meloxicam submicronized 5 mg capsule

Generic name:
Meloxicam - oral

Pronunciation
(mel-OX-i-kam)

Brand name(s)
Mobic , Vivlodex

Nonsteroidal anti-inflammatory drugs (including meloxicam) may rarely increase the risk of a heart attack or stroke. This effect can happen at any time while taking this drug but is more likely if you take it for a long time. The risk may be greater in older adults or 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). Do not take this drug right before or after heart bypass surgery (CABG).

Also, this drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning symptoms at any time while taking this drug. Older adults may be at higher risk for this effect. (See also Precautions and Drug Interactions sections.)

Stop taking meloxicam and get medical help right away if you notice any of the following rare but serious side effects: stomach/abdominal pain that doesn't go away, bloody or black/tarry stools, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, sudden vision changes, trouble speaking.

Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.

Meloxicam is used to treat arthritis. It reduces pain, swelling, and stiffness of the joints. Meloxicam is known as a nonsteroidal anti-inflammatory drug (NSAID).

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.

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 drug may also be used for gout attacks.

Read the Medication Guide provided by your pharmacist before you start taking meloxicam and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily. If you are taking the tablet or capsule form of this medication, drink a full glass of water (8 ounces/240 milliliters) with it unless your doctor tells you otherwise. Do not lie down for at least 10 minutes after taking the tablet or capsule form of this medication.

If you are taking the liquid form of this medication, shake the bottle gently before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

If you are taking the disintegrating tablet, do not remove the tablet from the packaging until you are ready to take it. With dry hands, peel back the foil to carefully remove the tablet. Do not push the tablet through the foil because doing so can damage it. Place the tablet on your tongue right away and allow it to dissolve. After the tablet has melted, it can be swallowed with or without liquid.

If stomach upset occurs while taking this medication, take it with food, milk, or an antacid. The dosage is based on your medical condition and response to treatment. The lowest effective dosage should always be used, and only for the prescribed length of time. Do not take more of this medication than prescribed because higher doses increase the chance of stomach ulcers/bleeding.

Meloxicam may come in different forms (such as tablet, capsule, liquid, disintegrating tablet). Do not switch between different forms without consulting your doctor.

It may take up to two weeks before you get the full benefit of this drug. Use this medication regularly to get the most benefit from it. Remember to use it at the same time each day.

Tell your doctor if your condition gets worse.

See also Warning section.

Stomach upset, nausea, dizziness, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• easy bruising/bleeding
• mental/mood changes
• signs of kidney problems (such as change in the amount of urine)
• symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including:

• nausea/vomiting that doesn't stop
• loss of appetite
• dark urine
• stomach/abdominal pain
• yellowing eyes/skin

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• fever
• swollen lymph nodes
• rash
• 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking meloxicam, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• asthma (including a history of worsening breathing after taking aspirin or other NSAIDs)
• liver disease
• stomach/intestine/esophagus problems (such as bleeding, ulcers, recurring heartburn)
• heart disease (such as history of heart attack)
• high blood pressure
• stroke
• blood disorders (such as anemia, bleeding/clotting problems)
• growths in the nose (nasal polyps)

Kidney problems can sometimes occur with the use of NSAID medications, including meloxicam. 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 a change in the amount of urine.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis).

This medication may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medication, may increase your risk for stomach bleeding. Limit alcohol and smoking. Consult your doctor or pharmacist for more information.

The disintegrating tablet form of meloxicam may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be at greater risk for stomach/intestinal bleeding, kidney problems, heart attack, and stroke while using this drug.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk and are unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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
• lithium
• methotrexate (high-dose treatment)
• "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.

If you are using the liquid form of meloxicam, tell your doctor if you are also using sodium polystyrene sulfonate.

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 meloxicam and may increase your risk of side effects if taken together. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: slow/shallow breathing, extreme drowsiness, severe stomach pain, vomit that looks like coffee grounds.

Do not share this medication with others.

Lab and/or medical tests (such as blood counts, blood pressure, kidney/liver function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Non-drug treatment for arthritis that is approved by your doctor (such as weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for more information.

If 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. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.

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.