Merocets Lozenges

1. Name Of The Medicinal Product

Merocets Lozenges.

2. Qualitative And Quantitative Composition

Cetylpyridinium Chloride EP 1.4mg / lozenge.

3. Pharmaceutical Form

Lozenge.

4. Clinical Particulars

4.1 Therapeutic Indications

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

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.

4.3 Contraindications

Known idiosyncrasy to cetylpyridinium chloride.

4.4 Special Warnings And Precautions For Use

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

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 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.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

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

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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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

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.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

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

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

60 months unopened.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

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

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 17905/0068.

9. Date Of First Authorisation/Renewal Of The Authorisation

23/03/2006

10. Date Of Revision Of The Text

23/03/2006