Patient Medication Information: uses, side effects, how to take - Apo-Indomethacin
Serious Warnings and Precautions
Heart and blood vessel problems:
Gastrointestinal (stomach and intestine) problems:
Talk to your healthcare professional about any medical conditions you have and drugs you are taking. Pregnancy:
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What is APO-INDOMETHACIN is used for?
APO-INDOMETHACIN is used in adults to treat the symptoms of certain types of arthritis disorders, such as:
- Rheumatoid Arthritis. APO-INDOMETHACIN may be taken alone or in combination with other medicines.
- Ankylosing (Rheumatoid) Spondylitis
- Osteoarthritis
- Severe osteoarthritis of the hip, when treatment with other medicines have not worked well
- Gout
How does APO-INDOMETHACIN work?
- APO-INDOMETHACIN 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-INDOMETHACIN only treats the symptoms and relieves pain and inflammation as long as you take it. APO-INDOMETHACIN does NOT cure the illness or stop it from getting worse.
What are the ingredients in APO-INDOMETHACIN?
Medicinal ingredients: Indomethacin
Non-medicinal ingredients: Cornstarch, lactose monohydrate, stearic acid and talc. The capsule shell includes the non-medicinal ingredients: D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, pharmaceutical ink and titanium dioxide. The pharmaceutical ink includes the non-medicinal ingredients: D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, iron oxide black, propylene glycol and shellac glaze.
APO-INDOMETHACIN comes in the following dosage forms:
Capsules: 25 mg or 50 mg.
Do not use APO-INDOMETHACIN if:
- you have heart bypass surgery (planning to have or recently had)
- 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 or later)
- you are currently breastfeeding (or planning to breastfeed)
- you are allergic to indomethacin or any other ingredients in this medicine or the container
- 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 an active stomach or intestine ulcer
- 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 18 years of age
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-INDOMETHACIN. Talk about any health conditions or problems you may have, including if you:
- have high blood pressure, high cholesterol or diabetes
- have or had heart attacks, chest pain, heart disease, stroke or heart failure
- have poor blood flow 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
Other warnings you should know about:
Serious side effects: APO-INDOMETHACIN can cause serious side effects, including:
Blood and bleeding problems:
- APO-INDOMETHACIN can cause blood problems, bleeding and prolonged bleeding.
Taking APO-INDOMETHACIN with the following drugs can increase the risk of bleeding:
- Anticoagulants (prevents blood clots), corticosteroids (anti-inflammatory), or antidepressants like selective serotonin reuptake inhibitors (SSRIs).
Serious Skin Reactions: In rare cases, serious, life-threatening allergic and skin reactions have been reported with some NSAIDs, such as APO-INDOMETHACIN. These skin problems
- most often happen during the first month of treatment. Tell your healthcare professional immediately if you notice any changes in your skin both during and after treatment.
APO-INDOMETHACIN might cause you to become more sensitive to sunlight. Sunlight or sunlamps may cause sunburn, skin blisters, skin rash, redness, itching or discolouration, 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-INDOMETHACIN. They will:
- Check your blood pressure.
- Check your eyes. APO-INDOMETHACIN 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 machinery: APO-INDOMETHACIN 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-INDOMETHACIN, do NOT drive or operate machinery.
Fertility in Women: APO-INDOMETHACIN 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-INDOMETHACIN. Talk to your healthcare professional if you have any 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-INDOMETHACIN. 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-INDOMETHACIN:
Acetylsalicylic Acid (ASA) or other NSAIDs, used to treat pain, fever and inflammation, like:
- celecoxib, diclofenac, ibuprofen, naproxen, diflunisal
- Antacids, used to treat symptoms of excess stomach acid
- 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 or to prevent blood clots, like warfarin, ASA, clopidogrel
- Medicines used to lower extra fluid levels (diuretics), like furosemide, hydrochlorothiazide
- Medicines used to treat diabetes, like sulphonylurea or other oral 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
- Digoxin, used to treat heart disorders
- Medicines used to treat different cancers, like methotrexate and pemetrexed
- Medicines used to treat bacterial infections (antibiotics) like quinolones
- Oral birth control, used to prevent pregnancy
- Probenecid, used to prevent gout
- Alcohol
How to take APO-INDOMETHACIN:
- Take APO-INDOMETHACIN exactly as your healthcare professional tells you. They should recommend the lowest dose possible for your treatment for the shortest time needed.
Take this medicine immediately 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 will be taking APO-INDOMETHACIN for more than 7 days, see your healthcare professional regularly. They will check if APO-INDOMETHACIN is working for you and if it is causing any side effects.
Usual Dose:
Adults 18 years and older:
- Your healthcare professional will decide on the best dosage for you based on your condition.
Your healthcare professional may lower your dose, stop your treatment for a period of time or recommend that you stop treatment completely. This may happen if you:
- experience serious side effects, or
- your disease gets worse.
Missed Dose:
- If you miss a dose of APO-INDOMETHACIN and remember within an hour or so, take it right away. Take your next dose at the usual time.
- If you do not remember until later, skip the missed dose. Take your next dose at the usual time.
- Do NOT double the dose to make up for the dose you have missed.
Overdose:
| If you think you, or a person you are caring for, have taken too much APO-INDOMETHACIN, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
What are possible side effects from using APO-INDOMETHACIN?
These are not all the possible side effects you may have when taking APO-INDOMETHACIN. If you experience any side effects not listed here, tell your healthcare professional.
- Nausea, vomiting, diarrhea, constipation, stomach upset/abdominal pain, heartburn, indigestion, feeling gassy
- Headache, dizziness, light-headedness
- Feeling of burning/prickliness/numbing
- Confusion, hard to concentrate or think, short-term memory loss, nervousness
- Bruises
- Skin rash
- Taste disorder, thirst, dry mouth
- Muscle pain
- Mouth sores
- Hair loss
- Increased sweating
- Problems with your period (women)
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, black tarry or bloody stool, dizziness, stomach pain, bloating, loss of appetite, weight loss, nausea, vomiting, constipation or diarrhea, | ✓ | ||
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 | ||
| chills or fever | |||
Hypertension (high blood pressure): fatigue, dizziness or fainting, chest pain | ✓ | ||
| 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 | ✓ | ||
| 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 | ✓ | ||
| 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 | ✓ | ||
| 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 | ✓ | ||
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 | ✓ | ||
Depression (sad mood that will not go away): difficulty sleeping or sleeping too much, changes in appetite or weight, reduced sex drive and thoughts of death or suicide. | ✓ | ||
Kidney disorder/problems (including kidney failure): nausea, vomiting, fever, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, increased or | ✓ | ||
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 | ||
decreased urine output, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, mental status changes (drowsiness, confusion, coma) | |||
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 | ✓ | ||
Lung problems, asthma: increased shortness of breath, wheezing, difficulty breathing, cough and chest tightness, irregular heartbeat | ✓ | ||
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. | ✓ | ||
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 | ✓ | ||
Tinnitus (hearing problems): includes ringing, buzzing, clicking or hissing in ears, loss of hearing | ✓ | ||
Vertigo (a sense of severe spinning dizziness, lightheadedness) | ✓ | ||
| RARE | |||
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 | |
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, hives, red or dry itchy skin, purple or red spots on skin | ||
| ✓ | ||
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
- Calling toll-free at 1-866-234-2345.
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.
Storage:
Store at controlled room temperature (15°-30°C).
Keep container tightly closed. Protect from light.
Do NOT keep expired medicine or medicine no longer needed. Return to your healthcare professional.
Keep out of reach and sight of children.
If you want more information about APO-INDOMETHACIN:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient 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.