Flector Topical Patch is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke, blood clots). The risk may be greater if you already have heart problems or if you take Flector Topical Patch for a long time. Do not use Flector Topical Patch right before or after bypass heart surgery.

Flector Topical Patch may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Flector Topical Patch is used for treating pain caused by minor strains, sprains, and bruises. It may also be used for other conditions as determined by your doctor.

Flector Topical Patch is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Before using Flector

Do NOT use Flector Topical Patch if:

• you are allergic to any ingredient in Flector Topical Patch
• you have had a severe allergic reaction:
• severe rash
• hives
• trouble breathing
• growths in the nose, dizziness due to aspirin or an NSAID (eg, ibuprofen, celecoxib)
• you have recently had or will be having bypass heart surgery
• your skin at the application site is broken or damaged
• you are in the last 3 months of pregnancy

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Flector Topical Patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine
• if you are taking any herbal product, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have skin problems (eg, eczema or skin inflammation)
• if you have an infection, burn, or wound at the application site
• if you have a history of kidney or liver disease
• if you have stomach or bowel problems (eg, bleeding, perforation, ulcers)
• if you have a history of swelling or fluid buildup
• if you have asthma
• if you have growths in the nose (nasal polyps), or mouth inflammation
• if you have high blood pressure, blood disorders (eg, porphyria)
• if you have bleeding or clotting problems,/
• if you have heart problems (eg, heart failure)
• if you have blood vessel disease
• if you are at risk for any of these diseases
• if you have poor health
• if you smoke
• if you drink alcohol
• if you have a history of alcohol abuse

Contact your doctor or health care provider right away if any of these apply to you.

How To Use Flector

Use Flector Topical Patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Flector Topical Patch comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Flector Topical Patch refilled.

Wash your hands before and right after you handle Flector Topical Patch.

Do NOT apply the patch to broken, damaged, or irritated skin.

Do not remove Flector Topical Patch from the pouch until you are ready to apply it. Be sure to reseal the pouch right away to keep unused patches from drying out.

To apply the patch, first remove the protective liner. Apply the patch to the most painful area, unless your doctor tells you otherwise. Press firmly and make sure the edges stick well to the skin.

Do not wear the patch while taking a bath or shower. Take your bath or shower between the time when you remove a used patch and apply a new one.

If the patch begins to fall off, tape the edges down to secure it.

After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets.

If you miss a dose of Flector Topical Patch, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 patches at once!

Ask your health care provider any questions you may have about the proper use of Flector Topical Patch.

Important Safety Information

Flector Topical Patch may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Flector Topical Patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Flector Topical Patch is for use on the skin only. Do not get it in your eyes, nose, or mouth. If you get Flector Topical Patch in your eye, wash the eye out with water or saline right away. Contact your doctor if irritation persists for more than 1 hour.

Do NOT use more than 1 patch at a time or use Flector Topical Patch for longer than prescribed without checking with your doctor.

If irritation occurs at the application site, remove the patch and contact your doctor.

Serious stomach ulcers or bleeding can occur with the use of Flector Topical Patch. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects.

Contact your doctor or emergency room at once if you:

• develop severe stomach or back pain
• black, tarry stools
• or vomit that looks like blood or coffee grounds

Flector Topical Patch is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Do not take aspirin while you are using Flector Topical Patch unless your doctor tells you to.

Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be performed while you use Flector Topical Patch. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Flector Topical Patch with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.

Flector Topical Patch should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Flector Topical Patch may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Flector Topical Patch while you are pregnant. It is not known if Flector Topical Patch is found in breast milk. Do not breast-feed while taking Flector Topical Patch.

In Case of Overdose

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Flector Topical Patch may be harmful if swallowed.

All medicines can cause side effects, but many people have no, or minor, side effects.

Seek medical attention right away if any of these SEVERE side effects occur:

• Severe allergic reactions:
• rash
• hives
• itching
• trouble breathing
• tightness in the chest
• swelling of the mouth, face, lips, or tongue
• bloody or black, tarry stools
• change in the amount of urine produced
• chest pain
• confusion
• dark urine
• depression
• fainting
• fast or irregular heartbeat
• fever, chills, or persistent sore throat
• mental or mood changes
• numbness of an arm or leg
• one-sided weakness
• red, swollen, blistered, or peeling skin
• ringing in the ears
• seizures
• severe headache or dizziness
• severe or persistent irritation at the application site
• severe or persistent stomach pain or nausea
• severe vomiting
• shortness of breath
• sudden or unexplained weight gain
• swelling of hands, legs, or feet
• unusual bruising or bleeding
• unusual joint or muscle pain
• unusual tiredness or weakness
• vision or speech changes
• vomit that looks like coffee grounds
• wheezing
• yellowing of the skin or eyes

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin)
• aspirin
• corticosteroids (eg, prednisone)
• heparin
• selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) - risk of stomach bleeding may be increased
• Probenecid - may increase the risk of Flector Topical Patch's side effects
• Cyclosporine, lithium, methotrexate, or quinolones (eg, ciprofloxacin)
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril)
• diuretics (eg, furosemide, hydrochlorothiazide) - effectiveness may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Flector Topical Patch may interact with other medicines that you take.

Check with your health care provider before you start, stop, or change the dose of any medicine.