DICLOFENAC SODIUM AND MISOPROSTOL- diclofenac sodium and misoprostol tablet, delayed release
Preferred Pharmaceuticals Inc.
----------
Diclofenac Sodium (dye kloe' fen ak soe' dee um) and Misoprostol (mye'' soe pros' tol) Delayed-Release Tablets, USP for oral use |
What is the most important information I should know about diclofenac sodium and misoprostol delayed-release tablets? Diclofenac sodium and misoprostol delayed-release tablets contains diclofenac (a nonsteroidal anti-inflammatory drug (NSAID)) and misoprostol, and can cause uterus to tear (uterine rupture), abortion, premature birth, or birth defects. The risk of uterine rupture increases as your pregnancy advances, if you have given birth to 5 or more children, and if you have had surgery on the uterus, such as a cesarean delivery. Do not take diclofenac sodium and misoprostol delayed-release tablets if you are pregnant.
What is the most important information I should know about medicines containing Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including:
Do not take NSAID containing medicines right before or after a heart surgery called a “coronary artery bypass graft (CABG)." Avoid taking NSAID containing medicines 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.
The risk of getting an ulcer or bleeding increases with:
NSAID containing medicines should only be used:
|
What are diclofenac sodium and misoprostol delayed-release tablets? Diclofenac sodium and misoprostol delayed-release tablet contains 2 medicines: 1. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?” 2. Misoprostol is a medicine used to protect the lining of the esophagus, stomach and intestines while taking diclofenac. Diclofenac sodium and misoprostol delayed-release tablets are a prescription medicine used to treat:
It is not known if diclofenac sodium and misoprostol delayed-release tablets are safe and effective for use in children. What are NSAIDs? NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis. |
Who should not take diclofenac sodium and misoprostol delayed-release tablets? Do not take diclofenac sodium and misoprostol delayed-release tablets:
|
Before taking diclofenac sodium and misoprostol delayed-release tablets, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and 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. |
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)?”
Get emergency help right away if you get any of the following symptoms:
Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:
If you take too much of your NSAID, call your healthcare provider or get medical help right away. These are not all 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. |
Other information about NSAIDs
|
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 healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals. |
Active ingredients: diclofenac sodium, misoprostol. Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, povidone, sodium hydroxide, talc, and triethyl citrate. |
Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ, 08807 For more information, go to www.amneal.com or call 1-877-835-5472 |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. 03-2023-04 |
Repackaged By: Preferred Pharmaceuticals Inc.
Dispense with Medication Guide available at:
documents.amneal.com/mg/diclo-misoprostol-dr.pdf