NUMARK SIMPLE LINCTUS BP, BELLS HEALTHCARE SIMPLE LINCTUS BP 125 MG PER 5ML ORAL SOLUTION, ALMUS SIMPLE LINCTUS COUGH RELIEF 125 MG PER 5 ML ORAL SOLUTION - summary of medicine characteristics

1. NAME OF THE MEDICINAL PRODUCT

Bell’s Healthcare Simple Linctus BP 125 mg per 5 ml Oral Solution

Numark Simple Linctus BP

Almus Simple Linctus Cough Relief 125 mg per 5 ml Oral Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Citric Acid Monohydrate BP 125 mg/5 ml.

Excipients: Sucrose 4.3g per 5ml. For full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Oral solution.

A clear, colourless liquid with the flavour of anise.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

The management of mild non-specific cough.

4.2 Posology and method of administration

Dosage

Adults and the Elderly : One or two 5ml teaspoons daily, or as required.

Not recommended for children.

Administration

For oral use.

4.3 Contraindications

Glucose malabsorption syndrome. Glucose intolerance due to sucrose or isomaltase deficiency. Hypersensitivity to any of the constituents.

Care should be taken in patients with Diabetes mellitus.

Keep out of the reach of children.

Not suitable for children under 12 years.

4.5 Interaction with other medicinal products and other forms of interaction

Citric acid may interact with potassium tartrate, carbonates and bicarbonates which therefore should not be administered at the same time.

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

None.

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. By reporting side effects you can help provide more information on the safety of this medicine.

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

Citric acid is fever reducing.

5.2. Pharmaco­kinetic properties

Citric acid monohydrate is absorbed from the gastrointesti­nal tract.

Sucrose is hydrolysed in the small intestine by the enzyme sucrase and converted to dextrose and levulose, which are then absorbed.

5.3 Preclinical safety data

No relevant information additional to that already contained elsewhere in the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Star Anise Oil

Polysorbate 20

Sucrose

Water Purified

6.2

None known.

6.3

3 years.

6.4 Special precautions for storage

Store at a temperature not exceeding 25°C.

6.5 Nature and contents of container

100 ml, 125 ml, 150 ml, 175 ml, 200 ml, 225 ml, 250 ml, 300 ml and 500 ml in amber glass bottles with pilfer proof cap or child resistant cap.

500 ml, 1 litre and 2 litre high density polyethylene bottle with screw on cap.

Not all packs may be marketed.

6.6 Special precautions for disposal

Not relevant.

7 MARKETING AUTHORISATION HOLDER

Bell, Sons and Co (Druggists) Ltd [Trading Style – Bell’s Healthcare]

Gifford House,

Slaidburn Crescent

Southport

Merseyside

PR9 9AL