INDICATION

CAMBIA is a prescription medicine used to treat migraine attacks in adults. It does not prevent or lessen the number of migraines you have, and it is not for other types of headaches. CAMBIA contains diclofenac potassium (a non-steroidal anti-inflammatory drug or NSAID).

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about CAMBIA?

CAMBIA contains diclofenac (a non-steroidal anti-inflammatory drug or NSAID).

NSAIDs, including CAMBIA, can cause serious side effects, including:

• Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
  • with increasing doses of NSAIDs
  • with longer use of NSAIDs

Do not take NSAIDs, including CAMBIA, right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

Avoid taking NSAIDs, including CAMBIA, after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

• Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
• anytime during use
• without warning symptoms
• that may cause death

The risk of getting an ulcer or bleeding increases with:

• past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
• taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
• increasing doses of NSAIDs
• longer use of NSAIDs
• smoking
• drinking alcohol
• older age
• poor health
• advanced liver disease
• bleeding problems

CAMBIA should only be used:

• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed

Who should not take CAMBIA?

Do not take CAMBIA:

• if you have had an asthma attack, hives, or other allergic reaction with aspirin, diclofenac, or any other NSAIDs.
• right before or after heart bypass surgery.

Before taking CAMBIA, tell your healthcare provider about all your medical conditions, including if you:

• have liver or kidney problems
• have a history of stomach ulcer or bleeding in your stomach or intestines
• have any allergies to any medicines
• have chest pain, shortness of breath, irregular heartbeats
• have high blood pressure
• have asthma
• are pregnant, think you might be pregnant, or are trying to become pregnant. Taking NSAIDs, including CAMBIA, at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy.
• are breastfeeding or plan to breastfeed.
• have a headache that is different from your usual migraine

Tell your doctor about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. NSAIDs, like CAMBIA, and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

Especially tell your doctor if you take:

• aspirin
• any anticoagulant medicines (warfarin, Coumadin, Jantoven)

Know the medicine you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

What are the possible side effects of CAMBIA?

CAMBIA can cause serious side effects, including:

See “What is the most important information I should know about CAMBIA?”

• new or worse high blood pressure
• heart failure
• liver problems including liver failure
• kidney problems including kidney failure
• bleeding and ulcers in the stomach and intestine
• low red blood cells (anemia)
• life-threatening skin reactions
• life-threatening allergic reactions
• asthma attacks in people who have asthma
• medication overuse headaches. Some people who use too much CAMBIA may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with CAMBIA.

Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms:

• shortness of breath or trouble breathing
• chest pain
• weakness in one part or one side of your body
• slurred speech
• swelling of the face or throat

Stop CAMBIA and call your healthcare provider right away if you have any of the following symptoms:

• nausea that seems out of proportion to your migraine
• sudden or severe pain in your belly
• more tired or weaker than usual
• diarrhea
• itching
• your skin or eyes look yellow
• indigestion or stomach pain
• vomit blood
• there is blood in your bowel movement or it is black and sticky like tar
• unusual weight gain
• skin rash or blisters with fever
• swelling of the arms, legs, hands and feet
• flu-like symptoms

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

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

Please see full  Prescribing Information including BOXED WARNING and  Medication Guide for more information about CAMBIA.