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Hyoscine Injection Bp 400mcg/Ml

Document: spc-doc_PL 01883-6135R change

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Hyoscine Injection BP 400mcg/ml

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Hyoscine Hydrobromide BP 0.04% w/v

3.    PHARMACEUTICAL FORM

Solution for Injection

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

a.    Nausea, vomiting, vertigo, labyrinthine disorders, motion sickness

b.    To prevent excessive bronchial salivary secretions during the use of general anaesthesia.

4.2    Posology and method of administration

By subcutaneous or intramuscular injection Adults and the elderly

1.    200 micrograms as a single dose

2.    200 - 600 micrograms, 30 - 60 minutes before induction of anaesthesia Children (over 4 months)

1.    6 micrograms/ kg as a single dose

2.    15 micrograms/ kg, 30 - 60 minutes before induction of anaesthesia Children (under 4 months)

Not recommended.

4.3 Contraindications

Glaucoma, acute porphyria and the onset of labour.

4.4 Special warnings and precautions for use

In some patients, especially the elderly, it may cause central anticholinergic syndrome (excitement, ataxia, hallucinations, behavioural abnormalities and drowsiness). Urinary retention, cardiovascular disease, paralytic ileus and pyloric stenosis. Caution is required in patients with asthma, hepatic or renal impairment, gastrointestinal obstruction, epilepsy and thyrotoxicosis.

4.5 Interactions with other medicinal products and other forms of interaction

The depressant actions of hyoscine may be enhanced by other CNS depressants such as alcohol, anaesthetics, antidepressants, hypnotics, monoamine oxidase inhibitors (MAOIs), muscle relaxants, phenothiazines, sedatives and tricyclic antidepressants.

The antimuscarinic effect of hyoscine is increased by amantadine (a dopaminergic), antihistamines, disopyramide (an anti-arrhythmic), nefopam (an analgesic) and phenothiazines (but reduced plasma levels).

The antimuscarinic effect of hyoscine is decreased by parasympathomimetics.

The effects of sublingual nitrates may be reduced by the antimuscarinic effects of hyoscine.

The gastrointestinal effects of domperidone, cisapride and metoclopramide are antagonised by hyoscine.

4.6 Pregnancy and lactation

There is evidence of hazard in human pregnancy, particularly before the onset of labour. The drug should only be used in pregnancy if there is no safer alternative.

4.7 Effects on ability to drive and use machines

Hyoscine may impair vision and cause drowsiness. It should be used with caution by anyone intending to drive or operate machinery.

4.8


Undesirable effects


Drowsiness, blurred vision, dry mouth, thirst and urinary retention. More rarely: excitement, confusional states, delirium and rashes. It may slow the heart.


4.9 Overdose

In the early stages the symptoms would be excitement, delirium, dilated pupils, rapid pulse, hot flushes, dry skin, dry mouth and thirst, (see also section 4.8).

Symptomatic and supportive treatment should be instituted (in the case of oral ingestion, gastric lavage should be included). In later stages, there may be respiratory depression and artificial respiration may be needed. Circulatory collapse may occur.


5 PHARMACOLOGICAL PROPERTIES


5.1 Pharmacodynamic properties

Hyoscine is an anti-muscarinic with action it suppresses salivation. In producing drowsiness and amnesia.


central and peripheral actions. As part of its peripheral its central action it depresses the cerebral cortex,


5.2 Pharmacokinetic properties

Hyoscine is readily absorbed by the gastro-intestinal tract. It is almost entirely metabolised with only a very small proportion being excreted in the urine.


5.3 Preclinical safety data

No additional pre-clinical data of relevance to the prescriber is available.


6 PHARMACEUTICAL PARTICULARS


6.1


List of excipients

Dilute Hydrobromic Acid, Sodium Chloride BP and Water for Injection BP.


6.2    Incompatibilities

None stated.

6.3    Shelf life

36 months

6.4 Special precautions for storage

Protect from light.

6.5 Nature and contents of container

Clear colourless 1ml ampoules of neutral glass. Packed in cartons of 10.

6.6 Instructions for use/handling

None stated.

7. MARKETING AUTHORISATION HOLDER

Macarthys Laboratories Ltd t/a Martindale Pharmaceuticals Bampton Road,

Harold Hill,

Romford,

RM3 8UG

8. MARKETING AUTHORISATION NUMBER

PL 1883/6135R

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

First authorised 10 May 1989

23 October 1999

Renewed


10.


DATE OF REVISION OF TEXT

June 1999