Diclofenac Sodium, Misoprostol Gastro-resistant tablet
What is this medicine?
DICLOFENAC; MISOPROSTOL (dye KLOE fen ak; mye soe PROST ole) is a combination of two different drugs. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). It is used to reduce swelling and to treat pain. Misoprostol protects the stomach against ulcers. This medicine is used for arthritis in people who are at high risk for stomach ulcers from NSAID treatment.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
asthma, especially aspirin sensitive asthma
coronary artery bypass graft (CABG) surgery within the past 2 weeks
drink more than 3 alcohol containing drinks a day
heart disease or circulation problems like heart failure or leg edema (fluid retention)
high blood pressure
stomach bleeding or ulcers
an unusual or allergic reaction to diclofenac, aspirin, other NSAIDs, misoprostol, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Long-term, continuous use may increase the risk of heart attack or stroke.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Elderly patients over 65 years old may have a stronger reaction and need a smaller dose.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This medicine may also interact with the following medications:
aspirin and aspirin like medicines
medicines for diabetes
medicines for high blood pressure
medicines that treat or prevent blood clots such as warfarin and other blood thinners
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Tell your doctor or health care professional if your pain does not get better. Talk to your doctor before taking another medicine for pain. Do not treat yourself.
This medicine does not prevent heart attack or stroke. In fact, this medicine may increase the chance of a heart attack or stroke. The chance may increase with longer use of this medicine and in people who have heart disease. If you take aspirin to prevent heart attack or stroke, talk with your doctor or health care professional.
Do not take medicines such as ibuprofen and naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many medicines available without a prescription should not be taken with this medicine.
This medicine can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Do not smoke cigarettes or drink alcohol. These increase irritation to your stomach and can make it more susceptible to damage from this medicine. Ulcers and bleeding can happen without warning symptoms and can cause death.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.
If you are female, do not use this medicine if you are pregnant. Do not get pregnant while taking this medicine and for at least one month (one full menstrual cycle) after stopping this medicine. If you can have children, use a reliable form of birth control while taking this medicine. Talk to your doctor about birth control options. If you become pregnant, think you are pregnant, or want to become pregnant, immediately call your doctor for advice.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
black or bloody stools, blood in the urine or vomit
difficulty breathing or wheezing
nausea or vomiting
slurred speech or weakness on one side of the body
unexplained weight gain or swelling
unusually weak or tired
yellowing of eyes or skin
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
gas or heartburn
menstrual irregularity or cramps
stomach pain or cramps
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at or below 25 degrees C (77 degrees F). Protect from moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.
March 21, 2017
U.S. FDA-approved Package Insert