Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVONORGESTREL
DUOPHARMA (M) SDN. BHD.
LEVONORGESTREL
10 Tablets; 10 Tablet Tablets
DUOPHARMA (M) SDN. BHD.
_Consumer Medication Information Leaflet (RIMUP) _ 1 ESTINOR TABLET Levonorgestrel (0.75mg) WHAT IS IN THE LEAFLET? 1. What ESTINOR is used for 2. How ESTINOR works 3. Before you use ESTINOR 4. How to use ESTINOR 5. While you are using it 6. Side effects 7. Storage and Disposal of ESTINOR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ESTINOR IS USED FOR ESTINOR is an emergency contraceptive only. It is not intended as a regular method of contraception. HOW ESTINOR WORKS ESTINOR contain the active ingredient of levonorgestrel. Levonorgestrel reduces the chance of pregnancy by inhibiting the ovulation. BEFORE YOU USE ESTINOR - _When you must not take it _ Do not take ESTINOR Tablet if you have an allergy to: • Levonorgestrel, the active ingredient in ESTINOR Tablet • any of the ingredients listed at the end of this leaflet. Do not take this medicine: if you are pregnant. if you suffer or have suffered from a severe liver disease if you have breast cancer - _Before you start to use it _ Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you have or have had any of the following medical conditions: you have diabetes you have high blood pressure you have liver disease or a liver tumour you have or have had yellowish-brown pigmentation patches on the skin, particularly of the face; if so, avoid too much exposure to the sun or ultraviolet radiation If any of these conditions apply to you it may not be suitable for you to take ESTINOR you have a disease of your gastro-intestinal tract (such as Crohn's disease) that interferes with the digestion and absorption of your food; you are vomiting or have severe diarrhoea - _Taking other medicines _ Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop. If you have used any of the medicines below during the last 4 weeks, Estinor may work le Lees het volledige document
[DUOPHARMA (M) SDN BHD] ESTINOR TABLET 0.75 MG DESCRIPTION: ESTINOR TABLET 0.75 MG: A round, green tablet, 7 mm in diameter with marking ‘DUO 861’ & ‘flower’. COMPOSITION: Each tablet contains d-Norgestrel 0.75 mg. PHARMACODYNAMICS: Levonorgestrel is progestogen derived from nortestosterone. It is more potent inhibitors of ovulation than norethisterone and have androgenic activity. PHARMACOKINETICS: Levonorgestrel is rapidly and almost completely absorbed after administration by mouth and undergoes little first pass hepatic metabolism. It is highly bound to plasma proteins; 42 to 68% to sex hormone binding globulin and 30 to 56% to albumin. The proportion bound to sex hormone binding globulin is higher when it is administered with an oestrogen. Levonorgestrel is metabolised in the liver to sulphate and glucuronide conjugates, which are excreted in the urine and to a lesser extent in the faeces. INDICATIONS: Oral contraception. The preparation is an oral contraceptive indicated for females having sexual intercourse occasionally. No more than 4 tablets can be taken monthly at 2 to 4 occasions. To females having sexual intercourse more frequently combined oral contraceptive / or other contraceptive methods are recommended. RECOMMENDED DOSAGE: In case of one or once repeated intercourse, one tablet should be taken after the first intercourse. In case intercourse is repeated several times, one tablet should be taken after the first intercourse and one tablet 8 hours later. In this case, 2 tablets are taken at one occasion. Women who have used enzyme-inducing drugs during the last 4 weeks and need emergency contraception are recommended to use a non-hormonal emergency contraceptive, i.e. Cu- IUD or take a double dose of levonorgestrel (i.e. No more than 4 tablets monthly taken together) for those women unable or unwilling to use Cu-IUD. ROUTE OF ADMINISTRATION : For oral use CONTRAINDICATIONS: Disease of the liver and the biliary tract, pregnancy jaundice in the history. WARNINGS AND PRECAUTIONS: A thorough per Lees het volledige document