Страна: Нидерландия
Език: нидерландски
Източник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DIENOGEST 2 mg/stuk ; ESTRADIOLVALERAAT 1 mg/stuk
Exeltis Healthcare S.L Avenue Miralcampo 7, Poligono Ind. Miralcampo 19200 AZUQUECA DE HENARES (SPANJE)
G03FA15
DIENOGEST 2 mg/stuk ; ESTRADIOLVALERAAT 1 mg/stuk
Filmomhulde tablet
IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYVINYLALCOHOL (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Dienogest And Estrogen
Hulpstoffen: IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; POLYVINYLALCOHOL (E1203); POVIDON K 30 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);
2018-06-21
1 PL.DIEEV.CC.NL.H.3591.001.IB.015 PACKAGE LEAFLET: INFORMATION FOR THE USER VELBIENNE 1 MG/2 MG, FILMOMHULDE TABLETTEN estradiol valerate and 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 Прочетете целия документ3. 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 Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen and a progestogen. is used in postmenopausal women with at least 12 months since their last natural period. is used for: RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During the menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (“hot flushes”). alleviates these symptoms after menopause. You will only be prescribed if your symptoms seriously hinder your daily life. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEDICAL HISTORY AND REGULAR CHECK-UPS The use of HRT carries risks which need to be considered when deciding whether to start taking it, or 2 PL.DIEEV.CC.NL.H.3591.001.IB.015 whether to carry on taking it. The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using H
1 SPC.DIEEV.CC.NL.H.3591.001.IB.0015 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Velbienne 1 mg/2 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: estradiol valerate 1.0 mg (equivalent to 0.764 mg estradiol) and dienogest 2.0 mg Excipients with known effect: each tablet contains 58.22 mg of lactose monohydrate. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Tablets are light pink and rounded with a diameter of 6 mm approx. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC I NDICATIONS Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women with more than one year post menopause. Experience of treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology How to start1 mg/2 mg Women who do not take hormone replacement therapy (HRT) or women who change from another continuous combined HRT product may start treatment at any time. Women changing from a continuous sequential HRT regimen should begin the day following completion of the prior regimen. Women changing from a cyclic HRT regimen should begin the day after the treatment-free period. Dosage One tablet is taken daily. Each blister pack contains tablets for 28 days of treatment. 2 SPC.DIEEV.CC.NL.H.3591.001.IB.0015 Method of Administration For oral use. The tablets are to be swallowed whole with some liquid. Treatment is continuous, which means that the next pack follows immediately without a break. The tablets should preferably be taken at the same time every day. In case a tablet is forgotten it should be taken as soon as possible. If more than 24 hours have elapsed no extra tablet needs to be taken. If several tablets are forgotten, bleeding may occur. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4) should be used. Additional information on special populations Paedia Прочетете целия документ