البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
PELARGONIUM SIDOIDES ROOTS (1: 8- 10) (EPS® 7630) DRIED LIQUID EXTRACT; EXTRACTING AGENT : ETHANOL 11% (W/W)
DR.SAMUELOV IMPORTING & MARKETING LTD, ISRAEL
R05FB01
FILM COATED TABLETS
PELARGONIUM SIDOIDES ROOTS (1: 8- 10) (EPS® 7630) DRIED LIQUID EXTRACT; EXTRACTING AGENT : ETHANOL 11% (W/W) 20 MG
PER OS
Not required
DR. WILLMAR SCHWABE GMBH &CO. KG, GERMANY
COUGH SUPPRESSANTS AND MUCOLYTICS
- Symptomatic treatment of acute bronchitis.- Traditional herbal medicinal product for use in the common cold.
2023-04-30
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT KALOBA TABLETS® FILM-COATED TABLETS For adults, adolescents and children over the age of 6 years 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet contains: Dried liquid extract of Pelargonium sidoides roots (1: 8- 10) (EPs® 7630) 20 mg Extraction agent: ethanol 11 % (w/w) For full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS -Symptomatic treatment of acute bronchitis - Traditional herbal medicinal product for use in the common cold 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Adults and adolescents over 12 years: 1 film-coated tablet 3 times daily Children aged 6-12 years: 1 film-coated tablet twice daily Tablets are taken with some liquid (preferably a glass of water) in the morning, midday and evening. Tablets are not to be taken in a lying position. After symptoms subside, it is recommended to continue the treatment for several days in order to prevent a relapse. The duration of treatment should not exceed 3 weeks. 4.3. CONTRA-INDICATIONS Kaloba® tablets are not to be used in cases of hypersensitivity to one of the components of the pharmaceutical. Kaloba® tablets are not to be taken in cases of severe hepatic diseases as no sufficient experience is available in this respect. 4.4. SPECIALS WARNINGS AND PRECAUTIONS FOR USE A doctor is to be consulted immediately if the condition does not improve within one week, in cases of fever lasting for several days or in cases of shortness of breath or bloody sputum. Cases of liver damage and hepatitis have been reported in connection with the use of medicinal products containing Pelargonium. Patients should be told to discontinue treatment with Kaloba® tablets immediately and to consult a doctor if signs indicating liver function disorders occur. Kaloba® tablets are not to be used in children under the age of 6 years. Patients with rare hereditary galactose intolerance, lactase deficiency or glucose- اقرأ الوثيقة كاملة