Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
PROPANTHELINE BROMIDE
Archimedes Pharma UK Limited
PROPANTHELINE BROMIDE
15 Milligram
Coated Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pro-banthine 15 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Propantheline Bromide Ph.Eur. 15 mg Excipients: also includes lactose monohydrate 31mg per tablet, and sucrose 26.74mg per tablet For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Coated Tablets (Tablets) Pink coloured, biconvex, sugar coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adjunctive in GI disorders characterised by smooth muscle spasm. Hyperhidrosis. Adult enuresis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults The recommended initial starting dose is one tablet before each meal, and two tablets at bedtime. Subsequently, dosage should be adjusted according to the patient’s individual response and tolerance. Doses up to 120mg may be required in some patients. Elderly Elderly patients may be more susceptible to antimuscarinic side effects; glaucoma and urinary retention may occur. Consideration should be given to the presence of other disease and concomitant drug therapy (see contraindications, warnings etc). Children Safety and efficacy of Pro-Banthine in children have not been established. Caution Food has been reported to reduce the bioavailability of Pro-Banthine. Tablets should be taken at least one hour before meals. Route of administration Oral. 4.3 CONTRAINDICATIONS Pro-Banthine is contraindicated in patients with obstructive diseases of the gastrointestinal or urinary tract, pyloric stenosis, paralytic ileus, intestinal atony, severe ulcerative colitis or toxic megacolon, hiatus hernia associated with reflux oesophagitis, unstable cardiovascular adjustment in acute haemorrhage, myasthenia gravis, prostatic enlargement and in patients who are hypersensitive to propantheline bromide. IRISH Прочитајте комплетан документ