IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
MECLOFENAMATE SODIUM - ORAL
COMMON BRAND NAME(S): Meclomen
WARNING: Nonsteroidal anti-inflammatory drugs (including meclofenamate) may rarely increase the risk for a (sometimes fatal) heart attack or stroke. This effect does not apply to low-dose aspirin. (See Drug Interactions section.) The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG). Also, this drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This bleeding can occur without warning symptoms at any time during treatment.
Stop taking this medication and seek immediate medical attention if you notice any of the following rare but very serious side effects: chest pain, severe dizziness, trouble breathing, weakness on one side of the body, sudden vision changes, slurred speech, black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds. (See also Precautions section.)
Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.
USES: Meclofenamate is used for the treatment of mild to moderate pain from various conditions (e.g., dental pain, osteoarthritis) and to decrease pain and blood loss from menstrual periods. It is also used alone or with other treatments to reduce pain, swelling, and joint stiffness from rheumatoid arthritis.
If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.
Meclofenamate is known as a nonsteroidal anti-inflammatory drug (NSAID).
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to treat gout attacks.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking meclofenamate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth, usually 3 to 4 times a day with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. Do not lie down for at least 10 minutes after taking this drug. If stomach upset occurs, take this medication with food, milk, or an antacid.
If you are using this medication for heavy or painful periods, it is usually taken 3 times a day. Take your first dose as soon as your period starts, and continue taking this medication for up to 6 days or as directed by your doctor.
Dosage is based on your medical condition and response to therapy. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Discuss the risks and benefits with your doctor or pharmacist.
For ongoing conditions such as arthritis, take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day. It may take 2-3 weeks of taking this drug regularly until you get the full benefit.
If you are taking this drug on an "as needed" basis (not on a regular schedule), it is usually taken every 4 to 6 hours as needed. The usual maximum dose is 400 milligrams each day. Remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medicine may not work as well. Pain relief usually starts within 1 hour after taking this medication. The drug may take longer to start working and may not work as well when taken with food.
Inform your doctor if your condition worsens or if you develop new symptoms.
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Nausea, vomiting, heartburn, dizziness, drowsiness, diarrhea, and headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. If you are taking this medication for heavy/painful periods, tell your doctor if you have spotting/bleeding between cycles or an unusually heavy menstrual flow.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, persistent/severe headache, fast/pounding heartbeat, hearing changes (e.g., ringing in the ears), mental/mood changes, stomach pain, difficult/painful swallowing, swelling of the ankles/feet/hands, sudden/unexplained weight gain, unusual tiredness.
Stop taking meclofenamate and tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), unexplained stiff neck, change in the amount/color of urine, vision changes.
This drug may rarely cause serious, possibly fatal liver disease. If you notice any of the following rare but very serious side effects, stop taking meclofenamate and consult your doctor or pharmacist immediately: persistent nausea/vomiting, severe stomach/abdominal pain, weakness, dark urine, yellowing eyes/skin.
A very serious allergic reaction to this drug is rare. However, stop taking meclofenamate and immediately seek medical attention if you notice any of the following symptoms of a serious allergic reaction: rash/blisters, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Meclofenamate (meclofenamate) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking meclofenamate, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG), active bleeding/sores in stomach/intestines (ulcer, gastrointestinal bleeding).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, bleeding/clotting problems, blood disorders (e.g., anemia), high blood pressure, diabetes, heart disease (e.g., history of heart attack), liver disease, growths in the nose (nasal polyps), obesity, tobacco use, history of stomach/intestine/esophagus problems (e.g., bleeding, ulcers, recurring heartburn), stroke, swelling of the ankles/feet/hands.
Kidney problems can sometimes occur with the use of NSAID medications, including meclofenamate. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have any unusual change in the amount of urine.
Before having surgery, tell your doctor or dentist that you are using this medication.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.
This medicine contains sodium. If you are on a salt-restricted diet or have any condition that requires you to restrict your intake of salt, consult your doctor or pharmacist about using this drug safely.
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially stomach bleeding and kidney problems.
Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.
This drug passes into breast milk. Consult your doctor before breast-feeding.
Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), cidofovir, corticosteroids (e.g., prednisone), lithium, methotrexate, "water pills" (diuretics such as furosemide).
This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.
Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or ketorolac). These drugs are similar to meclofenamate and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, vomit that looks like coffee grounds, extreme drowsiness, slow/shallow breathing, seizures.
NOTES: Do not share this drug with others.
Laboratory and/or medical tests (e.g., blood pressure, complete blood count, eye exams, liver and kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you are taking this drug on a regular schedule (not "as needed") and you miss a dose, 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.
STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised April 2015. Copyright(c) 2015 First Databank, Inc.