Document: spc-doc_PL 40378-0179 change

• spc-doc_PL 14251-0001
• spc-doc_PL 40378-0179

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Piroxicam 0.5% w/w Gel

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Piroxicam 0.5% w/w

Each gram of gel contains 5 mg of piroxicam.

Excipients with known effect

Each gram of gel contains 150 mg propylene glycol

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Gel for topical application Transparent light yellow gel

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Piroxicam Gel is a non-steroidal anti-inflammatory agent used for the treatment of a variety of conditions characterised by pain and inflammation or stiffness.

It is effective in the treatment of osteoarthritis of superficial joints, such as knee, acute musculo-skeletal injuries, periathritis, epicondylitis, tendonitis and tenosynovitis.

4.2 Posology and method of administration

Paediatric population

The safety and efficacy of Piroxicam Gel in children aged less than 12 years has not been established.

Adults: Piroxicam Gel is for external use only. No occlusive dressings should be employed. Apply 1 g of gel, corresponding to 3 cm, and rub into the affected site three to four times daily leaving no residual material on the skin. Therapy should be reviewed after 4 weeks.

Use in the Elderly : No special precautions are required

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Piroxicam gel should not be used in those patients who have previously shown a sensitivity to the gel or to piroxicam in any of its forms.

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

4.4 Special warnings and precautions for use

Life-threatening cutaneous reactions (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 excluded.

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.

If symptoms or signs of SJS or TEN (e.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 the patient has developed SJS or TEN with the use of piroxicam, piroxicam must not be re-started in this patient at any time.

If local irritation develops, the use of the Gel should be discontinued. Appropriate therapy should be instituted as necessary.

Keep away from the eyes and mucosal surfaces. Do not apply to any sites affected by open skin lesions, dermatoses or infection.

Use with care in patients with impaired hepatic function.

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.

Use with care in patients with renal impairment.

4.5 Interaction with other medicinal products and other forms of interaction

The potential exists for cross-sensitivity to aspirin and other non-steroidal antiinflammatory agents.

4.6 Fertility, pregnancy and lactation

Pregnancy

Inhibition of prostaglandin synthesis might adversely affect pregnancy. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and postimplantation loss. Therefore, the use of Piroxicam Gel during pregnancy is not recommended.

Breastfeeding

Piroxicam Gel is not recommended for use in nursing mothers as clinical safety has not been established.

Fertility

Based on the mechanism of action, the use of NSAIDs, including piroxicam may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including piroxicam should be considered.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Piroxicam Gel is well tolerated. Mild to moderate local irritation, erythema, pruritus and dermatitis may occur at the application site. The systemic absorption of Piroxicam Gel is very low. In common with other topical NSAIDs, systemic reactions occur infrequently and have included minor gastrointestinal 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 (See also section 4.3).

Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported very rarely (see section 4.4).

Contact dermatitis, eczema and photosensitivity skin reaction have also been observed from post-marketing experience.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

Overdose is unlikely to occur with this topical preparation.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory preparations, non-steroids for topical use

ATC code: M02AA07

Piroxicam is a non-steroidal anti-inflammatory agent useful in the treatment of inflammatory conditions. Although the mode of action for this agent is not precisely understood, piroxicam inhibits prostaglandin synthesis and release through a reversible inhibition of the cyclo-oxygenase enzyme. Data on the anti-inflammatory and analgesic effects of piroxicam gel compared with its vehicle and indomethacin 1% gel in rats and guinea pigs, Using established animal models of pain and inflammation, has shown piroxicam gel to be as effective as oral piroxicam and indomethacin 1% gel and significantly more effective than its vehicle.

5.2    Pharmacokinetic properties

On the basis of various pharmacokinetic and tissue distribution studies in animals, with piroxicam 0.5 % gel, the highest concentrations of piroxicam were achieved in tissues below the site of application with low concentrations being reached in the plasma. Piroxicam 0.5% gel was continuously and gradually released from the skin to underlying tissues, equilibrium between skin, and muscle or synovial fluid appeared to be reached rapidly, within a few hours of application.

From a pharmacokinetic study in man, 2 g of gel was applied to the shoulders of normal volunteers twice daily (corresponding to 20 mg piroxicam/day) for 14 days, plasma levels of piroxicam rose slowly, reaching steady state after about 11 days. The plasma levels at this time were between 300-400 ng/ml, or one-twentieth of those observed in subjects receiving 20 mg orally.

The serum half-life of piroxicam is approximately 50 hours.

5.3    Preclinical safety data

None stated.

6.1 List of excipients

Propylene glycol Isopropyl alcohol,

Macrogol 7 glycerol cocoate Hypromellose Sodium hydroxide Sodium metabisulphite Potassium dihydrogen phosphate Purified water.

6.2 Incompatibilities

None known.

6.3 Shelf life

Unopened: 36 months

After opening: 6 months

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

Aluminium tubes incorporating epoxy phenol internal lacquer with a membrane fitted with a polypropylene cap containing either 50g, 60g, 100g, or 112g of Piroxicam 0.5% w/w Gel.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements

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