4.1. Therapeutic indications

For the topical treatment of minor skin trauma such as abrasions, cuts, scratches, burns, bites or stings, when there is a risk of bacterial infection. As a topical antiseptic in minor surgery.

4.2. Posology and method of administration

Posology:

For topical administration.

Adults:

Germolene Wound Care Cream should be applied once or several times daily, as required, to cleaned wounds or affected areas of the skin. Wounds may be treated in the usual manner, i.e. either by application of a dressing or by being left uncovered.

Elderly:

As for adults.

Children:

As for adults.

4.3. Contraindications

Known hypersensitivity to the product or its components, especially chlorhexidine.

Must not be applied to a perforated eardrum.

4.4. Special warnings and precautions for use

Avoid contact with the ears or mucous membranes.

Application over extensive skin areas should be avoided.

If infection persists or the condition worsens, consult a doctor.

Rare but serious allergic reactions including anaphylaxis have been reported with use of chlorhexidine containing antiseptic products. If symptoms of a serious allergic reaction appear (e.g. wheezing or difficulty breathing, swelling of the face, hives that can quickly progress to more serious symptoms, severe rash, or shock), use must be discontinued immediately and doctor should be consulted.

Germolene Wound Care Cream 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 Germolene Wound Care Cream 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. An ophthalmologist's advice should be sought.

4.5. Interaction with other medicinal products and other forms of interaction

Chlorhexidine is incompatible with soaps and other anionic compounds. As a precaution against the possibility of interference (antagonism or inactivation), Germolene Wound Care Cream should not be used concurrently with other antiseptics

4.6. Pregnancy and lactation

There is no evidence to suggest that the use of the cream should be restricted during pregnancy and lactation.

4.7. Effects on ability to drive and use machines

None.

4.8. Undesirable effects

As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible.

Immune system disorders and skin and subcutaneous tissue disorders

Allergic skin reactions such as dermatitis contact, dermatitis allergic, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters. Hypersensitivity, anaphylactic reaction, and anaphylactic shock with respective laboratory and clinical manifestations including asthma syndrome, mild to moderate reactions potentially affecting skin, respiratory tract, gastrointestinal tract, and cardiovascular system, including symptoms such as rash, urticaria, edema, pruritus, and cardio- respiratory distress.

Eye disorder:

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 Card Scheme at: www.mhra.go.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

There is no danger with overdosage. Even when ingested accidentally by mouth, no special measures are necessary. In case of accidental conjunctival contact, which might cause some irritation, washing with water or saline would be sufficient.