Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Methoxyphenamine hydrochloride; Sodium citrate; Guaiphenesin
Phoenix Labs
R05CA; R05CA10
Methoxyphenamine hydrochloride; Sodium citrate; Guaiphenesin
20 mg/5ml/100 mg/5ml/200 mg/5ml
Syrup
Product not subject to medical prescription
Expectorants; combinations
Marketed
1979-05-23
Guide lines Unvarnished area Braille LOGISTICS PRODUCTION REGULATORY AFFAIRS QUALIFIED PERSON CASACOL (20+100+200) mg/5ml syrup PRODUCT Laboratórios Basi - Indústria Farmacêutica, S.A. CLIENT 330365.V02 INT. CODE NUNO TEC. 20/03/2015 DATE 23/03/2013 - 27/03/2013 - V02: 12/12/2016 UPDATES MM 000 000 000 MM 000 000 000 MM 200 280 10 NO. FOLDS: SIZE FOLDED: 3 200 x 35 MM 1,5 MM - MM 3,5 MM 12,5 x 8 FONTS Arial Arial Black PANTONE Black U - - - - - - 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 2. Before you take CASACOL 3. How to take CASACOL 4. Possible side effects 5. Storing 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 c Läs hela dokumentet
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 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _2_ _/_ _1_ _0_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _7_ _6_ _7_ _0 Läs hela dokumentet