দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Guaifenesin
JNTL Consumer Health I (Ireland) Limited
R05CA03
Guaifenesin
Syrup
guaifenesin
Not marketed
2024-03-22
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BENYLIN MUCUS COUGH HONEY & LEMON 100MG / 5ML SYRUP Guaifenesin 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 has 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 one week WHAT IS IN THIS LEAFLET: 1. What Benylin Mucus Cough Honey & Lemon 100mg/ 5ml Syrup is and what it is used for. 2. What you need to know before you take this Benylin Mucus Cough Honey & Lemon 100mg / 5ml Syrup 3. How to take Benylin Mucus Cough Honey & Lemon 100mg / 5ml Syrup. 4. Possible side effects. 5. How to store Benylin Mucus Cough Honey & Lemon 100mg / 5ml Syrup. 6. Contents of the pack and other information 1. WHAT BENYLIN MUCUS COUGH HONEY & LEMON 100MG / 5ML SYRUP IS AND WHAT IS IT USED FOR Benylin Mucus Cough Honey & Lemon 100mg / 5ml Syrup 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. This is a non-drowsy formulation. The medicine is for use in adults and adolescents aged 12 years and over. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS BENYLIN MUCUS COUGH HONEY & LEMON 100MG / 5ML SYRUP DO NOT TAKE THIS BENYLIN MUCUS COUGH HONEY & LEMON 100MG / 5ML SYRUP IF YOU - are allergic to guaifenesin or any of the other ingredients of this medicine listed in section 6 WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Benylin Mucus Cough Honey & Lemon 100mg / 5ml Syrup if you: • have had a cough for more than one week or your cough recurs or is accompanied by a fever, rash, or persistent headache. • have সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 26 March 2024 CRN00DTW0 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benylin Mucus Cough Honey & Lemon 100mg / 5ml Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION This product contains 20 mg guaifenesin in each ml. Excipient(s) with known effect Ethanol 0.1 ml/ml Glucose 698.4 mg/ml Sucrose 199.8 mg/ml Sodium citrate 2.1 mg/ml Sodium benzoate (E211) 2.0 mg/ml Propylene glycol (E1520) 5.8 mg/ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Syrup Clear yellow-brown colored syrup with a characteristic taste of honey and lemon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Benylin Mucus Honey & Lemon 100mg / 5ml Syrup indicated for the symptomatic relief of productive cough in adults and adolescents of 12 years and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents of12 years and above:_ 10 ml (200 mg guaifenesin) 4 times a day. Maximum daily dose: 40 ml (800 mg guaifenesin) _Paediatric population_ The safety and efficacy of Benylin Mucus Honey & Lemon 100mg / 5ml Syrup in children under 12 years has not yet been established No data are available _Elderly:_ As per adults. HEPATIC/RENAL IMPAIRMENT Caution should be exercised in severe hepatic and severe renal impairment (see Section 5.2). If cough persists for more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache, a physician should be consulted. Method of administration: Health Products Regulatory Authority 26 March 2024 CRN00DTW0 Page 2 of 5 Oral 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product should not be used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician. A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or সম্পূর্ণ নথি পড়ুন