Patient Information

Important Safety Information
Including Boxed Warnings

Approved Uses

Prescribing Information

Important Safety Information

VIMOVO is not right for everyone, including patients who have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine, patients who are allergic to any of the ingredients in VIMOVO, or women in late stages of pregnancy.

Serious allergic reactions, including skin reactions, can occur without warning and can be life-threatening; discontinue use of VIMOVO at the first appearance of a skin rash, or if you develop sudden wheezing; swelling of the lips, tongue or throat; fainting; or problems swallowing.

VIMOVO should be used at the lowest dose and for the shortest amount of time as directed by your health care provider.

Tell your health care provider right away if you develop signs of active bleeding from any source.

VIMOVO can lead to onset of new hypertension or worsening of existing high blood pressure, either of which may contribute to an increased risk of a heart attack or stroke.

Speak with your health care provider before starting VIMOVO if you

• Have a history of ulcers or bleeding in the stomach or intestines
• Have heart problems, high blood pressure, or are taking high blood pressure medications
• Have kidney or liver problems

Tell your health care provider about all of the medicines you take including prescription and non-prescription drugs, vitamins, and herbal supplements before starting VIMOVO.

Talk to your health care provider about your risk for bone fractures if you take VIMOVO for a long period of time.

Talk to your health care provider about your risk for developing low levels of magnesium if you take VIMOVO for a long period of time.

The most common side effects of VIMOVO include: inflammation of the lining of the stomach, indigestion, diarrhea, stomach ulcers, abdominal pain, and nausea.

Approved Uses for VIMOVO

VIMOVO is approved to relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment with NSAIDs.

VIMOVO is not recommended as a starting treatment for relief of acute pain. Controlled studies do not extend beyond
6 months.

For further information on VIMOVO, please see the full Prescribing Information, including Boxed Warnings.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

This product information is intended for US consumers only.

©2011 AstraZeneca. 1202400 9/11

VIMOVO is a registered trademark of the AstraZeneca group of companies.