AXSAIN

Adults and the elderly For topical administration to unbroken skin. Apply only a small amount of cream (pea size) to the affected area 3 or 4 times daily. These applications should be evenly spaced throughout the waking hours and not more often than every 4 hours.

The cream should be gently rubbed in, there should be no residue left on the surface. Axsain may cause transient burning on application. The burning is observed more frequently when application schedules of more than 4 times daily are used.

Hands should be washed immediately after application of Axsain with the fingers. Do not apply near the eyes. Patients using Axsain for the treatment of painful diabetic peripheral polyneuropathy should only do so under the direct supervision of a hospital consultant who has access to specialist resources.

The recommended duration of use in the first instance is 8 weeks, since there is no clinical trial evidence of efficacy for treatment of more than 8 weeks duration. After this time, it is recommended that the patient's condition should be fully clinically assessed prior to continuation of treatment, and regularly re- evaluated thereafter, by the supervising consultant.

Not suitable for use in children.

Axsain may cause skin irritation or transient burning on application. This burning is observed more frequently when application schedules of more than 4 times daily are utilised. The burning can be enhanced if too much cream is used and if it is applied just before or after a bath or shower.

Irritation of the mucous membranes of the eyes and respiratory tract (such as nasal and throat irritation) on application of Axsain cream has been reported rarely, resulting in symptoms such as coughing, sneezing and runny eyes. These events are usually mild and self-limiting.

There have been a few reports of dyspnoea, wheezing and exacerbation of asthma. 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.

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Not for use under tight bandages. Keep away from the eyes. Skin irritation has been reported following application of Axsain. The hands should be washed immediately after application of the cream, unless the hands are the treated areas, in which case, they should be washed 30 minutes after application.

Contact with eyes and mucous membranes should be avoided. Patients should avoid taking a hot bath or shower just before or after applying Axsain, as it can enhance the burning sensation. Patients and carers should avoid inhalation of vapours from the cream, as transient irritation of the mucous membranes of the eyes and respiratory tract (including exacerbation of asthma) has been reported.

If the condition worsens, seek medical advice. Excipients Benzyl alcohol may cause mild local irritation. g. contact dermatitis).

Axsain cream is contra-indicated for use on broken or irritated skin. 1.