Benylin Wet Cough Liquid

Alleviation of cough.

Shake the bottle before use.

Adults and children over 12 years: 10 mL - 20 mL (two - four medicine measures) every 4 hours.

Children 6 u2013 12 years old: 5 mL u2013 10 mL (one u2013 two medicine measures) every 4 hours.

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

If symptoms persist a doctor should be consulted. Not recommended for children under 4 years of age.

• Hypersensitivity to guaifenesin or to any of the other ingredients in Benylin Wet Cough (see section 6.1).
• Pregnancy and lactation (see section 4.6).
• Patients with acute porphyria.
• Not recommended for children under 4 years of age.

Benylin Wet Cough should not be taken for persistent or chronic cough, which occurs with smoking, asthma, emphysema or where cough is accompanied by excessive secretions except under the advice and supervision of a doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur or is accompanied by high fever, rash or persistent headache, consult a doctor.

Caution should be exercised when using Benylin Wet Cough in the presence of severe renal or severe hepatic impairment.

Benylin Wet Cough contains sorbitol and sodium benzoate. Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect.

The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicines for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Patients with hereditary fructose intolerance (HFI) should not take/be given Benylin Wet Cough.

Benylin Wet Cough contains sodium benzoate which may cause an increase in bilirubinaemia following its displacement from albumin and may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).

Benylin Wet Cough contains sodium. Benylin Wet Cough contains 57 mg sodium per 10 mL, equivalent to 2,85 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Guaifenesin may interfere with diagnostic measurements of urinary 5-hydroxy-indoleacetic acid or vanillylmandelic acid.

Benylin Wet Cough should not be used during pregnancy and lactation (see section 4.3).

Benylin Wet Cough can cause side effects, such as drowsiness or dizziness and may affect the ability to drive and use machinery. Caution is advised before driving a vehicle or operating machinery until the effects of Benylin Wet Cough are known.

Immune system disorders

• Less frequent: hypersensitivity

Nervous system disorders

• Less frequent: headache, drowsiness, dizziness

Gastrointestinal disorders

• Less frequent: diarrhoea, nausea, vomiting, upper abdominal pain

Skin and subcutaneous tissue disorders

• Less frequent: skin rash, urticaria

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of Benylin Wet Cough is important. It allows continued monitoring of the benefit/risk balance of Benylin Wet Cough. 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).

In large doses, guaifenesin will cause drowsiness, nausea and vomiting. It may also cause renal calculi. Treatment is symptomatic and supportive.