Country: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ascorbic acid
Thornton & Ross Ltd
A11GA01
Ascorbic acid
1mg/1mg
Not applicable
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060301
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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol, Ascorbic acid, Phenylephrine Hydrochloride 750/60/10 mg blackcurrant flavoured Powder for Oral solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5.0 g sachet of powder for oral solution contains: ACTIVE CONSTITUENTS: Paracetamol 750.0 mg Ascorbic Acid 60.0 mg Phenylephrine Hydrochloride 10.0 mg EXCIPIENTS: Sucrose 2725 mg For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for oral solution Pale purple coloured powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short term symptomatic relief of influenza, feverishness, chills and colds including headache, sore throat pain, aches and pains, nasal congestion, sinusitis and its associated pain and acute nasal catarrh. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration, dissolved in hot water. Dosage: Adults (including elderly) aged 16 years and over: One sachet in a tumbler full of hot water to be taken every four to six hours up to four times a day. Children: Not recommended for children under 16 years of age. Do not take continuously for more than 5 days without medical advice. 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol or any of the other constituents. Concomitant use of other sympathomimetic decongestants. Phaeochromocytoma. Closed angle glaucoma. Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, heart disease. Patients taking tricyclic antidepressants, or beta-blocking drugs and those patients who are taking or have taken, within the last two weeks, monoamine oxidase inhibitors (see section 4.5). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Medical advice should be sought before taking this product in patients with these conditions: • An enlargement of the prostate gland • Occulusive Vascular disease (e.g. R Lestu allt skjalið