4.1. Therapeutic indications

For relief of non productive (dry) coughs

4.2. Posology and method of administration

Oral.

Children's Dosage

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

Hypersensitivity to any of the ingredients.

4.4. Special warnings and precautions for use

Keep out of the reach and sight of children

Consult a doctor if symptoms persist for more than 5 days

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Excipient warnings:

This product contains 4.2g of maltitol liquid per 5ml dose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Calorific value 2.3 kcal/g of maltitol liquid. Maltitol may have a mild laxative effect.

This medicine contains 840mg sorbitol content (contained within Maltitol liquid at 20%) in each 5ml dose. Sorbitol is a source of fructose. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. 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.

Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

This medicine contains less than 1 mmol 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 metabolities in human milk.

4.7. Effects on ability to drive and use machines

Simple Linctus Paediatric Sugar Free has no influence on the ability to drive and use machines.

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.