Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN
McNeil Healthcare (Ireland) Ltd
R01BA52
PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN
100mg/5ml 30mg/5ml %v/v
Syrup
Product not subject to medical prescription
Sympathomimetics
Authorised
1997-03-07
PACKAGE LEAFLET: INFORMATION FOR THE USER PHLEGM GUAIFENESIN 100 MG/5 ML PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG/5 ML READ ALL OF THIS LEAFLET CAREFUL LY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 5 days. WHAT IS IN THIS LEAFLET 1. What Benylin Phlegm Cough plus Decongestant Syrup is and what it is used for 2. What you need to know before you use Benylin Phlegm Cough plus Decongestant Syrup 3. How to use Benylin Phlegm Cough plus Decongestant Syrup 4. Possible side effects 5. How to store Benylin Phlegm Cough plus Decongestant Syrup 6. Contents of the pack and other information 1 WHAT BENYLIN PHLEGM COUGH PLUS DECONGESTANT SYRUP IS AND WHAT IT IS USED FOR Benylin Phlegm Cough plus Decongestant is a medicine which is used to relieve chesty coughs, help clear the stuffy, blocked up feeling in your nose and sinuses and reduce catarrh. The syrup contains pseudoephedrine hydrochloride, which is a decongestant that relieves nasal and sinus congestion and guaifenesin, which is an expectorant that helps to loosen the mucus in your throat and chest. This medicine is for use by adults and children aged 12 years and over. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE BENYLIN PHLEGM COUGH PLUS DECONGESTANT SYRUP This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT USE THIS MEDICINE… n If you have ever had a BAD REACTION (ALLERGIC REACTION) to any of the ingredients _(listed in _ _section 6)_. n If you have HIGH BLOOD PRESSURE or HEART DISEASE. n If you ha Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benylin Phlegm Cough plus Decongestant Syrup Guaifenesin 100mg/5ml Pseudoephedrine Hydrochloride 30mg/5ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of syrup contains 100 mg of Guaifenesin and 30 mg of Pseudoephedrine Hydrochloride. Excipients: Also includes sucrose 3g per 5ml; Sunset Yellow (E110) 0.25mg per 5ml; Ponceau 4R (E124) 0.25mg per 5ml; Methyl hydroxybenzoate (E218) 5.0mg per 5ml, Propyl hydroxybenzoate (E216) 0.5mg per 5ml and ethanol (96%) 0.25ml per 5ml. _For a full list of excipients, see section 6.1_ 3 PHARMACEUTICAL FORM Syrup A clear orange-red, cherry-flavoured syrup. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Benylin Phlegm Cough plus Decongestant Syrup is indicated for the symptomatic relief of upper respiratory tract disorders accompanied by productive cough which benefits from a combination of a nasal decongestant and an expectorant. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS AND CHILDREN OVER 12 YEARS: 10 ml every 4-6 hours, up to four times a day CHILDREN UNDER 12 YEARS: This medicine is contra-indicated in children under 12 years of age (see section 4.3) OLDER PEOPLE: There have been no specific studies of Benylin Phlegm Cough plus Decongestant Syrup in the elderly. Experience has indicated that normal adult dosage is appropriate. HEPATIC DYSFUNCTION: Caution should be exercised when administering Benylin Phlegm Cough plus Decongestant to patients with severe hepatic impairment. RENAL DYSFUNCTION: Caution should be exercised when administering Benylin Phlegm Cough plus Decongestant to patients with mild to H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Read the complete document