Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Medicines Authority
THYMI HERBA, ALTHAEAE RADIX
Kwizda Pharma GmbH Effingergasse 21, Vienna 1160, Austria
R05CA10
THYMI HERBA 7.8 mg ALTHAEAE RADIX 55.3 mg
SYRUP
THYMI HERBA 7.8 mg ALTHAEAE RADIX 55.3 mg
POM
COUGH AND COLD PREPARATIONS
Withdrawn
2018-06-11
1/5 PACKAGE LEAFLET: INFORMATION FOR THE USER BRONCHOSTOP SYRUP Active substances: thyme herb dry extract, marshmallow root liquid extract 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 has 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 your doctor if you do not feel better or if you feel worse after 5 days. WHAT IS IN THIS LEAFLET 1. What Bronchostop syrup is and what it is used for 2. What you need to know before you take Bronchostop syrup 3. How to take Bronchostop syrup 4. Possible side effects 5. How to store Bronchostop syrup 6. Contents of the pack and other information 1. WHAT BRONCHOSTOP SYRUP_ _IS AND WHAT IT IS USED FOR Bronchostop syrup is a traditional herbal medicinal product used to relieve pharyngeal irritation and associated dry cough and to promote the expectoration of viscous mucus in cough associated with cold. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. Bronchostop syrup is intended for use in adults, adolescents and children from 2 years of age. Children between 2 and 4 years of age should use this product only upon doctor’s recommendation. You must talk to a doctor if you do not feel better or if you feel worse after 5 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRONCHOSTOP SYRUP DO NOT TAKE BRONCHOSTOP SYRUP if you are allergic to Marshmallow root, Thyme or to other members of the Lamiaceae family (e.g. Basil, Rosemary, Sage) or to any of the other ingredients of this medicine (listed in section 6). 2/5 WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Bronch Izlasiet visu dokumentu
1/4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bronchostop syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: 7.8 mg of extract (as dry extract) from _Thymus vulgaris_ L. and _Thymus zygis_ L., herba (Thymi herba) (7-13:1). Extraction solvent: water. 55.3 mg of extract (as liquid extract) from _Althaea officinalis_ L., radix (Althaeae radix) (1:12- 14). Extraction solvent: water. Excipients with known effect: Xylitol (E967) 307.74 mg methyl-4-hydroxybenzoate (E218) 0.84 mg propyl-4-hydroxybenzoate (E216) 0.45 mg sugars contained in raspberry juice concentrate: fructose app. 4 mg glucose app. 4 mg sucrose app. 0.4mg propylene glycol (E1520) 2.22 mg contained in raspberry aroma flavour For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup. Bronchostop syrup is a brown-red, viscous liquid with the scent and taste of thyme and raspberries. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Traditional herbal medicinal product used to relieve pharyngeal irritation and associated dry cough and to promote the expectoration of viscous mucus in cough associated with cold. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents over 12 years of age:_ 15 ml every 3 to 4 hours (4 to 6 times per day; maximum daily dose up to 90 ml) _Children between 4 – 12 years of age:_ 2/4 7.5 ml every 3 to 4 hours (4 to 6 times per day; maximum daily dose up to 45 ml) _Children between 2 – 4 years of age:_ After consultation with a doctor, 7.5 ml every 3 to 4 hours (4 to 6 times per day; maximum daily dose up to 45 ml) may be administered. _Children aged less than 2 years:_ The use in children under 2 years of age is not recommended. Method of administration: For oral use, undiluted. If required, Bronchostop syrup _ _ may be administered diluted in water or warm tea. Duration of use: Self-medication with Bronchostop syrup _ Izlasiet visu dokumentu