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BOOTS DRY COUGH RELIEF ORAL SOLUTION

Active substance(s): GLYCERIN / LIQUID SUGAR / GLYCERIN / LIQUID SUGAR / GLYCERIN / LIQUID SUGAR

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SUMMARY OF PRODUCT CHARACTERISTICS

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 Glycerin Liquid sugar (Equivalent to sucrose per 5ml 0.75 ml 1.93 ml 1.70 g)

3

PHARMACEUTICAL FORM
Oral Solution

4
4.1

CLINICAL PARTICULARS
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.

Contra-indications 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.

Interactions with other Medicaments 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. Overdose Overdosage would not be expected to cause any problems and treatment would be merely symptomatic and supportive.

4.9.

5
5.1

PHARMACOLOGICAL PROPERTIES
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. 6.1.

PHARMACEUTICAL PARTICULARS 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 None.

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.

Instruction for Use/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

10

DATE OF REVISION OF THE TEXT
09/11/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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