Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LORATADINE
Prestige Pharma Sdn Bhd
LORATADINE
100 Tablets; 300 Tablets; 500 Tablets
T.O. CHEMICALS (1979) LTD.
HALON _Loratadine_ (10mg) 1 _Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET 1. What _Halon_ is used for 2. How _Halon_ works 3. Before you use _Halon_ 4. How to use _Halon_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Halon_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _HALON _IS USED FOR _Halon _ contains the active ingredient _Loratadine_ . It is used to relief symptoms of allergic reactions. HOW _HALON _WORKS _Halon _ contains _ Loratadine _ which belong to a group of antihistamine compound that helps to stop histamine from working in the body. In an allergic reaction, the body releases histamine. Histamine causes rashes, sneezing, itching and other allergic ailments. _ _ BEFORE YOU USE _HALON_ - _When you must not use it_ _ _ Do not take _ Halon _ if you: _ _ Have ever had allergic reaction to _ _ _Loratadine _ the active ingredient or to any other ingredients in this product. _ _ _ _ _If you are not sure whether you should _ _start taking this medicine, consult your _ _doctor. _ _ _ _PREGNANCY AND LACTATION _ _ _ Do not use _Halon _ if you are pregnant, trying to get pregnant or think you may be pregnant. Do not use _Halon _ if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. _ _ - _Before you start to use it _ Tell your doctor if you have allergies to any other medicines, food, preservatives or dyes. Tell your doctor if you: • Have impaired liver function. • Are pregnant or think you are pregnant. • Breast feeding or plan to breast feed. _Halon_ is not recommended for children under 2 years of age. - _Taking other medicines _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines and Halon may interfere with each other. It is important to tell your doctor or pharmacist if you are taking: • Antibiotic; eg. Erythromycin to treat bacterial in Soma hati kamili
PLEASE READ CAREFULLY CONTENT Each tablet contains 10.0mg of loratadine DESCRIPTION A white oval, biplain tablets with bisec-line on one side and the word “HALON” on the other. INDICATIONS For relief of symptoms associated with allergic conditions. RECOMMENDED DOSAGE • Adult and children over 12 years of age: 1 tablet (10mg) once daily • Children 2 – 12 years of age: i) Body weight ≥ 30kg – 1 tablet (10mg) once daily ii) Body weight ≤ 30kg – ½ tablet (5mg) once daily For patients who have difficulties in swallowing the tablet form, the tablet may be crushed first and then mixed with a little bit of water for easy administration. ROUTE OF ADMINISTRATION For oral administration. CONTRAINDICATIONS Halon is contraindicated in patients who are hypersensitive to loratadine or to any of its ingredients. WARNINGS AND PRECAUTIONS Halon tablets should be administered with caution in patients with severe liver impairment. Administration of Halon should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index. DRUG INTERACTIONS When administered concomitantly with alcohol, Halon have no potentiating effects as measured by psychomotor performance studies. Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in elevated levels of loratadine, which may cause an increase in adverse events. Increase in plasma concentrations of loratadine has been reported after concomitant use with ketoconazole, erythromycin and cimetidine in controlled trials, but without clinically significant changes (including electrocardiographic). PREGNANCY AND LACTATION Pregnancy Large amount of data on pregnant women indicate no malformative nor feto/neonatal toxicity of loratadine. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Halon during pregnancy. Breast-feeding Loratadine is excreted Soma hati kamili