4.1. Therapeutic indications

For relief of non productive (dry) coughs

4.2. Posology and method of administration

Dose

Children:

1 to 5 years: Give one 5ml spoonful

6 to 12 years: Give two 5ml spoonfuls

Repeat up to four times a day if necessary.

4.3. Contraindications

Known hypersensitivity to any of the ingredients

4.4. Special warnings and precautions for use

Keep out of the sight and reach of children.

Consult a doctor if symptoms persist for more than 5 days

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Excipient warnings:

This medicine contains 4.4g of sucrose per 5ml. This should be taken into account in patients with diabetes mellitus.

This medicine contains 2.5mg sodium benzoate per 5ml dose.

This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially 'sodium-free'.

4.5. Interaction with other medicinal products and other forms of interaction

None known

4.6. Pregnancy and lactation

There are no or limited amount of data from the use of citric acid monohydrate in pregnant women.

Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).

There is insufficient information on the excretion of citric acid monohydrate metabolites in human milk.

4.7. Effects on ability to drive and use machines

None known

4.8. Undesirable effects

Tabulated list of adverse reaction(s)

Adverse reactions frequency are defined using the following convention:

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

System organ class (MedDRA)

Frequency

Adverse event

Immune System Disorders

Not known

Hypersensitivity

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Overdose with this preparation is unlikely to occur due to the low concentrations of the ingredients. However, in the event treatment should be symptomatic.