국가: 이스라엘
언어: 영어
출처: Ministry of Health
PRIMULA ROOT DRY EXTRACT (6-7:1); EXTRACTING AGENT : ETHANOL 47.4 % (V/V); THYME HERB DRY EXTRACT (6-10:1); EXTRACTING AGENT: ETHANOL 70.0 % (V/V)
DR.SAMUELOV IMPORTING & MARKETING LTD, ISRAEL
R05CA10
FILM COATED TABLETS
PRIMULA ROOT DRY EXTRACT (6-7:1); EXTRACTING AGENT : ETHANOL 47.4 % (V/V) 60 MG; THYME HERB DRY EXTRACT (6-10:1); EXTRACTING AGENT: ETHANOL 70.0 % (V/V) 160 MG
PER OS
Not required
BIONORICA SE, GERMANY
COMBINATIONS
For the relief of symptoms in acute bronchitis with coughs and colds associated with viscous mucus in children from 12 years of age, adolescents and adults.
2022-10-31
gbpz-bro-ft-1911101-il.indd 4-5 05.01.18 11:03 gbpz-bro-ft-1911101-il.indd 4-5 05.01.18 11:03 전체 문서 읽기
Page 1 of 6 This leaflet format has been determined by the Ministry of Health and the content thereof has been checked and approved on October 2017 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bronchiclear Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet contains: 60 mg of dry extract of primula root (6-7 : 1); extracting agent: ethanol 47.4% (V/V) 160 mg of dry extract of thyme herb (6-10 : 1); extracting agent: ethanol 70% (V/V). Excipients: Glycose syrup 34 mg Lactose monohydrate 50 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Green, round, biconvex film-coated tablets with semi-matte surface 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of symptoms in acute bronchitis with coughs and colds associated with viscous mucus in children from 12 years of age, adolescents and adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adolescents, children from the age of 12 years and adults take 1 film-coated tablet 3 times a day. The film-coated tablets should be swallowed unchewed, with sufficient liquid (preferably a glass of water) before meals. Do not chew, split or crush the film-coated tablet. The duration of treatment depends on the course of the disease. In each case, please note the information given in the first paragraph under “Special warnings and precautions for use" and the information under “Undesirable effects". Page 2 of 6 4.3 CONTRAINDICATIONS Bronchiclear must not be used in case of known hypersensitivity to the active substances or other labiates (_Lamiaceae_), birch, mugwort, celeriac or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If complaints persist for longer than 10 days or if shortness of breath, fever and purulent or bloody expectoration occur, a doctor should be consulted immediately. Caution should be exercised in patients with gastritis or gastric ulcer. In such patients Bronchiclear should be taken after meals wi 전체 문서 읽기