Pennsaid is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances in the body that cause pain and inflammation.

Pennsaid (diclofenac topical 2% solution) is used to treat pain in the knees caused by osteoarthritis.

Pennsaid is for use only on the knees and should not be used on other parts of the body.

Pennsaid 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.

Pennsaid may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

Before taking this medicine

Do not use Pennsaid just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

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. Even people without heart disease or risk factors could have a stroke or heart attack while using.

You should not use Pennsaid if you are allergic to diclofenac (Voltaren, Cataflam, Flector, and others)

Do not use Pennsaid if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure Pennsaid is safe for you, tell your doctor if you have:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

• a history of heart attack, stroke, or blood clot;

• a history of stomach ulcers or bleeding;

• asthma;

• liver or kidney disease; or

• fluid retention.

Diclofenac can affect ovulation and it may be harder to get pregnant while you are using this medicine.

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

It is not known whether diclofenac topical passes into breast milk or if it could harm a nursing baby. You should not breastfeed while using this medicine.

Pennsaid is not approved for use by anyone younger than 18 years old.

Use Pennsaid exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wash your hands after applying Pennsaid, unless you are treating the skin on your hands. Wait at least 10 minutes before dressing or wearing gloves. Wait at least 30 minutes before you bathe or shower.

Wait at until the area is dry before applying cosmetics, sunscreen, lotions, insect repellent, or other medicated skin products on the same area you treat with Pennsaid.

Do not apply Pennsaid to an open skin wound, or on areas of infection, rash, or burn. Do not cover treated skin with a bandage or expose it to heat from a hot tub, heating pad, or sauna.

To treat osteoarthritis knee pain with Pennsaid: Apply the solution only to clean, dry skin. Spread the solution over the front, back, and sides of the knee. Wait until the solution is completely dry before covering treated skin with clothing or applying any other skin products, including sunscreen.

Store Pennsaid at room temperature away from moisture and heat. Do not freeze.

Do not use Pennsaid just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

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. Even people without heart disease or risk factors could have a stroke or heart attack while using.

You should not use Pennsaid if you are allergic to diclofenac (Voltaren, Cataflam, Flector, and others)

Do not use Pennsaid if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure Pennsaid is safe for you, tell your doctor if you have:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

• a history of heart attack, stroke, or blood clot;

• a history of stomach ulcers or bleeding;

• asthma;

• liver or kidney disease; or

• fluid retention.

Diclofenac can affect ovulation and it may be harder to get pregnant while you are using this medicine.

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

It is not known whether diclofenac topical passes into breast milk or if it could harm a nursing baby. You should not breastfeed while using this medicine.

Pennsaid is not approved for use by anyone younger than 18 years old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. There have been no reported cases of overdose with Pennsaid. Overdoses of other similar medications have been known to cause stomach or intestinal bleeding, high blood pressure, kidney failure, trouble breathing, and coma or death.

Avoid exposing treated skin to heat, sunlight, or tanning beds.

Avoid getting Pennsaid near your eyes, nose, or mouth. If this does happen, rinse with water. Call your doctor if you have eye irritation that lasts longer than 1 hour.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin or other NSAIDs (such as celecoxib, Celebrex, Cambia, Cataflam, Voltaren, ibuprofen, Motrin, naproxen, Aleve, Anaprox, and others) while you are using this medicine.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to Pennsaid. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Get emergency medical help if you have signs of an allergic reaction to Pennsaid: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using Pennsaid and 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.

Stop using Pennsaid and call your doctor at once if you have:

• a skin rash, no matter how mild;

• shortness of breath (even with mild exertion);

• swelling or rapid weight gain;

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• lnausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;

• severe headache, pounding in your neck or ears, nosebleed, anxiety, confusion;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Pennsaid side effects may include:

• indigestion, gas, stomach pain, nausea, vomiting;

• diarrhea, constipation;

• headache, dizziness, drowsiness;

• stuffy nose;

• itching, increased sweating;

• increased blood pressure; or

• swelling or pain in your arms or legs.

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.

Do not use Pennsaid with aspirin or other NSAID medications (including celecoxib, Celebrex, Cambia, Cataflam, Voltaren, ibuprofen, Motrin, naproxen, Aleve, Anaprox, others).

Ask your doctor before using Pennsaid if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• aspirin or other NSAID pain medications (including celecoxib, Celebrex, Cambia, Cataflam, Voltaren, ibuprofen, Motrin, naproxen, Aleve, Anaprox, and others);

• antidepressant medications;

• cyclosporine;

• lithium;

• methotrexate;

• a blood thinner (warfarin, Coumadin, Jantoven);

• heart or blood pressure medication, including a diuretic or "water pill"; or

• steroid medicine (prednisone and others).

This list is not complete. Other drugs may interact with diclofenac topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.