Diclofenac Sodium, Topical

________________________________________________________________________

KEY POINTS

• The gel form of this medicine is put on the skin to treat actinic keratosis. Use it exactly as directed.
• NSAIDs may increase the chance of a heart attack or stroke that can lead to death. This medicine may cause ulcers and bleeding in the stomach and intestines at any time during treatment. This medicine should not be used right before or after a heart surgery called coronary artery bypass graft (CABG).
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: nonsteroidal anti-inflammatory drug (NSAID)

Generic and brand names: diclofenac sodium, topical; Solaraze

What is this medicine used for?

This medicine comes as a gel that is used on the skin to treat actinic keratosis (a type of skin growth caused by years of sun exposure).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Anemia or a blood clotting disorder
• Asthma or other breathing problems
• Heart disease, heart failure, or a heart attack
• High blood pressure
• Kidney or liver disease
• Nasal polyps
• Peripheral vascular disease
• Ulcers

Tell your healthcare provider if you drink alcohol or smoke regularly

Females of childbearing age: Tell your healthcare provider if you are pregnant or if you plan to become pregnant while taking this medicine. The manufacturer recommends that this medicine should not be used during late pregnancy. Do not breast-feed while taking this medicine without your healthcare provider’s approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 18.

Before and after you use this medicine, wash your skin with mild soap and warm water. Rinse and pat dry with a soft towel.

Do not apply the medicine to open wounds or to skin that is irritated, peeling, or infected.

If you have the gel, put a thin layer of medicine on the area where you need it to completely cover the sores. Using too much medicine or using it too often can increase the risk of side effects from absorption into your body.

If you have the solution, you may put the medicine directly on your knee, or put the drops into your hands and then rub the medicine into your knee. Do not shower or bathe for at least 30 minutes after using this medicine.

Do not cover the area with a bandage or apply heat to the area where you have used the medicine. Do not put insect repellant, sunscreen, or other products on the treated skin until the medicine has completely dried.

This medicine is for external use only. Do not get the medicine into your eyes, nose, or mouth. If you get the gel into your eyes, flush them thoroughly with cool water.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

Warning: This medicine may cause ulcers and bleeding in the stomach and intestines at any time during treatment. This may happen without warning symptoms. You may be at higher risk if you smoke, are over the age of 65 or in poor health, drink alcohol, or take this medicine for a long time. If you have stomach pain, or bloody or black tarry bowel movements, stop taking this medicine and contact your healthcare provider right away.

NSAIDs may increase the chance of a heart attack or stroke that can lead to death. This chance increases if you:

• Use NSAIDs for a long time
• Have heart disease

Talk with your healthcare provider about this.

This medicine should not be used right before or after a heart surgery called coronary artery bypass graft (CABG). Talk with your healthcare provider about this.

Contact your healthcare provider if your symptoms don't improve or if they get worse.

Avoid exposure to the sun and sunlamps while using this medicine. Exposure to the sun may make your condition worse. When outdoors, wear protective clothing. Do not use sunscreen lotions, cosmetics, or other skin medicines while using this medicine unless your healthcare provider approves. If you develop hives, an itchy rash, or peeling skin, stop taking the medicine and contact your provider right away.

Adults over the age of 65 may be at greater risk for side effects from this medicine. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; severe rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); blisters or peeling skin; sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking; crushing chest pain or chest heaviness; sudden shortness of breath.

Serious (Report these to your healthcare provider right away.): Painful or tingling skin; body ache; irregular heartbeat; unexplained swelling; black, tarry bowel movements; vomiting or coughing up blood or material that looks like coffee grounds; unusual bruising or bleeding; unusual vaginal bleeding; severe stomach pain; yellowing of your eyes or skin; swelling in your hands, feet, or ankles; severe nausea or diarrhea; decreased urination; fever.

Other: Itchy, dry, or scaly skin; headache, dizziness, trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Aspirin and other salicylates
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meclofenamate, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.