Duexis

DUEXIS, a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies and Use in Specific Populations].

DUEXIS
(dew-EX-iss)
(ibuprofen and famotidine) Tablets, For Oral Use

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

DUEXIS can cause serious side effects including:

• Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
  • with increasing doses of medicine containing NSAIDs
  • with longer use of medicine containing NSAIDs

Do not take DUEXIS right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking DUEXIS after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take DUEXIS after a recent heart attack.

• Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
  • anytime during use
  • without warning symptoms
  • that may cause death

The risk of getting an ulcer or bleeding increases with:

• past history of stomach ulcers, or stomach or intestinal bleeding with the use of NSAIDs
• taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
• increasing doses of NSAIDs
• longer use of NSAIDs
• smoking
• drinking alcohol
• older age
• poor health
• advanced liver disease
• bleeding problems

You should take DUEXIS exactly as prescribed, at the lowest dose possible and for the shortest time needed. DUEXIS contains a non-steroidal anti-inflammatory drug NSAID (ibuprofen). Do not use DUEXIS with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your healthcare provider first, because they may contain an NSAID also.

DUEXIS may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your healthcare provider.

DUEXIS contains ibuprofen, an NSAID and famotidine, a histamine H2 -receptor blocker medicine.

What is DUEXIS?

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.

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 end of this 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.

Before taking DUEXIS, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems.
• have high blood pressure.
• have heart problems.
• have asthma.
• have bleeding problems.
• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking DUEXIS during pregnancy. You should not take DUEXIS after 29 weeks of pregnancy.
• are breastfeeding or plan to breast feed. Ibuprofen and famotidine can pass into your breast milk. 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 over-the-counter medicines, vitamins and herbal supplements. DUEXIS and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

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 it.
• Do not change your dose or stop DUEXIS without first talking to your healthcare provider.
• Swallow DUEXIS tablets whole with liquid. Do not split, chew, crush or dissolve the DUEXIS tablet. Tell your healthcare provider if you cannot swallow the tablet whole. You may need a different medicine.
• If you forget to take your 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 DUEXIS, because they will not work in the same way.

What are the possible side effects of DUEXIS?

DUEXIS can cause serious side effects, including:

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

• heart attack
• stroke
• liver problems including liver failure
• new or worse high blood pressure
• heart failure
• kidney problems including kidney failure
• life-threatening allergic reactions
• asthma attacks in people who have asthma
• life-threatening skin reactions
• low red blood cells (anemia)

Other side effects of DUEXIS include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms:

• shortness of breath
• chest pain
• weakness in one part or side of your body
• slurred speech
• swelling of the face or throat

Stop taking DUEXIS and call your healthcare provider right away if you get any of the following symptoms:

• nausea
• more tired or weaker than usual
• diarrhea
• itching
• your skin or eyes look yellow
• indigestion or stomach pain
• flu-like symptoms
• vomit blood
• there is blood in your bowel movement or it is black and sticky like tar
• unusual weight gain
• skin rash or blisters with fever
• swelling of the arms, legs, hands, and feet

If you take too much DUEXIS, call your poison control center at 1-800-222-1222.

These are not all the possible side effects of DUEXIS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about 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 stomach and intestines.
• Some NSAIDs 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.

General information about the safe and effective use of DUEXIS

Medicines are sometimes prescribed for purposes other than those listed in a 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 that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

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, hypromellose, talc, FD&C Blue#2/Indigo Carmine Aluminum Lake, and FD&C Blue #1/Brilliant Blue FCF Aluminum Lake.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Famotidine and ibuprofen is usually taken 3 times each day. Follow your doctor's instructions.

Do not take more than your recommended dose. An ibuprofen overdose can damage your stomach or intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses). Use only the smallest amount of famotidine and ibuprofen needed to get relief from your pain, swelling, or fever.

Do not crush, chew, or break a famotidine and ibuprofen tablet. Swallow it whole.

If you use this medicine long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Ibuprofen and famotidine combination is used to relieve the symptoms of rheumatoid arthritis and osteoarthritis. It is used for patients who have an increased risk for stomach ulcers and who need to take a nonsteroidal anti-inflammatory drug (NSAID) for arthritis.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat pain, inflammation, swelling, stiffness, and joint pain. Famotidine is a histamine H2-receptor antagonist or H2-blocker. It works by decreasing the amount of acid produced by the stomach.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

Ibuprofen may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Check with your doctor right away if you are having chest pain or discomfort, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, shortness of breath, slurred speech, or weakness.

Ibuprofen may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

If you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

Check with your doctor right away if you have the following symptoms while using the medicine: blood in the urine, decrease in the frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These may be symptoms of a serious kidney problem.

This medicine may cause a serious type of allergic reaction, called anaphylaxis. This can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

Some people who have used this medicine had symptoms of meningitis. If you have fever, headache, nausea, vomiting, and stiff neck or back while using this medicine, check with your doctor right away.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop the medicine for a while, or to change to a different medicine before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies to evaluate the potential effects of Duexis on carcinogenicity, mutagenicity, or impairment of fertility have not been conducted.

In a 106-week study in rats and a 92-week study in mice, famotidine was given at oral doses of up to 2000 mg/kg/day (approximately 122 and 243 times the recommended human dose, respectively, based on body surface area). There was no evidence of carcinogenic potential for famotidine.

Famotidine was negative in the microbial mutagen test (Ames test) using Salmonella typhimurium and Escherichia coli with or without rat liver enzyme activation at concentrations up to 10,000 µg/plate. In in vivo mouse micronucleus test and a chromosomal aberration test with famotidine, no evidence of a mutagenic effect was observed.

In studies of famotidine in rats at oral doses of up to 2000 mg/kg/day (approximately 243 times the recommended human dose, based on body surface area), fertility and reproductive performance were not affected.

"See FDA-approved patient labeling (Medication Guide)"

Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide.

• Duexis, like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death [see Warnings and Precautions (5.1)].
• Duexis, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death [see Warnings and Precautions (5.4)].
• Duexis, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, Stevens Johnson Syndrome, and Toxic epidermal necrolysis, which may result in hospitalization and even death. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.
• Patients should be monitored for development of nephrotoxicity (e.g., azotemia, hypertension, and/or proteinuria). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.
• Duexis is not recommended in patients with creatinine clearance < 50 mL/min because of the seizures, delirium, coma and other CNS effect.
• Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.
• Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.
• Patients should be informed of the signs of anaphylaxis (e.g. difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help [see Warnings and Precautions (5.7)].
• Patients should be informed that in late pregnancy, as with other NSAIDs, Duexis should be avoided because it may cause premature closure of the ductus arteriosus.
• Duexis tablets should be swallowed whole, and should not be cut to supply a lower dose. Do not chew, divide, or crush tablets [see Dosage and Administration (2)].
• Patients should be instructed that if a dose is missed, it should be taken as soon possible. However, if the next schedule dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.

Distributed by:
Horizon Pharma USA, Inc.
1033 Skokie Boulevard, Suite 355
Northbrook, IL 60062

Manufactured by:
Pharmaceutics International, Inc.
10819 Gilroy Road
Hunt Valley, MD 21031

sanofi-aventis Canada
2150 St-Elzear Blvd. West
Laval, Québec H7L 4A8
Canada

Medication Guide
Duexis® (due ex is)
(ibuprofen and famotidine)
tablets

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:

• with longer use of NSAID medicines
• in people who have heart disease

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
• may cause death

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

• taking medicines called steroid hormones (corticosteroids) and blood thinners (anticoagulants)
• longer use of the NSAID
• smoking
• drinking alcohol
• older age
• having poor health

NSAID-containing medicines, such as Duexis, should only be used:

• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed

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 NSAID medicine
• 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)?

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

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 stomach and intestines.
• 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

What is Duexis?

Duexis contains 2 medicines:

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 stomach acid.

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 NSAID medicine.
• 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 heart problems
• have a history of stomach ulcers
• have or had bleeding problems
• have liver or kidney problems
• have ulcerative colitis or Crohn's disease (inflammatory bowel disease or IBD)
• have any other medical conditions
• 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:

• Aspirin
• Warfarin (Coumadin)

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 emergency room right away.

If you take more Duexis than your doctor recommends, call your Poison Control Center at 1-800-222-1222.

• Your doctor may do certain tests from time to time to check you for side effects of Duexis.

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
  numbness or weakness of the face, arm or leg, especially on one side of the body sudden confusion, trouble speaking or understanding	sudden trouble seeing in one or both eyes sudden trouble walking, dizziness, loss of balance or coordination sudden, severe headache

  Signs and symptoms of a Heart Attack
  chest discomfort in the center of your chest that lasts for more than few minutes, or that goes away or comes back chest discomfort that feels like uncomfortable pressure or squeezing. chest fullness or pain	pain or discomfort in your arms, back, neck, jaw or stomach shortness of breath with or without chest discomfort break out in a cold sweat nausea or vomiting

• 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)
  • having bloody diarrhea
  • 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 if you get:
  • swelling of your lips, tongue, or face
  • throat tightness
  • rash
  • problems breathing or swallowing
• 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:

  skin rash or acne dry skin itching blisters on your skin blisters or sores in your mouth

  peeling of your skin fever muscle or joint aches redness or swelling of your face, hands, or soles of your feet

• Liver problems. Tell your healthcare provider right away if you have any of these following symptoms of liver problems:
  • dark (tea colored) urine
  • yellowing of your skin or whites of your eyes
  • light-colored bowel movements (stools)
  • fever
  • nausea (feeling sick to your stomach)
  • feel unwell or like you have the flu
  • pain or tenderness on your right side below your ribs
  • tiredness
  • loss of appetite

• Low red blood cell count (anemia). Symptoms of anemia include shortness of breath and tiredness.
• 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:

  headache fever nausea vomiting stiff neck rash

  unusual sensitivity to light muscle pains chills confusion drowsiness

• 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 1-800-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 dry.

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

April 2011

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

NDC 75987-010-03

Duexis®

(ibuprofen and famotidine) Tablets
800 mg/26.6 mg

90 Tablets

Rx ONLY

ATTENTION PHARMACIST: Dispense
attached Medication Guide to each patient.

HORIZON
PHARMA

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Use is generally considered acceptable; according to some manufacturers, use is not recommended. Excreted into human milk: Yes (famotidine, ibuprofen) Comments: The effects in the nursing infant are unknown.

Transient growth depression was observed in animal studies at maternotoxic doses of at least 300 times the usual human dose of famotidine. Histamine H2-receptor blockade is known to stimulate prolactin secretion; while this usually does not occur with famotidine, rare cases of hyperprolactinemia and galactorrhea have been reported. Due to both ibuprofen and famotidine being used in infants at doses much higher than those excreted in breast milk, adverse effects in breastfed infants are unlikely to occur.