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IMPORTANT FACTS ABOUT THE SAFETY AND EFFICACY OF DUEXIS

DUEXIS proven to reduce the risk of developing stomach ulcers caused by ibuprofen by 50%

In 2 studies of people who required NSAID treatment for chronic painful conditions such as osteoarthritis and rheumatoid arthritis, treatment with DUEXIS reduced the risk of developing stomach ulcers by about 50% compared with people in the studies who took ibuprofen without any gastroprotective medicine.

  • DUEXIS 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.
  • DUEXIS can cause an increased risk of bleeding, ulcers, and tears (perforation) 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 intestine bleeding are at greater risk for getting an ulcer or bleeding.
  • You should take DUEXIS exactly as prescribed, at the lowest dose possible and for the shortest time needed.
  • The most common side effects of DUEXIS include nausea, diarrhea, constipation, upper abdominal pain and headache.

Taking DUEXIS with low-dose aspirin

If you take low-dose aspirin (less than or equal to 325 mg/day) and also need to take a prescription-strength NSAID for osteoarthritis or rheumatoid arthritis symptoms, DUEXIS may be an option for you and your doctor to consider.

However, it's important to be aware that all prescription NSAIDs, including DUEXIS, increase the chance of heart attack or stroke, which can lead to death.

Data have not shown that taking aspirin while on an NSAID like ibuprofen reduces the risk of serious blood clotting events, including heart attack and stroke, associated with NSAID use.

You should never use DUEXIS as a substitute for low-dose aspirin in preventing heart attack or stroke.

Taking aspirin and an NSAID is not generally recommended because of the increased risk of side effects, including serious ones. Tell your doctor if you take or plan to take aspirin.

Please see the Medication Guide and full Prescribing Information for more information.

This information does not take the place of talking with your health care provider about your medical condition or your treatment.

 

IMPORTANT SAFETY INFORMATION

 

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

  • DUEXIS 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.
  • DUEXIS can cause an increased risk of bleeding, ulcers, and tears (perforation) 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 intestine bleeding are at greater risk for getting an ulcer or bleeding.
  • You should take DUEXIS exactly as prescribed, at the lowest dose possible and for the shortest time needed.

DUEXIS can cause serious side effects. Stop taking DUEXIS 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.
  • Any type of rash. This could be a sign of a serious skin reaction.

These are not all of the possible side effects of DUEXIS. Please talk to your doctor if you experience any symptoms that bother you or that do not go away. If you take too much DUEXIS, call your poison control center at 1-800-222-1222.

 

INDICATIONS AND USAGE

What is DUEXIS® (ibuprofen and famotidine)?

DUEXIS contains two medicines: ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), and famotidine, a histamine H2-receptor blocker medicine.

DUEXIS is a prescription medicine used to:

  • relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis.
  • decrease the risk of developing ulcers of the stomach and upper intestines (upper gastrointestinal ulcers) in people taking ibuprofen for rheumatoid arthritis and osteoarthritis.

It is not known if DUEXIS is safe and effective in children.

 

Who should not use DUEXIS?

Do not take DUEXIS:

-if you are allergic to ibuprofen, famotidine, any other histamine H2-receptor blocker, or any of the ingredients in DUEXIS. See the Medication Guide for a complete list of ingredients.

- if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.

- right before or after heart bypass surgery called coronary artery bypass graft.

 

How should I take DUEXIS?

Take DUEXIS exactly as your health care provider tells you to take it. Do not change your dose or stop DUEXIS without first talking to your health care provider. Swallow DUEXIS tablets whole with liquid. Do not split, chew, crush, or dissolve the DUEXIS tablet. If you forget to take a dose of DUEXIS, 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. You should not take an ibuprofen tablet and famotidine tablet together instead of taking a DUEXIS tablet, because they will not work in the same way.

 

What are the possible side effects of DUEXIS?

The most common side effects of DUEXIS include nausea, diarrhea, constipation, upper abdominal pain, and headache.

 

What other medications might interact with DUEXIS?

Do not use DUEXIS while taking other NSAIDs unless your health care provider says it is OK. 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 DUEXIS 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 NSAIDs and cause serious side effects.

 

What should I tell my health care provider?

Before starting DUEXIS, 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, bleeding problems, asthma, or are pregnant, trying to become pregnant, or breast feeding. 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.

 

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. You may also contact the Horizon Pharma Medical Information Department toll-free at 1-866-479-6742 or medicalinformation@horizonpharma.com.

 

The risk information provided here is not comprehensive. To learn more, talk about DUEXIS with your health care provider or pharmacist. Click here for the Prescribing Information and Medication Guide or call 1-866-479-6742.