Hyospasmol 10 mg. Sugar-coated tablet

HYOSPASMOL is used in the treatment of conditions associated with gastrointestinal spasm.

Adult dose: 20 mg four times daily.
Paediatric dose: Children 1 to 3 years: 5 mg to 10 mg three times daily.
Children 3 to 6 years: 10 mg three times daily.
Children 6 to 12 years: 10 mg to 20 mg three times daily.

• Enlarged prostate.
• Closed angle glaucoma or narrow angle between the iris and cornea as HYOSPASMOL increases intra-ocular pressure.

Antimuscarinic medicines should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure, and in cardiac surgery, where it may further accelerate the heart-rate. Care is required in patients with acute myocardial infarction as ischaemia and infarction may be made worse.

Porphyria: The safe use of HYOSPASMOL is contentious in patients with porphyria.

HYOSPASMOL contains lactose monohydrate and sucrose which may have an effect on the glycaemic control of patients with diabetes mellitus. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption, sucrose-isomaltase insufficiency or fructose intolerance should not take HYOSPASMOL.

The effects of antimuscarinic medicines may be enhanced by the concomitant administration of other medicines with antimuscarinic properties, such as amantadine, some antihistamines, butyrophenones and phenothiazines, and tricyclic antidepressants. The reduction in gastric motility caused by antimuscarinic medicines may affect the absorption of other medicines.

Not known.

Not specified.

Dryness of the mouth, with difficulty in swallowing and talking, thirst, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and dysrhythmias, and urinary urgency, difficulty and retention, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation. Occasionally vomiting, giddiness and staggering may occur. Retrosternal pain may occur due to increased gastric reflux.

Symptoms: Toxic doses cause tachycardia, rapid respiration, hyperpyrexia, and central nervous system stimulation marked by restlessness, confusion, excitement, paranoid and psychotic reactions, hallucinations and delirium, and occasionally seizures or convulsions. A rash may appear on the face or upper trunk. In severe intoxication central stimulation may give way to central nervous system depression, coma, circulatory and respiratory failure, and death. Quaternary ammonium antimuscarinic medicines usually have some ganglion-blocking activity so that high doses may cause postural hypotension and impotence; in toxic doses non-depolarising neuromuscular block may be produced. There is considerable variation in susceptibility to the belladonna alkaloids; recovery has occurred after 1 g, whereas deaths have been reported from doses of 100 mg or less for adults and 10 mg for children.

Treatment: Treatment is to empty the stomach by aspiration and lavage or by induction of emesis. The giving of activated charcoal to reduce absorption prior to lavage, has been suggested. Supportive therapy should be given as required.