Zipsor is a nonsteroidal anti-inflammatory drug (NSAID). Diclofenac potassium works by reducing substances in the body that cause pain and inflammation.

Zipsor capsules are used to treat mild to moderate acute pain in adults and pediatric patients 12 years of age or older.

Zipsor is supplied as a 25mg liquid capsule.

Zipsor may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using diclofenac.

The chance of a person getting an ulcer or intestinal bleeding increases with the following; when taking medicines called “corticosteroids” and “anticoagulants”, with longer use, with smoking or drinking alcohol, with older age, and when in poor health.

Zipsor can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Diclofenac may also cause stomach or intestinal bleeding, which can be fatal.

Before taking this medicine

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

Do not use Zipsor if you are allergic to beef or beef protein.

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

• heart disease, high blood pressure;

• ulcers or bleeding in your stomach;

• asthma;

• liver or kidney disease; or

• if you smoke.

Diclofenac can affect ovulation and it may be harder to get pregnant while you are using this medicine.

If you are pregnant, you should not take Zipsor unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Zipsor is not approved for use by anyone younger than 12 years old.

Take Zipsor exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Use the lowest dose that is effective in treating your condition.

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

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

Usual Adult Dose for Pain:

Oral:
Diclofenac potassium liquid-filled capsules: 25 mg orally 4 times a day
Comment: Diclofenac potassium liquid filled capsules are not interchangeable with other diclofenac products containing the sodium or potassium salt.

Usual Pediatric Dose for Pain:

Diclofenac potassium liquid-filled capsules:
12 years and older: 25 mg orally four times a day
Comments: Use the lowest effective dose for the shortest duration consistent with treatment goals.

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

Do not use Zipsor if you are allergic to beef or beef protein.

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

• heart disease, high blood pressure;

• ulcers or bleeding in your stomach;

• asthma;

• liver or kidney disease; or

• if you smoke.

Diclofenac can affect ovulation and it may be harder to get pregnant while you are using this medicine.

If you are pregnant, you should not take Zipsor unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Zipsor is not approved for use by anyone younger than 12 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Avoid taking aspirin or other NSAIDs unless your doctor tells you to.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to diclofenac (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Get emergency medical help if you have signs of an allergic reaction to Zipsor (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using Zipsor and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

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 Zipsor and call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;

• flu-like symptoms;

• heart problems - swelling, rapid weight gain, feeling short of breath;

• kidney problems - little or no urinating, painful or difficult urination, swelling in your arms or legs, feeling tired or short of breath;

• liver problems - nausea, diarrhea, stomach pain (upper right side), tiredness, itching, dark urine, jaundice (yellowing of the skin or eyes); or

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common Zipsor side effects may include:

• indigestion, gas, nausea, vomiting, stomach pain;

• diarrhea, constipation;

• headache, dizziness, drowsiness;

• abnormal lab tests;

• itching, sweating;

• stuffy nose;

• increased blood pressure; or

• swelling or pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before using Zipsor if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your other medicines, especially:

• heart or blood pressure medication, including a diuretic or "water pill";

• other forms of diclofenac (Arthrotec, Flector, Pennsaid, Solaraze, Voltaren Gel);

• a blood thinner - warfarin, Coumadin, Jantoven; or

• other NSAIDs - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with diclofenac, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.