Endoact 2 mg Tablets

ENDOACT is a hormone preparation for the long-term treatment of endometriosis (painful symptoms due to displaced tissue of the lining of the womb). ENDOACT contains a hormone, the progestogen dienogest. ENDOACT tablets cause the shrinking of the endometrial tissue and reduces associated complaints such as pelvic pain and painful monthly bleedings. ENDOACT is for use in adolescents after menarche (first menstrual bleeding) from 12 years of age onward, and adults.

Do not take ENDOACT:

• If you are hypersensitive (allergic) to dienogest or any of the other ingredients of ENDOACT (listed in section 6);
• if you are suffering from a blood clot (thromboembolic disorder) in your veins. Thrombosis is the formation of blood clots which block blood vessels. 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 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 instance, 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 any of these conditions appear for the first time while using ENDOACT, stop taking it at once or consult your doctor.

Do not share medicines prescribed for you with any other person. Always take ENDOACT exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The following statement applies to ENDOACT unless otherwise prescribed by your doctor. Please observe these instructions for use, otherwise you will not fully benefit from ENDOACT.

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 dosage of ENDOACT 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 for bleeding. This means that after the first pack has been finished the next should be started without interruptions.

Your doctor will tell you how long your treatment with ENDOACT will last. If you have the impression that the effect of ENDOACT is too strong or too weak, tell your doctor or pharmacist.

If you take more ENDOACT 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 ENDOACT

ENDOACT will be less effective if you miss a tablet. If you miss one or more tablets, take one tablet only as soon as you remember, and then continue the next day taking the tablet at your usual time. If you vomit within 3-4 hours of taking ENDOACT or you have severe diarrhoea, there is a risk that the active substance in the tablet will not be taken up by your body. This situation is almost the same as forgetting a tablet. After vomiting or diarrhoea within 3-4 hours of taking ENDOACT, you should take another tablet as soon as possible. Do not take a double dose to make up for a forgotten tablet. If you have missed several doses, consult your doctor.

If you stop taking ENDOACT

If you stop taking ENDOACT, your original endometriosis symptoms may return. Do not stop taking/using ENDOACT unless your doctor tells you to. If you have any further questions on how to take this medicine ask your doctor or pharmacist.

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

If any of the following happens, stop taking ENDOACT 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;
• skin rash, lesions, itchiness of the skin, blistering or peeling of the skin or any other type of skin irritation; or
• chest tightness, difficulty breathing, feeling dizzy or fainting due to low blood pressure.

These are all very serious side effects. If you have them, you may have had a serious reaction to ENDOACT. 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 possible signs of a blood clot:

• 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.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Weight gain;
• depressed mood, problems sleeping, nervousness, loss of 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 or irritability.

Less frequent side effects:

• Anaemia;
• weight loss or increase in appetite;
• anxiety, depression or mood swings;
• imbalance in the autonomic nervous system (controls unconscious bodily functions, e.g. perspiration) or disturbed attention;
• dry eye;
• tinnitus;
• unspecific circulatory problems or uncommon palpitations;
• 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, severe itching of the whole body, male pattern hair growth (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, hypersensitive response to light or problems with skin pigmentation;
• pains in your bones, muscle spasms, pains and/or a 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;
• swelling due to fluid retention.

Additional side effects in adolescents (12 to under 18 years): Loss of bone density. 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 healthcare professional. This includes any possible side effects not listed in this leaflet. You can report side effects to Actor Pharma (Pty) Ltd via email: [email protected] or telephonically on 011 312 3812. 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 ENDOACT.

Store at or below 25 °C in a cool, dry place. Store in the original packaging to protect from light and moisture. Store all medicines out of reach of children. Do not refrigerate or freeze. Do not use after the expiry date stated on the carton and blister strip. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).