Informations for option: Numark Simple Linctus Bp, show other option

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1. Numark Simple Linctus Bp
2. Numark Simple Linctus Bp

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Simple Linctus BP Morrisons Simple Linctus BP Asda Simple Linctus BP Numark Simple Linctus BP

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.

4.4 Special warnings and precautions for use

Care should be taken in patients with Diabetes mellitus.

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.

4.6 Pregnancy and lactation

No data are available.

4.7 Effects on ability to drive and use machines

None.

4.8    Undesirable effects

It is possible that citric acid ingested in large quantities or frequently may cause gastric irritation, or erosion of dental enamel.

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

4.9    Overdose

There is no evidence that overdose is harmful.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Citric acid is fever reducing.

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    Incompatibilities

None known.

6.3 Shelf life

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.