Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol; Phenylephrine hydrochloride
Reckitt Benckiser Healthcare (UK) Ltd
N02BE51
Paracetamol; Phenylephrine hydrochloride
1gram ; 12.2mg
Powder for oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5000158069862
OBJECT 1 LEMSIP MAX HONEY & GINGER FLAVOUR POWDER FOR ORAL SOLUTION Summary of Product Characteristics Updated 07-Sep-2016 | Reckitt Benckiser Healthcare (UK) Ltd 1. Name of the medicinal product Lemsip Max Honey & Ginger Flavour Powder for Oral Solution. 2. Qualitative and quantitative composition _Active Ingredients_ _Mg/Sachet_ _Specification_ Paracetamol 1000.00 Ph Eur Phenylephrine hydrochloride* 12.20 Ph Eur * Equivalent to phenylephrine (base) 10.0 mg. 3. Pharmaceutical form A white to off-white powder for oral solution 4. Clinical particulars 4.1 Therapeutic indications For relief of the symptoms of colds and influenza, including the relief of aches and pains, sore throat, headache, nasal congestion and lowering of temperature. 4.2 Posology and method of administration Oral administration after dissolution in water. Adults and children over 12: One sachet dissolved by stirring in hot water and sweetened to taste. The dose may be repeated in 4-6 hours. No more than four doses should be taken in 24 hours. Not to be given to children under 12 without medical advice. There is no indication that dosage need be modified in the elderly. 4.3 Contraindications • Hypersensitivity to paracetamol, phenylephrine or any other ingredient. • Severe coronary heart disease and cardiovascular disorders. • Hypertension. • Hyperthyroidism. • Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors (see section 4.5). 4.4 Special warnings and precautions for use Use with caution in patients with Raynaud's phenomenon or diabetes mellitus. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Patients should be advised not to take other paracetamol -containing products concurrently. Each sachet contains approximately 2.0 g of carbohydrate. Due to its aspartame content this product should not be given to patients Lire le document complet