দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
TRIPROLIDINE HYDROCHLORIDE; Dextromethorphan hydrobromide
McNeil Healthcare (Ireland) Ltd
R05X
TRIPROLIDINE HYDROCHLORIDE; Dextromethorphan hydrobromide
5 mg/0.625 mg/5ml
Syrup
Product not subject to medical prescription
OTHER COLD PREPARATIONS
Marketed
1998-03-20
BENYLIN CHILDREN'S COUGHS & COLDS _5MG/0.625MG PER 5ML _ _SYRUP_ DEXTROMETHORPHAN, TRIPROLIDINE ■ This medicine is used to help relieve children’s dry cough and cold symptoms. ■ This medicine is for use by children aged 6 to 12 years. ■ DO NOT USE THIS MEDICINE: ■ There are some people who should not use this medicine. _To find out if your child is one _ _of _ _them see section _ _2>_ ■ If your child has ever had a BAD REACTION to any of the ingredients. _See section _ _6>_ ■ SPEAK TO YOUR DOCTOR: ■ If your child suffers from any of the conditions mentioned in section 2. _See section _ _2>_ ■ If your child is taking any OTHER MEDICINES . _See section _ _2>_ ■ FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. _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 child's symptoms worsen or do not improve after a few days. 1 WHAT THE MEDICINE IS FOR Benylin Children's Coughs & Colds Syrup is a medicine which is used to help relieve the symptoms of colds and dry coughs. The liquid contains dextromethorphan (an antitussive) to help stop coughing and triprolidine (an antihistamine) to help stop sneezing, runny nose and watery eyes. The medicine is for use in children aged 6 to 12 years. 2 BEFORE GIVING THE MEDICINE TO YOUR CHILD This medicine is suitable for most children but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. X DO NOT GIVE THIS MEDICINE… ■ If your child has ever had a BAD REACTION to any of the ingredients. ■ If your child is taking, or has taken in the last two weeks, DRUGS FOR DEPRESSION known as Monoamine Oxidase Inhibitors (MAOIs). ■ If your child is taking _selective serotonin reuptake inhibitors _ (used to treat DEPRESSION and ANXIETY ) such as fluoxetine, paroxetine and sertraline). ■ If your child is taking ANY OTHER COUGH AND COLD MEDICINE. ■ If your child has serio সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 12 December 2018 CRN008K16 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benylin Children’s Coughs and Colds 5mg/0.625mg per 5ml Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml contains 5 mg Dextromethorphan hydrobromide and 0.625 mg Triprolidine hydrochloride. Excipients: Each 5ml contains liquid maltitol 4080mg and methyl hydroxybenzoate (E218) 5mg. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Syrup Clear colourless syrup. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Benylin Children’s Coughs & Colds is indicated for the symptomatic relief of dry unproductive cough and rhinorrhoea associated with the common cold and influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS AND CHILDREN 12 YEARS AND OVER: Not appropriate. CHILDREN AGED 6 TO 12 YEARS: 10 ml three or four times daily. Leave at least 4 hours between doses. Maximum daily dose: 40 ml (4 doses). Use only when simple measures have failed to provide adequate relief. Use for more than five consecutive days is not recommended. Health Products Regulatory Authority 12 December 2018 CRN008K16 Page 2 of 12 CHILDREN UNDER 6 YEARS: Benylin Children's Coughs and Colds Syrup is contraindicated in children under the age of 6 years. [See Section 4.3] HEPATIC DYSFUNCTION Caution should be exercised when administering this product to patients with hepatic impairment. METHOD OF ADMINISTRATION For oral use. 4.3 CONTRAINDICATIONS Benylin Children's Coughs and Colds Syrup is contraindicated in individuals with hypersensitivity to dextromethorphan, triprolidine or to any of the excipients listed in section 6.1. Benylin Children's Coughs and Colds Syrup is contraindicated in patients who are receiving monoamine oxidase inhibitors (MAOIs) or who have received these within the previous 14 days. There is a risk of serotonin syndrome with the concomitant use of dextromethorphan and MAOIs, and the concomitant use of this product and MAOIs may cause a r সম্পূর্ণ নথি পড়ুন