Floctafenine belongs to the class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is used for the short-term treatment of mild to moderate pain. It acts by blocking the production of chemicals that are involved in causing pain and inflammation.

Your doctor may have suggested Floctafenine for conditions other than those listed in these drug information articles. As well, some forms of Floctafenine may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking Floctafenine, speak to your doctor. Do not stop taking Floctafenine without consulting your doctor.

Do not give Floctafenine to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Floctafenine if their doctor has not prescribed it.

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The recommended adult dose of floctafenine is 200 mg to 400 mg every 6 to 8 hours as needed for pain relief. The maximum daily recommended dose is 1,200 mg.

Take floctafenine tablets with a full glass of water immediately after a meal or with food or milk.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Floctafenine exactly as prescribed by your doctor. Do not take Floctafenine more often or for a longer period of time than prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Floctafenine at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Floctafenine. If you are concerned about side effects, discuss the risks and benefits of Floctafenine with your doctor.

The following side effects have been reported by at least 1% of people taking Floctafenine. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal or stomach cramps, pain, or discomfort (mild to moderate)
• Diarrhea
• dizziness, drowsiness, or lightheadedness
• headache (mild to moderate)
• heartburn, indigestion, nausea, or vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Stop taking the medication and seek immediate medical attention if any of the following occur:

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Floctafenine.

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200 mg
Each creamy white, round, biconvex tablet engraved "FLO" over "200" on one side, contains 200 mg floctafenine. Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, stearic acid, magnesium stearate, and colloidal silicon dioxide.

400 mg
Each creamy white, round, biconvex tablet engraved "FLO" over "400" on one side, contains 400 mg floctafenine. Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, stearic acid, magnesium stearate, and colloidal silicon dioxide.

Floctafenine should not be taken by anyone who:

• is allergic to floctafenine or to any of the ingredients of the medication
• is currently taking other NSAIDs
• is taking beta-blocker medications (e.g., Propranolol, Metoprolol)
• has had an allergic reaction to Asa or other anti-inflammatory medications
• has or has recently had an inflammatory disease of the stomach and intestines such as stomach or intestinal ulcer or Ulcerative Colitis
• has severe heart failure, Coronary Artery Disease, or ischemic cardiomyopathy
• has significant liver impairment or active liver disease
• has significantly impaired or deteriorating kidney function

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There may be an interaction between floctafenine and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Floctafenine. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Floctafenine.

Drowsiness/reduced awareness: Some people have reported headache, dizziness, lightheadedness, and confusion while taking Floctafenine. Do not drive vehicles or undertake other potentially hazardous activties until you have determined that Floctafenine does not affect you in this way.

Fluid and electrolyte balance: Fluid retention and edema have been reported with use of Floctafenine. People with the following medical conditions should be closely monitored by their doctor while taking floctafenine:

• any other condition that might lead to fluid retention
• certain heart conditions (e.g., Congestive Heart Failure)
• high blood pressure
• Kidney Disease or reduced kidney function
• recovering from a surgical operation under general anesthesia

There is a risk of high blood potassium with NSAID treatment. Those most at risk include seniors, those with conditions such as Diabetes or kidney failure, and those taking beta-adrenergic blockers, angiotensin converting enzyme (ACE) inhibitors, or some diuretics (water pills).

Heart problems: NSAID medications may increase the risk of heart attacks, strokes, and Blood Clots. The risk is greater with higher doses and long-term use. People at risk of heart problems, such as those with high blood pressure, High Cholesterol, diabetes, peripheral arterial disease, heart failure, or coronary artery disease, should discuss with their doctor how Floctafenine may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Floctafenine, and whether any special monitoring is needed.

Infection: Floctafenine may mask the signs of an infection, such as a fever.

Kidney function: Long-term use of floctafenine may lead to a higher risk of reduced kidney function. This is most common for people who already have kidney disease, liver disease, or heart failure; for people who are take diuretics (water pills); and for seniors.

Liver function: Floctafenine may cause liver problems. If you have a liver condition, you may need more frequent checkups with your doctor. If you develop signs of a liver problem (such as yellow skin or eyes, dark urine, pale stools, abdominal pain, or itchy skin), stop taking the medication and see your doctor as soon as possible.

Stomach problems: Stomach ulcers, perforation, and bleeding from the stomach have been known to occur during therapy with floctafenine. These complications can occur at any time, and are sometimes severe enough to require immediate medical attention. The risk of ulcers and bleeding are increased for people taking higher doses of NSAIDs for longer periods of time.

Floctafenine should be taken under close medical supervision by people prone to irritation of the stomach and intestines, particularly those who have had a stomach ulcer, bloody stools, or diverticulosis or other inflammatory disease of the stomach or intestines (such as ulcerative colitis or Crohn's Disease). In these cases, your doctor must weigh the benefits of treatment against the possible risks.

Stop taking the medication and contact your doctor immediately if you experience symptoms or signs suggestive of stomach ulcers or bleeding in the stomach (black, tarry stools). These reactions can occur at any time during treatment without warning.

Sun sensitivity: Floctafenine may make your skin more sensitive to the sun. While you are using Floctafenine, avoid excessive sun exposure, including tanning beds and sun lamps. If you experience Sunburn with itching, swelling, and blistering, stop taking Floctafenine and contact your doctor.

Pregnancy: Floctafenine should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Floctafenine, contact your doctor immediately.

Breast-feeding: Floctafenine passes into breast milk and should not be used by breast-feeding mothers.

Children: The safety and effectiveness of using Floctafenine have not been established for children.

Seniors: Seniors appear to have a higher risk of side effects with Floctafenine. The lowest effective dosage should be used under close medical supervision.

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