Țară: Armenia
Limbă: engleză
Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
paracetamol, phenylephrine (phenylephrine hydrochloride), ascorbic acid
SmithKline Beecham S.A. Ctra. de Ajalvir
N02BE51
paracetamol, phenylephrine (phenylephrine hydrochloride), ascorbic acid
750mg+ 10mg+ 60mg
powder for oral solution with lemon flavour
(10) sachets 5g
OTC
Registered
2017-05-04
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Coldrex® HotRem 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE CONSTITUENTS: Paracetamol 750.00 mg Phenylephrine Hydrochloride 10.00 mg Ascorbic acid 60.00 mg 3. PHARMACEUTICAL FORM Powder for oral solution with lemon flavour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The short term symptomatic relief of cold & flu symptoms including headache, sore throat, nasal congestion, sinusitis and its associated pain, body aches and pains, and fever. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Empty the contents of the sachet into a beaker and fill with very hot water. Stir well. Add cold water as necessary. Adults (including the elderly) and children aged 12 years and over: One sachet to be taken every four to six hours as required. Maximum daily dose - five sachets in any 24 hour period. Minimum dosing interval: 4 hours. Not recommended for children under the age of 12 years, except on medical advice. Maximum duration of use without medical advice: 7 days. If symptoms persist, consult a doctor. Do not exceed the stated dose. The lowest dose necessary to achieve efficacy should be used. 4.3 CONTRAINDICATIONS This product is contraindicated in following cases: • Hypersensitivity to paracetamol, phenylephrine, ascorbic acid or any of the excipients; • Patiens, who are taking, or have taken, within the last two weeks, monoamine oxidase inhibitors, which typically are used to treat depression; • Pheochromocytoma; • Closed-angle glaucoma; • Hepatic or severe renal insufficiency; • Hypertension; • Hyperthyroidism; • Diabetes • Heart disease • Patients, taking beta-blockers and tricyclic antidepressants . 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE CONTAINS PARACETAMOL. Do not use with any other paracetamol-containing products, decongestants (medicines for the relief congestion or blocked nose) or cold and flu medicines. The concomitant use with other products containing paracetamol may lead to an overd Citiți documentul complet