Maa: Malta
Kieli: englanti
Lähde: Medicines Authority
GUAIFENESIN
Cupal Limited 103 - 105 Bath Road Slough, SL1 3UK, United Kingdom
R05CA03
GUAIFENESIN 50 mg/5ml
SYRUP
GUAIFENESIN 50 mg/5ml
OTC
COUGH AND COLD PREPARATIONS
Withdrawn
2007-07-12
Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF MEDICINAL PRODUCT Family Meltus Chesty Coughs Honey & Lemon Flavour 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Guaiphenesin 50mg 3. PHARMACEUTICAL FORM Syrup. 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications Symptomatic relief of deep chesty cough and to soothe the throat. 4.2 Posology and Method of Administration Route of administration: Oral. Dosage may be repeated 3 - 4 times daily. Adults and children over 12 years : Two to four 5ml spoonsful Children 6 - 12 years : Two 5ml spoonsful Children 2 - 6 years : One 5ml spoonful Children under 2 years : On medical advice only. 4.3 Contraindications None known. 4.4 Special Warnings None. 4.5 Interaction with Other Medicaments and Other Forms of Interaction None known. 4.6 Pregnancy and Lactation May be used. 4.7 Effects on Ability to Drive and use Machines None known. Page 2 of 3 4.8 Undesirable Effects Some gastro-intestinal discomfort. Very large doses may cause nausea and vomiting. 4.9 Overdose Very large doses may cause nausea and vomiting. The drug is however, rapidly metabolised and excreted in the urine. Treatment Patient should be kept under observation and treated symptomatically. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic Properties The Guaiphenesin is an expectorant. The sugar, honey and glycerin have a demulcent effect. 5.2 Pharmacokinetic Properties Guaiphenesin is absorbed from the gastrointestinal tract. It is metabolised and excreted in the urine. 5.3 Pre-clinical Safety Data There are no preclinical data of relevance to the prescriber wh Lue koko asiakirja