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|Diclofenac Enteric-Coated Tablets

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Diclofenac Enteric-Coated Tablets

Generic Name: Diclofenac Enteric-Coated Tablets (dye-KLOE-fen-ak)
Brand Name: Voltaren

Diclofenac Enteric-Coated 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, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Diclofenac Enteric-Coated Tablets for a long time. Do not use Diclofenac Enteric-Coated Tablets right before or after bypass heart surgery.

Diclofenac Enteric-Coated 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 Enteric-Coated Tablets is used for:

Treating rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis. It may also be used for other conditions as determined by your doctor.

Diclofenac Enteric-Coated 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 Enteric-Coated Tablets if:

you are allergic to any ingredient in Diclofenac Enteric-Coated Tablets
you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)
you have recently had or will be having bypass heart surgery
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.

Before using Diclofenac Enteric-Coated Tablets:

Some medical conditions may interact with Diclofenac Enteric-Coated 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 product, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of kidney or liver disease, 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 for any of these diseases
if you have hearing problems, poor health, dehydration or low fluid volume, or low blood sodium levels, you drink alcohol, or you have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Diclofenac Enteric-Coated Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because risk of stomach bleeding may be increased
Probenecid because it may increase the risk of Diclofenac Enteric-Coated Tablets"s side effects
Cyclosporine, lithium, methotrexate, or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Diclofenac Enteric-Coated Tablets
Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Diclofenac Enteric-Coated Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Diclofenac Enteric-Coated 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 Enteric-Coated Tablets:

Use Diclofenac Enteric-Coated Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Diclofenac Enteric-Coated Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Diclofenac Enteric-Coated Tablets refilled.
Take Diclofenac Enteric-Coated 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 Enteric-Coated Tablets whole. Do not break, crush, or chew before swallowing.
Take Diclofenac Enteric-Coated Tablets with a full glass of water (8 oz/240 mL) as directed by your doctor.
If you miss a dose of Diclofenac Enteric-Coated 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. 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 Enteric-Coated Tablets.

Important safety information:

Diclofenac Enteric-Coated Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Diclofenac Enteric-Coated 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 Enteric-Coated Tablets. Taking it in high doses, for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Diclofenac Enteric-Coated Tablets with food will NOT reduce the risk of these effects. If you have severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling, contact your doctor or emergency room right away.
Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
Diclofenac Enteric-Coated 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 using Diclofenac Enteric-Coated Tablets unless your doctor tells you to.
Do not switch between different forms of Diclofenac Enteric-Coated Tablets (eg, enteric-coated tablets, immediate-release tablets) unless your doctor tells you to. They may not provide the same amount of medicine to your body.
Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be performed while you use Diclofenac Enteric-Coated 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 Enteric-Coated Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially bleeding and kidney problems.
Diclofenac Enteric-Coated Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Diclofenac Enteric-Coated Tablets may cause harm to the fetus. Do not use 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 using Diclofenac Enteric-Coated Tablets while you are pregnant. It is not known if Diclofenac Enteric-Coated Tablets is found in breast milk. Do not breast-feed while taking Diclofenac Enteric-Coated Tablets.

Possible side effects of Diclofenac Enteric-Coated Tablets:

All medicines can 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; dark urine; 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; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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

Proper storage of Diclofenac Enteric-Coated Tablets:

Store Diclofenac Enteric-Coated 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 Enteric-Coated Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Diclofenac Enteric-Coated Tablets, please talk with your doctor, pharmacist, or other health care provider.
Diclofenac Enteric-Coated 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.

This information is a summary only. It does not contain all information about Diclofenac Enteric-Coated Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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