DEQUADIN
Active substance(s): DEQUALINIUM CHLORIDE
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dequadin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 0.25 mg dequalinium chloride BP
3
PHARMACEUTICAL FORM
Lozenge
4
4.1
CLINICAL PARTICULARS
Therapeutic indications
For the local therapy of most of the common infections of the mouth 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 a dosage reduction in the 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.
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 not considered to constitute 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 should not present a problem other than gastrointestinal discomfort.
Treatment should be symptomatic.
5
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Dequalinium chloride is a quaternary ammonium antiseptic active against many
gram-positive and gram-negative bacteria, yeasts and fungi.
5.2
Pharmacokinetic properties
Not available.
5.3
Preclinical safety data
There are no preclinical safety data of relevance to the consumer.
6
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Icing sugar, citric acid monohydrate, liquid glucose, sodium saccharin, camphor,
magnesium stearate, gelatin, sunset yellow, lime flavour, peppermint oil. Purified
water not detected in final formulation.
6.2
Incompatibilities
None.
6.3
Shelf life
3 years.
6.4
Special precautions for storage
Do not store above 25°C
6.5
Nature and contents of container
PVC/PVDC blister strips sealed with aluminium foil enclosed in a cardboard carton
to give packs of 20 or 40 lozenges.
6.6
Special precautions for disposal
None
7
MARKETING AUTHORISATION HOLDER
RECKITT BENCKISER HEALTHCARE (UK) LIMITED
DANSOM LANE
HULL
EAST YORKSHIRE
HU8 7DS
UNITED KINGDOM
8
MARKETING AUTHORISATION NUMBER(S)
PL 00063/0402
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/06/2007
10
DATE OF REVISION OF THE TEXT
01/08/2008
1
NAME OF THE MEDICINAL PRODUCT
Dequadin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 0.25 mg dequalinium chloride BP
3
PHARMACEUTICAL FORM
Lozenge
4
4.1
CLINICAL PARTICULARS
Therapeutic indications
For the local therapy of most of the common infections of the mouth 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 a dosage reduction in the 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.
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 not considered to constitute 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 should not present a problem other than gastrointestinal discomfort.
Treatment should be symptomatic.
5
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Dequalinium chloride is a quaternary ammonium antiseptic active against many
gram-positive and gram-negative bacteria, yeasts and fungi.
5.2
Pharmacokinetic properties
Not available.
5.3
Preclinical safety data
There are no preclinical safety data of relevance to the consumer.
6
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Icing sugar, citric acid monohydrate, liquid glucose, sodium saccharin, camphor,
magnesium stearate, gelatin, sunset yellow, lime flavour, peppermint oil. Purified
water not detected in final formulation.
6.2
Incompatibilities
None.
6.3
Shelf life
3 years.
6.4
Special precautions for storage
Do not store above 25°C
6.5
Nature and contents of container
PVC/PVDC blister strips sealed with aluminium foil enclosed in a cardboard carton
to give packs of 20 or 40 lozenges.
6.6
Special precautions for disposal
None
7
MARKETING AUTHORISATION HOLDER
RECKITT BENCKISER HEALTHCARE (UK) LIMITED
DANSOM LANE
HULL
EAST YORKSHIRE
HU8 7DS
UNITED KINGDOM
8
MARKETING AUTHORISATION NUMBER(S)
PL 00063/0402
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/06/2007
10
DATE OF REVISION OF THE TEXT
01/08/2008
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
