Details for: MINT-INDOMETHACIN
Company: MINT PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02461811 | MINT-INDOMETHACIN | INDOMETHACIN | 25 MG | CAPSULE | ORAL |
| 02461536 | MINT-INDOMETHACIN | INDOMETHACIN | 50 MG | CAPSULE | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Your health care provider has prescribed MINT-INDOMETHACIN, for you for one or more of the following medical conditions:
- treat the symptoms of certain types of arthritis, including gout.
- helps to relieve joint pain, swelling, stiffness and fever by reducing the production of certain substances (prostaglandins)
- help to control inflammation and other body reactions.
What it does
MINT-INDOMETHACIN (Indomethacin Capsules), as a nonsteroidal anti-inflammatory drug (NSAID), can reduce the chemicals produced by your body which cause pain and swelling.
MINT-INDOMETHACIN, as a nonsteroidal anti-inflammatory drug (NSAID), does NOT cure your illness or prevent it from getting worse. MINT-INDOMETHACIN can only relieve pain and reduce swelling as long as you continue to take it.
When it should not be used
DO NOT TAKE MINT-INDOMETHACIN if you have any of the following medical conditions:
- Heart bypass surgery (planning to have or recently had)
- Severe, uncontrolled heart failure
- Bleeding in the brain or other bleeding disorders
- Current pregnancy (after 28 weeks of pregnancy) Currently breastfeeding (or planning to breastfeed)
- Allergy to ASA (Acetylsalicylic Acid) or other NSAIDs (Nonsteroidal Anti- Inflammatory Drugs)
- Ulcer (active)
- Bleeding from the stomach or gut (active)
- Inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis)
- Liver disease (active or severe)
- Kidney disease (severe or worsening)
- High potassium in the blood
Patients who took a drug in the same class as MINT-INDOMETHACIN after a type of heart surgery (coronary artery bypass grafting (CABG)) were more likely to have heart attacks, strokes, blood clots in the leg(s) or lung(s), and infections or other complications than those who did NOT take that drug.
MINT-INDOMETHACIN should NOT be used in children since the safety and effectiveness have NOT been established.
What the medicinal ingredient is
Indomethacin
What the non-medicinal ingredients are
Non-medicinal ingredients: Lactose monohydrate, sodium lauryl sulphate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate and empty gelatin capsules (FD&C Blue #1, D&C Yellow #10, titanium dioxide, gelatin and purified water) imprinted in black ink (shellac, propylene glycol, black iron oxide and potassium hydroxide).
What dosage form it comes in
MINT-INDOMETHACIN (indomethacin) is available as follows:
Capsules: 25 mg or 50 mg.
Warnings and precautions
If you have, or previously had, any of the following medical conditions, see your health care provider to discuss treatment options other than MINT-INDOMETHACIN:
- Heart Attack or Angina
- Stroke or Mini-stroke
- Loss of Vision
- Current Pregnancy (less than 28 weeks)
- Congestive Heart Failure
Before taking this medication, tell your health care provider if you have any of the following:
- High blood pressure
- High cholesterol
- Diabetes mellitus or on a low sugar diet
- Atherosclerosis
- Poor circulation to your extremities
- Smoker or ex-smoker
- Kidney disease or urine problems
- Previous ulcer or bleeding from the stomach or gut
- Previous bleeding in the brain
- Bleeding problems
- Family history of allergy to NSAIDs, such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic acid, tolmetin, or valdecoxib (NOT a complete list)
- Family history of asthma, nasal polyps, long-term swelling of the sinus (chronic sinusitis) or hives
- Family history of allergy to sulfonamide drugs
- A previous allergic reaction could increase the risk of an allergic reaction to MINT-INDOMETHACIN.- if you ever had an ulcer with or without bleeding, of the stomach, duodenum, or any part of the digestive tract, liver or kidney diseases or any other medical problems.
Also, before taking this medication, tell your health care provider if you are planning to get pregnant.
Note also that MINT-INDOMETHACIN is not recommended for use during pregnancy and that one should not breast-feed while on MINT-INDOMETHACIN.
While taking this medication:
- tell any other doctor, dentist, pharmacist or other health care professional that you see, that you are taking this medication, especially if you are planning to have heart surgery;
- do NOT drink alcoholic beverages while taking this medication because you would be more likely to develop stomach problems;
- fertility may be decreased. The use of MINT-INDOMETHACIN is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping MINT-INDOMETHACIN should be considered.
- be cautious about driving or participating in activities that require alertness if you are drowsy, dizzy or lightheaded after taking this medication;
- check with your physician if you are not getting any relief or if any problems develop;
- report any untoward reactions to your physician. This is very important as it will aid in the early detection and prevention of potential complications.
- your regular medical checkups are essential;
- if you require more information on this drug, consult your physician or pharmacist.
- keep this medication, and all others, out of the reach of children
Interactions with this medication
Talk to your health care provider and pharmacist if you are taking any other medication (prescription or non-prescription) such as any of the following (NOT a complete list):
- Acetylsalicylic Acid (ASA) or other NSAIDs e.g. ASA, celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen
- Antacids
- Antidepressants
- Selective Serotonin Reuptake Inhibitors (SSRIs) e.g. citalopram, fluoxetine, paroxetine, sertraline
- Blood pressure medications
- ACE (angiotensin converting enzyme) inhibitors e.g. enalapril, lisinopril, perindopril, Ramipril
- ARBs (angiotensin II receptor blockers) e.g. candesartan, irbesartan, losartan, valsartan
- Blood thinners e.g. warfarin, ASA, clopidogrel
- Corticosteroids (including glucocorticoids) e.g. prednisone
- Cyclosporin
- Digoxin
- Diuretics e.g. furosemide, hydrochlorothiazide
- Lithium
- Methotrexate
- Oral contraceptives
- Oral hypoglycemics (diabetes medications)
- Tacrolimus
Do not take ASA (acetylsalicylic acid), ASA compounds or other drugs used to relieve symptoms of arthritis while taking MINT-INDOMETHACIN unless directed to do so by your physician.
If you are prescribed this medication for use over a long period of time, your physician will check your health during regular visits to assess your progress and to ensure that this medication is not causing unwanted effects.
Along with its beneficial effects, MINT-INDOMETHACIN like other NSAID drugs, may cause some undesirable reactions. Elderly, frail or debilitated patients often seem to experience more frequent or more severe side effects. Although not all of these side effects are common, when they do occur they may require medical attention. Check with physician immediately if any of the following are noted:
- bloody or black tarry stools.
- shortness of breath, wheezing, any trouble in breathing or tightness in the chest;
- skin rash, swelling, hives or itching;
- indigestion, nausea, vomiting, stomach pain or diarrhea;
- yellow discolouration of the skin or eyes, with or without fatigue;
- any changes in the amount or colour of your urine (such as dark, red or brown);
- swelling of the feet or lower legs;
- blurred vision or any visual disturbance;
- mental confusion, depression, dizziness, lightheadedness, hearing problems.
Your health care provider may prescribe low dose ASA (acetylsalicylic acid) as a blood thinner to reduce your risk of having a heart attack or stroke while you are taking MINT-INDOMETHACIN. Take only the amount of ASA prescribed by your health care provider. You are more likely to upset or damage your stomach if you take both MINT-INDOMETHACIN and ASA than if you took MINT-INDOMETHACIN alone.
Proper use of this medication
Usual Dose
In chronic disorders, treatment should be started with a dosage of 25 mg two or three times a day. By starting therapy with low dosage, increased gradually when necessary, maximum benefit will be produced with fewer adverse reactions. Always give MINT-INDOMETHACIN with food immediately after meals or with antacids to reduce gastric irritation.
As with all drugs, the lowest possible effective dose should be utilized for each individual patient.
HOW TO USE THIS MEDICINE
To lessen stomach upset, take this medicine immediately after a meal or with food or milk. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhea) occurs and continues, contact your physician.
PLEASE ADHERE TO THE DOSAGE AND ADMINISTRATION INSTRUCTIONS WHICH YOUR PHYSICIAN HAS GIVEN YOU
- Do not take more of it, do not take it more often, and do not take it for a longer period of time than your physician prescribed.
If you are taking MINT-INDOMETHACIN to relieve arthritis, you must take it regularly as prescribed by your physician. In some types of arthritis, up to 2 weeks may pass before you begin to feel better and up to 1 month may pass before you feel the full effects of this medicine.
| Medical condition | Age group | Starting dose | Maximum dose (per day) | Maximum duration of Treatment (days) |
|---|---|---|---|---|
| Rheumatoid Arthritis and Ankylosing (Rheumatoid) Spondylitis | Adult | 25 mg; 2 or 3 times daily | 200 mg | 2 to 3 weeks |
| Sever Osteoarthritis and Degenerative Joint Disease of the hip | Adult | 25 mg; 2 or 3 times daily | 200 mg | 2 to 3 weeks |
| Gout | Adult | 50 mg; three times daily | Not applicable | 5 days |
Take MINT-INDOMETHACIN only as directed by your health care provider. Do NOT take more of it, do NOT take it more often and do NOT take it for a longer period of time than your health care provider recommended. If possible, you should take the lowest dose of this medication for the shortest time period. Taking too much MINT-INDOMETHACIN may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other diseases or take other medications.
If you will be using MINT-INDOMETHACIN for more than 7 days, see your health care provider regularly to discuss whether this medicine is working for you and if it is causing you any unwanted effects.
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.
MINT-INDOMETHACIN is NOT recommended for use in children since safety and effectiveness have NOT been established.
MINT-INDOMETHACIN must be taken with food.
Missed Dose
If you miss a dose of MINT-INDOMETHACIN and remember within an hour or so, take it right away. Then go back to your regular dosing schedule.
But if you do not remember until later, do not take the missed dose at all and do not double the next one. Instead, go back to your regular dosing schedule.
Overdose
If you take more than the prescribed dose, contact your health care provider immediately.
In case of accidental overdose, consult a physician immediately or contact your regional Poison Control Centre.
Side effects and what to do about them
MINT-INDOMETHACIN may cause some side effects, especially when used for a long time or in large doses. When these side effects occur, you may require medical attention. Report all symptoms or side effects to your health care provider.
MINT-INDOMETHACIN may cause you to become drowsy or tired. Be careful about driving or participating in activities that require you to be alert. If you become drowsy, dizzy or light-headed after taking MINT-INDOMETHACIN, do NOT drive or operate machinery.
MINT-INDOMETHACIN may cause you to become more sensitive to sunlight. Any exposure to 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, check with your health care provider.
Check with your health care provider IMMEDIATELY if you develop chills, fever, muscle aches or pains, or other flu-like symptoms, especially if they occur before or together with a skin rash. These symptoms may be the first signs of a SERIOUS ALLERGIC REACTION to this medication.
| Symptom | STOP taking MINT-INDOMETHACIN and get emergency medical attention immediately | STOP taking MINT-INDOMETHACIN and talk to your physician or pharmacist |
|---|---|---|
| Bloody or black tarry stools | ✔ | |
| Shortness of breath, wheezing, and trouble breathing or chest tightness | ✔ | |
| Skin rash, hives, swelling or itching | ✔ | |
| Blurred vision, or any visual disturbance | ✔ | |
| Any change in the amount or colour of your urine (red or brown) | ✔ | |
| Any pain or difficulty experienced while Urinating | ✔ | |
| Swelling of the feet, lower legs; weight Gain | ✔ | |
| Vomiting or persistent indigestion, nausea, stomach pain or diarrhea | ✔ | |
| Yellow Discolouration of the skin or eyes, with or without itchy skin | ✔ | |
| Malaise, fatigue, loss of appetite | ✔ | |
| Headaches, stiff neck | ✔ | |
| Mental confusion, depression | ✔ | |
| Dizziness, lightheadedness | ✔ | |
| Hearing Problems | ✔ |
This is NOT a complete list of side effects. If you develop any other symptoms while taking MINT-INDOMETHACIN, see your health care provider.
How to store
Store between 15 and 30°C. Protect from moisture. Store in a tight container.
Do NOT keep outdated medicine or medicine no longer needed. Any outdated or unused medicine should be returned to your pharmacist.
Keep out of reach and sight of children.
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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
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.
More information
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.mintpharmaceuticals.com
or by contacting the sponsor, Mint Pharmaceuticals Inc., at:
1-877-398-9696
This leaflet was prepared by
Mint Pharmaceuticals Inc.
Mississauga, Ontario L5T 1J6
Last prepared: February 16, 2017