Glycerin, Lemon and Honey with Glucose

1. Name Of The Medicinal Product

Glycerin, Lemon and Honey with Glucose or

Honey, Lemon and Glycerine

2. Qualitative And Quantitative Composition

Each 5ml of solution contains:-

1.36g Glycerol BP

Excipients: Each 5ml contains Syrup (sucrose) 1.7g, Liquid Glucose 280.0mg

For full list of excipients see section 6.1

3. Pharmaceutical Form

Linctus

4. Clinical Particulars

4.1 Therapeutic Indications

A soothing preparation for relief of the symptoms of coughs and sore throats.

4.2 Posology And Method Of Administration

Oral.

Recommended doses

Adults: two 5ml spoonfuls.

Children over 1 year: one 5ml spoonful.

Dosage schedule

May be repeated every 4 hours if required.

The product may be taken for up to 5 days, following which, if symptoms persist, medical advice should be sought.

Shake the bottle.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep all medicines out of the reach and sight of children.

Not suitable for children under 1 year.

Not suitable for use in diabetics.

If symptoms persist, consult your doctor

Patients with rare glucose-galactose malabsorption 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 considered likely if this product is used in the above conditions, however, as with all medicines, its use should be avoided unless recommended by a doctor.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None anticipated at the recommended dosage.

4.9 Overdose

Overdose with this preparation is unlikely to occur, however, large doses of glycerin may cause thirst, headache, nausea, vomiting, diarrhoea, hyperglycaemia, dehydration, dizziness and mental confusion. Cardiac arrhythmias have been reported. Treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Glycerol acts as a demulcent to soothe the passage of the upper respiratory tract.

5.2 Pharmacokinetic Properties

Glycerol is readily absorbed from the intestine and is metabolised to carbon dioxide and glycogen.

5.3 Preclinical Safety Data

None known.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lemon soluble essence

Syrup

Purified water

Lemon juice

Citric acid monohydrate

Honey

Liquid glucose

6.2 Incompatibilities

None stated.

6.3 Shelf Life

100ml: 24 months unopened.

200ml: 24 months unopened.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

100ml: glass bottle with plastic cap or polypropylene child-resistant cap with a saranex faced EPE liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.

200ml: glass bottle with plastic cap or polypropylene child-resistant cap with a saranex faced EPE liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

L.C.M. Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

England

8. Marketing Authorisation Number(S)

PL 12965/0013

9. Date Of First Authorisation/Renewal Of The Authorisation

06.04.99

10. Date Of Revision Of The Text

24/08/2009