VIMOVO™ (naproxen/esomeprazole magnesium) Delayed-Release Tablets

Patient Information

Important Safety Information
including Boxed Warnings

Approved Uses

Prescribing Information

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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.

Important Safety Information

Like all medications that contain nonsteroidal anti-inflammatory drugs (NSAIDs), VIMOVO may increase the chance of a heart attack or stroke that can lead to death. This chance increases
- With longer use of NSAID medicines
- In people who have heart disease
NSAID-containing medications, such as VIMOVO, should never be used before or after a type of heart surgery called coronary artery bypass graft (CABG)
As with all medications that contain NSAIDs, VIMOVO may increase the chance of stomach and intestinal problems, such as bleeding or an ulcer, which can occur without warning and may cause death
- Elderly patients are at greater risk for serious gastrointestinal events

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

Review all the medications, even over-the-counter medications, you are taking with your health care provider 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.

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

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.

VIMOVO is a trademark of the AstraZeneca group of companies.