Krajina: Európska únia
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
ulipristal
Laboratoire HRA Pharma
G03AD02
ulipristal acetate
Sex hormones and modulators of the genital system, , Emergency contraceptives
Contraception, Postcoital
Emergency contraception within 120 hours (five days) of unprotected sexual intercourse or contraceptive failure.
Revision: 30
Authorised
2009-05-15
37 B. PACKAGE LEAFLET 38 PACKAGE LEAFLET: INFORMATION FOR THE USER ELLAONE 30 MG 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 ellaOne is and what it is used for 2. What you need to know before you take ellaOne 3. How to take ellaOne 4. Possible side effects 5. How to store ellaOne 6. Contents of the pack and other information - Useful information about contraception 1. WHAT ELLAONE IS AND WHAT IT IS USED FOR ellaOne is an emergency contraceptive ellaOne 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 it is more effective if you take it as soon as possible after unprotected sex. This medicine is suitable for any woman of childbearing age, including adolescents. You can take the tablet at any time in the menstrual cycle. ellaOne 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 taki Prečítajte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ellaOne 30 mg tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg ulipristal acetate. Excipients with known effect Each tablet contains 237 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet White to marble creamy, round curved tablet of 9 mm diameter engraved with _“еllа”_ on both sides. 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. The 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 ulipristal acetate can be made. _Severe hepatic impairment_ In the absence of specific studies, ulipristal acetate is not recommended. _Paediatric population _ There is no relevant use of ulipristal acetate for children of prepubertal age in the indication emergency contraception _. _ 3 Adolescents: ulipristal acetate for emergency contraception 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 6.1 4.4 SPECI Prečítajte si celý dokument