Consumer medicine information

Feldene Gel

Piroxicam

BRAND INFORMATION

Brand name

Feldene Gel

Active ingredient

Piroxicam

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Feldene Gel.

What is in this leaflet

This leaflet answers some common questions about FELDENE Gel.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you using FELDENE Gel against the benefits they expect it will have for you.

If you have any concerns about using FELDENE Gel, ask your doctor or pharmacist.

Read this leaflet carefully before using FELDENE Gel and keep it with your medicine. You may need to read it again.

What FELDENE Gel is used for

FELDENE Gel is used to temporarily relieve the pain and inflammation associated with:

  • Sprains/Strains
  • Tendonitis.

FELDENE Gel belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDS). Although it can relieve the symptoms of pain and inflammation (heat, throbbing, swelling, redness), it will not cure the underlying tissue damage and it will not treat bruises. Feldene Gel is not a heat rub.

Your doctor or pharmacist may recommend FELDENE Gel for other purposes.

Before you use FELDENE Gel

When you must not use it

  1. Do not use FELDENE Gel if you have an allergy to:
  • piroxicam (the active ingredient in FELDENE Gel) or any of the ingredients listed at the end of this leaflet
  • other medicines containing piroxicam (Feldene, Feldene-D, Pirox, Mobilis, Candyl, Fensaid)
  • aspirin
  • any other medicine that is a NSAID.
    Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines.

If you are not sure if you are taking one of these medicines, ask your doctor or pharmacist.

Signs of an allergic reaction to these medicines may include

  • asthma, wheezing or shortness of breath
  • runny nose
  • nasal polyps (growths inside your nose)
  • swelling of the face, lips, or tongue which may cause difficulty in swallowing or breathing
  • hives, itching or skin rash
  • fainting.

If you are allergic to aspirin or NSAID medicines and use FELDENE Gel, these symptoms may be severe.

If you are not sure whether you should be using FELDENE Gel, talk to your doctor or pharmacist.

  1. Do not use FELDENE Gel if the expiry date marked on the packaging has passed, even though the gel may look alright.
  2. Do not use FELDENE Gel if the packaging is torn or shows signs of tampering
  3. Do not let children of 12 years and under use FELDENE Gel.
    There is not enough information to recommend the use of FELDENE Gel in children of this age group.
  4. Do not use on broken or infected skin.

Before you start to use it

You must tell your doctor or pharmacist if:

  1. You are allergic to any other medicines, foods, dyes or preservatives.
  2. You have any of these medical conditions, or have had them in the past:
  • stomach ulcers
  • bleeding from the bowel or stomach
  • asthma
  • kidney, liver or heart problems
  • raised blood pressure
  • swelling with fluid (oedema)
  • bleeding problems
  • inflammation of the intestines such as Crohn's disease.
  1. you are pregnant or breast feeding
    Like most NSAID medicines, FELDENE Gel is not recommended for use during pregnancy or breast feeding.
    NSAIDs have been associated with reversible infertility in some women. The use of NSAIDs in early pregnancy can increase the risk of spontaneous abortion.

Your doctor or pharmacist will discuss the risks and benefits of using it.

Taking other medicines

Tell your doctor or pharmacist if you are taking ANY other medicines, including any medicine you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines important to mention include:

  • aspirin and salicylates (e.g. Disprin, Aspro)
  • other NSAID medicines (e.g. Voltaren, Naprosyn)
  • warfarin, a medicine used to stop blood clots (e.g., Coumadin, Marevan)
  • methotrexate, a medicine used to treat arthritis and some cancers
  • phenytoin, a medicine used to treat epilepsy
  • certain antibiotics called sulphonamides
  • some medicines used to treat diabetes
  • lithium, a medicine used to prevent or treat certain mental health disorders
  • cimetidine, a medicine used to treat ulcers
  • frusemide, also known as a "fluid" tablet, is a medicine used to remove excess fluid from the body.

If you are not sure if you are taking any of the medicines mentioned in this leaflet, check with your doctor or pharmacist.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while using FELDENE Gel.

If you have not told your doctor or pharmacist about these things, tell them before you start using FELDENE Gel.

How to use FELDENE Gel

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information given in this leaflet.

How to apply the gel

Use the gel only on healthy skin. Do not put it on open wounds or injuries or on skin that has a rash or infection.

Rub in l g of the gel (approximately 3 cm or 1 and a quarter inches) to the sore or swollen area, 3 or 4 times a day.

It is important to rub the gel in completely, because any gel left on the skin may cause mild (but temporary) staining of the skin or clothes.

Wash your hands after each application.

Do not cover the affected area with a dressing or bandage

How long to use it

FELDENE Gel may be used for up to two weeks only.

If your symptoms do not improve after two weeks or get worse, stop using it and tell your doctor or pharmacist.

If you forget to use it

Use it as soon as you remember then go back to using it as you would normally.

Do not use twice as much to make up for what you have missed.

If you use too much (overdose)

If you, a child or anyone else, accidentally swallows FELDENE Gel, immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. Keep the telephone numbers for these places handy.

If used properly on your skin, there is little risk of overdosage with this medicine.

While you are using FELDENE Gel

Things you must do

If you become pregnant while using FELDENE Gel, tell your doctor or pharmacist immediately.

Tell all doctors, dentists and pharmacists you visit that you are using FELDENE Gel.

If you are about to start any new medicines, tell your doctor or pharmacist that you are using FELDENE Gel.

Things you must not do

Do not let the gel get in your eyes. If this happens, rinse your eyes with clean water and tell your doctor or pharmacist.

Do not put it inside the mouth or vagina.

Never swallow the gel.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not use FELDENE Gel to treat any other medical complaints unless your doctor or pharmacist says you can.

Side effects

Tell your doctor or pharmacist as soon as possible if you have any problems while using FELDENE Gel, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like all medicines, FELDENE Gel may cause some side effects. However, very little of the active ingredient passes into the blood stream; if side effects do occur, most are likely to be minor and temporary.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • mild itching, redness, swelling, blistering or dermatitis of the skin in the treated area.

Mild skin irritation may occur where the gel was applied.

Tell your doctor or pharmacist immediately if you notice any of the following:

  • feeling sick (nausea)
  • indigestion
  • stomach pain.

If any of the following happen, STOP using Feldene Gel and tell your doctor or pharmacist immediately or go to Accident and Emergency at your nearest hospital:

  • swelling of the face, lips or tongue which may cause difficulty swallowing or breathing
  • asthma, wheezing or shortness of breath
  • sudden or severe itching, skin rash, or hives over larger areas of skin.

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects have been reported very rarely when the active ingredient in FELDENE has been taken by mouth as tablets or capsules.

Other side effects not listed above may also occur in some patients. Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Do not be alarmed by the list of possible side effects. You may not experience any of them.

After using FELDENE Gel

Storage

Keep FELDENE Gel where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep FELDENE Gel in a cool, dry place where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills

Heat and dampness can destroy some medicines.

Always replace the cap after use.

Disposal

If your doctor or pharmacist tells you to stop using FELDENE Gel, or the expiry date has passed, ask your pharmacist what to do with any leftover gel.

Product description

What it looks like

FELDENE Gel is a clear, pale yellow gel. It comes in tubes of 25 grams or 50 grams.

Ingredients

The active ingredient of FELDENE Gel is piroxicam. There are 5 mg of piroxicam in each gram of gel.

The inactive ingredients are:

  • benzyl alcohol
  • carbomer 980
  • di-isopropanolamine
  • ethanol
  • hydroxyethy1cellulose
  • propylene glycol
  • water.

Sponsor

Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
AUSTRALIA

Toll Free Number: 1800 675 229

Australian Registration Number

  • AUST R 49700

This leaflet was updated in May 2013.

®Registered Trademark

© Pfizer Australia Pty Ltd 2013.

BRAND INFORMATION

Brand name

Feldene Gel

Active ingredient

Piroxicam

Schedule

Unscheduled

 

Name of the medicine

Piroxicam.

Excipients

Carbomer 980, propylene glycol, ethanol, benzyl alcohol, di-isopropanolamine, hydroxyethylcellulose and purified water.

Description

Chemical name: 4-hydroxy-2-methyl-N-(pyridin-2-yl)-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide. Molecular formula: C15H13N3O4S. MW: 331.4. CAS: 36322-90-4. Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID) of the chemical class N-heterocyclic carboxamides of 1,2-benzothiazine-1,1-dioxide. Piroxicam is an amphoteric compound. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.5) as determined by ultraviolet absorption spectrophotometry in methanol/water (2.5/97.5, v/v) solvent medium. It occurs as a white to off white, crystalline solid, poorly soluble in water, dilute acid and most organic solvents. It is slightly soluble in alcohols and in aqueous alkaline solution. It is a hygroscopic solid which melts in the range 196 to 200°C.

Pharmacology

Pharmacodynamics.

Piroxicam is a NSAID which also possesses analgesic and antipyretic properties. While its mode of action is not fully understood, independent studies in vitro as well as in vivo have shown that piroxicam interacts at several steps in the immune and inflammation responses through the following mechanisms: inhibition of prostanoid synthesis, including prostaglandins, through a reversible inhibition of the cyclooxygenase enzyme; inhibition of neutrophil aggregation in blood vessels; inhibition of lysosomal enzyme release from stimulated leucocytes; inhibition of polymorphonuclear cell and monocyte migration to the area of inflammation; inhibition of superoxide anion generation by the neutrophil; and reduction of both systemic and synovial fluid rheumatoid factor production in patients with seropositive rheumatoid arthritis.
Piroxicam has been shown to inhibit chemotaxis of polymorphonuclear leucocytes and the migration of leucocytes in canine synovitis test. The drug also inhibits collagen induced platelet aggregation. It is established that piroxicam does not act by pituitary adrenal axis stimulation. Studies in vitro have not revealed any negative effect on cartilage metabolism.

Pharmacokinetics.

Pharmacokinetic and tissue distribution studies in rats and dogs have shown that piroxicam 0.5% gel is continuously and gradually released from the skin to underlying muscle or synovial fluid. In addition, equilibrium between skin and muscle or synovial fluid appears to be reached rapidly, within a few hours after application.
In human pharmacokinetic studies, when a dose of piroxicam 15 mg as Feldene 0.5% Gel was applied topically to intact skin of the backs of 8 normal volunteers and any residue removed after 8 hours, serum concentrations rose steadily to a mean of 147 picogram/L 23 hours after application, a peak level about 1/15 of that following an equivalent oral dose. The elimination half-life was about 50 hours and most drug was recovered as the inactive 5-hydroxy metabolite.
Furthermore, following repeated topical applications of Feldene 0.5% Gel (piroxicam 20 mg/day) to 20 normal volunteers for 14 consecutive days, it was estimated that the quantity of piroxicam bioavailable by the transdermal route represented 3% of oral bioavailability at equivalent dosage. Use of an occlusive dressing appeared to increase the bioavailability.

Indications

Feldene 0.5% Gel is indicated for the temporary (up to two weeks) topical treatment of acute soft tissue injuries including sprains, strains and tendonitis.

Contraindications

Feldene Gel should not be used in those patients who have previously shown a hypersensitivity to the gel or piroxicam in any of its dosage forms; or in whom a hypersensitive reaction(s) (e.g. asthma, rhinitis, nasal polyps, angioedema or urticaria) has been precipitated by aspirin or other NSAIDs, since cross sensitivity exists.

Precautions

Gastrointestinal effects.

In common with other topical NSAIDs, the systemic absorption of Feldene Gel is very low and systemic reactions occur infrequently. They 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.
Feldene Gel should be used with extreme caution in patients with a peptic ulcer, active gastrointestinal bleeding or active inflammatory disease of the gastrointestinal tract or with a recent history of these conditions or severe renal impairment.

Local irritation.

If local irritation develops, the use of Feldene Gel should be discontinued and appropriate therapy instituted as necessary. Do not apply to the eyes or other mucosal surfaces. Do not apply Feldene Gel to broken skin, infected sites, exudative dermatoses or other open skin lesions, or skin conditions affecting the site of application.

Skin reactions.

NSAIDs, including systemically administered piroxicam, may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), which can be fatal and occur without warning. These reactions have not been associated with topical piroxicam, but the possibility of occurring with topical piroxicam cannot be ruled out. These serious adverse events are idiosyncratic and are independent of dose or duration of use. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Piroxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity, and must not be restarted in this patient at any time. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of a skin rash, mucosal lesion or any other sign of hypersensitivity.

Renal effects.

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.

Effects on 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.

Use in pregnancy.

(Category C)
Inhibition of prostaglandin synthesis might adversely affect pregnancy. 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 preimplantation and postimplantation loss.
NSAIDs given during the latter part of pregnancy, may cause closure of the foetal ductus arteriosus, prolong labour and delay birth. Continuous treatment with NSAIDs during the last month of pregnancy should be given only on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided.
Although no teratogenic effects were seen in animal testing, Feldene Gel should not be used in pregnant women or those likely to become pregnant unless the expected benefits outweigh the potential risk.

Use in lactation.

Studies in 6 women treated for up to 52 days have shown that piroxicam appeared in breast milk in a concentration approximately 1% to 3% of that reached in maternal plasma.
Feldene is not recommended for nursing mothers unless the expected benefits outweigh any potential risk, as clinical safety has not been demonstrated.

Paediatric use.

The use of Feldene in children under the age of 12 years is not recommended as safety and efficacy in this age group are not established.

Preclinical safety data.

Acute and chronic toxicity and irritation studies have been carried out in animals. In an acute study, albino rats were given a single dermal application of gel of 5 g/kg. No deaths, toxic signs or skin irritation were observed and no gross changes were found at autopsy.
In a one month study, albino rats received a daily application of gel to dorsal skin of 1 g per rat. No skin irritation was noted at the treatment sites, and no drug related changes were observed. The gel was also evaluated for primary skin irritation, eye irritation, and phototoxicity in rabbits and for photoallergy and skin sensitisation potential in guinea pigs, all according to standard established protocols. No skin reactions were found after application of 0.5% gel or the vehicle to intact rabbit skin, however piroxicam gel produced slight erythema and oedema on abraded skin.
The anti-inflammatory and analgesic effects of Feldene 0.5% Gel were studied in rats and guinea pigs using such standard models of pain and inflammation as carrageenan induced rat paw oedema, ultraviolet erythema in guinea pigs, traumatic oedema in rats, cotton pellet induced granuloma formation in rats and adjuvant induced arthritis in cats. Feldene 0.5% Gel was comparable to indomethacin 1% gel in all of these models and was comparable to orally administered piroxicam in inhibiting inflammation of the rat paw oedema model.
Oedema, erythema, tissue proliferation, fever and pain can all be inhibited in laboratory animals by the administration of Feldene Gel.

Interactions

The following discussion describes the potential for systemically administered piroxicam to interact with other medications. Interactions between Feldene Gel and other drugs have not been specifically studied.

Anticoagulants.

The concurrent use of NSAIDs and coumarin anticoagulants (including warfarin) has been associated with severe, sometimes fatal, haemorrhage. The exact mechanism of the interaction between warfarin and NSAIDs is unknown, but may involve enhanced bleeding from NSAID induced gastrointestinal ulceration, or an additive effect of anticoagulation by warfarin and inhibition of platelet function by NSAIDs. These effects should be considered and patients monitored closely when anticoagulants are being used. Warfarin should be used in combination with piroxicam only if necessary.
Piroxicam is highly protein bound and therefore might be expected to displace other protein bound drugs. The physician should closely monitor dosage requirements of coumarin anticoagulants and other drugs that are highly protein bound when these are administered concomitantly with piroxicam. Such drugs include warfarin, phenytoin, sulphonamides and sulphonylureas.

Methotrexate.

Extreme care should also be exercised in giving methotrexate to patients using piroxicam, because lethal interactions have been reported between NSAIDs and methotrexate.

Aspirin.

As with other NSAIDs, the use of piroxicam in conjunction with aspirin or the concomitant use of two NSAIDs is not recommended because data are inadequate to demonstrate that the combination produces greater benefit than with the drug alone and the potential for adverse reactions is increased.
Plasma levels of piroxicam are depressed to approximately 80% of their normal values when piroxicam is administered systemically in conjunction with aspirin (3900 mg/day) but concomitant administration of antacids has no effect on piroxicam plasma levels.

Lithium.

NSAIDs including piroxicam have been shown to decrease the renal clearance and increase steady-state plasma concentrations of lithium. Plasma lithium concentrations should be monitored when initiating, adjusting or discontinuing concurrent piroxicam therapy.

Cimetidine.

Results of two separate studies indicate a slight increase in absorption of orally administered piroxicam following cimetidine administration but no significant changes in elimination parameters. Cimetidine increases the area under the curve (AUC 0-120 hours) and Cmax of piroxicam by approximately 13 to 15%. Elimination rate constants and half-life show no significant differences. The small but significant increase in absorption is unlikely to be clinically significant. It is not known what effect the concurrent administration of cimetidine has on the pharmacokinetics of topically administered piroxicam.

Cholestyramine.

Cholestyramine has been shown to enhance the oral clearance and decrease the half-life of systemically administered piroxicam. To minimise this interaction, it is prudent to administer piroxicam at least 2 hours before or 6 hours after cholestyramine.

Frusemide.

As with other NSAIDs, care should be taken in the administration of piroxicam in combination with frusemide for treating cardiac failure because NSAIDs antagonise the diuretic effect of frusemide.

Diuretics and other antihypertensives.

Systemically administered NSAIDs can reduce the efficacy of diuretics and other antihypertensive drugs.
In patients with impaired renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the coadministration of an ACE inhibitor or an angiotensin II antagonist with a cyclooxygenase inhibitor can increase the deterioration of renal function, including the possibility of acute renal failure, which is usually reversible. Therefore the concomitant administration of these drugs should be done with caution, especially in elderly patients. Patients should be adequately hydrated and the need to monitor renal function should be assessed in the beginning of the concomitant treatment and periodically thereafter.

Digoxin.

Concomitant systemic administration of NSAIDs with digoxin may increase plasma digoxin levels.

Corticosteroids or selective serotonin reuptake inhibitors (SSRIs).

Concomitant systemic administration of NSAIDs and corticosteroids or selective serotonin reuptake inhibitors (SSRIs) increases the risk of gastrointestinal ulceration or bleeding.

Cyclosporin or tacrolimus.

Concomitant systemic administration of NSAIDs with cyclosporin or tacrolimus increases the risk of nephrotoxicity.

Adverse Effects

Side effects possibly related to treatment with Feldene Gel have been reported infrequently. In clinical trials the vast majority of side effects involved mild or moderate local irritation, erythema, rash, pityroid desquamation, pruritus and related local reactions at the application site. Mild but transient skin discolouration and staining of clothing have been noted when the gel is not rubbed in completely.
In postmarketing experience, the following additional dermatological effects have been reported: contact dermatitis, eczema and photosensitivity skin reaction.
The systemic absorption of Feldene 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.
Photoallergic reactions have been infrequently associated with systemic administration of Feldene.

Dosage and Administration

Feldene Gel at a dosage of 1 g, approximately 3 cm linear (corresponding to 5 mg of piroxicam), should be applied to the affected site three or four times per day for up to two weeks. Feldene Gel is intended for external use only. No occlusive dressing should be employed. Rub in the gel leaving no residual material on the skin.

Overdosage

Insufficient human data are available to fully assess the toxicity following acute overdosage.

Signs and symptoms.

Mild symptoms of lethargy, drowsiness and gastrointestinal upset have been reported following acute overdosage with systemically administered piroxicam. Rarely severe overdose may cause hypotension, coma, respiratory depression, gastrointestinal bleeding or acute renal insufficiency. Low grade fever and sinus tachycardia have been reported following NSAID overdose. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following overdose.

Treatment of overdosage.

In the event of overdosage (e.g. accidental ingestion) with Feldene Gel, supportive and symptomatic therapy is indicated. Studies indicate that administration of activated charcoal may result in reduced absorption and reabsorption of piroxicam thus reducing the total amount of active drug available. Activated charcoal is most effective when administered within 1 hour of ingestion. In patients who are not fully conscious or who have an impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube once the airway is protected. Haemodialysis, forced diuresis or haemoperfusion are probably ineffective in enhancing elimination, since the drug is highly protein bound. There appears to be no indication for alkalinisation of the urine.
In the case of accidental ingestion, seek professional advice or contact the Poisons Information Centre (Australia 131 126) for advice on the management of an overdose. Do this even if there are no signs of discomfort or poisoning.

Presentation

Gel, 5 mg/g (≡ 0.5% anhydrous piroxicam by weight) (pale yellow, clear): 25 g, 50 g (tube).

Storage

Store below 30°C.

Poison Schedule

Unscheduled.