Dequacaine Lozenges

Země: Malta

Jazyk: angličtina

Zdroj: Malta Medicines Authority

Aktivní složka:

DEQUALINIUM CHLORIDE, BENZOCAINE

Dostupné s:

Reckitt Benckiser Healthcare International Limited Thane Road, Nottingham NG90 2DB, United Kingdom

ATC kód:

R02AA20

INN (Mezinárodní Name):

DEQUALINIUM CHLORIDE 0.25 mg BENZOCAINE 10 mg

Léková forma:

LOZENGE

Složení:

DEQUALINIUM CHLORIDE 0.25 mg BENZOCAINE 10 mg

Druh předpisu:

OTC

Terapeutické oblasti:

THROAT PREPARATIONS

Stav Autorizace:

Withdrawn

Datum autorizace:

2008-07-07

Charakteristika produktu

Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Dequacaine. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each lozenge contains 0.25mg dequalinium chloride BP and
10.0mg benzocaine BP. 

3. PHARMACEUTICAL 
FORM 

Lozenge. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

For the relief of severe sore throats. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Adults and Children over 12 years:  One lozenge to be sucked slowly
every 
two hours as required.  Not more than 8 lozenges to be taken in any
24 hours. 

Children under 12 years:  Not suitable. 

Elderly:  There is no need for dosage reduction in the elderly. 

4.3 CONTRAINDICATIONS 

Patients hypersensitive to any of the ingredients or to
para-aminobenzoic acid 
and its derivatives. 

Patients with low plasma cholinesterase concentrations. 

4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Dequacaine should be used with caution in patients with myasthenia
gravis. 

The label states: 
Warning:  Do not exceed the stated dose. 
Keep all medicines out of the reach of children. 
If symptoms persist consult your doctor. 

4.5 
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION 

Page 2 of 4 

Dequacaine is contraindicated in those patients
taking anticholinesterases.  
Benzocaine is metabolised to para-aminobenzoic acid and Dequacaine
may 
therefore antagonise the effects of sulphonamides. 

4.6 
PREGNANCY AND LACTATION 

The safety of Dequacaine during pregnancy and lactation has not
been 
established.  As local anaesthetics can cross the placenta, it is
recommended 
that this product is not taken during pregnancy.  No information in
the use of 
this product in lactation is available and it is recommended that
Dequacaine is 
not taken whilst breast-feeding. 

4.7 
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 

No adverse effects known