Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

NSAIDs can cause serious side effects, including:

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Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:

o

with increasing doses of NSAIDs

o

with longer use of NSAIDs

Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)."

Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

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Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:

o

anytime during use

o

without warning symptoms

o

that may cause death

The risk of getting an ulcer or bleeding increases with:

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past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs

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taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs"

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increasing doses of NSAIDs

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longer use of NSAIDs

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smoking

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drinking alcohol

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older age

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poor health

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advanced liver disease

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bleeding problems

NSAIDs should only be used:

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exactly as prescribed

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at the lowest dose possible for your treatment

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for the shortest time needed

What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.

Who should not take NSAIDs?

Do not take NSAIDs:

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if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs

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right before or after heart bypass surgery.

Before taking NSAIDs, tell your health care provider about all of your medical conditions, including if you:

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have liver or kidney problems

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have high blood pressure

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have asthma

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are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy.

•

are breastfeeding or plan to breast feed.

Tell your health care provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking new medicine without talking to your health care provider first.

What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:

See "What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?"

•

new or worse high blood pressure

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heart failure

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liver problems including liver failure

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kidney problems including kidney failure

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low red blood cells (anemia)

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life-threatening skin reactions

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life-threatening allergic reactions

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Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting and dizziness.

Get emergency help right away if you get any of the following symptoms:

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shortness of breath or trouble breathing

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chest pain

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weakness in one part or side of your body

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slurred speech

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swelling of the face or throat

Stop taking your NSAID and call your health care provider right away if you get any of the following symptoms:

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nausea

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more tired or weaker than usual

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diarrhea

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itching

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your skin or eyes look yellow

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indigestion or stomach pain

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flu-like symptoms

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vomit blood

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there is blood in your bowel movement or it is black and sticky like tar

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unusual weight gain

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skin rash or blisters with fever

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swelling of the arms, legs, hands, and feet

If you take too much of your NSAID, call your health care provider or get medical help right away. These are not all the possible side effects of NSAIDs. For more information, ask your health care provider or pharmacist about NSAIDs.

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

Other information about NSAIDs

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Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

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Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your health care provider before using over-the-counter NSAIDs for more than 10 days.

General information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your health care provider. You can ask your pharmacist or health care provider for information about NSAIDs that is written for health professionals.

Distributed by: Lupin Pharmaceuticals, Inc, Baltimore, Maryland 21202, United States

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

For more information, call 1-800-399-2561.

This Medication Guide has been approved by the U.S. Food and Drug Administration.                              Revised 01/2022

Instructions for Use

DICLOFENAC (dye-KLOE-fen-ak)

SODIUM TOPICAL SOLUTION, 2 % w/w

Read the Medication Guide that comes with diclofenac sodium topical solution first. Be sure that you read, understand and follow these Instructions for Use before you use diclofenac sodium topical solution for the first time.

Important: For use on the skin only (topical). Do not get diclofenac sodium topical solution in your eyes, nose or mouth.

Before you use diclofenac sodium topical solution:

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Apply diclofenac sodium topical solution exactly as your healthcare provider tells you. Talk with your healthcare provider or pharmacist if you are not sure.

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Only use diclofenac sodium topical solution to treat pain from osteoarthritis in your knee or knees.

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Apply diclofenac sodium topical solution on clean, dry skin that does not have any cuts, infections or rashes.

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Use diclofenac sodium topical solution two times a day on your knee or knees as prescribed.

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If you get diclofenac sodium topical solution in your eyes, rinse your eyes right away with water or saline. Call your healthcare provider if your eyes are irritated for more than one hour.

Diclofenac sodium topical solution comes in a pump bottle or in a sample packet from your healthcare provider

If you are using a diclofenac sodium topical solution pump bottle follow the steps below:

Before you use diclofenac sodium topical solution pump bottle for the first time, you will need to prime the pump. To prime the pump, remove the cap (See Figure A) and fully press the top of the pump all the way down 4 times while holding the bottle in an upright position (See Figure B). Dispense this portion of the medicine into a tissue or paper towel and throw it away in a trash can. The pump is now ready to use. You should not need to prime the pump again.

Figure A.

Figure B.

Steps for using diclofenac sodium topical solution pump bottle:

Step 1:    Wash your hands with soap and water before applying diclofenac sodium topical solution.

Step 2:    Remove the bottle cap and press the pump head down firmly and fully to dispense diclofenac sodium topical solution into the palm of your hand. Release the pump head and then press the pump head down firmly and fully a second time. When you use your diclofenac sodium topical solution pump bottle, you can hold the bottle at an angle. Put 2 pumps of diclofenac sodium topical solution on your hand (See Figure C).

Figure C.

Step 3:    Apply diclofenac sodium topical solution evenly around the front, back, and sides of your knee. Diclofenac sodium topical solution should be applied without massaging the knee (See Figures D and E).

Figure D.

Figure E.

Step 4:    Repeat Steps 2 and 3 for your other knee if your healthcare provider has prescribed diclofenac sodium topical solution for both knees.

Step 5:    Wash your hands with soap and water right away after applying diclofenac sodium topical solution.

Step 6:    Replace the cap on the bottle and store in an upright position.

If you are using a diclofenac sodium topical solution sample packet follow the steps below:

Steps for using a diclofenac sodium topical solution sample packet:

Step 1: Wash your hands with soap and water before applying diclofenac sodium topical solution.

Step 2: Cut open the sample packet using scissors or completely tear the packet at the notch on the dotted line (See Figure A). Do not use your teeth to open the sample packet (See Figure A).

Figure A.

Step 3: Squeeze from the bottom of the sample packet to the top to remove contents. Squeeze all of the diclofenac sodium

topical solution out of the sample packet into the palm of your hand (See Figure B).

Figure B.

Step 4: Apply diclofenac sodium topical solution evenly around the front, back, and sides of your knee. Diclofenac sodium topical solution should be applied without massaging the knee (See Figures C and D).

Step 5: Repeat steps 2 through 4 for your other knee if your healthcare provider has prescribed diclofenac sodium topical solution for both knees.

Step 6: Wash your hands with soap and water right away after applying diclofenac sodium topical solution.

Step 7: Throw away the empty sample packet into a trash can.

After you use diclofenac sodium topical solution:

Do not:

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cover your knee with clothing until your knee is completely dry.

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put sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medicines on your knee until it is completely dry.

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take a shower or a bath for at least 30 minutes after you put diclofenac sodium topical solution on your knee(s).

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use heating pads or cover the treated area with bandages where you have applied diclofenac sodium topical solution.

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exercise following application of diclofenac sodium topical solution.

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use sunlamp and tanning beds. Protect your treated knee from sunlight. Wear clothes that cover your skin if you have to be in the sunlight.

How should I store diclofenac sodium topical solution?

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Store diclofenac sodium topical solution at room temperature between 68°F to 77°F (20°C to 25°C).

Keep diclofenac sodium topical solution and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed by:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Revised: 01/2022