Dividol®

Properties

Dividol® exerts a spasmolytic action on the smooth muscle of the gastrointestinal, biliary and genito-urinary tracts. Peripheral anticholinergic actions results from a ganglion-blocking action within the visceral wall as well as from an anti-muscarinic activity.


Following oral and intravenous administration, hyoscine butylbromide concentrates in the tissue of the gastrointestinal tract, liver and kidneys. As a quarternary ammonium derivative, hyoscine butylbromide does not pass the blood-brain barrier or enter the central nervous system.


Following oral administration, hyoscine butybromide is only partially absorbed. Nevertheless, despite the briefly measurable low blood levels, hyoscine butylbromide remains available at the site of action because of its high tissue affinity.

Indications

Dividol® tablets are indicated for the relief of spasm of the genito-urinary tract or gastro-intestinal tract, for the symptomatic relief of Irritable Bowel Syndrome, and in the prevention and treatment of spasmodic dysmenorrhoea.

Dosage

Dividol® tablets should be swallowed whole with adequate water.

Adults:

two tablets four times daily.For the symptomatic relief of Irritable Bowel Syndrome, the recommended starting dose is 1 tablet three times daily; this can be increased up to 2 tablets four times daily if necessary. In spasmodic dysmenorrhoea, treatment should commence two days before the expected onset of the period and continue for three days after menstruation has begun.


Children:

6-12 years: 1 tablet three times daily. No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

Contra-indications

Dividol® tablets should not be administered to patients with myasthengia gravis, megacolon and narrow angle glaucoma. In addition, they should not be given to patients with a known hypersensitivity to hyoscine butybromide or any of the excipients.

Special warnings and special precautions for Use

Dividol® should be used with caution in patients with hepatic or renal impairment since central nervous system effects occur more often in these patients.

Use with caution in children since they may be more susceptible to the side-effects of Dividol®.

Dividol tablets should be used with caution in patients with gastro-intestinal obstruction.

Condition characterised by tachycardia (e.g. thyrotoxicosis, cardiac insufficiency or failure, cardiac surgery); Pyrexia.

Advise patients to see urgent opthalmological advice in case they develop a painful red eye, loss of vision.


Interaction with other medications and other forms of interactions

The concurrent use of Dividol® with other anticholinergic drugs may produce additive adverse effects. Dividol® administration may affect the absorption of the following drugs: Paracetamol , Levodopa, Ketoconazole, Digoxin, Riboflavin and potassium chloride wax-matrix preparations. Metoclopramide, B-adrenergic agents, butyrophenones, phenothiazines,disopyramide.