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Alliance Pharmaceuticals

Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB

Telephone: +44 (0)1249 466 966
Fax: +44 (0)1249 466 977
WWW: http://www.alliancepharma.co.uk
Medical Information e-mail: medinfo@alliancepharma.co.uk

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Summary of Product Characteristics last updated on the eMC: 15/08/2011

SPC	Anbesol Liquid

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

Anbesol Liquid

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Lidocaine hydrochloride Ph Eur	0.9%w/w
Chlorocresol Ph Eur	0.1%w/w
Cetylpyridinium chloride Ph Eur	0.02%w/w

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3. PHARMACEUTICAL FORM

Liquid for oral administration

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the temporary relief of pain caused by recurrent mouth ulcers, denture irritation and teething.

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4.2 Posology and method of administration

Adults, the elderly and children: Apply undiluted to the affected area with the fingertip. Two applications immediately will normally be sufficient to obtain pain relief. Use up to 8 times a day.

Babies teething: One application only. Do not repeat for at least half an hour. Use up to 8 times a day.

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4.3 Contraindications

Patients with known history of hypersensitivity or allergic type reactions to any of the constituents of the product.

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4.4 Special warnings and precautions for use

If symptoms persist for more than 7 days consult your doctor or dentist. For babies teething, do not repeat for at least half an hour.

Keep all medicines out of the reach of children.

Do not exceed the stated dose.

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4.5 Interaction with other medicinal products and other forms of interaction

None known.

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4.6 Pregnancy and lactation

No special precautions required.

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4.7 Effects on ability to drive and use machines

None known.

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4.8 Undesirable effects

There have been reports of non-specific ulceration following oral cetylpyridinium chloride therapy.

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4.9 Overdose

Ingestion of the complete contents of the marketed pack would not be expected to cause any adverse effects.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Lidocaine hydrochloride

Absorption and fate: lidocaine is readily absorbed from mucous membranes and through damaged skin. Lidocaine undergoes first-pass metabolism in the liver and about 90% is dealkylated to form monoethylglycinexylidide and glycinexylidide. Further metabolism occurs and the metabolites are excreted in the urine with less than 10% as unchanged lidocaine.

Chlorocresol

Absorption: there is no significant absorption of chlorocresol through the skin or mucous.

Cetylpyridinium chloride

Absorption: there is no significant absorption of cetylpyridinium chloride through the skin or mucous membranes.

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5.2 Pharmacokinetic properties

Lidocaine hydrochloride

White crystalline powder soluble in water and alcohol.

Mechanism of action/effect: lidocaine is a local anaesthetic of the amide type, which acts by reversible inhibition of nerve impulse generation and transmission.

Chlorocresol

Colourless crystals or a white crystalline powder slightly soluble in water and alcohol.

Chlorocresol has a disinfectant action.

Cetylpyridinium chloride

A white unctuous powder soluble in water and alcohol.

Mechanism of action/effect: cetylpyridinium chloride has a disinfectant action.

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5.3 Preclinical safety data

None stated

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6. PHARMACEUTICAL PARTICULARS

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