Land: Malta
Taal: Engels
Bron: Medicines Authority
GUAIFENESIN, METHOXYPHENAMINE HYDROCHLORIDE, SODIUM CITRATE
Phoenix Healthcare Ltd Suite 12 Bunkilla Plaza Bracetown Business Park Clonee Co Meath, Ireland
R05CA03
SODIUM CITRATE 200 mg/5ml GUAIFENESIN 100 mg/5ml METHOXYPHENAMINE HYDROCHLORIDE 20 mg/5ml
SYRUP
SODIUM CITRATE 200 mg/5ml GUAIFENESIN 100 mg/5ml METHOXYPHENAMINE HYDROCHLORIDE 20 mg/5ml
POM
COUGH AND COLD PREPARATIONS
Authorised
2005-11-09
PATIENT INFORMATION LEAFLET CASACOL EXPECTORANT SYRUP METHOXYPHENAMINE HYDROCHLORIDE, 20MG/5ML GUAIPHENESIN, 100MG/5ML SODIUM CITRATE, 200MG/5ML Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. Nevertheless you still need to use CASACOL carefully to get the best results from it. • Keep this leaflet you may need to read it again. • Ask your pharmacist if you need more information or advice. • YOU MUST SEE A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT IMPROVE AFTER 5 DAYS. IN THIS LEAFLET 1. What CASACOL is used for 4. Possible side effects 2. Before you take CASACOL 5. Storing CASACOL 3. How to take CASACOL 6. Further information 1. WHAT IS CASACOL AND WHAT IT IS USED FOR The name of your medicine is CASACOL EXPECTORANT SYRUP. The active substances are Methoxyphenamine Hydrochloride 20mg, Guaiphenesin 100mg and Sodium Citrate 200mg per 5ml syrup. The other ingredients are Propylene Glycol, Saccharin Sodium, Nipasept (ethyl- (E214), propyl-(E216) and methyl-(E218) hydroxybenzoate), Linctus flavour, Ponceau 4R (E124), Sorbitol (E420) and Purified Water. CASACOL is a sugar-free syrup. CASACOL Expectorant Syrup is an expectorant and decongestant. It liquefies tenacious mucous and facilitates easier breathing. CASACOL is used to treat cough and congestion associated with the common cold, bronchitis, etc. 2. BEFORE YOU TAKE CASACOL To make sure it is safe for you to take CASACOL, please read the following section carefully. If you are receiving medication, or are under a doctor’s care, consult him before using CASACOL. DO NOT TAKE CASACOL • If you are suffering from impaired renal function. • If Lees het volledige document
Page 1 of 5 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 Each 5 ml contains: Methoxyphenamine hydrochloride 20 mg Guaiphenesin 100 mg Sodium citrate 200 mg 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. Page 2 of 5 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). 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 wit Lees het volledige document