Pajjiż: Malta
Lingwa: Ingliż
Sors: Medicines Authority
Menarini International Operations Luxembourg S.A 1 Avenue de la Gare, L-1611, Luxembourg
R06AX29
BILASTINE 20 mg
TABLET
BILASTINE 20 mg
OTC
ANTIHISTAMINES FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2023-04-03
Page 1 of 6 PACKAGE LEAFLET Page 2 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GOSALL 20 MG TABLETS BILASTINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. − Keep this leaflet. You may need to read it again. − Ask your pharmacist if you need more information or advice. − If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. − You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET: 1. What Gosall is and what it is used for 2. What you need to know before you take Gosall 3. How to take Gosall 4. Possible side effects 5. How to store Gosall 6. Contents of the pack and other information 1. WHAT GOSALL IS AND WHAT IT IS USED FOR Gosall contains the active substance bilastine which is an antihistamine. Gosall 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). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GOSALL DO NOT TAKE GOSALL: if you are allergic to bilastine or any of the other ingredients of this medicine (listed in section 6). _ _ WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Gosall if you have moderate or severe renal impairment and in addition you are taking other medicines (see “Other medicines and Gosall”). CHILDREN DO NOT GIVE THIS MEDICINE TO CHILDREN UNDER 12 YEARS OF AGE. DO NOT exceed the recommended dose. If symptoms persist, consult your doctor. OTHER MEDICINES AND GOSALL Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular, please discuss with your doc Aqra d-dokument sħiħ
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 11 1. NAME OF THE MEDICINAL PRODUCT Gosall 20 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of bilastine. For the _ _ full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Tablet. 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. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria. Gosall is indicated in adults and adolescents (12 years of age and over). _ _ 4.2 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 section 4.5). 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 complaints. _Special populations _ Elderly No dosage adjustments are required in elderly _ _ patients (see sections _ _ 5.1 and 5.2). Renal impairment Studies conducted in adults in special risk groups (renally impaired patients) indicate that it is not necessary to adjust the dose of bilastine in adults (see section 5.2). Hepatic impairment There is no clinical experience in adult patients with hepatic impairment. However, since bilastine is not metabolized and is eliminated as unchanged in urine and feces, hepatic impairment is not expecte Aqra d-dokument sħiħ