Country: Malta
Bahasa: Inggeris
Sumber: Malta Medicines Authority
DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Cupal Limited 103 - 105 Bath Road Slough, SL1 3UK, United Kingdom
R05D
DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 10 mg/5ml
ORAL LIQUID
DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 10 mg/5ml
OTC
COUGH AND COLD PREPARATIONS
Withdrawn
2007-06-12
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Adult Meltus Dry Coughs with Congestion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dextromethorphan hydrobromide BP 10.00 mg /5ml Pseudoephedrine hydrochloride BP 10.00 mg /5ml For excipients, see 6.1. 3. PHARMACEUTICAL FORM Oral liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The symptomatic relief of dry painful tickly coughs and catarrh. 4.2 POSOLOGY AND ROUTE OF ADMINISTRATION Oral Use. ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS OF AGE: One or two 5ml spoonfuls to be taken four times a day. Not to be given to children under 12 years of age. 4.3 CONTRAINDICATIONS Patients with cardiovascular disease, hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma, closed angle glaucoma. Use with caution in patients with liver disease and asthma. May increase the difficulty of micturation in patients with prostatic enlargements. Hypersensitivity to any of the ingredients. If also taking monoamine oxidase inhibitors. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not exceed the stated dose. If symptoms persist or worsen, seek medical advice. Keep out of the reach of children. If pregnant or taking regular medication, consult your doctor before taking this product. Page 2 of 4 4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Mono-amine oxidase inhibitors. The activity of the pseudoephedrine content is diminished by guanethidine, reserpine and methyldopa and may be diminished or enhanced by tricyclic antidepressants; it may diminish the effects of guanethidine and may increase the possibility of arrhythmias in digitalised patients. Use with caution in patients with diabetes. 4.6 PREGNANCY AND LACTA Baca dokumen lengkap