Χώρα: Ολλανδία
Γλώσσα: Ολλανδικά
Πηγή: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LEVONORGESTREL 1,5 mg/stuk
Healthypharm B.V. Nieuwe Donk 3 4879 AC ETTEN-LEUR
G03AD01
LEVONORGESTREL 1,5 mg/stuk
Tablet
LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551),
Oraal gebruik
Levonorgestrel
Hulpstoffen: LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; POVIDON K 25 (E 1201); SILICIUMDIOXIDE (E 551);
1900-01-01
PL Levonorgestrel PT1531, deletion of BRS, update of EEA product list 2023-03 PACKAGE LEAFLET Package leaflet: Information for the user Levonorgestrel HTP 1,5 mg, tabletten Levonorgestrel [FOR MEDICINES AVAILABLE WITHOUT A PRESCRIPTION:] 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. See section 4. WHAT IS IN THIS LEAFLET 1. Whatis and what it is used for 2. What you need to know before you take Διαβάστε το πλήρες έγγραφο3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed. It is about the following cases: • 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 out ahead of time, in the case of a failed interruption during coitus interruptus (e.g. sperm ejaculated in vagina or on external genitalia). contains a synthetic hormone like active substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is better to take it withi
SmPC Levonorgestrel PT1531, change of address of the MAH and BRS 2021-07 Page 1 of 7 SUMMARY OF PRODUCTS CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levonorgestrel HTP 1,5 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.5 mg of levonorgestrel. Excipient with known effect Each tablet contains 154 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Round, white to off-white, 8.00 mm diameter, uncoated flat tablets debossed ‘1.5’ on one side and other side plain. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One tablet should be taken 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 tablet, another tablet 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, i.e. Cu-IUD or take a double dose of levonorgestrel (i.e. 2 tablets taken together) for those women unable or unwilling to use Cu- IUD (see section 4.5).1.5 mg 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 barrier method (e.g. condom, diaphragm or cap) until the next menstrual period starts. The use of Διαβάστε το πλήρες έγγραφο1.5 mg does not contraindicate the continuation of regular hormonal contraception. SmPC Levonorgestrel PT1531, change of address of the MAH and BRS 2021-07 Page 2 of 7 _Paediatric population: _ There is no relevant use of for children of prepubertal age in the indication emergency contraception. Method of administration For oral use. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the