Visafem 2 mg Tablets

VISAFEM contains a hormone, the progestogen dienogest. VISAFEM is a preparation for the treatment of endometriosis (painful symptoms in which the lining of the womb grows outside the womb).

Do not take VISAFEM:

• if you are hypersensitive (allergic) to dienogest or any of the other ingredients of VISAFEM (listed in section 6)
• if you are pregnant or suspect pregnancy
• if you are breastfeeding your baby
• if you are suffering from a blood clot (thromboembolic disorder) in your veins. This may occur, for example, in the blood vessels of the legs (deep vein thrombosis) or the lungs (pulmonary embolism). See also “VISAFEM and venous blood clots” below
• if you have or have ever had a severe arterial disease, including cardiovascular disease, such as a heart attack, stroke or heart disease which causes a reduced blood supply (angina pectoris). See also “VISAFEM and arterial blood clots” below
• if you have diabetes with blood vessel damage
• if you have or have ever had severe liver disease (and your liver function values have not returned to normal). Symptoms of liver disease may be yellowing of the skin and/or itching of the whole body
• if you have or have ever had a benign or malignant liver tumour
• if you suffer or have ever suffered, or if it is suspected that you suffer from a malignant sex-hormone dependent tumour such as cancer of the breast or the genital organs
• if you have any unexplained vaginal bleeding.

Warnings and precautions

Take special care with VISAFEM: You must not use hormonal contraceptives of any form (tablet, patch, intrauterine system) while taking VISAFEM. VISAFEM is NOT a contraceptive. If you want to prevent pregnancy, you should use condoms or other non-hormonal contraceptive precautions. Tell your doctor if any of the following conditions applies to you:

• if you have conditions of the uterus, these conditions may cause your menstrual bleeding (period) to be heavier than usual and continue for longer than usual
• if you have ever had a blood clot (venous thromboembolism) or anyone in your immediate family has had a blood clot at a relatively early age
• if you are overweight
• if you become immobile due to any reason, the use of VISAFEM should be stopped. Talk to your doctor about this before you stop taking VISAFEM
• if you have to go for surgery, treatment with VISAFEM should be stopped 4 weeks before surgery. Your doctor will tell you when you can start taking VISAFEM again
• if you experience symptoms such as pain and swelling in one leg, chest pain or numbness on one side of your body talk to your doctor immediately. These symptoms may be an indication of a blood clot and treatment with VISAFEM should be stopped immediately
• it is important to self-examine your breasts on a regularly basis for possible lumps or swelling. If you feeling anything unusual during your self-examination please contact your doctor immediately
• if you experience upper stomach pain, yellowing of the whites of the eyes and skin, nausea (being sick), vomiting (feeling sick), chest pain, shortness of breath, blood in your urine, contact your doctor immediately
• if you have a family history or if you have been diagnosed with osteoporosis (a condition in which the bones become brittle and fragile from loss of tissue, typically as a result of hormonal changes or deficiency of calcium or vitamin D)
• if you have ever suffered from depression
• if you have high blood pressure or develop high blood pressure while taking VISAFEM
• if you develop a liver disease while taking VISAFEM. Symptoms may include yellowing of the skin or eyes or itching all over your body
• if you have diabetes or had diabetes temporarily during previous pregnancy
• if you have ever had chloasma (golden-brown patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation while taking VISAFEM
• if you become pregnant while taking VISAFEM, consult your doctor immediately
• if you suffer from pain in your lower abdomen, breast tenderness, changes in your menstrual cycle (period) while taking VISAFEM, these may be symptoms of ovarian cysts (a solid or fluid-filled sac or pocket (cyst) within or on the surface of an ovary

Do not share medicines prescribed for you with any other person. Always take VISAFEM exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. You can start treatment with VISAFEM on day one of your natural cycle. Adults: take one tablet every day, preferably at the same time with some liquid as needed. When a pack is finished the next one should be started without interruption. Continue to take the tablets also on days of menstrual bleeding.

If you take more VISAFEM than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take a dose of VISAFEM

If you vomit within 3-4 hours of taking VISAFEM or you have severe diarrhoea, there is a risk that the active substance in the tablet will not be taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea within 3-4 hours of taking VISAFEM, you should take another tablet as soon as possible. Do not take a double dose to make up for forgotten individual doses.

If you stop taking VISAFEM

Do not stop taking PRODUCT NAME, unless your doctor has instructed you to do so. If you stop taking VISAFEM, your original endometriosis symptoms may return.

VISAFEM can have side effects. Not all side effects reported for VISAFEM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VISAFEM, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop taking VISAFEM and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to VISAFEM. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Less frequent:
• changes in the way your heart beats, for example, if you notice it beating faster
• shortness of breath, difficulty breathing
• a frequent or intense urge to pee, even though little comes out when you do, burning when you pee, strange-smelling pee, fever, feeling tired, pain in your lower back.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent:
• weight gain
• feeling depressed and/or nervous, sleeping problems
• changes in your mood, loss of sex drive
• headache, migraine (throbbing headache usually on one side of your head with sensitivity to light and sound, nausea and vomiting)
• nausea (feeling sick), stomach pain, flatulence (passing wind), bloating and swelling in the belly area, vomiting (being sick)
• acne, hair loss (temporarily)
• back pain
• breast tenderness, pelvic and lower back pain, hot flushes, menstrual bleeding between your periods (spotting)
• chronic tiredness, irritability.

Less frequent:

• dizziness
• weight loss, increased appetite
• feeling anxious, mood swings
• sweating abnormalities, which could alternate between sweating too much and not sweating enough
• high activity level with a short attention span
• dry eyes, tinnitus (ringing in the ears)
• low blood pressure (feeling lightheaded)
• diarrhoea (loose stool), constipation
• swollen, puffy, dark red, sensitive gums
• dry, itchy skin
• abnormal growth of hair on a woman's face and body
• nail disorders (loosening or separation of a fingernail or toenail from its nail bed)
• dandruff (small pieces of dead skin in your hair)
• red, swollen and sore skin sometimes with small blisters
• abnormal hair growth
• patchy loss of skin colour, which usually first appears on the hands and face
• pain and heaviness in the arms and legs, involuntary contractions of a muscle, pain in your bones
• itching, irritation or sore in or around the vagina, vaginal discharge
• swelling of all or part of the breast(s), breast lumps.

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 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 VISAFEM.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 30 °C. Store in the outer carton box packaging to protect from light. Do not use after the expiry date stated on the label / carton / bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).