Diclofenac (By mouth)

Introduction

Diclofenac (dye-KLOE-fen-ak)

Treats pain caused by arthritis, ankylosing spondylitis, or other medical problems. Also treats acute migraine attacks in adults. This is a nonsteroidal antiinflammatory medicine (NSAID).

Brand Name(s)

Voltaren, Voltaren-XR, Zipsor, Cambia, Cataflam

When This Medicine Should Not Be Used

How to Use This Medicine

Capsule, Liquid, Tablet, Coated Tablet, Long Acting Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
• Swallow the tablet whole with a full glass of water. Do not break, crush, or chew it.
• It is best to take this medicine with food or milk, so it does not upset your stomach. The oral solution should be taken on an empty stomach.
• Use this medicine for the shortest time possible and in the smallest dose possible. This will help lower the risk of side effects.
• To use the oral solution: Open the packet of medicine right before you use it. Empty the contents of the packet into a cup with 1 to 2 ounces (30 to 60 milliliters [mL]) of water. Do not use any liquid other than water for mixing the medicine.
• Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. .
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using aspirin, a blood thinner (such as warfarin, Coumadin®), a steroid medicine (such as cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, or Orapred®), or a diuretic or "water pill" (such as furosemide, hydrochlorothiazide [HCTZ], torsemide, Demadex®, or Lasix®).
• Do not use any other NSAID medicine unless your doctor says it is okay. Some other names are ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Ecotrin®, and Motrin®.
• Make sure your doctor knows if you are also using cyclosporine (Neoral®, Sandimmune®), lithium (Eskalith®), methotrexate (Rheumatrex®), or a blood pressure medicine (such as enalapril, lisinopril, Accupril®, Lotrel®, or Zestril®).
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breast feeding. Do not use this medicine during the later part of a pregnancy unless your doctor tells you to.
• Make sure your doctor knows if you have kidney disease, liver disease, anemia, aspirin-sensitive asthma, bleeding problems, high blood pressure, congestive heart failure (CHF), heart or circulation problems, or a history of stomach ulcers or bleeding.
• This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.
• This medicine might cause bleeding in your stomach or intestines. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid medicine or a blood thinner).
• Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.
• This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or nonsteroidal antiinflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.
• Make sure any doctor or dentist who treats you knows that you are using this medicine.
• Tell your doctor if you have phenylketonuria (PKU). The oral powder for solution contains phenylalanine, which can make this condition worse.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Bloody or black, tarry stools.
• Chest pain, shortness of breath, or coughing up blood.
• Change in how much or how often you urinate
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Problems with vision, speech, or walking.
• Severe stomach pain.
• Shortness of breath, cold sweat, and bluish-colored skin.
• Skin rash.
• Sudden or severe headache.
• Swelling in your hands, ankles, or feet.
• Unexplained weight gain.
• Unusual bleeding or bruising.
• Vomiting blood or something that looks like coffee grounds.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Mild nausea, stomach pain, constipation, or diarrhea.
• Ringing in your ears.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088