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Diclofenac Sodium

Marque(s):

• Voveran Emugel

Fabricant:

• Novartis International AG

Diseases:

• Osteoarthritis / Rheumatoid Arthritis

What is diclofenac topical?

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

Diclofenac topical (for the skin) is used to treat joint pain caused by osteoarthritis. Pennsaid is for use on the knees. Voltaren Topical is for use on the hands, wrists, elbows, knees, ankles, or feet. This medicine may not be effective in treating arthritis pain elsewhere in the body.

Diclofenac topical is used to treat warty overgrowths of skin (actinic keratoses) on sun-exposed areas of the body.

Diclofenac topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about diclofenac topical?

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 this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

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

What should I discuss with my healthcare provider before using diclofenac topical?

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

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

You should not use this medicine if you are allergic to diclofenac (Voltaren, Cataflam, Flector, and others), or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure diclofenac 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;

• fluid retention.

Using diclofenac topical during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

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

How should I use diclofenac topical?

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 this medicine, unless you are treating the skin on your hands. Wait at least 10 minutes before dressing or wearing gloves. Wait at least 1 hour before you bathe or shower.

Do not apply to an open skin wound, or on areas of infection, rash, burn, or peeling skin. Do not cover treated skin with a bandage or expose it to heat from a hot tub, heating pad, or sauna. Heat or bandaging can increase the amount of diclofenac you absorb through your skin.

To treat actinic keratosis : Apply enough gel to cover each lesion and rub in gently. Do not apply diclofenac topical more than 2 times daily and never use more than your prescribed dose. Diclofenac topical may be used for up to 90 days.

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.

To treat osteoarthritis pain (with Voltaren Topical): This medicine is supplied with dosing cards that show you how much gel to use for a 2-gram dose or a 4-gram dose. Squeeze the gel onto this card along the line for your dose. Use no more gel than will fit on the length of your dosing line. Wipe the card directly onto the treatment area and rub gently into the skin.

Store at room temperature away from moisture and heat. Do not freeze. Store Pennsaid in an upright position.

What happens if I miss a dose?

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.

What should I avoid while using diclofenac topical?

Do not use cosmetics, sunscreen, lotions, insect repellant, or other medicated skin products on the same area you treat with diclofenac topical.

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

Avoid getting this medicine 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 while you are using diclofenac topical.

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 diclofenac. 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.

Diclofenac topical side effects

Although the risk of serious side effects is low when diclofenac is applied to the skin, this medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Get emergency medical help if you have signs of an allergic reaction: 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: chestpain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

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

• the first sign of any skin rash, no matter how mild;

• shortness of breath (even with mild exertion), swelling in your arms or legs;

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

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

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

• high blood pressure--severe headache, pounding in your neck or ears, nosebleed, anxiety, confusion;

• low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• severe skin reaction--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 side effects may include:

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

• diarrhea, constipation;

• headache, dizziness, drowsiness;

• stuffy nose;

• itching, increased sweating;

• increased blood pressure; or

• skin redness, itching, dryness, scaling, or peeling where the medicine was applied.

This is not a complete list of side effects and others may occur.

What other drugs will affect diclofenac topical?

Ask your doctor before using diclofenac topical 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:

• 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.