Medine.co.uk

Glycerin Lemon And Honey With Glucose

Document: spc-doc_PL 12965-0013 change

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Glycerin, Lemon and Honey with Glucose

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of solution contains:-Glycerol 1.36g

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

For a 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    Fertility, 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

Immune system disorder: hypersensitivity reactions, including anaphylaxis. 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

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

24 months unopened

6.4    Special precautions for storage

Store below 25°C

6.5    Nature and contents of container

200ml: Amber glass bottle with white 28mm cap with Tamper Evident band and EPE/Saranex liner

6.6    Special precautions for disposal

None stated

7    MARKETING AUTHORISATION HOLDER

L.C.M. Ltd

Linthwaite Laboratories

Huddersfield

HD75QH

England

8    MARKETING AUTHORISATION NUMBER(S)

PL 12965/0013

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30/03/1994

10


DATE OF REVISION OF THE TEXT

20/05/2015