Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Levomenthol; Guaifenesin
JNTL Consumer Health I (Ireland) Limited
R05CA; R05CA03
Levomenthol; Guaifenesin
Syrup
Expectorants; guaifenesin
Marketed
2011-09-09
turn over PACKAGE LEAFLET: INFORMATION FOR THE USER PHLEGM Guaifenesin 100mg/5ml Levomenthol 1.1mg/5ml Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take 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 feel worse after 3 days. WHAT IS IN THIS LEAFLET 1. What Benylin Phlegm Cough Syrup is and what it is used for 2. What you need to know before you take Benylin Phlegm Cough Syrup 3. How to take Benylin Phlegm Cough Syrup 4. Possible side-effects 5. How to store Benylin Phlegm Cough Syrup 6. Contents of the pack and other information 1 WHAT BENYLIN PHLEGM COUGH SYRUP IS AND WHAT IS IT USED FOR Benylin Phlegm Cough is a medicine which is used to help relieve chesty coughs. It contains Guaifenesin (an expectorant) to help loosen mucus (phlegm) from the lungs and make it easier to cough up, and Levomenthol to help you breathe more easily by easing congestion. The medicine is for use in adults and children aged 12 years and over. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENYLIN PHLEGM COUGH 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 TAKE BENYLIN PHLEGM COUGH SYRUP ■ If you are allergic to guaifenesin or levomenthol or to any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Benylin Phlegm Cough Syrup ■ If you suffer from LIVER or KIDNEY PROBLEMS. ■ If you have been told by your doctor that you have an intolerance to some sugars. ■ If you have had a COUGH for a few weeks that Read the complete document
Health Products Regulatory Authority 28 March 2024 CRN00DHHF Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benylin Phlegm Cough Syrup Guaifenesin 100 mg/5ml Levomenthol 1.1 mg/ 5ml Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mls contains 100 mg guaifenesin and 1.1 mg levomenthol Excipients with known effect: Each 5ml contains Glucose liquid 3.5g Sucrose 1g Ponceau 4R (E124) 0.25mg Sodium benzoate (E211) 10mg Sodium 16.4mg Ethanol 197mg Propylene glycol (E1520) 1.07mg Invert sugar 6.75mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Syrup. Clear, red syrup having a characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Benylin Phlegm Cough Syrup is indicated for the symptomatic relief of productive cough. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN OVER 12 YEARS: Oral. Two 5 ml spoonfuls every 4 to 6 hours. Do not give more than 4 doses in 24 hours. Maximum daily dose 40ml. CHILDREN UNDER 12 YEARS: Not recommended. [See section 4.3]. THE ELDERLY: As for adults. HEPATIC/RENAL DYSFUNCTION Experience with the use of this product suggests that normal adult dosage is appropriate for mild to moderate dysfunction. Caution should be exercised in severe hepatic and severe renal impairment. [See section 4.4]. 4.3 CONTRAINDICATIONS This product is contraindicated in individuals with known hypersensitivity to the active substance or to any of the excipients. Benylin Phlegm Cough Syrup should not be used in children under the age of 12 years. Health Products Regulatory Authority 28 March 2024 CRN00DHHF Page 2 of 6 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Benylin Phlegm Cough Syrup should be not used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician. Caution should be exercised when using the product in the presence of severe renal or severe hepatic impairment. [See section 4.2]. This medicinal product contains 3.5g glucose Read the complete document