Trifena

Trifena (for the skin) is a combination medicine used in adults and children who are at least 12 years old to temporarily relieve pain.

Trifena may also be used for reasons not mentioned in this medication guide.

Trifena can raise your chances of having a fatal heart attack or stroke. Do not use Trifena right before or after heart bypass surgery (coronary artery bypass graft, or CABG). This medicine may also lead to stomach or intestinal bleeding, which can be fatal.

You should not use this medicine if you are allergic to diclofenac, lidocaine, and menthol, or to other NSAIDs (nonsteroidal anti-inflammatory drugs), such as aspirin.

Trifena can increase your risk of a fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). This medicine may also cause stomach or intestinal bleeding, which can be fatal. This can happen without warning, especially in older adults.

Tell your doctor if you have or have ever had:

• a blood cell disorder called methemoglobinemia (in you or a family member);
• heart disease, high blood pressure, high cholesterol, smoking, diabetes;
• a habit of drinking more than 3 alcoholic beverages per day;
• if you are age 60 or older;
• a heart attack, stroke, or blood clot;
• blisters, hives, skin redness;
• stomach ulcers or bleeding;
• asthma;
• fluid retention; or
• liver or kidney disease.

If you are pregnant, you should not use Trifena unless your doctor tells you to. Using an NSAID (diclofenac) during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Ask a doctor if it is safe to breastfeed while using this medicine.

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

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Trifena may cause serious side effects. Stop using Trifena and call your doctor at once if you have:

• high blood pressure, heart disease, cirrhosis or other liver disease, kidney disease, asthma, or have had a stroke;
• symptoms that last for more than 7 days, or improve but come back after 3 days; or
• pale, gray, or blue colored skin, headache, rapid heart rate, shortness of breath, feeling light-headed, or tired.

Common side effects of Trifena may include:

• pain, burning, irritation, or skin changes at the site where the medicine was applied.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Apply Trifena to the affected area for up to 12 hours.

Clean and dry the affected area before application. You may wear clothing over the area of application. Wash your hands after handling Trifena.

Remove the film and throw it away by folding in half so the adhesive sides stick to itself. Keep used and unused skin patches out of the reach of children or pets.

If a burning feeling or irritation occurs during application, wash Trifena off your skin and do not reapply Trifena until the irritation is less intense.

Do not take by mouth. Topical medicine is for use only on the skin. Rinse with water if this medicine gets in your eyes or mouth.

Do not apply Trifena in the eyes, nose, mouth, or to an open skin wound or on areas of infection, rash, burn, or peeling skin.

Do not use large amounts of diclofenac, lidocaine, and menthol topical without medical advice.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if your symptoms clear up and then come back within 3 days.

Store tightly closed at room temperature, away from moisture, heat or open flame.

Trifena is used as needed. If you have a dosing schedule and miss a dose, skip it. Do not take two doses at once.

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

Trifena is flammable. Do not use it near high heat or open flame. Do not smoke until the medicine has completely dried on your skin.

Avoid exposing the treated skin to heat, sunlight, or tanning beds. Heat can increase the amount of diclofenac, lidocaine, and menthol topical that you absorb through your skin.

Tell your doctor about all your other medicines, especially:

• a diuretic or "water pill";
• a blood thinner--warfarin, Coumadin, Jantoven;
• steroids; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete, and many other drugs may affect Trifena. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.