Vimovo

Disclaimer

Vimovo Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

NAPROXEN/ESOMEPRAZOLE - ORAL

(na-PROX-en/ES-oh-MEP-ra-zole)

COMMON BRAND NAME(S): Vimovo

WARNING: The naproxen in this combination medication may rarely cause blood clots to form, causing a heart attack or stroke. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG). Also, this drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This can occur without warning symptoms and at any time during treatment. The risk of bleeding is greater in older adults. Esomeprazole decreases the risk of bleeding.

Stop taking this medication and get medical help right away if you notice any of the following rare but very serious side effects: chest/jaw/left arm pain, severe dizziness, weakness on one side of the body, vision changes, slurred speech, black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds. (See also Precautions section.)

Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.

USES: This medication is used to treat the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis when there is a high risk for stomach bleeding/ulcer. This product contains 2 medications: esomeprazole and naproxen. This product should not be used to relieve sudden pain. The naproxen starts to work slower than other naproxen products because of a special coating (delayed-release).

If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It reduces pain, swelling, and joint stiffness. Naproxen can cause stomach ulcers, especially in patients with a history of stomach ulcers. Esomeprazole is a proton pump inhibitor (PPI) that blocks acid production in the stomach. This combination provides the benefits of naproxen and may reduce the risk of ulcers or bleeding that can occur with naproxen use.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually twice daily (in the morning and evening) at least 30 minutes before a meal. Take it with a full glass (8 ounces or 240 milliliters) of water unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug. Swallow the tablet whole. Do not break, chew, crush or dissolve the tablet. Doing so can destroy the slow release of the drug and may increase side effects. If needed, you can take antacids while using this medication.

The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose, take it more frequently, or take it for longer than prescribed.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. It may take up to 2 weeks of taking this drug until you get the full benefit.

Tell your doctor if your condition persists or worsens.

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