Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ulipristal Acetate; ULIPRISTAL ACETATE
HYPHENS PHARMA SDN. BHD.
Ulipristal Acetate; ULIPRISTAL ACETATE
1tablet Tablets
CENEXI
ELLA ® 30MG TABLET _Ulipristal acetate 30mg _ _Consumer Medication Information Leaflet (RiMUP)_ 1 WHAT IS IN THIS LEAFLET 1. What Ella is used for 2. How Ella works 3. Before you take Ella 4. How to take Ella 5. While you are taking Ella 6. Side effects 7. Storage and disposal of Ella 8. Product description 9. Manufacturer & Product Registration Holder 10. Date of revision 11. Serial number 1. WHAT ELLA IS USED FOR Ella is an emergency contraceptive intended to prevent pregnancy after unprotected sex or if your contraceptive method has failed. For example: - if you 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. This medicine is suitable for any woman of childbearing age, including adolescents. You can take the tablet at any time in the menstrual cycle. 2. HOW ELLA WORKS Ella 30mg tablet contains the substance _ulipristal _ _acetate_ which acts by modifying the activity of the natural hormone progesterone which is necessary for ovulation to occur. As a result, this medicine works by postponing ovulation. Emergency contraception is not effective in every case. Of 100 women who take this medicine, approximately 2 will become pregnant. This medicine is a contraceptive used to prevent a pregnancy from starting. If you are already pregnant, it will not interrupt an existing pregnancy. Ella 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, it will not stop you from becoming pregnant. Unprotected sex at any time during your cycle can lead to pregnancy. Ella is not used for regular contraception. Emergency contraception does not protect against sexually transmitted infections. Only condoms can protect you from sexual Прочитајте комплетан документ
D3, PROPOSED PI FOR ELLA (CLEAN COPY) 1. NAME OF THE MEDICINAL PRODUCT Ella 30 mg tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg ulipristal acetate. Excipients with known effect: Each table contains 237mg 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 engraved with code _“еllа” _ on both faces 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. Ella can be taken at any time during the menstrual cycle If vomiting occurs within 3 hours of Ella 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 Ella is administered. _Special populations_ _ _ _Renal impairment: _ No dose adjustment is necessary _ _ _Hepatic impairment _ In the absence of specific studies, no alternate dose recommendations for Ella can be made. _Severe hepatic impairment:_ In the absence of specific studies, Ella is not recommended. _Paediatric population _ There is no relevant use of Ella for children of prepubertal age in the indication emergency contraception _._ Adolescents: Ella 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. This 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 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Ella is for occasional use only. It should in no instance replace a regular contraceptiv Прочитајте комплетан документ