Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients, families, or their caregivers of the following information before initiating therapy with diclofenac sodium/misoprostol and periodically during the course of ongoing therapy.
- Advise females that diclofenac sodium/misoprostol is contraindicated in pregnant women. Use of misoprostol, a component of diclofenac sodium/misoprostol during pregnancy can result in maternal and fetal harm, including abortion, premature birth, birth defects and uterine rupture. Use of diclofenac may cause oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus [see Warnings and Precautions (5.11), Use in Specific Populations (8.1)].
- Advise patients not to give diclofenac sodium/misoprostol to other females of reproductive potential [see Boxed Warning].
- Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with diclofenac sodium/misoprostol. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4) and Use in Specific Populations (8.3)].
Advise females of reproductive potential that diclofenac sodium/misoprostol may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women [see Use in Specific Populations (8.3)].
Cardiovascular Thrombotic Events
Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [see Warnings and Precautions (5.1)].
Gastrointestinal Bleeding, Ulceration, and Perforation
Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see Warnings and Precautions (5.2)].
Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop diclofenac sodium/misoprostol and seek immediate medical therapy [see Warnings and Precautions (5.3)].
Heart Failure and Edema
Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see Warnings and Precautions (5.5)].
Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [see Contraindications (4) and Warnings and Precautions (5.7)].
Serious Skin Reactions, including DRESS
Advise patients to stop taking diclofenac sodium/misoprostol immediately if they develop any type of rash or fever and contact their healthcare provider as soon as possible [see Warnings and Precautions (5.9, 5.10)].
Avoid Concomitant Use of NSAIDs
Inform patients that the concomitant use of diclofenac sodium/misoprostol with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [see Warnings and Precautions (5.2) and Drug Interactions (7)]. Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia.
Use of NSAIDS and Low-Dose Aspirin
Inform patients not to use low-dose aspirin concomitantly with diclofenac sodium/misoprostol until they talk to their healthcare provider [see Drug Interactions (7)].
This product’s labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.
|Medication Guide for diclofenac sodium/misoprostolA combination of diclofenac a Nonsteroidal Anti-inflammatory Drug (NSAID) and misoprostol a GI mucosal protective prostaglandin E1 analog|
|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Revised: August 2021|
|What is the most important information I should know about diclofenac sodium/misoprostol?|
|Diclofenac sodium/misoprostol contains diclofenac (a nonsteroidal anti-inflammatory drug (NSAID)) and misoprostol, and can cause abortion, premature birth, birth defects, and the uterus to tear (uterine rupture). 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/misoprostol if you are pregnant.|
|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 is diclofenac sodium/misoprostol? Diclofenac sodium/misoprostol contains 2 medicines:|
|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 diclofenac sodium/misoprostol? Do not take diclofenac sodium/misoprostol:|
|Before taking diclofenac sodium/misoprostol, 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 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.|
|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, crospovidone, hydrogenated castor oil, hypromellose, lactose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone (polyvidone) K-30, sodium hydroxide, starch (corn), talc, triethyl citrate. This product’s labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.For more information, go to www.greenstonellc.com or call 1-800-438-1985|
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