国: スウェーデン
言語: スウェーデン語
ソース: Läkemedelsverket (Medical Products Agency)
dienogest
Laboratorios Leon Farma S.A.
G03DB08
dienogest
2 mg
Tablett
laktosmonohydrat Hjälpämne; dienogest 2 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 1 x 28 tabletter (kalenderförpackning); Blister, 3 x 28 tabletter (kalenderförpackning); Blister, 6 x 28 tabletter (kalenderförpackning)
Godkänd
2019-06-07
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DIENOGEST LEÓN FARMA 2 MG TABLETS 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. Do not pass it on to others. It may harm them, even if their symptoms 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. Whatis and what it is used for 2. What you need to know before you take 完全なドキュメントを読む3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR is a preparation for the treatment of endometriosis (painful symptoms due to displaced tissue of the lining of the womb). contains a hormone, the progestogen dienogest. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE 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 _“ 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 _" 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 had a BENIGN OR MALIGNANT LIVER TUMOUR
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dienogest León Farma 2 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg dienogest Excipient with known effect: each tablet contains 60.9 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White, round, tablets with a diameter of 5 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of endometriosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology:_ The dosage ofis 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 完全なドキュメントを読む. If contraception is required, non-hormonal methods of contraception should be used (e.g. barrier method). _Management of missed tablets:_ The efficacy of 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:_ is not indicated in children prior to menarche. The safety and efficacy of dienogest 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 is no relevant indication for use of in the Geriatric population. _Patients with hepatic impa