Nalfon

Fenoprofen is a prescription medication used to treat pain and redness, swelling, and heat (inflammation) caused by medical conditions such as arthritis, menstrual cramps, and other types of short-term pain. Fenoprofen belongs to a class of drugs called non-steroidal anti-inflammatory drugs, or NSAIDs, which work by stopping substances in your body that cause inflammation and pain.

This medication comes in capsule and tablet forms, and is taken up to 6 times a day with food or milk to prevent upset stomach.

Common side effects include stomach pain, constipation, and diarrhea. Fenoprofen can also cause dizziness. Do not drive or operate heavy machinery until you know how fenoprofen affects you.

Fenoprofen is a prescription medication used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as arthritis, menstrual cramps, and other types of short-term pain.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Pedinol Pharmacal, Inc.

• Ranbaxy Pharmaceuticals, Inc.

• Xspire Pharma

Serious side effects have been reported with fenoprofen. See the “Drug Precautions” section.

Common side effects include:

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

This is not a complete list of fenoprofen side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• aspirin (Ecotrin)
• angiotensin-converting enzyme (ACE) inhibitors such as
  • benazepril (Lotensin, Lotensin HCT)
  • captopril (Capoten, Capozide)
  • enalapril (Vasotec, Vaseretic)
  • fosinopril (Monopril, Monopril HCT)
  • lisinopril (Prinivil, Prinzide, Zestril, Zestoretic)
  • moexipril (Univasc, Uniretic)
  • quinapril (Accupril, Accuretic, Quinaretic)
  • ramipril (Altace)
  • trandolapril (Mavik, Tarka)
• diuretics such as
  • spironolactone (Aldactone)
  • triamterene (Dyrenium)
  • amiloride (Midamor)
  • hydrochlorothiazide (HCTZ)
  • chlorthalidone (Hygroton, Thalitone)
  • furosemide (Lasix)
  • bumetanide (Bumex)
  • torsemide (Demadex)
• lithium (Lithobid, Eskalith)
• methotrexate (Trexall, Rheumatrex)
• warfarin
• phenobarbital

This is not a complete list of fenoprofen drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with fenoprofen including the following:

• heart attack or stroke. Tell your healthcare provider right away if you have some or all of the following symptoms of a heart attack or stroke:
  • shortness of breath
  • chest pain
  • weakness
  • slurring of speech
• new hypertension or worsening of preexisting hypertension. Have your blood pressure watched by your doctor closely if taking fenoprofen, especially if you have a history of hypertension or are taking medications to treat hypertension.
• congestive heart failure. Tell your healthcare provider right away if you have some or all of the following symptoms congestive heart failure:
  • swelling in the arms or legs
  • shortness of breath
  • unexplained weight gain
  • fatigue
• serious and sometimes fatal skin reaction. Tell your healthcare provider right away if you have some or all of the following symptoms of a serious skin reaction:
  • rash
  • blistering
  • itching
  • fever
• stomach bleeding and ulceration (holes or sores of your stomach or intestines). Tell your healthcare provider right away if you have some or all of the following symptoms of a stomach bleed or ulceration:
  • pain
  • blood in stools (black or tarry stools)
  • coughing up of blood
  • indigestion or general stomach discomfort

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

• taking medicines called "corticosteroids" and "anticoagulants"
• longer use
• smoking
• drinking alcohol
• older age
• having poor health

• liver toxicity. Tell your healthcare provider right away if you have some or all of the following symptoms of liver toxicity:
  • flu-like symptoms
  • itchiness
  • fatigue
  • nausea
  • yellow tinting of the skin or eyes
• kidney injury. Patients at greatest risk of this are those who already have renal dysfunction, heart failure, liver injury, those taking diuretics or ACE inhibitors, and the elderly.
• anaphylactoid reaction. Tell your healthcare provider right away if you have some or all of the following symptoms of an anaphylactoid reaction:
  • swelling of the face or throat or trouble swallowing
  • difficulty breathing, coughing, chest tightness, wheezing
  • dizziness, fainting, rapid or weak heartbeat
  • flushing, itching, hives or a feeling of warmth
• pregnancy. In late pregnancy (at 30 weeks and beyond), fenoprofen should be avoided since it may cause premature closure of the ductus arteriosus.
• pre-existing asthma. Fenoprofen should not be taken in patients with aspirin-sensitive asthma and should be used with caution in patients with preexisting asthma.
• anemia. Tell your healthcare provider right away if you have some or all of the following symptoms of anemia:
  • shortness of breath
  • dizziness
  • headache
  • coldness in the hands and feet
  • pale skin
  • chest pain

Fenoprofen can cause dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Do not take fenoprofen if the following has occurred:

• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine, including fenoprofen
• coronary artery bypass graft (CABG) surgery; fenoprofen is not to be used for treating pain before or after this surgery

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of fenoprofen, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking fenoprofen, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine, including fenoprofen
• are schedule to undergo coronary artery bypass graft (CABG) surgery. Fenoprofen is not to be used for treating pain before or after this surgery
• have liver problems
• have kidney problems
• have heart problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Fenoprofen falls into category C at weeks 0 to 29 of pregnancy and category D starting at week 30 of pregnancy. There are no adequate and well-controlled studies in pregnant women.

• At weeks 0 to 29, fenoprofen should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.
• Starting at 30-weeks of pregnancy, fenoprofen and other NSAIDs should be avoided by pregnant women as they can cause harm to the unborn baby when given to a pregnant woman starting at 30-weeks gestation.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if fenoprofen crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using fenoprofen.

Take fenoprofen exactly as prescribed.

This medication comes in capsule and tablet forms, and is taken up to 6 times a day with food or milk to prevent upset stomach.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of fenoprofen at the same time.

Take fenoprofen exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The fenoprofen dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your liver function
• your kidney function

The recommended dose for fenoprofen for mild to moderate pain is 200 mg by mouth every 4 to 6 times a day.

The recommended dose range for fenoprofen for rheumatoid arthritis or osteoarthritis is 400 to 600 mg by mouth 3 to 4 times a day. The total daily dose should not exceed 3200 mg of fenoprofen.

If you take too much fenoprofen, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store fenoprofen at room temperature between 20˚-25˚C (68˚-77˚F).
• Preserve in well-closed containers.
• Keep this and all medicines out of the reach of children.

Cardiovascular Risk

• Non-Steroidal Anti-Inflammatory (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
• Fenoprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.