Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Bilastine
A. MENARINI SINGAPORE PTE. LTD.
Bilastine
120 ml
BERLIN-CHEMIE AG
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ BILAXTEN _®_ 2.5 MG/ML ORAL SOLUTION Bilastine 1 WHAT IS IN THIS LEAFLET 1. What Bilaxten used for 2. How Bilaxten works 3. Before you use Bilaxten 4. How to use Bilaxten 5. While you are using Bilaxten 6. Side effects 7. Storage and Disposal of Bilaxten 8. Product Description 9. Manufacturer and Product Registration holder 10. Date of revision WHAT BILAXTEN IS USED FOR Bilaxten is used to relieve the symptoms of hayfever (sneezing, itchy, runny, blocked-up nose and red and watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes (hives or urticaria). HOW BILAXTEN WORKS Bilaxten contains the active substance bilastine which is an antihistamine. Bilastine is a non-drowsy, long-acting antihistamine that helps to relieve symptoms of allergy such as sneezing, tearing and itching. It blocks the effects of histamine, a chemical substance produced by the body in response to foreign substances which the body is allergic to. BEFORE YOU USE BILAXTEN _- When you must not use it _ If your child is allergic to bilastine or any of the other ingredients of this medicine. _- Before you start to use it _ Do not give this medicine to children under 6 years of age with a body weight below 20 kg since no sufficient data are available. Talk to your doctor or pharmacist before using Bilaxten if your child has moderate or severe renal or hepatic impairment or if your child is taking other medicines. _- Taking other medicines _ Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines should not be taken together and others may need their doses to be altered when taken together. Always inform your doctor or pharmacist if your child is using or receiving any of the following medicines in addition to Bilaxten. • Ketoconazole (an antifungal medicine) • Erythromycin (an antibiotic) • Diltiazem (to treat angina) • Cyclosp Perskaitykite visą dokumentą
PACKAGE INSERT BILAXTEN 2.5 MG/ML ORAL SOLUTION 1. NAME OF THE MEDICINAL PRODUCT Bilaxten 2.5 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 2.5 mg of bilastine. Excipients with known effect: methyl parahydroxybenzoate (E218) (1.0 mg/ml), propyl parahydroxybenzoate (E216) (0.2 mg/ml) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral Solution. Clear, colourless, slightly viscous aqueous solution of pH 3.0-4.0, without precipitate 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria. Bilaxten 2.5 mg/ml Oral Solution is indicated in children aged 6 to 11 years with a body weight of at least 20 kg. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Paediatric population _ Children 6 to 11 years of age with a body weight of at least 20 kg 10 mg bilastine (4 ml of oral solution) once daily for the relief of symptoms of allergic rhino- conjunctivitis (seasonal allergic rhinitis and perennial allergic rhinitis) and urticaria. The oral solution should be taken one hour before or two hours after intake of food or fruit juice (see section 4.5). Children under 6 years of age and under 20 kg Currently available data are described in section 4.4, 4.8, 5.1 and 5.2 but no recommendation on a posology can be made. Therefore bilastine should not be used in this age group. _Adults: _ In adults and adolescents (over 12 years of age) the administration of bilastine 20 mg tablets is appropriate. Duration of treatment: For allergic rhino-conjunctivitis the treatment should be limited to the period of exposure to allergens. For seasonal allergic rhinitis treatment could be discontinued after the symptoms have resolved and reinitiated upon their reappearance. In perennial allergic rhinitis continued treatment may be proposed to the patients during the allergen exposure periods. For urticaria the duration of treatment depends on the type, duration and course of the com Perskaitykite visą dokumentą