Patient Medication Information: uses, side effects, how to take - Apo Piroxicam Cap 10mg
Serious Warnings and Precautions
Heart and blood vessel problems:
Stomach and intestine (gastrointestinal) problems:
Pregnancy:
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What is APO-PIROXICAM used for?
APO-PIROXICAM is used to treat the signs and symptoms of arthritis disorders such as:
- rheumatoid arthritis
- osteoarthritis (degenerative joint disease)
- ankylosing spondylitis
How does APO-PIROXICAM work?
APO-PIROXICAM belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). It can reduce the chemicals produced by your body, which cause pain and swelling.
APO-PIROXICAM only treats the symptoms and relieves pain and inflammation as long as you take it. APO-PIROXICAM does not cure the illness or stop it from getting worse.
What are the ingredients in APO-PIROXICAM?
Medicinal ingredients: piroxicam
Non-medicinal ingredients: D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose monohydrate, microcrystalline cellulose, cornstarch, stearic acid, talc and titanium dioxide.
The edible white ink on the capsule shells contain the following non-medicinal ingredients: ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.
APO-PIROXICAM comes in the following dosage forms:
Capsules: 10 mg and 20 mg.
Do not use APO-PIROXICAM if:
- you are planning to have or have recently had heart bypass surgery
- you have severe, uncontrolled heart failure
- you have bleeding in the brain or other bleeding disorders
- you are pregnant and in a later stage of pregnancy (28 weeks of pregnancy or later)
- you are currently breastfeeding (or are planning to breastfeed)
- you are allergic to piroxicam or any other ingredients in this medicine or part of the container
- you have a history of asthma, hives, growths in your nose, sinus swelling or symptoms of an allergic reaction after taking Acetylsalicylic Acid (ASA) or other NSAIDs
- you have active stomach or intestine ulcers
- you have active bleeding from the stomach or gut
- you have inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis)
- you have liver disease (active or severe)
- you have kidney disease (severe or worsening)
- you have high potassium in the blood
- you are under 16 years of age
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-PIROXICAM. Talk about any health conditions or problems you may have, including if you:
- have high blood pressure, high cholesterol or diabetes
- have atherosclerosis. This is when fats and cholesterol build up in your arteries
- have or had heart attacks, chest pain, heart disease, stroke or heart failure
- have poor circulation to your extremities (like your hands and feet)
- smoke or used to smoke
- drink a lot of alcohol
- have a stomach infection
- have liver or kidney problems, urine problems or are dehydrated
- have a history of ulcer or bleeding from the stomach or gut (small or large intestine)
- have other bleeding or blood problems
- have asthma
- have immune system problems
- are taking other NSAID products including low-dose ASA or aspirin
- are on a low-salt diet
- are pregnant, planning on becoming or become pregnant while taking APO-PIROXICAM.
Other warnings you should know about:
Blood and bleeding problems:
- APO-PIROXICAM can cause blood problems, bleeding and prolonged bleeding.
Taking APO-PIROXICAM with the following drugs can increase your risk for bleeding:
- Anticoagulants, which prevent blood clots
- Corticosteroids, which treat inflammation
- Selective serotonin reuptake inhibitors (SSRIs), which treat depression
Serious Skin Reactions: In rare cases, serious, life-threatening allergic and skin reactions have been reported with some NSAIDs, such as APO-PIROXICAM. These skin problems happen most often during the first month of treatment. Tell your healthcare professional immediately if you notice any changes in your skin during or after your treatment.
APO-PIROXICAM might cause you to become more sensitive to sunlight. Sunlight or sunlamps may cause sunburn, skin blisters, skin rash, redness, itching, changes in skin color, or vision changes. If you have a reaction from the sun, talk to your healthcare professional.
Check-ups and testing: You will have regular visits with your healthcare professional during treatment with APO-PIROXICAM to monitor your health. They will:
- Check your blood pressure.
- Check your eyes. APO-PIROXICAM can cause blurred or reduced vision.
- Do blood and urine tests to check your liver, kidney and blood health.
Surgery: Tell any doctor, dentist, pharmacist or healthcare professional that you see, that you are taking this medicine. This is especially important if you are planning to have heart surgery.
Driving and Using Machines: APO-PIROXICAM may cause eye or nervous system problems. This includes tiredness, trouble sleeping, blurred vision, spinning or dizziness (vertigo), hearing problems or depression. Be careful about driving or doing activities that require you to be alert. If you become drowsy, dizzy or light-headed after taking APO-PIROXICAM, do NOT drive or operate machinery.
Fertility in Women: APO-PIROXICAM may affect your fertility. This means that it may be difficult for you to have a child. If you have trouble having a child, you might need to stop taking APO-PIROXICAM. Talk to your healthcare professional if you have questions about this.
Adults (65 years or older): Side effects like gastrointestinal problems may happen more often. Your healthcare professional might have you start with a lower dose of APO-PIROXICAM. They will monitor your health during and after treatment.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with APO-PIROXICAM:
- Acetylsalicylic Acid (ASA) or other NSAIDs used to treat pain, fever and inflammation like celecoxib, diclofenac, ibuprofen, naproxen
- medicines used to treat depression (antidepressants) like citalopram, fluoxetine, paroxetine, sertraline and lithium
- medicines used to treat high blood pressure like enalapril, ramipril, candesartan, irbesartan, propranolol
- medicines used as blood thinners like warfarin, ASA, clopidogrel
- medicines used to lower extra fluid levels (called diuretics) like furosemide, hydrochlorothiazide
- medicines used to treat diabetes like sulphonylurea or other hypoglycemics
- medicines used to lower the risk of organ rejection like tacrolimus and cyclosporin
- corticosteroids (including glucocorticoids) such as prednisone, used as an anti-inflammatory
- cholestyramine, used to lower cholesterol levels
- digoxin, used to treat heart disorders
- medicines used to treat different cancers, like methotrexate and pemetrexed
- medicines used to treat bacterial infections called quinolone antibacterials
- alcohol
How to take APO-PIROXICAM
Take APO-PIROXICAM exactly as your healthcare professional has told you. They should
- recommend the lowest dose possible for your treatment for the shortest time needed.
You may be told to take your APO-PIROXICAM once per day or twice per day.
Swallow capsules whole after a meal with food or milk.
- This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours.
- If you have indigestion, nausea, vomiting, stomach pain or diarrhea after taking your APO-PIROXICAM, contact your healthcare professional.
Usual dose:
Adults 16 years and older:
Your healthcare professional will decide the best dose for you based on your condition. They will tell you how much to take and how often to take it.
Your healthcare professional may change your dose, stop your treatment for a period of time or recommend that you stop treatment completely. This may happen if:
- you have serious side effects, or
- your condition gets worse.
Overdose:
| If you think you, or a person you are caring for, have taken too much APO-PIROXICAM, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
Once per day treatment:
If you miss a dose of APO-PIROXICAM and it is:
- within 8 hours of when you should have taken your dose: take it right away.
- more than 8 hours late: skip the dose and continue with your usual schedule.
Twice per day treatment:
If you miss a dose of APO-PIROXICAM and it is
- within 2 hours of the missed dose: take it right away.
- more than 2 hours late: skip the missed dose and continue with your usual schedule.
What are possible side effects from using APO-PIROXICAM?
These are not all the possible side effects you may have when taking APO-PIROXICAM. If you experience any side effects not listed here, tell your healthcare professional.
APO-PIROXICAM may cause side effects, some of which can be serious. When these side effects occur, you may require medical attention. Report all symptoms or side effects to your health care provider.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| COMMON | |||
| Gastrointestinal (GI) problems (bleeding, blockage, holes, ulcers or inflammation in your GI tract): blood in vomit, bloody or black tarry stools, dizziness, stomach pain, bloating, loss of appetite, weight loss, nausea, vomiting, diarrhea, constipation, chills or fever | X | ||
| Hypertension (high blood pressure): fatigue, dizziness or fainting, chest pain | X | ||
| UNCOMMON | |||
| Anaphylaxis/hypersensitivity (severe allergic reactions): sudden wheeziness and chest pain or tightness; or swelling of eyelids, face, lips, tongue or throat, swelling or anaphylactic reaction/shock | X | ||
| Aseptic meningitis (inflammation of the protective lining of the brain that is not caused by infection): headaches, stiff neck, nausea and vomiting, fever or clouding of consciousness | X | ||
| Blood problems (low white and/or red blood cell or platelet count): feeling tired or weak, pale skin, bruising or bleeding for longer than usual if you hurt yourself, fever, chills | X | ||
| Congestive heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise | X | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Cystitis (bladder infection): increased need to urinate, pain in the pelvis or lower back, frequent urination during the night, cloudy urine that may contain blood, burning or pain urinating | X | ||
| Depression (sad mood that will not go away): difficult sleeping or sleeping too much, changes in appetite or weight, reduced sex drive and thoughts of death or suicide | X | ||
| Kidney disorder/problems (including kidney failure): nausea, vomiting, fever, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, increased or decreased urine output, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, mental status changes (drowsiness, confusion, coma) | X | ||
| Liver problems (including hepatitis, liver failure, cholestasis): yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness | X | ||
| Lung problems, asthma: increased shortness of breath, wheezing, difficulty breathing, cough and chest tightness, irregular heartbeat | X | ||
| Myocardial infarction (heart attack): pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat | X | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Stroke (bleeding or blood clot in the brain): sudden numbness, weakness or tingling of the face, arm, or leg, particularly on one side of the body, sudden headache, blurry vision, difficulty swallowing or speaking, or lethargy, dizziness, fainting, vomiting, trouble understanding, trouble with walking and loss of balance | X | ||
| Tinnitus (hearing problems): includes ringing, buzzing, clicking or hissing in ears, loss of hearing | X | ||
| Vertigo (a sense of severe spinning dizziness, lightheadedness) | X | ||
| RARE | |||
Serious Skin Reactions: fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, swelling of face and/or legs, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine or dark urine | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Store at controlled room temperature (15°C to 30°C).
Do NOT keep expired medicine or medicine you no longer need. Return all outdated or unused medicine to your pharmacist.
Keep out of reach and sight of children.
If you want more information about APO-PIROXICAM:
Talk to your healthcare professional
Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website: http://www.apotex.ca/products or by calling 1-800-667-4708.