Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Guaifenesin
Reckitt Benckiser Healthcare (UK) Ltd
R05CA03
Guaifenesin
10mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03090200; GTIN: 5000158064034 5011417566817
OBJECT 1 LEMSIP COUGH CHESTY Summary of Product Characteristics Updated 14-Dec-2017 | Reckitt Benckiser Healthcare (UK) Ltd 1. Name of the medicinal product Lemsip Cough for Chesty Cough 50mg/5ml Oral Solution 2. Qualitative and quantitative composition Guaifenesin 50mg/5ml Excipient(s): Sucrose: 3.965 g per 5ml dose Sodium: 3.66 mg (0.16mmol) per 5ml dose For full list of excipients, see section 6.1 . 3. Pharmaceutical form Oral solution 4. Clinical particulars 4.1 Therapeutic indications Symptomatic relief of deep chesty coughs and to soothe the throat. 4.2 Posology and method of administration For oral administration. Under 12 years: On medical advice only To be taken three or four times daily. Glass bottle Adults and children 12 years and over: two to four 5ml spoonfuls. PETE plastic bottle Adults and children 12 years and over: 10 ml dose (fill measure cup to 10 ml); 15 ml (one 10 ml measure in cup followed by a 5 ml measure); 20 ml (10 ml taken twice). Rinse the measure cup after use. 4.3 Contraindications Hypersensitivity to guaifenesin or to any of the excipients. 4.4 Special warnings and precautions for use This medicine contains 0.16 mmol (or 3.66 mg) sodium per 5 ml dose. To be taken into consideration by patients on a controlled sodium diet. Contains 3.965 g of sucrose per 5 ml dose. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 4.5 Interaction with other medicinal products and other forms of interaction If urine is collected within 24 hours of a dose of the medicinal product, a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5- HIAA) and vanillylmandelic acid (VMA). Guaifenesin may increase the rate of absorption of paracetamol. 4.6 Pregnancy and lactation Guaifenesin has been linked with an increased risk of neural tube defects in a smal Read the complete document