Merocaine

1. Name Of The Medicinal Product

Merocaine.

2. Qualitative And Quantitative Composition

Cetylpyridinium Chloride BP 1.40mg; Benzocaine Ph Eur 10.00mg.

3. Pharmaceutical Form

Lozenge.

4. Clinical Particulars

4.1 Therapeutic Indications

Merocaine provides 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 the 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 over 12 years: Allow to dissolve slowly in the mouth. One lozenge every 2 hours as needed but not more than 8 lozenges in 24 hours.

4.3 Contraindications

Idiosyncrasy to any of the ingredients.

4.4 Special Warnings And Precautions For Use

None known.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is no or inadequate evidence of safety of cetylpyridinium chloride or benzocaine in human pregnancy, but they have been widely used for many years without apparent ill-consequence. No data are available on the use of Merocaine lozenges during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Allergic reactions and methaemoglobinaemia have been reported with benzocaine. If symptoms persist, or are severe, or are accompanied by fever, headache, nausea and vomiting, consult a doctor.

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 vasopressor drugs if necessary) should apply.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Cetylpyridinium Chloride: topical antibacterial 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; 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

Packs of 24 lozenges. PVC/PVdC/aluminium foil laminate blister in cardboard cartons.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

SSL International PLC. Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA.

8. Marketing Authorisation Number(S)

PL 17905/0066.

9. Date Of First Authorisation/Renewal Of The Authorisation

23/03/06

10. Date Of Revision Of The Text

23/03/06