Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
GUAIFENESIN
McNeil Healthcare (Ireland) Ltd
R05CA03
GUAIFENESIN
50mg / 5ml N/A
Syrup
Product not subject to medical prescription
Expectorants
Authorised
1998-07-27
PIL - proposed clean Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER Children’s Chesty Coughs _50 MG/5 ML SYRUP _ _6-12 YEARS _ _G_UAIFENESIN . 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 your child gets 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 your child does not feel better or feels worse after a few days. WHAT IS IN THIS LEAFLET 1. What Benylin Children’s Chesty Coughs Syrup is and what it is used for 2. What you need to know before you take Benylin Children’s Chesty Coughs Syrup 3. How to use Benylin Children’s Chesty Coughs Syrup PIL - proposed clean Page 2 of 7 4. Possible side effects 5. How to store Benylin Children’s Chesty Coughs Syrup 6. Contents of the pack and other information 1. WHAT BENYLIN CHILDREN’S CHESTY COUGH SYRUP IS AND WHAT IT IS USED FOR Benylin Children’s Chesty Cough Syrup is a medicine which is used to help relieve chesty coughs in children. It contains guaifenesin (an expectorant) to help loosen mucus (phlegm) from the lungs and make it easier to cough up. The medicine is for use in children aged 6-12 years. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BENYLIN CHILDREN’S CHESTY COUGH SYRUP This medicine is suitable for most children but a few children should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benylin Children’s Chesty Cough 50mg/5ml Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml contains 50 mg guaifenesin. Excipients with known effect: sorbitol liquid (E420) 2.525g per 5ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Syrup A colourless to slightly yellow, clear syrup. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Benylin Children's Chesty Cough is indicated for the symptomatic relief of productive coughs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN 12 YEARS AND OVER: Not appropriate. CHILDREN AGED 6 TO 12 YEARS: Oral.10 ml three or four times daily Maximum daily dose: 40 ml Use only when simple measures have failed to provide adequate relief. Use for more than five consecutive days is not recommended. CHILDREN UNDER 6 YEARS: Not recommended. [See Section 4.3] 4.3 CONTRAINDICATIONS Use in patients hypersensitive to the active ingredients. Use in patients at risk of developing respiratory failure. Use in children under 6 years of age is contraindicated. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE BENYLIN Children's 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. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _7_ _/_ _1_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _9_ _2_ _6_ _0_ _p_ _a_ _g_ _e_ _ _ সম্পূর্ণ নথি পড়ুন