INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
HYOSPASMOL® TABLETS
HYOSPASMOL® INJECTION

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

HYOSPASMOL^® TABLETS
HYOSPASMOL^® INJECTION

COMPOSITION:
Each tablet contains:
10 mg Hyoscine Butylbromide (Hyoscine n-Butylbromide).
Each mL of injection contains:
20 mg Hyoscine Butylbromide (Hyoscine n-Butylbromide).

PHARMACOLOGICAL CLASSIFICATION:
A 11.2 Gastro-intestinal antispasmodics.

PHARMACOLOGICAL ACTION:
Hyoscine butylbromide is a quaternary ammonium anticholinergic agent, the peripheral effects of which are similar to those of atropine, but weaker and of shorter duration.

INDICATIONS:
Hyoscine butylbromide is used in the treatment of conditions associated with gastro-intestinal spasm.

CONTRA-INDICATIONS:
Enlarged prostate. Closed angle glaucoma, or narrow angle between the iris and cornea as hyoscine increases intra-ocular pressure.

WARNING:
The safe use of Hyospasmol is contentious in patients with porphyria.

DOSAGE AND DIRECTIONS FOR USE:
Adult dose:

Tablets:	20 mg four times daily.
Injection:	20 mg i.m. or i.v., two or three times daily.

Paediatric dose:

Tablets:	Children 1 - 3 years: 5-10 mg three times daily.
	Children 3 - 6 years: 10 mg three times daily.
	Children 6 - 12 years: 10-20 mg three times daily.
Injection:	Infants and children up to 3 years: 5 mg i.m. or i.v., two or three times daily.
	Children 3 - 12 years: 10 mg i.m. or i.v., two or three times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
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 arrhythmias, and urinary urgency, difficulty and retention, as well as reduction in the tone and motility of the gastro-intestinal tract leading to constipation. Occasionally vomiting, giddiness and staggering may occur.
Retrosternal pain may occur due to increased gastric reflux.
Antimuscarinic agents 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.
The effects of antimuscarinic agents 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 agents may affect the absorption of other medicines.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
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 agents 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 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.

IDENTIFICATION:
Tablets: Round, white sugar-coated tablets.
Injection: Clear, colourless solution in amber ampoules.

PRESENTATION:
Tablets: Securitainers of 10 and 100 tablets.
Injection: Amber glass ampoules containing 20 mg in 1 mL.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Tablets: L/11.2/59.
Injection: L/11.2/60.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited, 7 Fairclough Road, PORT ELIZABETH 6001.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
2/78

        D640
        A & S PRINTERS.

Updated on this site: October 2004
Source: Community Pharmacy
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