ALLERGEX 4 mg TABLETS

SCHEDULING STATUS:
ALLERGEX 4 mg TABLETS

COMPOSITION:
Each Allergex tablet contains:

PHARMACOLOGICAL CLASSIFICATION:
A 5.7.1. Medicines affecting autonomic functions –Antihistamines.

PHARMACOLOGICAL ACTION:
Chlorpheniramine maleate is an antihistamine.

INDICATIONS:
Allergic and anaphylactic conditions such as hay fever, vasomotor rhinitis, urticaria, angioneurotic oedema, drug reactions, contact dermatitis, atopic dermatitis, insect bites, pruritus ani and pruritus vulvae.

CONTRA-INDICATIONS:
Epilepsy. Acute attacks of asthma. Premature infants and new-born babies. Safety in pregnancy has not yet been established.

WARNINGS:
The use of this medicine leads to drowsiness which is aggravated by the simultaneous intake of alcohol. Patients should be warned not to drive a motor vehicle or operate machinery, as impaired decision-making could lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:
Allergex: 1 - 4 tablets daily in divided doses.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Sedation varying from slight drowsiness to deep sleep and including lassitude, dizziness and incoordination.
Gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, anorexia or increased appetite and epigastric pain. Antimuscarinic effects including blurred vision, difficulty in micturition, dysuria, dryness of the mouth and tightness of the chest may be produced. Other central effects include hypotension, muscular weakness, tinnitus, euphoria and headache.
Paradoxical CNS stimulation may occur, especially in children, with insomnia, nervousness, tachycardia, tremors and convulsions.
Chlorpheniramine maleate may produce epileptiform seizures in patients with focal lesions of the cerebral cortex. Allergic reactions and cross-sensitivity to related drugs may be produced. Because of its antimuscarinic properties chlorpheniramine maleate should be used with care in conditions such as narrow angle glaucoma, urinary retention and prostatic hypertrophy. Monoamine oxidase inhibitors may enhance the antimuscarinic effects of antihistamines and antihistamines have an additive antimuscarinic action with other antimuscarinic drugs such as atropine and tricyclic antidepressants.
Antihistamines may suppress positive skin test results and should be stopped several days before the test.
The sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers may be enhanced.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may be fatal especially in infants and children in whom the main symptoms are CNS stimulation and antimuscarinic effects, including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse and death may occur.
In adults, the usual symptoms are of CNS depression with drowsiness, coma and convulsions. Hypotension may occur. Elderly patients are more susceptible to the CNS depressant and hypotensive effects even at therapeutic levels.
Treatment: Symptomatic and supportive.

IDENTIFICATION:
Allergex: Yellow, round, normal, convex, scored tablets.

PRESENTATION:
Allergex tablets: 30’s, 100’s and 1000’s.

STORAGE INSTRUCTIONS:
Store below 30°C in airtight containers. Protect from light.
KEEP OUT OF THE REACH OF CHILDREN.

REFERENCE NUMBER:
Allergex: C668 (Act 101/1965)
S2

PROPRIETARY NAME
(and dosage form):