Benylin Original Syrup 5 ml Syrup

BENYLIN u00ae ORIGINAL is indicated for the relief of cough.

A maximum of four doses per day should not be exceeded.

Adults and children over 12 years: One to two medicine measures (5 mL -10 mL) every 4 hours.

Children 6 to 12 years: A half to one medicine measure (2,5 mL u2013 5 mL) every 4 hours.

Children under 6 years of age: Not recommended for children under 6 years of age.

• Known hypersensitivity to diphenhydramine hydrochloride, ammonium chloride or any of the other ingredients of BENYLIN u00ae ORIGINAL (see section 6.1).
• Diphenhydramine should not be used with monoamine oxidase inhibitors or within 14 days of stopping monoamine oxidase inhibitor treatment.
• BENYLIN u00ae ORIGINAL is contraindicated during acute asthmatic attacks.
• Patients with liver or renal impairment.
• Should not be used in children under the age of 6 years.

• BENYLIN u00ae ORIGINAL may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol, sedatives, tranquilisers or other central nervous system depressants. Paradoxical stimulation may occur, especially in high doses, and in children or elderly patients. 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.
• Do not use with any other product containing diphenhydramine, even one used on skin.
• Patients should not use BENYLIN u00ae ORIGINAL for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a doctor.
• Use with caution in conditions such as glaucoma, urinary retention or prostatic hyperplasia.
• Use with caution in patients with respiratory conditions such as emphysema, chronic bronchitis or acute or chronic bronchial asthma.
• Use with caution in patients with cardiovascular disease.
• If symptoms persist or worsen, or if new symptoms occur, stop using BENYLIN u00ae ORIGINAL and consult your doctor.
• BENYLIN u00ae ORIGINAL 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 ORIGINAL.
• BENYLIN u00ae ORIGINAL contains sugar, sucrose and glucose (see section 2), which may have an effect on the glycaemic control of patients with diabetes mellitus.
• BENYLIN u00ae ORIGINAL 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).
• BENYLIN u00ae ORIGINAL contains alcohol. It contains 0,258 mL of alcohol (ethanol) in each 5 mL. The small amount of alcohol in BENYLIN u00ae ORIGINAL will not have any noticeable effects.

• Diphenhydramine may enhance the sedative effects of central nervous system depressants, including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquilisers.
• Diphenhydramine should not be used with monoamine oxidase inhibitors or within 14 days of stopping monoamine oxidase inhibitor treatment.
• Diphenhydramine may have an additive effect with medicines such as atropine, tricyclic antidepressants and monoamine oxidase inhibitors.
• Diphenhydramine may mask the damage caused by ototoxic medicines such as aminoglycoside antibiotics and may affect the metabolism of other medicines in the liver.
• Laboratory tests: Positive results from skin tests may be suppressed by diphenhydramine.

Pregnancy: Safety during pregnancy has not been established.

Lactation: Diphenhydramine crosses the placenta and is excreted into breast milk. Mothers on BENYLIN u00ae ORIGINAL should not breastfeed their infants.

BENYLIN u00ae ORIGINAL may cause side effects, such as drowsiness, dizziness, incoordination 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 (see above).

The following side effects are for diphenhydramine and ammonium chloride and the frequencies are estimated from spontaneous reporting rates.

Blood and lymphatic system disorders: Less frequent: Agranulocytosis, leucopenia, haemolytic anaemia and thrombocytopenia.

Immune system disorders: Less frequent: Angioedema, hypersensitivity, allergic reactions and anaphylaxis.

Metabolism and nutrition disorders: Less frequent: Increased appetite, anorexia.

Psychiatric disorders: Less frequent: Confusional state, irritability, hallucinations, euphoria and nervousness.

Nervous system disorders: Frequent: Sedation varying from slight drowsiness to deep sleep including lassitude, dizziness, and incoordination, headache and antimuscarinic effects, such as dry mouth and thickened respiratory tract secretions. Less frequent: Agitation, abnormal coordination, convulsions (large doses may precipitate fits in epileptics), headache, insomnia, paraesthesia, sedation, somnolence, deepening coma, extrapyramidal effects and tremor. BENYLIN u00ae ORIGINAL may act as a cerebral stimulant in infants and children. Symptoms of stimulation include insomnia, nervousness, tachycardia, tremors and convulsions. Elderly patients are more susceptible to central nervous system effects.

Eye disorders: Less frequent: Blurred vision.

Ear and labyrinth disorders: Less frequent: Tinnitus.

Cardiac disorders: Less frequent: Palpitations and tachycardia.

Vascular disorders: Less frequent: Hypotension. Elderly patients are more susceptible to hypotensive effects.

Respiratory, thoracic and mediastinal disorders: Less frequent: Chest discomfort, chest tightness, dry throat and nasal dryness.

Gastrointestinal disorders: Less frequent: Abdominal pain, epigastric pain, application site reaction (burning sensation, glossitis, glossodynia, oral hypoaesthesia, lip blister, dry lip, lip pain, mouth ulceration, oral discomfort, oral disorder, erythema of oral mucosa, oropharyngeal blistering, stomatitis, tongue disorder, tongue eruption), dry mouth, diarrhoea, constipation, dyspepsia, nausea and vomiting.

Skin and subcutaneous tissue disorders: Less frequent: Pruritus, rash, photosensitisation and urticaria.

Musculoskeletal and connective tissue disorders: Less frequent: Muscular weakness.

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

General disorders and administration site conditions: Less frequent: Asthaenia.

Investigations: Frequency unknown: Suppression of positive skin test results.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of BENYLIN u00ae ORIGINAL is important. It allows continued monitoring of the benefit/risk balance of BENYLIN u00ae ORIGINAL. 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 central nervous system (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. Other symptoms of overdose include: Mild to moderate symptoms: Anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel sounds), tachycardia, mild hypertension, nausea and vomiting are common after overdose. Agitation and confusion may develop with moderate poisoning. Severe symptoms: Effects may include delirium, hypotension, QRS widening, and ventricular dysrhythmias, including torsades de pointe, but are generally reported in adults after large ingestions. Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma or seizures.

Ammonium chloride: Large doses of ammonium chloride may cause nausea, vomiting, drowsiness, thirst, headache, hyperventilation, profound acidosis and hypokalaemia. Excessive doses may give rise to hepatic encephalopathy. Metabolic acidosis occurred with the prolonged intake of ammonium chloride above the recommended dose and/or in cases of renal impairment. Symptoms of metabolic acidosis may include headache, generalised muscle weakness, hyperventilation, hyperreflexia, progressive drowsiness, mental confusion and coma. Treatment is symptomatic and supportive.