Acriflex 0.25% w / w Chlorhexidine Gluconate Cream

1. Name Of The Medicinal Product

Acriflex (0.25% w/w Chlorhexidine Gluconate) Cream

2. Qualitative And Quantitative Composition

Acriflex (0.25% w/w Chlorhexidine Gluconate) Cream contains:

Chlorhexidine Gluconate 20% solution BP 1.25% v/w.

For excipients, see 6.1.

3. Pharmaceutical Form

Cream for topical administration to human beings.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of minor burns and scalds, scratches, cuts and abrasions, sunburn blisters and infected cracked skin.

4.2 Posology And Method Of Administration

For general use, apply freely and smooth gently into the skin. For cuts abrasions, burns etc. spread freely and, if necessary, cover with a dressing.

There are no recommended dosage schedules as the product is for use as needed.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep away from the eyes.

Avoid contact with the brain, meninges and middle ear. Not for use in body cavities.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No harmful effects in human pregnancy have been reported. Nevertheless, like all medicines, care should be exercised during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Skin irritation may occur occasionally. Rarely, generalised allergic reactions to chlorhexidine have been reported.

4.9 Overdose

Overdosage is extremely unlikely. Chlorhexidine is poorly absorbed and systemic effects are unlikely even if large amounts are swallowed. However, gastric lavage followed by supportive measures may be used as appropriate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Chlorhexidine is a bisbiguanide disinfectant which is effective against a wide range of vegetative gram-positive and gram-negative bacteria.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Arlatone 983 S

Cetostearyl Alcohol BP

Liquid Paraffin BP

Dimeticone 20 BPC

Glycerol BP

Quinoline Yellow Lake 250

Purified Water BP

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years unopened.

6.4 Special Precautions For Storage

None stated.

6.5 Nature And Contents Of Container

Internally lacquered aluminium, blind end tubes containing 25gm and 30gm of product, closed with a polyolefin cap in a cardboard outer.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0116

9. Date Of First Authorisation/Renewal Of The Authorisation

31 March 2003

10. Date Of Revision Of The Text

20^th October 2003

11 DOSIMETRY

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not Applicable