PRO-BANTHINE Tablet Ref.[27547] Active ingredients: Propantheline

Posology

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).

Paediatric population

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.

Method of administration

Oral.

Intensification of the usual side effects may occur. In severe intoxication disturbances of the central nervous system may occur resulting in convulsion, coma, circulatory failure, respiratory depression, delirium, hallucinations and restlessness. Toxic doses of propantheline bromide may produce non-depolarising neuromuscular blocking effects with paralysis of voluntary muscle.

In the event of overdosage, empty the stomach and give activated charcoal. Excitement may be controlled by diazepam. Supportive treatment may require oxygen, assisted ventilation and the administration of fluids. In severe cases (convulsions, hyperpyrexia, respiratory depression) the use of intravenous physostigmine (0.5mg to 2mg) should be considered. Since it has a brief duration of action of about 1 to 2 hours, it may be necessary to repeat injections up to a total dose of 5mg.

18 months.

Do not store above 25°C.

Foil/PVC-PVdC strips of 100 or 112 tablets.

HDPE bottles of the appropriate size to accommodate 1000 or 5000 tablets.

Not all pack sizes may be marketed.

No special requirements.