Dolobid (Diflunisal)

DOLOBID can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

DOLOBID may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using DOLOBID, especially in older adults.

You should not use DOLOBID if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure DOLOBID is safe for you, tell your doctor if you have:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a history of heart attack, stroke, or blood clot;
• a history of stomach ulcers or bleeding;
• asthma;
• liver or kidney disease; or
• fluid retention.

Taking DOLOBID during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using DOLOBID.

DOLOBID can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

DOLOBID is not approved for use by anyone younger than 12 years old. Ask a doctor before giving this medicine to a child or teenager with a fever, flu symptoms, or chicken pox.

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using DOLOBID and call your doctor at once if you have:

• changes in your vision;
• the first sign of any skin rash, no matter how mild;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
• low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, vomiting, stomach pain, indigestion;
• diarrhea, constipation, gas;
• dizziness, drowsiness, headache, tired feeling;
• rash; or
• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin or other NSAIDs while you are taking DOLOBID.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to DOLOBID. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb DOLOBID.

Ask your doctor before using DOLOBID if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• acetaminophen (Tylenol);
• cyclosporine;
• lithium;
• methotrexate;
• a blood thinner (warfarin, Coumadin, Jantoven);
• heart or blood pressure medication, including a diuretic or "water pill"; or
• steroid medicine (such as prednisone).

This list is not complete. Other drugs may interact with DOLOBID, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Do not crush, break, or chew a DOLOBID tablet. Swallow it whole.

If you use this medicine long-term, you may need frequent medical tests.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using DOLOBID.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include vomiting, diarrhea, gasping for breath, fast heart rate, sweating, confusion, extreme drowsiness, and fainting.

Since DOLOBID is sometimes used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.