Summary of Product Characteristics (SmPC) - Glycerin, Lemon and Honey with Glucose
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 with known effects
Each 5ml of solution contains:
Syrup (Sucrose) 1.6g and Liquid Glucose 280.0mg
For the 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.
This product contains 3.3g of sucrose per 10ml dose. To be taken into account in people with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
If symptoms persist, consult your doctor.
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
6.1 List of excipients
Lemon soluble essence
Syrup (sucrose)
Purified water
Lemon juice
Citric acid monohydrate (E330) Honey
Liquid glucose
6.2 Incompatibilities
None stated
6.3 Shelf life
24 months unopened
6.4 Special precautions for storage
Store below 25ºC
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
HD7 5QH
England
8 MARKETING AUTHORISATION NUMBER(S)
PL 12965/0013
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/03/1994
10 DATE OF REVISION OF THE TEXT
21/01/2021