Uses of Diclofenac Gel:

• It is used to treat a precancerous skin problem called actinic keratosis.

What do I need to tell my doctor BEFORE I take Diclofenac Gel?

• If you have an allergy to diclofenac or any other part of diclofenac gel (3%).
• If you have an allergy to aspirin or NSAIDs.
• If you are allergic to diclofenac gel (3%); any part of diclofenac gel (3%); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have ever had asthma caused by a salicylate drug like aspirin or a drug like this one like NSAIDs.
• If you have any of these health problems: Dehydration, GI (gastrointestinal) bleeding, heart failure (weak heart), kidney disease, or liver disease.
• If you have had a recent heart attack.
• If you are having trouble getting pregnant or you are having your fertility checked.
• If you are pregnant or may be pregnant. Do not take diclofenac gel (3%) if you are in the third trimester of pregnancy. You may also need to avoid diclofenac gel (3%) at other times during pregnancy. Talk with your doctor to see when you need to avoid taking diclofenac gel (3%) during pregnancy.
• If you are taking any other NSAID.
• If you are taking a salicylate drug like aspirin.
• If you are taking pemetrexed.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with diclofenac gel (3%).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take diclofenac gel (3%) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Diclofenac Gel?

• Tell all of your health care providers that you take diclofenac gel (3%). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• If you smoke, talk with your doctor.
• If you have asthma, talk with your doctor. You may be more sensitive to diclofenac gel (3%).
• Talk with your doctor before you drink alcohol.
• Do not use on skin that has any problems.
• Do not use more than told. Unsafe side effects may happen.
• Do not use longer than you have been told by the doctor.
• Avoid sunlight on treated area.
• The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
• The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
• If you are taking aspirin to help prevent a heart attack, talk with your doctor.
• This medicine may cause harm if swallowed. If diclofenac gel (3%) is swallowed, call a doctor or poison control center right away.
• This medicine is not approved for use in children. Talk with the doctor.
• If you are 65 or older, use diclofenac gel (3%) with care. You could have more side effects.
• NSAIDs like diclofenac gel (3%) may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when diclofenac gel (3%) is stopped. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking diclofenac gel (3%), call your doctor right away.

How is this medicine (Diclofenac Gel) best taken?

Use diclofenac gel (3%) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take diclofenac gel (3%) by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use.
• Clean affected part before use. Make sure to dry well.
• If you get diclofenac gel (3%) in your eyes, wash right away with water. If you have eye irritation that lasts or a change in eyesight, call your doctor.
• Put a thin layer on the affected skin and rub in gently.
• Do not use sunscreen, insect repellant, or other drugs on affected part.
• If putting diclofenac gel (3%) on the hand, do not wash your hands for at least 1 hour after putting on.
• Do not use heat or bandages on the treated part.
• Let the drug dry for at least 10 minutes before you cover it with clothes or gloves.
• Do not bathe, shower, or swim for 1 hour after putting on.
• Do not use on open wounds or infected skin.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
• Chest pain or pressure or a fast heartbeat.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Feeling very tired or weak.
• Flu-like signs.
• Very bad back pain.
• Very bad belly pain.
• A burning, numbness, or tingling feeling that is not normal.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Diclofenac Gel?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Skin irritation.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Diclofenac Gel?

• Store at room temperature. Do not freeze.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Protect gel from heat.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time diclofenac gel (3%) is refilled. If you have any questions about diclofenac gel (3%), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.