País: Holanda
Língua: holandês
Origem: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ULIPRISTALACETAAT 30 mg/stuk
Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)
G03AD02
ULIPRISTALACETAAT 30 mg/stuk
Filmomhulde tablet
HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT (E468) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
Ulipristal
1900-01-01
Ulipristal acetate NL-H-4446_ PSUSA 01.2022 implemented 23.02.2022 C2-Internal PACKAGE LEAFLET: INFORMATION FOR THE USER MISSTALA 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 Misstala is and what it is used for 2. What you need to know before you take Misstala 3. How to take Misstala 4. Possible side effects 5. How to store Misstala 6. Contents of the pack and other information - Useful information about contraception 1. WHAT MISSTALA IS AND WHAT IT IS USED FOR Misstala is an emergency contraceptive Misstala 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 the tablet at any time in the menstrual cycle. Misstala 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 profess Leia o documento completo
Ulipristal acetate NL-H-4446_ renewal 20.6.2023 C2-Internal SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Misstala 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). 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. 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. Ulipristal acetate NL-H-4446_ renewal 20.6.2023 C2-Internal _ _ _Paediatric population _ There is no relevant use of ulipristal acetate for children of prepubertal age in the indication emergency contraception _. _ 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 tak Leia o documento completo