SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Merocaine

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Cetylpyridinium chloride    1.4mg/lozenge.

Benzocaine    10.0mg/lozenge.

Also contains sucrose, glucose liquid and sunset yellow. For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Lozenge

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Merocaine Lozenges provide rapid and profound local anaesthetic action and topical antibacterial effects for the temporary relief of pain and discomfort in sore throat and superficial mouth infections. Indicated for relief of minor throat irritations and adjunctively, for symptomatic relief of pain and discomfort in more serious throat infections, such as tonsillitis and pharyngitis.

4.2 Posology and method of administration

Route of administration:    Oral

Adults and Children 12 years and over:

Allow to dissolve slowly in mouth. One lozenge every 2 hours as needed but not more than 8 lozenges in 24 hours.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients

4.4 Special warnings and precautions for use

Label: If sore throat persists for more than three days consult your doctor.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Keep out of the reach and sight of children.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, 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 Merocaine lozenges in pregnancy.

However, as with all medicines, caution should be exercised during pregnancy and lactation

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Allergic reactions and methaemoglobinaemia hae been reported with Benzocaine. "If symptoms persist, or are severe, or are accompanied by fever, headache, nausea and vomiting, consult your doctor". - appears on label.

4.9 Overdose

No experience of overdosage.

Treatment

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

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Cetylpyridinium Chloride - topical anticaterial agent. Benzocaine - local anaesthetic.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lime Oil Lemon Oil Sucrose granular. Glucose Liquid 80% Quinoline Yellow E104 FD&C Blue No. 2 Isopropyl Alcohol Ethyl Alcohol Purified Water

6.2 Incompatibilities

None known.

6.3    Shelf life

36 months unopened

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

1.    24 Lozenges: PVC/PVdC/alumlnium foil laminate blister in cardboard cartons.

2.    8 Lozenge Sample pack as above.

3.    4 Lozenge Sample pack - Blister as above in cardboard wallet.

6.6 Special precautions for disposal

None stated.

7    MARKETING AUTHORISATION HOLDER

Aventis Pharma Limited T/A Sanofi-Aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 04425/0691

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

31/01/2006

10 DATE OF REVISION OF THE TEXT

29/12/2014