Страна: Армения
Език: английски
Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ambroxol (ambroxol hydrochloride)
Berlin-Chemie AG
R05CB06
ambroxol (ambroxol hydrochloride)
30mg
tablets
(10/1x10/) in blister, (20/2x10/) in blister, (50/5x10/) in blister
OTC
Registered
2015-09-18
- Page 1 of 5 - S UM M A RY O F P RO DU C T C H A R AC TE R I S TI CS 1. NAME OF THE MEDICINAL PRODUCT FLAVAMED ® COUGH TABLETS 30 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains 30 mg ambroxol hydrochloride. Excipients with known effect 40 mg lactose monohydrate per tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White, round, biplane tablets with bevelled edges and a break-mark on one side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mucolytic therapy in acute and chronic bronchopulmonary diseases that are accompanied by a disturbance to mucus formation and transport. Flavamed ® cough tablets are indicated in children from six years, adolescents and adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Unless otherwise prescribed, the following dosages are recommended for Flavamed ® cough tablets: _Children up to 6 years: _ Flavamed ® cough tablets are contraindicated in children under 6 years (see section 4.3). _Children from 6 to 12 years: _ As a rule, ½ a Flavamed ® cough tablets each is taken 2 - 3 times daily (equivalent to 15 mg ambroxol hydrochloride 2 - 3 times). _Adults and adolescents above 12 years: _ As a rule, 1 Flavamed ® cough tablets each is taken 3 times daily during the first 2 - 3 days (equivalent to 30 mg ambroxol hydrochloride 3 times); after that, 1 Flavamed ® cough tablets each is taken twice daily (equivalent to 30 mg ambroxol hydrochloride twice). Note: For adults, doses might be increased up to 60 mg twice daily (equivalent to 120 mg ambroxol hydrochloride/day) if needed. _Paediatric population _ See section 4.3 for use in children under 6 years. Method of administration Flavamed cough tablets are for oral use. The tablets are best swallowed whole after meals with sufficient liquid. - Page 2 of 5 - Flavamed cough tablets should not be taken for longer than 4 - 5 days without the advice of a doctor. See section 4.4 for dosage in renal and hepatic diseases. 4.3 Прочетете целия документ