IMPORTANT WARNING:

Why is this medication prescribed?

Fenoprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Fenoprofen is also used to relieve mild to moderate pain from other causes. Fenoprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

How should this medicine be used?

Fenoprofen comes as a capsule and a tablet to take by mouth. It is usually taken with a full glass of water three or four times a day for arthritis or every 4-6 hours as needed for pain. Fenoprofen can be taken with meals or milk to reduce stomach upset. Your doctor may also recommend that you take fenoprofen with an antacid to reduce stomach upset. If you take fenoprofen regularly, take it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fenoprofen exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are taking fenoprofen to relieve the symptoms of arthritis, your symptoms may begin to improve within a few days. It may take 2-3 weeks or longer for you to feel the full benefit of fenoprofen.

Other uses for this medicine

Fenoprofen is also used to treat ankylosing spondylitis (arthritis that mainly affects the spine) and gouty arthritis (attacks of severe joint pain and swelling caused by a build-up of certain substances in the joints). It is also sometimes used to reduce fever. Talk to your doctor about the risks of using this medication to treat your condition.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking fenoprofen,

• tell your doctor and pharmacist if you are allergic to fenoprofen, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in fenoprofen capsules. Ask your pharmacist for a list of the inactive ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); diuretics ('water pills'); lithium (Eskalith, Lithobid); oral medications for diabetes ; methotrexate (Rheumatrex); phenobarbital; phenytoin (Dilantin); and sulfa antibiotics such as sulfisoxazole (Gantrisin) and sulfamethoxazole (in Bactrim, in Septra). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); swelling of the hands, feet, ankles, or lower legs ; a hearing impairment; anemia (blood cells do not bring enough oxygen to all parts of the body); or liver or kidney disease.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breast-feeding. If you become pregnant while taking fenoprofen, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking fenoprofen.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• remember that alcohol can add to the drowsiness caused by this drug. Do not drink alcohol while taking this medication.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Fenoprofen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nervousness
• drowsiness
• sweating
• constipation
• ringing in the ears

Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately. Do not take any more fenoprofen until you speak to your doctor.

• blurred vision
• shaking of a part of the body that you cannot control
• unexplained weight gain
• fever
• blisters
• rash
• itching
• hives
• swelling of the eyes, face, lips, tongue, throat, hands, arms, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• yellowing of the skin or eyes
• excessive tiredness
• unusual bleeding or bruising
• lack of energy
• upset stomach
• loss of appetite
• pain in the upper right part of the stomach
• flu-like symptoms
• pale skin
• fast or pounding heartbeat
• cloudy, discolored, or bloody urine
• back pain
• difficult or painful urination

Fenoprofen may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• heartburn
• upset stomach
• vomiting
• stomach pain
• dizziness
• unsteadiness or difficulty balancing
• headache
• ringing in the ears
• shaking of a part of the body that you cannot control
• drowsiness
• confusion

What other information should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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