ประเทศ: ไอร์แลนด์
ภาษา: อังกฤษ
แหล่งที่มา: HPRA (Health Products Regulatory Authority)
PSEUDOEPHEDRINE HYDROCHLORIDE ; DEXTROMETHORPHAN HYDROBROMIDE ; TRIPROLIDINE HYDROCHLORIDE
Johnson & Johnson (Ireland) Limited
R01BA52
PSEUDOEPHEDRINE HYDROCHLORIDE ; DEXTROMETHORPHAN HYDROBROMIDE ; TRIPROLIDINE HYDROCHLORIDE
30/10/1.25 Milligram
Syrup
Product not subject to medical prescription
pseudoephedrine, combinations
Marketed
1984-03-15
PACKAGE LEAFLET BENYLIN DUAL ACTION DRY SYRUP Pseudoephedrine 30 mg, Dextromethorphan 10 mg, triprolidine 1.25 mg _Cough & Congestion_ ■ This medicine is used to help relieve symptoms of cold and flu including irritating dry cough and related congestion symptoms. ■ This medicine is for use by adults and children aged 12 years and over. ■ DO NOT USE THIS MEDICINE: ■ There are some people who should not use this medicine. _To find out if you are one _ _of them See Section 2>_ ■ If you have ever had a BAD REACTION to any of the ingredients. _For the list of _ _ingredients See Section 6>_ ■ SPEAK TO YOUR DOCTOR: ■ If you suffer from any of the conditions mentioned in Section 2. _See Section 2>_ ■ If you are taking any OTHER MEDICINES. _See Section 2>_ ■ FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. These are shown in the tables. _See Section 3>_ NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. Keep the leaflet: you might need it again. Ask your pharmacist if you need more information or advice. Go to see your doctor if your symptoms worsen or do not improve after a few days. 1 WHAT THE MEDICINE IS FOR Benylin Dual Action Dry is a medicine which is used to help relieve dry coughs and related congestion symptoms. The liquid contains triprolidine hydrochloride which is an antihistamine that helps stop sneezing, runny nose and watery eyes, pseudoephedrine hydrochloride which is a decongestant that unblocks stuffy noses and dextromethorphan hydrobromide which is an antitussive to help stop coughing. The medicine is for use in adults and children aged 12 years and over. 2 BEFORE TAKING THIS MEDICINE 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 to any of the ingredients. ■ If you have HIGH BLOOD PRESSURE or HEART DISEASE. ■ If you are taking beta blockers (used to treat HIGH BLOOD PRESSURE). ■ If you are taking, or have taken อ่านเอกสารฉบับเต็ม
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benylin Dual Action Dry Syrup Pseudoephedrine 30mg Dextromethorphan 10mg Triprolidine 1.25mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of Benylin Dual Action Dry Syrup contains Pseudoephedrine Hydrochloride 30 mg Dextromethorphan Hydrobromide 10 mg Triprolidine Hydrochloride 1.25 mg Excipients: contains Sorbitol Solution (70%) 1000.0mg, Sucrose 2835.0mg, sodium Benzoate (E211) 5.0mg, Ponceau 4R (E124) 0.8mg and Ethanol (96% v/v) 201.5mg. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Syrup A clear, bright red, blackberry-flavoured syrup. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BENYLIN Dual Action Dry Syrup is indicated for the relief of dry cough and upper respiratory tract congestion such as is associated with the common cold and influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS AND CHILDREN 12 YEARS AND OVER: 10 ml every 4-6 hours, up to four times a day Maximum daily dose: 40ml (80mg dextromethorphan, 240mg pseudoephedrine and 10mg triprolidine). CHILDREN UNDER 12 YEARS: This medicine is contraindicated in children under the age of 12 years. [See section 4.3] USE IN THE ELDERLY There have been no specific studies of Benylin Dual Action Dry Syrup in the elderly. Experience has indicated that normal adult dosage is appropriate. 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_ _ _ _1_ _3_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _8_ _4_ _8_ อ่านเอกสารฉบับเต็ม