BRADOSOL PLUS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
DOMIPHEN BROMIDE LIDOCAINE HYDROCHLORIDE
Available from:
Novartis Consumer Health UK Limited
Dosage:
0.5mg/5mg Per Cent
Pharmaceutical form:
Lozenges
Authorization date:
1994-03-08
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bradosol Plus Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains:
Domiphen Bromide 0.5 mg
Lidocaine Hydrochloride 5.0 mg
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
A bright green, flat-biconvex cylindrical lozenge.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an adjunct in
the management of superficial infections of the mouth and
oropharynx.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Adults and Children over 12 years only:
One lozenge to be sucked every 2-3 hours as required
A maximum number of 8 lozenges per day should not be exceeded
Method of administration:
Oromucosal use
4.3 CONTRAINDICATIONS
Use in patients hypersensitive to the active ingredients.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
The local anaesthetic may affect swallowing reflexes.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None.
4.6 PREGNANCY AND LACTATION
No information given.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 30/08/2005_
_CRN 2014252_
_page number: 1_
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
4.8 UNDESIRABLE EFFECTS
This product may give rise to allergic reactions, sensitisation
may also develop.
4.9 OVERDOSE
No information given.
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
Antiseptic/local anaesthetic combination lozenge.
5.2 PHARMACOKINETIC PROPERTIES
No information given.
5.3 PRECLINICAL SAFETY DATA
No information given.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Citric acid monohydrate
Menthol
Eucalyptus oil
Quinoline yellow (E104)
Indigo carmine (E132)
Acesulfame Potassium
Isomalt
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
1 year.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not sto
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