Nalfon

DRUG DESCRIPTION

Nalfon® (fenoprofen calcium capsules, USP) is a nonsteroidal, anti-inflammatory, antiarthritic drug. Nalfon capsules contain fenoprofen calcium as the dihydrate in an amount equivalent to 200 mg (0.826 mmol) or 400 mg (1.65 mmol) of fenoprofen. The 200 mg capsules contain cellulose, gelatin, iron oxides, silicone, titanium dioxide, and other inactive ingredients. The 400 mg capsules contain gelatin, sodium lauryl sulfate, iron oxide yellow, FD&C Blue 1, titanium dioxide, FD&C Red 40, crospovidone, talc, and magnesium stearate. Chemically, Nalfon (fenoprofen calcium) is an arylacetic acid derivative.

The structural formula is as follows:

Nalfon® (fenoprofen calcium) structural formula illustration

Benzeneacetic acid, ?-methyl-3-phenoxy-,
calcium salt dihydrate, (±)-

Nalfon (fenoprofen calcium) is a white crystalline powder that has the structural formula C30H26Ca06•2H20 representing a molecular weight of 558.65. At 25°C, it dissolves to a 15 mg/mL solution in alcohol (95%). It is slightly soluble in water and insoluble in benzene.

The pKa of Nalfon (fenoprofen calcium) is a 4.5 at 25°C.

What are the possible side effects of fenoprofen (Nalfon)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking fenoprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • confusion, tremors or shaking;
  • ...

Read All Potential Side Effects and See Pictures of Nalfon »

What are the precautions when taking fenoprofen calcium (Nalfon)?

Before taking fenoprofen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease, aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver...

Read All Potential Precautions of Nalfon »


Nalfon Consumer (continued)

SIDE EFFECTS: Upset stomach, gas, constipation, diarrhea, nausea, vomiting, headache, drowsiness, dizziness, or fatigue may occur. If any of these effects persist or worsen, notify 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 immediately if any of these unlikely but serious side effects occur: stomach pain, swelling of the hands or feet, sudden or unexplained weight gain, vision changes, hearing changes (e.g., ringing in the ears), mental/mood changes, fast/pounding heartbeat, persistent/severe headache, fainting, difficult/painful swallowing.

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, frothy or pink urine, frequent/burning/painful urination, signs of infection (e.g., fever, persistent sore throat), easy bruising or bleeding, unexplained stiff neck.

This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking fenoprofen and consult your doctor or pharmacist immediately: yellowing eyes or skin, dark urine, unusual/extreme tiredness, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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: Before taking fenoprofen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease, aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, poorly controlled diabetes, stomach/intestine/esophagus problems (e.g., bleeding, ulcers, recurring heartburn), heart disease (e.g., congestive heart failure, history of heart attack), stroke, high blood pressure, swelling (edema, fluid retention), dehydration, blood disorders (e.g., anemia), bleeding or clotting problems, asthma, growths in the nose (nasal polyps).

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

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 stop smoking. Consult your doctor or pharmacist for more information.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially stomach bleeding and kidney effects.

This medication is not recommended for use during pregnancy due to possible harm to an unborn baby and interference with normal labor/delivery. Consult your doctor for more details.

This drug passes into breast milk. Consult your doctor before breast-feeding.


Nalfon Patient Information Including Side Effects

Brand Names: Nalfon

Generic Name: fenoprofen (Pronunciation: fen oh PROE fen)

  • What is fenoprofen (Nalfon)?
  • What are the possible side effects of fenoprofen (Nalfon)?
  • What is the most important information I should know about fenoprofen (Nalfon)?
  • What should I discuss with my healthcare provider before taking fenoprofen (Nalfon)?
  • How should I take fenoprofen (Nalfon)?
  • What happens if I miss a dose (Nalfon)?
  • What happens if I overdose (Nalfon)?
  • What should I avoid while taking fenoprofen (Nalfon)?
  • What other drugs will affect fenoprofen (Nalfon)?
  • Where can I get more information?

What is fenoprofen (Nalfon)?

Fenoprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Fenoprofen works by reducing hormones that cause inflammation and pain in the body.

Fenoprofen is used to treat pain or inflammation caused by arthritis.

Fenoprofen may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fenoprofen (Nalfon)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking fenoprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • confusion, tremors or shaking;
  • urinating less than usual or not at all;
  • pain, burning, or bleeding when you urinate;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

  • upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;
  • dizziness, headache, nervousness;
  • skin itching or rash;
  • dry mouth;
  • increased sweating, runny nose;
  • blurred vision; or
  • ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fenoprofen (Nalfon)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking fenoprofen. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

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