Germolene Antiseptic Cream

The product will be recommended as an antiseptic (to help prevent secondary infection), local anaesthetic and emollient for minor cuts and grazes, minor burns and scalds and blisters, stings and insect bites, spots and other minor skin conditions, chapped or rough skin.

All age groups:

Thoroughly clean the affected area of skin, apply the cream and rub gently. In the case of cuts or particularly tender areas, rubbing may be avoided by applying on a piece of white lint or gauze.

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).

Consult your doctor if symptoms persist.

Keep out of the reach of children

For external use only

Replace cap firmly after use

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 Antiseptic 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 Antiseptic 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.

The product 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).

Chlorhexidine is incompatible with anionic agents.

The product is not contraindicated during pregnancy and lactation. However, as with all medicines during pregnancy, caution should be exercised.

None known.

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

Repeated Topical Application

Frequently repeated topical application on the same site could theoretically lead to skin irritation. However, since the product is only intended for minor skin trauma, extensive exposure is unlikely.

Accidental or Deliberate Ingestion

The product would only be expected to be harmful if orally ingested in very large quantities. This is unlikely due to the unpleasant taste of the product. In such a case the primary concern would be the phenol intake which can cause nausea, vomiting, diarrhoea and headache.

Treatment

Gastric lavage with water and charcoal. Administration of demulcents such as egg white or milk and supportive measures.

Phenol – antiseptic and local anaesthetic.

Chlorhexidine digluconate – antiseptic.

The product has a local action with minimal risk of systemic effects.

Preclinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product.

Cetostearyl alcohol

Light liquid paraffin

Polyoxyethylene - (21) - stearyl ether

Polyoxyethylene - (2) - stearyl ether

Dimethicone

Methyl salicylate

Sunset yellow (E110)

Ponceau 4R (E124)

Deionised water.

Chlorhexidine is incompatible with anionic agents.

Three years

Do not store above 25° C.

a) Flexible aluminium tubes internally lacquered, fitted with an integral nozzle and a polypropylene cap. 5 g, 30 g, 33 g, 55 g or 120 g tubes are contained in boxboard carton.

b) Aluminium laminate tubes for 5g, 20g, 30g, 33g, 35g, 40g or 55g pack sizes consisting of 150µ m polyethylene / 5µ m polyacrylate outer layer, 30µ m aluminium and an inner layer of 30µ m polyacrylate / 60µ m polyethylene, fitted with a HD polyethylene shoulder, an aluminium/EAA/surlyn tamper evident seal, with a polypropylene cap.

Not applicable.