APO-PIROXICAM
| 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 APO-PIROXICAM? |
APO-PIROXICAM contains the active ingredient piroxicam. APO-PIROXICAM 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 APO-PIROXICAM? in the full CMI.
| 2. What should I know before I use APO-PIROXICAM? |
Do not use if you have ever had an allergic reaction to piroxicam or any of the ingredients listed at the end of the CMI. Do not use, 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. Do not take APO-PIROXICAM 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 APO-PIROXICAM? in the full CMI.
| 3. What if I am taking other medicines? |
Some medicines may interfere with APO-PIROXICAM 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 APO-PIROXICAM? |
The usual dose 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 APO-PIROXICAM? in the full CMI.
| 5. What should I know while using APO-PIROXICAM? |
| Things you should do |
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| Things you should not do |
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| Driving or using machines |
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| Drinking alcohol |
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| Looking after your medicine |
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For more information, see Section 5. What should I know while using APO-PIROXICAM? 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 lightheadedness, 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.
APO-PIROXICAM
Active ingredient(s): Piroxicam
| Consumer Medicine Information (CMI) |
This leaflet provides important information about using APO-PIROXICAM. 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 APO-PIROXICAM.
Where to find information in this leaflet:
1. Why am I using APO-PIROXICAM?
2. What should I know before I use APO-PIROXICAM?
3. What if I am taking other medicines?
4. How do I use APO-PIROXICAM?
5. What should I know while using APO-PIROXICAM?
6. Are there any side effects?
7. Product details
| 1. Why am I using APO-PIROXICAM? |
APO-PIROXICAM contains the active piroxicam. APO-PIROXICAM 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).
APO-PIROXICAM 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 APO-PIROXICAM can relieve the symptoms of pain and inflammation, it will not cure your condition.
Your doctor may have prescribed APO-PIROXICAM for another reason. Ask your doctor if you have any questions about why APO-PIROXICAM has been prescribed for you.
| 2. What should I know before I use APO-PIROXICAM? |
Warnings
Do not use APO-PIROXICAM if:
- You are allergic or hypersensitive to:
- Piroxicam (the active ingredient in APO-PIROXICAM) or any of the capsule ingredients listed at the end of this leaflet (see Product Description), or other medicines containing piroxicam. Always check the ingredients to make sure you can use this medicine.
- 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.
- You are taking aspirin or any other medicine that is an NSAID.
- You have had a severe allergic reaction to any medicine in the past, especially skin reactions.
- You have had a skin reaction to piroxicam in the past.
- You have a gastric ulcer (ie stomach or duodenal ulcer), a recent history of one or have had gastric ulcers before.
- 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.
- You have severe kidney disease.
- You have severe heart failure.
- You have severe liver failure. You are about to have or have had recent coronary artery bypass surgery.
- You are in your third trimester of pregnancy or are breastfeeding.
Do not give APO-PIROXICAM to children of 12 years and under.
The safety and effectiveness of APO-PIROXICAM in this age group have not been established.
If you are not sure whether you should be taking APO-PIROXICAM, contact your doctor.
Do not take APO-PIROXICAM if the packaging is torn or shows signs of tampering.
Do not take APO-PIROXICAM 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. - 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 APO-PIROXICAM 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 APO-PIROXICAM 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 APO-PIROXICAM.
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 APO-PIROXICAM if you are pregnant, or intend on becoming pregnant, unless your doctor says otherwise.
APO-PIROXICAM is not to be used at all during the third trimester of pregnancy.
APO-PIROXICAM 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 APO-PIROXICAM during pregnancy.
Tell your doctor if you are breast-feeding or plan to breast-feed.
APO-PIROXICAM is not to be used during breastfeeding. Like most NSAID medicines, the active ingredient in APO-PIROXICAM 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 APO-PIROXICAM 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 APO-PIROXICAM.
| 4. How do I use APO-PIROXICAM? |
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 APO-PIROXICAM until your doctor tells you to stop.
When and how long to take APO-PIROXICAM
- Try to take your APO-PIROXICAM at the same time each day, either morning or evening.
- Keep taking APO-PIROXICAM every day until your doctor tells you to stop.
- You may need to take APO-PIROXICAM for a long time.
If you need to take APO-PIROXICAM for a long time, see your doctor for regular check-ups so that he/she can monitor your condition and treatment.
How to take APO-PIROXICAM
- Swallow the capsules whole with water.
- It is best to take APO-PIROXICAM immediately after food to avoid the chance of an upset stomach.
If you forget to take APO-PIROXICAM
APO-PIROXICAM should be used regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember, then go back to taking it as you would normally.
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 take too much APO-PIROXICAM
If you think that you have used too much APO-PIROXICAM, 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 APO-PIROXICAM? |
Things you should do
- If you become pregnant while taking APO-PIROXICAM, tell your doctor immediately.
- If you are about to start any new medicines, tell your doctor and pharmacist that you are taking APO-PIROXICAM.
- Tell all doctors, dentists and pharmacists who are treating you that you are taking APO-PIROXICAM.
- If you are going to have surgery, including dental surgery, tell your doctor or dentist that you are taking APO-PIROXICAM.
- APO-PIROXICAM can slow down blood clotting. If you get an infection while taking APO-PIROXICAM, tell your doctor. APO-PIROXICAM 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.
Remind any doctor, dentist or pharmacist you visit that you are using APO-PIROXICAM.
Things you should not do
- Do not give APO-PIROXICAM to anyone else, even if they have the same condition as you.
- Do not take APO-PIROXICAM 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 APO-PIROXICAM affects you.
As with other NSAID medicines, APO-PIROXICAM 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 APO-PIROXICAM. As with other NSAIDs medicines, alcohol may increase your risk of developing stomach problems.
Looking after your medicine
- Keep your medicine in its pack until it is time to take it.
- Keep it in a cool, dry place where the temperature stays below 25°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.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
| 6. Are there any side effects? |
Check with your doctor as soon as possible if you have any problems while taking APO-PIROXICAM, 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.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Common side effects
| Common side effects | What to do |
Gastrointestinal related:
| Speak to your doctor if you have any of these side effects and they worry you. |
Serious side effects
| Serious side effects | What to do |
Gastrointestinal symptoms:
| 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 APO-PIROXICAM contains
| Active ingredient (main ingredient) | Piroxicam (10 mg or 20 mg) |
| Other ingredients (inactive ingredients) | APO-PIROXICAM capsules also contain:
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| Potential allergens | This medicine contains sulfites and sugars (as lactose). |
Do not take this medicine if you are allergic to any of these ingredients.
What APO-PIROXICAM looks like
APO-PIROXICAM capsules are available as:
- APO-PIROXICAM 10 mg – deep powder blue opaque body, maroon opaque cap, hard gelatin capsule, filled with off-white powder, marked ‘APO 10’. (Aust R 75039). A box contains 50 capsules.
- APO-PIROXICAM 20 mg – maroon body and cap, hard gelatin capsule, filled with off-white powder, marked ‘APO 20’. (Aust R 75043). A box contains 25 capsules.
Who distributes APO-PIROXICAM
Arrotex Pharmaceuticals Pty Ltd
Cremorne VIC 3121
This leaflet was prepared in March 2023.
Published by MIMS May 2023