Allergex 4mg Tablets

Allergic and anaphylactic conditions such as hay fever, vasomotor rhinitis, urticaria, angioedema, drug reactions, contact dermatitis, atopic dermatitis, insect bites, pruritus and pruritus vulvae.

Posology
Adults and children 12 years or older: One 4 mg ALLERGEX TABLET every 4 to 6 hours, up to a maximum of 24 mg in 24 hours.
Children 6 to 12 years: 2 mg (Half a ALLERGEX TABLET) every 4 to 6 hours, up to a maximum of 12 mg in 24 hours.
Children up to 6 years: Use is not recommended.

Method of administration
Oral administration

Hypersensitivity to Chlorpheniramine or to any of the excipients of ALLERGEX TABLETS listed in section 6.1. Epilepsy, Acute attacks of asthma. Premature infants and new-born babies.

Chlorphenamine 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. Paradoxical CNS stimulation may occur, especially in children, with insomnia, nervousness, tachycardia, tremors and convulsions. The use of this medicine may lead to drowsiness that 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. The sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers may be enhanced. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption or fructose intolerance should not take ALLERGEX TABLETS. Contains Lactose which may have an effect on the glycaemic control of patients with diabetes mellitus. Patients receiving MAO inhibitor therapy should not take ALLERGEX TABLETS. The anticholinergic properties of Chlorpheniramine are intensified by monoamine oxidase inhibitors (MAOIs). (See section 4.5)

The sedation effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers may be enhanced. Monoamine oxidase inhibitors may enhance the antimuscarinic effects of antihistamines and antihistamines have an additive antimuscarinic action with other antimuscarinic medicine such as atropine and tricyclic antidepressants. Monoamine oxidase inhibitors will potentiate both the drowsiness effect and the anticholinergic effect if taken with ALLERGEX TABLETS. Concurrent use is not recommended. (See Section 4.4) Antihistamines may suppress positive skin test results and should be stopped several days before the test.

Fertility
Safety in fertility has not yet been established.
Pregnancy
Safety in pregnancy has not yet been established.
Breastfeeding
Safety in lactation has not yet been established.

This medicine may lead to drowsiness, dizziness, blurred vision and impaired concentration that may be aggravated by simultaneous intake of alcohol or other central nervous system depressants. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.

System Organ Class Frequency Undesirable effects
Nervous system disorders Frequent Sedation, lassitude, incoordination, dizziness, headache
Eye disorders Frequent Blurred vision
Gastrointestinal disorders Frequent Frequency unknown Nausea, vomiting, diarrhea or constipation, increased appetite, epigastric pain and dry mouth
Immune system disorders Frequency unknown Allergic reaction and cross sensitivity to related medicines may be produced
Metabolism and nutritional disorders Frequency unknown Anorexia
Musculoskeletal and connective tissue disorders Frequency unknown Muscular weakness
Renal and urinary disorders Frequency unknown Difficulty in micturition and dysuria
Cardiac disorders Frequency unknown Tachycardia, tremors, and convulsions
Respiratory, thoracic and mediastinal disorders Frequency unknown Tightness of the chest
Vascular disorders Frequency unknown Hypotension
Ear and labyrinth disorders Frequency unknown Tinnitus

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8 May also report to Adcock Ingram Limited using the following email: [email protected]

Overdosage may be fatal especially in infants and children in whom the main symptoms are Central Nervous System (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 the CNS depression with drowsiness, coma and convulsions. Hypotension may occur. Elderly patients are more susceptible to the CNS depression and hypotensive effects even at therapeutic levels.
Treatment: Symptomatic and supportive.