This information is intended for use by health professionals

1. Name of the medicinal product

Boots Tickly Cough Relief Oral Solution

Boots Dry Cough Relief Oral Solution

2. Qualitative and quantitative composition

Active ingredient

per 5ml

Glycerin

Liquid sugar

(Equivalent to sucrose

0.75 ml

1.93 ml

1.70 g)

3. Pharmaceutical form

Oral Solution

4. Clinical particulars
4.1 Therapeutic indications

For the relief of irritating, tickling dry coughs and sore throats.

4.2 Posology and method of administration

Adults and children over 5 years: 10 ml

Children 1 - 5 years: 5 ml

The dose may be repeated three or four times a day.

Children under one year: Not to be given to children under 1 year.

Elderly: There is no need for dosage reduction in the elderly.

For oral administration.

4.3 Contraindications

Hypersensitivity or intolerance to any of the ingredients.

4.4 Special warnings and precautions for use

Diabetics should take note of the carbohydrate contents of this product.

Do not give to children under one year.

Keep all medicines out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions known.

4.6 Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established, but is not considered to constitute a hazard during these periods.

4.7 Effects on ability to drive and use machines

Not applicable.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Overdosage would not be expected to cause any problems and treatment would be merely symptomatic and supportive.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Glycerin and sucrose have demulcent properties and will soothe irritated sore throats and possibly block sensory cough receptors within the respiratory tract.

5.2 Pharmacokinetic properties

Glycerin 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

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6. Pharmaceutical particulars
6.1 List of excipients

Citric acid monohydrate

Sodium benzoate

Cough Syrup 513277

Black Treacle

Liquid glucose

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

A white flint glass bottle with an aluminium roll-on pilfer proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.

Alternative cap: A wadless polypropylene tamper evident cap.

Pack size: 200ml.

or

An amber glass bottle with an aluminium roll-on pilfer proof cap with a triseal LDPE/EPE/LDPE) liner.

Pack size: 125ml.

or

An amber PET bottle with a child resistant polypropylene cap fitted with an expanded polyethylene liner.

Pack size: 150ml or 300ml

6.6 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham

NG2 3AA

Trading as: BCM

8. Marketing authorisation number(s)

PL 00014/0550

9. Date of first authorisation/renewal of the authorisation

13 December 1995 / 12 December 2000

10. Date of revision of the text

28th February 2020