GenRx Piroxicam Capsules
Contains the active ingredient, Piroxicam (pir-oks-i-kam)
Consumer Medicine Information
For a copy of a large print leaflet, Ph: 1800 195 055 1800 195 055
What is in this leaflet
This leaflet answers some common questions about GenRx Piroxicam capsules.
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 has weighed the risks of you using this medicine against the benefits expected for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may want to read it again.
What Piroxicam is used for
The name of your medicine is GenRx Piroxicam. It contains the active ingredient, piroxicam.
Piroxicam is used to treat some symptoms such as swelling, stiffness and joint pain caused by:
rheumatoid arthritis (when the tissue around a joint becomes thickened and inflamed leading to a build-up of fluid on the joint)
osteoarthritis (when the cartilage between two bones becomes damaged)
ankylosing spondylitis (a type of arthritis affecting the spine).
How it works
Piroxicam belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by relieving pain and inflammation.
Piroxicam does not cure arthritis and it will help you only when you are taking it.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed Piroxicam for another reason.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
Before you take Piroxicam
When you must not take it
Do not take this medicine if:
1.you have any of the following problems affecting your digestive system or you have had it recently:
a peptic ulcer (i.e. stomach or duodenal ulcer)
you are vomiting blood, or material that looks like coffee grounds
you are bleeding from the rectum (back passage), have black, sticky bowel motions (stools)
inflammation of the lining of the stomach or bowel (e.g. Crohn's disease and ulcerative colitis).
2.you have recently had heart (coronary artery) bypass surgery.
3.you have serious kidney or liver problems.
4.you have a condition called severe heart failure.
5.you are or have ever been hypersensitive or allergic to:
medicines containing piroxicam
any other NSAID medicine.
Examples of hypersensitivity and allergy include asthma, shortness of breath, wheezing or difficulty breathing, fainting, nasal polyps (growths inside the nose), angioedema (swollen face, lips, tongue or other parts of the body), or urticaria (rash, itching or hives on the skin).
If you are allergic to aspirin or NSAID medicines and take Piroxicam the symptoms may be severe.
Examples of serious allergic reactions include erythema multiforme (red patches on the arms, legs and face with blisters on the lips and lining of the mouth), Stevens-Johnson syndrome and toxic epidermal necrolysis (rash with blisters, and blisters covering large areas of the body; peeling or burning of the skin).
Make especially sure that you tell your doctor if you have had these or any type of skin reaction before.
Many medicines used to treat headache, period pain and other aches and pains contain aspirin or are NSAID medicines.
Your pharmacist or doctor will know if you are taking any of these medicines.
6.you are allergic or intolerant to lactose.
This medicine contains lactose.
7.you are allergic to any of the other ingredients listed at the end of this leaflet.
8.you are over 80 years of age, unless your doctor says it is OK.
Piroxicam is not recommended for this age group.
9.the expiry date on the pack has passed.
If you take this medicine after the date has passed it may have no effect at all, or worse, an entirely unexpected effect.
10.the packaging is torn or shows signs of tampering or if the medicine does not look quite.
If it has expired or is damaged, return it to your pharmacist for disposal.
Do not give this medicine to children under 12 years of age. The safety and effectiveness of this medicine in this age group have not been established.
If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist.
Before you start to take it
Tell your doctor if you have allergies, hypersensitivity, or intolerance to:
any other medicines including aspirin or other NSAID medicines
any other substances, such as foods, preservatives or dyes
lactose - this medicine contains lactose.
Tell your doctor if you are pregnant or plan to become pregnant. Like most NSAID medicines, Piroxicam is not recommended for use during pregnancy. It may affect your developing baby if you take it while you are pregnant, especially during the last three months of pregnancy. Your doctor will discuss the benefits and risks of taking it during pregnancy.
Tell your doctor if you are breast-feeding or plan to breast-feed. Like most NSAID medicines, the active ingredient in this medicine passes into breast milk and may affect your baby. Your doctor will discuss the benefits and risks of using this medicine while breast-feeding.
Tell your doctor if you have or have had any medical conditions, especially the following:
heartburn, indigestion, stomach ulcer or other stomach problems
kidney or liver problems
high blood pressure or heart problems
swelling of the feet or ankles (oedema)
a tendency to bleed.
Tell your doctor if you currently have an infection. Piroxicam may hide some signs of infection (such as pain, fever, swelling or redness). This may lead you to mistakenly believe that you are better or that the infection is not serious.
Tell your doctor if you plan to have surgery.
If you have not told your doctor about any of the above, tell them before you start taking this medicine. Your doctor may want to take special care if you have any of these conditions.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines and Piroxicam may interfere with each other.
aspirin, salicylates or any other anti-inflammatory agents used to relieve pain, swelling and other symptoms of inflammation
diuretics (also called fluid or water tablets)
medicines used to treat high blood pressure or heart problems. These include digoxin, ACE inhibitors, angiotensin receptor blockers and beta blockers
warfarin or other medicines used to stop blood clots
medicines used to treat diabetes called sulphonylureas
methotrexate (used to treat arthritis, psoriasis and some cancers)
phenytoin (used to treat epilepsy or convulsions)
medicines to treat depression such as lithium and SSRIs
steroids (medicines used to treat allergies and hormone imbalances)
cyclosporin or tacrolimus (given to help prevent rejection of transplanted organs).
These medicines may be affected by piroxicam, or may affect how well it works, or the combination may increase the risk of side effects or cause or worsen some medical conditions. You may need different amounts of your medicine, or you may take it for a shorter period of time, or you may need to take different medicines. Your doctor will advise you.
Ask your doctor or pharmacist if you are not sure if you are taking any of these medicines. Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Piroxicam.
How to take Piroxicam
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How much to take
The dose varies from person to person.
Normally you would start with 10mg. After that the usual dose is 10 to 20mg taken once each day.
Look at the label on the pack to see what dose you should take.
How to take it
Swallow the capsules whole, with a glass of water.
When to take it
Take this medicine with or immediately after food to reduce the chance of a stomach upset.
Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
How long to take it for
Keep taking Piroxicam for as long as your doctor tells you.
Make sure you have enough medicine to last over weekends and holidays. This medicine will not cure your condition but it should help to control pain, swelling and stiffness.
If you have arthritis, you may have to take your medicine every day for a long time. Keep in touch with your doctor during this time.
If you forget to take it
If you miss a dose and remember in less than 12 hours, take it straight away, then continue as normal the next day.
If it is over 12 hours, skip that day's dose but be sure that to take the next day's dose when it is due.
Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.
If you have missed several doses, consult your doctor.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 for Australia) or go to the Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much of this medicine.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much Piroxicam, you may feel sick, dizzy, drowsy or confused, or have stomach pain, vomiting or headache.
While you are taking Piroxicam
Things you must do
Be alert for any signs of allergy or hypersensitivity, or signs that this medicine may be seriously affecting your stomach or intestine or cardiovascular system. In particular, watch for skin rashes, passing or vomiting blood, feeling faint or having chest pain or tightness (see 'Side Effects' for full details). Report anything new or unusual to your doctor immediately.
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking this medicine.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking this medicine.
If you plan to have surgery, including dental surgery, tell your surgeon, doctor or dentist that you are taking piroxicam. Piroxicam can slow down blood clotting.
If you become pregnant while taking this medicine, tell your doctor immediately.
If you get an infection while taking Piroxicam, tell your doctor. Piroxicam may hide some of the signs of an infection and may make you think, mistakenly, that you are better or that it is not serious.
Signs of an infection may include fever, pain, swelling and redness.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
Go to your doctor regularly for a check-up. Your doctor may occasionally do a blood test to check your potassium levels and see how your kidneys are working.
Things you must not do
Do not give your medicine to anyone else, even if they have the same symptoms as you.
Do not take this medicine to treat any other complaints unless your doctor or pharmacist tells you to.
Things to be careful of
Be careful while driving or operating machinery until you know how Piroxicam affects you. As with other NSAID medicines, piroxicam may cause dizziness, drowsiness and blurred vision in some people.
If this occurs, do not drive, operate machinery or do anything else that could be dangerous.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine. Piroxicam helps most people with arthritis and ankylosing spondylitis, but may have unwanted affects in a few people.
All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time, they are minor and temporary. You may need medical treatment if you get some of the side effects.
If you are over 70 years of age, you may have a high chance of getting side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
stomach upsets including nausea (feeling sick), vomiting, heartburn, indigestion, cramps
constipation, diarrhoea, stomach pain, wind
loss of appetite
buzzing or ringing in the ears
hair loss or thinning
change in mood, for example depression
sore mouth or tongue.
The above side effects are usually mild.
Tell your doctor immediately if you notice any of the following:
severe pain or tenderness in the stomach, often with nausea and vomiting
eye problems such as blurred vision, sore red eyes, itching
severe dizziness, spinning sensation
fast or irregular heart beat
difficulty hearing, deafness
unusual bruising or bleeding, reddish or purple blotches under the skin
signs of frequent infections such as fever, chills, sore throat or mouth ulcers
signs of anaemia such as tiredness, being short of breath and looking pale
a change in the colour of the urine, blood in the urine
a change in the amount of urine passed, burning feeling when passing urine
yellowing of the eyes or the skin (jaundice)
unusual weight gain, swelling of the ankles or legs
the symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal.
The side effects above may be serious. You may need urgent medical attention. Serious side effects are rare.
STOP taking your medicine and either tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:
vomiting blood or material that looks like coffee grounds
bleeding from your back passage (rectum), black sticky stools or bloody diarrhoea
swelling of the face, lips or tongue which may make swallowing or breathing difficult
asthma, wheezing or shortness of breath
sudden or severe itching, skin rash, hives
fainting, seizures or fits
pain or tightness in the chest.
These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell while you are taking, or soon after you have finished taking this medicine, even if it is not on the lists of side effects. Other side effects not listed above may also occur in some people.
Tell your doctor if you notice any other effects.
After taking Piroxicam
Keep your medicine in its original packaging until it is time to take it. If you take it out of the pack it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25 °C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink.
Do not leave your medicine in the car or on window sills. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor or pharmacist tells you to stop taking piroxicam or your medicine has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.
Where to go for further information
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.
What GenRx Piroxicam capsules look like
GenRx Piroxicam 10mg capsules: maroon cap/blue body, marked "APO 10".
Available in blister packs of 50 capsules.
GenRx Piroxicam 20mg capsules: maroon cap/maroon body, marked "APO 20".
Available in blister packs of 25 capsules.
GenRx Piroxicam 10mg capsules contain 10mg of piroxicam.
GenRx Piroxicam 20mg capsules contain 20mg of piroxicam.
They also contain the following inactive ingredients:
allura red AC
iron oxide red
brilliant blue FCF.
GenRx Piroxicam capsules do not contain gluten, sucrose, tartrazine or any other azo food dyes.
Australian Registration Numbers
GenRx Piroxicam 10mg capsules (blister packs):
AUST R 75039
GenRx Piroxicam 20mg capsules (blister packs):
AUST R 75043
Apotex Pty Ltd
ABN 52 096 916 418
66 Waterloo Road
North Ryde NSW 2113
GenRx is a registered trade mark of Apotex Pty Ltd.
This leaflet was prepared in:
Published by MIMS/myDr August 2008
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