Nazione: Paesi Bassi
Lingua: olandese
Fonte: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DIENOGEST
Hormosan Pharma GmbH
G03DB08
DIENOGEST
Filmomhulde tablet
HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; KATOENZAADOLIE, GEHYDREERD ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
Dienogest
2019-10-17
PACKAGE LEAFLET: INFORMATION FOR THE USER DIENOGEST HORMOSAN 2 MG FILMOMHULDE TABLETTEN dienogest READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dienogest Hormosan is and what it is used for 2. What you need to know before you take Dienogest Hormosan 3. How to take Dienogest Hormosan 4. Possible side effects 5. How to store Dienogest Hormosan 6. Contents of the pack and other information 1. WHAT DIENOGEST HORMOSAN IS AND WHAT IT IS USED FOR Dienogest Hormosan is a preparation for the treatment of endometriosis (painful symptoms due to displaced tissue of the lining of the womb). Dienogest Hormosan contains a hormone, the progestogen dienogest. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIENOGEST HORMOSAN _ _ DO NOT TAKE DIENOGEST HORMOSAN 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 “Dienogest Hormosan and venous blood clots” below - 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 "Dienogest Hormosan and arterial blood clots" below - have DIABETES with blood vessel damage - 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 - have or have ever h Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dienogest Hormosan 2 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg dienogest Excipient with known effect: Each tablet contains 54.3 mg lactose (as monohydrate). Each tablet contains 0.2 mg sodium. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White, round, biconvex film-coated tablets with a embossed “2” on one side and an approximate diameter and thickness of 6.1 mm and 2.7 mm, respectively. 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 Dienogest Hormosan 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. There is no experience with Dienogest Hormosan treatment >15 months in patients with endometriosis. Treatment can be started on any day of the menstrual cycle. Any hormonal contraception needs to be stopped prior to initiation of Dienogest Hormosan. If contraception is required, non-hormonal methods of contraception should be used (e.g. barrier method). _Management of missed tablets: _ _ _ The efficacy of Dienogest Hormosan may be reduced in the event of missed tablets, vomiting and/or diarrhea (if occurring 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: _ _ _ Dienogest Hormosan is not indicated in children prior to menarche. Th Leggi il documento completo