RELIVIATE ACHES AND JOINT PAIN RELIEF 0.5%W/W GEL, PIROXICAM MANX 0.5%W/W GEL - summary of medicine characteristics

Summary of medicine characteristics - RELIVIATE ACHES AND JOINT PAIN RELIEF 0.5%W/W GEL, PIROXICAM MANX 0.5%W/W GEL

SUMMARY OF PRODUCT CHARACTERISTICS1 NAME OF THE MEDICINAL PRODUCTSUMMARY OF PRODUCT CHARACTERISTICS1 NAME OF THE MEDICINAL PRODUCT

Piroxicam Manx 0.5%w/w Gel

Reliviate Aches and Joint Pain Relief 0.5%w/w Gel

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Piroxicam gel 0.5% w/w

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Topical Gel

4. CLINICAL PARTICULARS

4.1. Therapeutic Indications

For the local symptomatic relief of pain and stiffness accompanying non-serious arthritic conditions; and pain or swelling accompanying sprains, strains and sports injuries.

4.2 Posology and method of administration

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

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The potential exists for cross sensitivity to aspirin and other nonsteroidal 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.

4.4. Special warnings and precautions for use

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 (Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) have been reported with the systemic administration of piroxicam and very rarely in the case of topical piroxicam.

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 a patient has developed SJS or TEN with the use of piroxicam, piroxicam must not be restarted in this patient at any time.

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

4.5. Interactions with other medicinal products and other forms of interaction

Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically administered preparation is extremely remote. Where aspirin or other NSAID tablets are taken concurrently, it is important to bear in mind that these may increase the incidence of undesirable effects.

4.6. Fertility, pregnancy and lactation

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.

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 post-implantation loss. Therefore, the use of Piroxicam 0.5%w/w Gel during pregnancy is not recommended.

Breast-feeding

Piroxicam 0.5%w/w Gel is not recommended for use in nursing mothers as clinical safety has not been established.

4.7 Effects on ability to drive and use machines

There should be no effect on the patient’s ability to drive and use machinery.

4.8. Undesirable effects

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.

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

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.

PHARMACOLOGICAL PROPERTIESPHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

ATC Code: M02A A07

Piroxicam is a cyclo-oxygenase (COX) inhibitor which has anti-inflammatory effects, in addition to having anti-pyretic and analgesic effects. Piroxicam’s main mechanism of action is by inhibition of the enzyme cyclo-oxygenase in the arachidonic acid metabolism pathway, resulting in reduced prostaglandin synthesis. Piroxicam inhibits prostaglandin (thromboxane) synthesis in the platelet, and thus inhibits the secondary phase of platelet aggregation.

5.2 Pharmacokinetic properties

Pharmacokinetic and tissue distribution studies have shown that the highest levels of piroxicam were achieved in tissues below the site of application with low levels in the plasma. A study in healthy human volunteers has shown that plasma concentrations following repeated topical application of a piroxicam 5% gel are about 5% of the level observed after equivalent doses of oral or intramuscular piroxicam.

5.3 Preclinical safety data

It is generally accepted that topical NSAID therapy provides a safer means of drug delivery than conventional routes. Clinical trials and post-marketing experience suggest that topical piroxicam is well-tolerated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Propylene glycol

isopropyl alcohol

macrogol 7 glyceryl cocoate hypromellose, sodium hydroxide sodium metabisulphite (E223) potassium dihydrogen phosphate purified water.

6.2 Incompatibilities

None known.

6.3 Shelf life

Three (3) years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Aluminium tubes with a polypropylene cap containing 30 g.

6.6 Special precautions for disposal

Apply 1 g of the gel (about 3 cms or 11/4 inches) and rub into the affected area.

Apply to three or four times a day. Occlusive dressings should not be used.

7 MARKETING AUTHORISATION HOLDER

Manx Healthcare Limited

Taylor Group House

Wedgnock Lane

Warwick

CV34 5YA

8 MARKETING AUTHORISATION NUMBER(S)

PL 14251/0028