Bradosol Sugar Free Original Citrus

1. Name Of The Medicinal Product

Bradosol ® Sugar Free Original Citrus

2. Qualitative And Quantitative Composition

Benzalkonium chloride solution (equivalent to 0.5mg benzalkonium chloride in each lozenge)

For excipients see 6.1.

3. Pharmaceutical Form

Lozenge.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of sore throats.

4.2 Posology And Method Of Administration

Adults (including the elderly) and children over 5 years:

One lozenge to be dissolved slowly in the mouth whenever required.

Method of administration: For oromucosal use.

4.3 Contraindications

None known.

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 overdose 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

There are no findings in the preclinical testing which are of relevance to the prescriber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Citric Acid

Menthol

Eucalyptus oil

Quinoline yellow (E104)

Indigo-carmine (E132)

Acesulfame K

Isomalt

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Blister pack containing 20 lozenges.

6.6 Special Precautions For Disposal And Other Handling

Medicines should be kept out of the reach of children.

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 00030/0104

9. Date Of First Authorisation/Renewal Of The Authorisation

1 March 1998

10. Date Of Revision Of The Text

23 December 2002

Legal category: GSL