Country: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ULIPRISTALACETAAT
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
G03AD02
ULIPRISTALACETAAT
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
Oraal gebruik
Ulipristal
2019-09-19
Sandoz B.V. Page 1/8 Ulipristalacetaat Sandoz 30 mg, filmomhulde tablet RVG 122840 1313-v3 1.3.1.3 Package leaflet Mei 2022 BIJSLUITER: INFORMATIE VOOR DE PATIËNT ULIPRISTALACETAAT SANDOZ 30 MG, FILMOMHULDE TABLET ulipristalacetaat _ _ 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 doctor or pharmacist 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 doctor or pharmacist This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [NATIONALLY COMPLETED NAME] IS AN EMERGENCY CONTRACEPTIVE [Nationally completed name] 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. [NATIONALLY COMPLETED NAME] 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 symp Baca dokumen lengkap
Sandoz B.V. Page 1/13 Ulipristalacetaat Sandoz 30 mg, filmomhulde tablet RVG 122840 1311-v4 1.3.1.1 Samenvatting van de Produc Februari 2022 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ulipristalacetaat Sandoz 30 mg, filmomhulde tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30 mg of ulipristal acetate. Excipients with known effect Each film-coated tablet contains 228 mg lactose. Each film-coated tablet contains less than 1 mmol (23 mg) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Round, white, biconvex, film-coated tablet, embossed with “U30” on one side, with a diameter of approximately 9 mm and thickness of 4.5 mm. 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 (see sections 4.4 and 4.6). Sandoz B.V. Page 2/13 Ulipristalacetaat Sandoz 30 mg, filmomhulde tablet RVG 122840 1311-v4 1.3.1.1 Samenvatting van de Produc Februari 2022 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. Adoles Baca dokumen lengkap