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    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Blended 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

8    MARKETING AUTHORISATION NUMBER(S)

PL 00014/5149R

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

07/02/1989

10 DATE OF REVISION OF THE TEXT

4^th June 2015