OA/RA SYMPTOM RELIEF

Reduced risk of stomach ulcer

VIMOVO combines relief from OA/RA symptoms with reduced risk of developing stomach ulcers in one tablet

Frequently Asked Questions

VIMOVO is a prescription 2-in-1 combination tablet that contains 2 medicines, Naproxen and Esomeprazole magnesium

  • Naproxen is a nonsteroidal anti-inflammatory drug (NSAID)
  • Esomeprazole magnesium is a Proton Pump Inhibitor, a medicine that may help reduce stomach acid

VIMOVO is used to:

  • Relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults and juvenile idiopathic arthritis (JIA) in adolescent patients
  • Decrease the risk of developing ulcers in the stomach in patients who are taking naproxen
  • It is not known if VIMOVO is safe and effective in children less than 12 years of age or who weigh less than 84 pounds (38 kg)

You should take VIMOVO exactly as prescribed, at the lowest dose possible and for the shortest time needed. VIMOVO may help your acid-related symptoms, but you could still have serious stomach problems.

VIMOVO contains naproxen (an NSAID) and esomeprazole magnesium. NSAID-containing medicines, such as VIMOVO, increase the chance of a heart attack or stroke that can lead to death. This risk may occur early in treatment. This chance increases:

  • With increasing doses of medicine containing NSAIDs
  • With longer use of medicines containing NSAIDs

VIMOVO should never be used right before or after a heart surgery called a coronary artery bypass graft (CABG). You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

NSAID-containing medicines, such as VIMOVO, can cause ulcers and bleeding in the stomach and intestines at any time during treatment.

Ulcers and bleeding:

  • Can occur anytime during use
  • Can happen without warning symptoms
  • May cause death

The chance of a person getting an ulcer or bleeding with NSAIDs increases with:

  • Past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
  • Taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
  • Longer use of NSAIDs
  • Increasing doses of NSAIDs
  • Smoking
  • Drinking alcohol
  • Older age
  • Advanced liver disease
  • Bleeding problems
  • Having poor health

Talk to your health care provider or pharmacist before using other medicines that contain NSAIDs, including low-dose aspirin, during treatment with VIMOVO.

VIMOVO is available by prescription only. Ask your health care provider if VIMOVO may be right for you.

You should not take VIMOVO:

  • If you had an asthma attack, hives or other allergic reaction after taking aspirin or other NSAID medicines
  • Right before or after a heart surgery called coronary artery bypass graft surgery
  • If you are taking a medicine that contains rilpivirine (Edurant, Complera, Odefsey) used to treat HIV-1 (Human Immunodeficiency Virus)
  • If you know you are allergic to naproxen, esomeprazole magnesium, omeprazole, any other PPI medicine or any of the ingredients in VIMOVO
  • If you are in the late stages of pregnancy (after 30 weeks of pregnancy)

Before you take VIMOVO, you should tell your health care provider if you:

  • Have asthma
  • Have high blood pressure (hypertension)
  • Have heart problems
  • Have low magnesium levels in your blood
  • Have ulcerative colitis or Crohn’s disease (inflammatory bowel disease or IBD)
  • Have a history of stomach ulcers
  • Take or plan to take low-dose aspirin
  • Have liver or kidney problems
  • Have any other medical conditions
  • Are pregnant or plan to become pregnant. VIMOVO should not be used by pregnant women late in their pregnancy. See Medication Guide for more information
  • Are breastfeeding or plan to breastfeed. VIMOVO can pass into your milk and may harm your baby. You should not breastfeed while taking VIMOVO. Talk to your health care provider about the best way to feed your baby if you take VIMOVO

You should tell your health care provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Since VIMOVO contains naproxen, talk to your health care provider before taking any other NSAID-containing products. NSAIDs may be present in over-the-counter medications for treatment of colds, fever or insomnia; refer to the label of over-the-counter medications you are taking or ask your pharmacist.

Using VIMOVO with other medicines can cause serious side effects. VIMOVO may affect the way other medicines work, and other medicines may affect how VIMOVO works. Especially tell your doctor if you take:

  • Aspirin, Warfarin (Coumadin, Jantovin), Rifampin (Rifater, Rifamate, Rimactane, Rifadin), Digoxin (Lanoxin) and Clopidogrel (Plavix)
  • Diuretics
  • Medications for high blood pressure or heart problems
  • Antidepressants
  • Methotrexate (Otrexup, Rasuvo, Trexall, Xatmep)
  • Steroid Hormones (corticosteroids)
  • St. John’s Wort

Ask your health care provider about VIMOVO; only your health care provider can offer information that is specific to your own health history.

Nonsteroidal anti-inflammatory drugs are used to treat pain and redness, swelling and heat (inflammation) from medical conditions, including different types of arthritis (e.g., osteoarthritis and rheumatoid arthritis).

Esomeprazole magnesium is a Proton Pump Inhibitor (PPI), a medicine that may help reduce stomach acid.

  • Take VIMOVO exactly as prescribed by your health care provider
  • Take 1 VIMOVO tablet 2 times each day
  • Take VIMOVO at least 30 minutes before a meal
  • Swallow VIMOVO tablets whole with liquid. Do not split, chew, crush, or dissolve VIMOVO
  • You can use antacids while taking VIMOVO

If you take too much VIMOVO, call your health care provider or your poison control center at 1-800-222-1222 right away or go to the nearest emergency room.

If you forget to take a dose of VIMOVO, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take 2 doses at 1 time to make up for a missed dose.

  • Store VIMOVO at room temperature between 68°F to 77°F (20°C to 25°C)
  • Store VIMOVO in the original container and keep the bottle tightly closed

INDICATIONS AND USAGE
What is VIMOVO® (naproxen and esomeprazole magnesium)?

VIMOVO contains two medicines: naproxen, a nonsteroidal anti-inflammatory drug (NSAID) and esomeprazole magnesium, a proton pump inhibitor (PPI). VIMOVO is a prescription medicine used in adults and adolescents, 12 years of age and older who weigh at least 84 pounds (38 kg), who need to take naproxen for relief of symptoms of arthritis and who also need to decrease the risk of developing stomach ulcers caused by naproxen. The naproxen in VIMOVO is used for the relief of signs and symptoms of:

  • osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in adults
  • juvenile idiopathic arthritis (JIA) in adolescents

The esomeprazole magnesium in VIMOVO is used to decrease the risk of developing stomach ulcers in people who are taking naproxen.

It is not known if VIMOVO is safe and effective in children less than 12 years of age or who weigh less than 84 pounds (38 kg). You should not take a naproxen tablet and an esomeprazole magnesium tablet together instead of taking VIMOVO, because they will not work the same way. Studies in people who take VIMOVO have not extended past 6 months.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about VIMOVO?
  • VIMOVO can cause an increased risk of a heart attack or stroke that can lead to death. This risk may occur early in treatment and may increase with longer use and with increasing doses of medicine containing NSAIDs.
  • VIMOVO can cause an increased risk of bleeding, ulcers, and tears (perforations) of the esophagus, stomach, and intestines. These events can occur at any time during use, without warning symptoms, and may cause death. Elderly patients and patients with a history of ulcer disease or stomach or intestinal bleeding are at greater risk for getting an ulcer or bleeding.
  • You should take VIMOVO exactly as prescribed, at the lowest dose possible and for the shortest time needed.
VIMOVO can cause serious side effects. Stop taking VIMOVO and call your doctor or go to your emergency department right away if you get:
  • Difficulty breathing, swelling of the face or throat. These could be signs of a serious allergic reaction.
  • Chest pain, shortness of breath, weakness in one part or side of your body, or slurring of speech. These could be signs of a serious blood clotting event.
  • Upper stomach pain, upset stomach, black, tarry stools, or vomiting of blood. These could be signs of an esophagus, stomach, or intestinal ulcer, bleed, or tear. Note: if you are also taking low-dose aspirin, you are at increased risk for esophagus, stomach, or intestinal bleeding.
  • Nausea, more tired or weaker than usual, itching, yellowing of the skin or eyes, right upper abdomen tenderness, and “flu-like” symptoms. These could be signs of a liver problem.
  • Shortness of breath, unexplained weight gain, or swelling of the arms, legs, hands, or feet. These could be signs of a serious heart problem.
  • Diarrhea that does not improve. This could be a sign of an infection called Clostridium difficile infection.
  • Any type of rash. This could be a sign of a serious skin reaction.
  • New or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. These could be signs of certain types of lupus erythematosus.
  • Decreased volume of urine or blood in urine. These could be signs of a kidney problem.

These are not all of the possible side effects of VIMOVO. Please talk to your doctor if you experience any symptoms that bother you or that do not go away. If you take too much VIMOVO, call your poison control center at 1-800-222-1222.
Who should not use VIMOVO?
  • DO NOT USE VIMOVO:
    • if you are allergic to naproxen, esomeprazole magnesium, omeprazole, any other PPI medicine, or any of the ingredients in VIMOVO. See the Medication Guide for a complete list of ingredients.
    • if you have had an asthma attack, hives, or other allergic reaction after taking aspirin or any other NSAIDs.
    • right before or after a heart bypass surgery called coronary artery bypass graft.
    • If you are in the 30th week of pregnancy until delivery
    • If you are taking a medicine that contains rilpivirine (Edurant, Complera, Odefsey) used to treat HIV-1 (Human Immunodeficiency Virus).
How should I take VIMOVO?

Take VIMOVO exactly as your health care provider tells you to take it. Take VIMOVO at least 30 minutes before a meal. Swallow VIMOVO tablets whole with liquid. Do not split, chew, crush, or dissolve the VIMOVO tablet. If you forget to take a dose of VIMOVO, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take 2 doses at one time to make up for a missed dose.
What are the possible side effects of VIMOVO?

The most common side effects of VIMOVO are inflammation of the lining of the stomach and diarrhea.
What other medications might interact with VIMOVO?

Avoid using VIMOVO while taking other naproxen-containing products or other non-aspirin NSAIDs, clopidogrel, St. John’s Wort, or rifampin. NSAIDs may be present in over-the-counter medications for treatment of colds, fever, or insomnia; refer to the label of over-the-counter medications you are taking or ask your pharmacist. Do not use VIMOVO and low-dose aspirin until you talk to your health care provider. Tell your health care provider about all of the medicines you take as some medicines can react with VIMOVO and cause serious side effects.
What should I tell my health care provider?

Before starting VIMOVO, tell your health care provider if you have a history of ulcer disease or esophagus, stomach, or intestine bleeding, liver or kidney problems, high blood pressure, heart problems, asthma, low magnesium levels, ulcerative colitis or Crohn’s disease, or are pregnant, trying to become pregnant, or breast feeding. Taking NSAIDs, such as VIMOVO, at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to use VIMOVO for more than 2 days when you are between 20 and 30 weeks of pregnancy, your health care provider may need to monitor the amount of fluid in your womb around your baby. You should not use VIMOVO after about 30 weeks of pregnancy. Talk to your health care provider about the risk of bone fractures or a certain type of stomach growths or developing low magnesium or vitamin B-12 levels if you take VIMOVO for a long period of time. Also tell your health care provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. Do not start taking new medicines without talking to your health care provider first.

Please see the Medication Guide and Prescribing Information or visit VIMOVO.com for additional information. 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.

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

What is VIMOVO® (naproxen and esomeprazole magnesium)?

VIMOVO contains two medicines: naproxen, a nonsteroidal anti-inflammatory drug (NSAID) and esomeprazole magnesium, a proton pump inhibitor (PPI). VIMOVO is a prescription medicine used in adults and adolescents, 12 years of age and older who weigh at least 84 pounds (38 kg), who need to take naproxen for relief of symptoms of arthritis and who also need to decrease the risk of developing stomach ulcers caused by naproxen. The naproxen in VIMOVO is used for the relief of signs and symptoms of:

  • osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in adults
  • juvenile idiopathic arthritis (JIA) in adolescents

INDICATIONS AND USAGE
What is VIMOVO® (naproxen and esomeprazole magnesium)?

VIMOVO contains two medicines: naproxen, a nonsteroidal anti-inflammatory drug (NSAID) and esomeprazole magnesium, a proton pump inhibitor (PPI). VIMOVO is a prescription medicine used in adults and adolescents, 12 years of age and older who weigh at least 84 pounds (38 kg), who need to take naproxen for relief of symptoms of arthritis and who also need to decrease the risk of developing stomach ulcers caused by naproxen. The naproxen in VIMOVO is used for the relief of signs and symptoms of:

  • osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in adults
  • juvenile idiopathic arthritis (JIA) in adolescents

The esomeprazole magnesium in VIMOVO is used to decrease the risk of developing stomach ulcers in people who are taking naproxen.

It is not known if VIMOVO is safe and effective in children less than 12 years of age or who weigh less than 84 pounds (38 kg). You should not take a naproxen tablet and an esomeprazole magnesium tablet together instead of taking VIMOVO, because they will not work the same way. Studies in people who take VIMOVO have not extended past 6 months.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about VIMOVO?
  • VIMOVO can cause an increased risk of a heart attack or stroke that can lead to death. This risk may occur early in treatment and may increase with longer use and with increasing doses of medicine containing NSAIDs.
  • VIMOVO can cause an increased risk of bleeding, ulcers, and tears (perforations) of the esophagus, stomach, and intestines. These events can occur at any time during use, without warning symptoms, and may cause death. Elderly patients and patients with a history of ulcer disease or stomach or intestinal bleeding are at greater risk for getting an ulcer or bleeding.
  • You should take VIMOVO exactly as prescribed, at the lowest dose possible and for the shortest time needed.
VIMOVO can cause serious side effects. Stop taking VIMOVO and call your doctor or go to your emergency department right away if you get:
  • Difficulty breathing, swelling of the face or throat. These could be signs of a serious allergic reaction.
  • Chest pain, shortness of breath, weakness in one part or side of your body, or slurring of speech. These could be signs of a serious blood clotting event.
  • Upper stomach pain, upset stomach, black, tarry stools, or vomiting of blood. These could be signs of an esophagus, stomach, or intestinal ulcer, bleed, or tear. Note: if you are also taking low-dose aspirin, you are at increased risk for esophagus, stomach, or intestinal bleeding.
  • Nausea, more tired or weaker than usual, itching, yellowing of the skin or eyes, right upper abdomen tenderness, and “flu-like” symptoms. These could be signs of a liver problem.
  • Shortness of breath, unexplained weight gain, or swelling of the arms, legs, hands, or feet. These could be signs of a serious heart problem.
  • Diarrhea that does not improve. This could be a sign of an infection called Clostridium difficile infection.
  • Any type of rash. This could be a sign of a serious skin reaction.
  • New or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. These could be signs of certain types of lupus erythematosus.
  • Decreased volume of urine or blood in urine. These could be signs of a kidney problem.

These are not all of the possible side effects of VIMOVO. Please talk to your doctor if you experience any symptoms that bother you or that do not go away. If you take too much VIMOVO, call your poison control center at 1-800-222-1222.
Who should not use VIMOVO?
  • DO NOT USE VIMOVO:
    • if you are allergic to naproxen, esomeprazole magnesium, omeprazole, any other PPI medicine, or any of the ingredients in VIMOVO. See the Medication Guide for a complete list of ingredients.
    • if you have had an asthma attack, hives, or other allergic reaction after taking aspirin or any other NSAIDs.
    • right before or after a heart bypass surgery called coronary artery bypass graft.
    • If you are in the 30th week of pregnancy until delivery
    • If you are taking a medicine that contains rilpivirine (Edurant, Complera, Odefsey) used to treat HIV-1 (Human Immunodeficiency Virus).
How should I take VIMOVO?

Take VIMOVO exactly as your health care provider tells you to take it. Take VIMOVO at least 30 minutes before a meal. Swallow VIMOVO tablets whole with liquid. Do not split, chew, crush, or dissolve the VIMOVO tablet. If you forget to take a dose of VIMOVO, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take 2 doses at one time to make up for a missed dose.
What are the possible side effects of VIMOVO?

The most common side effects of VIMOVO are inflammation of the lining of the stomach and diarrhea.
What other medications might interact with VIMOVO?

Avoid using VIMOVO while taking other naproxen-containing products or other non-aspirin NSAIDs, clopidogrel, St. John’s Wort, or rifampin. NSAIDs may be present in over-the-counter medications for treatment of colds, fever, or insomnia; refer to the label of over-the-counter medications you are taking or ask your pharmacist. Do not use VIMOVO and low-dose aspirin until you talk to your health care provider. Tell your health care provider about all of the medicines you take as some medicines can react with VIMOVO and cause serious side effects.
What should I tell my health care provider?

Before starting VIMOVO, tell your health care provider if you have a history of ulcer disease or esophagus, stomach, or intestine bleeding, liver or kidney problems, high blood pressure, heart problems, asthma, low magnesium levels, ulcerative colitis or Crohn’s disease, or are pregnant, trying to become pregnant, or breast feeding. Taking NSAIDs, such as VIMOVO, at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to use VIMOVO for more than 2 days when you are between 20 and 30 weeks of pregnancy, your health care provider may need to monitor the amount of fluid in your womb around your baby. You should not use VIMOVO after about 30 weeks of pregnancy. Talk to your health care provider about the risk of bone fractures or a certain type of stomach growths or developing low magnesium or vitamin B-12 levels if you take VIMOVO for a long period of time. Also tell your health care provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. Do not start taking new medicines without talking to your health care provider first.

Please see the Medication Guide and Prescribing Information or visit VIMOVO.com for additional information. 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.