that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using combined oral contraceptives compared to never users. The increased risk gradually disappears during the course of the 10 years after cessation of combined oral contraceptive use. These studies do not provide evidence for causation. The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in combined oral contraceptive users (due to more regular clinical monitoring), the biological effects of combined oral contraceptives or a combination of both. Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent combined oral contraceptive users is small in relation to the lifetime risk of breast cancer. Breast cancers diagnosed in ever users tend to be less advanced clinically than the cancers diagnosed in never users.
Established risk factors for the development of breast cancer include increasing age, family history, obesity, nulliparity, and late age for first full term pregnancy.

Carbohydrate and lipid metabolic effects.

Glucose intolerance has been reported in combined oral contraceptive users. Women with impaired glucose tolerance or diabetes mellitus who use combined oral contraceptives should be carefully monitored (see Section 4.3 Contraindications). The requirement for insulin or oral antidiabetics can either increase or decrease. In general, the urine should be checked for sugar before the prescription of and at six month intervals during the use of oral contraceptives in prediabetic and diabetic patients.
A small proportion of women will have adverse lipid changes while taking oral contraceptives. Nonhormonal contraception should be considered in women with uncontrolled dyslipidaemias.
Persistent hypertriglyceridaemia may occur in a small proportion of oral contraceptive users. Elevations of plasma triglycerides in combined oral contraceptive users may lead to pancreatitis and other complications.
Estrogens increase serum high-density lipoproteins (HDL cholesterol), whereas a decline in serum HDL cholesterol has been reported with many progestational agents. Some progestogens may elevate low-density lipoprotein (LDL) levels and may render the control of hyperlipidaemias more difficult. The net effect of a COC depends on the balance achieved between doses of estrogen and progestogen and the nature and absolute amount of progestogens used in the contraceptive. The amount of both hormones should be considered in the choice of a COC.
Women who are being treated for hyperlipidaemias should be followed closely if they elect to use combined oral contraceptives.

Genital bleeding.

In some women withdrawal bleeding may not occur during the inactive tablet interval. If Minulet has not been taken according to directions prior to the first missed withdrawal bleed, or if two consecutive withdrawal bleeds are missed, tablet taking should be discontinued and a nonhormonal back-up method of contraception used until the possibility of pregnancy is excluded.
Breakthrough bleeding or spotting may occur in women taking combined oral contraceptives, especially during the first three months of use. If this bleeding persists or recurs, nonhormonal causes should be considered and adequate diagnostic measures may be indicated to rule out pregnancy, infection, malignancy, or other conditions. If pathology has been excluded, continuation of Minulet or a change to another formulation may solve the problem. Changing to a regimen with a higher estrogen content may be useful in minimising menstrual irregularity.
Some women may encounter postpill amenorrhoea (possibly with anovulation) or oligomenorrhoea, especially when such a condition was pre-existent.

Ocular lesions.

Optic neuritis and retinal vascular thrombosis, which may lead to partial or complete loss of vision, have been reported in association with oral contraceptive use. Oral contraceptives should be discontinued and the cause immediately evaluated if there are signs or symptoms such as visual changes; onset of proptosis, diplopia; papilloedema or retinal vascular lesions.

Gallbladder disease.

Earlier epidemiological studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. However, the results of more recent studies indicate the risk of gallbladder disease may be minimal.

Hepatic neoplasia/liver disease/hepatitis C.

In rare cases hepatic adenomas and in extremely rare cases, hepatocellular carcinoma may be associated with combined oral contraceptive use. The risk appears to increase with duration of combined oral contraceptive use. Rupture of hepatic adenomas may cause death through intra-abdominal haemorrhage.
If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occurs, differential diagnostic consideration should be given to the presence of a liver tumour.
Women with a history of combined oral contraceptive related cholestasis or women with cholestasis during pregnancy are more likely to have this condition with combined oral contraceptive use. If these patients receive a combined oral contraceptive they should be carefully monitored and, if the condition recurs, the combined oral contraceptive should be discontinued.
Hepatocellular injury has been reported with combined oral contraceptive use. Early identification of drug related hepatocellular injury can decrease the severity of hepatotoxicity when the drug is discontinued. If hepatocellular injury is diagnosed, patients should stop their combined oral contraceptive use, use a nonhormonal form of contraception and consult their doctor.
Acute or chronic disturbances of liver function require the discontinuation of combined oral contraceptive use until liver function has returned to normal (see Section 4.3 Contraindications).

Hepatitis C.

During clinical trials with patients treated for HCV infections with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, transaminase (ALT) elevations higher than 5 times the upper limit of normal (ULN) occurred significantly more frequently in women using ethinylestradiol-containing medications such as COCs. ALT elevations have also been observed with anti-viral HCV medicinal products including glecaprevir/pibrentasvir (see Section 4.3 Contraindications; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). Prescribers should consult the relevant anti-viral medicine product safety information. Patients taking a COC should therefore be switched to an alternative method of contraception (e.g. progestogen-only contraception or non-hormonal methods) prior to starting therapy.

Depression.

Women with a history of depression who use combined oral contraceptives should be carefully observed and the drug discontinued if depression recurs to a serious degree. Patients becoming significantly depressed while taking combined oral contraceptives should stop the medication and use an alternative method of contraception in an attempt to determine whether the symptom is drug related.

Sexually transmissible diseases.

Patients should be counselled that Minulet does not protect against HIV infection (AIDS) and other sexually transmissible diseases. The woman should be advised that additional measures are needed to prevent the transmission of STDs.

Vomiting and/or diarrhoea.

Diarrhoea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations (see Section 4.2 Dose and Method of Administration).

Other.

These agents may cause some degree of fluid retention. Women with cardiac or renal dysfunction or asthma require careful observation since these conditions may be exacerbated by the fluid retention, which may occur in users of oral contraceptives.
Serum folate levels may be depressed by oral contraceptive use. Women who became pregnant shortly after discontinuing these medicines may have a greater chance of developing folate deficiency and its complications. Folate supplementation may be required if a woman becomes pregnant shortly after ceasing tablet taking.

Moniliasis.

Women should be warned that vulvovaginal monilial infection may occur or recur, and of the need for appropriate treatment.

Adolescent women.

Estrogens may accelerate epiphyseal closure. Preferably they should not be prescribed before regular menstruation is established, and with discretion until bone growth is complete.

Use in the elderly.

Combined oral contraceptives are not indicated for use in postmenopausal women.

Paediatric use.

Safety and efficacy of combined oral contraceptives have been established in women of reproductive age. Use of these products before menarche is not indicated.

Effects on laboratory tests.

Estrogen containing preparations can affect many laboratory tests. Some examples are:
1. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin-III; increased noradrenaline induced platelet aggregability.
2. Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein bound iodine (PBI), T4 by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered.
3. Reduced response to metyrapone test.
The results of these tests should not be regarded as reliable until oral contraceptive use has been discontinued for 1-2 months. Abnormal tests should then be repeated.
Oral contraceptives may produce false positive results when neutrophil alkaline phosphatase activity is evaluated for the early diagnosis of pregnancy.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The prescribing information of concomitant medications should be consulted to identify potential interactions.
Interactions between ethinylestradiol and other substances may lead to decreased or increased ethinylestradiol concentrations, respectively.
Concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin, and medicinal products such as those containing glecaprevir/pibrentasvir may increase the risk of ALT elevations (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use, Hepatic neoplasia/liver disease/hepatitis C). Therefore, COC users must switch to an alternative method of contraception (e.g. progestogen-only contraception or non-hormonal methods) prior to starting therapy with anti-viral HCV medicinal products such as glecaprevir, pibrentasvir, ombitasvir, paritaprevir, ritonavir, dasabuvir. COCs can be restarted 2 weeks following completion of treatment with an anti-viral HCV medicinal product.

Drugs that may decrease ethinylestradiol concentrations.

Decreased ethinylestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the oral contraceptive.
Examples of substances that may decrease serum ethinylestradiol concentrations include any substance that reduces gastrointestinal transit time and, therefore, ethinylestradiol absorption, and substances that induce hepatic microsomal enzymes, such as anticonvulsants (phenytoin, primidone, barbiturates), rifampicin, rifabutin, griseofulvin, topiramate, modafinil, ritonavir, dexamethasone and some protease inhibitors, certain antibiotics (e.g. ampicillin and other penicillins, tetracyclines, chloramphenicol) and phenylbutazone.
Breakthrough bleeding has been reported in patients taking oral contraceptives and St John's wort (Hypericum perforatum). St John's wort may induce hepatic microsomal enzymes, which theoretically may result in reduced efficacy of oral contraceptives. If oral contraceptives and St. John's wort are used concomitantly, a nonhormonal backup method of birth control is recommended.
These have been reported to result in contraceptive failure, presumably by hepatic enzyme induction and/or reduced enterohepatic circulation of sex steroids due to changes in bowel flora.
During concomitant use of Minulet and substances that may lead to decreased ethinylestradiol serum concentrations, it is recommended that a nonhormonal back-up method of birth control (such as condoms and spermicide) be used in addition to the regular intake of Minulet. In the case of prolonged use of such substances combined oral contraceptives should not be considered the primary contraceptive.
After discontinuation of substances that may lead to decreased ethinylestradiol serum concentrations, use of a nonhormonal back-up method is recommended for at least 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have lead to induction of hepatic microsomal enzymes, resulting in decreased ethinylestradiol serum concentrations. It may sometimes take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use and rate of elimination of the inducing substance.
There have been reports of pregnancy when COCs were co-administered with certain antibiotics (e.g. ampicillin, other penicillins, tetracyclines).

Drugs that may increase ethinylestradiol concentrations.

Examples of substances that may increase ethinylestradiol concentrations include atorvastatin, competitive inhibitors for sulphation in the gastrointestinal wall, such as ascorbic acid and paracetamol and substances that inhibit cytochrome P450 3A4 isoenzymes such as indinavir, and fluconazole.

Effect of ethinylestradiol on the metabolism of other drugs.

Ethinylestradiol may interfere with the metabolism of other drugs by inhibiting hepatic microsomal enzymes, or by inducing hepatic drug conjugation, particularly glucuronidation. Accordingly, plasma and tissue concentrations may either be increased (e.g. ciclosporin, theophylline, corticosteroids) or decreased (e.g. lamotrigine).
Increased intermenstrual bleeding has been reported during concomitant administration of nitrofurantoin, phenoxymethyl penicillin and neomycin.

Drugs that may be affected by oral contraceptives.

Antidiabetic agents.

Oral contraceptives may impair glucose tolerance, and there may occasionally be a small increase in insulin requirements or oral antidiabetic agents. Diabetic women should be watched closely.

Anticoagulants.

The effectiveness of bishydroxycoumarin may be reduced (the use of oral contraceptives in patients with some form of clotting disorder would be contraindicated).
Estrogens may possibly inhibit the metabolism of tricyclic antidepressants such as imipramine and desmethylimipramine leading to increased plasma levels and accumulation.
Oral contraceptives may interfere with the oxidative metabolism of diazepam and chlordiazepoxide resulting in plasma accumulation of the parent compound. Women receiving these benzodiazepines on a long-term basis should be monitored for increased sedative effects.
Estrogens may enhance the effects of glucocorticoids.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

The first spontaneous ovulation after stopping oral contraceptives is sometimes delayed; and there is evidence of temporary impairment of fertility in some women who discontinue oral contraception, which appears to be independent of the duration of use. This has been observed more often in women with a history of oligomenorrhoea or secondary amenorrhoea. Impairment diminishes with time, but may be evident up to 30 months after cessation of oral contraception in nulliparous women. It should be suggested to women who decide to become pregnant that alternative methods of contraception be used until they have their first spontaneous period, so that the estimated date of delivery may be made with more certainty.
(Category B3)
Pregnancy must be excluded before starting Minulet. If pregnancy occurs during use of Minulet, the preparation must be withdrawn immediately.
Oral contraceptives have not been shown to have any deleterious effects on the fetus or to increase the incidence of miscarriage in women who discontinue their use prior to conception. However, in women who discontinue oral contraceptives with the intent of becoming pregnant, a nonhormonal method of contraception is recommended for three months before attempting to conceive.
Studies do not suggest a teratogenic effect when oral contraceptives are taken inadvertently during early pregnancy.
Animal studies have shown that high doses of progestogens can cause masculinisation of the female fetus. The results of these experiments in animals do not seem to be relevant to humans because of the low doses used in oral contraceptives.
The increased risk of VTE during the postpartum period (recent delivery or second trimester abortion) should be considered when restarting Minulet.
Small amounts of contraceptive steroids and/or metabolites have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. Lactation may be influenced by combined oral contraceptives as they may reduce the quantity and change the composition of breast milk. The use of combined oral contraceptives is generally not recommended until the nursing mother has completely weaned her child.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The most serious adverse reactions associated with the use of oral contraceptives are indicated, see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use.
Adverse reactions are listed in Table 2 per CIOMS frequency categories: Very common: ≥ 10%; common: ≥ 1% and < 10%; uncommon: ≥ 0.1% and < 1%; rare: ≥ 0.01% and < 0.1%; very rare: < 0.01%.
Use of combined oral contraceptives has been associated with an increased risk of the following.
Arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, venous thrombosis, transient ischaemic attack and pulmonary embolism.
Cervical intraepithelial neoplasia and cervical cancer.
Breast cancer diagnosis.
Benign hepatic tumours (e.g. focal nodular hyperplasia, hepatic adenomas).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Signs and symptoms.

Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females.

Recommended treatment.

There is no specific antidote and further treatment, if necessary is directed to the symptoms.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The hormonal components of Minulet inhibit ovulation by suppressing gonadotrophin release. Secondary mechanisms, which may contribute to the effectiveness of Minulet as a contraceptive, include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation). The Pearl index for Minulet is 0.06.

Noncontraceptive benefits.

In addition to providing protection against pregnancy, oral contraceptives have been reported to be associated with the following beneficial effects: a reduction in the incidence of benign breast disease; a reduction in iron deficiency anaemia; a reduction in the risk of endometrial carcinoma; a reduction in the incidence of ectopic pregnancy; a reduction in the incidence of pelvic inflammatory disease; a reduction in the incidence of ovarian cysts; a reduction in the incidence of dysmenorrhoea; a reduction in the severity of acne; a possible reduction in the incidence of ovarian carcinoma.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Ethinylestradiol and gestodene are rapidly and almost completely absorbed from the gastrointestinal tract.
Peak plasma levels of each drug are reached within 1-2 hours. Postmaximum concentration curves show two phases with half-lives of 1 and 15 hours in the case of gestodene, and 1-3 and approximately 24 hours in the case of ethinylestradiol.

Distribution.

Gestodene is extensively plasma protein bound to sex hormone binding globulin (SHBG). Ethinylestradiol is bound in plasma to albumin and enhances the binding capacity of SHBG.

Metabolism/excretion.

After oral administration, gestodene, unlike ethinylestradiol, is not subject to first-pass metabolism. Following oral administration, gestodene is completely bioavailable, ethinylestradiol about 40%.
The elimination half-life for gestodene is approximately 16-18 hours after multiple oral doses. The drug is primarily metabolised by reduction of the A ring followed by glucuronidation. About 50% of gestodene is excreted in the urine and 33% is eliminated in the faeces.
The elimination half-life for ethinylestradiol is approximately 25 hours. It is primarily metabolised by aromatic hydroxylation but a wide variety of hydroxylated and methylated metabolites are formed, and these are present both free and as conjugates with glucuronide and sulphate. Conjugated ethinylestradiol is excreted in bile and subject to enterohepatic recirculation. About 40% of the drug is excreted in the urine and 60% is eliminated in the faeces.

5.3 Preclinical Safety Data

Carcinogenicity.

Preclinical studies revealed an increased incidence of mammary and hepatic tumours in gestodene treated rats. The reason for such increases in tumour incidence is unknown. The relationship of this finding to the development of similar tumours in women using gestodene has not been established.

Genotoxicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

White active tablet.

Lactose monohydrate, maize starch, povidone, sodium calcium edetate, magnesium stearate, sucrose, calcium carbonate, purified talc, macrogol 6000, glycol montanate.

Red placebo tablet.

Lactose monohydrate, maize starch, povidone, sodium calcium edetate, magnesium stearate, sucrose, calcium carbonate, purified talc, macrogol 6000, glycol montanate, brilliant scarlet 4R, erythrosine.
Minulet does not contain gluten, tartrazine or any other azo dyes.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Three month pack containing three blisters:
One month pack containing 1 blister; two month pack containing 2 blisters; and four month pack containing 4 blisters are registered but not marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Chemically, ethinylestradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol and has the following structural formula.
Chemical Formula: C20H24O. Molecular Weight: 296.41. Melting Point: 181-185°C.
Ethinylestradiol is an estrogen.
Ethinylestradiol is a white to creamy white, odourless, crystalline powder. It is insoluble in water and soluble in alcohol, chloroform, ether, vegetable oils, and aqueous solutions of alkali hydroxides.
The chemical name for gestodene is 17α ethinyl-13-ethyl-17β-hydroxy-4, 15-gonadiene-3-one and has the following structural formula.
Chemical Formula: C21H26O2. Molecular Weight: 310.44. Melting Point: 196-202°C.
Gestodene is a progestogen, which is a gonane derivative.
Gestodene is a white to off-white crystalline powder that is easily soluble in chloroform and dioxane and soluble in acetone and methanol.

CAS number.

Ethinylestradiol.

57-63-6.

Gestodene.

60282-87-3.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes