Merocaine

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

BENZOCAINE, CETYLPYRIDINIUM CHLORIDE

Beschikbaar vanaf:

SSL Internatinal PLC 103 - 105 Bath Road Slough, SL1 3UK, United Kingdom

ATC-code:

R02AA

INN (Algemene Internationale Benaming):

BENZOCAINE 10 mg CETYLPYRIDINIUM CHLORIDE 1.4 mg

farmaceutische vorm:

LOZENGE

Samenstelling:

BENZOCAINE 10 mg CETYLPYRIDINIUM CHLORIDE 1.4 mg

Prescription-type:

OTC

Therapeutisch gebied:

THROAT PREPARATIONS

Autorisatie-status:

Withdrawn

Autorisatie datum:

2006-12-05

Productkenmerken

Page 1 of 3 
SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Merocaine. 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Cetylpyridinium Chloride    1.40mg/lozenge. 
Benzocaine  

10.0mg/lozenge. 

3 PHARMACEUTICAL 
FORM 
Lozenge. 

4 CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
Merocaine Lozenges provide 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 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 OF AGE: 
Allow to dissolve slowly in mouth.  One lozenge every 2 hours as
needed but not more than 
8 lozenges in 24 hours. 
4.3 CONTRA-INDICATIONS 
Idiosyncrasy to any of the ingredients and to any of
the excipients. 
4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
E132 can cause skin sensitivity, a rash similar to nettle
rash, itching, nausea, high blood 
pressure and breathing problems. 
E104 can cause dermatitis. 
4.5 
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS 
None known. 
Page 2 of 3 
4.6 
USE DURING PREGNANCY AND LACTATION 
There is no or inadequate evidence of safety of
cetylpyridinium chloride or benzocaine in 
human pregnancy, but they have been in
wide use 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�