Primolut N tablets

Perimenopause is the stage leading up to menopause during which your menstrual pattern changes. Your menstrual periods can become irregular, your periods may skip a month, or you may experience heavier or lighter bleeding. 

Primolut N can be used to treat irregular, painful or heavy periods. Primolut N contains norethisterone, which belongs to a group of medicines called progestogens, which are female hormones. It works by mimicking the action of progesterone to regulate the menstrual cycle and alleviate symptoms.  

The tablet should be swallowed with a drink of water. If you have a sensitive stomach, it is best to take the tablet with or after meals to avoid feeling sick. 

NOTE: 

You must make sure that you are not pregnant while taking a course of Primolut N. If you have sexual intercourse, you should use non-hormonal barrier methods of contraception (for example, a condom). If you have a regular cycle of 28 days and do not get a withdrawal bleed during treatment, you may be pregnant. Stop taking Primolut N until you are sure you are not pregnant. 

Dosage 

Dosage varies per person and is determined by a doctor for each specific patient depending on the symptoms. General guidelines for use in adults: 

Dysfunctional (irregular) bleeding 

• Take three tablets a day for 10 days. The bleeding generally stops within one to three days. In some cases, it may take five days for the bleeding to stop. To achieve the optimum result from your treatment it is important that you continue to take Primolut N regularly even after the bleeding has stopped (a total of 30 tablets for a 10-day course). About two to four days after you have finished the course, you will have a withdrawal bleed, similar to your period. 

Although Primolut N has been prescribed to stop irregular periods, you may experience irregular bleeding during the first few months of use. See the package leaflet for more information. 

• 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. 

Primolut N can also be used to treat other conditions or symptoms. See the package leaflet for dosage instructions.  

If you use more/forget to use Primolut N 

If you take more Primolut N than you should, talk to your doctor or pharmacist straight away. Taking too many tablets is unlikely to cause serious problems. You may experience nausea, vomiting or withdrawal bleeding may occur. No special treatment is necessary. 

If you forget to take Primolut N, you may take the forgotten dose as soon as you remember unless it is almost time for your next scheduled dose. Do not take a double dose to make up for a forgotten one. Forgetting to take a tablet for several days in a row can lead to irregular bleeding. 

Do not take Primolut N if: 

• You are pregnant or think you may be pregnant. 
• You are breastfeeding. 
• You have, or have had, a severe liver disease. In this case, you should consult your doctor before taking Primolut N. 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 ever had a heart attack or stroke. 
• You have, or have had, a condition that is linked to an increased risk of heart attack (e.g., angina pectoris or chest pain) or mini-stroke (also known as TIA or transient ischaemic attack). 
• You have any condition which makes you more at risk of a blood clot. 
• You have a disorder affecting your blood clotting (e.g., protein C deficiency). 
• You have, or have had, a type of migraine associated with focal neurological symptoms (migraine with aura), where you have also had problems with seeing, speaking or had weakness or numbness in any part of your body. 
• You have diabetes with damaged blood vessels. 
• You have, have had, or may have cancer of the breast or the genital organs. 
• You have any unexplained vaginal blood loss. 
• You are allergic to any of the other ingredients in this medicine (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. See the package leaflet for a list of situations. Always consult a doctor if a condition or situation applies to you. 

The use Primolut N has been associated with an increased risk of a number of serious side effects, such as thrombosis and cancer. Please refer to the package leaflet for more information on these risks. 

Other medicines and Primolut N 

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Primolut N may interact with some medicines. See the package leaflet for more information on this topic.  

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects that have been reported with Primolut N include: 

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

• Vaginal bleeding, including spotting (with continuous use). 
• Extremely light menstrual blood flow (hypomenorrhoea). 

Common (may affect up to 1 in 10 people): 

• Headache. 
• Nausea. 
• Vomiting. 
• Disruption of menstrual cycle (amenorrhoea) with continuous use. 
• Fluid retention (oedema). 

Uncommon (may affect up to 1 in 100 people): 

• Migraine. 

Rare (may affect up to 1 in 1,000 people): 

• Allergic reaction. 
• Changes in liver function blood test results. 
• Yellow discolouration of the skin and white of the eye (jaundice). 
• Skin rash, with symptoms such as severe itching and/or bumps (nettle rash, hives). 

Very rare (may affect up to 1 in 10,000 people): 

• Visual disturbances, such as seeing shimmering or flashing lights. 
• Shortness of breath (dyspnoea). 
• Increased or decreased sexual drive.  
• Acne, depressed mood, water and salt retention (oedema), weight gain and excessive growth of facial or body hair (hirsutism) may occur with high doses or long-term use. 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 

What Primolut N contains:  

• The active substance is norethisterone. Each tablet contains 5 mg of norethisterone. 
• The other ingredients are: lactose monohydrate, maize starch and magnesium stearate. 

Manufacturers: 

Bayer AG 
Berlin 
Germany 

Bayer Weimar GmbH und Co. KG 
Weimar
Germany 

Primolut N is only available on prescription in the United Kingdom. A doctor can write a prescription for Primolut N after an online consultation. The cost of the consultation is included in the price.  

Read the official package leaflet before use. The package leaflet contains important information on the use and the risks associated with Primolut N. The package leaflet for Primolut N is available for download here.