Medication Guide DUEXIS® (due ex is)(ibuprofen and famotidine)
Read this Medication Guide before you start taking DUEXIS and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about DUEXIS? DUEXIS contains ibuprofen [a nonsteroidal anti-inflammatory drug (NSAID)] and famotidine. NSAID-containing medicines, such as DUEXIS, may increase the chance of a heart attack or stroke that can lead to death. This chance increases: NSAID-containing medicines, such as DUEXIS, should never be used right before or after a heart surgery called a coronary artery bypass graft (CABG). NSAID-containing medicines, such as DUEXIS can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:
• can happen without warning symptoms
The chance of a person getting an ulcer or bleeding with NSAIDs increases with:
• taking medicines called steroid hormones (corticosteroids) and blood thinners
NSAID-containing medicines, such as DUEXIS, should only be used:
• at the lowest dose possible for your treatment
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:
• different types of arthritis (rheumatoid arthritis and osteoarthritis)
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:
• If you had an asthma attack, hives, or other allergic reaction with aspirin or any other
• For pain right before or after heart bypass surgery
Tell your healthcare provider:
• about all of your medical conditions.
• about all of the medicines you take. NSAIDs and some other medicines can interact
with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
• if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
• if you are breastfeeding. Talk to your healthcare provider. What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Serious side effects include: Other side effects include:
• heart failure from body swelling (fluid
• kidney problems including kidney failure
• bleeding and ulcers in the stomach and
• liver problems including liver failure
Get emergency help right away if you have any of the following symptoms:
• weakness in one part or side of your body
Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:
• there is blood in your bowel movement
• swelling of the arms and legs, hands and
These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can
cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the
• Some of these NSAID medicines are sold in lower doses without a prescription (over-the
counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.
NSAID medicines that need a prescription Generic Name Requires Prescription
Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Motrin, Tab-Profen, Vicoprofen (combined with hydrocodone), Combunox (combined with oxycodone), DUEXIS (combined with famotidine)
Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Meloxicam Mobic Nabumetone Relafen Naproxen
Naprosyn, Anaprox, Anaprox DS, Prevacid NapraPAC (Prevacid copackaged with Naprosyn),Vimovo (combined with esomeprazole)
Oxaprozin Daypro Enteric coated naproxen
Piroxicam Feldene Sulindac Clinoril Tolmetin
What is DUEXIS?
1. Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID). Please read the above
information regarding the benefits and risks of NSAIDs, including ibuprofen, a component of DUEXIS.
2. Famotidine is a histamine 2 (H2)-receptor antagonist, a medicine that may help reduce
DUEXIS is a prescription medicine used to:
• relieve 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 who are taking ibuprofen for rheumatoid arthritis and osteoarthritis. DUEXIS was studied mostly in people less than 65 years of age and who
did not have a prior history of ulcers of the stomach and upper intestines.
It is not known if DUEXIS is safe or effective in children.
Who should not take DUEXIS? Do not take DUEXIS:
• If you had an asthma attack, hives, or other allergic reaction after taking aspirin or other
• For pain right before or after heart bypass surgery.
• If you are in the late stages of pregnancy (after 30 weeks of pregnancy).
• If you are allergic to any other histamine 2 (H2)-receptor antagonist.
What should I tell my healthcare provider before taking DUEXIS? Before you take DUEXIS, tell your healthcare provider if you:
• have high blood pressure (hypertension)
• have ulcerative colitis or Crohn’s disease (inflammatory bowel disease or IBD)
• are pregnant or plan to become pregnant. DUEXIS should not be used by pregnant
women late their pregnancy. See “What is the most important information I should know about DUEXIS?”
• are breast-feeding or plan to breast-feed. DUEXIS can pass into your milk and may harm
your baby. You should not breast-feed while taking DUEXIS. Talk to your healthcare provider about the best way to feed your baby if you take DUEXIS.
Tell your healthcare provider about all of the medicines you take including prescription and
nonprescription medicines, vitamins, and herbal supplements. Since DUEXIS contains ibuprofen,
talk to your healthcare provider before taking any other NSAID containing products.
Using DUEXIS with other medicines can cause serious side effects. DUEXIS may affect the way
other medicines work and other medicines may affect how DUEXIS works.
Especially, tell your doctor if you take:
How should I take DUEXIS?
• Take DUEXIS exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how many DUEXIS to take and when to take them.
• Do not stop DUEXIS without first talking to your healthcare provider.
• Swallow DUEXIS tablets whole. Do not crush, split or chew DUEXIS tablets.
• 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.
• If you take too much DUEXIS, tell your healthcare provider or go to the nearest hospital
If you take more DUEXIS than your doctor recommends, call your Poison Control Center at 1800-222-1222.
• Your doctor may do certain tests from time to time to check you for side effects of
What are the possible side effects of DUEXIS? DUEXIS may cause serious side effects. See “What is the most important information I should know about DUEXIS?”
• Stroke or Heart Attack. If you have heart disease you may be at risk for a heart attack
or stroke while taking DUEXIS. Call your healthcare provider or get medical help right away if you have any of these signs and symptoms:
Signs and symptoms of a Stroke Signs and symptoms of a Heart Attack
chest discomfort in the center of your
minutes, or that goes away or comes back
• New or worsening high blood pressure (hypertension). Your healthcare provider
should check your blood pressure while you are taking DUEXIS.
• Heart problems such as congestive heart failure. Tell your healthcare provider about any
swelling of your body, hands or feet, sudden weight gain or trouble breathing.
• Active bleeding. Tell your doctor if you have signs of active bleeding including:
passing black sticky bowel movements (stools)
vomiting or coughing up blood or dark particles that look like coffee grounds
• Kidney problems. Long term use of NSAIDS, including ibuprofen which is a medicine in
DUEXIS can cause kidney problems. Your healthcare provider should do blood test to check your kidneys.
• Serious allergic reactions. Tell your healthcare provider or get medical help right away
swelling of your lips, tongue, or face
• Serious skin reactions. NSAIDS, including ibuprofen which is a medicine in DUEXIS can
cause a serious skin reaction called Stevens-Johnson Syndrome, toxic epidermal necrolysis or other serious skin reactions that may affect any part of your body. These
serious skin reactions may be life threatening and you may need to be treated in a hospital. Stop taking DUEXIS and call your healthcare provider right away if you have any of these symptoms:
• Liver problems. Tell your healthcare provider right away if you have any of these
• yellowing of your skin or whites of your eyes
• light-colored bowel movements (stools)
• nausea (feeling sick to your stomach)
• feel unwell or like you have the flu
• pain or tenderness on your right side below your ribs
• Low red blood cell count (anemia). Symptoms of anemia include shortness of breath
• Meningitis. Ibuprofen, one of the medicines in DUEXIS may cause meningitis, a serious
brain problem. Call your healthcare provider right away if you have any of the following symptoms of meningitis:
• Eye problems. Tell your healthcare provider if you develop blurred or decreased vision,
changes in color vision, or any other problems with your eyes.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUEXIS. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.
How should I store DUEXIS?
Store DUEXIS at 59°F to 86°F (15°C to 30°C).
Keep DUEXIS in the original container and keep the bottle tightly closed.
Keep DUEXIS and all medicines out of the reach of children. General information about DUEXIS.
Medicines are sometimes prescribed for purposes other than those listed in this Medication Guide. Do not use DUEXIS for a condition for which it was not prescribed. Do not give DUEXIS to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about DUEXIS. If you would like more information, ask your healthcare provider. You can ask your healthcare provider or pharmacist for information that is written for healthcare professionals.
For more information, go to www.DUEXIS.com or call 1-866-479-6742
What are the ingredients in DUEXIS? Active ingredients: ibuprofen and famotidine Inactive ingredients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, purified water, povidone, titanium dioxide, polyethylene glycol, polysorbate 80, polyvinyl alcohol, talc, FD&C Blue #2/Indigo Carmine Aluminum Lake and FD&C Blue #1/Brilliant Blue FDF Aluminum Lake
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Horizon Pharma USA, Inc. 1033 Skokie Blvd. Ste. 355 Northbrook, Illinois 60062
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