DICLOFENAC SODIUM- diclofenac sodium gel
Medsource Pharmaceuticals
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This Medication Guide has been approved by the U.S. Food and Drug Administration. | |
Revised: August 2023 | |
Dispense with Medication Guide available at: https://www.taro.com/usa-medication-guides | |
Medication Guide
Diclofenac (dye-KLOE-fen-ak) Sodium Topical Gel, 3% |
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What is the most important information I should know about diclofenac sodium topical gel and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? | |
NSAIDs can cause serious side effects, including:
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.
The risk of getting an ulcer or bleeding increases with:
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NSAIDs should only be used:
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What is diclofenac sodium topical gel?
Diclofenac sodium topical gel is an NSAID that is used on the skin (topical) to treat a skin condition called actinic keratosis. Diclofenac sodium topical gel is not for use in children. |
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Do not use diclofenac sodium topical gel:
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Before using diclofenac sodium topical gel, tell your healthcare provider about all of your medical conditions, including if you:
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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 topical gel?
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What should I avoid while using diclofenac sodium topical gel?
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What are the possible side effects of diclofenac sodium topical gel? | |
Diclofenac sodium topical gel and other NSAIDs can cause serious side effects, including: | |
See "
What is the most important information I should know about diclofenac sodium topical gel and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?"
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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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Stop using diclofenac sodium topical gel and call your healthcare provider right away if you get any of the following symptoms: | |
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Application site skin reactions are common with diclofenac sodium topical 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 topical 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. These are not all of the possible side effects of NSAIDs. For more information, ask your healthcare 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. |
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Other information about NSAIDs | |
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How should I store diclofenac sodium topical gel?
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Keep diclofenac sodium topical gel and all medicines out of the reach of children. | |
General information about the safe and effective use of diclofenac sodium topical gel. | |
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use diclofenac sodium topical gel for a condition for which it was not prescribed. Do not give diclofenac sodium topical 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 topical gel, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about diclofenac sodium topical gel that is written for health professionals. | |
What are the ingredients in diclofenac sodium topical gel? | |
Active ingredient:diclofenac sodium | |
Inactive ingredients:benzyl alcohol, hyaluronate sodium, polyethylene glycol monomethyl ether, and purified water. | |
Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 | |
Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 | |
For more information, call 1-866-923-4914. |