Consumer medicine information

Noriday 28 Day



Brand name

Noriday 28-Day

Active ingredient





Consumer medicine information (CMI) leaflet

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

What is in this leaflet

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.

What NORIDAY is used for

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.

Before you start to take NORIDAY

When you must not take it

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.

Before you start to take it

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.

Taking other medicines

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.

How to take NORIDAY

How to take it

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.

When to take it

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 a tablet

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 miss a period

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.

If you take too much (overdose)

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.

While you are taking NORIDAY

Things you must do

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.

Things you must not do

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.

Things to be careful 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 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.

Side effects

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.

After stopping NORIDAY

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.

After taking NORIDAY


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.

Product description

What it 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.


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

This leaflet was prepared in February 2020.

® Registered trademark

Published by MIMS May 2020


Brand name

Noriday 28-Day

Active ingredient





1 Name of Medicine


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

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.


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.


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.


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

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


No data available.


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.


7 Medicine Schedule (Poisons Standard)


Summary Table of Changes