Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
METHOXYPHENAMINE HYDROCHLORIDE GUAIFENESIN SODIUM CITRATE
Phoenix Healthcare Ltd
20/100/200 MG/5ml
2011-06-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Casacol Expectorant Syrup, Methoxyphenamine hydrochloride, 20mg/5ml Guaiphenesin, 100mg/5ml Sodium Citrate, 200mg/5ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Also contains Sorbitol (E420), Ponceau 4R (E124), Nipasept [methyl (E218), ethyl (E214) and propyl (E216) Hydroxybenzoate] For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Syrup. A pale red straw coloured liquid with a faint odour of cherry, contained in an amber glass bottle. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated in the treatment of cough and congestion associated with the common cold, bronchitis, etc Children aged 6-12 years: Casacol is indicated for second line use only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION (A) ADULTS: One or two 5ml spoonfuls 3 to 4 times daily. (B) CHILDREN AGED 6 TO 12 YEARS: 5ml 3 to 4 times daily. Maximum daily dose: 20ml syrup. Not more than 4 doses should be given in any 24 hours. Do not exceed stated dose. Use in children aged between 6-12 years should be under the supervision of a healthcare professional (doctor/pharmacist). The duration of use should be restricted to no more than 5 days. Use in children under 6 years is contra-indicated (see section 4.3). Each 5 ml contains: Methoxyphenamine hydrochloride 20 mg Guaiphenesin 100 mg Sodium citrate 200 mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/02/2012_ _CRN 2084351_ _page number: 1_ 4.3 CONTRAINDICATIONS 1. Coronary thrombosis, hypertension, hyperthyroidism, closed-angle glaucoma and urinary retention. 2. Concurrent treatment with monoamine oxidase inhibitors, or within 10 days of stopping such treatment. 3. Concurrent treatment with other sympath Read the complete document