Consumer medicine information

Noriday 28 Day

Norethisterone

BRAND INFORMATION

Brand name

Noriday 28-Day

Active ingredient

Norethisterone

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Noriday 28 Day.

SUMMARY CMI

NORIDAY® 28 DAY

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 NORIDAY 28 DAY?

NORIDAY 28 DAY contains the active ingredient norethisterone. NORIDAY 28 DAY is used to prevent pregnancy.

For more information, see Section 1. Why am I using NORIDAY 28 DAY? in the full CMI.

2. What should I know before I use NORIDAY 28 DAY?

Do not use if you have ever had an allergic reaction to norethisterone, or any other similar oral contraceptives, 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 NORIDAY 28 DAY? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with NORIDAY 28 DAY 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 NORIDAY 28 DAY?

  • Take one tablet at the same time every day, regardless of whether you have sex.
  • See the full CMI for instructions on how to start taking NORIDAY 28 DAY for the first time.

More instructions can be found in Section 4. How do I use NORIDAY 28 DAY? in the full CMI.

5. What should I know while using NORIDAY 28 DAY?

Things you should do
  • Remind any doctor, dentist, or pharmacist you visit that you are using NORIDAY 28 DAY.
  • Tell your doctor immediately if you become pregnant while taking NORIDAY 28 DAY.
  • 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 NORIDAY 28 DAY 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 NORIDAY 28 DAY affects you before you drive or use machines. NORIDAY 28 DAY may cause dizziness in some people.
Looking after your medicine
  • Keep NORIDAY 28 DAY in a cool, dry place where the temperature stays below 25°C.
  • Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack, they may not keep well.

For more information, see Section 5. What should I know while using NORIDAY 28 DAY? in the full CMI.

6. Are there any side effects?

Common side effects include changes to your bleeding patterns, 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), significant rise in blood pressure, worsening of existing conditions such as porphyria.

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

NORIDAY® 28 DAY

Active ingredient(s): norethisterone

Consumer Medicine Information (CMI)

This leaflet provides important information about using NORIDAY 28 DAY. 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 NORIDAY 28 DAY.

Where to find information in this leaflet:

1. Why am I using NORIDAY 28 DAY?
2. What should I know before I use NORIDAY 28 DAY?
3. What if I am taking other medicines?
4. How do I use NORIDAY 28 DAY?
5. What should I know while using NORIDAY 28 DAY?
6. Are there any side effects?
7. Product details

1. Why am I using NORIDAY 28 DAY?

NORIDAY 28 DAY contains the active ingredient norethisterone. NORIDAY 28 DAY is a birth control pill commonly known as a "progestogen-only" pill or "mini pill". NORIDAY 28 DAY is used to prevent you from becoming pregnant.

NORIDAY 28 DAY is usually given to women who are unable to take other types of birth control pills (oral contraceptives) or use intrauterine devices (IUDs).

NORIDAY 28 DAY causes changes to the mucus of the cervix and the lining of the womb and affects the hormonal control system of the body, which may all contribute to the birth control (contraceptive) action.

The effectiveness of the "progestogen-only" pill is lower than that of other birth control pills.

If taken according to directions it is expected that if 100 women used the progestogen-only pill for 1 year approximately 4 pregnancies may occur compared to less than 1 pregnancy in women using an oral contraceptive containing an estrogen and progestogen.

Your doctor may have prescribed NORIDAY 28 DAY for another reason.

Ask your doctor if you have any questions about why NORIDAY 28 DAY has been prescribed for you.

2. What should I know before I use NORIDAY 28 DAY?

Warnings

Do not use NORIDAY 28 DAY if:

  • You are allergic to norethisterone, or any of the ingredients listed at the end of this leaflet.
    Some of the symptoms of 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.
  • You have, or have had, any of the following conditions:
    - a stroke or heart attack
    - inflammation, infection or clotting in any blood vessel(s), including a clot in the lung
    - liver disease (including tumours of any type), a history of jaundice or cholestatic jaundice of pregnancy or severe generalised itch in the body during pregnancy; Dubin-Johnson Syndrome or Rotor Syndrome
    - sickle cell anaemia
    - lipid metabolism disorders
    - a history of herpes of pregnancy
    - otosclerosis (an ear disorder) which worsened in past pregnancies
    - a family history of breast nodules, fibrocystic disease or have had an abnormal mammograph.
    - cancer or suspected cancer of the breast or sex organs (e.g. cervix, vagina, ovaries, womb) or known or suspected estrogen-dependent tumours
    - abnormal vaginal bleeding, the cause of which is unknown
  • You are pregnant or suspect that you may be pregnant
  • You have not had your first period

Check with your doctor if you:

  • Take any medicines for any other condition
  • Are a heavy smoker (15 or more cigarettes per day), especially if you are aged over 35 years.
    Oral contraceptives increase your risk of having a stroke or heart attack. Smoking while taking oral contraceptives further increases this risk.
  • You or anyone in your immediate family has, or has had blood clots in the legs or lungs
  • Are overweight, has recently had or are planning to undergo major surgery, or are confined to bed for long periods of time
  • Have, or have had, any other medical conditions, such as:
    - liver, kidney or heart disease
    - high blood pressure
    - high cholesterol
    - diabetes
    - epilepsy
    - asthma
    - migraine
    - depression
  • Are lactose intolerant. This medicine contains lactose.

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.

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

Small amounts of the drug are found to be excreted into breast milk and there are rare reports of adverse effects on the nursing child, including jaundice.

Your doctor can discuss the risks and benefits involved with you.

Long-term use

The effects of long-term use of "progestogen-only" pills are not known, therefore women should be aware of the serious side effects which have occurred with other oral contraceptives known as "Combined Oral Contraceptives" (contraceptives that contain estrogen and progestogen hormones).

The most serious known side effect with Combined Oral Contraceptive use is abnormal blood clotting and the increased risk of a woman having a heart attack.

See further information under Section 6. Are there any side effects?

Medical check ups

Before you start to take NORIDAY 28 DAY 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 NORIDAY 28 DAY and affect how well it or the other medicine works. This may lead to unwanted side effects, reduce the effect of NORIDAY 28 DAY and/or the other medicine.

These medicines include:

  • Rifampicin for the treatment of tuberculosis.
  • Medicines used to treat epilepsy or fits such as barbiturates, primidone, phenytoin and carbamazepine.
  • Antibiotics such as ampicillin
  • Anti-fungal agents such as griseofulvin.
  • St John's Wort, an ingredient found in medicines you can purchase without a prescription from a pharmacy, supermarket or health food shop.
  • Some antiviral medicines (including protease inhibitors) used in the treatment of HIV/AIDS and hepatitis C
  • Antacids used for indigestion or heartburn
    Antacids may decrease the absorption of NORIDAY 28 DAY. If you need to take an antacid while on NORIDAY 28 DAY, you should take these medicines at least 2 hours apart.

Your doctor will advise you if you need to take extra contraceptive precautions for the time that you are taking these medicines or if you have recently stopped taking these medicines.

This is particularly important if you need to take antibiotics or medicines for epilepsy.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect NORIDAY 28 DAY.

4. How do I use NORIDAY 28 DAY?

How much to take

  • Take one tablet every day.
  • Follow the instructions provided and use NORIDAY 28 DAY until your doctor tells you to stop.

When to take NORIDAY 28 DAY

  • NORIDAY 28 DAY should be taken at the same time every day regardless of whether you have sex.

How to take NORIDAY 28 DAY

  • Swallow one NORIDAY 28 DAY tablet with a glass of water.

How to start taking NORIDAY 28 DAY for the first time:

  • To begin NORIDAY 28 DAY, take your first tablet on the first day of your next period, that is, the day your bleeding begins.
  • Take your first tablet from the top row of the strip. Take the tablet which corresponds to the appropriate day of the week. For example, if your first day of bleeding is on TUESDAY, you should take the tablet marked "TUE" from the top row.
  • Continue to take one tablet every day, following the arrows around the strip, until you finish all 28 tablets.
  • When you have finished your first strip of tablets start the next strip the following day by taking a white tablet from the top row that matches the day of the week.
  • Repeat this sequence of tablet taking for as long as birth control is required. Continue taking the tablets whether you have a period or not.
  • During the first two weeks of the course only, it is important to use an additional non-hormonal birth control method to provide added protection (such as condoms or a diaphragm with contraceptive gel, but not the rhythm or temperature methods).
  • Make sure you always have a new strip of tablets available so that you can continue to take the tablets without interruption.

Switching to NORIDAY 28 DAY from another 21 or 28 Day oral contraceptive:

See your doctor or pharmacist for directions.

If you vomit or have diarrhoea after taking NORIDAY 28 DAY

If you suffer from a stomach upset which results in vomiting or diarrhoea, the effectiveness of NORIDAY 28 DAY will be reduced.

During any period of vomiting or diarrhoea, continue taking NORIDAY 28 DAY tablets. Also use a non-hormonal method of contraception (such as condoms or a diaphragm with contraceptive gel, but not the rhythm or temperature methods) until your next period occurs.

If you forget to take NORIDAY 28 DAY

NORIDAY 28 DAY should be taken 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.

If you miss a tablet:

  • If you are less than 3 hours late in taking your tablet, you should take that tablet at once and then take the next one at the usual time.
  • If you are more than 3 hours late in taking your tablet, still take the tablet, but an additional non-hormonal method of contraception must also be used until your next period occurs (such as condoms or a diaphragm with contraceptive gel, but not the rhythm or temperature methods).

If you miss two or more tablets:

  • Stop taking NORIDAY 28 DAY immediately and use a non-hormonal method of birth control (such as condoms or a diaphragm with contraceptive gel, but not the rhythm or temperature methods).
  • Continue this until your period has occurred or until your doctor has confirmed that you are not pregnant.
  • When you begin taking NORIDAY 28 DAY again, start the tablets from a new strip and follow the instructions as if starting NORIDAY 28 DAY therapy for the first time.
  • During the first 2 weeks of this first course only, it is important to use an additional non-hormonal method of contraception (such as condoms or a diaphragm with contraceptive gel, but not the rhythm or temperature methods).

If your doctor has told you to take NORIDAY 28 DAY differently, or you are unclear about the above directions, discuss this with them.

If you have trouble remembering to take your tablets, ask your pharmacist for some hints.

If you take too much NORIDAY 28 DAY

If you think that you have taken too much NORIDAY 28 DAY, 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.

Overdosage may cause nausea, breast tenderness, dizziness and/or fatigue. This may be followed by vaginal bleeding in some women.

5. What should I know while using NORIDAY 28 DAY?

Things you should do

  • Tell all doctors, dentists and pharmacists who are treating you that you are taking NORIDAY 28 DAY.
  • Tell the hospital doctor that you are taking NORIDAY 28 DAY birth control pills if you need to have an operation or go to hospital in an emergency.
  • If you are about to be started on any new medicine, tell your doctor or dentist and your pharmacist that you are taking NORIDAY 28 DAY.
  • Tell your doctor if you feel depressed, think you are retaining water, experience headaches or experience persistent or recurrent irregular bleeding.
    Your doctor will assess your condition and advise whether or not you should continue to take NORIDAY 28 DAY.
  • If you are about to have any blood tests, tell your doctor you are taking NORIDAY 28 DAY. It may interfere with the results of some tests.

Missed periods

  • If you have taken all the tablets correctly, you should not be concerned if you have missed a period. Continue to take your tablets as usual.
  • However, if you have missed two periods, you should stop taking NORIDAY 28 DAY immediately and use a non-hormonal method of birth control (such as condoms or a diaphragm with contraceptive gel, but not the rhythm or temperature methods).
    Continue this until your doctor has confirmed that you are not pregnant.
  • If you have missed taking one or more tablets or have not taken them correctly and have not had a period within 6 weeks of your last period, you should stop taking the tablets immediately and use another non-hormonal method of birth control (such as condoms or a diaphragm with contraceptive gel, but not the rhythm or temperature methods).
    Continue this until your doctor has confirmed that you are not pregnant.

Call your doctor straight away if you:

  • Become pregnant, or think you are pregnant, while taking NORIDAY 28 DAY.

Things to be aware of

  • Slight breast tenderness or a feeling of sickness may occur in the first few months of use. This usually improves or stops with continued use.
  • If vaginal irritation or discharge occurs, it may be an indication of yeast infection for which treatment is available from your doctor.
  • Women who take NORIDAY 28 DAY may find a change in the pattern of their period. Changes may occur to the amount of flow as well as the duration of the period. A change in length of your menstrual cycle may also occur.
    See your doctor if such bleeding persists, or if heavier bleeding occurs.

Medical check up

  • Visit your doctor regularly for check-ups, including blood pressure, breast, abdomen and pelvic organs checks including a Pap smear and urine tests.
  • A Pap smear can detect any abnormal cells from the cervix, which may develop into cancer. Cervical cancer has been reported to occur more frequently in women who use oral contraceptives.
  • Your doctor will advise you of the type and frequency of any tests required.

Breast cancer risk

  • Perform regular, breast self-examination.
    Examining your breasts for lumps or any changes in size or shape can help you find a breast cancer early. Breast cancer has been found more frequently in women who use oral contraceptives. It is not known whether this increase is caused by the use of oral contraceptives, or if it is due to the fact that users were examined more often, and therefore the breast cancer was detected earlier.
    If you are unsure, ask your doctor about breast self-examination.

Sexually transmitted disease (STD)

  • If you are worried about contracting a sexually transmitted disease (STD) use a barrier contraceptive method.
  • NORIDAY 28 DAY does not protect against the transmission of STDs such as HIV-AIDS, chlamydia, genital herpes and warts, gonorrhoea, hepatitis B or human papilloma virus. To protect against STDs, ask your partner to wear a condom when having sexual intercourse with you.

Things you should not do

  • Do not take NORIDAY 28 DAY if the packaging is torn or shows signs of tampering.
  • Do not use this medicine after the expiry date. If it is expired or is damaged, return it to your pharmacist for disposal. NORIDAY 28 DAY may have no effect at all, or worse, have an entirely unexpected effect, if you take it after the expiry date.
  • Do not stop taking NORIDAY 28 DAY, or change the dosage, without checking with your doctor.
    If you stop taking NORIDAY 28 DAY or do not take a tablet every day, without using another form of contraception, you may become pregnant.
  • Do not smoke while you are taking oral contraceptives.
    Cigarette smoking increases the risk of blood clotting and damage to the heart and blood vessels from birth control pills. The risk increases with age and with heavy smoking (15 or more cigarettes per day), especially in women over 35 years of age.
  • Do not stop taking your tablets if a full monthly period or slight spotting starts before all tablets have been taken. Slight spotting during tablet taking is normally of no significance.
    See your doctor if bleeding persists, or if heavier bleeding occurs.
  • Do not take NORIDAY 28 DAY past the expiry date shown on the label.
    If you take the tablets after the expiry date has passed, they may not work as well.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how NORIDAY 28 DAY affects you.

NORIDAY 28 DAY may cause dizziness in some people.

Drinking alcohol

No information available.

Looking after your medicine

  • Keep your NORIDAY 28 DAY tablets in a dry place, at a temperature below 25°C.
  • Do not keep your tablets in the refrigerator.

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.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

After stopping NORIDAY 28 DAY

Delays in becoming pregnant may occur after NORIDAY 28 DAY therapy is stopped. This is more likely to occur in women whose periods were irregular before using birth control pills.

See your doctor if you continue to experience difficulties in falling pregnant.

When to discard your medicine

If your doctor tells you to stop taking NORIDAY 28 DAY or if the tablets have passed their expiry date, ask your pharmacist what to do with any that are 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. 

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.

Since the effects of long-term use of "progestogen-only" pills are not known, women should be aware of the serious side effects which have occurred with other oral contraceptives known as "Combined Oral Contraceptives". The "Combined Oral Contraceptives" contain estrogen and progestogen hormones.

The most serious known side effect with Combined Oral Contraceptive use is abnormal blood clotting which may have serious consequences. Deaths have occurred in some women as a result of blood clots carried by the blood stream causing obstruction of blood vessels in the lungs or in the brain. The risk of developing blood clotting disorders and other blood vessel diseases in oral contraceptive users increases with age from 30 years onwards. Cigarette smoking also increases the risk. These problems may persist after a woman has stopped taking the birth control pill.

The use of a Combined Oral Contraceptive can increase the risk of a woman having a heart attack. Other risk factors for a heart attack include cigarette smoking, high blood pressure, high cholesterol, obesity, diabetes, a history of pre-eclamptic toxaemia in pregnancy and age over 40 years.

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

Side effectsWhat to do
Reproductive or breast problems:
  • pain or bleeding after intercourse
  • break-through bleeding
  • spotting
  • change in menstrual flow
  • absence of periods
  • changes in cervical secretions
  • discharge, itching, pain in the vaginal area, or changes in vaginal secretions
  • breast changes (pain, tenderness, enlargement or secretion)
  • reduced sex drive
Stomach problems, such as:
  • changes in appetite
  • gastric or stomach discomforts including abdominal pain, cramps, nausea and vomiting
Difficulties thinking or working because of:
  • Dizziness, tiredness, nervousness
  • changes in mood, including depression
  • feeling very thirsty, dry mouth, frequently needing to urinate
Changes to your appearance such as:
  • change in weight
  • retention of fluids
  • acne
  • dark discolouration of the skin
  • blotchy discolouration on the face or arms or legs (which may persist after the tablets have been stopped)
  • rash (with or without itching)
  • excessive hair growth or hair loss

NORIDAY 28 DAY may also impact the results of your cholesterol and liver function tests.

Speak to your doctor if you have any of these side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Reproductive problems:
  • effects on the development of your foetus
Worsening of your existing conditions such as:
  • porphyria (a group of disorders that can cause skin or nerve problems)
Pain or discomfort:
  • sharp, one-sided abdominal pain
  • unexplained or persistent pains in the head, chest, stomach or legs
  • severe pain, swelling or discolouration in either of your legs
Problems with your eyes or eyesight:
  • gradual or sudden, partial or complete loss of vision
  • double vision, or symptoms of severe vision impairment
  • eye protrusion, swelling of the eye or eye lesions
Migraines:
  • migraine headaches for the first time
  • more frequent or severe migraines if you already suffer from them
Changes to your body:
  • breast lumps
  • jaundice or a yellowing of the skin or eyes, often with fever, fatigue, loss of appetite, dark coloured urine, nausea and vomiting. Taking oral contraceptives may be associated with liver disease, including liver cancer.
  • swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.
  • rise in blood pressure
    You may experience headache, blurred vision or palpitations. Sometimes your blood pressure may rise without you experiencing any symptoms. It is important to keep your routine doctor's appointments so that you blood pressure can be checked.
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.

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.

You may wish to discuss these, or any of the side effects listed above, with your doctor if you are concerned.

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 NORIDAY 28 DAY contains

Active ingredient
(main ingredient)		norethisterone 350 micrograms (mcg)
Other ingredients
(inactive ingredients)
  • magnesium stearate
  • povidone
  • maize starch
  • lactose monohydrate

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

NORIDAY 28 DAY does not contain sucrose, gluten or tartrazine.

What NORIDAY 28 DAY looks like

NORIDAY 28 DAY is available in calendar packs consisting of four strips of tablets (4 months' supply) each with 28 white tablets marked "SEARLE" on one side and "NY" on the other. (AUST R 10052).

Who distributes NORIDAY 28 DAY

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

This leaflet was prepared in November 2023.

Published by MIMS January 2024

BRAND INFORMATION

Brand name

Noriday 28-Day

Active ingredient

Norethisterone

Schedule

S4

 

1 Name of Medicine

Norethisterone.

2 Qualitative and Quantitative Composition

Each Noriday tablet contains 0.35 mg norethisterone.

Excipients with known effect.

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

3 Pharmaceutical Form

Tablets.
Noriday tablets are available as round white tablets marked "SEARLE" on one side and "NY" on the reverse in "calendar" packs of 28 tablets in PVC/aluminium blister.

4 Clinical Particulars

4.1 Therapeutic Indications

Noriday is an oral contraceptive for women who will not or cannot tolerate other oral contraceptives or intrauterine devices.

Advice to the patient.

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

4.2 Dose and Method of Administration

One Noriday 0.35 mg tablet should be taken daily, at about the same time each day, starting on the first day of menstruation. Tablets should be taken continuously, without interruption, whether bleeding occurs or not. This is especially important for patients new to progestogen-only oral contraception. Each subsequent pack is started on the day after the previous pack is finished.
If a tablet is missed and there is a delay of more than 3 hours after the normal time of taking the tablet, protection is reduced and additional means of contraception should be used along with Noriday until menstrual bleeding occurs. The patient should be advised that if prolonged bleeding occurs, she should consult her physician.
If the patient has missed 1 or 2 tablets and does not have a period within 6 weeks of the last period, she should stop taking Noriday and use another method of nonhormonal contraception until pregnancy has been ruled out. If more than 2 tablets have been missed, Noriday should be discontinued immediately and a method of nonhormonal contraception should be used until menses has occurred or pregnancy has been excluded. Alternatively, if the patient has taken the tablets correctly, and if menses does not appear within 60 days from the last period, a method of nonhormonal contraception should be substituted until pregnancy is ruled out. The possibility of pregnancy should be considered before tablet-taking is resumed if three or more tablets have been missed.
Noriday may be prescribed in the postpartum period either immediately or at the first postpartum examination whether or not menstruation has resumed.

4.3 Contraindications

Thrombophlebitis, thromboembolic disorders, cerebral vascular disease, myocardial infarction, or a history of these conditions.
Patients with liver disease or history of cholestatic jaundice of pregnancy and in Dubin-Johnson Syndrome or Rotor Syndrome.
Hepatic adenomas or carcinomas.
Known or suspected carcinoma of the breast and/or genital organs, or known or suspected hormone-dependent neoplasia.
Undiagnosed abnormal genital bleeding.
Known or suspected pregnancy.
Sickle cell anaemia.
Disturbed lipid metabolism.
History of herpes of pregnancy.
Otosclerosis with deterioration in previous pregnancy.
Hypersensitivity to any component of the product.

4.4 Special Warnings and Precautions for Use

The effects of long-term use with low dose single progestogen therapy remain to be determined. Until then, the same precautions (outlined below) associated with oestrogen-progestogen combination therapy should apply to progestogen-only contraceptives.

General.

Before prescribing oral contraceptives, a complete medical family history and physical examination is desirable. The pre-treatment and periodic physical examinations should include special reference to blood pressure, breasts, abdomen and pelvic organs, including Papanicolaou smear and laboratory tests. Such medical examinations should be repeated periodically during the use of progestogen-only contraceptives.
The effectiveness of progestogen only oral contraceptives, such as Noriday, is lower than that of the sequential or combination oral contraceptives containing both oestrogen and progestogen. If 100 women utilised an oestrogen containing oral contraceptive for a period of 1 year, generally less than 1 pregnancy would be expected to occur; however, if Noriday had been utilised approximately 4 pregnancies might occur.
An alteration in menstrual patterns in many patients is likely to be induced by using continuous progestogens. The amount and duration of flow, and cycle length, will probably be quite variable; therefore, the physician should be alert to the possibility of other causes of irregular genital bleeding and consider adequate diagnostic measures. The patient should be advised that if prolonged bleeding occurs she should consult her physician. If one menstrual period is missed and the progestogen-only contraceptive has not been taken according to directions, or if two consecutive menstrual periods are missed, the possibility of pregnancy should be evaluated. In addition, a non-hormonal backup method of contraception should be used.
The efficacy of Noriday may be affected when absorption is impaired by vomiting or diarrhoea. If in doubt about the absorption of a tablet, the patient should be advised to treat the incident as a missed tablet (see Section 4.2 Dose and Method of Administration).

Thromboembolic disorders.

An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. The physician should be alert to the earliest manifestations of thrombotic and thromboembolic disorders, e.g. thrombophlebitis, cerebrovascular disorders (including haemorrhage), myocardial infarction, pulmonary embolism, mesenteric thrombosis and retinal thrombosis. Should any of these occur or be suspected, the drug should be discontinued immediately.
A two to six fold increase in relative risk of post-operative thromboembolic complications has been reported with the use of oral contraceptives, therefore, the physician should consider discontinuing therapy at least six weeks prior to and two weeks after elective surgery. It is also recommended that oral contraceptive therapy should be discontinued during prolonged periods of bed rest.
Care should be used when prescribing progestogen-only contraceptives to women predisposed to thromboembolic disorders (e.g. a history of thromboembolic events, thrombophilia, cardiovascular disease or women who are obese or experience prolonged immobilisation).

Myocardial infarction.

An increased risk of myocardial infarction and transient ischaemic attack associated with the use of oral contraceptives has been reported confirming a previously suspected association. Studies found that the greater the number of underlying risk factors for coronary artery disease (cigarette smoking, hypertension, hypercholesterolaemia, obesity, diabetes, history of pre-eclamptic toxaemia) the higher the risk of developing myocardial infarction, regardless of whether the patient was an oral contraceptive user or not. Oral contraceptives, however, were found to be an additional factor. As the risk of myocardial infarction is substantially increased in women aged 40 or over, the use of oral contraceptives in women of this age group is not recommended.
In terms of relative risk, it has been estimated that oral contraceptive users who do not smoke (smoking is considered a major predisposing condition to myocardial infarction) are about twice as likely to have a fatal myocardial infarction as non-users who smoke.

Cigarette smoking.

Cigarette smoking increased the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use. The risk increases with age particularly after 30 years and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should not smoke.

Elevated blood pressure.

Susceptible women may experience a rise in blood pressure following the administration of contraceptive steroids. Blood pressure should be measured at intervals and care should be exercised in prescribing these preparations for patients with hypertension.

Ocular lesions.

There have been reports of neuro-ocular lesions such as optic neuritis or retinal thrombosis with the use of oral contraceptives. Oral contraceptives should be discontinued if there is gradual or sudden, partial or complete loss of vision; onset of proptosis or diplopia; onset or aggravation of migraine or development of headache of a new pattern which is recurrent, persistent or severe; papilloedema; or any evidence of retinal vascular lesions. Appropriate diagnostic and therapeutic measures should be taken immediately.

Hepatic tumours.

Benign hepatic adenomas appear to be associated with the use of oral contraceptives. Although benign and rare, hepatic adenomas may rupture and cause death through intra-abdominal bleeding. This has been reported in short-term as well as long-term users of oral contraceptives, although one study relates risk with duration of use of the contraceptive. While hepatic adenoma is a rare lesion, it should be considered in women presenting with abdominal pain and tenderness, abdominal mass or shock.
A few cases of hepatocellular carcinoma have been reported in women taking oral contraceptives. The relationship of these drugs to this type of malignancy is not known at this time.

Carcinoma of breast.

Although there is no confirmed evidence to indicate that an increased risk of cancer is associated with the use of oral contraceptives, close clinical surveillance is nevertheless essential in all women taking these drugs.
Studies reported a slightly increased relative risk of having breast cancer diagnosed in women who are currently using combined oral contraceptives (COC) and progestin only contraceptives compared to never-users. The increased risk gradually disappears during the course of the 10 years after cessation of COC use. These studies do not provide evidence for causation. The observed pattern of increased risk of breast cancer diagnosis may be due to earlier detection of breast cancer in COC users (due to more regular clinical monitoring), the biological effects of COCs, 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 COC 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. The risk of having breast cancer diagnosed in progestogen-only pill users is possibly of similar magnitude to that associated with COC. However, for progestogen-only preparations, the evidence is based on much smaller populations of users and so is less conclusive than that for COCs.

Carcinoma of reproductive organs.

In cases of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate diagnostic measures should be taken to eliminate the possibility of malignancy. Women with a strong family history of breast cancer or who have breast nodules, fibrocystic disease, or abnormal mammograms should be monitored with particular care.
Several epidemiological studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intra-epithelial neoplasia or invasive cervical cancer. It is not known whether the use of oral contraceptives is causative but an independent association has been consistently shown. The studies suggest that there is an "ever used" effect in addition to the duration of use. These findings must be balanced against evidence of significant effects attributable to sexual behaviour, smoking, the presence of human papilloma virus and other factors. In view of the above, periodical cervical smears should form part of the routine follow up of women who have previously used oral contraceptives. As part of the routine counselling, advice that hormonal contraception does not protect against the transmission of sexually transmittable diseases, including human papilloma virus, should be made clear. Patients may not be aware that barrier contraceptive measures are necessary to reduce the risk of transmission of human papilloma virus.

Ectopic pregnancy.

Ectopic as well as intrauterine pregnancy may occur in contraceptive failures. However, in oral contraceptive failures, the ratio of ectopic to intrauterine pregnancies is higher than in women who are not receiving oral contraceptives, since the drugs are more effective in preventing intrauterine than ectopic pregnancies. The higher ectopic-intrauterine ratio has been reported with both combination products and progestogen-only oral contraceptives.
In addition, the symptoms of ectopic pregnancy and the adverse reactions to low dose progestogen administration (i.e. breakthrough bleeding, spotting, menstrual irregularity and amenorrhoea) are similar. The possibility of an ectopic pregnancy should be considered whenever a patient receiving a low-dose progestogen contraceptive experiences pelvic discomfort.

Delayed follicular atresia (ovarian cysts).

If follicular development occurs, atresia of the follicle is sometimes delayed and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these enlarged follicles are asymptomatic, in some cases they may be associated with mild abdominal pain.

Carbohydrate and lipid effects.

A decrease in glucose tolerance has been observed in a significant percentage of patients on oral contraceptives. For this reason, prediabetics and diabetics should be carefully observed while receiving oral contraceptives.
An increase in triglycerides and total phospholipids has been observed in patients receiving oral contraceptives.

Liver disease.

Women with a history of oral contraceptive related cholestasis or women with cholestasis during pregnancy are more likely to have this condition with oral contraceptive use. If these patients receive progestogen-only oral contraceptives they should be carefully monitored and, if the condition recurs, progestogen-only oral contraceptive use should be discontinued.
Progestins may be poorly metabolised in patients with impaired liver function. If progestogen-only oral contraceptives are prescribed for these patients, they should be carefully observed.

Migraine/headache.

The onset or exacerbation of migraine or development of headache with a new pattern that is recurrent, persistent, or severe requires discontinuation of progestogen-only oral contraceptives and evaluation of the cause.
Women with migraine (particularly migraine with aura) who take progestogen-only oral contraceptives may be at increased risk of stroke.

Fluid retention.

Progestogens may cause some degree of fluid retention. Conditions which might be influenced by this factor, such as epilepsy, migraine, asthma, cardiac or renal dysfunction, require careful observation.

Depressive disorder.

Oral contraceptives may cause depressive disorder. Patients with a history of depressive disorder should be carefully observed during treatment.

Prolonged therapy.

Any possible influence of prolonged Noriday therapy on pituitary, ovarian, adrenal, hepatic or uterine function awaits further study. The age of the patient constitutes no absolute limiting factor, although treatment with Noriday may mask the onset of the climacteric.

Use in the elderly.

No data available.

Paediatric use.

Use of this product before menarche is not indicated.

Effects on laboratory tests.

The pathologist should be advised of Noriday therapy when relevant specimens are submitted.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The effectiveness of progestin-only pills may be reduced by hepatic enzyme-inducing drugs such as phenytoin, primidone, carbamazapine, barbiturates, rifampicin and other antibiotics such as ampicillin and griseofulvin, some protease inhibitors, and possibly St. John's wort. During concomitant use of progestogen-only oral contraceptives and substances that may affect the contraceptive efficacy of progestogen-only oral contraceptives, it is recommended that a non-hormonal back-up method of birth control be used in addition to the regular intake of Noriday. Use of a non-hormonal back-up method of birth control is advisable after discontinuation of substances that have led to induction of hepatic microsomal enzymes. It may take several weeks until enzyme induction has subsided, depending on dosage, duration of use, and rate of elimination of the inducing substance. For women receiving long-term therapy with hepatic enzyme inducers, another method of contraception should be considered.
Other mechanisms which may affect the contraceptive efficacy of progestogen-only oral contraceptives include any substance that reduces gastrointestinal transit time.
The prescribing information of concomitant medications should be consulted to identify potential interactions.
Noriday should be administered at least 2 hours apart from antacids, as antacids may impair the absorption of Noriday.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B3)
Animal studies have shown that high doses of progestogens can cause masculinization of the female foetus.
 Numerous studies have evaluated progestogen-only oral contraceptive use in breast-feeding women and their infants. Small amounts of progestins and/or their metabolites have been identified in the milk of nursing mothers. Very rarely, adverse effects on the child have been reported, including jaundice.

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)

Adverse reaction by system organ class.

Reproductive system and breast disorders.

Amenorrhea, breakthrough bleeding/spotting, menstrual irregularities, breast pain, enlargement, tenderness, secretion; galactorrhea; ectopic pregnancy; delayed follicular atresia; vaginal discharge; vaginitis, masculinisation of the female foetus, change in cervical erosion.

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

Hepatic adenoma.

Metabolism and nutrition disorders.

Glucose intolerance, changes in appetite (increase or decrease), exacerbation of porphyria.

Psychiatric disorders.

Mood Disturbances, mental depression, decreased libido.

Nervous system disorders.

Headache, including severe headache, dizziness, nervousness.

Eye disorders.

Retinal vascular thrombosis.

Vascular disorders.

Pulmonary embolism, venous thromboembolism; including deep vein thrombosis and thrombophlebitis, myocardial infarction, stroke.

Gastrointestinal disorders.

Abdominal pain, abdominal cramps, abdominal distention, nausea, vomiting, gastrointestinal disturbance.

Hepato-biliary disorders.

Cholestasis, cholestatic jaundice.

Skin and subcutaneous tissue disorders.

Acne, alopecia, hirsutism, chloasma/melasma that may persist, rash (allergic) with or without pruritus.

Musculoskeletal, connective tissue and bone disorders.

Leg cramp, pain.

Immune system disorders.

Anaphylactic/anaphylactoid reactions including urticaria, throat tightness, facial edema.

General disorders and administration site reactions.

Fatigue, oedema.

Investigations.

Increased AST, ALT, bilirubin, decreased HDL, increased blood pressure, changes in weight (increase or decrease).

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

Exact toxic doses have not been determined. When oral contraceptives are the sole medication taken as an acute overdose, the patient may remain clinically well. Overdosage may cause nausea, vomiting, breast tenderness, dizziness, fatigue, somnolence and withdrawal bleeding may occur in females.
In the case of overdosage or accidental ingestion, the patient should be observed and given supportive treatment, as there is no specific antidote.
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.

Norethisterone is a synthetic steroidal progestogen oral contraceptive. The mechanism of conception control is not known. Suggested mechanisms of action are increased viscosity of the cervical mucus, changes in the endometrium making it unsuitable for nidation to take place, some inhibition of the secretion of pituitary gonadotrophins.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Magnesium stearate, povidone, maize starch, lactose monohydrate.

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

Stored below 25°C.

6.5 Nature and Contents of Container

Noriday Tablets are presented in "calendar" packs of 28 tablets in PVC/aluminium blister.

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.

The chemical name of norethisterone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one. The chemical structure of norethisterone is shown below. The empirical formula is C20H26O2 and the molecular weight is 298.4.
Norethisterone (B.P.) is a white to creamy-white odourless crystalline powder with a slightly bitter taste, insoluble in water and sensitive to light.

CAS number.

68-22-4.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes