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McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG Medical Information Direct Line: 01344 864042 Medical Information e-mail: medinfo@its.jnj.com 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: 18/02/2010

SPC	Benylin Children's Apple Flavour Cough Syrup

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

Benylin Children's Apple Flavour Cough Syrup or CalCough Infant Syrup

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient

% v/v

ml/5ml

Glycerol

For excipients see 6.1

15.0

0.75

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3. PHARMACEUTICAL FORM

Syrup

A clear colourless syrup with an apple flavour.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the relief of dry tickly coughs.

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4.2 Posology and method of administration

Oral use.

Children 3 months - 1 year: one 5ml spoonful three to four times a day.

Children 1 to 5 years: two 5ml spoonfuls three to four times a day.

Children under 3 months: not recommended.

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4.3 Contraindications

Hypersensitivity to any of the ingredients.

Not recommended for children under 3 months.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

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4.4 Special warnings and precautions for use

If symptoms persist for more than 3 days consult your doctor.

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 drug interactions.

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4.6 Pregnancy and lactation

Not applicable.

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4.7 Effects on ability to drive and use machines

No or negligible influence.

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4.8 Undesirable effects

Maltitol may have a mild laxative effect.

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4.9 Overdose

Overdosage with this product may possibly cause diarrhoea. Treatment should be symptomatic.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

The ATC code is R05FB01.

Glycerol has demulcent properties and may possibly block sensory cough receptors in the respiratory tract.

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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 oxidized to carbon dioxide and water. It may also be excreted in the urine unchanged.

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5.3 Preclinical safety data

Not applicable

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Maltitol liquid (E965)

Hydroxyethylcellulose

Sodium benzoate

Citric acid monohydrate

Sodium citrate