Benylin Paediatric Syrup

BENYLIN u00ae PAEDIATRIC is indicated for the relief of cough and its congestive symptoms and for treatment of hay fever and other allergic conditions affecting the upper respiratory tract.

A maximum of four doses per day should not be exceeded. Shake the bottle before use. Children 6 to 12 years: Two 5 mL medicine measures (10 mL) every 3 hours. Children below 6 years of age: Not recommended

Known hypersensitivity to diphenhydramine hydrochloride or to any of the other ingredients in BENYLIN u00ae PAEDIATRIC (see section 6.1). Diphenhydramine hydrochloride should not be used with monoamine oxidase inhibitors or within 14 days of stopping monoamine oxidase inhibitor treatment. Contraindicated during acute asthmatic attacks, and in patients with impaired hepatic or renal function. BENYLIN u00ae PAEDIATRIC should not be used in children below 6 years of age.

BENYLIN u00ae PAEDIATRIC may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant medicines. In infants and children, it may act as a cerebral stimulant. Symptoms of stimulation include insomnia, nervousness, tachycardia, tremors and convulsions. Large doses may precipitate fits in epileptics. Deepening coma, extrapyramidal effects and photosensitization of the skin may occur.

Elderly patients are more susceptible to the central nervous system depressant and hypotensive effects. Do not use with any other product containing diphenhydramine even ones used on skin. The positive results of skin tests may be suppressed. Diphenhydramine hydrochloride has anticholinergic properties and should be used with care in conditions such as a respiratory condition including emphysema (adult products), chronic bronchitis, or acute or chronic bronchial asthma, glaucoma, urinary retention and prostatic hypertrophy. Diphenhydramine hydrochloride should be used with caution in patients with liver impairment or cardiovascular disease.

Patients should not use BENYLIN u00ae PAEDIATRIC for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician.

BENYLIN u00ae PAEDIATRIC contains sugar: sucrose and glucose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take BENYLIN u00ae PAEDIATRIC.

BENYLIN u00ae PAEDIATRIC contains sodium benzoate. An increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).

The anticholinergic effects of atropine and tricyclic antidepressants may be enhanced by diphenhydramine hydrochloride. Monoamine oxidase inhibitors (MAOIs) may enhance the anticholinergic effects. Diphenhydramine hydrochloride may mask the warning symptoms of damage caused by ototoxic medicines, such as aminoglycoside antibiotics, and may affect the metabolism of other medicines in the liver. It may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.

Safety in pregnancy and lactation has not been established. Diphenhydramine crosses the placenta and is excreted into breast milk.

BENYLIN u00ae PAEDIATRIC may cause drowsiness, dizziness or blurred vision. Patients should be warned not to drive a motor vehicle, operate dangerous machinery or climb dangerous heights as impaired decision making could lead to accidents.

Blood and the lymphatic system disorders: Less frequent: thrombocytopenia Frequency unknown: agranulocytosis, leucopenia and haemolytic anaemia

Immune system disorders: Frequency unknown: allergic reactions, anaphylaxis

Endocrine disorders: Less frequent: epigastric pain

Metabolism and nutrition disorders: Less frequent: anorexia, increased appetite

Psychiatric disorders: Less frequent: euphoria, confusional state, irritability, hallucination, nervousness

Nervous system disorders: Frequent: sedation Less frequent: headache, agitation, abnormal coordination, convulsion, dizziness, insomnia, paraesthesia, somnolence, tremor

Eye disorders: Less frequent: blurred vision

Ear and labyrinth disorders: Less frequent: tinnitus

Cardiac disorders: Less frequent: palpitations, tachycardia

Vascular disorders: Less frequent: hypotension

Respiratory, thoracic and mediastinal disorders: Less frequent: tightness of the chest, dry throat, nasal dryness

Gastrointestinal disorders: Less frequent: nausea, vomiting, diarrhoea, constipation, dryness of the mouth

Skin and subcutaneous tissue disorders: Less frequent: rash, pruritus, urticaria

Musculoskeletal, connective tissue and bone disorders: Less frequent: muscular weakness

Renal and urinary disorders: Less frequent: difficulty in micturition, dysuria, urinary retention

General disorders and administration site conditions: Less frequent: asthenia

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of BENYLIN u00ae PAEDIATRIC is important. It allows continued monitoring of the benefit/risk balance of BENYLIN u00ae PAEDIATRIC. 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. For further information, please contact the Johnson & Johnson call centre on 0860 410032 (landline).

Diphenhydramine hydrochloride: Overdosage may be fatal especially in infants and children.

In infants and children CNS stimulation predominates over CNS depression causing ataxia, excitement, tremors, psychoses, hallucinations and convulsions; hyperpyrexia may also occur. Deepening coma and cardiorespiratory collapse may follow. In adults: CNS depression with drowsiness, coma and convulsions, progressing to respiratory failure or possibly cardiovascular collapse. Treatment is symptomatic and supportive.