Primolut N Tablets

Primolut N tablets are used to treat dysfunctional bleeding, primary and secondary amenorrhoea, premenstrual syndrome, delay of menstrual period, in combination with estrogen hormone replacement therapy and endometriosis.

The active pharmaceutical ingredient in Primolut N Tablets is Norethisterone Acetate. Primolut N is available as 5 mg tablets.

Active Ingredient

Chemical Structure

Indications

Timing of menstruation

Disturbances of the monthly bleeding

Lack of the monthly bleeding

Premenstrual complaints

Endometriosis

Dysfunctional Bleeding: The recommended dose of Primolut N is 1 tablet to be taken 3 times daily for 10 daysPrimary and Secondary Amenorrhoea:

Endometrial priming with an estrogen must be carried out before beginning treatment with Primolut N. Thereafter 1 tablet of Primolut N is given 1 to 2 times daily for 10 days.

Recommended Adult Dosage

Timing of Menstruation:Women not at risk of pregnancy during the treatment cycle can postpone their monthly menstrual bleeding with administration of Primolut N. The recommended dosage is 1 tablet Primolut N 2 to 3 times daily for not longer than 10-14 days, beginning about 3 days before the expected menstruation. Bleeding will occur 2-3 days after having stopped medication.

Recommended Adult Dosage

Premenstrual Syndrome:One tablet of Primolut N taken 1 to 3 times daily during the luteal phase (days past ovulation) of the cycle may relieve or improve premenstrual symptoms such as headaches, depressive moods, water retention, and a feeling of tension in the breasts.

Recommended Adult Dosage

Endometriosis:Treatment with Primolut N has to start between the first and fifth day of the cycle with 1 tablet twice daily. In the event of spotting, the dose can be increased to 2 tablets twice daily. If bleeding stops, dose reduction to the initial dose should be considered. Treatment is to be continued for at least 4 to 6 months.

Recommended Adult Dosage

Missed Dose

If you miss a dose, take it as soon as you remember. However, if you remember when it is almost time for your next dose, take only your usual dose at that time. Do not take two doses at once.

Contraindications

Primolut N Tablets are contraindicated in the following cases:

Known hypersensitivity to to Norethisterone or any of the other ingredients present in the medicine.

Known or suspected pregnancy

Lactation

Thromboembolic disorders, thrombophlebitis, cerebral apoplexy or a history of these conditions

Contraindications

Patients with arterial and cardiovascular disease present or in history

Diabetes mellitus with vascular involvement.

Presence or history of severe hepatic disease as long as liver function values have not returned to normal

Presence or history of liver tumors (benign or malignant)

Contraindications

Known or suspected sex hormone-dependent malignancies.

Dubin-Johnson syndrome.

Rotor syndrome.

Missed abortion.

Undiagnosed vaginal or urinary bleeding.

Undiagnosed breast pathology

Side Effects of Primolut N Tablets

In the indication of endometriosis, changes in bleeding pattern including irregular bleeding, scanty bleeding and the absence of bleeding may occur. Other side effects that have been reported in users of Primolut N are abnormal vision, nausea, headache, fluid retention, migraine, shortness of breath and hypersensitivity reactions (e.g rash, hives).

Warnings And Precautions

Use of oral estrogen/progestogen containing ovulation inhibitors increases the incidence of thromboembolic diseases.

In rare cases, benign liver tumors, and even more rarely, malignant liver tumors have been reported in users of hormonal substances such as the one contained in Primolut N.

Strict medical supervision is necessary if the patient suffers from diabetes.

Overdosage Symptoms

Studies conducted with norethisterone acetate did not indicate a risk ofacute adverse effects in case of inadvertent intake of a multiple of the daily therapeutic dose.

Primolut N Tablets Manufactured by Zydus Healthcare

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Primolut N Tablets

The Swiss Pharmacy, Geneva Switzerland