SAVLON ANTISEPTIC

For cutaneous use only. Apply the cream over the affected area after cleansing.

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. 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*.

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. uk/yel1owcard.

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.

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.

8). 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.

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