البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
COMMON SORREL HERB; ELDER FLOWER; GENTIAN ROOT; PRIMULA FLOWER WITH CALYX; VERBENA HERB
DR.SAMUELOV IMPORTING & MARKETING LTD, ISRAEL
COATED TABLETS
COMMON SORREL HERB 36 MG; GENTIAN ROOT 12 MG; PRIMULA FLOWER WITH CALYX 36 MG; ELDER FLOWER 36 MG; VERBENA HERB 36 MG
PER OS
Not required
BIONORICA SE, GERMANY
Provides relief of symptoms in the nose and its sinuses in connection with common cold, in adults and children older than 12 years.
2022-04-30
Page 1 of 5 _ _ This leaflet format has been determined by the Ministry of Health and the content thereof has been checked and approved on May 2017 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sinuclear Coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active pharmaceutical ingredients: 1 coated tablet contains: Verbena herb, powdered 36 mg; Gentian root, powdered 12 mg; Common Sorrel herb, powdered 36 mg; Elder flower, powdered 36 mg; Primula flower with calyx, powdered 36 mg. Excipients: Glucose syrup 2.750 mg Lactose monohydrate 48.490 mg Sucrose 123.816 mg Sorbitol 0.444 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet The coated tablets are green, round, biconvex with a smooth surface. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Provides relief of symptoms in the nose and its sinuses in connection with common cold, in adults and children older than 12 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Unless prescribed otherwise, adults and adolescents from 12 years of age take 1 coated tablet 3 times a day. Coated tablets to be taken unchewed – preferably with some liquid. Crushing/halving: do not crush or halve the coated tablet. Unless prescribed otherwise, the duration of administration is 7 – 14 days. Also observe the instructions under 4.4 ”Special warnings and precautions for use”. Page 2 of 5 4.3 CONTRAINDICATIONS Sinuclear must not be taken in case of known hypersensitivity to one of the pharmaceutical ingredients or to any of the excipients of Sinuclear. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE There are no sufficient investigations on the use of Sinuclear in children under the age of 12 years. Therefore, Sinuclear should not be used in children under the age of 12 years. Patients with the rare hereditary problems of fructose intolerance, galactose intolerance e.g. galacotosaemia, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrose- isomaltase insufficiency should not take Sinuclear. In the اقرأ الوثيقة كاملة