Norethisterone

Consumer Medicine Information

This leaflet answers some common questions about NORIDAY 28 Day tablets.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking NORIDAY against the benefits it is expected to have for you.

Use NORIDAY as directed by your doctor and follow advice given in this leaflet.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

NORIDAY is a birth control pill commonly known as a “progestogen-only” pill or “mini pill”. NORIDAY is usually given to women who are unable to take other types of birth control pills (oral contraceptives) or use intrauterine devices (IUDs).

NORIDAY 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 oestrogen and progestogen.

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

NORIDAY 28 day is only available on a prescription from your doctor.

This medicine is prescribed for you and should not be given to others.

NORIDAY 28 Day tablets are not suitable for some women.

If you have or have had any of these problems, do not take NORIDAY until you have talked to your doctor.

Do not take it if

you have had a stroke or heart attack.

you have or have had inflammation, infection or clotting in any blood vessel(s), including a clot in the lung.

you have or have had 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.

you have abnormal vaginal bleeding, the cause of which is unknown.

you are pregnant or suspect that you may be pregnant.

you have cancer or suspected cancer of the breast or sex organs (e.g. cervix, vagina, ovaries, womb) or known or suspected oestrogen-dependent tumours.

you have a family history of breast nodules, fibrocystic disease or have had an abnormal mammograph.

you have sickle cell anaemia.

you have lipid metabolism disorders.

you have a history of herpes of pregnancy.

you have otosclerosis (an ear disorder) which worsened in past pregnancies.

you have not had your first period

you have an allergy to norethisterone or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include:

asthma, wheezing or shortness of breath

swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing

hives, itching or skin rash

fainting

Tell your doctor about any existing medical condition as this may be affected by taking the birth control pill.

Do not take NORIDAY if the packaging is torn or shows signs of tampering.

You must have a thorough medical check up, including a Pap smear, breast check, blood pressure check and urine test.

You must tell your doctor if:

you 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

you are overweight, has recently had or are planning to undergo major surgery, or are confined to bed for long periods of time

you have liver, kidney or heart disease.

you have high blood pressure.

you have high cholesterol.

you have diabetes.

you have epilepsy.

you have asthma.

you have migraine.

you have or have had depression.

you are lactose intolerant. This medicine contains lactose.

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

Some medicines may interfere with the effectiveness of NORIDAY. These include medicines such as:

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.

If you need to take an antacid while on NORIDAY, 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.

Swallow one NORIDAY tablet with a glass of water at approximately the same time each day.

Follow the instructions below carefully to ensure birth control reliability.

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.

If you are switching to NORIDAY 28 Day from another 21 or 28 Day oral contraceptive, please see your doctor or pharmacist for directions.

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

During any period of vomiting or diarrhoea, continue taking NORIDAY 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.

Take your tablet at approximately the same hour each day.

Taking your tablet at the same time each day will also help you remember when to take the tablets.

If you forget to take NORIDAY it may not work as well in protecting you from becoming pregnant.

Do not try to make up for missed doses by taking more than one tablet at a time.

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 more than two tablets:

Stop taking NORIDAY 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 again, start the tablets from a new strip and follow the instructions as if starting NORIDAY 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 differently, or you are unclear about the above directions, discuss this with him or her.

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

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 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.

Immediately telephone your doctor or pharmacist or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think you or anyone else may have taken too much NORIDAY. Do this even if there are no signs of discomfort or poisoning.

Serious ill effects have not been reported in young children who have taken large doses of birth control pills.

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

Tell all doctors, dentists and pharmacists who are treating you that you are taking NORIDAY.

Tell the hospital doctor that you are taking NORIDAY 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.

If you become pregnant while taking NORIDAY, see your doctor immediately.

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.

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.

If you are worried about contracting a sexually transmitted disease (STD) use a barrier contraceptive method.

NORIDAY 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.

Tell your doctor if you feel depressed, think you are retaining water, experience headaches or experience persistent or recurrent irregular bleeding.

Your doctor will make an assessment of your condition and advise whether or not you should continue to take NORIDAY.

Tell your doctor if you are breastfeeding, or are planning to breast-feed.

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.

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) and is quite marked 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 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.

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 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.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking NORIDAY.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

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

Tell your doctor if you notice any of the following and they worry you:

Dizziness, tiredness, nervousness

changes in appetite

reduced sex drive

gastric or stomach discomforts including abdominal pain, cramps, nausea and vomiting

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)

change in weight

feeling very thirsty, dry mouth, frequently needing to urinate

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)

changes in mood, including depression

excessive hair growth or hair loss\

may affect the development of your foetus

changes to the results of your cholesterol and liver function tests

exacerbation of porphyria

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 oestrogen 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.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

sharp, one-sided abdominal pain

unexplained or persistent pains in the head, chest, stomach or legs

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

migraine headaches for the first time

more frequent or severe migraines if you already suffer from them

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

rise in blood pressure

swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.

Rarer side effects associated with the use of NORIDAY and combined oral contraceptives are not listed here. You may wish to discuss these, or any of the side effects listed above, with your doctor if you are concerned.

Side effects not previously reported with NORIDAY may also occur.

If you notice anything unusual while you are taking NORIDAY, see your doctor.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Delays in becoming pregnant may occur after NORIDAY 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.

Keep your tablets in a safe place away from the sight and reach of children.

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

Keep your NORIDAY tablets in a dry place, at a temperature below 25°C.

Do not keep your tablets in the refrigerator.

Do not store NORIDAY or any other medicine in the bathroom or near a sink.

Do not leave it in the car on hot days or on window sills.

Heat and dampness can destroy some medicines.

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

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.

Each white tablet contains

norethisterone 350 micrograms (mcg).

magnesium stearate

povidone

maize starch

lactose monohydrate.

NORIDAY does not contain sucrose, gluten or tartrazine.

NORIDAY can be identified by the Australian Register Number on the carton labels.

NORIDAY 28 Day Tablets –

AUST R 10052

Pfizer Australia Pty Ltd

Sydney, NSW

Toll Free Number: 1800 675 229

www.pfizer.com.au

 

This leaflet was prepared in February 2020.

 

^® Registered trademark