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Forest Laboratories UK Limited

Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL

Telephone: +44 (0)1322 421 800
Fax: +44 (0)1322 291 306
WWW: http://www.forestlabs.com
Medical Information e-mail: medinfo@forest-labs.co.uk

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Summary of Product Characteristics last updated on the eMC: 27/04/2012

SPC	Venos 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

Beechams Veno's Cough Mixture

Veno's Cough Syrup

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Glucose liquid 3.18 g, Treacle 1.35 g

For excipients, see 6.1.

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3. PHARMACEUTICAL FORM

Syrup

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Recommended for the symptomatic relief of sore throat and unproductive cough in minor respiratory tract infections.

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4.2 Posology and method of administration

Adults and children over the age of 12: Take one 5 ml or 10 ml dose (one or two 5 ml spoonfuls). Repeat the dose every 2 or 3 hours.

Children aged 3 to under 12 years: Take one 5 ml dose (one 5 ml spoonful) and give every 2 to 3 hours. Do not give to children under 3 years except on medical advice.

Route of Administration

Oral

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4.3 Contraindications

Hypersensitivity to glucose, treacle or any other of the ingredients.

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4.4 Special warnings and precautions for use

Special Label Warnings

Keep all medicines out of the sight and reach of children.

If symptoms persist consult your doctor.

Total sugars content 3.6 g per 5 ml.

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4.5 Interaction with other medicinal products and other forms of interaction

None

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4.6 Pregnancy and lactation

Use in pregnancy and lactation is not contraindicated. However, as with all medicines, caution should be exercised during pregnancy and lactation.

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4.7 Effects on ability to drive and use machines

None

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4.8 Undesirable effects

Immune system disorders

Hypersensitivity reactions e.g. skin rash

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4.9 Overdose

The product does not contain any ingredient in a high enough concentration to cause toxic effects; therefore no specific symptoms of overdosage would be anticipated and no antidotes would be required.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Treacle and glucose liquid are demulcents, which will help relieve an unproductive cough and will soothe a sore throat.

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5.2 Pharmacokinetic properties

None Stated.

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5.3 Preclinical safety data

There are no preclinical data of any relevance additional to that already included in other sections of the SmPC.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Capsicum tincture, aniseed oil, xanthan gum, camphor racemic, glacial acetic acid, sodium benzoate, sodium metabisulphite (E223), levomenthol, water and colour caramel (E150).

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6.2 Incompatibilities

None

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6.3 Shelf life

Unopened: Three years

Opened: Six months

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6.4 Special precautions for storage

None

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6.5 Nature and contents of container

Clear glass bottle with a roll-on, pilfer proof, aluminium cap containing a melinex-coated aluminium-faced pulp-board wad. The bottle is contained in a boxboard carton.

Pack sizes: 100 ml, 160 ml.

Not all pack sizes may be marketed.

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6.6 Special precautions for disposal and other handling

None

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7. MARKETING AUTHORISATION HOLDER

Forest Laboratories UK Limited

Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford