Țară: Țările de Jos
Limbă: olandeză
Sursă: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ESTRIOL 50 µg/g
Italfarmaco, S.A. C/ San Rafael, 3 Poligono Industrial 28108 ALCOBENDAS (SPANJE)
G03CA04
ESTRIOL 50 µg/g
Gel voor vaginaal gebruik
CARBOMEER 971P ; GLYCEROL (E 422) ; NATRIUMHYDROXIDE (E 524) ; NATRIUMMETHYLPARAHYDROXYBENZOAAT (E 219) ; NATRIUMPROPYLPARAHYDROXYBENZOAAT ; POLYCARBOFIL ; WATER, GEZUIVERD ; ZOUTZUUR (E 507), CARBOMEER 971P ; GLYCEROL (E 422) ; NATRIUMHYDROXIDE (E 524) ; NATRIUMMETHYLPARAHYDROXYBENZOAAT (E 219) ; NATRIUMPROPYLPARAHYDROXYBENZOAAT (E 217) ; POLYCARBOFIL ; WATER, GEZUIVERD ; ZOUTZUUR (E 507),
Vaginaal gebruik
Estriol
Hulpstoffen: CARBOMEER 971P; GLYCEROL (E 422); NATRIUMHYDROXIDE (E 524); NATRIUMMETHYLPARAHYDROXYBENZOAAT (E 219); NATRIUMPROPYLPARAHYDROXYBENZOAAT (E 217); POLYCARBOFIL; WATER, GEZUIVERD; ZOUTZUUR (E 507);
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER BLISSEL 50 MICROGRAM/G, GEL VOOR VAGINAAL GEBRUIK Estriol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Blissel is and what it is used for 2. What you need to know before you use Blissel 3. How to use Blissel 4. Possible side effects 5. How to store Blissel 6. Contents of the pack and other information 1. WHAT BLISSEL IS AND WHAT IT IS USED FOR Blissel belongs to a group of medicines called vaginal (local) Hormone Replacement Therapy (HRT). It is used to relieve menopausal symptoms in the vagina such as dryness or irritation. In medical terms this is known as ‘vaginal atrophy’. It is caused by a drop in the levels of oestrogen in your body. This happens naturally after the menopause. Blissel works by replacing the oestrogen which is normally produced in the ovaries of women. It is inserted into your vagina, so the hormone is released where it is needed. This may relieve discomfort in the vagina. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BLISSEL 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 whether to carry on taking it. Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary. Once you have started on Blissel you should see your doctor for regular check Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Blissel 50 microgram/g, gel voor vaginaal gebruik 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g vaginal gel contains 50 micrograms estriol. Excipients: 1 g vaginal gel contains 1.60 mg of sodium methyl parahydroxybenzoate and 0.20 mg of sodium propyl parahydroxybenzoate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal gel Gel homogeneous, colourless, clear to slightly translucent. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of symptoms of vaginal atrophy due to oestrogen deficiency in postmenopausal women 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Blissel 50 micrograms/g vaginal gel is an estrogen-only product for vaginal use. Guidance on how to start therapy and maintenance Blissel can be started any time after the manifestation of atrophic vaginitis. Initial treatment: One applicator-dose of vaginal gel per day for 3 weeks (suitably at bedtime). As maintenance treatment one applicator-dose of vaginal gel twice a week (suitably at bedtime) is recommended. An evaluation of treatment continuation after 12 weeks should be carried out by the physician. For initiation and continuation of treatment of post- menopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4) should be used. For oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains within the normal postmenopausal range, it is not recommended to add a progestagen (but see section 4.4). A missed dose should be administered as soon as remembered, unless it is more than 12 hours overdue. In the latter case the missed dose should be skipped and the next dose should be administered at the normal time. Administration: Blissel has to be applied into the vagina using a dose-marked applicator, following carefully “Instructions for use” included in the information leaflet, and below. One applicator-dose (applicator filled to the mark) delivers a dose of 1 g vaginal gel cont Citiți documentul complet