País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Levonorgestrel 1.5mg
CARSL Consulting
Levonorgestrel 1.5 mg
1.5 mg
Tablet
Active: Levonorgestrel 1.5mg Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Potato starch Purified talc
Blister pack, Aluminium/PVC, 1 tablet
Restricted
Restricted
Gedeon Richter Ltd
Package - Contents - Shelf Life: Blister pack, Aluminium/PVC - 1 tablets - 36 months from date of manufacture stored at or below 25°C
2004-05-11
LEVONELLE-1 CMI 1 CONSUMER MEDICINE INFORMATION LEVONELLE-1 _LEVONORGESTREL 1.5 MG TABLET _ READ THIS LEAFLET BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, nurse, pharmacist or family planning clinic. • This medicine has been prescribed for you personally and you should not pass it on to others. WHAT IS LEVONELLE-1 USED FOR AND HOW DOES IT WORK LEVONELLE-1 is an emergency contraceptive that can be used after unprotected sex or where a contraceptive method has failed. This type of contraception is often called "the morning-after pill". Each pack of LEVONELLE-1 contains a complete treatment which is one round, white tablet. This tablet contains 1.5 milligrams of levonorgestrel, which is the active ingredient. LEVONELLE-1 also contains the inactive ingredients: potato starch, maize starch, colloidal silica anhydrous, magnesium stearate, talc and lactose monohydrate. HOW DOES LEVONELLE-1 WORK? LEVONELLE-1 prevents about 84% of expected pregnancies when the tablet is taken within 72 hours (3 days) of unprotected sex. LEVONELLE-1 will not prevent a pregnancy in every instance, but the tablet is more effective the sooner it is taken after unprotected sex. It is better to take it within 12 hours rather than delay until the third day. LEVONELLE-1 is thought to work by: • Stopping your ovaries from releasing an egg; • Preventing sperm from fertilising any egg you may have already released; or • Stopping a fertilised egg from attaching itself to your womb lining. So LEVONELLE-1 stops a pregnancy before it is established. It does not work if you are already pregnant. LEVONELLE-1 CMI 2 BEFORE YOU USE LEVONELLE-1 If any of these apply to you, tell your doctor, nurse, or pharmacist before you take LEVONELLE-1, as emergency contraception may not be suitable for you. DO NOT TAKE LEVONELLE-1 IF: • you are p Llegiu el document complet
1 DATA SHEET LEVONELLE ® -1 _LEVONORGESTREL 1.5 MG TABLETS _ PRESENTATION Each round white tablet contains 1.5 mg of levonorgestrel. Do not halve tablet. Dose equivalence when the tablet is divided has not been established. USES ACTIONS The precise mode of action of LEVONELLE-1 is not known. At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest. It may also cause endometrial changes that discourage implantation. LEVONELLE-1 is not effective once the process of implantation has begun. At the recommended regimen, levonorgestrel is not expected to induce significant modification of blood clotting factors, and lipid and carbohydrate metabolism. EFFICACY It was estimated from the results of an earlier clinical study (Lancet, 1998; 352: 428- 433), that levonorgestrel, taken as two 750 microgram doses with a 12 hour interval, prevents 85% of expected pregnancies. Efficacy appears to decline with time of start of treatment after intercourse (95% within 24 hours, 85% 24-48 hours, 58% if started between 48 and 72 hours). Efficacy after 72 hours is not known. Results from a recent clinical study (Lancet 2002; 360: 1803-1810) showed that a 1500 microgram single dose of LEVONELLE-1, when taken within 72 hours of unprotected sex, prevented 84% of expected pregnancies. This was in comparison with 79% of expected pregnancies when two 750 microgram tablets were taken 12 hours apart). It is therefore, recommended that the complete course of one tablet of LEVONELLE-1 is taken as soon as possible (and no later than 72 hours) after unprotected intercourse. 2 PHARMACOKINETICS Orally administered levonorgestrel is rapidly and almost completely absorbed. The results of a pharmacokinetic study carried out with 15 healthy women showed that following ingestion of one tablet of Llegiu el document complet