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Summary of Product Characteristics last updated on the eMC: 28/09/2006

SPC	Merocets Lozenges

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

Merocets Lozenges.

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Cetylpyridinium Chloride EP 1.4mg / lozenge.

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3. PHARMACEUTICAL FORM

Lozenge.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Relief of sore throat and other symptoms associated with mouth and throat infections.

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4.2 Posology and method of administration

Oral (lozenge). Adults, the elderly and children over 6 years: One lozenge every 3 hours. Allow the lozenge to dissolve slowly in the mouth. Children under 6 years: not recommended.

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4.3 Contraindications

Known idiosyncrasy to cetylpyridinium chloride.

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4.4 Special warnings and precautions for use

If sore throat persists for more than three days consult a doctor.

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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

There is no or inadequate evidence of safety of cetylpyridinium chloride in human pregnancy but it has been in wide use for many years without apparent ill consequences. No data are available on the use of Merocets lozenges in pregnancy.

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4.7 Effects on ability to drive and use machines

Not applicable.

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4.8 Undesirable effects

Very rare reports of urticaria. Infrequent and transient complaints of a burning sensation of the mouth.

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4.9 Overdose

No experience of overdosage but normal procedures of gastric lavage and maintenance of respiration and circulation (using vasopressor drugs if necessary) should apply.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Cetylpyridinium chloride is a surface active quaternary ammonium compound with antibacterial properties.

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5.2 Pharmacokinetic properties

Cetylpyridinium chloride exerts its antimicrobial activity topically in the mouth and throat as it dissolves from the lozenge. Pharmacokinetic data are not available.

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5.3 Preclinical safety data

None stated.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Sucrose; Glucose Liquid; Peppermint Oil; Sunset Yellow; Quinoline Yellow; Ethyl Alcohol; Purified Water.

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6.2 Incompatibilities

Not applicable.

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