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

Cambia oral powder is used to treat a migraine headache attacks, with or without aura, in adults 18 years of age and older. It is not used to prevent migraine headaches. Do not use Cambia to treat a cluster headache.

Cambia will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

You should not use Cambia if you have a history of allergic reaction to aspirin or NSAIDs (non-steroidal anti-inflammatory drugs).

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

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

Before taking this medicine

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

Diclofenac can also increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

You should not use Cambia 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 Cambia to treat a cluster headache.

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 Cambia 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.

Cambia is not approved for use by anyone younger than 18 years old.

Take Cambia oral powder exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Take one dose of Cambia to treat your migraine headache:

• remove one single dose packet from a set of three packets
• open the packet only when you are ready to use it
• empty contents of packet into 1 to 2 ounces or 2 to 4 tablespoons (30 to 60 mL) of water. Do not use any other form of liquid
• mix well and drink the water and powder mixture
• throw away empty packet in a safe place and out of the reach of children
• taking Cambia with food may cause a reduction in effectiveness compared to taking Cambia on an empty stomach.

Call your doctor if your headache does not completely go away after taking Cambia. Do not take a second dose without your doctor's advice. Overuse of migraine headache medicine can make headaches worse. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks

If you use Cambia 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.

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

Usual Adult Dose for Migraine:

Diclofenac potassium for oral solution packets: 50 mg (1 packet) orally once

Comments: This drug is not indicated for the prophylactic therapy of migraine or for use in cluster headaches; the safety and efficacy of a second dose has not been established.

Use: For acute treatment of migraine with or without aura.

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

Diclofenac can also increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

You should not use Cambia 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 Cambia to treat a cluster headache.

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 Cambia 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.

Cambia is not approved for use by anyone younger than 18 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 Cambia (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 Cambia 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 Cambia 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 Cambia 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 Cambia 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.