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BOOTS COMPANY PLC

1 Thane Road West, Beeston, Nottingham, NG2 3AA

Telephone: +44 (0)1159 595 306
Fax: +44 (0)1159 592 565

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 22/12/2011

SPC	Boots Dry Cough Relief Oral Solution

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Boots Dry Cough Relief Oral Solution

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient

per 5ml

Glycerin

Liquid sugar

(Equivalent to sucrose

0.75 ml

1.93 ml

1.70 g)

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3. PHARMACEUTICAL FORM

Oral Solution

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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

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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.

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4.3 Contraindications

Hypersensitivity or intolerance to any of the ingredients.

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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.

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4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions known.

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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.

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4.7 Effects on ability to drive and use machines

Not applicable.

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4.8 Undesirable effects

Immune system disorder: hypersensitivity reactions, including anaphylaxis.

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4.9 Overdose

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

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5. PHARMACOLOGICAL PROPERTIES

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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.

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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.

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5.3 Preclinical safety data

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

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Citric acid monohydrate

Sodium benzoate

Cough Syrup 513277

Black Treacle