DEQUADIN 0.25 MG LOZENGES

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

DEQUALINIUM CHLORIDE

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
Dequadin 0.25 mg Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 0.25 mg dequalinium chloride
Excipient:
Sunset yellow (E110) 0.4 mg per lozenge.
Sucrose 998.925mg per lozenge.
Liquid Glucose 50mg per lozenge.
_For full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Lozenge.
Round, pale-orange lozenges.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the local therapy of most of the common infections of the mouth and oropharynx including: vincents angina,
pharyngitis, sore throats, tonsillitis, stomatitis, aphthous ulcers, thrush, glossitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adults and children over 10 years:
One lozenge to be sucked every 2 to 3 hours, up to a maximum of eight in one day.
Elderly:
There is no need for dosage reduction in elderly.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The label states:
Keep all medicines out of the reach of children.
If symptoms persist, consult your doctor.
Warning: Do not exceed the stated dose.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/12/2009_
_CRN 2076741_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
No clinically significant drug interactions known.
4.6 PREGNANCY AND LACTATION
The safety of Dequadin during pregnancy and lactation has not been established, but it is considered a hazard.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
No adverse effects known.
4.8 UNDESIRABLE EFFECTS
Occasional hypersensitivity reactions and soreness of the tongue are possible.
4.9 OVERDOSE
Overdosage sh
                                
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