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?
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Things you should do
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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.
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Things you should not do
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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.
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Driving or using machines
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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.
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Drinking alcohol
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Alcohol may interfere with FELDENE and may affect how well it works. Ask your doctor
or pharmacist for more information.
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Looking after your medicine
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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.
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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.
Active ingredient(s):
Piroxicam (pir-oks-i-kam)
Full 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?
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.
2. You are taking aspirin or any other medicine that is also an NSAID
3. You have had a severe allergic reaction to any medicine in the past, especially skin
reactions
4. You have had a skin reaction to piroxicam in the past
5. You have a gastric ulcer (i.e. stomach or duodenal ulcer), a recent history of one,
or have had gastric ulcers before
6. 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
7. You have severe kidney disease
8. You have severe heart failure
9. You have severe liver failure
10. You are about to have or have had recent coronary artery bypass surgery
11. 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.
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
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Active ingredient
(main ingredient)
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Piroxicam (10 mg or 20 mg)
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Other ingredients
(inactive ingredients)
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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
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Potential Allergens
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Feldene contains sugars (as lactose)
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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
This leaflet was prepared in December 2022.
® Registered Trademark