Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
KETOTIFEN FUMARATE
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
KETOTIFEN FUMARATE
100 ml; 100 ml
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ __________________________________________________________________________________________________________ 1 U-KEFEN SYRUP 1MG/5ML Ketotifen Fumarate (1mg/5ml) WHAT IS IN THIS LEAFLET: 1. What U-Kefen Syrup is used for 2. How U-Kefen Syrup works 3. Before you use U-Kefen Syrup 4. How to use U-Kefen Syrup 5. While you are using it 6. Side Effects 7. Storage and Disposal U-Kefen Syrup 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT U-KEFEN SYRUP IS USED FOR It is indicated for the prevention of asthma and has also been given in the treatment of allergic conditions such as rhinitis (inflammation of the inside of the nose) and conjunctivitis (inflammation of the membrane lining the eyelids). HOW U-KEFEN SYRUP WORKS Ketotifen is the active ingredient of U- Kefen Syrup. Ketotifen is an antihistamine with anti-allergy properties. Histamine is a chemical released into the body during an allergic condition. U-Kefen Syrup works by blocking the effects of the naturally occuring chemical histamine in your body. BEFORE YOU USE U-KEFEN SYRUP - _ When you must not use it _ If you are allergic to ketotifen or other ingredients of the syrup. If you are taking oral anti-diabetic agents. If you are breastfeeding. - _ Before you start to use it _ You must tell your doctor if: you have allergies to any medicine which you have taken previously to treat your current condition. you are pregnant, trying to get pregnant, think you may be pregnant or breast-feeding._ _ _ _ - _ Taking other medicines _ The following medicines may interact with U-Kefen Syrup: Sedatives (chemical substances used to reduce tension and anxiety and to induce calm). Hypnotics (chemical substances to induce sleep). Antihistamines. Alcohol. Tell your doctor and pharmacist if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. HOW TO USE U-KEFEN SYRU Прочитайте повний документ
7073-04 U-KEFEN TABLETS 1 MG U-KEFEN SYRUP 1MG/5ML NAME AND STRENGTH OF ACTIVE INGREDIENT: (i) U-KEFEN TABLETS 1MG Each tablet contains Ketotifen Fumarate equivalent to Ketotifen...…………….…………………1mg (ii) U-KEFEN SYRUP 1MG/5ML Each 5ml syrup contains Ketotifen Fumarate equivalent to Ketotifen……………………….……1mg PRODUCT DESCRIPTION: (i) U-KEFEN TABLETS 1MG A white, scored, flat of diameter 7mm round tablet with ‘MPI’ marking. (ii) U-KEFEN SYRUP 1MG/5ML A clear liquid with tutti frutti flavour and sweet taste. PHARMACODYNAMICS : Ketotifen has the properties of the antihistamines in addition to action on mast cells analogous to those of sodium cromoglycate. In addition to its antihistaminic action, inhibition of phosphodiesterases, blockade of calcium channels, inhibition of the release of mixture of leukotrienes known as slow-reacting substance of anaphylaxis (SRS-A) and functional antagonism of the effects of SRS-A have been demonstrated, and there is now some evidence for an effect on 2-receptor or mediated reactions. PHARMACOKINETICS: Ketotifen fumarate is absorbed from the gastrointestinal tract and together with metabolites, is excreted in the urine and faeces. It has a very slow onset of action, it must be administered on a regular basis for 6-12 weeks before any beneficial effect is seen. INDICATION: Ketotifen is used in the prophylactic treatment of asthma and has also been given in the treatment of allergic conditions such as rhinitis and conjunctivitis. RECOMMENDED DOSAGE: Adults: 1mg of ketotifen (1 tablet or 5ml syrup) twice daily with food, increased if necessary to 2mg (2 tablets or 10ml syrup) twice daily. Children over 2 years may be given 1mg (1 tablet or 5ml syrup) twice daily. It must be administered on a regular basis for 6–12 weeks before any beneficial effects is seen. Patients known to be easily sedated should begin treatment with 0.5–1mg (½ to 1 tablet or 2.5 to 5ml syrup) at night for the first few days. ROUTE OF ADMINISTRATION: Oral CONT Прочитайте повний документ