Tixylix Honey Lemon & Glycerol Oral Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glycerin, Honey and Lemon Linctus
Glycerin, Honey and Lemon Soothing Cough Syrup
Tixylix Honey, Lemon & Glycerol Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients per 5ml
Honey 1.11g
Glycerin Ph Eur 0.75ml
Liquid sugar 2.2ml
3 PHARMACEUTICAL FORM
Oral solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of coughs and sore throats.
4.2 Posology and method of administration
For oral administration.
Adults and children over 12 years l0ml Children 5-12 years 5ml
Children 1 to 5 years 2.5ml
The dose may be taken up to three or four times a day, if needed. Elderly There is no need for dosage reduction in the elderly.
4.3 Contraindications
Hypersensitivity or intolerance to any of the ingredients.
4.4 Special warnings and precautions for use
If symptoms persist consult your doctor.
Keep all medicines out of the reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant drug interactions known.
4.6 Fertility, pregnancy and lactation
The safety of Glycerin, Honey and Lemon Linctus during pregnancy and lactation has not been established, but it is not considered to constitute a hazard during these periods.
4.7 Effects on ability to drive and use machines
No known adverse effects.
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
Overdosage is unlikely to present a problem and treatment need only be symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Glycerin, syrup and honey have demulcent properties and will soothe irritated sore throats and possibly block sensory cough receptors within the respiratory tract.
5.2 Pharmacokinetic properties
Glycerol is readily absorbed from the gastrointestinal tract and undergoes extensive metabolism principally in the liver. It may be used in the synthesis of lipids, and is metabolised to glucose or glycogen or oxidised to carbon dioxide and water. It may also be excreted in the urine unchanged.
Sucrose is hydrolysed in the small intestine by the enzyme sucrase to glucose and fructose which are then absorbed.
5.3 Preclinical safety data
Not applicable
6.1 List of Excipients
Lemon oil
Citric acid monohydrate Terpeneless lemon oil Benzoic acid Distilled lime oil Purified water
6.2 Incompatibilities
None stated
6.3 Shelf life
36 months
6.4 Special precautions for storage
None stated
6.5 Nature and contents of container
An amber or white flint glass bottle with an unlined polypropylene cap.
Alternative cap: a roll-on pilfer-proof cap with a flowed-in liner or a triseal (LDPE/EPE/LDPE) liner.
Pack size: 100ml, 200ml.
6.6 Special precautions for disposal
None stated
7 MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
Trading as: BCM
MARKETING AUTHORISATION NUMBER(S)
PL 00014/5149R
9
10
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07/02/1989
DATE OF REVISION OF THE TEXT
24/11/2015