מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
GUAIFENESIN; TRIPROLIDINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Glaxo Wellcome UK Limited
R01BA52
GUAIFENESIN; TRIPROLIDINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
ORAL SOLUTION
GUAIFENESIN 100 mg/5ml; TRIPROLIDINE HYDROCHLORIDE 1.25 mg/5ml; PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5ml
OTC
NASAL PREPARATIONS
Authorised
2006-05-29
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER ACTIFED EXPECTORANT Pseudoephedrine hydrochloride 30 mg, Triprolidine hydrochloride 1.25 mg and Guaiphenesin 100mg/5ml Oral Solution ATTENTION Actifed Expectorant is authorised for use without the need of a medical prescription in Adults and Children over 12 years as recommended by your pharmacist. In Children between 2-11 years of age, this product is authorised for use only against a medical prescription as recommended by your doctor. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed/recommended for you or your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same. If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1 What Actifed Expectorant is and what it is used for 2 What you need to know before you use Actifed Expectorant 3 How to use Actifed Expectorant 4 Possible side effects 5 How to store Actifed Expectorant 6 Contents of the pack and other information 1 WHAT ACTIFED EXPECTORANT IS AND WHAT IT IS USED FOR Actifed Expectorant contains 30 mg Pseudoephedrine hydrochloride, 1.25 mg Triprolidine hydrochloride and 100 mg Guaiphenesin (the active ingredients) in each 5 ml dose. There are also some inactive ingredients in Actifed Expectorant. Actifed Expectorant is used for the relief of symptoms of chesty coughs and colds. Pseudoephedrine hydrochloride is a decongestant, which means it acts to relieve blocked sinuses and noses. Triprolidine hydrochloride is an antihistamine, which means it will help stop sneezing, watering and soreness in the nose and eyes. Guaiphenesin is an expectorant, which means it helps to loosen stubborn mucus (phlegm) קרא את המסמך השלם
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Actifed Expectorant 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Triprolidine Hydrochloride 1.25mg, Pseudoephedrine Hydrochloride 30mg and Guaiphenesin 100mg in each 5ml 3. PHARMACEUTICAL FORM Oral solution CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Actifed Expectorant is indicated for symptomatic relief of upper respiratory tract disorders accompanied by productive cough, which benefit from the administration of a nasal decongestant. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For oral administration only. Users should be advised to seek medical advice if symptoms persist for more than 7 days. Do not exceed the stated dose or frequency of dosing. Avoid use with other anti-histamine-containing products, including cough and cold medicines (see Section 4.4.). Adults (including the elderly) and children aged 12 years and over 10ml every 4-6 hours as required. Maximum daily dose: 40ml syrup in any 24 hours. Actifed Expectorant may be diluted 1:1 (1 in 2) or 1:3 (1 in 4) with unpreserved syrup BP. These dilutions have a shelf life of 4 weeks if stored at 25 o C. Older people There have been no specific studies of pseudoephedrine, triprolidine or guaifenesin in the elderly. The elderly are more likely to experience the Page 2 of 11 neurological anticholinergic effects of triprolidine, including confusion, and to develop paradoxical excitation [see Section 4.4.]. Patients with hepatic impairment Triprolidine is eliminated primarily by hepatic metabolism therefore consideration should be given to reducing the dose in those with severe hepatic impairment [see Section 4.4.]. Patients with renal impairment Pseudoephedrine is primarily excreted renally. Pseudoephedrine should not be used by those with severe renal impairment (see Section 4.3.) and should be used with caution in those with moderate renal impairment (see Section 4.4.). 4.3. CONTRAINDICATIONS Hypersensitivity to pseudoephedrine hydrochloride, triprolidine hydrochloride, קרא את המסמך השלם