INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo SCOPEX Injection/SCOPEX Tablets

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

SCOPEX Injection/SCOPEX Tablets

COMPOSITION
Injection: Each 1 mL contains: Hyoscine Butylbromide 20 mg
Tablet: Each tablet contains: Hyoscine Butylbromide 10 mg
Preservative: Nipastat 0,126% m/m (in core) 

PHARMACOLOGICAL CLASSIFICATION:
A 5.4 Cholinolytics (anticholinergics).

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
Patients with prostatic enlargement, paralytic ileus or pyloric stenosis, close-angle glaucoma or with a narrow angle between the iris and the cornea. Due to the risk of provoking hyperpyrexia it should not be given to patients, especially children where the ambient temperature is high. It should not be given to patients with myasthenia gravis unless it is given to reduce adverse muscarinic effects of an anticholinesterase agent.
Safety during pregnancy and lactation has not been established.

WARNINGS
The use of this medicine may cause drowsiness; patients so affected should not drive or operate machinery. Alcohol should be avoided.

DOSAGE AND DIRECTIONS FOR USE
Injection: 20 mg (1 ampoule) intramuscularly, subcutaneously or intravenously, repeated after 30 minutes if necessary.
Oral dose: Two tablets (20 mg) four times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects of antimuscarinic agents include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilation of the pupils (mydriasis) with loss of accommodation (cyclopegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation.
Occasionally vomiting, confusion, giddiness and staggering may occur. High doses may cause postural hypotension and impotence. Hyoscine Butylbromide does not readily cross the blood-brain barrier, so central effects are less frequent.
Use with caution in children, geriatric patients, patients with diarrhoea, fever, and in conditions characterised by tachycardia. Care is required in patients with acute myocardial infarction and in patients with hypertension. In patients with ulcerative colitis its use may lead to ileus or megacolon, and its effects on lower oesophageal sphincter may exacerbate reflux.
The effects of Hyoscine Butylbromide may be enhanced by the concomitant administration of other medicines with antimuscarinic properties, such as amantadine, some antihistamines, butyrophenones, phenothiazines and tricyclic antidepressants. The absorption of other medicines may also be affected due to the reduction in gastric motility.

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 case of oral overdosage the stomach should be emptied by aspiration and lavage or by emesis.
Further treatment is symptomatic and supportive.

IDENTIFICATION
Injection: Clear, colourless to almost colourless solution.
Tablet: Round and smooth, white sugar-coated tablet. Odourless.

PRESENTATION
1 mL amber glass ampoules in packs of 10's and 100's.
Securitainers containing 10, 100 and 500 tablets.

STORAGE INSTRUCTIONS
Store below 25°C in airtight containers and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER/REFERENCE NUMBER
Injection: C688 (Act 101/1965)
Tablet : C674 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT
The Premier Pharmaceutical Co. Ltd.
Adcock Ingram Park 17
Harrison Avenue Bryanston Ext. 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT
4 April 1997

        09000
        01/99
        Britepak

Updated on this site: March 2002
Current: October 2005
Hospital Pharmacy

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