PIROXICAM MANX

Posology Adults:

Apply 1 g of the gel (about 3 cms or 11/4 inches) and rub into the affected area until the gel completely disappears. Wash hands immediately after use. Apply three times a day. Individual doses should be administered at least 4 hours apart.

If the symptoms do not improve by day 7, or if they worsen in the first 7 days, a consultation with a doctor is recommended. Do not use for more than 14 days unless recommended by a doctor. Occlusive dressings should not be used.

Children:

Do not use on patients under 18 years of age.

Elderly:

No special precautions are necessary. Method of Administration Topical On first use, discard any small amount of liquid present when withdrawing product from the tube. The product can then be used normally.

Mild to moderate local irritation, erythema, pruritus and dermatitis may occur at the application site. Contact dermatitis, eczema and photosensitivity skin reactions have been reported. The systemic absorption of piroxicam gel is very low.

In common with other topical NSAIDs, systemic reactions occur infrequently and have included minor gastro-intestinal side-effects such as nausea and dyspepsia. Cases of abdominal pain and gastritis have been reported rarely. There have been isolated reports of bronchospasm and dyspnoea.

4). 4) has been reported with an unknown frequency. 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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If local irritation develops discontinue use of the product. Keep away from the eyes and mucosal surfaces. Do not apply to any sites affected by open skin lesions, dermatoses or infection. Topical application of large amounts of piroxicam gel may result in increased systemic absorption of piroxicam with increased potential for systemic side effects.

Avoid excessive exposure to sunlight of the treated area to reduce the potential for development of photosensitivity reactions. Piroxicam Manx Gel should be used with caution in patients who have a history of serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens Johnson syndrome or toxic epidermal necrolysis.

Life-threatening cutaneous reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the systemic administration of piroxicam.

These reactions have not been associated with topical piroxicam, but the possibility of occurring with topical piroxicam cannot be ruled out. Patients should be advised of the signs and symptoms and monitored closely for skin reactions.

The highest risk for occurrence of SJS or TEN is within the first weeks of treatment. g. progressive skin rash often with blisters or mucosal lesions) are present, piroxicam treatment should be discontinued. The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug.

Early withdrawal is associated with a better prognosis. If a patient has developed SJS or TEN with the use of piroxicam, piroxicam must not be restarted in this patient at any time. Cases of fixed drug eruption (FDE) have been reported with piroxicam.

Piroxicam should not be reintroduced in patients with history of piroxicam-related FDE. Potential cross reactivity might occur with other oxicams. Use with caution in patients with impaired hepatic function. Use with caution in patients with renal impairment.

NSAIDs, including piroxicam, may cause interstitial nephritis, nephrotic syndrome and renal failure. There have also been reports of interstitial nephritis, nephrotic syndrome and renal failure with topical piroxicam, although the causal relationship to treatment with topical piroxicam has not been established.

As a result, the possibility that these events may be related to the use of topical piroxicam cannot be ruled out. The label will include the following warnings: • Do not apply more of this medicine than the label tells you to • Not recommended for patients aged under 18 years • Use this medicine only on your skin • Do not use if you are pregnant or breastfeeding • Do not use if you are allergic to any of the ingredients or have experienced problems with aspirin, ibuprofen, piroxicam or related painkillers (including when taken by mouth) • Do not use if you have ever had a severe skin reaction after applying or taking any other medicines • Consult your doctor before use if you have asthma, active peptic ulcer or a history of liver or kidney problems • If the symptoms do not get better after 7 days or if they worsen, consult your doctor This medicine contains 150 mg propylene glycol in each 1 ¼ (3cm) application which is equivalent to 150 mg / 1 g of gel.

1. The potential exists for cross sensitivity to aspirin and other non-steroidal anti- inflammatory agents. Piroxicam Manx Gel should not be used in patients in whom aspirin and other non- steroidal anti-inflammatory agents induce the symptoms of asthma, nasal polyps, angioneurotic oedema or urticaria.

Third trimester of pregnancy.