Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
PSEUDOEPHEDRINE HYDROCHLORIDE; Guaifenesin
Johnson & Johnson (Ireland) Limited
R01BA; R01BA52
PSEUDOEPHEDRINE HYDROCHLORIDE; Guaifenesin
30 mg/5ml + 100 mg/5ml
Syrup
Product not subject to medical prescription
Sympathomimetics; pseudoephedrine, combinations
Marketed
1997-04-07
Package leaflet: Information for the user BENYLIN PHLEGM COUGH PLUS DECONGESTANT SYRUP GUAIFENESIN 100MG/5ML PSEUDOEPHEDRINE HYDROCHLORIDE 30MG/5ML . READ ALL OF THIS LEAFLET CAREFULLY 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. X DO NOT USE THIS MEDICINE… ■ If you have ever had a BAD REACTION ( ALLERGIC REACTION ) to any of the ingredients ( _listed in _ _section 6_ ). ■ If you have HIG Lue koko asiakirja
Health Products Regulatory Authority 21 September 2021 CRN00C1H7 Page 1 of 9 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 5ml of syrup contains 100 mg Guaifenesin and 30mg Pseudoephedrine hydrochloride. Excipients with known effect: Each 5ml contains: Sucrose 3g Sunset yellow (E110) 0.25mg Ponceau 4R (E124) 0.25mg Methyl hydroxybenzoate (E218) 5.0mg Propyl hydroxybenzoate (E216) 0.5mg Ethanol 188mg Benzyl alcohol 0.02mg 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 moderate renal impairment. Health Products Regulatory Authority 21 September 2021 CRN00C1H7 Page 2 of 9 METHOD OF ADMINISTRATION For oral use 4.3 CONTRAINDICATIONS Benylin Phlegm Cough plus Decongestant Syrup is contra-indicated in individuals with known hypersensitivity to Pseudoephedrine, Guaifenesin or to any of the excipients listed in section 6.1. Benylin Phlegm Cough plus Deconges Lue koko asiakirja