Consumer medicine information

Feldene; Feldene-D

Piroxicam

BRAND INFORMATION

Brand name

Feldene-D

Active ingredient

Piroxicam

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Feldene; Feldene-D.

SUMMARY CMI

FELDENE®; FELDENE-D®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using FELDENE?

FELDENE contains the active ingredient piroxicam. FELDENE is used to treat the symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, a chronic inflammatory rheumatic disorder that primarily affects, but is not limited to, the spine.

For more information, see Section 1. Why am I using FELDENE? in the full CMI.

2. What should I know before I use FELDENE?

Do not use if you have ever had an allergic reaction to FELDENE, if you have any active inflammatory disease or ulcers, if you have any kidney, liver or heart problems,any other medicine containing piroxicam, aspirin or medicines known as NSAIDs or any of the ingredients listed at the end of the CMI.

Do not take FELDENE if you are pregnant in your third trimester of pregnancy, or you are breastfeeding. If you are pregnant at any stage, please speak to your doctor first about this medicine.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use FELDENE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with FELDENE and affect how it works. Examples of such medicines include aspirin or other NSAIDs, warfarin, digoxin, medicine for diabetes or epilepsy or depression, certain antibiotics, diuretics, medicine for blood pressure or cholesterol and alcohol. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use FELDENE?

The usual dose of FELDENE is between 10 mg and 20 mg, taken as a single dose each day. However, depending on your condition and how you react to the medicine, your doctor may ask you to take some other dose.

More instructions can be found in Section 4. How do I use FELDENE? in the full CMI.

5. What should I know while using FELDENE?

Things you should do
  • If you become pregnant while taking FELDENE, tell your doctor immediately.
  • If you get an infection while taking FELDENE, tell your doctor.
  • Tell all doctors, dentists and pharmacists who are treating you that you are taking FELDENE.
Things you should not do
  • Do not give FELDENE to anyone else, even if they have the same condition as you.
  • Do not take FELDENE to treat any other complaints unless your doctor tells you to.
Driving or using machines
  • Be careful driving or operating machinery until you know how FELDENE affects you.
  • As with other NSAID medicines, FELDENE may cause dizziness, drowsiness or blurred vision
Drinking alcohol
  • Alcohol may interfere with FELDENE and may affect how well it works. Ask your doctor or pharmacist for more information.
Looking after your medicine
  • Keep them in a cool, dry place where the temperature stays below 30°C.
  • Keep your capsules or tablets where young children cannot reach them.

For more information, see Section 5. What should I know while using FELDENE? in the full CMI.

6. Are there any side effects?

All medicines can have side effects. Sometimes they are serious, most of the time they are not. Some of the common side effects are upset stomach (nausea or vomiting, cramps), diarrhoea or constipation, dizziness or lightheaded-ness, headache. Some side effects may be serious and need medical attention. If you experience serious allergic reaction, vomiting blood or see blood in stool, fainting or chest tightness/pain, go to Emergency at your nearest hospital immediately. If you are over 65 years of age, you may have an increased chance of getting side effects.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

FELDENE®; FELDENE-D®

Active ingredient(s): Piroxicam (pir-oks-i-kam)


Consumer Medicine Information (CMI)

This leaflet provides important information about using FELDENE. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using FELDENE.

Where to find information in this leaflet:

1. Why am I using FELDENE?
2. What should I know before I use FELDENE?
3. What if I am taking other medicines?
4. How do I use FELDENE?
5. What should I know while using FELDENE?
6. Are there any side effects?
7. Product details

1. Why am I using FELDENE?

FELDENE contains the active ingredient piroxicam. FELDENE belongs to a group of medicines called Non-Steroidal Anti-inflammatory Drugs (NSAIDs). These medicines work by relieving pain and inflammation (heat, throbbing, swelling, redness).

FELDENE is used to treat the symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, a chronic inflammatory rheumatic disorder that primarily affects, but is not limited to, the spine.

Although FELDENE can relieve the symptoms of pain and inflammation, it will not cure your condition.

Your doctor may have prescribed FELDENE for another reason.

Ask your doctor if you have any questions about why FELDENE has been prescribed for you.

2. What should I know before I use FELDENE?

Warnings

Do not use FELDENE if:

  1. You are allergic or hypersensitive to:
  • Piroxicam (the active ingredient in FELDENE) or any of the capsule or tablet ingredients listed at the end of this leaflet (see Product Description), or other medicines containing piroxicam.
  • Aspirin
  • Any other medicine that is also an NSAID
    Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines.
  1. You are taking aspirin or any other medicine that is also an NSAID
  2. You have had a severe allergic reaction to any medicine in the past, especially skin reactions
  3. You have had a skin reaction to piroxicam in the past
  4. You have a gastric ulcer (i.e. stomach or duodenal ulcer), a recent history of one, or have had gastric ulcers before
  5. You have or have had inflammation and/or ulceration of the lining of the stomach or bowel
    Some examples of these conditions include Crohn's disease and ulcerative colitis
  6. You have severe kidney disease
  7. You have severe heart failure
  8. You have severe liver failure
  9. You are about to have or have had recent coronary artery bypass surgery
  10. You are in your third trimester of pregnancy or are breastfeeding

Do not give FELDENE to children of 12 years and under.

The safety and effectiveness of FELDENE in this age group have not been established.

If you are not sure whether you should be taking FELDENE, contact your doctor.

Do not take FELDENE if the packaging is torn or shows signs of tampering.

Do not take FELDENE if the expiry date (EXP) printed on the pack has passed.

Tell your doctor if:

  • You have any allergies to:
    - Any other medicines including aspirin or other NSAID medicines
    - Any other substances, such as foods, preservatives or dyes.
  • If you have or have had any of the following medical conditions
    - Heartburn, indigestion, stomach ulcers or other stomach problems
    - Bowel or intestinal problems
    - Asthma
    - Kidney disease
    - Liver disease
    - Heart failure
    - Heart disease
    Use of FELDENE may increase your risk of developing a heart condition such as heart attack even if you don't have a history of heart disease.
    - High blood pressure
    - Swelling of the ankles or feet (oedema)
    - A tendency to bleed
  • You currently have an infection
    If you take FELDENE while you have an infection, it may hide some of the signs of an infection (e.g. pain, fever, swelling or redness). This may make you think, mistakenly, that you are better or that it is not serious.

If you have not told your doctor or pharmacist about any of the above, tell them before you start to take FELDENE.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Do not take FELDENE if you are pregnant, or intend on becoming pregnant, unless your doctor says otherwise.

FELDENE is not to be used at all during the third trimester of pregnancy.

FELDENE should not be used during the first two trimesters of pregnancy unless the expected benefits to the mother outweigh the risks to the baby. Seek advice from your doctor.

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 will discuss the risks and benefits of taking FELDENE during pregnancy.

Tell your doctor if you are breast-feeding or plan to breast-feed.

FELDENE is not to be used during breastfeeding.

Like most NSAID medicines, the active ingredient in FELDENE passes into breast milk and may affect your baby.

3. What if I am taking other medicines?

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

Some medicines may interfere with FELDENE and affect how it works. These include:

  • Aspirin (including low doses used to prevent your blood from clotting in certain heart conditions), salicylates or other NSAIDs
  • Warfarin or similar medicines including Eliquis, Xarelto or Pradaxa that are used to stop blood clots
  • Digoxin or digitoxin, medicines used to treat heart failure
  • Tablets used to treat diabetes
  • Certain antibiotics called sulphonamides
  • Phenytoin, a medicine used to treat epilepsy
  • Lithium, a medicine used to treat some types of depression
  • Selective serotonin reuptake inhibitors, medicines used to treat depression
  • Corticosteroids, medicines used to suppress the immune system or reduce inflammation
  • Methotrexate, a medicine used to treat arthritis and some cancers
  • Diuretics, also called fluid or water tablets
  • Medicines used to treat high blood pressure
  • Colestyramine, a medicine used to reduce cholesterol.
  • Alcohol

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect FELDENE.

4. How do I use FELDENE?

How much to take

  • The usual dose is between 10 mg and 20 mg, taken as a single dose each day.
  • Follow the instructions provided and use FELDENE until your doctor tells you to stop.

When and how long to take FELDENE

  • Try to take your FELDENE at the same time each day, either morning or evening.
  • It is best to take FELDENE immediately after food to avoid the chance of an upset stomach.
  • Keep taking FELDENE every day until your doctor tells you to stop
  • You may need to take FELDENE for a long time

If you need to take FELDENE for a long time, see your doctor for regular check-ups so that he/she can monitor your condition and treatment.

How to take FELDENE

Swallow the capsules whole with water.

If you are taking the dispersible tablets (FELDENE-D), allow the tablet to dissolve in a glass of water and then drink it straight away.

If you forget to use FELDENE

FELDENE should be used regularly at the same time each day.

If it is almost time for your next dose (e.g. within 2 or 3 hours), skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, check with your doctor or pharmacist.

If you use too much FELDENE

If you take too much FELDENE, you may feel sick or have stomach pain, vomiting, headache, dizziness, drowsiness and confusion. You may need urgent medical attention.

You should immediately:

  • Phone the Poisons Information Centre
    (by calling 13 11 26), or
  • Contact your doctor, or
  • Go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using FELDENE?

Things you should do

  • If you become pregnant while taking FELDENE, tell your doctor immediately.
  • If you are about to start any new medicines, tell your doctor and pharmacist that you are taking FELDENE.
  • Tell all doctors, dentists and pharmacists who are treating you that you are taking FELDENE.
  • If you are going to have surgery, including dental surgery, tell your doctor or dentist that you are taking FELDENE.
  • FELDENE can slow down blood clotting. If you get an infection while taking FELDENE, tell your doctor.
    FELDENE may hide some of the signs of an infection (e.g. pain, fever, redness, swelling). You may think, mistakenly, that you are better or that the infection is not serious.

Things you should not do

  • Do not give FELDENE to anyone else, even if they have the same condition as you.
  • Do not take FELDENE to treat any other complaints unless your doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how FELDENE affects you.

As with other NSAID medicines, FELDENE may cause dizziness, drowsiness or blurred vision in some people.

If this happens, do not drive or do things that could be dangerous if you are not alert.

Drinking alcohol

Tell your doctor if you drink alcohol.

Be careful of drinking alcohol whilst taking FELDENE. As with other NSAIDs medicines, alcohol may increase your risk of developing stomach problems.

Looking after your medicine

  • Keep your capsules or tablets in their pack until it is time to take them.
  • Keep them in a cool, dry place where the temperature stays below 30°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • In the bathroom or near a sink, or
  • In the car or on window sills.

Do not use this medicine after the expiry date.

Keep it where young children cannot reach it.

When to discard your medicine

If your doctor tells you to stop taking FELDENE, or the capsules or tablets have passed their expiry date, ask your pharmacist what to do with any left over.

6. Are there any side effects?

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

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

If you are over 65 years of age, you may have an increased chance of getting side effects. Ask your doctor or pharmacist if you have any further questions about side effects.

Common side effects

Common side effectsWhat to do
Gastrointestinal related:
  • Stomach upset including nausea (feeling sick), vomiting
  • heartburn, indigestion, cramps
  • Loss of appetite
  • Constipation
  • Diarrhoea
  • Pain in the stomach
  • Wind
Alertness and sleep:
  • Dizziness
  • Light-headedness
  • Drowsiness, sleepiness
Aches and pains:
  • Headache
  • Sore mouth or tongue
Other
  • Buzzing or ringing in the ears
  • Hair loss or thinning
  • Loose nails
  • Change in mood, for example depression.
Speak to your doctor if you have any of these side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Call your doctor immediately:
Gastrointestinal symptoms:
  • Severe pain or tenderness in the stomach
Skin related symptoms:
  • Bleeding or bruising more easily than normal, reddish or purple blotches under the skin
  • Yellowing of the skin and eyes, also called jaundice
  • Symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal
Other:
  • Visual disturbances such as blurred vision
  • Severe dizziness, spinning sensation
  • Increase in blood pressure
  • Fast or irregular heartbeat, also called palpitations
  • Difficulty hearing, deafness
  • Signs of frequent or worrying infections such as fever, severe chills, sore throat or mouth ulcers
  • Signs of anaemia such as tiredness, being short of breath and looking pale
  • Unusual weight gain, swelling of ankles or legs
Seek Emergency medical attention:
  • Vomiting blood or material that looks like coffee grounds
  • Bleeding from your back passage (rectum), black sticky motions (stools) or bloody diarrhoea
  • Swelling of the face, lips or tongue which may make swallowing or breathing difficult
  • Asthma, wheezing, shortness of breath
  • Sudden or severe itching, skin rash, hives
  • Fainting
  • Pain or tightness in the chest
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What FELDENE contains

Active ingredient
(main ingredient)
Piroxicam (10 mg or 20 mg)
Other ingredients
(inactive ingredients)

FELDENE capsules also contain:

  • Lactose monohydrate
  • Maize starch
  • Magnesium stearate
  • Sodium lauryl sulfate
  • Gelatin
  • Erythrosine
  • Titanium dioxide
  • Brilliant blue FCF (133) (10 mg only)

FELDENE-D dispersible tablets also contain:

  • Lactose monohydrate
  • Cellulose
  • Hydroxypropyl cellulose
  • Sodium stearylfumarate
Potential AllergensFeldene contains sugars (as lactose)

Do not take this medicine if you are allergic to any of these ingredients.

What FELDENE looks like

FELDENE capsules are available as:

  • FELDENE 10 mg - blue/red, marked FEL10 on one side and Pfizer on the other. (Aust R 47656)

FELDENE-D dispersible tablets are available as:

  • FELDENE-D 20 mg - white, oblong, scored, capsule-shaped, marked FEL/20 on one side and plain on the other. (Aust R 37312).

Who distributes FELDENE

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedinfo.com.au

This leaflet was prepared in December 2022.

® Registered Trademark

Published by MIMS February 2023

BRAND INFORMATION

Brand name

Feldene-D

Active ingredient

Piroxicam

Schedule

S4

 

1 Name of Medicine

Piroxicam.

2 Qualitative and Quantitative Composition

Feldene (piroxicam) 10 mg capsules.
Feldene-D (piroxicam) 20 mg tablets.

Excipient(s) with known effect.

Sugars (as lactose).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Feldene 10 mg capsules are blue and red in colour, marked FEL10 on one side and Pfizer on the other.
Feldene-D 20 mg dispersible tablets are white, oblong, scored, capsule-shaped and marked FEL/20 on one side and plain on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

Piroxicam is indicated for symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

4.2 Dose and Method of Administration

Pregnancy.

For patients in their third trimester of pregnancy or are breastfeeding, see Section 4.3 Contraindications; Section 4.6 Fertility, Pregnancy and Lactation.

Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

After assessing the risk versus benefit for each patient, use the minimum effective dose for the shortest duration possible. The duration of treatment should preferably be limited to 14 days. If continued treatment is considered necessary, this should be accompanied by evaluation at 14 days and subsequent frequent review with regards to efficacy, risk factors and ongoing need for treatment.
The dose should be adjusted to each individual patient's response and toleration. In studies to date, the optimal response generally has been achieved at a daily dose of 20 mg, given as a single dose. The recommended starting dose is 10 mg and administration of doses higher than 20 mg daily carries an increased risk of adverse effects and is not recommended.
Feldene-D dispersible tablets should be dispersed in a minimum of 50 mL of water and then swallowed.

4.3 Contraindications

Piroxicam should not be administered to patients with active peptic ulcerations, active gastrointestinal ulceration, bleeding or perforation, active inflammatory disease of the gastrointestinal tract or with a history of these conditions.
Piroxicam should not be used in those patients who have previously shown a hypersensitivity to the drug or in whom a hypersensitive reaction(s) (e.g. asthma, nasal polyps, angioedema or urticaria) has been precipitated by aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), since cross sensitivity exists.
Piroxicam should not be administered to patients with a history of previous severe allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, or those who have exhibited a previous skin reaction (regardless of severity) to piroxicam.
Piroxicam is contraindicated in patients in their third trimester of pregnancy or are breastfeeding (see Section 4.6 Fertility, Pregnancy and Lactation).
Piroxicam is contraindicated in the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
Piroxicam is contraindicated in patients with severe renal failure.
Piroxicam is contraindicated in patients with severe hepatic impairment.
Piroxicam is contraindicated in patients with severe heart failure.
Piroxicam should not be administered concomitantly with other NSAIDs, including cyclooxygenase-2 (COX-2) selective NSAIDs and aspirin at analgesic doses.

4.4 Special Warnings and Precautions for Use

Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms. The clinical benefit and tolerability should be re-evaluated periodically and treatment should be immediately discontinued at the first appearance of cutaneous reactions or relevant gastrointestinal events. Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs. Piroxicam should only be commenced after careful weighing of the risks and benefits in each individual patient.

Cardiovascular effects.

Cardiovascular thrombotic events.

NSAIDs may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal. This risk may increase with dose or duration of use. The relative increase of this risk appears to be similar in those with or without known CV disease or CV risk factors. However, patients with CV disease, history of atherosclerotic CV disease or CV risk factors may be at greater risk in terms of absolute incidence, due to their increased rate at baseline. To minimise the potential risk for an adverse CV event in patients treated with piroxicam, especially those with CV risk factors, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV toxicity and the steps to take if they occur (see Section 4.3 Contraindications).
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV events associated with NSAID use.

Hypertension.

NSAIDs, including piroxicam, may lead to the onset of new hypertension or worsening of pre-existing hypertension. Patients taking anti-hypertensives with NSAIDs may have an impaired anti-hypertensive response. For example, the anti-hypertensive effect of thiazide diuretics and beta-blocking agents is antagonised by NSAIDs. NSAIDs, including piroxicam, should be used with caution in patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and throughout the course of therapy.

Heart failure.

Fluid retention and oedema, (mainly ankle oedema), has been reported in patients taking NSAIDs, including piroxicam. Therefore, piroxicam should be used with caution in patients with compromised cardiac function and other conditions predisposing to or worsened by fluid retention. Patients with pre-existing congestive heart failure or hypertension should be closely monitored.

Risk of GI ulceration, bleeding and perforation with NSAID therapy.

NSAIDs, including piroxicam, can cause serious, potentially fatal gastrointestinal (GI) toxicity, including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine.
GI toxicity can occur at any time, with or without warning symptoms, in patients treated chronically with NSAID therapy. The frequency of such events may increase with dose or duration of use. Although minor upper GI problems, such as dyspepsia, are common, usually developing early in therapy, physicians should remain alert for ulceration and bleeding in patients treated chronically with NSAIDs even in the absence of previous GI tract symptoms. Administration of doses of greater than 20 mg per day carries an increased risk of GI side effects. Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious GI toxicity, relative to other NSAIDs (see Section 4.3 Contraindications).
Patients most at risk of developing these types of GI complications with NSAIDs are the elderly; patients with CV disease; patients using concomitant corticosteroids, antiplatelet drugs (such as aspirin), selective serotonin reuptake inhibitors (SSRIs), patients ingesting alcohol or patients with a history of GI disease (such as ulceration, GI bleeding or inflammatory conditions); and patients with a history of smoking or alcoholism. Piroxicam should either not be prescribed, or be prescribed with caution in these patients (see Section 4.3 Contraindications).
Age over 70 years is associated with high risk of complications. The administration to patients older than 80 years should be avoided. In patients observed in clinical trials of several months to two years duration, symptomatic upper GI ulcers, gross bleeding or perforation appear to occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. Patients taking concomitant oral corticosteroids, selective serotonin reuptake inhibitors (SSRIs) or anti-platelet agents such as low dose aspirin are at increased risk of serious GI complications.
Patients and physicians should remain alert for signs and symptoms of GI ulceration and/or bleeding during piroxicam treatment. Patients should be asked to report any new or unusual abdominal symptom during treatment. If a GI complication is suspected during treatment, piroxicam should be discontinued immediately and additional clinical evaluation and treatment should be considered.

Asthma.

Piroxicam should be used with caution in patients with asthma because bronchial smooth muscle spasm may be aggravated by prostaglandin inhibition.

Haemorrhagic tendencies.

Piroxicam, like other NSAIDs, decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined and in patients undergoing surgery and in patients with haemorrhagic disorders. Dosage requirements of coumarin anticoagulants and other drugs that are highly protein bound should be closely and very regularly monitored when these are administered concomitantly with piroxicam. Such drugs include warfarin, hydantoins, sulphonamides and sulfonylureas. Bleeding has been reported rarely when piroxicam as well as other NSAIDs have been administered to patients on coumarin-type anticoagulants (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Concomitant use of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor antagonists and anti-inflammatory drugs and thiazide diuretics.

The use of an ACE inhibiting drug (ACE inhibitor or angiotensin receptor antagonist), and an anti-inflammatory drug (NSAID or COX-2 inhibitor) and a thiazide diuretic at the same time, increases the risk of renal impairment. This includes use in fixed-combination products containing more than one class of drug. Concomitant use of all three classes of these medications should be accompanied by increased monitoring of serum creatinine, particularly at the institution of the treatment. The concomitant use of drugs from these three classes should be used with caution particularly in elderly patients or those with pre-existing renal impairment.

Use with oral anticoagulants.

The concomitant use of NSAIDs, including piroxicam, with oral anticoagulants increases the risk of GI and non-GI bleeding and should be given with caution. Oral anticoagulants include warfarin/coumarin-type anticoagulants and novel oral anticoagulants (e.g. apixaban, dabigatran, rivaroxaban). Anticoagulation/INR should be monitored in patients taking a warfarin/coumarin-type anticoagulant (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Masking of signs of infection.

As with other NSAIDs, the anti-inflammatory, antipyretic and analgesic effects of piroxicam may mask the signs of infection (pain, fever, etc.).

Ophthalmological monitoring.

Adverse ophthalmological effects have been observed with NSAIDs; accordingly, patients who develop visual disturbances during treatment with piroxicam should have an ophthalmological examination.

Skin reactions.

NSAIDs may very rarely cause serious cutaneous adverse events such as drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome (see Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome), exfoliative dermatitis, toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), which can be fatal and occur without warning. These serious adverse events are idiosyncratic and are independent of dose or duration of use. Evidence from observational studies suggests that piroxicam may be associated with a higher risk of severe cutaneous adverse reactions than other non-oxicam NSAIDs. 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. 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.
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 (see Section 4.8 Adverse Effects (Undesirable Effects)).

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome.

DRESS syndrome has been reported in patients taking NSAIDs. Some of these events have been fatal or life-threatening. DRESS syndrome typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS syndrome may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue the NSAID and evaluate the patient immediately.

Use in hepatic impairment.

As with other NSAIDs, borderline elevations of liver function tests may occur in up to 15% of patients. A patient with symptoms or signs suggesting impaired hepatic function or in whom an abnormal liver function test has been reported should be evaluated for evidence of development of some severe hepatic dysfunction. These abnormalities may progress, remain essentially unchanged or be transient with continued therapy. The ALT (SGPT) is probably the most sensitive indicator of liver dysfunction. Meaningful (3 x upper limit of normal) elevations of ALT or AST (SGOT) occurred in controlled trials in less than 1% of patients.
Physician and patients should remain alert for the hepatotoxicity. Patients should be informed about the signs and/or symptoms of hepatotoxicity (e.g. nausea, fatigue, lethargy, pruritus, jaundice, abdominal tenderness in the right upper quadrant and "flu-like" symptoms) and the steps to take should these signs and/or symptoms occur. Severe hepatic reactions, including jaundice and cases of fatal hepatitis, have been reported with piroxicam. Although such reactions are rare, if abnormal liver tests persist or worsen, if clinical signs consistent with liver disease develop or if systemic manifestations occur (e.g. eosinophilia, rash etc.), piroxicam should be discontinued.

Use in renal impairment.

As with other NSAIDs, long-term administration of piroxicam to animals has resulted in renal papillary necrosis and other pathology. In rare cases, NSAIDs may cause interstitial nephritis, glomerulitis, haematuria, proteinuria, papillary necrosis and, occasionally, nephrotic syndrome.
NSAIDs inhibit the synthesis of renal prostaglandin which plays a supportive role in the maintenance of renal perfusion in patients whose renal blood flow and blood volume are decreased. In these patients, administration of an NSAID may precipitate overt renal decompensation, which is typically followed by recovery to the pre-treatment state on discontinuation of the NSAID. Patients at greatest risk of this complication include those with impaired liver or renal function (e.g. liver cirrhosis, nephrotic syndrome, overt renal disease), with heart failure, taking diuretics or the elderly. Such patients should be carefully monitored while receiving NSAID therapy.
Blood urea nitrogen elevation has been observed in some patients. These elevations are not progressive over the course of treatment with piroxicam, a plateau being reached which returns to or towards baseline levels if treatment is stopped. The rise in blood urea nitrogen as a rule is not associated with elevations in serum creatinine.
As with other NSAIDs, it is recommended that piroxicam be given under close supervision in patients with a history of impaired renal function, and periodic renal function tests carried out.
Caution should be used when initiating treatment with piroxicam in patients with severe dehydration. Caution is also recommended in patients with kidney disease (see Section 4.3 Contraindications).
Lower doses should be considered in patients with impaired renal function and they should be carefully monitored.

Use in the elderly.

See Section 4.4 Special Warnings and Precautions for Use, Risk of GI ulceration, bleeding and perforation with NSAID therapy, Concomitant use of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor antagonists and anti-inflammatory drugs and thiazide diuretics, Use in renal impairment. Also see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions, Antihypertensives.

Paediatric use.

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

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Anticoagulants.

The concurrent use of NSAIDs and coumarin anticoagulants (including warfarin) has been associated with severe, sometimes fatal, haemorrhage. Patients should be monitored closely if piroxicam is administered concurrently with oral anticoagulants, including warfarin/coumarin-type anticoagulants and novel oral anticoagulants (e.g. apixaban, dabigatran, rivaroxaban) (see Section 4.4 Special Warnings and Precautions for Use, Use with oral anticoagulants).
Piroxicam, like other NSAIDs, decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.
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.
Warfarin should be used in combination with piroxicam only if necessary (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions, Protein bound agents).

Protein bound agents.

Piroxicam is highly protein bound and therefore might be expected to displace other protein bound drugs. The physician should closely monitor dosage requirements of drugs that are highly protein bound when these are administered concomitantly with piroxicam. Such drugs include coumarin anticoagulants (e.g. warfarin), hydantoins, sulphonamides and sulphonylureas.

Methotrexate.

When methotrexate is administered concurrently with NSAIDs, including piroxicam, the NSAID may decrease elimination of methotrexate resulting in increased plasma levels of methotrexate. Extreme care should be exercised in giving methotrexate especially high doses, to patients on piroxicam therapy, 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 (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use).
Plasma levels of piroxicam are depressed to approximately 80% of their normal values when piroxicam is administered in conjunction with aspirin (3900 mg/day), but concomitant administration of antacids has no effect on piroxicam plasma levels.
Piroxicam interferes with the antiplatelet effect of low dose aspirin, and thus may interfere with aspirin's prophylactic treatment of CV disease.

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 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.

Colestyramine.

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

Furosemide (frusemide).

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

Antihypertensives.

NSAIDs can reduce the efficacy of diuretics and other antihypertensive drugs, including ACE inhibitors, angiotensin II antagonists (AIIAs; also known as angiotensin receptor blockers or ARBs) and beta-blockers (see Section 4.4 Special Warnings and Precautions for Use, Hypertension).
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 AIIA and/or a diuretic with a cyclooxygenase inhibitor can increase the deterioration of renal function, including the possibility of acute renal failure, which is usually reversible.
The occurrence of these interactions should be considered in patients taking piroxicam with an ACE inhibitor or an AIIA and/or a diuretic. Thus, caution should be taken when administrating piroxicam with these drugs, especially in elderly patients (see Section 4.4 Special Warnings and Precautions for Use, Concomitant use of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor antagonists and anti-inflammatory drugs and thiazide diuretics).
Patients should be adequately hydrated and the need to monitor renal function should be assessed before, and periodically during, concomitant treatment.

Cardiac glycosides (digoxin and digitoxin).

Concomitant administration of NSAIDs with cardiac glycosides (e.g. digoxin, digitoxin) may exacerbate cardiac failure, reduce glomerular filtration rate (GFR) and increase plasma glycoside levels.

Corticosteroids or selective serotonin reuptake inhibitors (SSRIs).

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

Ciclosporin or tacrolimus.

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

Poor metabolisers of CYP2C9 substrates.

Patients who are known or suspected to be poor CYP2C9 metabolisers based on previous history/experience with other CYP2C9 substrates should be administered piroxicam with caution as they may have abnormally high plasma levels due to reduced metabolic clearance.

4.6 Fertility, Pregnancy and Lactation

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.
(Category C)
Piroxicam is contraindicated in the third trimester of pregnancy.
Piroxicam should not be used during the first two trimesters of pregnancy unless the expected benefits to the mother outweigh the risks to the fetus. If there is a compelling need for NSAID treatment during the first or second trimester, limit use to the lowest effective dose and shortest duration possible.
Data from epidemiological studies suggest an increased risk of miscarriage and congenital malformation associated with NSAID use in early pregnancy.
In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss.

Oligohydramnios and neonatal renal impairment.

Use of NSAIDs in the second or third trimester may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Oligohydramnios is generally seen after days to weeks of treatment, although it has been reported as soon as 48 hours after NSAID initiation. Oligohydramnios is usually, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some post-marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
Consider ultrasound monitoring of amniotic fluid if treatment extends beyond 48 hours. Discontinue treatment with NSAIDs if oligohydramnios occurs.
NSAIDs given during the third trimester of pregnancy may cause premature closure of the fetal ductus arteriosus, fetal renal impairment, inhibition of platelet aggregation. And may delay labour and delay birth. It is not known if piroxicam or its metabolites cross the placenta. However because of the effects of drugs in this class (i.e. inhibitors of prostaglandins) on the fetal CV system, the use of piroxicam is contraindicated during the third trimester of pregnancy.
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. Therefore, piroxicam is contraindicated for nursing mothers.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Results from clinical trials involving approximately 2300 patients (of whom about 400 were treated for more than one year and 170 for more than two years) indicate that about 30% of patients reported side effects at a dose of 20 mg/day. This increased with doses of 30-40 mg/day.

More common reactions (more than 3%).

Gastrointestinal.

These have been the most frequent side effects, occurring in about 20%. Approximately 5% discontinued therapy, with an overall incidence of peptic ulcer of about 1%. The gastrointestinal side effects included abdominal discomfort (5.7%), flatulence (5.2%), nausea (4.8%), abdominal pain (4.7%), epigastric distress (4.1%), constipation (3.8%) and diarrhoea (3.2%).

Central nervous system.

Dizziness (4.1%), headache (4.1%).

Less common reactions (less than 3%).

Auditory and vestibular.

Tinnitus, vertigo, deafness.

Laboratory abnormalities.

Elevated levels of liver enzymes (LDH, alkaline phosphatase, transaminases); elevation of blood urea nitrogen (BUN) and serum creatinine; depression of levels of haemoglobin and haematocrit; depression of levels of serum proteins, platelet and white blood cell count.

Cardiovascular.

Hypertension, tachycardia, palpitations.

Skin and subcutaneous tissue disorders.

Skin rash (2.4%), pruritus (1.1%), onycholysis, alopecia. Photoallergic reactions have been infrequently associated with therapy. As with other NSAIDs, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), toxic epidermal necrolysis (Lyell's disease) and Stevens-Johnson syndrome may develop in rare cases. Vesiculobullous reactions have been reported rarely.

Gastrointestinal.

Anorexia, vomiting, indigestion, pancreatitis, hepatitis.

Central nervous system.

Sedation, drowsiness (2.1%), others (each less than 1%) include amnesia, anxiety, depression, malaise, hallucinations, insomnia, dream abnormalities, nervousness, paraesthesia, personality change, tremors, akathisia.

Genitourinary.

Oedema (2.7%), others (less than 1%) dysuria, urinary frequency, haematuria, oliguria, menorrhagia.

Eyes, nose, throat.

Stomatitis (1.0%), blurred vision, eye irritation/swelling, epistaxis, glossitis.

Haematological.

Decreases in haemoglobin and haematocrit, unassociated with obvious gastrointestinal bleeding, have occurred. Anaemia has been reported. Thrombocytopenic and nonthrombocytopenic purpura (Henoch-Schonlein), petechial rash, ecchymosis, leucopenia and eosinophilia have been reported. Rare cases of aplastic anaemia and haemolytic anaemia are also reported.

Miscellaneous (each less than 1.0%).

Breathlessness, chest pain, hyperglycaemia, hypoglycaemia, thirst, chills, sweating, flushing, increased appetite, weight increase or decrease. Rare anecdotal reports of positive antinuclear antibodies.

Serious or life threatening reactions.

Peptic ulceration and gastrointestinal haemorrhage may occur. The patient should be admitted to hospital to determine the underlying lesion, followed by appropriate treatment.

Post-marketing experience.

In post-marketing experience, the following adverse effects have occurred from NSAID use that cannot be excluded as a class-effect:

Central nervous system.

Aseptic meningitis.

Renal.

Nephrotic syndrome, glomerulonephritis, interstitial nephritis; renal failure.

Body as a whole.

Fluid retention.

Gynaecological.

Decreased female fertility.

Pregnancy, puerperium and perinatal conditions.

Oligohydramnios, ductus arteriosus premature closure, prolonged labour, prolonged pregnancy, neonatal renal impairment.

Skin and subcutaneous tissue disorders.

Dermatitis exfoliative, erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, fixed drug eruption.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

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. 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.

Recommended treatment.

In the event of acute overdosage with piroxicam, supportive and symptomatic therapy is indicated. There are no specific antidotes. Emesis and/or gastric lavage and/or activated charcoal may be considered dependent upon amount ingested and time since ingestion. 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.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

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.
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.
Subacute and chronic toxicity studies have been carried out in rats, mice, dogs, and monkeys. The pathology most often seen was that characteristically associated with the animal toxicology of NSAIDs: renal papillary necrosis and gastrointestinal lesions.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Piroxicam is well absorbed following oral administration. The extent and rate of absorption are not influenced by administration in the fasting state. The plasma half-life is approximately 36-45 hours in man and stable plasma concentrations are maintained throughout the day on once daily dosage. After repeated administration, plasma concentrations increase for five to seven days, by which time a steady state is reached which is not exceeded following further constant daily drug administration.

Distribution.

Piroxicam is highly protein bound (99%) and therefore might be expected to displace other protein bound drugs (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions, Protein bound agents).

Metabolism and excretion.

Piroxicam is extensively metabolised and less than 5% of the daily dose is excreted unchanged in urine and faeces. One important metabolic pathway is hydroxylation of the pyridyl ring of the piroxicam side chain, followed by conjugation with glucuronic acid and urinary elimination. Approximately 5% of the dose is metabolised to and excreted as saccharin.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Feldene capsules contain the following inert ingredients: lactose monohydrate, maize starch, magnesium stearate/sodium lauryl sulfate 9:1 blend, gelatin, erythrosine, titanium dioxide, brilliant blue FCF.
Feldene-D dispersible tablets contain the following inert ingredients: lactose monohydrate, microcrystalline cellulose, hyprolose, sodium stearyl fumarate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Feldene 10 mg capsules are available in PVC/Al blister packs of 50 capsules.
Feldene-D 20 mg dispersible tablets are available in PVC/Al blister packs of 25 tablets.
Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Feldene and Feldene-D contain the active ingredient piroxicam. 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.

Chemical structure.


Chemical name: 4-Hydroxy-2-methyl -N-(pyridin-2-yl)-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide.
Molecular formula: C15H13N3O4S.
Molecular weight: 331.4.

CAS number.

36322-90-4.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (S4).

Summary Table of Changes