Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Dextromethorphan hydrobromide; Pseudoephedrine hydrochloride
The Boots Company Plc
R05DA; R05DA20
Dextromethorphan hydrobromide; Pseudoephedrine hydrochloride
10 / 30 mg/5ml
Oral solution
Product not subject to medical prescription
Opium alkaloids and derivatives; combinations
Not marketed
1999-11-26
INFORMATION FOR THE USER Dry Cough & Congestion Relief Oral Solution Dextromethorphan Hydrobromide 10 mg/5 ml, Pseudoephedrine Hydrochloride 30 mg/5 ml READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it. Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice WHAT THIS MEDICINE IS FOR This medicine contains Dextromethorphan, a cough suppressant, which acts to reduce coughing. It also contains Pseudoephedrine, a decongestant, which acts to relieve a blocked nose. It can be used to relieve symptoms of dry and tickly coughs, blocked sinuses and catarrh. Dry coughs do not produce phlegm or mucus on the chest. For children, simple treatments should be tried first before you give this medicine. Further information on “TREATING COUGHS AND COLDS IN CHILDREN” is provided at the end of this leaflet. BEFORE YOU TAKE THIS MEDICINE This medicine can be taken by adults and children of 6 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first. DO NOT TAKE: IF YOU ARE ALLERGIC to any of the ingredients in this medicine (see “What is in this medicine”) IF YOU ARE ALLERGIC TO OTHER DECONGESTANTS IF YOU HAVE SEVERE KIDNEY PROBLEMS IF YOU HAVE HEART OR BLOOD VESSEL DISEASE IF YOU HAVE HIGH BLOOD PRESSURE (including that due to a tumour near your kidney) IF YOU HAVE DIABETES IF YOU HAVE AN OVERACTIVE THYROID IF YOU HAVE RAISED PRESSURE IN THE EYE (glaucoma) IF YOU HAVE DIFFICULTY BREATHING IF YOU HAVE A LONG-TERM COUGH or one which produces lots of phlegm IF YOU ARE HAVING AN ASTHMA ATTACK IF YOU HAVE DIFFICULTY IN PASSING URINE IF YOU ARE TAKING ANY OF THESE MEDICINES: - Monoamine oxidase inhibitors or moclobemide (for depression), or have taken them in th Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 19 February 2020 CRN00955K Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Boots Pharmaceuticals Dry Cough & Congestion Relief Oral Solution Dextromethorphan Hydrobromide 10 mg/5 ml Pseudoephedrine Hydrochloride 30 mg/5 ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients per 5 ml Pseudoephedrine hydrochloride 30 mg Dextromethorphan hydrobromide 10 mg Excipients: also contains 2.65g sucrose per 5ml, 77.76mg ethanol 96% per 5ml and 14.78mg sodium per 5ml. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral Solution A clear, yellow, viscous liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of dry, tickly coughs and the symptoms of nasal congestion associated with blocked sinuses and catarrh. For children aged 6 to 12 years: For the relief of dry, tickly coughs and the symptoms of nasal congestion associated with blocked sinuses and catarrh when simple measures have failed. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults and children 12 years and over: Two 5ml spoonfuls to be taken three times a day. Elderly: The normal adult dose is appropriate in the elderly. Children 6-12 years: One 5ml spoonful to be taken three times a day. This medicine is contraindicated in children under 6 years of age (See section 4.3) Children of 6-12 years of age: Not to be used for more than 5 days without the advice of a doctor. Parents and carers should seek medical attention if the child's condition deteriorates during treatment. Warning: Do not exceed the stated dose. Keep out of the sight and reach of children. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or any of the excipients. Health Products Regulatory Authority 19 February 2020 CRN00955K Page 2 of 7 Severe renal impairment. Cardiovascular disease including hypertension and ischaemic heart disease. Diabetes mellitus. Phaeochromocytoma. Hyperthyroidism. Closed angle glaucoma. Prostatic enlargement (patients wit Lesen Sie das vollständige Dokument