Solvetta 2 mg Tablets

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

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

• If you are hypersensitive (allergic) to dienogest or any other ingredients in SOLVETTA (see WHAT SOLVETTA CONTAINS).
• If you are suffering from blood clots (thromboembolic disorder) in your veins. Thrombosis is the formation of a blood clot which blocks 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 supply to the heart which cause reduced blood supply to the heart (angina pectoris).
• If you have a condition in which the body does not produce enough insulin or else the body tissues are not able to use the insulin present. This leads to hyperglycaemia (too much sugar in the blood).
• 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 include; fever, yellowing of the skin and eyes, itching and dark coloured urine.
• If you have or have ever had a non-invasive or invasive cancer of the liver.
• If you suffer or have ever suffered from malignant 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 SOLVETTA see section “What SOLVETTA contains”.

If any of these conditions appear for the first time while using SOLVETTA, stop taking it at once or consult your doctor.

Do not share medicines prescribed for you with any other person. Always take your SOLVETTA tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. 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 usual dose is one SOLVETTA 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. Your doctor will tell you how long your treatment with SOLVETTA will last. Do not stop treatment early If you have the impression that the effect of SOLVETTA is too strong or too weak, tell your doctor or pharmacist.

If you take more SOLVETTA than you should You should not take more than what your doctor tells you to. Overdosage may potentiate adverse effects (see “possible side effects”). In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Take this leaflet and any remaining tablets with you so that the doctor knows what you have taken.

If you forget to take SOLVETTA The efficacy of SOLVETTA may be reduced in the event of missed tablets, vomiting and/or diarrhoea (if occurring within 3 to 4 hours after taking the tablet). In the event of missed tablet(s), you should take one tablet only, as soon as you remember, and should then continue the next day to take the tablet at your usual time. A tablet not absorbed due to vomiting or diarrhoea should likewise be replaced by one tablet. Do not take a double dose to make up for forgotten individual doses. If you stop taking SOLVETTA If you stop taking SOLVETTA, your original endometriosis complaints may re-occur. Your doctor will tell you for how long you should take SOLVETTA.

SOLVETTA can have side effects. Not all side effects reported for SOLVETTA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following possible signs of thrombosis happens, stop taking SOLVETTA and tell your doctor immediately or go to casualty department at your nearest hospital:

• Breathlessness, which may be very severe and usually worsens on lying down,
• Severe pain in the chest which may reach the left arm,
• Dizziness or fainting,
• Weakness or numbness in any part of your body,
• Severe pain or swelling in either of your legs.

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

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

• A lump in your breast,
• Unusual, heavy vaginal bleeding,
• Any unusual, severe or prolonged headache or migraine attack,
• Severe pain in your abdomen,
• An unusual cough,
• Partial or complete loss of vision, or double vision,
• Slurring or speech disability,
• Sudden changes to your hearing, sense of smell or taste,
• Other abdominal complaints that are different to the symptoms you commonly experience from your endometriosis.

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

• Weight gain,
• Depressed mood (including thoughts of suicide), 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.

Tell your doctor if you notice any of the following side effects that have been reported less frequently:

• 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 lump in the breast (breast mass, fibrocystic breast disease, breast induration),
• Swelling due to fluid retention,
• You feel a lump in your breast,
• You have unusual, heavy vaginal bleeding,
• You experience other abdominal complaints, if they are different to the symptoms you commonly experience from your endometriosis, you should contact your doctor immediately because extra-uterine pregnancy or an internal bleeding from a liver tumour must be considered.

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 SOLVETTA.

Store at or below 25 °C. Store in the original package in order to protect from light. KEEP OUT OF THE REACH OF CHILDREN. Do not use after the expiry date printed on the label or carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).