Merocets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Merocets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetylpyridinium chloride 1.4mg/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
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 6 years and over: One lozenge every 3 hours. Allow the lozenge to dissolve slowly in the mouth.
Children under 6 years: not recommended.
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.
Sunset yellow (E110) may cause allergic reactions Keep out of the reach and sight of children.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
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 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
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.
5.1 Pharmacodynamic properties
Cetylpyridinium chloride is a surface active quartemary 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 (E110), quinoline yellow (E104), 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
PVC/PVdC/aluminium foil laminate blister in cardboard cartons. Packs of 24, sample pack of 8 lozenges.
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
8
MARKETING AUTHORISATION NUMBER(S)
PL 04425/0692
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
31/01/2006
10 DATE OF REVISION OF THE TEXT
17/12/2014