Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levonorgestrel
Bayer Plc
G03AC03
Levonorgestrel
1.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07030500; GTIN: 5016703008729
1 Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes. If you have any doubts or queries about your medication, please contact your doctor or pharmacist. PACKAGE LEAFLET: INFORMATION FOR THE USER LEVONELLE ® 1500 MICROGRAM TABLET 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. - 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. WHAT IS IN THIS LEAFLET: 1. What Levonelle 1500 microgram tablet (hereinafter Levonelle 1500) is and what it is used for 2. What you need to know before you take Levonelle 1500 3. How to take Levonelle 1500 4. Possible side effects 5. How to store Levonelle 1500 6. Contents of the pack and other information 1. WHAT LEVONELLE 1500 IS AND WHAT IT IS USED FOR Levonelle 1500 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). Levonelle 1500 contains a synthetic hormone like active substance called levonorgestrel. It prevents about 84% of expected pr Lue koko asiakirja
OBJECT 1 LEVONELLE 1500 MICROGRAM TABLET Summary of Product Characteristics Updated 12-Dec-2017 | Bayer plc 1. Name of the medicinal product Levonelle ® 1500 microgram tablet 2. Qualitative and quantitative composition Each tablet contains 1500 micrograms of levonorgestrel Excipient with known effect: 142.5 mg lactose monohydrate. For excipients see section 6.1 3. Pharmaceutical form Tablet Almost white, flat, rimmed tablet of about 8 mm diameter with an impressed mark of “G00” on one side. 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 For oral 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 (ie 2 tablets taken together) for those women unable or unwilling to use Cu-IUD (see section 4.5). Levonelle 1500 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 Levonelle 1500 does not contraindicate the continuation of regular hormonal contraception. _Paediatric population_: There is no relevant use of Levonelle 1500 for children of prepubertal age in the indication emergency contraception Levonelle 1500 is not recommended in children. . 4.3 Contraindications Hypersensitivity to the active substance or any of the excipients listed in section 6.1. 4.4 Special warnings and precautions for use Emergency contraception is an occasional method. It shou Lue koko asiakirja