Celebrex

What is Celebrex?

Celebrex is a nonsteroidal anti-inflammatory drug (NSAID) that is used for the management of the signs and symptoms of:

• Osteoarthritis
• Rheumatoid arthritis
• Juvenile rheumatoid arthritis
• Ankylosing Spondylitis

Celebrex is also used for the management of:

• Acute pain in adults
• Primary dysmenorrhea

Celebrex helps to treat the pain, redness, swelling, and heat (inflammation) associated with the above conditions.

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

Celebrex and other NSAIDs can cause serious side effects, including:

• Increased risk of heart attack or stroke that can lead to death. This risk may happen early in treatment and many increase:
  • with increasing doses of Celebrex
  • with long use of Celebrex

Do not take Celebrex or other NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)". Avoid taking Celebrex 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 Celebrex after a recent heart attack.

• You may have an 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", "antiplatelet drugs", "anticoagulants", "SSRIs" or "SNRIs"
• increasing doses of Celebrex
• longer use of Celebrex
• smoking
• drinking alcohol
• older age
• poor health
• advanced liver disease
• bleeding problems

Celebrex should only be used:

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

Who should not take Celebrex?

Do not take Celebrex:

• if you have a known hypersensitivity to celecoxib or any of the other ingredients in Celebrex
• if you have demonstrated allergic-type reactions to sulfonamides
• 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 are more than 29 weeks pregnant

What should I tell my healthcare provider before taking Celebrex?

Before taking Celebrex and other NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems
• have high blood pressure
• have asthma
• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking Celebrex or other NSAIDs during pregnancy. You should not take Celebrex and other NSAIDs after 29 weeks of pregnancy
• are breastfeeding or plan to breast feed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs 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 Celebrex?

• Take Celebrex exactly as prescribed. Your healthcare provider may need to change your dose of Celebrex until the dose us right for you.
• Use the lowest possible dose for the shortest time needed.
• Call your healthcare provider if the dose you are prescribed does not control your pain.
• Celebrex can be taken with or without food.

What should I avoid while taking Celebrex?

• Taking Celebrex with other NSAIDs or salicylates (e.g. diflunisal, salsalate) should be avoided due to the increased risk of gastrointestinal toxicity.
• You should speak to your healthcare provided before taking Celebrex with low dose aspirin.

What are the possible side effects of Celebrex?

Celebrex and other NSAIDs can cause serious side effects, including:

• see "What is the most important information I should know about Celebrex?"
• new or worse high blood pressure
• heart failure
• liver problems including liver failure
• kidney problems including kidney failure
• low red blood cells (anaemia)
• life-threatening skin reactions
• life-threatening allergic reactions

Other side effects of Celebrex and other NSAIDs include:

• stomach pain
• constipation
• diarrhea
• gas
• heartburn
• nausea
• vomiting
• dizziness

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

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

• nausea
• more tired and 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 Celebrex call your healthcare provider or get medical help right away.

These are not all the possible side effect of Celebrex. For more information, ask your healthcare provider or pharmacist about Celebrex. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Celebrex

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Celebrex for a condition for which it was not prescribed. Do not give Celebrex to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about Celebrex, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Celebrex that is written for health professionals.

How should I store Celebrex?

• Store at room temperature 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF)
• Keep Celebrex and all medicines out of reach of children

What are the ingredients in Celebrex?

Active ingredient: celecoxib

Inactive ingredients: croscarmellose sodium, gelatin unspecified, lactose monohydrate, magnesium stearate, povidone unspecified, sodium lauryl sulfate