INDICATION

RELAFEN® DS is indicated for:

• Relief of signs and symptoms of osteoarthritis and rheumatoid arthritis

IMPORTANT SAFETY INFORMATION ABOUT RELAFEN® DS

What is the most important information I should know about RELAFEN® DS and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

RELAFEN® DS (nabumetone) Tablets is an NSAID.

RELAFEN® DS 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 RELAFEN® DS
  • with longer use of RELAFEN® DS

Do not take RELAFEN® DS right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

Avoid taking RELAFEN® DS 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 RELAFEN® DS 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 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

RELAFEN® DS should only be used:

• Exactly as prescribed
• At the lowest dose possible for your treatment
• For the shortest time needed

What are NSAIDs, including RELAFEN® DS?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.

RELAFEN® DS Consumer Important Safety Information
19-RE-002

Do not use RELAFEN® DS:

• If you are allergic to nabumetone or any components of the drug product
• 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
• If you have active ulcer disease or any history of bleeding in the stomach or intestines
• If you have had bleeding in the brain, a tendency to bleed, or have decreased ability for your blood to clot
• If you have kidney disease

Before taking RELAFEN® DS or any NSAID, tell your healthcare provider about all of your medical conditions,
including if you:

• have liver or kidney problems
• have high blood pressure or heart failure
• have asthma
• have bleeding problems
• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking
• NSAIDs during pregnancy. You should not take RELAFEN® DS after 29 weeks of pregnancy.
• are breastfeeding or plan to breast feed. Some RELAFEN® DS can pass into your breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription or over-thecounter medicines, vitamins or herbal supplements. RELAFEN® DS 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.

What are the possible side effects of RELAFEN® DS?

RELAFEN® DS can cause serious side effects, including:

See “What is the most important information I should know about RELAFEN® DS and medicines called
Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”

• new or worse high blood pressure
• heart failure
• liver problems including liver failure
• kidney problems including kidney failure
• low red blood cells (anemia)
• life-threatening skin reactions
• life-threatening allergic reactions
• Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea,
  vomiting, and dizziness.

Most common side effects with RELAFEN® DS include: diarrhea, indigestion, abdominal pain, constipation, gas, nausea, blood in stool, dry mouth, stomach inflammation, mouth inflammation, vomiting, dizziness, headache, fatigue, increased sweating, insomnia, nervousness, sleepiness, itching, rash, ringing in ear, and swelling.

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

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

RELAFEN® DS Consumer Important Safety Information
19-RE-002

Stop taking RELAFEN® DS 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 RELAFEN® DS, call your healthcare provider or get medical help right away. These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed Warning and patient Medication Guide.