AXSAIN Cream Ref.[49944] Active ingredients: Capsaicin

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands

4.1. Therapeutic indications

1. For the symptomatic relief of neuralgia associated with and following Herpes Zoster infections (post-herpetic neuralgia) after open skin lesions have healed.

2. For the symptomatic management of painful diabetic peripheral polyneuropathy.

4.2. Posology and method of administration

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. 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.

4.9. Overdose

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Aluminium tubes with epoxyphenolic lining and polypropylene cap, containing 45g of cream.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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