Patient Medication Information: uses, side effects, how to take - Odan-Indomethacin
Serious Warnings and Precautions
Heart and blood vessel problems:
- ODAN-INDOMETHACIN can cause heart and blood vessel problems like heart attacks, stroke, blood clots, high blood pressure and heart failure. These can lead to death.
- The risk of having heart problems is higher if you take ODAN-INDOMETHACIN for long periods of time and/or at higher doses and/or in people who have heart disease.
- Tell your healthcare professional if you have or have had heart problems, high blood pressure or diabetes.
Gastrointestinal (stomach and intestine) problems:
- ODAN-INDOMETHACIN can cause stomach and intestine problems like ulcers, inflammation, bleeding, holes/perforation, blockage or pain.
Talk to your healthcare professional about any medical conditions you have and drugs you are taking.
Pregnancy:
DO NOT take ODAN-INDOMETHACIN if you are pregnant and in a later stage of pregnancy (28 weeks or later).
If you are pregnant and in an earlier stage of pregnancy (less than 28 weeks) only Take
ODAN-INDOMETHACIN if you are told to do so by your healthcare professional.
- Medicines like ODAN-INDOMETHACIN may cause harm to you and your baby. Your healthcare professional will need to closely monitor your health and that of your baby (including your amniotic fluid levels) if they prescribe ODAN-INDOMETHACIN during this time.
- Tell your healthcare professional right away if you become pregnant, or think you may be pregnant or want to get pregnant during treatment with ODAN-INDOMETHACIN
What is ODAN-INDOMETHACIN used for?
ODAN-INDOMETHACIN is used in adults and adolescents (15 years of age and older) to treat the symptoms of certain types of arthritis disorders, such as:
- Rheumatoid Arthritis. ODAN-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 ODAN-INDOMETHACIN work?
ODAN-INDOMETHACIN belongs to a group of medicines called nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances produced by your body which cause pain and swelling.
ODAN-INDOMETHACIN does NOT cure your illness or prevent it from getting worse. It can only relieve pain and reduce inflammation as long as you continue to take it.
What are the ingredients in ODAN-INDOMETHACIN?
Medicinal ingredients: indomethacin
Non-medicinal ingredients: suppocire
ODAN-INDOMETHACIN comes in the following dosage forms:
Suppositories: 50 mg and 100 mg.
Do not use ODAN-INDOMETHACIN if:
- you have heart bypass surgery (planning to have or recently had)
- you are pregnant and in a later stage of pregnancy (28 weeks or later)
- you are currently breastfeeding (or planning to breastfeed)
- you have severe, uncontrolled heart failure
- you have bleeding in the brain or other bleeding disorders
- 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 or a history of recurring 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 younger than 15 years of age
- You take other NSAIDs drugs used to relieve symptoms of arthritis.
- You have a recent history of bleeding or inflammation of the rectum
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ODAN-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
- have mental disturbance, convulsions, or Parkinsonism
- have urine abnormalities.
Other warnings you should know about:
Serious side effects: ODAN-INDOMETHACIN can cause serious side effects, including:
Blood and bleeding problems:
ODAN-INDOMETHACIN can cause blood problems, bleeding and prolonged bleeding. Taking ODAN-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 ODAN-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.
ODAN-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 ODAN-INDOMETHACIN. They will:
- Check your blood pressure.
- Check your eyes. ODAN-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: ODAN-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 ODAN-INDOMETHACIN, do NOT drive or operate machinery.
Fertility in Women: ODAN-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 ODAN-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 ODAN-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 ODAN-INDOMETHACIN:
Acetylsalicylic Acid (ASA) or other NSAIDs, used to treat pain, fever and inflammation, like:
- celecoxib, diclofenac, ibuprofen, naproxen
- Acetaminophen, used to treat reduce fever and relieve pain
- Medicines used as blood thinners or to prevent blood clots, like warfarin, ASA, clopidogrel
- Medicines used to treat diabetes, like sulphonylurea or other oral hypoglycemics
- Medicines used to lower extra fluid levels (diuretics), like furosemide, hydrochlorothiazide
- Medicines used to treat high blood pressure like enalapril, ramipril, candesartan, irbesartan, propranolol
- Medicines used to treat different cancers, like methotrexate and pemetrexed
- Medicines used to treat bacterial infections (antibiotics) like quinolones and aminoglycosides
- Oral birth control, used to prevent pregnancy
- Colchicine and Probenecid, used to prevent gout
- Corticosteroids (including glucocorticoids such as prednisone), used as an anti-inflammatory
- Medicines used to lower the risk of organ rejection, like tacrolimus and cyclosporin
- Digoxin, used to treat heart disorders
- Medicines used to treat depression (antidepressants) like citalopram, fluoxetine, paroxetine, sertraline, and lithium
- Gold Compounds
- Potassium Supplements
- Valproic Acid
- Zidovudine
- Alcohol
How to take ODAN-INDOMETHACIN:
- Take ODAN-INDOMETHACIN exactly as your healthcare professional tells you. They should recommend the lowest dose possible for your treatment for the shortest time needed.
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.
Serious Drug Interactions
Do not take ODAN-INDOMETHACIN with diflunisal as it can cause fatal intestinal bleeding.
- ODAN-INDOMETHACIN suppositories are individually wrapped in plastic shells. Make sure that the wrapping material is fully removed before inserting into the rectum.
- Do not take suppositories by mouth.
How to insert ODAN-INDOMETHACIN:
- 1. If the bowel needs to be emptied, this should be done before inserting into rectum
- 2. For ease of insertion, lubricate the tapered end of the suppository with cold water.
- 3. Lie down on your side and use your finger to push the suppository as high as possible into the rectum.
- 4. If it is pushed out, wash it off in cold water and reinsert. If the suppository cannot be retained, do not use and consult a healthcare professional.
Usual dose:
Adolescents (15 years of age or older) and Adult Dosage: 100 to 200 mg per day.
- A daily dose of 100 mg can be given as 50 mg twice a day or 100 mg at night.
- Doses higher than 100 mg should be taken twice a day
- Your healthcare professional may adjust your dose depending on how you respond or if you experience side effects
Overdose:
Missed Dose:
- If you miss a dose of ODAN-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.
What are possible side effects from using ODAN-INDOMETHACIN?
These are not all the possible side effects you may have when taking ODAN-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
If you think you, or a person you are caring for, have taken too much ODAN-INDOMETHACIN, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
- Increased sweating
- Problems with your period (women)
Serious side effects and what to do about them
| Talk to your healthcare | Stop taking drug | ||
| professional | |||
| Symptom/ effect | and get immediate | ||
| Only if | In all cases | ||
| medical help | |||
| severe | |||
| VERY COMMON | |||
| Rectal problems related to the use of suppositories: inflamed, burning sensation, feeling that you need to pass stool, bleeding, pain, itching and discomfort | ✓ | ||
| 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, 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 | ✓ | ||
Serious side effects and what to do about them
| Talk to your healthcare | Stop taking drug | ||
| professional | |||
| Symptom/ effect | and get immediate | ||
| Only if | In all cases | ||
| medical help | |||
| severe | |||
| 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 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
| Talk to your healthcare | Stop taking drug | ||
| professional | |||
| Symptom/ effect | and get immediate | ||
| Only if | In all cases | ||
| medical help | |||
| severe | |||
| 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.
Storage:
- ODAN-INDOMETHACIN suppositories should be stored at room temperature, between 15 and 30°C.
- Keep out of reach and sight of children.
- Do not keep outdated medicine or medicine no longer needed.
If you want more information about ODAN-INDOMETHACIN:
- 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; or by calling the manufacturer at 1-888-666-6326.
Last Revised: AUG 23, 2023
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.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.