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Primolut N

Active Ingredients:norethisterone

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions printed on the pharmacist label, ask your doctor or pharmacist for help.

How to take it

Swallow the tablets whole with a glass of water.

If you have sexual intercourse, you should use non-hormonal methods (e.g. barrier methods) of contraception. If you think you might have fallen pregnant despite such protective measures, stop taking the tablets and see your doctor. He/she will check you are not pregnant before you can recommence tablet taking. Your doctor will advise you on how to take your tablets. The dosage will vary depending on why you have been given this medicine. The following dosages are recommended:

Dysfunctional bleeding (Disturbances of your period)

Take 1 tablet 3 times daily for 10 days. In most cases bleeding will stop within 1 to 3 days, but Primolut N must be taken for the full 10 days. About 2 to 4 days after you stop taking the tablets, withdrawal bleeding will occur with the intensity and duration of normal menstruation.

Occasionally, slight bleeding may reoccur after the initial bleeding stops. If this happens do not stop taking the tablets. Keep taking the tablets for the full 10 days. If vaginal bleeding does not stop, despite taking the tablets correctly or if, after an initial suspension of bleeding, fairly heavy bleeding reoccurs while you are taking the tablets, you should contact your doctor. Your doctor will need to consider other causes for the bleeding. To prevent dysfunctional bleeding from re-occurring your doctor may decide that you should take Primolut N regularly (1 tablet 1 to 2 times daily from the 16th to the 25th day of the cycle (1st day of the cycle = 1st day of the last bleeding). Withdrawal bleeding occurs a few days after the last tablet intake. If you are unsure about when to take the tablets ask your pharmacist or doctor.

Primary and secondary amenorrhoea (lack of a period)

Hormone treatment of secondary amenorrhoea can be carried out only after the exclusion of pregnancy. Primary or secondary amenorrhoea is sometimes caused by a prolactinoma (an alteration of a gland in the brain producing increased amounts of a hormonelike substance) which needs to be excluded by your doctor before starting treatment with Primolut N. Your doctor will prescribe you an oestrogen (usually for 14 days) before you begin treatment with Primolut N. You then take 1 tablet of Primolut N 1 to 2 times daily for 10 days. Withdrawal bleeding occurs a few days after taking the last tablet.

If sufficient oestrogen production by your body has been achieved, your doctor may try to stop the oestrogen treatment and to induce cyclical bleeding by just administering 1 tablet of Primolut N twice daily from the 16th to the 25th day of the cycle. If you are unsure about when to take the tablets ask your doctor or pharmacist.

Premenstrual syndrome

Take one tablet 1 to 3 times daily during the 2ndhalf (luteal phase) 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

Monthly menstrual bleeding can be delayed by taking Primolut N. However, this method should be used by you only if you are not at risk of pregnancy during the treatment cycle.

Dosage: Take 1 tablet 2 to 3 times daily for no longer than 10 to 14 days, beginning about 3 days before expected menstruation. Bleeding will occur 2 to 3 days after you stop taking the tablets.

Endometriosis

Treatment should begin 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. With uninterrupted daily intake, ovulation and menstruation do not usually occur. After discontinuation of hormone treatment withdrawal bleeding will occur.

If you forget to take it

The efficacy of Primolut N could be reduced if you forget to take a tablet as directed. You should only take the last missed tablet, as soon as you remember, and then continue tablet intake at your usual time on the next day. Do not take a double dose to make up for forgotten individual doses.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (Australia: 13 11 26 or New Zealand: 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Primolut N. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Primolut N.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.

It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

It may interfere with the results of some tests.

Keep all of your doctor's appointments so that your progress can be checked. Contact your doctor as soon as possible if:

  • you notice any changes in your health, especially involving any of the items mentioned in this leaflet (see also: "Before you take Primolut N"; do not forget about the items related to your immediate family)
  • you feel a lump in your breast
  • you are going to use other medications (see "Before you take Primolut N")
  • you are to be immobilised or are to have surgery (consult your doctor at least six weeks in advance)
  • you have unusual, heavy vaginal bleeding
  • you have been experiencing unusually severe headaches;
  • you are experiencing abnormal vision
  • you have severe stomach pain.

Stop taking tablets and see your doctor immediately if you notice possible signs of thrombosis:

  • an unusual cough
  • severe pain in the chest which may reach the left arm
  • breathlessness
  • any unusual, severe, or prolonged headache or migraine attack
  • partial or complete loss of vision, or double vision
  • slurring or speech disability
  • sudden changes to your hearing, sense of smell, or taste
  • dizziness or fainting
  • weakness or numbness in any part of your body
  • severe pain in your abdomen
  • severe pain or swelling in either of your legs.

The situations and symptoms mentioned above are described and explained in more detail elsewhere in this leaflet.

Things you must not do

Do not take Primolut N to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor.

If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects.

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