Feminor 5 mg Tablet, 1 strip

Feminor 5 mg Tablet, 1 strip

COMPOSITION

Each film-coated tablet contains Norethisterone BP 5 mg.

PHARMACOLOGY

Feminor tablet is a preparation of Norethisterone which 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.

INDICATION

Metropathia haemorrhagica (dysfunctional uterine bleeding), premenstrual syndrome, postponement of menstruation, endometriosis & menorrhagia.

DOSAGE AND ADMINISTRATION

Route of Administration : Orally.

Metropathia haemorrhagica (dysfunctional uterine bleeding) : 1 tablet 3 times daily 10 days.

Bleeding is arrested usually within 1-3 days. A withdrawal bleeding resembling normal menstruation occurs within 2-4 days after discontinuing treatment.

Prophylaxis against recurrence of dysfunctional bleeding : If there are no signs of resumption of normal ovarian function (no rise in the second half of the cycle of the morning temperature, which should be measured daily) recurrence must be anticipated. Cyclical bleeding can be established with 1 tablet twice daily from the 19th to the 26th day of the cycle.

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 2-3 tablets daily from the 19th to 26th day of 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 case of too frequent menstrual bleeding, and in special circumstances (e.g. operations, travel, spots) the postponement of menstruation is possible. 1 tablet of Feminor three times daily, starting 3 days before the expected onset of menstruation.

A normal. period should occur 2-3 days after the patient has stopped taking tablets.

Endometriosis (pseudo-pregnancy therapy) : Long-term treatment is commenced on the 5th day of the cycle with 2 tablets of Feminor daily for the first few weeks. In the event of spotting, the dosage is increased to 4, and if necessary 5 tablets daily. After bleeding has ceased, the initial dose is usually sufficient. 4-6 months continuously, or longer if necessary.

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

OR AS DIRECTED BY THE PHYSICIAN

CONTRAINDICATION

• Pregnancy

• Severe disturbances of liver function

• Dubin Johnson syndrome

• Rotor syndrome

• Previous or existing liver tumours

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

• Current thromboembolic processes

• Hypersensitivity to the active substance or to any of the excipients.

WARNING & PRECAUTION

There is a general option, based on statistical evidence that users or 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 realized that in a few cases they are fatal. Although Feminor 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 rare cases, malignant liver tumours leading in isolated cases to life-threatening intraabdominal haemorrhage have been observed after the use of hormonal substances such as the one contained in Feminor. 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.

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

Reasons for stopping Feminor immediately.

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

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

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

• Pending operations (six weeks beforehand), immobilization (e.g.after accidents)

• Onset of jaundice, hepatitis, general pruritus

• Significant rise in blood pressure

• Pregnancy

SIDE EFFECTS

Common:

Breakthrough Bleeding

• Spotting, Amenorrhea, Eedema • Change in weight (decreases, increases)

• Change in cervical secretions • Cholestatic jaundice

• Rash, melisma, acne • Breast enlargement

• Migrane • Nausea

• Insomnia

Rare :

• Loss of vision

• Presence of blood in cough

• Pain in chest

USE IN PREGNANCY AND LACTATION

During pregnancy : The administration of Feminor during pregnancy is contraindicated. During Lactation : Feminor should not be used during lactation.

USE IN CHILDREN & ADOLESCENTS

Use in children is not recommended.

DRUG INTERACTION

With Medicine : It should be administered with caution together with enzyme inducers as they may accelerate its metabolism. With food & others : Food interaction is not known.

OVERDOSE

Sign of an overdose include feeling or being sick, breast enlargement or vaginal bleeding. In case of overdose contact your Doctor immediately.

STORAGE

Store below 300  C, protected from light & moisture. Keep all medicines out of reach of children.

PACKING

Each box contains 6 x 10 tablets in blister strips.