Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVONORGESTREL
PAHANG PHARMACY SDN. BHD.
LEVONORGESTREL
10Tablet Tablets; 2Tablet Tablets
Gedeon Richter Plc.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ POSTINOR-2 ® TABLETS Levonorgestrel (0.75 mg) 1 WHAT IS IN THIS LEAFLET 1. What _Postinor-2_ is used for 2. How _Postinor-2_ works _3._ _ _ Before you use _Postinor-2 _ 4. How to use _Postinor-2_ 5. While you are using it 6. Side effects _7._ _ _ Storage and Disposal of _Postinor-2 _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _POSTINOR-2_ IS USED FOR _Postinor-2_ tablet is an emergency contraceptive preparation that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed. HOW _POSTINOR-2_ WORKS _Postinor-2_ tablet contains a synthetic hormone-like active substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours (3 days) of having unprotected sex. It will not prevent a pregnancy in every time _Postinor-2_ tablet is thought to work by: • stopping your ovaries from releasing an egg; • preventing sperm from fertilising any egg you may have already released. _Postinor-2_ can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. BEFORE YOU USE _POSTINOR-2 _ _- When you must not use it _ - If you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section Product Description). - A previous ectopic pregnancy or previous infection of the Fallopian tubes (the tubes that connect the ovaries (where the eggs are produced) with the womb) increases the risk of a new ectopic pregnancy. If any of these apply to you, _Postinor-2_ tablet may not be suitable for you, or other types of emergency contraception may be better for you. There is some evidence that _Postinor-2_ may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, _Postinor-2_ is still recommended for all women regardless of their weight or BMI. _Children and adolescents _ Прочитать полный документ
ACTIVE SUBSTANCE 0.75 mg levonorgestrel in each tablet. Other ingredients: silica colloidal anhydrous, magnesium stearate, potato starch, talc, maize starch, lactose monohydrate. PRODUCT DESCRIPTION Tablet. Almost white, round, rimmed, flat tablets with an impressed mark of “INOR”on one side. PHARMACODYNAMICS/PHARMACOKINETICS Pharmacodynamic properties Pharmacotherapeutic group: Sex hormones and modulators of the genital system, Emergency contraceptives, ATC code: G03AD01 The precise mode of action of levonorgestrel 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. Levonorgestrel is not effective once the process of implantation has begun. Efficacy It was estimated from the results of an earlier clinical study, that 750 micrograms of 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). Results from a recent clinical study showed that two 750 microgram tablets of levonorgestrel taken at the same time (and within 72 hours of unprotected sex) prevented 84% of expected pregnancies. There was no difference between pregnancy rates in case of women who were treated on the third or the fourth day after the unprotected act of intercourse (p>0.2). There is limited and inconclusive data on the effect of high body weight/high BMI on the contraceptive efficacy. In three WHO studies no trend for a reduced efficacy with increasing body weight/ BMI was observed (Table 1), whereas in the two other studies (Creinin et al., 2006 and Glasier et al., 2010) a reduced contraceptive efficacy was observed with increasing body weight or BMI (Table 2). Both meta‑analyses excluded intake later than 72 hours after unprotected intercourse Прочитать полный документ