Simple Linctus Sugar Free (Thornton & Ross Ltd)

1. Name Of The Medicinal Product

Simple Linctus Sugar Free

2. Qualitative And Quantitative Composition

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

Excipients: Each 5ml contains Liquid Maltitol 4.2g

For 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.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

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

There are no known side effects from using this medicine when used as directed, however, if you notice any side effects, stop use and consult a doctor or pharmacist.

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. Pharmaceutical Particulars

6.1 List Of Excipients

Aniseed Flavour (contains propylene glycol) PHL-090803

Glycerol (E422)

Liquid Maltitol

Sodium Benzoate (E211)

Purified water

6.2 Incompatibilities

Not Applicable.

6.3 Shelf Life

12 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

100ml:	Amber glass bottle with plastic cap and liner or white 28mm cap with tamper evident band and EPE Saranex liner
200ml:	Amber glass bottle with plastic cap and liner or white 28mm cap with tamper evident band and EPE Saranex liner
500ml:	Amber glass bottle with plastic cap and liner or white 28mm cap with tamper evident band and EPE Saranex liner.
2000ml:	Amber glass bottle with plastic cap and liner.

6.6 Special Precautions For Disposal And Other Handling

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

02/07/2010

10. Date Of Revision Of The Text

25/01/2011

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable