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Diclofenac extended-release tablets

Pronunciation

Generic Name: diclofenac (dye-KLOE-fen-ak)
Brand Name: Voltaren XR

Diclofenac extended-release tablets is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, a heart attack, stroke). The risk may be greater if you already have heart problems or if you take diclofenac extended-release tablets for a long time. Do not use diclofenac extended-release tablets right before or after bypass heart surgery.

Diclofenac extended-release tablets may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.


Diclofenac extended-release tablets is used for:

Treating pain and inflammation caused by certain conditions (eg, rheumatoid arthritis, osteoarthritis). It may also be used for other conditions as determined by your doctor.

Diclofenac extended-release tablets is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Do NOT use diclofenac extended-release tablets if:

  • you are allergic to any ingredient in diclofenac extended-release tablets
  • you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or another NSAID (eg, ibuprofen, celecoxib)
  • you have recently had or will be having bypass heart surgery
  • you have severe kidney problems
  • you are in the last 3 months of pregnancy

Contact your doctor or health care provider right away if any of these apply to you.

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Before using diclofenac extended-release tablets:

Some medical conditions may interact with diclofenac extended-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney or liver problems, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)
  • if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation
  • if you have high blood pressure, blood disorders (eg, porphyria), bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk of any of these diseases
  • if you have poor health, dehydration or low fluid volume, or low blood sodium levels, or you drink alcohol or have a history of alcohol abuse

Some MEDICINES MAY INTERACT with diclofenac extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin), aspirin, clopidogrel, corticosteroids (eg, prednisone), direct factor Xa inhibitors (eg, rivaroxaban), heparin, prasugrel, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of bleeding, including stomach bleeding, may be increased
  • Azole antifungals (eg, itraconazole, voriconazole), bisphosphonates (eg, risedronate), or probenecid because they may increase the risk of diclofenac extended-release tablets's side effects
  • Rifamycins (eg, rifampin) because they may decrease diclofenac extended-release tablets's effectiveness
  • Cyclosporine, lithium, methotrexate, other NSAIDs (eg, ibuprofen), quinolones (eg, ciprofloxacin), or tenofovir because the risk of their side effects may be increased by diclofenac extended-release tablets
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by diclofenac extended-release tablets
  • Medicines that may harm the liver (eg, acetaminophen, ketoconazole, isoniazid, certain medicines for HIV infection, certain antibiotics or seizure medicines) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if diclofenac extended-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use diclofenac extended-release tablets:

Use diclofenac extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Diclofenac extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get diclofenac extended-release tablets refilled.
  • Take diclofenac extended-release tablets by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
  • Swallow diclofenac extended-release tablets whole. Do not break, crush, or chew before swallowing.
  • Take diclofenac extended-release tablets with a full glass of water (8 oz/240 mL) as directed by your doctor.
  • If you miss a dose of diclofenac extended-release tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about the proper use of diclofenac extended-release tablets.

Important safety information:

  • Diclofenac extended-release tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use diclofenac extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Serious stomach ulcers or bleeding can occur with the use of diclofenac extended-release tablets. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking diclofenac extended-release tablets with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Diclofenac extended-release tablets is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Do not take aspirin while you are taking diclofenac extended-release tablets unless your doctor tells you to.
  • Do not switch between different forms of diclofenac extended-release tablets (eg, enteric-coated tablets, extended-release tablets) unless your doctor tells you to. They may not provide the same amount of medicine to your body.
  • Lab tests, including kidney and liver function, blood electrolyte levels, complete blood cell counts, and blood pressure, may be performed while you use diclofenac extended-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use diclofenac extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
  • Diclofenac extended-release tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Diclofenac extended-release tablets may cause harm to the fetus. Do not take it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking diclofenac extended-release tablets while you are pregnant. It is not known if diclofenac extended-release tablets is found in breast milk. Do not breast-feed while taking diclofenac extended-release tablets.

Possible side effects of diclofenac extended-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting or diarrhea; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the skin or eyes); unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea, vomiting, or stomach pain; slow or troubled breathing; tremor; unusual bleeding or bruising; vomit that looks like coffee grounds.

Proper storage of diclofenac extended-release tablets:

Store diclofenac extended-release tablets at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep diclofenac extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about diclofenac extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Diclofenac extended-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take diclofenac extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about diclofenac extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to diclofenac extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using diclofenac extended-release tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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