Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
DIENOGEST
BAYER ISRAEL LTD
G03FA15
TABLETS
DIENOGEST 2 MG
PER OS
Required
BAYER WEIMAR GMBH UND CO.KG, GERMANY
DIENOGEST AND ESTROGEN
DIENOGEST AND ESTROGEN
Treatment of endometriosis.
2016-06-30
PACKAGING TECHNOLOGY BERLIN SGQCL page 1 Bayer AG client: JS86 material-no.: 88544374 PZ: 2599F-4A code-no.: 616 name: LF-VISABELLE TABL IL country: IL/-/BPH colors: BLACK version: 15.12.2021/01 Restricted Document dimension: 160 X 594 MM VISABELLE ® TABLETS Each tablet contains: Dienogest 2 mg Inactive ingredients and allergens: See section 6 “Further Information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1) WHAT IS THE MEDICINE INTENDED FOR? Visabelle is intended for the treatment of endometriosis (symptoms of pain due to displaced tissue of the lining of the womb). THERAPEUTIC GROUP: Visabelle belongs to a group of hormonal medicines called progestogens. 2) BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: ∙ You are pregnant or breastfeeding. ∙ You are SENSITIVE (ALLERGIC) to dienogest or to any of the other ingredients contained in the medicine. For the list of inactive ingredients, see section 6 “Further Information”. ∙ You suffer from a BLOOD CLOT (venous thrombosis) in the veins, for example, in the blood vessels of the legs (deep vein thrombosis) or in the lungs (pulmonary embolism). See “Visabelle and blood clots in the vein” in section 2. ∙ You suffer, or have suffered in the past, from a SEVERE ARTERIAL DISEASE, including a cardiovascular disease such as HEART ATTACK, STROKE or a HEART DISEASE which causes a reduced blood supply (angina pectoris). See “Visabelle and blood clots in the artery” in section 2. ∙ You suffer from DIABETES with vascular damage. ∙ You suffer, or have suffered in the past, from a SEVERE LIVER DISEASE (and liver function values are still not normal). Symptoms of liver disease may be yellowing of the skin and/or itching all over the bod Olvassa el a teljes dokumentumot
RESTRICTED SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Visabelle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg dienogest. Excipient with known effect: each tablet contains 62.8 mg lactose monohydrate. For the full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Tablet White to off-white, round, flat-faced, bevelled-edge tablets with a debossed “B” on one side and a diameter of 7 mm . 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of endometriosis . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Method of administration: _ For oral use. _ _ _Posology _ _ _ The dosage of Visabelle is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. The tablet can be taken with or without food. Tablets must be taken continuously without regard to vaginal bleeding. When a pack is finished the next one should be started without interruption. Treatment can be started on any day of the menstrual cycle. Any hormonal contraception needs to be stopped prior to initiation of Visabelle. If contraception is required, non-hormonal methods of contraception should be used (e.g. barrier method). RESTRICTED Management of missed tablets: The efficacy of Visabelle may be reduced in the event of missed tablets, vomiting and/or diarrhea (if occuring within 3-4 hours after tablet taking). In the event of one or more missed tablets, the woman should take one tablet only, as soon as she remembers, and should then continue the next day at her usual time. A tablet not absorbed due to vomiting or diarrhea should likewise be replaced by one tablet. _ADDITIONAL INFORMATION ON SPECIAL POPULATIONS _ _Paediatric population: _ Visabelle is not indicated in children prior to menarche. The safety and efficacy of Visabelle was investigated in an uncontrolled clinical trial over 12 months in 111 adolescent women (12-<18) with clinically suspected or confirmed endometriosis (see sections 4.4 and 5.1). _Geriatric population: _ There i Olvassa el a teljes dokumentumot