PRO-BANTHINE 15 Milligram Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PROPANTHELINE BROMIDE

Available from:

Archimedes Pharma UK Limited

INN (International Name):

PROPANTHELINE BROMIDE

Dosage:

15 Milligram

Pharmaceutical form:

Coated Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Summary of Product characteristics

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