NORIDAY Tablet Ref.[27757] Active ingredients: Norethisterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

4.1. Therapeutic indications

Noriday is a progestogen-only oral contraceptive. It is particularly useful for women for whom oestrogens may not be appropriate.

4.2. Posology and method of administration

Posology

Starting on the first day of menstruation, one pill every day without a break in medication for as long as contraception is required. Additional contraceptive precautions (such as a condom) should be taken for the first 7 days of the first pack. Pills should be taken at the same time each day.

Missed pills

If a pill is missed within 3 hours of the correct dosage time then the missed pill should be taken as soon as possible; this will ensure that contraceptive protection is maintained. If a pill is taken 3 or more hours late it is recommended that the woman takes the last missed pill as soon as possible and then continues to take the rest of the pills in the normal manner. However, to provide continued contraceptive protection it is recommended that an alternative method of contraception, such as a condom, is used for the next 7 days.

Changing from another oral contraceptive

In order to ensure that contraception is maintained it is advised that the first pill is taken on the day immediately after the patient has finished the previous pack.

Use after childbirth, miscarriage or abortion

The first pill should be taken on the 21st day after childbirth. This will ensure the patient is protected immediately. If there is any delay in taking the first pill, contraception may not be established until 7 days after the first pill has been taken. In these circumstances women should be advised that extra contraceptive methods will be necessary.

After a miscarriage or abortion patients can take the first pill on the next day; in this way they will be protected immediately.

Vomiting and diarrhoea

Gastrointestinal upsets, such as vomiting and diarrhoea, may interfere with the absorption of the pill leading to a reduction in contraceptive efficacy. Women should continue to take Noriday, but they should also be advised to use another contraceptive method during the period of gastrointestinal upset and for the next 7 days.

Method of administration

For oral use.

4.9. Overdose

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may be manifested by nausea, vomiting, breast enlargement and vaginal bleeding. There is no specific antidote and treatment should be symptomatic. Gastric lavage may be employed if the overdose is large and the patient is seen sufficiently early (within four hours).

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Do not store above 25°C. Keep the blister in the outer carton in order to protect from light and moisture.

6.5. Nature and contents of container

Noriday tablets are supplied in pvc/foil blister packs of 28 and 84 tablets.

Blister packaging consists of 250 micron PVC and 20 micron aluminium foil.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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