Flector Topical

In the U.S.

• Flector
• Klofensaid II
• Pennsaid
• Rexaphenac
• Solaraze
• Voltaren

Available Dosage Forms:

• Gel/Jelly
• Solution
• Cream
• Spray
• Patch, Extended Release

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure this medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid medicine or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while using this medicine: blistering, peeling, loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting of blood or material that looks like coffee grounds, or yellow skin or eyes. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Check with your doctor immediately if you notice any of these warning signs.

This medicine may cause a serious allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant can harm your unborn baby. Do not use this medicine during the latter part of a pregnancy unless your doctor tells you to.

If your symptoms become worse, check with your doctor.

Diclofenac may cause redness, soreness, scaling, and peeling of the affected skin. Do not stop using this medicine without first checking with your doctor. If the reaction is very uncomfortable, check with your doctor.

While using this medicine, your skin may become more sensitive to sunlight than usual, and too much sunlight may increase the effects of the medicine. During this period of time:

• Stay out of direct sunlight, especially between the hours of 10 AM and 3 PM, if possible.
• Wear protective clothing, including a hat and sunglasses.
• Do not use a sunlamp or tanning bed or booth.
• Make sure you have discussed the use of a sun block product with your doctor.

If you have a severe reaction from the sun, check with your doctor.

Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop treatment for awhile, or to change to a different nonsteroidal antiinflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Diclofenac can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use Flector just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance while using Flector Patches.

Before using Flector, tell your doctor if you are allergic to any drugs, or if you have heart disease, congestive heart failure, high blood pressure, a history of heart attack or stroke, a history of stomach ulcer or bleeding, liver or kidney disease, a blood clotting disorder, asthma or polyps in your nose, or if you smoke.

While the risk of absorbing diclofenac into your bloodstream is low, an NSAID may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

Flector may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are using Flector, especially in older adults.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Common side effects of Flector Patch include: increased liver enzymes. See below for a comprehensive list of adverse effects.

Applies to diclofenac topical: topical application cream, topical application gel/jelly, topical application patch extended release, topical application solution, topical application spray

Along with its needed effects, diclofenac topical (the active ingredient contained in Flector Patch) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking diclofenac topical:

• Application site reactions, including skin rash, pain, tingling, or burning sensation
• flu-like syndrome (body ache, headache, fever, with or without chills)
• itching skin

• Blood in the urine
• cough
• dry, itching, or burning eyes
• eye pain
• headaches, including migraines
• increased sensitivity of the skin
• nasal congestion
• pain or tenderness around the eyes and cheekbones
• redness of the skin
• redness or swelling of the eyes
• skin rash other than at the application site
• sore throat
• tightness in the chest
• troubled breathing
• ulcers or sores on the skin, other than at the application site

Some side effects of diclofenac topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning skin
• dry skin
• scaly skin
• thickened skin
• tingling skin

• Acne
• back pain
• belching
• bleeding skin
• chest pain
• diarrhea
• heartburn
• indigestion
• joint pain
• lack or loss of strength
• loss or thinning of the hair
• muscle pain
• neck pain
• runny nose
• stomach upset or pain