Primolut N Tablets - Product Information

Primolut N is used for timing of menstruation and to treat disturbances of the monthly bleeding (dysfunctional bleeding), lack of the monthly bleeding (primary and secondary amenorrhoea), premenstrual complaints (premenstrual syndrome), in combination with oestrogen hormone replacement therapy, and endometriosis (a disease leading to symptoms caused by womb-lining tissue growing outside the womb, Primolut N therapy causes the shrinking of this unwanted tissue)


Primolut N Tablets - Contraindications

Primolut N is contraindicated in women that have an allergy to Norethisterone Acetate, the active ingredient in Primolut N or any of the inactive ingredients present in the medicine. This medicine is contraindicated in pregnant women as it may affect the developing baby. Do not breastfeed if you are taking this medicine as the active ingredient in Primolut N passes into breast milk and there is a possibility that the baby may be affected. Primolut N Tablets are also contraindicated in the following cases:

  • Patients having a disorder affecting the blood circulation (thromboembolic processes)
  • Women suffering from or have suffered from any disease of the heart or blood vessels.
  • Patients having diabetes mellitus with blood vessel damage.
  • Patients suffering or have suffered from a severe liver disease (as long as the liver function values have not returned to normal).
  • Having or have had a benign or malignant liver tumor.
  • Women suffering from or have suffered from from a malignant sex hormone dependent tumor such as cancer of the breast or the genital organs.
  • Women suffering from a condition called Dubin-Johnson syndrome or Rotor syndrome.
  • Having vaginal bleeding or blood in your urine for which a cause has not been identified.
  • Having breast disease for which a cause has not been identified.
  • In women that have had a miscarriage.


Primolut N Tablets - Dosage

The tablets have to be swallowed whole with a glass of water. The recommended dosage of Primolut N for various indications is given below:
Dysfunctional Bleeding:
Primolut N 1 tablet is to be taken 3 times daily for 10 days
Primary 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.
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.
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.
Treatment with Primolut N has to start between the first and 5th 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.


Side Effects of Primolut N Tablets

In case of women being treated for endometriosis, changes in bleeding pattern including irregular bleeding, scanty bleeding and the absence of bleeding may occur. The side effects that have been reported in users of Primolut N are abnormal vision, nausea, headache, fluid retention, and migraine.


Primolut N Tablets - More Details

For more details read the prescription information or watch the presentation below.