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Merocets

Document: spc-doc_PL 04425-0693 change

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Merocets Plus

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Cetylpyridinium chloride    1.4mg/lozenge

Menthol    5.0mg/lozenge

Eucalyptus oil    3.0mg/lozenge

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

3    PHARMACEUTICAL FORM

Oral Lozenge

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Symptomatic treatment of sore throats. Symptomatic relief of nasal congestion.

4.2    Posology and method of administration

Oral

Adults and children 6 years and over: One lozenge every 3 hours. Allow the lozenge to dissolve slowly in the mouth.

Hypersensitivity to the active substance or to any of the excipients

4.4 Special warnings and precautions for use

Label: If sore throat persists, 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 adequate 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.

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

4.7 Effects on ability to drive and use machines

None known.

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 should apply.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Cetylpyridinium chloride is a surface active quarternary 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 granular, glucose liquid, ethyl alcohol, purified water.

6.2 Incompatibilities

Not applicable

36 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 (for 24 and 8 lozenges pack size) and cardboard wallet (for 4 lozenge pack size).

Pack sizes: 24 (marketed pack size), 8 (sample pack size), 4 (sample pack size).

6.6 Special precautions for disposal

None stated.

7 MARKETING AUTHORISATION HOLDER

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

or trading as

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

MARKETING AUTHORISATION NUMBER(S)

8


PL 04425/0693

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

28/01/1998

10    DATE OF REVISION OF THE TEXT

17/12/2014