BENYLIN CHILDRENS CHESTY COUGHS, CALCOUGH SIX PLUS

Posology Adults and children aged 12 years and over:

Not applicable. Children aged 6 to 12 years: 10 ml syrup four times daily. Maximum daily dose: 40 ml syrup (400 mg guaifenesin) Not to be used for more than 5 days without the advice of a doctor. Parents and carers should seek medical attention if the child’s condition deteriorates during treatment.

3). Method of administration For oral use Do not exceed the stated dose. Keep out of the sight and reach of children.

The safety of guaifenesin is based on available data from clinical trials and adverse drug reactions (ADRs) identified during post-marketing experience.

The frequencies are provided according to the following convention:

Very common ≥1/10 Common ≥1/100 and < 1/10 Uncommon ≥1/1,000 and <1/100 Rare ≥1/10,000 and <1/1,000 Very rare <1/10,000 Not known (cannot be estimated from the available data) ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’.

Adverse Drug Reactions Identified during Clinical Trials, Epidemiology studies and Post-Marketing Experience with Guaifenesin. Frequency Category estimated from Clinical Trials or Epidemiology Studies Body system (SOC) Incidence Adverse Event Preferred Term Immune system disorders Not known Hypersensitivity reactions (hypersensitivity, pruritus and urticaria) Rash Gastrointestinal disorders Not known Abdominal pain upper Diarrhoea Nausea Vomiting Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ask a doctor before use if your child suffers from chronic cough, if he/she has asthma or is suffering from an acute asthma attack. Stop use and ask a healthcare professional if your child’s cough lasts for more than 5 days, comes back, or is accompanied by a fever, rash or persistent headache.

Do not give with a cough suppressant. Caution should be exercised in the presence of severe renal or severe hepatic impairment. Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose. Do not take with any other cough and cold medicine.

05g sorbitol in each 10 ml dose. 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 medicinal products 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 this medicinal product. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. 65% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

2 mg benzoate salt in each 10 ml dose. 1 mg benzyl alcohol in each 10 ml dose. Benzyl alcohol may cause allergic reactions. This medicine must be used with caution in patients with renal or hepatic impairment, or in patients who are pregnant or breast-feeding, because of the risk of accumulation and toxicity (metabolic acidosis).

BENYLIN

Children's Chesty Coughs is contraindicated in individuals with known hypersensitivity to the product, or any of its components. Not to be used in children under the age of 6 years.