Kraj: Malta
Język: angielski
Źródło: Medicines Authority
GUAIFENESIN, LEVOMENTHOL
Johnson & Johnson (Ireland) Limited Airton Road Tallaght, Dublin 24, Dublin, Ireland
R05CA10
GUAIFENESIN 100 mg/5ml LEVOMENTHOL 1.1 mg/5ml
SYRUP
GUAIFENESIN 100 mg/5ml LEVOMENTHOL 1.1 mg/5ml
OTC
COUGH AND COLD PREPARATIONS
Authorised
2006-08-10
turn over PACKAGE LEAFLET: INFORMATION FOR THE USER Non-Drowsy Chesty Coughs Syrup GUAIFENESIN 100 MG/5 ML LEVOMENTHOL 1.1 MG/5 ML 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 Non-Drowsy Chesty Coughs Syrup is and what it is used for 2. What you need to know before you take Benylin Non-Drowsy Chesty Coughs Syrup 3. How to take Benylin Non-Drowsy Chesty Coughs Syrup 4. Possible side-effects 5. How to store Benylin Non-Drowsy Chesty Coughs Syrup 6. Contents of the pack and other information 1 WHAT BENYLIN NON-DROWSY CHESTY COUGHS SYRUP IS AND WHAT IT IS USED FOR Benylin Non-Drowsy Chesty Coughs Syrup 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 NON-DROWSY CHESTY COUGHS 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 NON-DROWSY CHESTY COUGHS 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 Non-Drowsy Chesty Coughs Syrup... ■ If you suffer from LIVER or KID Przeczytaj cały dokument
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BENYLIN Non-drowsy for Chesty Coughs Syrup Guaifenesin 100mg/5ml Levomenthol 1.1mg/5ml 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 10mg Sodium 16.4mg per 5ml Ethanol 0.7mg 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 Non-drowsy for Chesty Coughs 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 four times a day. CHILDREN UNDER 12 YEARS: Not recommended (see section 4.3). THE ELDERLY: As for adults. HEPATIC/RENAL DYSFUNCTION Page 2 of 8 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 Pharmacokinetics]. Page 3 of 8 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE BENYLIN Non-drowsy for Chesty Coughs 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 Pharmacokinetics]. Benylin Non-Drowsy for Chesty Coughs should not be used in children under the age of 12 years. This medicinal product contains 3.5 g glucose per 5ml, 1 g of sucrose per 5ml and 6.75mg invert sugar per 5ml. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary Przeczytaj cały dokument