Solaraze (Diclofenac Sodium)

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, or burn. 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 SOLARAZE you absorb through your skin.

To treat actinic keratosis (with Solaraze): Apply enough gel to cover each lesion and rub in gently. Do not apply Solaraze gel more than 2 times daily and never use more than your prescribed dose.

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.

To treat arthritis pain in the foot, spread the gel out onto all areas of the foot including the toes and soles. When treating the hand, spread the gel out onto all areas of the hand including the fingers and palms.

If you use this medicine long-term, you may need frequent medical tests.

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

Seek emergency medical attention or call the Poison Help line.

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.

Although the risk of serious side effects is low when SOLARAZE 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: 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 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 or rapid weight gain;
• signs of stomach bleeding--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
• 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.

SOLARAZE 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).

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

You should not use this medicine if you are allergic to SOLARAZE (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 SOLARAZE 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 SOLARAZE 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 SOLARAZE topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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

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

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

Avoid taking aspirin or other NSAIDs.

Ask your doctor before using SOLARAZE 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 SOLARAZE topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.