Voltaren Gel

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

Voltaren gel is used to treat joint pain caused by osteoarthritis in the hands, wrists, elbows, knees, ankles, or feet. Other brands of topical diclofenac are used to treat a skin condition called actinic keratosis.

Voltaren gel may not be effective in treating arthritis pain elsewhere in the body. Do not use this medicine for strains, sprains, bruises, or sports injuries.

Use Voltaren 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 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 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.

If you are using this medicine without a prescription for arthritis pain, do not use it on more than 2 body areas at the same time. It may take up to 7 days to work. Stop using the medicine and ask your doctor if your pain does not improve within 7 days, or if you need to use it for more than 21 days.

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

You should not use Voltaren 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 a fatal heart attack, heart failure, 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 gel, especially in older adults.

Voltaren gel can increase your risk of a fatal heart attack, heart failure, 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, heart failure, or heart attack while using Voltaren gel. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

You should not use Voltaren 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.

Do not use this medicine on a child without medical advice. Some brands are not approved for use in anyone under 18 years old.

To make sure Voltaren 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 gel unless your doctor tells you to. Using an NSAID at about 20 weeks of pregnancy or later can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy. You should not use NSAIDs after about 30 weeks of pregnancy.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Get emergency medical help if you have signs of an allergic reaction to Voltaren 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 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 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.

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 extremitiesUpper 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 extremitiesMaximum dose: 32 g/day over all affected jointsComments:-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 hand, and the fingers.-The accompanying dosing card should be used for application; consult manufacturer's product information for instructions.

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 repellent, or other medicated skin products on the same area you treat with Voltaren gel.

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

Avoid getting Voltaren 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 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.

Ask your doctor before using Voltaren 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.