Simple Linctus BP (Pinewood Healthcare)

1. Name Of The Medicinal Product

Simple Linctus BP

2. Qualitative And Quantitative Composition

Citric Acid Monohydrate 125mg/5ml equivalent to 114.29mg/5ml Anhydrous Citric Acid.

3. Pharmaceutical Form

Oral Solution

4. Clinical Particulars

4.1 Therapeutic Indications

For the management of a mild non-specific cough.

4.2 Posology And Method Of Administration

Adults: One or two 5ml teaspoonfuls three or four times daily

4.3 Contraindications

Should not be used in patients with glucose malabsorption syndrome or glucose intolerance.

Should not be used in patients with glucose-galactose intolerance syndrome.

Should not be used in patients with sucrase-isomaltase deficiency

4.4 Special Warnings And Precautions For Use

Contains 3.95g of sucrose per 5ml dose. Care should be taken with patients who suffer from diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicinal product contains 6.3 vol % ethanol (alcohol, 96%), i.e. up to 505mg per 10ml dose, equivalent to 12ml beer, 5ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

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

Not Applicable

4.7 Effects On Ability To Drive And Use Machines

Not Applicable

4.8 Undesirable Effects

Not Applicable

4.9 Overdose

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Not applicable

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

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Colour 1508 Red (Anstead) (E123)

Glycerol (E422)

Chloroform

Ethanol (96%)

Sugar (Mineral Water Grade)

Aniseed Oil

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

100ml, 200ml and 500ml III Amber glass bottles with pilfer proof cap.

500ml, 1L and 2L High Density Polyethylene with tamper evident cap.

6.6 Special Precautions For Disposal And Other Handling

No special instruction

7. Marketing Authorisation Holder

Pinewood Laboratories Limited

Ballymacarbry

Clonmel

Co Tipperary

8. Marketing Authorisation Number(S)

PL 04917/0011

9. Date Of First Authorisation/Renewal Of The Authorisation

Last renewal 27/05/1994

10. Date Of Revision Of The Text

November 2008