Primolut N 5 mg Tablets

PRIMOLUT N is a progestin, a synthetic hormonal product having properties in common with the natural female hormone progesterone. PRIMOLUT N also has a residual androgenic (male sex hormone) effect. PRIMOLUT N is used for timing of menstruation and to treat disturbances of the monthly bleeding (dysfunctional bleeding), absence of menstruation (primary and secondary amenorrhoea), and endometriosis (a disease leading to complaints caused by womb-lining tissue growing outside the womb).

Do not use PRIMOLUT N:

• If you are hypersensitive (allergic) to norethisterone or any of the other ingredients of PRIMOLUT N (listed in section 6)
• If you are pregnant or think you might be pregnant
• If you are breastfeeding
• If you have (or have ever had) a heart attack or stroke (caused by a blood clot or a rupture of a blood vessel in the brain)
• If you have (or have ever had) a disease that can be an indicator (a) of a future heart attack (for example, angina pectoris which causes severe chest pain which may spread to the left arm) or (b) of a stroke (for example, a minor stroke with no residual effects, also called a transient ischaemic attack)
• If you have a severe or multiple risk factor(s) for blood clots
• If you have (or have ever had) a certain kind of migraine (with so-called focal neurological symptoms such as visual symptoms, speech disability, or weakness, or numbness in any part of your body)
• If you have diabetes with damaged blood vessels.
• If you have or have had a severe liver disease and have been told by your doctor that your liver function values have not yet returned to normal. Symptoms of a liver disease may be, for instance, yellowing of the skin and/or itching of the whole body.
• If you are taking any antiviral medicines which contain ombitasvir, paritaprevir, or dasabuvir, and combinations of these. These antiviral medicines are used to treat chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus)
• If you have or have had a benign or malignant liver tumour.
• If you have or have had a malignant sex hormone-dependent tumour such as cancer of the breast or the genital organs.

If any of the above conditions appears for the first time while taking PRIMOLUT N, stop taking it at once and consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking PRIMOLUT N. The sexual steroid (progesterone) that is contained in this product is partly converted into estrogen. Therefore, the general warnings associated with the use of combined oral contraceptives should be considered in addition for PRIMOLUT N. In some situations, you need to take special care while taking PRIMOLUT N, and your doctor may need to examine you regularly. Consult your doctor before starting to use PRIMOLUT N, if any of the following conditions apply to you or if any of them develop or worsen while you are taking PRIMOLUT N:

• if you smoke
• if you have diabetes (metabolic disease with elevated blood sugar levels)
• if you are seriously overweight
• if you have high blood pressure
• if you have a heart valve disorder or a certain heart rhythm disorder
• if you have had a thrombosis/embolism
• if anyone in your immediate family has had a thrombosis (venous thromboembolism in a sibling or a parent at a relatively early age), a heart attack or a stroke at a young age
• if you have an inflammation of your veins (superficial phlebitis)
• if you have varicose veins
• if anyone in your immediate family has had breast cancer
• if you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation
• if you have a history of depression
• if you suffer from migraine
• if you have epilepsy (see “Other medicines and PRIMOLUT N”)
• if you or someone in your immediate family has ever had high blood levels of cholesterol or triglycerides (fatty substances)
• if you have a disease of the liver or gall bladder
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• if you have systemic lupus erythematosus (or SLE, a disease of the immune system)
• if you have hemolytic uremic syndrome (or ‘HUS’, a disorder of blood coagulation causing failure of the kidneys)
• if you have sickle cell disease
• if you have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, or a neurological disease called Sydenham's chorea)
• if you have hereditary angioedema. Consult your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue or throat, and/or difficulty swallowing, or hives, together with difficulty breathing. Products containing estrogens may induce or worsen symptoms of angioedema

If any of the above conditions appears for the first time, recurs or worsen while using PRIMOLUT N, you should contact your doctor.

Do not share medicines prescribed for you with any other person. If you have sexual intercourse, you should use non-hormonal methods (for example a condom) of contraception instead of taking a contraceptive pill. If you think you might have become pregnant despite the protective measures, the treatment must be interrupted until the situation has been clarified by your doctor.

The following dosages are recommended:

• Dysfunctional bleeding Take one tablet of PRIMOLUT N 5 mg 3 times daily for 10 days. In the majority of cases this will stop bleeding from the womb (uterine bleeding) that is not caused by organic defects within 1 to 3 days, nevertheless to ensure treatment success PRIMOLUT N 5 mg tablets must be taken for the full 10 days. About 2 to 4 days after completion of the treatment, withdrawal bleeding will occur with the intensity and duration of normal menstruation. Occasionally, slight bleeding may occur after the initial cessation of bleeding. Do not stop or interrupt tablet intake if this occurs. If vaginal bleeding does not stop although you have taken your tablets correctly, an organic or extra-genital cause must be considered, which, if so, will mostly require other measures. This also applies when after an initial cessation of bleeding, fairly heavy bleeding reoccurs during tablet intake. If this happens you should contact your doctor.
• Primary and secondary amenorrhea Hormone treatment of secondary amenorrhea can be carried out only after pregnancy is ruled out. Primary or secondary amenorrhea is sometimes caused by a prolactinoma (an alteration of a gland in the brain producing increased amounts of a hormone-like substance) which needs to be excluded by your doctor before starting treatment with PRIMOLUT N. Your doctor will prescribe you an estrogen (e.g. for 14 days) before you start with PRIMOLUT N 5 mg. Thereafter you take 1 tablet of PRIMOLUT N 5 mg 1 to 2 times daily for 10 days. Withdrawal bleeding occurs within a few days of intake of the last tablet. If sufficient estrogen production in your body has been achieved, an attempt can be made to stop the estrogen treatment and to trigger cyclical bleeding by administering 1 tablet of PRIMOLUT N 5 mg twice daily from the 16th to the 25th day of the cycle.
• Premenstrual syndrome, cyclical mastopathy One tablet of PRIMOLUT N 5 mg taken 1 to 3 times daily during the 2nd half (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 postponed with administration of PRIMOLUT N 5 mg. However, this method should be used by you only if you are not at risk of pregnancy during the treatment cycle. Take 1 tablet PRIMOLUT N 5 mg 2 to 3 times daily for no longer than 10 to 14 days, beginning about 3 days before the expected menstruation. Bleeding will occur 2 to 3 days after medication has been stopped.
• Endometriosis Start treatment between the first and 5th day of the cycle with 1 tablet PRIMOLUT N 5 mg twice daily. If spotting occurs, the dose can be increased to 2 tablets twice daily. If bleeding ceases, you may consider returning to the initial dose. Continue treatment for at least 4 to 6 months. With uninterrupted daily intake, ovulation and menstruation do not usually occur. After stopping the hormone treatment withdrawal bleeding will occur.

If you take more PRIMOLUT N than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital of poison centre. There have been no reports of serious harmful effects from taking too many PRIMOLUT N tablets at one time. If you have taken several tablets at a time, you may experience nausea, vomiting or vaginal bleeding.

If you forget to take PRIMOLUT N If you forget a dose, wait until it is time to take your next prescribed dose. Do not take the missed dose. Do not take a double dose to make up for forgotten individual doses.

If you stop taking PRIMOLUT N There are no specific withdrawal symptoms if you stop PRIMOLUT N but there is the possibility that the original complaints re-occur.

PRIMOLUT N can have side effects. Not all side-effects reported for PRIMOLUT N are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PRIMOLUT N, please consult your health care provider for advice. Side effects are more common during the first months of treatment with PRIMOLUT and disappear with continued treatment. In addition to the side effects listed in the section entitled “Warnings and precautions” the following side effects have been reported in users of PRIMOLUT preparations, although PRIMOLUT could not always be confirmed as the cause. Below we list possible side effects by the parts of the body they affect and by how common they are:

Frequent

• Uterine/Vaginal bleeding including Spotting*
• Weak periods (Hypomenorrhea)*
• Headache
• Nausea
• Absence of periods (Amenorrhea)*
• Generalized swelling (Oedema)

Less frequent

• Migraine
• Hypersensitivity reactions
• Nettle rash (Urticaria)
• Rash
• Visual disturbances
• Shortness of breath (Dyspnoea)

* if taken for Endometriosis

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of PRIMOLUT N.

Store at or below 30 °C. Keep in well closed containers and protect from light. Store all medicines out of reach of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).