Visanne 2 mg Tablets

VISANNE is a hormone preparation for the treatment of endometriosis (painful symptoms due to displaced tissue of the lining of the womb). VISANNE contains a hormone, the progestogen dienogest. VISANNE tablets cause the shrinking of the endometrial tissue and reduces associated complaints such as pelvic pain and painful monthly bleedings.

Do not take VISANNE: (You must not use VISANNE if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use VISANNE.)

• If you are suffering from blood clot (thromboembolic disorder) in your veins. Thrombosis is the formation of a blood clot which may block a blood vessel. Thrombosis sometimes occurs in the deep veins of the legs (deep vein thromboembolism). If this blood clot breaks away from the veins where it is formed, it may reach and block arteries of the lungs, causing a so-called “pulmonary embolism”. This may occur for example in the blood vessels of the legs (deep vein thrombosis) and the lungs (pulmonary embolism).
• If you have or have ever had several arterial diseases, including cardiovascular diseases such as a heart attack, stroke or heart diseases which cause reduced blood supply to the heart (angina pectoris).
• If you have diabetes mellitus.
• If you suffer or have ever suffered from severe liver disease (as long as your liver function values have not returned to normal). Symptoms of liver diseases may be, for instances, yellowing of the skin and/or itching of the whole body.
• If you have or have ever had a non-invasive or invasive cancer of the liver.
• If you suffer or have ever suffered from invasive sex hormone-dependent tumour such as cancer of the breast or the genital organs.
• If you have unexplained vaginal bleeding.
• If you are allergic to dienogest or any of the other ingredients of VISANNE see section “What VISANNE contains”. If any of these conditions appear for the first time while using VISANNE, stop taking it at once or consult your doctor.

Warnings and precautions:

You must not use hormonal contraceptives of any form (tablet, patch, intrauterine system) while taking VISANNE. VISANNE is NOT a contraceptive. If you want to prevent pregnancy, you should use condoms or other nonhormonal contraceptive precautions. In some situations you need to take special care while using VISANNE, and your doctor may need to examine you regularly. Tell your doctor if any of the following conditions applies to you:

• 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 have a close relative who has had breast cancer
• If you have ever suffered from depression
• If you have high blood pressure or develop high blood pressure while taking VISANNE
• If you develop a liver disease while taking VISANNE. Symptoms may include yellowing of the skin or eyes or itching all over your body. Inform your doctor also if such symptoms occurred during a previous pregnancy
• 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
• If you suffer from pain in your lower abdomen while taking VISANNE.

Always take VISANNE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The following statement applies to VISANNE unless otherwise prescribed by your physician. Please observe these instructions for use, otherwise you will not fully benefit from VISANNE.

Tablet-taking from the very first pack has to start on day 1 of the natural cycle (i.e. the first day of your menstrual bleeding). The recommended dose is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. Tablets must be taken throughout 28 days without regard to bleeding. This means that after the first pack has been finished, the next should be started without interruptions.

VISANNE can cause side effects. You may experience changes in your bleeding patterns, such as infrequent or frequent bleeding, irregular bleeding, prolonged bleeding, or your periods may stop completely. Stop taking VISANNE and see your doctor immediately if you notice possible signs of thrombosis which include:

• breathlessness;
• an unusual cough;
• severe pain in the chest which may reach the left arm;
• 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.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• a lump in your breast;
• unusual, heavy vaginal bleeding;
• other abdominal complaints that are different to the symptoms you commonly experience from your endometriosis.

In addition to the adverse effects listed in the other sections below, we list possible side effects:

Frequent:

• weight gain;
• depressed mood, problems sleeping, nervousness, loss on interest in sex, or changed mood;
• headache or migraine;
• nausea, abdominal pain, wind, swollen tummy or vomiting;
• acne or hair loss;
• back pain;
• breast discomfort, ovarian cyst or hot flushes;
• uterine/vaginal bleeding including spotting;
• weakness (asthenic conditions) or irritability.

Less frequent:

• weight loss or increased appetite;
• anxiety, depression or mood swings;
• imbalance in the autonomic nervous system (controls unconscious bodily functions e.g. perspiration) or disturbed attention;
• dry eyes;
• tinnitus;
• unspecified circulatory problems or palpitations (e.g. transient feeling of fatigue or dizziness);
• low blood pressure;
• shortness of breath;
• diarrhoea, constipation, abdominal discomfort, inflammation of the stomach and intestines (gastrointestinal inflammation), inflammation of the gums (gingivitis);
• dry skin, excessive sweating, itching of the whole body, male pattern hair growth (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, hypersensitive response to light or problem with skin pigmentation (e.g. patches of darker pigmentation in the facial area);
• pain in your bones, muscle spasm, pains and/or sensation of heaviness in your arms and hands or legs and feet;
• urinary tract infection;
• vaginal thrush, dryness of the genital area, vaginal discharge, pelvic pain, atrophic inflammation of the genitals with discharge (atrophic vulvovaginitis) or a lump or lumps in the breast (breast mass, fibrocystic breast disease, breast induration);
• swelling due to fluid retention.

Not all side effects reported for VISANNE are included in this leaflet. Should your general health worsen while taking VISANNE, please consult your doctor, pharmacist or healthcare professional for advice. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell 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 “6.04 Adverse Drug Reactions Form”, found online under SAHPRA’s publications: https//www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help more information on safety of VISANNE.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Store at or below 30 °C. Do not use VISANNE after the expiry date which is stated on the pack. Medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.