DEQUACAINE LOZENGES, BENZOCAINE 10 MG, DEQUALINIUM
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
DEQUALINIUM CHLORIDE BENZOCAINE
Available from:
Reckitt Benckiser Ireland Ltd
Dosage:
0.25 Milligram
Pharmaceutical form:
Lozenges
Authorization date:
2009-02-06
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dequacaine Lozenges
Benzocaine 10 mg
Dequalinium chloride 0.25 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 0.25 mg dequalinium chloride and 10 mg benzocaine
Excipients:
Sorbitol (E420)
Sugar base (consisting of glucose and sucrose) 2.6g/lozenge.
_For full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Lozenge.
Round, yellow lozenges.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of severe sore throats and for the relief of pain and discomfort in the oral cavity associated with
superficial infection of the oropharynx or with dental procedures.
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 elderly.
4.3 CONTRAINDICATIONS
Patients sensitive 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
Speak to your doctor before use if you are pregnant, breast feeding, taking any medicines (especially sulphonamides) or
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/12/2009_
_CRN 2076715_
_page number: 1_
suffer from Myasthenia Gravis.
The label states:
Warning: Do not exceed the stated dose. Keep all medicines out of the reach of the children. If symptoms persist or are
accompanied by fever, headache, nausea or vomiting consult your doctor.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Dequacaine
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