TRAXAM

5cm) of gel) into the affected area(s) 2 to 4 times a day. If symptoms do not resolve within 14 days, the patient should be reviewed. The total daily dose should not exceed 25g per day irrespective of the number of affected areas.

Elderly:

No special dosage recommendations are made for elderly patients. Paediatric population Safe use of this medicine in early childhood has not been established. Method of administration Topical application to affected area. Hands should be washed following application of this medicine unless they are the treatment site.

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: common (≥1/100, <1/10), rare (≥1/10,000, ≤1/1000), Not known (cannot be estimated from the available data).

The overall incidence of side effects reported with this medicine is low (less than 2%). MedDRA System Organ Class Frequency Undesirable Effects Rare Hypersensitivity reactions such as widespread rashes (including urticaria) and bronchospasm Immune system disorders Not known Anaphylaxis Nervous system disorders Common Paraesthesia which recover spontaneously upon cessation of treatment are the most common reactions.

Respiratory, thoracic and mediastinal disorders Not known Respiratory reactivity comprising asthma, aggravated asthma or dyspnoea Gastrointestinal disorders Rare Gastrointestinal disturbances Common Mild erythema, irritation, dermatitis, pruritis which recover spontaneously upon cessation of treatment are the most common reactions.

Skin and subcutaneous tissue disorders Not known Purpura, angioedema, bullous dermatoses (including epidermal necrolysis and erythema multiforme) and skin photosensitivity. 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/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Use of this medicine should be limited to intact and non-diseased skin. Contact with mucous membranes and the eyes should be avoided. Discontinue if rash develops. This medicine should not be applied with occlusive dressings at the same site as other topical preparations.

Topical application of large amounts may result in systemic effects, such as hypersensitivity, asthma and renal disease. To avoid the possibility of photosensitivity, patients should be advised against excessive exposure to sunlight of treated areas.

Safe use of this medicine in early childhood has not been established. Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard.

Washing clothing and bedding may reduce product build-up but not totally remove it. This medicine contains 300 mg of alcohol (ethanol) in each 1 g which is equivalent to 300 mg/g (30%w/w). It may cause burning sensation on damaged skin.

1. Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory drugs.