DICLOFENAC SODIUM- diclofenac sodium gel 
GLENMARK PHARMACEUTICALS INC., USA

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Medication Guide

Diclofenac Sodium (dye-KLOE-fen-ak SOE-dee-um)
Gel, 3%

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

NSAIDs can cause serious side effects, including:

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 or use 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 or use NSAIDs after a recent heart attack.

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:

past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
increasing doses of NSAIDs
longer use of NSAIDs
smoking
drinking alcohol
older age
poor health
advanced liver disease
bleeding problems

NSAIDs should only be used:

exactly as prescribed
at the lowest dose possible for your treatment
for the shortest time needed

What is diclofenac sodium gel?

Diclofenac sodium gel is a NSAID that is used on the skin (topical) to treat a skin condition called actinic keratosis (AK). Diclofenac sodium gel is not for use in children.

 
Do not use diclofenac sodium gel:

Before using diclofenac sodium gel, tell your healthcare provider about all of your medical conditions, including if you:

have liver or kidney problems
have high blood pressure
have asthma
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 breastfeed. You and your healthcare provider should decide if you will use diclofenac sodium gel or breastfeed.

Tell your healthcare 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 any new medicine without talking to your healthcare provider first.

How should I use diclofenac sodium gel?

Use diclofenac sodium gel exactly as your healthcare provider tells you to use it.
Apply diclofenac sodium gel 2 times a day.
Apply enough diclofenac sodium gel to cover each skin lesion (usually a pea-sized amount) and gently rub in.
Diclofenac sodium gel may be used for 60 to 90 days. You may not see improvement of skin lesions for up to 30 days after stopping treatment. See your healthcare provider if lesions do not respond to treatment.
Avoid getting diclofenac sodium gel in your eyes, nose and mouth. If diclofenac sodium gel gets into your eyes, nose or mouth wash out your eyes, nose or mouth with water or saline right away. Call your healthcare provider if irritation continues for more than 1 hour.
Wash your hands well after applying diclofenac sodium gel.

What should I avoid while using diclofenac sodium gel?

Avoid spending time in sunlight or artificial light, such as tanning beds or sunlamps. Diclofenac sodium gel can make your skin sensitive to sunlight and the light from tanning beds and sunlamps. Talk to your healthcare provider about sun protection measures and wear loose-fitting clothes that cover your skin while out in sunlight. Stop using diclofenac sodium gel if you notice that you are beginning to get sunburn.
Do not apply diclofenac sodium gel to open skin wounds, skin infections, or peeling skin.

What are the possible side effects of diclofenac sodium gel?

Diclofenac sodium gel and other NSAIDs can cause serious side effects, including:

See “What is the most important information I should know about diclofenac sodium gel and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

life threatening allergic reactions
worsening of asthma in people who are aspirin-sensitive
life-threatening skin reactions
liver problems including liver failure
new or worse high blood pressure
heart failure
kidney problems including kidney failure
low red blood cells (anemia)

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:

shortness of breath or trouble breathing
chest pain
weakness in one part or side of your body
slurred speech
swelling of the face or throat

Stop using diclofenac sodium gel and call your healthcare provider right away if you get any of the following symptoms:

nausea

more tired or weaker than usual

diarrhea

itching

your skin or eyes look yellow

indigestion or stomach pain

flu-like symptoms

vomit blood

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

unusual weight gain

skin rash or blisters with fever

swelling of the arms, legs, hands and feet

nausea
more tired or weaker than usual
diarrhea
itching
your skin or eyes look yellow
indigestion or stomach pain
flu-like symptoms
vomit blood
there is blood in your bowel movement, or it is black and sticky like tar
unusual weight gain
skin rash or blisters with fever
swelling of the arms, legs, hands and feet

Application site skin reactions are common with diclofenac sodium gel including: skin redness, itching, rash, dry skin, scaling, and peeling.

If you take too much NSAID, call your healthcare provider or get medical help right away.

 
Diclofenac sodium gel may cause fertility problems in females, which may affect your ability to have a child. Talk to your healthcare provider if this a concern for you.

Other information about NSAIDs

Aspirin is a 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.
Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs.

How should I store diclofenac sodium gel?

Store diclofenac sodium gel at room temperature 68°F to 77°F (20°C to 25°C).
Keep diclofenac sodium gel away from heat. Avoid freezing diclofenac sodium gel.

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

General information about the safe and effective use of diclofenac sodium gel.

 
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use diclofenac sodium gel for a condition for which it was not prescribed. Do not give diclofenac sodium gel to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about diclofenac sodium gel, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about diclofenac sodium gel that is written for health professionals.

What are the ingredients in diclofenac sodium gel?

Active ingredient: diclofenac sodium

Inactive ingredients: benzyl alcohol, sodium hyaluronate, polyethylene glycol monomethyl ether, and purified water.

Trademarks are the property of their respective owners.

Medication Guide available atwww.glenmarkpharma-us.com/medguides

Manufactured by:

Glenmark Pharmaceuticals Limited

Colvale-Bardez, Goa 403513, India

Manufactured for:

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Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

 
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 05/2022
Revised: 5/2022
GLENMARK PHARMACEUTICALS INC., USA