Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LORATADINE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
LORATADINE
20 Tablet Tablets; 10 Tablet Tablets; 100 Tablet Tablets; 30 Tablet Tablets
NOVARTIS BANGLADESH LTD
TIRLOR ® 10 MG TABLETS Loratadine 10 mg Tablets _Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET: 1. What is TIRLOR used for 2. How TIRLOR works 3. Before you use TIRLOR 4. How to use TIRLOR 5. While you are using it 6. Side effects 7. Storage and disposal of TIRLOR 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT IS TIRLOR USED FOR? This medicine is prescribed to relieve symptoms associated with allergic rhinitis such as sneezing, runny or itchy nose and itchy, red or teary eyes. It is also used to relieve symptoms such as itching and hives. HOW TIRLOR WORKS? TIRLOR is an anti-allergy medicine. It helps to control your allergic reaction and its symptoms. BEFORE YOU USE TIRLOR _WHEN YOU MUST NOT USE IT _ - if you are allergic (hypersensitive) to loratadine or to any of the other excipients of TIRLOR. PREGNANCY AND LACTATION Tell your doctor or pharmacist if you are pregnant, or are planning to become pregnant or if you are breast-feeding before taking any medicine. You should not use this medicine during pregnancy and when you are breast- feeding unless your doctor has specifically recommended it. _BEFORE YOU START USE IT _ Tell your doctor if you have any of the following illnesses before taking this medicine: - Severe liver disease - If you have to undergo any skin tests, it may be necessary to stop taking this medicine at least 2 days before the test to make sure the result of test is correct. _TAKING OTHER _ _MEDICINES_ _ _ Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine. This includes medicines that can be bought without a prescription and herbal medicines. Potential interaction may occur with some medicines that make some liver enzymes less active resulting in elevated levels of loratadine, which may cause an increase in adverse events. HOW TO USE TIRLOR ? _- HOW MUCH TO USE _ The doctor will prescribe the individual dose which is appropriate for you. It is important that you take y Lire le document complet
TIRLOR ® 10 MG TABLETS 1. NAME OF THE MEDICINAL PRODUCT Tirlor ® 10 mg Tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg loratadine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, uncoated round convex tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Loratadine is indicated for the relief of symptoms associated with allergic rhinitis, urticaria and other allergic dermatological condition. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, including th e elderly, and children over 12 years of age 10 mg once daily Children 6 - 12 years of age Body weight > 30 kg: 10 mg once daily Efficacy and safety of_ _loratadine in children under 2 years has not been established. Patients with hepatic impairment Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg. Patients with renal impairment No dose adjustments are required in patients with renal insufficiency. Elderly No dose adjustments are required in the elderly. Method of administration For oral use. It may be taken without regard to mealtime. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Loratadine should be administered with caution in patients with severe liver impairment. The administration of loratadine should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index. TIRLOR ® 10 MG TABLETS 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION When administered concomitantly with alcohol, loratadine has 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 (s Lire le document complet