Primolut N^®

Each tablet contains 5 milligrams of norethisterone BP.

For excipients, see 6.1.

Tablet.

White, uncoated tablets impressed with 'AN' in a regular hexagon on one side.

Metropathia haemorrhagica. Premenstrual syndrome. Postponement of menstruation. Endometriosis. Menorrhagia. Dysmenorrhoea.

The tablets are to be swallowed whole with some liquid.

Not intended for use in children.

Metropathia haemorrhagica (dysfunctional uterine bleeding): 1 tablet 3 times daily for 10 days. Bleeding is arrested usually within 1-3 days. A withdrawal bleeding resembling normal menstruation occurs within 2-4 days after discontinuing treatment. One tablet twice daily from the 19^th to the 26^th day of the two subsequent cycles should be given to prevent recurrence of the condition.

To ensure treatment success, Primolut N must be taken for the full 10 days. Occasionally, slight bleeding may occur after the initial suspension of bleeding. Treatment should not be interrupted or suspended in these cases.

If vaginal bleeding does not stop, despite correct tablet intake, an organic cause or an extra-genital factor (e.g. polyps, carcinoma of the cervix uteri or endometrium, myoma, residua of abortion, extra-uterine pregnancy, or coagulation disorders) must be considered so that other measures are then mostly required. This also applies to cases where after an initial suspension of bleeding, fairly heavy bleeding reoccurs during tablet intake.

Premenstrual syndrome (including premenstrual mastalgia): Premenstrual symptoms such as headache, migraine, breast discomfort, water retention, tachycardia, and psychological disturbances may be relieved by the administration of 1-3 tablets daily from the 19^th to the 26^th day of the cycle. Treatment should be repeated for several cycles. When treatment is stopped, the patient may remain symptom-free for a number of months.

Postponement of menstruation: In cases of too frequent menstrual bleeding, and in special circumstances (e.g. operations, travel, sports) the postponement of menstruation is possible. The dosage is 1 tablet of Primolut N three times daily, starting 3 days before the expected onset of menstruation and continuing for not longer than 10 to 14 days. A normal period should occur 2-3 days after the patient has stopped taking tablets. This method should be restricted to users who are not at risk of pregnancy during the treatment cycle.

Endometriosis (pseudo-pregnancy therapy): Treatment should begin between the first and 5th day of the cycle with 1 of tablet Primolut N twice daily. In the event of spotting, the dose can be increased to 2 tablets twice daily. If bleeding ceases, dose reduction to the initial dose should be considered. Treatment is to be continued for at least 4 to 6 months. With uninterrupted daily intake, ovulation and menstruation do not usually occur.

Menorrhagia (hypermenorrhoea): 1 tablet 2-3 times a day from the 19^th to the 26^th day of the cycle (counting the first day of menstruation as day 1).

Dysmenorrhoea: Functional or primary dysmenorrhoea is almost invariably relieved by the suppression of ovulation. 1 tablet three times daily for 20 days, starting on the fifth day of the cycle (the first day of menstruation counting as day 1). Treatment should be maintained for three to four cycles followed by treatment-free cycles. A further course of therapy may be employed if symptoms return.

1. Pregnancy.

2. Severe disturbances of liver function.

3. Dubin-Johnson syndrome.

4. Rotor syndrome.

5. Previous or existing liver tumours.

6. History during pregnancy of idiopathic jaundice, severe pruritus or herpes gestationis.

7. Current thromboembolic processes.

8. Hypersensitivity to the active substances or to any of the excipients.

There is a general opinion, based on statistical evidence, that users of combined oral contraceptives experience, more often than non-users, venous thromboembolism, arterial thrombosis, including cerebral and myocardial infarction, and subarachnoid haemorrhage. Full recovery from such disorders does not always occur, and it should be realised that in a few cases they are fatal. Although Primolut N does not contain oestrogen, one should keep the possibility of an increased thromboembolic risk in mind, particularly where there is a history of thromboembolic disease or in the presence of severe diabetes with vascular changes or sickle-cell anaemia.

In rare cases benign, and in even rarer cases, malignant liver tumours leading in isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances such as the one contained in Primolut N. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential diagnosis and, if necessary, the preparation should be withdrawn.

Primolut N can influence carbohydrate metabolism. Parameters of carbohydrate metabolism should be examined carefully in all diabetics before and regularly during treatment.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Reasons for stopping Primolut N immediately

1. Occurrence for the first time of migrainous headaches or more frequent occurrence of unusually severe headaches

2. Sudden perceptual disorders (e.g. disturbances of vision or hearing)

3. First signs of thrombophlebitis or thromboembolic symptoms, feeling of pain and tightness in the chest

4. Pending operations (six weeks beforehand), immobilisation (e.g. after accidents)

5. Onset of jaundice, hepatitis, general pruritus

6. Significant rise in blood pressure

7. Pregnancy.

None known.

The administration of Primolut N during pregnancy is contraindicated.

None known.

Side-effects rarely occur in doses of 15mg daily. Amongst those recorded are slight nausea, exacerbation of epilepsy, migraine and various skin disorders. With extremely high doses there may be cholestatic liver changes.

There have been no reports of ill-effects from overdosage and treatment is generally unnecessary. There are no special antidotes, and treatment should be symptomatic.

ATC Code: G03D

Norethisterone has progestational actions similar to those of progesterone, but is a more potent inhibitor of ovulation and has weak oestrogenic and androgenic properties. It is used to treat a number of disorders of the menstrual cycle.

Norethisterone is absorbed from the gastro-intestinal tract and its effects last for at least 24 hours. It is excreted in the urine.

There are no preclinical safety data which could be of relevance to the prescriber and which are not already included in other relevant sections of the SPC.

lactose

maize starch

magnesium stearate

Not known.

5 years.

Not applicable.

Cardboard carton containing 3 blisters of 10 tablets.

Keep out of the reach of children.

Bayer plc

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

United Kingdom

Trading as Bayer plc, Bayer Schering Pharma

PL 00010/0553

1 May 2008

4 December 2008