Celecoxib 200mg Capsules

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

CELECOXIB - ORAL

(SEL-e-KOX-ib)

COMMON BRAND NAME(S): Celebrex

WARNING: Nonsteroidal anti-inflammatory drugs (including celecoxib) may rarely increase the risk of a heart attack or stroke. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG). Also, this drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning symptoms at any time while taking this drug. Older adults may be at higher risk for this effect. (See also Precautions and Drug Interactions sections.) Stop taking celecoxib and get medical help right away if you notice any of the following rare but serious side effects: bloody or black/tarry stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, sudden vision changes, slurred speech. Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.

USES: This medication is a nonsteroidal anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor, which relieves pain and swelling (inflammation). It is used to treat arthritis, acute pain, and menstrual pain and discomfort. The pain and swelling relief provided by this medication helps you perform more of your normal daily activities. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. This drug works by blocking the enzyme in your body that makes prostaglandins. Decreasing prostaglandins helps to reduce pain and swelling.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This medication may also be used to treat gout attacks.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using celecoxib and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once or twice daily. To decrease the chance of stomach upset, this drug is best taken with food. The dosage is based on your medical condition and response to treatment. Take this medication at the lowest effective dose and only for the prescribed length of time (see also Warning section). Take this medication with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for 10 minutes after taking this medication. For certain conditions (such as arthritis), it may take up to two weeks of taking this drug regularly before you get the full benefit. If you are taking this drug on an \"as needed\" basis (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

SIDE EFFECTS: See also Warning section. Stomach upset or gas may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: severe headache, unexplained weight gain, swelling of the hands or feet, pain/swelling/warmth in the groin/calf, change in amount of urine, difficult/painful swallowing, unusual tiredness. This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section. Before taking celecoxib, tell your doctor or pharmacist if you are allergic to it; or to aspirin, other NSAIDs (such as ibuprofen), other COX-2 inhibitors; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), liver disease, stomach/intestine/esophagus problems (such as bleeding, ulcers, recurring heartburn), heart disease (such as angina, heart attack), high blood pressure, stroke, blood disorders (such as anemia, bleeding/clotting problems), growths in the nose (nasal polyps). Kidney problems can sometimes occur with the use of NSAID medications, including celecoxib. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have any unusual change in the amount of urine. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and smoking. Consult your doctor or pharmacist for more information. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially stomach bleeding and kidney problems. Caution is advised when using this drug for children with a certain type of arthritis (systemic onset juvenile rheumatoid arthritis) because they may be at increased risk for a very serious bleeding/clotting problem (disseminated intravascular coagulation). Get medical help right away if your child develops sudden bleeding/bruising or bluish skin in the fingers/toes. Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), cidofovir, lithium, pemetrexed, \"water pills\" (diuretics such as furosemide). This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, \"blood thinners\" such as dabigatran/enoxaparin/warfarin, among others. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as naproxen or ibuprofen). These drugs are similar to celecoxib and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe stomach pain, coffee ground-like vomit, change in amount of urine, slow or shallow breathing, severe headache, or loss of consciousness.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as complete blood count, liver and kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Non-drug treatment for arthritis that is approved by your doctor (such as weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for specific instructions.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised May 2014. Copyright(c) 2014 First Databank, Inc.