Diclofenac Sodium and Misoprostol (Page 10 of 11)

17 PATIENT COUNSELING INFORMATION

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 and misoprostol delayed-release tablets and periodically during the course of ongoing therapy.

Embryo-Fetal Toxicity

Advise females that diclofenac sodium and misoprostol delayed-release tablets are contraindicated in pregnant women. Use of misoprostol, a component of diclofenac sodium and misoprostol delayed-release tablets 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 and misoprostol delayed-release tablets 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 and misoprostol delayed-release tablets. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4) and Use in Specific Populations (8.3)].

Infertility

Advise females of reproductive potential that diclofenac sodium and misoprostol delayed-release tablets 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)].

Hepatotoxicity

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 and misoprostol delayed-release tablets 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)].

Anaphylactic Reactions

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 and misoprostol delayed-release tablets 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 and misoprostol delayed-release tablets 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 and misoprostol delayed-release tablets until they talk to their healthcare provider [see Drug Interactions (7)].

Manufactured By:

Teva Pharmaceuticals USA, Inc.

Parsippany, NJ 07054

Rev. E 9/2021

Repackaged By: Preferred Pharmaceuticals INC

MEDICATION GUIDE for

Diclofenac Sodium (dye kloe’ fen ak soe’ dee um) and Misoprostol (mye” soe pros’ tol) Delayed-Release Tablets

A combination of diclofenac a Nonsteroidal Anti-inflammatory Drug (NSAID) and misoprostol a GI mucosal protective prostaglandin E1 analog

What is the most important information I should know about diclofenac sodium and misoprostol delayed-release tablets?

Diclofenac sodium and misoprostol delayed-release tablets contain 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 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:

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

○ with increasing doses of NSAIDs

○ with longer use of NSAIDs

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

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

○ anytime during use

○ without warning symptoms

○ 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”, “antiplatelet drugs”, “anticoagulants”, “SSRIs”, or “SNRIs”
increasing doses of NSAIDs
older age
longer use of NSAIDs
poor health
smoking
advanced liver disease
drinking alcohol
bleeding problems

NSAID containing medicines should only be used:

○ exactly as prescribed

○ at the lowest dose possible for your treatment

○ for the shortest time needed

What is diclofenac sodium and misoprostol delayed-release tablets?

Diclofenac sodium and misoprostol delayed-release tablets 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 is a prescription medicine used to treat:

symptoms of osteoarthritis or rheumatoid arthritis in people at high risk of developing stomach (gastric) and intestinal (duodenal) ulcers while taking NSAIDs.

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 and misoprostol delayed-release tablets?

Do not take diclofenac sodium and misoprostol delayed-release tablets:

if you are allergic to diclofenac, misoprostol or any other ingredients in diclofenac sodium and misoprostol delayed-release tablets. See the end of this Medication Guide for a list of ingredients in diclofenac sodium and misoprostol delayed-release tablets.
if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
right before or after heart bypass surgery.
if you are pregnant.
If you currently have bleeding in your stomach (gastrointestinal bleeding).

Before taking diclofenac sodium and misoprostol delayed-release tablets, 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. See “Who should not take diclofenac sodium and misoprostol delayed-release tablets?”
are breastfeeding or plan to 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.

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
heart failure
liver problems including liver failure
kidney problems including kidney failure
low red blood cells (anemia)
life-threatening skin reactions
life-threatening allergic reactions
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
slurred speech
chest pain
swelling of the face or throat
weakness in one part or side of your body

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

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

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.
Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare 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 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 monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, povidone K-30, sodium hydroxide, corn starch, talc, and triethyl citrate.

Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054

For more information, call Teva at 1-888-838-2872.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. D 9/2021

Repackaged By: Preferred Pharmaceuticals INC

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