SUMMARY CMI

VALETTE^®

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 VALETTE?

VALETTE contains the active ingredients dienogest and ethinylestradiol. VALETTE is used to prevent pregnancy. It is also used to treat mild to moderate acne in women seeking oral contraception.

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

2. What should I know before I use VALETTE?

Do not use if you have ever had an allergic reaction to dienogest and/or ethinylestradiol (the active ingredients in VALETTE) or any of the ingredients listed at the end of the CMI, if you're taking antiviral medicines, have or had a blood clot and other associated disorders. Do not use VALETTE if you have problems affecting your liver or pancreas or if you have cancers that grow under the influence of sex hormones.

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 VALETTE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with VALETTE 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 VALETTE?

• Take one tablet daily at about the same time each day. Swallow the tablet whole with a full glass of water.
• You must take VALETTE every day regardless of how often you have sex.
• If you vomit within 3-4 hours or have severe diarrhoea after taking a white active tablet, the active ingredients may not have been completely absorbed. This is like missing a tablet. Follow the advice for missed tablets.

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

5. What should I know while using VALETTE?

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

6. Are there any side effects?

Common side effects: nausea, vomiting or diarrhoea, stomach pain, changes in weight, increased appetite, headache/ migraines, mood changes, including depression, acne, hair loss, rash or itching, breast pain, breast enlargement or swelling, abnormal vaginal discharge or bleeding, signs of vaginal fungal or yeast infection (e.g. discharge and itching in the vagina), rash, itching, abnormal periods or painful periods, symptoms of ovarian cysts (e.g. pelvic pain, pain during sex), fatigue.

Serious side effects: signs of a blood clot, allergic reaction, rapid heartbeat, darkening of the skin or pigment patches on the skin, particularly of the face, breast lumps.

For more 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

VALETTE^® (VAL·ette)

Active ingredients: dienogest and ethinylestradiol

Consumer Medicine Information (CMI)

This leaflet provides important information about using VALETTE. 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 VALETTE.

Where to find information in this leaflet:

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

1. Why am I using VALETTE?

VALETTE contains the active ingredients dienogest and ethinylestradiol. VALETTE is combined oral contraceptive, commonly known as a ‘birth control pill’ or ‘the Pill’.

VALETTE is used to prevent pregnancy.

It is also used to treat mild to moderate acne in women seeking oral contraception.

You may also experience the following benefits:

• more regular and lighter periods potentially resulting in a decreased risk in anaemia (iron deficiency)
• a decrease in period pain
• reduction of greasiness in skin and hair

Some conditions such as pelvic inflammatory disease, ovarian cysts, ectopic pregnancy (where the foetus is carried outside of your womb), lumpy breasts and cancer of the uterus (womb) and ovaries may be less common in women taking VALETTE.

When taken correctly, it prevents you from becoming pregnant in several ways, including:

• inhibiting ovulation (egg release)
• changing the cervical mucus consistency, making it more difficult for the sperm to reach the egg

When the Pill is taken by women under close observation in clinical trials, it is more than 99% effective in preventing pregnancy. However, in real life the Pill is around 92% effective. This is because pills might be missed, or taken with medicines that may interfere with their effectiveness, or may not be absorbed due to vomiting and diarrhoea.

Like all oral contraceptives, VALETTE is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted infections.

2. What should I know before I use VALETTE?

Warnings

Do not use VALETTE if:

• you are allergic to dienogest and/or ethinylestradiol, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.
• you are taking any of the following medicines: antiviral medicines which contain glecaprevir, pibrentasvir, sofosbuvir, velpatasvir, voxilaprevir, ombitasvir, paritaprevir, or dasabuvir, and combinations of these. These antiviral medicines are used to treat chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus)
• you have, or have had a blood clot in:
  - the blood vessels of the legs (deep vein thrombosis - DVT)
  - the lungs (pulmonary embolism - PE)
  - the heart (heart attack)
  - the brain (stroke)
  - other parts of the body
• you are concerned about an increased risk of blood clots
• you have, or have had:
  - any blood clotting disorders such as Protein C deficiency, Protein S deficiency, Leiden Factor V mutation, Antithrombin III deficiency or other inherited blood clotting conditions
  - a confirmed blood test showing:
  -- increased levels of homocysteine
  -- antiphospholipid antibodies (APLAs) e.g. anticardiolipin-antibodies and lupus anticoagulant. These may increase your risk for blood clots or pregnancy losses (miscarriage)
  - major surgery after which you have not been able to move around for a period of time
  - angina (chest pain)
  - migraine, where you have also had problems with seeing, speaking or had weakness or numbness in any part of your body
  - high risk of blood clots due to conditions such as diabetes with blood vessel damage, severe high blood pressure or severe high or low level of fats in your blood
  - pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your blood
  - severe liver disease and your liver function has not returned to normal
  - cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs)
  - a benign or malignant liver tumour
  - unexplained vaginal bleeding

Check with your doctor if you:

• have any other medical conditions, such as:
  - heart valve disorders or certain heart rhythm disorders
  - high cholesterol or triglycerides
  - jaundice (yellowing of the skin) and/or pruritus (itching of the skin) related to cholestasis (condition in which the flow of bile from the liver stops or slows)
  - gall bladder disease
  - Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)
  - systemic lupus erythematosus (SLE – a disease affecting the skin all over the body)
  - haemolytic uraemic syndrome (HUS – a disorder of blood coagulation causing failure of the kidneys)
  - sickle cell disease
  - a condition that occurred for the first time, or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, a neurological disease called Sydenham's chorea)
  - chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face) – if so, avoid exposure to the sun or ultraviolet radiation
  - hereditary angioedema – you should see your doctor immediately if you experience symptoms of angioedema, such as swollen face, tongue and/or pharynx and/or difficulty swallowing, or hives together with difficulty in breathing
• take any medicines for any other condition
• smoke
• or anyone in your immediate family has had blood clots in the legs (DVT) or lungs (PE), a heart attack, a stroke, breast cancer or high cholesterol
• are overweight
• have intolerance to some sugars. VALETTE contains lactose (milk sugar).

If any of the above conditions appear for the first time, or recur or worsen while taking VALETTE, you should tell your doctor.

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

Do not take VALETTE if you are pregnant or think you might be pregnant. The possibility of pregnancy should be ruled out before starting VALETTE.

Talk to your doctor if you are breastfeeding or intend to breastfeed. VALETTE is generally not recommended if you are breastfeeding.

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/foods and VALETTE may interfere with each other. These include:

• medicines used to treat tuberculosis, such as rifampicin, rifabutin
• medicines used to treat epilepsy, such as phenytoin, primidone, barbiturates (e.g. phenobarbitone), carbamazepine, oxcarbazepine, topiramate, felbamate, lamotrigine
• medicines used to treat HIV, such as ritonavir or nevirapine
• some medicines used to treat hepatitis C virus (HCV), such as boceprevir, telaprevir, glecaprevir, pibrentasvir, ombitasvir, paritaprevir, dasabuvir
• macrolide antibiotics (e.g. clarithromycin, erythromycin)
• medicines used to treat fungal infections, such as ketoconazole, itraconazole, voriconazole, fluconazole and griseofulvin
• medicines used to treat depression such as nefazodone, fluvoxamine
• antacids such as cimetidine
• blood pressure medication such as diltiazem, verapamil
• etoricoxib, an anti-inflammatory medicine used to treat pain
• tizanidine, melatonin or midazolam which are medicines that relax the body
• theophylline, a medicine that helps with breathing
• cyclosporin, an immunosuppressant medicine
• herbal medicines containing St John's Wort
• grapefruit juice

These medicines/foods may be affected by VALETTE, or may affect how well it works. Your doctor may need to alter the dose of your medicine, or prescribe a different medicine.

You may need to use additional barrier methods of contraception (such as condoms or a diaphragm) while you are taking any of these medicines with VALETTE and for some time after stopping them.

Your doctor will be able to tell you how long you will need to use additional contraceptive methods.

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

4. How do I use VALETTE?

How much and when to take

• Take one tablet daily at about the same time each day. You must take VALETTE every day regardless of how often you have sex. This will also help you remember when to take it.
• Swallow the tablet whole with a full glass of water.
• It does not matter if you take it before or after food.
• Follow the instructions provided and use VALETTE until your doctor tells you to stop.

How to use VALETTE

• Take your first tablet from the green area on the blister pack corresponding to the day of the week.
• Follow the direction of the arrows on the blister pack until all the tablets have been taken.
• A period should begin 2-3 days after starting to take the brown inactive tablets (last row) and may not have finished before the next pack is started
• Always start a new blister pack on the same day of the week as your previous pack.
• If you vomit within 3-4 hours or have severe diarrhoea after taking a white active tablet, the active ingredients may not have been completely absorbed. This is like missing a tablet. Follow the advice for missed tablets.

Taking VALETTE for the first time

If you are starting VALETTE after a natural cycle, and you have not used a hormonal contraceptive in the past month, start on the first day of your period, i.e. on the first day of your menstrual bleeding.

You may also start on days 2 5 of your period, but in that case make sure you also use additional barrier contraceptive precautions (e.g. condom) for the first 7 days of tablet-taking.

Your doctor will advise you when to start if you:

• are taking VALETTE after having a baby
• have had a miscarriage or an abortion

Changing from another contraceptive

Changing from a combined oral contraceptive:

Start taking VALETTE on the day after taking the last active tablet in your previous Pill pack. Bleeding may not occur until the end of the first pack of VALETTE.

You can also switch to VALETTE after taking one or more inactive tablets in your previous Pill pack, but no later than the day after taking the last inactive tablet.

If you are not sure which were the active or inactive tablets in your previous Pill pack, ask your doctor or pharmacist. Your previous Pill pack may have different colour tablets to those of VALETTE.

Changing from a progestogen-only pill (‘minipill’):

Stop taking the minipill on any day and start taking VALETTE at the same time the day after you took your last minipill.

You must also use additional barrier contraceptive precautions (e.g. condoms or a diaphragm) for the first 7 days of tablet taking when having intercourse.

Changing from a progestogen-only injection, implant or intrauterine system (IUS):

Start taking VALETTE when your next injection is due, or on the day that your implant or IUS is removed.

You must also use additional barrier contraceptive precautions (e.g. condoms or a diaphragm) for the first 7 days of tablet taking when having intercourse.

Changing from a vaginal ring:

Start on the day of removal of the ring but at the latest when the next application would have been due.

Stopping VALETTE

You can stop taking VALETTE at any time. If you are considering becoming pregnant, it is recommended that you begin taking a vitamin supplement containing folic acid. It is best that you start taking folic acid tablets before you stop taking VALETTE and not stop until your doctor advises this. Ask your doctor or pharmacist about suitable supplements. It is both safe and recommended that you take folic acid during pregnancy.

If you forget to take VALETTE

If you miss a tablet and take the missed tablet within 12 hours of missing it, you should still be protected against pregnancy.

If you are more than 12 hours late follow these detailed instructions.

For VALETTE to be most effective, white active tablets need to be taken uninterrupted for 7 days.

If you have been taking the white active tablets for 7 uninterrupted days and miss a white active tablet, take the missed tablet as soon as you remember, then go back to taking your medicine as you would normally, even if this means taking two tablets in one day.

You will not need to use additional barrier contraceptive precautions.

The chance of pregnancy after missing a white active tablet depends on when you missed the tablet. There is a higher risk of becoming pregnant if you miss a tablet at the beginning or end of a pack.

If after taking your missed tablet you have less than 7 days of white active tablets left in a row, you should finish the active tablets in your pack but skip the brown inactive tablets and start a new pack with the white active tablets corresponding to the correct day of the week.

This is the best way to maintain contraceptive protection. However, you may not have a period until the end of the white active tablets of the second pack. You may have spotting or breakthrough bleeding on tablet-taking days.

If you have been taking the white active tablets for less than 7 days and miss a white active tablet, take the missed tablet as soon as you remember, then go back to taking your medicine as you would normally, even if this means taking two tablets in one day. In addition, you must also use additional barrier contraceptive precautions (e.g. condoms or a diaphragm) for the next 7 days.

If you have had sexual intercourse during that time, there is a possibility of pregnancy and you may need emergency contraception.

If you forget to take more than one white active tablet, seek advice from your doctor or pharmacist about what to do.

If you have had sexual intercourse in the week before missing your tablets, there is a possibility of becoming pregnant.

If you forget to take a brown inactive tablet, take it as soon as you remember and take the next tablet at the usual time.

You should still be protected against pregnancy because the brown tablets do not contain any active ingredients.

Please see the diagram at the end of this leaflet for “Summary of advice if you missed an active tablet more than 12 hours ago”.

Ask your doctor or pharmacist to answer any questions you may have.

If you take too much VALETTE

If you think that you have taken too much VALETTE, 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.

You may need urgent medical attention.

If you take several white active tablets at once, you may feel sick or vomit or may bleed from the vagina. Even girls who have not yet started to menstruate but have accidentally taken this medicine may experience such bleeding.

5. What should I know while using VALETTE?

Things you should do

• Tell any doctor, dentist or pharmacist you visit that you are using VALETTE.
• If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.
• Have regular check-ups with your doctor. When you are taking VALETTE, your doctor will tell you to return for regular check-ups, including getting a Cervical Screening Test. Your doctor will advise how often you need a Cervical Screening Test. A Cervical Screening Test can detect abnormal cells lining the cervix. Sometimes abnormal cells can progress to cancer.

Stop taking VALETTE and call your doctor straight away if you notice the following signs:

• one-sided 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
• sudden onset of unexplained shortness of breath or rapid breathing
• sudden coughing or coughing up of blood
• sharp chest pain or sudden severe pain in the chest which may increase with deep breathing
• severe light headedness or dizziness
• rapid or irregular heartbeat
• sudden pain, swelling and slight blue discoloration of an extremity
• 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, slurred speech or aphasia; sudden partial or complete loss of vision, double vision, painless blurring of vision which can progress to loss of vision
• sudden, severe or prolonged headache with no known cause
• loss of consciousness or fainting with or without seizure
• 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
• extreme weakness and anxiety

Surgery and prolonged immobilisation

If you are going to have surgery, tell the surgeon or anaesthetist beforehand that you are taking VALETTE.

The risk of having blood clots is temporarily increased as a result of major surgery, any surgery to the legs or pelvis, neurosurgery or major trauma. In women who take VALETTE, the risk may be higher.

In women at risk of prolonged immobilisation (including major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma), your doctor may tell you to stop taking (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. Your doctor may prescribe other treatment (e.g. treatment for blood clots) if VALETTE has not been discontinued in advance.

Temporary immobilisation

Other risk factors for blood clotting include temporary immobilisation including air travel of greater than 4 hours, particularly in women with other risk factors. Consult your doctor if you plan to air travel for more than 4 hours.

Consult your doctor if you develop high blood pressure while taking VALETTE – you may be told to stop taking it.

Pregnancy

If you become pregnant while taking this medicine, tell your doctor immediately.

Unexpected bleeding

If you have unexpected bleeding and it continues, becomes heavy, or occurs again, tell your doctor.

When taking these tablets for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary products, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to VALETTE, usually after about 3 months.

Period

If you have missed a period, but you have taken all your tablets, it is very unlikely that you are pregnant as long as:

• you have taken the white active tablets at the right time
• you have not been taking medicine(s) that may interfere with VALETTE
• you have not vomited or had severe diarrhoea during this cycle

If this is so, continue to take VALETTE as usual. If you have any concerns consult your doctor or pharmacist.

If you miss your period twice in a row, you may be pregnant even if you have taken VALETTE correctly. Stop taking VALETTE and seek advice from your doctor. You must use a non-hormonal method of contraception (such as condoms or a diaphragm) until your doctor rules out pregnancy.

Sexually transmitted infections (STIs)

VALETTE will not protect you from HIV-AIDS or any other Sexually Transmitted Infections (STIs), such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, human papilloma virus and syphilis.

To protect yourself from STIs, you will need to use additional barrier contraceptives (e.g. condoms).

Things you should not do

• Do not take VALETTE to treat any other conditions, unless your doctor tells you to.
• Do not give your medicine to anyone else.
  Do not stop taking this medicine or change the dosage without checking with your doctor. You may become pregnant if you are not using any other contraceptive and you stop taking VALETTE, or do not take a tablet every day.

Driving or using machines

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

Looking after your medicine

• Keep your tablets in the blister pack until it is time to take them.
• Keep your tablets in a cool dry place where the temperature stays below 30°C.

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.

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.

Less serious side effects

Serious side effects

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.

Blood clots and the Pill

Blood clots may block blood vessels in your body. This type of blood clot is also called thrombosis.

Blood clots sometimes occur in the deep veins of the legs (DVT). If a blood clot breaks away from the veins where it has formed, it may reach and block the blood vessels of the lungs, causing pulmonary embolism (PE).

Blood clots can also occur in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke).

Blood clots are a rare occurrence and can develop whether or not you are taking the Pill. They can also happen during pregnancy. The risk of having blood clots is higher in the Pill users than in non-users, but not as high as during pregnancy.

The risk of a blood clot is highest during the first year of taking VALETTE for the first time, or after having a break from VALETTE for 4 weeks or more.

If you notice possible signs of a blood clot, stop taking VALETTE and consult your doctor immediately.

To prevent pregnancy, you must also use additional barrier contraceptive precautions (e.g. condoms or a diaphragm).

If you are concerned about an increased risk of blood clots while on VALETTE, speak to your doctor.

Cancer and the Pill

Breast cancer has been diagnosed slightly more often in women who take the Pill than in women of the same age who do not take the Pill.

This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after women stop taking the Pill. It is not known whether the difference is caused by the Pill. It may be that these women were examined more often, so that the breast cancer was noticed earlier.

It is important that you check your breasts regularly and contact your doctor if you feel any lumps.

In rare cases benign liver tumours and, even more rarely, malignant liver tumours have been reported in users of the Pill. These tumours may lead to internal bleeding.

Contact your doctor immediately if you have severe pain in your abdomen.

Cervical cancer has been reported to occur more often in women who have been taking the Pill for a long time. This finding may not be caused by the Pill, but may be related to sexual behaviour and other factors.

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 VALETTE contains

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

VALETTE tablets do not contain gluten, tartrazine or azo dyes.

What VALETTE looks like

VALETTE comes in a box containing either 1 or 3 blister packs. Each blister pack contains 21 white active tablets and 7 brown inactive tablets. The blister pack is marked with days of the week next to each tablet (Aust R 122788).

Who distributes VALETTE

Bayer Australia Ltd
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073

See Bayer Australia website (www.bayer.com.au) for latest Australian Consumer Medicine Information.

Missed taking VALETTE?

See the end of this leaflet.

® Registered Trademark of Bayer AG, Germany
© Bayer Australia Ltd
All rights reserved.

This leaflet was prepared in August 2024.

Published by MIMS October 2024

1 Name of Medicine

Valette (dienogest and ethinylestradiol).

2 Qualitative and Quantitative Composition

Valette is a combined oral contraceptive (COC) preparation containing the synthetic progestogen, dienogest and the synthetic estrogen, ethinylestradiol as the active substances.
Valette tablets are contained in blister packs. Each blister contains 21 white active tablets containing dienogest 2 mg and ethinylestradiol 30 microgram, followed by 7 brown placebo tablets.

Excipients with known effect.

3 Pharmaceutical Form

The small active tablets are small round white glossy coated tablets.
The inactive tablets are large round brown coated tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

Valette is indicated for use as an oral contraceptive and in the treatment of mild to moderate acne in women who seek oral contraception.

4.2 Dose and Method of Administration

Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly.
Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet taking is continuous. One tablet is to be taken continuously for 28 consecutive days. Each subsequent pack is started the day after the last tablet of the previous pack. Withdrawal bleeding usually starts on day 2-3 after starting the brown placebo tablets (last row) and may not have finished before the next pack is started.

How to start Valette.

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

Changing from a combined hormonal contraceptive (COC) or vaginal ring.

Changing from a progestogen only method (minipill, injection, implant) or from a progestogen releasing intrauterine system (IUS).

Following first trimester abortion.

Following delivery or second trimester abortion.

Management of missed tablets.

Week 1.

Week 2.

Week 3.

Advice in case of gastrointestinal disturbances.

How to delay a period.

4.3 Contraindications

Combined oral contraceptive (COCs) including Valette, 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 COC use, the product should be stopped immediately.
Presence or risk of venous thromboembolism (VTE) (see Section 4.4 Special Warnings and Precautions for Use):
current VTE (on anticoagulants) or history of deep venous thrombosis [DVT] or pulmonary embolism [PE];
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.
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]);
known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (e.g. anticardiolipin-antibodies and lupus anticoagulant);
history of migraine with focal neurological symptoms;
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, severe hypertension, severe dyslipoproteinaemia.
Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
Valette is contraindicated for concomitant use with the medicinal products glecaprevir, pibrentasvir, sofosbuvir, velpatasvir, voxilaprevir, ombitasvir, paritaprevir or dasabuvir and combinations of these (see Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
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.
Hypersensitivity to any of the ingredients contained in Valette.

4.4 Special Warnings and Precautions for Use

If any of the conditions/ risk factors mentioned below are present, the benefits of Valette use 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 on whether Valette use should be discontinued.

Circulatory disorders.

Risk factors for VTE.

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

Risk factors for ATE.

Symptoms of ATE.

Tumours.

Other conditions.

Medical examination/ consultation.

Sexually transmitted infections (STIs) including human immunodeficiency virus (HIV) infections and AIDS.

Reduced efficacy.

Reduced cycle control.

Alanine transaminase (ALT) elevations.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Note.

Effect of other medicines on Valette.

Substances increasing the clearance of COCs (diminished efficacy of COCs by enzyme induction).

Substances with variable effects on the clearance of COCs.

Substances decreasing the clearance of COCs (enzyme inhibitors).

Effects of Valette on other medication.

Pharmacodynamic interactions.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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)

Various adverse effects have been associated with oral contraceptive use. The most serious adverse effects associated with the use of oral contraceptives are dealt with under Section 4.4 Special Warnings and Precautions for Use.
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 on whether its use should be discontinued.

Clinical trial data.

Infections and infestations.

Neoplasms benign, malignant and unspecified (incl. cysts and polyps).

Blood and lymphatic system disorders.

Endocrine disorders.

Metabolism and nutrition disorders.

Psychiatric disorders.

Nervous system disorders.

Eye disorders.

Ear and labyrinth disorders.

Cardiac disorders.

Vascular disorders.

Respiratory thoracic and mediastinal disorders.

Gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

Musculoskeletal and connective tissue disorders.

Reproductive system and breast disorders.

General disorders and administration site conditions.

Investigations.

Congenital familial and genetic disorders.

Postmarketing data.

Cardiovascular.

Genital tract.

Digestive.

Nervous system.

Musculoskeletal.

Respiratory tract.

Skin.

Eyes.

Metabolic.

Haemic and lymphatic.

Body as a whole.

Breast disorders.

Immune system disorders.

Special senses.

Reporting suspected adverse effects.

4.9 Overdose

There have been no reports of serious deleterious effects from overdose. On the basis of general experience with COCs, symptoms that may occur in case of overdose of active tablets are: nausea, vomiting and withdrawal bleeding. There are no antidotes and further treatment should be symptomatic. The later may occur in girls before their menarche, if they have accidentally taken the product.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Acne.

5.2 Pharmacokinetic Properties

Bioavailability studies have been conducted with Valette.

Dienogest.

Absorption.

Distribution.

Metabolism.

Excretion.

Steady state conditions.

Ethinylestradiol.

Absorption.

Distribution.

Metabolism.

Excretion.

Steady state conditions.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Valette tablets contain the following excipients: lactose monohydrate, maize starch, magnesium stearate, sucrose, liquid glucose, calcium carbonate, povidone, macrogol 35000, carnauba wax, maltodextrin and titanium dioxide.
Each placebo tablet contains: lactose monohydrate, maize starch, purified talc, magnesium stearate, povidone, sucrose, macrogol 6000, calcium carbonate, titanium dioxide, glycerol, ferric oxide, glycol montanate.

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 30°C.
Keep the blister in the outer carton. Protect from light.

6.5 Nature and Contents of Container

Valette tablets are contained in blister packs. Each blister contains 21 white active tablets containing dienogest 2 mg and ethinylestradiol 30 microgram, followed by 7 brown placebo tablets.
Blister packs are PVC/Al blister pack.
Carton containing blister packs of 1 x 28, 2 x 28, 3 x 28 or 4 x 28 tablets. Not all pack sizes may be 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.

Dienogest.

CAS number.

Chemical structure.

Ethinylestradiol.

CAS number.

References

1. Dinger JC, Heinemann LA, Kuhl-Habich D. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance study on Oral Contraceptives based on 142,475 women-years of observation. Contracept 2007; 75:344-54.
2. Heit JA, Kobbervig CE, James AH et al. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30 year population based study. Ann Intern Med. 2005; 143:697-706.

7 Medicine Schedule (Poisons Standard)

Prescription Medicine.

Summary Table of Changes