Meclofenamate is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat fever or mild to moderate pain in adults. Meclofenamate is also used to relieve symptoms of osteoarthritis or rheumatoid arthritis in adults, and juvenile arthritis in children who are at least 14 years old.

Meclofenamate is also used to treat menstrual pain or heavy menstrual bleeding.

Meclofenamate is sometimes used long-term to treat symptoms of ankylosing spondylitis, gouty arthritis, or shoulder pain caused by bursitis or tendinitis.

Meclofenamate may also be used for purposes not listed in this medication guide.

Meclofenamate can increase your risk of fatal heart attack or stroke. Do not use meclofenamate just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Meclofenamate may also cause stomach or intestinal bleeding, which can be fatal.

Meclofenamate comes as a capsule to take by mouth. It is usually taken three or four times a day for arthritis, three times a day for heavy menstrual blood loss, or every 4 to 6 hours as needed for pain. Meclofenamate may be taken with food or milk to prevent nausea. If you take meclofenamate regularly, take it at the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take meclofenamate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are taking meclofenamate to reduce heavy menstrual bleeding, your bleeding should decrease during your treatment. Call your doctor if your bleeding does not decrease or if you experience spotting or bleeding between menstrual periods.

If you are taking meclofenamate to relieve the symptoms of arthritis, your symptoms may begin to improve within a few days. It may take 2 to 3 weeks or longer for you to feel the full benefit of meclofenamate.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the lowest dose that is effective in treating your condition.

Do not take more than 400 milligrams (mg) of meclofenamate in one day.

If you use meclofenamate long-term, you may need frequent medical tests at your doctor's office.

Store at room temperature, away from moisture, heat, and light.

Meclofenamate can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Meclofenamate may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using meclofenamate, especially in older adults.

You should not use meclofenamate if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Tell your doctor if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

• a heart attack, stroke, or blood clot;

• stomach ulcers or bleeding;

• liver or kidney disease;

• asthma; or

• fluid retention.

If you are pregnant, you should not take meclofenamate unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Tell your doctor if you are breastfeeding.

Meclofenamate is not approved for use by anyone younger than 14 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include weakness, drowsiness, nausea, vomiting, and stomach pain.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to meclofenamate (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Get emergency medical help if you have signs of an allergic reaction (sneezing, runny or stuffy nose, hives, wheezing or trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Meclofenamate may cause serious side effects. Stop using meclofenamate and call your doctor at once if you have:

• a skin rash, no matter how mild;

• shortness of breath (even with mild exertion);

• swelling or rapid weight gain;

• nausea, diarrhea, flu-like symptoms (fever, swollen glands, muscle aches, severe weakness);

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; o

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Older adults may be more likely to have symptoms of stomach bleeding.

Common side effects of meclofenamate may include:

• indigestion, stomach pain, nausea;

• diarrhea, constipation; or

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before using meclofenamate if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your other medicines, especially:

• lithium;

• methotrexate;

• a blood thinner (warfarin, Coumadin, Jantoven);

• heart or blood pressure medication, including a diuretic or "water pill"; or

• steroid medicine (such as prednisone).

This list is not complete. Other drugs may affect meclofenamate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.