Bradosol Sugar Free Cherry Menthol

1. Name Of The Medicinal Product

Bradosol ® Sugar Free Cherry Menthol

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.

3. Pharmaceutical Form

Lozenge.

Bright red flat cylindrical lozenge.

4. Clinical Particulars

4.1 Therapeutic Indications

The lozenges are intended for the relief of sore throats.

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.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

If symptoms persist, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Use during pregnancy or lactation is not restricted.

4.7 Effects On Ability To Drive And Use Machines

The ability to drive or use machines is not affected.

4.8 Undesirable Effects

None known.

4.9 Overdose

No examples of overdosage have been reported.

5. Pharmacological Properties

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.

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.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Citric Acid

Menthol

Eucalyptus oil

Cherry Flavour FC 900476

Cochineal carmine (E120)

Acesulfame K

Isomalt

6.2 Incompatibilities

None.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store at room temperature (below 25°C).

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.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Trading as Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

8. Marketing Authorisation Number(S)

PL 00030/0105

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 1 March 1998

10. Date Of Revision Of The Text

28 October 2005

Legal category: GSL