Summary of Product Characteristics (SmPC) - Simple linctus paediatric sugar free

1 NAME OF THE MEDICINAL PRODUCT

Simple Linctus Paediatric Sugar Free

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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

3 PHARMACEUTICAL FORM

Oral Solution

4 CLINICAL PARTICULARS

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Acid Preparations

ATC Code: A09 AB

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

No data of relevance, which is additional to that included on other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Aniseed Flavour (contains propylene glycol (E1520)

Glycerol (E422)

Liquid Maltitol (E965, contains Sorbitol)

Sodium Benzoate (E211)

Purified water

6.2 Incompatibilities

None.

6.3 Shelf life

36 months unopened, 3 months after first opening.

6.4 Special precautions for storage

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.

6.5 Nature and contents of container

200ml: Amber glass bottle with a 28mm Child-resistant cap with Tamper Evident band and

EPE/Saranex liner.

6.6 Special precautions for disposal

Any unused product or waste material should be dispersed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Thornton & Ross Ltd.

Linthwaite Laboratories

Huddersfield

HD7 5QH.

8 MARKETING AUTHORISATION NUMBER(S)

PL: 00240/0362

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

21/10/2024

10 DATE OF REVISION OF THE TEXT