Chemmart Piroxicam Capsules

Contains the active ingredient, piroxicam (pir-oks-i-kam)

Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before taking your medicine. This leaflet answers some common questions about piroxicam. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

• if there is anything you do not understand in this leaflet,
• if you are worried about taking your medicine, or
• to obtain the most up-to-date information

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is used for

The name of your medicine is Chemmart Piroxicam Capsules. It contains the active ingredient, piroxicam.

It 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).

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

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

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.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

There is no evidence that this medicine is addictive.

Use in children

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.

Before you take this medicine

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 currently taking aspirin or any other NSAID medicine
6. it has passed the expiry date (EXP) printed on the pack
7. the packaging is torn, shows signs of tampering or it does not look quite right
8. you are allergic or intolerant to lactose
   This medicine contains lactose.
9. you are allergic to any of the other ingredients listed at the end of this leaflet.
10. you are or have ever been hypersensitive or allergic to:
    - medicines containing piroxicam
    - aspirin
    - any other NSAID medicine.

Symptoms of hypersensitivity and allergic reaction may include cough, shortness of breath, wheezing or difficulty breathing; nasal polyps (growths inside the nose), swelling of the face, lips, tongue, throat or other parts of the body, rash itching or hives on the skin, fainting or hayfever-like symptoms.

If you think you are having an allergic reaction, contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.

If you are allergic to aspirin or NSAID medicines and take piroxicam the symptoms may be severe.

Examples of serious allergic reactions affecting the skin 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. You must not take piroxicam if you have had an allergic reaction to piroxicam, aspirin or other NSAID medicines.
Many medicines used to treat headache, period pain and other aches and pains contain aspirin or are NSAID medicines.

11. you are over 80 years of age, unless your doctor says it is OK.
    Piroxicam is not recommended for this age group.

Before you start to take it

Before you start taking this medicine, tell your doctor if:

1. 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.

2. You have or have had any medical conditions, especially the following:

• heartburn, indigestion, stomach ulcer or other stomach problems
• asthma
• kidney or liver problems
• high blood pressure or heart problems
• swelling of the feet or ankles (oedema)
• a tendency to bleed
• an existing 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.

3. 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.
4. 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.
5. You have recently been vaccinated or plan to get a vaccination.
6. You are planning to have surgery.
7. You are currently receiving or are planning to receive dental treatment.
8. You are taking or are planning to take any other medicines.

This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Some medicines may interact with piroxicam.

These include:

• 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
• sulphonamide antibiotics
• 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).

If you are taking any of these you may need a different dose or you may need to take different medicines.

Other medicines not listed above may also interact with piroxicam.

How to take this medicine

Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information in this leaflet.

How much to take

Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

Normally you would start with 10mg. After that the usual dose is 10 to 20mg taken once each day.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

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 this medicine at about the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.

How long to take it for

Keep taking your medicine for as long as your doctor tells you. This is normally for a few weeks and then your doctor will review your treatment.

This medicine will not cure your condition but it should help to control pain, swelling and stiffness.

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 missed doses. This may increase the chance of unwanted side effects.

If you have missed several doses, consult your doctor.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.

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 or faint or become unconscious and/or have problems breathing.

While you are taking this medicine

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 your doctor that you are taking this medicine if:

• you are about to be started on any new medicine
• you plan to have any vaccinations or immunisations
• you become pregnant or plan to breastfeed
• you are about to have any blood tests
• you are going to have surgery, including dental surgery. Piroxicam can slow down blood clotting so it is important that your doctor, dentist or surgeon knows that you are taking it.
• you get an infection. 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.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects by checking your potassium levels and seeing how your kidneys are working. Go to your doctor regularly for a check-up.

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking this medicine.

Things you must not do

Do not:

• give this medicine to anyone else, even if their symptoms seem similar to yours
• take your medicine to treat any other condition unless your doctor or pharmacist tells you to
• stop taking your medicine, or change the dosage, without first checking with your doctor.

Things to be careful of

Be careful while driving or operating machinery until you know how this medicine 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.

Possible side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking piroxicam or if you have any questions or concerns. If you are over 70 years of age, you may have a higher chance of getting side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor or pharmacist if you notice any of the following and they worry you. This list includes the more common side effects. Mostly, these are mild:

• stomach upsets including nausea (feeling sick), vomiting, heartburn, indigestion, cramps
• constipation, diarrhoea, stomach pain, wind
• loss of appetite, weight loss or gain
• dizziness, light-headedness
• feeling thirsty
• chills, sweating or flushing
• sleepiness, drowsiness
• headache
• buzzing or ringing in the ears
• hair loss or thinning
• loose nails
• change in mood, for example anxiety, nervousness or depression, or personality change
• sore mouth or tongue
• nose bleed
• problems sleeping, strange dreams
• memory loss
• heavy periods
• numbness or tingling in hands or feet
• mild skin rash.

Tell your doctor as soon as possible if you notice any of the following.

These may be serious side effects. You may need medical attention. Most of these side effects are rare.

• 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
• high or low blood sugar
• 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
• high blood pressure
• hallucinations (seeing, feeling or hearing things that are not there)
• shaking or feeling uncoordinated.

If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

These are very serious side effects and are usually very rare. You may need urgent medical attention or hospitalisation.

• vomiting blood or material that looks like coffee grounds
• bleeding from your back passage (rectum), black sticky stools or bloody diarrhoea
• seizures or fits
• pain or tightness in the chest, possibly also with breathlessness
• meningitis (stiff neck, light sensitivity, drowsiness / confusion, unconsciousness and/or convulsions).

Other side effects not listed above may also occur in some people. (See "Allergic Reactions" below also).

Tell your doctor if you notice any other effects.

Allergic reactions

If you think you are having an allergic reaction to piroxicam, stop taking this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

• cough, shortness of breath, wheezing or difficulty breathing
• swelling of the face, lips, tongue, throat or other parts of the body
• sudden or severe itching rash, itching or hives on the skin
• fainting
• hayfever-like symptoms
• serious skin reactions such as red patches on the arms, legs and face with blisters on the lips and lining of the mouth, or rash with blisters, or blisters covering large areas of the body; peeling or burning of the skin.

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it. If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 25°C.

Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep this medicine 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.

Disposal

If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What Chemmart Piroxicam capsules look like

Chemmart Piroxicam 10mg capsules
Maroon cap/blue body, marked "APO 10".
Blister packs of 50 capsules.

Chemmart Piroxicam 20mg capsules
Maroon cap/maroon body, marked "APO 20".
Blister packs of 25 capsules.

Ingredients

Each capsule contains 10 mg or 20 mg of piroxicam as the active ingredient.

It also contains the following inactive ingredients:

• lactose
• microcrystalline cellulose
• maize starch
• stearic acid
• purified talc
• gelatine
• titanium dioxide
• allura red AC
• iron oxide red
• brilliant blue FCF.

This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

Chemmart Piroxicam 10mg capsules
Blister packs
AUST R 75037.

Chemmart Piroxicam 20mg capsules
Blister packs
AUST R 75041.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

Chemmart is a registered trade mark of Symbion Pty Ltd.

 This leaflet was last updated in:
June 2012.

Published by MIMS/myDr October 2012

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