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).

Acriflex must not come into contact with the eye. Serious cases of persistent corneal injury, potentially requiring corneal transplant, were reported following accidental ocular exposure to chlorhexidine containing medicinal products despite taking eye protective measures due to migration of solution beyond the intended surgical preparation area. Extreme care must be taken during application to ensure that Acriflex does not migrate beyond its intended application site into the eyes. Particular care should be taken in anaesthetised patients, who are unable to immediately report ocular exposure. If Acriflex comes into contact with the eyes, wash out promptly and thoroughly with water. An ophthalmologist's advice should be sought.

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 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).

Eye disorders

Frequency not known: Corneal erosion, epithelium defect/corneal injury, significant permanent visual impairment*.

Cases of severe corneal erosion and permanent significant visual impairment due to inadvertent ocular exposure have been reported post-marketing, leading to some patients requiring corneal transplant (see section 4.4).

Reporting of suspected adverse reactions

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.