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Novartis Consumer Health
Novartis Consumer Health UK Ltd, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK
Telephone: +44 (0)1276 687300
Fax: +44 (0)1276 687284
Medical Information Direct Line: +44 (0)1403 323 046
Medical Information e-mail: medicalaffairs.uk@novartis.com
Customer Care direct line: +44 (0)1276 687290
Medical Information Fax: +44 (0)1403 324 024

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Summary of Product Characteristics last updated on the eMC: 15/04/2011
SPC Bradosol Sugar Free Cherry Menthol


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1. NAME OF THE MEDICINAL PRODUCT

Bradosol ® Sugar Free Cherry Menthol


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient:

Benzalkonium Chloride Solution 0.067% v/w

(equivalent to 0.5 mg benzalkonium chloride per lozenge)

For excipients, see 6.1.


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3. PHARMACEUTICAL FORM

Lozenge.

Bright red flat cylindrical lozenge.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

The lozenges are intended for the relief of sore throats.


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4.2 Posology and method of administration

The route of administration is oral.

The recommended dose for all ages, including the elderly and children over 5 years, is one lozenge to be dissolved slowly in the mouth whenever required.

Medicines should be kept out of the reach of children.


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4.3 Contraindications

Hypersensitivity to any of the ingredients.


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4.4 Special warnings and precautions for use

If symptoms persist, consult your doctor.


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


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4.6 Pregnancy and lactation

Use during pregnancy or lactation is not restricted.


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4.7 Effects on ability to drive and use machines

The ability to drive or use machines is not affected.


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4.8 Undesirable effects

None known.


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4.9 Overdose

No examples of overdosage have been reported.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Benzalkonium chloride is a quarternary ammonium antiseptic/disinfectant, being a typical cationic surfactant with bactericidal activity against gram-positive and some gram-negative organisms.


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5.2 Pharmacokinetic properties

The product is dissolved in the mouth and is dependent on local distribution for the treatment of superficial infections of the mouth and throat.


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5.3 Preclinical safety data

Not applicable.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Citric Acid

Menthol

Eucalyptus oil

Cherry Flavour FC 900476

Cochineal carmine (E120)

Acesulfame K

Isomalt


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6.2 Incompatibilities

None.


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6.3 Shelf life

36 months.


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6.4 Special precautions for storage

Store at room temperature (below 25°C).


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6.5 Nature and contents of container

Blister pack made from 250 micron PVC/PVDC (40g.s.m) and 20 micron aluminium foil.

Packs contain 1, 2, 3, 4, 20 or 24 lozenges.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

None.


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7. MARKETING AUTHORISATION HOLDER

Novartis Consumer Health UK Limited

Trading as Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex

RH12 5AB


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00030/0105


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1 March 1998


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10. DATE OF REVISION OF THE TEXT

28 October 2005

Legal category: GSL



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/21056/SPC/


Active Ingredients/Generics

 
  benzalkonium chloride