Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ULIPRISTALACETAAT 30 mg/stuk
Helm AG Nordkanalstrasse 28 20097 HAMBURG (DUITSLAND)
G03AD02
ULIPRISTALACETAAT 30 mg/stuk
Filmomhulde tablet
HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD, HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD
Oraal gebruik
Ulipristal
2019-01-28
Seite 1 von 8 PACKAGE LEAFLET: INFORMATION FOR THE USER EVANTE 30 MG FILMOMHULDE TABLET Ulipristal acetate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other healthcare professional has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your pharmacist, doctor, or other healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What EVANTE is and what it is used for 2. What you need to know before you use EVANTE 3. How to use EVANTE 4. Possible side effects 5. How to store EVANTE 6. Contents of the pack and other information - Useful information about contraception 1. WHAT EVANTE IS AND WHAT IT IS USED FOR EVANTE is an emergency contraceptive EVANTE is a contraceptive intended to prevent pregnancy after unprotected sex or if your contraceptive method has failed. For example: • if you had sex without protection; • if your or your partner’s condom tore, slipped or came off, or if you forgot to use one; • if you did not take your contraceptive pill as recommended. You should take the tablet as soon as possible after sex, and within a maximum of 5 days (120 hours). This is because the sperm can survive up to 5 days in your body after intercourse. This medicine is suitable for any woman of childbearing age, including adolescents. You can take this tablet at any time in the menstrual cycle. EVANTE does not work if you are already pregnant. If your menstrual period is late, there is a possibility that you may be pregnant. When your period is late or when you have symptoms of pregnancy (heavy breasts, morning sickness) you should consult a doctor or other healthcare professional before taking the tablet. If you have unprotected sex after taking the tablet, Lees het volledige document
Seite 1 von 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Evante 30 mg filmomhulde tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg ulipristal acetate. Excipients with known effect: Each tablet contains 240.0 mg of lactose (as monohydrate) and 1.35 mg sodium. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet White, round, biconvex, film-coated tablet of 9.0 – 9.2 mm diameter embossed with _“U30” _ on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure. This tablet can be taken at any time during the menstrual cycle. If vomiting occurs within 3 hours of the tablet intake, another tablet should be taken. If a woman’s menstrual period is late or in case of symptoms of pregnancy, pregnancy should be excluded before the tablet is administered. Special populations _Renal impairment _ No dose adjustment is necessary. _Hepatic impairment _ In the absence of specific studies, no alternate dose recommendations for EVANTE can be made. _Severe hepatic impairment _ In the absence of specific studies, EVANTE is not recommended. _Paediatric population _ There is no relevant use of ulipristal acetate for children of prepubertal age in the indication emergency contraception _. _ Seite 2 von 10 Adolescents: ulipristal acetate is suitable for any woman of child bearing age, including adolescents. No differences in safety or efficacy have been shown compared to adult women aged 18 and older (see section 5.1). Method of administration Oral use. The tablet can be taken with or without food. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6. Lees het volledige document