Primolut N

• For menstrual problems and endometriosis
• To delay menstruation
• Do not use during pregnancy or while breastfeeding
• Primolut N is not a contraceptive. Use another alternative form of non-hormonal contraception to avoid getting pregnant!

Primolut N contains norethisterone, which belongs to a group of medicines called progestogens, which are female hormones. This medicine helps regulate the growth and shedding of the womb lining.

Primolut N can be used in several different circumstances:

• To treat irregular, painful or heavy periods (e.g., in young women or menopausal women).
• To treat disruption of menstrual cycle (primary or secondary amenorrhoea).
• To treat endometriosis (where tissue from the lining of the womb is present in places where it is not normally found, such as in the ovaries). Primolut N reduces womb-lining tissue in places outside the womb.
• To delay periods.

Always use this medication as directed by your doctor. Primolut N tablets should be taken with a drink of water, preferably after meals to avoid or reduce stomach distress or nausea.

Dosage

Dosage is determined by a doctor for each specific patient depending on the condition and symptoms. The recommended dose in adults is:

Irregular periods

• Take three tablets a day for 10 days. The bleeding generally stops within one to three days, sometimes after five days. Continue to take the medicine regularly even after the bleeding has stopped (a total of 30 tablets for a 10day course). About two to four days after you have finished the course, you will have a withdrawal bleed, similar to your period.
• To prevent recurrence of irregular bleeding, you should continue to use Primolut N for the next three menstruation cycles. Take one tablet of Primolut N once or twice a day from day 16 to 25 of your cycle (the first cycle day is the first day of the last withdrawal bleed). You will have another withdrawal bleed several days after you have finished taking a course of Primolut N.

Absence of periods

• Your doctor has prescribed an oestrogen alongside Primolut N to promote endometrial growth. Start taking the oestrogen according to the doctor's instructions, and take one tablet of Primolut N once or twice a day, from day 16 to 25 of the course. If your oestrogen production is sufficient, stop taking the oestrogen and start taking one tablet of Primolut N twice a day from day 16 to 25 of your cycle. A few days after you stop taking Primolut N, you will get a withdrawal bleed (around day 28 of the course).

Endometriosis

• Start the course between day 1 and 5 of your cycle (day 1 of your cycle is the day your period starts). Take one tablet of Primolut N twice a day. If you experience slight blood loss (spotting) during the course, your doctor will double the dose (two tablets twice daily). Reduce the dosage to the previous level if spotting no longer occurs. You will need to take Primolut N for at least four to six months. A few days after you stop taking Primolut N, you will get a withdrawal bleed.

To delay periods

• Take one tablet of Primolut N twice to three times a day, about three days before the start of your period. Do not use Primolut N for more than 10 to 14 days. Two to three after you stop taking Primolut N, you will get a withdrawal bleed. You should only use Primolut N to delay your period if you are sure that you are not pregnant.
• If you want to advance your period, ask your doctor to prescribe another medicine.

Alcohol/driving

This medicine does not affect your reaction time. There are no food or alcohol restrictions with this medicine.

If you use more/forget to use Primolut N

If you take more Primolut N tablets than you were told to, consult your doctor or pharmacist.

If you miss a dose, you may take it as soon as you remember to, unless it is almost time for your next scheduled dose. Do not take a double dose to make up for the forgotten one.

Primolut N is not suitable for everyone. Do not use this medicine if:

• You are pregnant or think you may be pregnant.
• You are breastfeeding.
• You have, or have had, a severe liver disease. Wait until the blood tests show that your liver is working normally before using Primolut N.
• You have, or have had, a benign or malignant tumour in the liver.
• You have, or have had, a blood clot in a blood vessel of your legs (deep vein thrombosis), your lungs (pulmonary embolus) or other organs.
• You have, or have had, a heart attack or stroke, a condition that is linked to an increased risk of heart attack (e.g., angina pectoris or TIA).
• You have any condition which makes you more at risk of a blood clot.
• You have a bleeding disorder.
• You have a history of migraine, where you have also had problems with seeing, speaking or had weakness or numbness in any part of your body.
• You have diabetes with blood vessel damage.
• You have, or have had, breast cancer or cancer of the genital organs.
• You have any unexplained vaginal bleeding.
• You are allergic to any of the ingredients in Primolut N (see section 'What Primolut N contains').

When should this medicine be used with caution?

In some cases special care should be taken when using Primolut N or you may need to be monitored regularly while using it. See the package leaflet for a list of situations in which this warning applies.

Pregnancy and breastfeeding

Do not use this medicine if you are pregnant, planning a pregnancy or breastfeeding without consulting a doctor first.

Other medicines and Primolut N

Primolut N may interact with other medicines. For more information, see the package leaflet.

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. The doctor will have a list of medicines that you should avoid mixing it with.

Like all medicines, Primolut N can cause side effects, although some people may not experience any. Side effects that are known to be associated with Primolut N include:

Very common (may affect more than 1 in 10 people):

• With continuous use: vaginal bleeding (spotting) or periods that are much shorter than normal and where blood flow is reduced.

Common (may affect up to 10 in 100 people):

• With continuous use: absence of a period.
• Headache.
• Nausea, vomiting.
• Fluid retention.

Uncommon (may affect up to 10 in 1000 people):

• Migraine.

For a list of rare side effects, please see the package leaflet. These include a number of severe side effects, such as a light increased risk of having a blood clot in the veins and arteries or certain types of cancer. Read through this information carefully. Consult a doctor if you experience any side effects.

Each tablet Primolut N contains 5 mg norethisterone. The other ingredients are: lactose monohydrate, maize starch and magnesium stearate.

The manufacturers of Primolut N are:

Bayer AG
13342 Berlin, Germany

Bayer Weimar GmbH und Co. KG
Weimar, Germany

Read the package leaflet before use.