Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
KETOTIFEN FUMARATE
SUNWARD PHARMACEUTICAL SDN. BHD.
KETOTIFEN FUMARATE
250 ml; 200 ml; 250 ml; 200 ml; 1000 ml; 100 ml mL; 100 ml mL; 120 ml mL; 120 ml mL
SUNWARD PHARMACEUTICAL SDN. BHD.
ZADIPRO SYRUP _Consumer Medication Information Leaflet (RiMUP)_ Ketotifen Fumarate (1mg/5ml) WHAT IS IN THIS LEAFLET: 1. What Zadipro Syrup is used for 2. How Zadipro Syrup works 3. Before you use Zadipro Syrup 4. How to use Zadipro Syrup 5. While you are using it 6. Side effects 7. Storage & disposal of Zadipro Syrup 8. Product description 9. Manufacturer and Product Registration Holder 10.Date of revision WHAT ZADIPRO SYRUP IS USED FOR It is used as a p r e v e n t i o n treatment of asthma associated with allergy. It i s also used for t h e prevention and relief of allergic sympto ms associated with conditions such as allergic rhinitis (an allergic inflammation of the inside of the nose), allergic bronchitis (inflammation of the windpipe and airways within the lungs) skin rashes and hay fever. HOW ZADIPRO SYRUP WORKS The active ingredients in the medicine is ketotifen. Ketotifen is an antihistamine and is able to relieve the allergic conditions through the blockade of allergic reactions caused by chemicals in the body which are realsed upon sensitization by allergens. BEFORE YOU USE ZADIPRO SYRUP _When you must not use it_ • If you are allergic to ketotifen or any other ingredients in the product _Before you start to use it_ You should check with your doctor:- If you are or think you may be pregnant If you are planning to become pregnant If you are breastfeeding Is should not be used to treat acute asthma attacks. _Taking other medicines_ There are a few medicines which may not mix with Zadipro. It is important to tell your doctor HOW TO USE ZADIPRO _How much to use_ You should take Zadipro Syrup exactly as advised by your doctor or pharmacist. The amount you take each day will depend on your condition. Do not take more or less than what your doctor prescribes. The normal dosage for adults ranges from 1mg (5ml) - 2mg (10ml) 2 times daily. If you are susceptible to sedation, a progressive regimen is recommended during the 1st week of treatment commencing with 0.5mg ( 2.5ml ) twice daily or 1mg (5m Прочетете целия документ
DRUG INTERACTIONS: Ketotifen may potentiate the effects of CNS depressant, alcohol and other antihistamines. Concomitant administration of ketotifen with oral antidiabetic drug can lead to a reversible fall in thrombocyte count. USE IN PREGNANCY & LACTATION: Although there is no evidence of any teratogenic effect, ketotifen like all drugs, should be given to pregnant and nursing women only under compelling circumstances. DOSAGE: Oral administration. Adult : 1mg (5ml) - 2mg (10ml) 2 times daily. In patients susceptible to sedation, a progressive regimen is recommended during the 1st week of treatment commencing with 0.5mg (2.5ml) twice daily or 1mg (5ml) in the evening only and increasing to the full therapeutic dose. If necessary, the dosage may be increased up to 4mg (20ml) a day in 2 divided doses. Syrup : Children above 3 years - 1mg (5ml) twice daily. 6 months to 3 years - 0.5mg (2.5ml) twice daily. SYMPTOMS AND TREATMENT FOR OVERDOSAGE AND ANTIDOTE(S): The main symptoms of acute overdosage include: drowsiness to severe sedation, confusion and disorientation; tachycardia and hypotension; especially in children, hyperexcitability or convulsions; reversible coma. Treatment should be symptomatic. If the drug has been taken recently, the stomach should be emptied. If necessary, symptomatic treatment and monitoring of the cardiovascular system; if excitation or convulsions are present: short-acting barbiturates, benzodiazepines. PACK SIZE: Syrup : A bottle of 100ml and 120ml. PACK SIZE (EXPORT ONLY): Syrup : A bottle of 200ml, 250ml and 1 litre. SHELF LIFE: Bottle HDPE : 1.5 years Bottle PET : 2 years PRODUCT DESCRIPTION : Syrup : Clear, colourless syrup with peach flavour. STORAGE CONDITIONS: Store at or below 30ºC. Protect from light. PACKAGE INSERT SL344A-R4 Revision Date : 19/07/2023 PROPERTIES Ketotifen is a non-bronchodilator anti-asthmatic drug with anti-anaphylactic and antihistaminic properties. Studies on the mode of action of ketotifen have shown the following properties of ketotifen which may contribu Прочетете целия документ