País: Países Bajos
Idioma: neerlandés
Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LEVONORGESTREL 0,75 mg/stuk
Laboratorios Leon Farma, S.A. C/ La Vallina s/n. P.I Navatejera 24008 NAVATEJERA (LEON) (SPANJE)
G03AD01
LEVONORGESTREL 0,75 mg/stuk
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188, CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188
Oraal gebruik
Levonorgestrel
2014-04-30
LF-Levo-NL-NL.H.2749.001.IB.012-Day 0 PACKAGE LEAFLET: INFORMATION FOR THE USER _TANSY 750 MICROGRAM TABLETTEN _ Levonorgestrel READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. . • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. FOR OTC PRODUCTS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told to 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 of pharmacist. This include any possible effect not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Tansy 750 microgram tabletten is and what it is used for 2. What you need to know before you take Tansy 750 microgram tabletten 3. How to take Tansy 750 microgram tabletten 4. Possible side effects 5. How to store Tansy 750 microgram tabletten 6. Content of the pack and other information 1. WHAT TANSY 750 MICROGRAM TABLETTEN IS AND WHAT IT IS SUED Tansy 750 microgram tabletten is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual method of contraception has failed. When should emergency contraception be used? • No contraception was used during the sexual intercourse • The contraception measure was used incorrectly, for example as if a condom was penetrated, slipped away or used in a wrong way, if vaginal pessary or diaphragm changed position, burst, was broken or taken ou Leer el documento completo
1 SPC-Levo-NL-NL.H.2749.001.IB.012-Day 0 Page 1/8 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tansy 750 microgram tabletten. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 750 micrograms of levonorgestrel. Excipient with known effect: 44 mg of lactose monohydrate For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. Tansy 750 microgram tabletten tablet is round and white, with approximate 6 mm of diameter and marked “C” on one side and “2” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraception method. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Two tablets should be taken together as soon as possible, preferably within 12 hours and no later than 72 hours after unprotected intercourse (see section 5.1). If vomiting occurs within three hours of taking the tablets, another two tablets should be taken immediately. Women who have used enzyme-inducing drugs during the last 4 weeks and need emergency contraception are recommended to use a non-hormonal EC(emergency contraception), i.e. Cu-IUD or take a double dose of levonorgestrel (i.e. 4 tablets taken together) for those women unable or unwilling to use Cu-IUD (see section 4.5). Tansy 750 microgram tabletten can be used at any time during the menstrual cycle unless menstrual bleeding is overdue. After using emergency contraception, it is recommended to use a local barrier method (e.g. condom, diaphragm, spermicide, cervical cap) until the next menstrual period starts. The use of Tansy 750 microgram tabletten does not contraindicate the continuation of regular hormonal contraception. 2 SPC-Levo-NL-NL.H.2749.001.IB.012-Day 0 Page 2/8 _ _ _ _ _Paediatric population _ _ _ There is no relevant use of Tansy 750 microgram tabletten for children of prepubertal age in the indication emergency contraception. Method of administration For oral administration. 4.3 CONTRAINDICATIONS H Leer el documento completo