Consumer Information for: MEFENAMIC

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Your health care provider has prescribed MEFENAMIC (Mefenamic Acid) for you for one or more of the following medical conditions:

  • discomfort caused by muscular aches
  • headache
  • primary dysmenorrhea
  • dental pain.
What it does

MEFENAMIC (Mefenamic acid) as a nonsteroidal antiinflammatory drug (NSAID), can reduce the chemicals produced by your body which cause pain and swelling. MEFENAMIC (Mefenamic acid) has demonstrated analgesic, anti-inflammatory and antipyretic properties. These effects may be due to MEFENAMIC’s (Mefenamic acid) dual action on prostaglandins, one of a number of hormone-like substances that participate in a wide range of body functions. MEFENAMIC (Mefenamic acid), as a nonsteroidal anti-inflammatory drug (NSAID), does NOT cure your illness or prevent it from getting worse. MEFENAMIC can only relieve pain and reduce swelling as long as you continue to take it.

When it should not be used

DO NOT TAKE MEFENAMIC 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 MEFENAMIC 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.

MEFENAMIC should NOT be used in patients under 18 years of age since the safety and effectiveness have NOT been established.

What the medicinal ingredient is

Mefenamic Acid 250 mg

What the non-medicinal ingredients are

Croscarmellose sodium, colloidal silicon dioxide, FD&C yellow #10, FD&C yellow #6, FD&C blue #1, gelatin, microcrystalline cellulose, sodium lauryl sulfate, stearic acid and titanium dioxide.

What dosage form it comes in

Each capsule USP, contains 250 mg of Mefenamic acid

Warnings and precautions

Serious 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 MEFENAMIC

  • 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, longterm swelling of the sinus (chronic sinusitis) or hives
  • Any other medical problem
Serious gastrointestinal toxicity such as bleeding, ulceration, and perforation, can occur at any time, with or without warning symptoms, if you are treated chronically with MEFENAMIC. If diarrhea or skin rash appear, you should discontinue MEFENAMIC immediately.

Blood counts and liver function should be monitored during longterm therapy. MEFENAMIC may enhance the effects of your oral anticoagulants medication.

Also, before taking this medication, tell your health care provider if you are planning to get pregnant.

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 MEFENAMIC is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping MEFENAMIC should be considered.
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
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 MEFENAMIC. 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 MEFENAMIC and ASA than if you took MEFENAMIC alone
Proper use of this medication

Usual Dose

Medical Condition Age Group Starting Dose Maximum Dose (per day) Maximum Duration Of Treatment (days)
Acute pain, Headache >18 y.o 2 capsules of 250 mg with meals 1250 mg 7
Primary dysmenorrhea >18 y.o 2 capsules of 250 mg with meals 1250 mg 3

Take MEFENAMIC 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 MEFENAMIC 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 MEFENAMIC 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.

MEFENAMIC is NOT recommended for use in patients under 18 years of age since safety and effectiveness have NOT been established.

MEFENAMIC must be taken with food.

Capsules should be swallowed whole. DO NOT open, divide, crush, or chew the capsules.

Overdose

If you take more than the prescribed dose, contact your health care provider immediately.

If you think you have taken too much MEFENAMIC, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose

If a dose is missed, you should take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Side effects and what to do about them

MEFENAMIC 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.

MEFENAMIC 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 MEFENAMIC, do NOT drive or operate machinery.

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.

Serious side effects, how often they happen and what to do about them
Symptom / effect STOP taking MEFENAMIC and talk to your physician or pharmacist STOP taking MEFENAMIC and get emergency medical attention IMMEDIATEL Y
Common
Bloody or black tarry stools   ✔
Shortness of breath, wheezing, any 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 ✔ Call your doctor immediately  
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 MEFENAMIC, see your health care provider. These side effects are rare.

How to store

Do NOT keep outdated medicine or medicine no longer needed. Any outdated or unused medicine should be returned to your pharmacist.

Keep the capsules in a dry place at normal room temperature (15°C to 30°C) in the packaging that they come in.

Keep out of reach of children.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

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: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about MEFENAMIC:

This leaflet was prepared by AA Pharma Inc.

Last revised: April 10, 2019

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