Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Bilastine
A. MENARINI SINGAPORE PTE. LTD.
Bilastine
30tablet Tablets; 20tablet Tablets; 10tablet Tablets; 4tablet Tablets; 40tablet Tablets; 50tablet Tablets
A. Menarini Manufacturing Logistics and Services S.r.l.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ BILAXTEN® 20MG TABLETS Bilastine 20mg Page 1 WHAT IS IN THIS LEAFLET • What is BILAXTEN® is used for • How BILAXTEN® works • Before you use BILAXTEN® • How to take BILAXTEN® • While you are using BILAXTEN® • Side effects • Storage and Disposal of BILAXTEN® • Product description • Manufacturer and Product Registration Holder • Date of Revision WHAT BILAXTEN® IS USED FOR BILAXTEN® contains bilastine which is an antihistamine. 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. They may also be used to treat itchy skin rashes (hives or urticaria). HOW BILAXTEN® WORKS 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 take it_ _ _ Do not take it if you are allergic (hypersensitive) to bilastine or any of the other ingredients of BILAXTEN® (see Product description). Do not give this medicine to children under 12 years of age. Ask your doctor or pharmacist for appropriate dosages in children under 12 years”. Other forms of this medicine – bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/mL oral solution may be more suitable for children 6 to 11 years of age with a body weight of at least 20 kg - ask your doctor or pharmacist. Do not give Bilastine to children under 6 years of age with a body weight below 20 kg since no sufficient data are available. _BEFORE YOU START TO TAKE IT_ _ _ Inform your doctor if you have moderate or severe renal impairment and you are taking other medicines (see “Taking other medicines”). Driving and using machines It has been demonstrated that bilastine 20 mg does not affect the driving performance in adults. However the re Lesen Sie das vollständige Dokument
BILAXTEN® 20 mg tablets Bilastine NAME OF THE MEDICINAL PRODUCT BILAXTEN 20 mg Tablets QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of Bilastine. PHARMACEUTICAL FORM Oval biconvex scored white tablets (length 10 mm, width 5 mm) . The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. CLINICAL PARTICULARS Therapeutic indications Symptomatic treatment of allergic rhino -conjunctivitis (seasonal and perennial) and urticaria. BILAXTEN 20mg Tablet is indicated in adults and adolescents (12 years of age and over). Posology and method of administration Posology Adults and adolescents (12 years of age and over) 20 mg bilastine (1 tablet) once daily for the relief of symptoms of allergic rhinoconjunctivitis (SAR and PAR) and urticaria. The tablet should be taken one hour before or two hours after intake of food or fruit juice (see interaction with other medicinal products and other form s of interaction) Special populations Older people No dosage adjustments are required in older patients (see section s Pharmacodynamic and Pharmacokinetic properties). There is little experience in patients above the age of 65. Patients with r enal impairment No dosage adjustment is required in patients with renal impairment. (See section Pharmacokinetic properties). Patients with h epatic impairment There is no clinical experience in patients with hepatic impairment. Since bilastine is not meta bolized and renal clearance is its major elimination route, hepatic impairment is not expected to increase systemic exposure above the safety margin. Therefore, no dosage adjustment is required in patients with hepatic impairment (see section Pharmacokinet ic properties). Paediatric population There is no relevant use of bilastine in children aged 0 to 2 years in the indications allergic rhino -conjunctivitis and urticaria. The safety and efficacy in children below 12 years have not yet been established. Duration of treatment: For allergic rhinitis the treatment should be lim Lesen Sie das vollständige Dokument