ACRIFLEX 0.25% W/W CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Acriflex 0.25% w/w Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Acriflex 0.25% w/w Cream contains:

Chlorhexidine Gluconate 0.25% w/w (included as Chlorhexidine Gluconate 20% solution 1.25% v/w).

For the full list of excipients, see sections 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

Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8)

4.4. Special warnings and precautions for use

Acriflex contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. Acriflex should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8).

Keep away from the eyes.

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

4.5. Interactions 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 disorders

Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.

Immune disorders

Frequency not known: Hypersensitivity including anaphylactic shock (see

sections 4.3 and 4.4).

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Care Scheme at: www.mhra.gov.uk/yellowcard.

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

Liquid Paraffin

Dimeticone 20

Glycerol (E422)

Quinoline Yellow Lake (E104)

Purified Water

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 30gm of product, closed with a polyolefin cap in a cardboard outer.

6.6. Instructions for use/handling

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.