Voltaren Arthritis Pain gel contains diclofenac, a nonsteroidal anti-inflammatory drug (NSAID). Diclofenac works by reducing substances in the body that cause pain and inflammation.

Voltaren Arthritis Pain gel is used to treat joint pain caused by osteoarthritis in the hands, wrists, elbows, knees, ankles, or feet.

Voltaren Arthritis Pain gel may not be effective in treating arthritis pain elsewhere in the body.

You should not use Voltaren Arthritis Pain gel if you have ever had asthma or a severe allergic reaction caused by aspirin, diclofenac (Cataflam, Voltaren), or another nonsteroidal anti-inflammatory drug (NSAID).

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 Voltaren Arthritis Pain gel, especially in older adults.

Before taking this medicine

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

You should not use Voltaren Arthritis Pain gel 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 Voltaren Arthritis Pain gel is safe for you, tell your doctor or pharmacist 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; ot

• 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 Voltaren Arthritis Pain gel 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 may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Use Voltaren Arthritis Pain gel exactly as prescribed by your doctor or as instructed on the packaging. 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 Voltaren Arthritis Pain gel, 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 osteoarthritis pain with Voltaren Arthritis Pain gel: 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.

Usual Adult Dose for Osteoarthritis:

1% Gel:
Lower Extremities: Apply 4 g to the affected foot, knee, or ankle 4 times a day and rub in gently; not to exceed 16 g/day to any single joint of the lower extremities

Upper Extremities: Apply 2 g to the affected hand, wrist, or elbow 4 times a day and rub in gently; not to exceed 8 g/day to any single joint of the upper extremities

Maximum dose: 32 g/day over all affected joints

Comments:
-When used on the lower extremities, the gel should be applied to the entire affected foot, knee, or ankle; the entire foot includes the sole, the top of the foot, and the toes.
-When used on the upper extremities, apply to the entire affected hand, wrist, or elbow; the entire hand includes the palm, the back of the hands, and the fingers.
-The accompanying dosing card should be used for application; consult manufacturer product information for instructions.

Use: For the relief of pain associated with osteoarthritis of the joints amenable to topical treatment, such as the knees and those of the hands; this drug has not been evaluated for use on the spine, hip, or shoulder.

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

You should not use Voltaren Arthritis Pain gel 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 Voltaren Arthritis Pain gel is safe for you, tell your doctor or pharmacist 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; ot

• 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 Voltaren Arthritis Pain gel 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 may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

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.

Do not use cosmetics, sunscreen, lotions, insect repellant, or other medicated skin products on the same area you treat with Voltaren Arthritis Pain gel.

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

Avoid getting Voltaren Arthritis Pain gel 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 Voltaren Arthritis Pain gel.

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.

Get emergency medical help if you have signs of an allergic reaction to Voltaren Arthritis Pain gel (hives, sneezing, runny or stuffy nose, wheezing or trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using Voltaren gel 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 Voltaren Arthritis Pain gel and seek emergency medical attention 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.

Also call your doctor at once if you have:

• a skin rash, no matter how mild;

• swelling, rapid weight gain;

• severe headache, blurred vision, pounding in your neck or ears;

• little or no urination;

• liver problems - nausea, diarrhea, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or

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

Common Voltaren Arthritis Pain gel side effects may include:

• heartburn, 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before using Voltaren Arthritis Pain gel 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.