4.1. Therapeutic indications

The cleansing and prevention of infection in all types of lesions, ranging from minor skin disorders or blisters, to minor burns and small wounds.

4.2. Posology and method of administration

For cutaneous use only.

Apply the cream over the affected area after cleansing.

4.3. Contraindications

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

4.4. Special warnings and precautions for use

For external use only.

Avoid contact with the middle ear, meninges and other nervous tissue.

Savlon 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 Savlon 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. If Savlon Antiseptic Cream comes into contact with the eyes, wash out promptly and thoroughly with water. An ophthalmologist's advice should be sought.

Keep all medicines away from children.

If symptoms persist, stop using and consult your doctor.

The product is incompatible with anionic substances (e.g. soap)

Information concerning excipients

Savlon cream contains:

• Chlorhexidine which 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. Savlon Antiseptic Cream 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).

• Cetostearyl Alcohol may cause local skin reactions (e.g. contact dermatitis).

• Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216):

may cause allergic reactions (possibly delayed).

• Aseptic perfume-This medicine contains fragrances with limonene, linalool, benzyl benzoate and citral which may cause allergic reactions.

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

No interaction studies have been performed.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of chlorhexidine digluconate and cetrimide in pregnant women.

The potential risk for humans is unknown but is most likely very low since chlorhexidine digluconate and cetrimide are poorly absorbed following topical application.

Breast-feeding

It is not known whether chlorhexidine digluconate and cetrimide are excreted in breast milk. There is no adequate data from the use of chlorhexidine and cetrimide in breast-feeding women. However, it is unlikely that the products are excreted in breast milk, since the products are poorly absorbed. After topical usage of the product, as a general precaution, rinse nipples thoroughly with water before breast-feeding.

Fertility

No data are available on fertility outcomes.

4.7. Effects on ability to drive and use machines

Savlon has no influence on the ability to drive and use machines.

4.8. Undesirable effects

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as:: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Immune system disorders

Very rare: Anaphylactic reaction

Very rare: Angioedema, urticaria

Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).

Skin and subcutaneous tissue disorders

Very rare: Skin irritation

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

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).

Paediatric population

No investigations in children have been performed. However, frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

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/yel1owcard.

4.9. Overdose

Symptoms

While accidental ingestion is unlikely to cause any systemic effects due to the poor absorption of Chlorhexidine digluconate and cetrimide, ingestion of high concentrations may cause esophageal damage and necrosis with symptoms such as nausea and vomiting. Cetrimide has depolarising muscle relaxant properties and toxic symptoms include dyspnoea and cyanosis due to paralysis of the respiratory muscles, possibly leading to asphyxia. CNS depression (sometimes preceded by excitement and convulsions), hypotension, coma, and death may also occur.

Management

Treatment of poisoning is symptomatic; demulcents and diluents may be given if necessary but emesis and lavage should be avoided. Activated charcoal may be considered if the patient presents within an hour of ingestion.

Corticosteroids may reduce oropharyngeal edema.