Merocets Plus
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