This information is intended for use by health professionals
Simple Linctus Paediatric Sugar Free
Citric Acid Monohydrate 31.25mg/5ml dose.
Excipient(s) with known effect:
Liquid Maltitol (E965, contains Sorbitol) 4.2g/5ml dose
For the full list of excipients see section 6.1
For relief of non productive (dry) coughs
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.
Hypersensitivity to any of the ingredients.
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.
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.
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.
Simple Linctus Paediatric Sugar Free has no influence on the ability to drive and use machines.
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)
Immune System Disorders
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.
Overdose with this preparation is unlikely to occur due to the low concentrations of the ingredients. However, in the event treatment should be symptomatic.
Pharmacotherapeutic Group: Acid Preparations
ATC Code: A09 AB
Citric acid is absorbed after oral administration. It is found naturally in the body and is widely distributed. It is metabolised to carbon dioxide and water in Kreb's citric acid cycle. Citric acid is normally excreted in the urine in amounts ranging from 0.4 to 1.5g daily and this amount is not increased unless very large doses are administered.
No data of relevance, which is additional to that included on other sections of the SPC.
Aniseed Flavour (contains propylene glycol (E1520))
Liquid Maltitol (E965, contains Sorbitol)
Sodium Benzoate (E211)
36 months unopened, 3 months after first opening.
Do not store above 25°C
The following additional phrases appear on the 2 litre pack:
Do not store part full bottles.
Pre-pack in tightly closed dispensing containers once opened.
200ml: Amber glass bottle with a 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex liner.
Any unused product or waste material should be dispersed of in accordance with local requirements.
Thornton & Ross Ltd.