Simple Linctus Sugar Free – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Simple Linctus Sugar Free

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Citric acid monohydrate (E330) 125mg per 5ml.

Excipients with known effects

Excipients: Each 5ml contains:

Liquid Maltitol (E965) 4.2g (contains Sorbitol 840mg) Sodium benzoate (E211) 2.5mg

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 the symptoms of coughs.

4.2 Posology and method of administration

Oral.

Recommended doses

Adults, the elderly and children over 12 years: one 5ml spoonful, repeated up to four times per day.

Children under 12 years: not recommended.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings and precautions for use

This medicinal product is not recommended for the use in children below the age of 12 years due to lack of data on safety and efficacy.

This medicine contains 840mg sorbitol in each 5ml dose. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.

This medicine also contains 4.2g of maltitol liquid (E965) per 5ml dose. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially ‘sodium-free’. This medicine contains 2.5mg sodium benzoate per 5ml dose.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

No adverse effects are known for the product, however as with all medicines use should be avoided during pregnancy unless recommended by a doctor.

4.7 Effects on ability to drive and use machines

Simple Linctus 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).

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 active substance, however in the event of an overdose, treatment should be symptomatic.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Cough and Cold Preparations

ATC Code: R05

5.2 Pharmacokinetic properties

None stated

5.3 Preclinical safety data

None.

6.1 List of excipients

Aniseed Flavour (contains propylene glycol) PHL-090803

Glycerol (E422)

Liquid Maltitol (E965) (contains Sorbitol) Sodium Benzoate (E211)

Purified water

6.2 Incompatibilities

Not Applicable.

6.3. Shelf life

36 months unopened. Discard 2 months after first opening.

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

200ml: Amber glass bottle with plastic cap and liner or white 28mm cap with tamper evident band and EPE Saranex liner

6.6 Special precautions for disposal

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

7 MARKETING AUTHORISATION HOLDER

L.C.M. Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

8 MARKETING AUTHORISATION NUMBER(S)

PL 12965/0050

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

21/10/2024

10 DATE OF REVISION OF THE TEXT

21/10/2024