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Chemical Name: DICLOFENAC (dye-KLOE-fen-ak) and MISOPROSTOL (mye-soe-PROST-ole)
This medicine is a nonsteroidal anti-inflammatory agent (NSAID) and
prostaglandin analog combination used to relieve joint pain, swelling, and
stiffness caused by arthritis in patients at high risk of developing ulcers.
WARNING: THIS MEDICINE MUST NOT BE USED DURING PREGNANCY because birth defects,
fetal, and maternal death have occurred. This medicine must not be used in women
of childbearing age unless there are no alternatives. When this medicine has
been used to start labor or when used for abortion after the first 3 months of
pregnancy, uterine rupture has occurred. Discuss the risks and benefits with
your doctor before using this medicine. If a woman must use this medicine, four
requirements must be met: 1) negative pregnancy test within 2 weeks before
starting use of this medicine; 2) be able use effective measures to prevent
pregnancy (contraception); 3) receive oral and written warnings on the dangers
of misoprostol use in women of childbearing age and the risk of possible birth
control failure; 4) must begin use of this drug only on the second or third day
of next normal menstrual period. This medicine must not be shared with others.
WARNING: THE RISK OF SERIOUS AND SOMETIMES FATAL HEART PROBLEMS, HEART ATTACK,
AND STROKE may be increased with the use of this medicine. This risk may be
increased the longer you use this medicine. Risk may also be higher in patients
who have heart problems or who are at risk for heart problems. THIS MEDICINE
SHOULD NOT BE USED to treat pain before or after coronary artery "heart bypass"
(CABG) surgery. THE RISK OF SERIOUS AND SOMETIMES FATAL STOMACH AND BOWEL
PROBLEMS, including bleeding, ulcers, and holes in the stomach and bowel, is
increased while using this medicine. These problems may occur at any time during
therapy, with or without symptoms. Elderly patients are at higher risk for
serious stomach problems. Ask your doctor or pharmacist for more information
about this medicine and its side effects. Some medicines or medical conditions
may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all
prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS
MEDICINE if you are also taking heparins or tacrolimus. ADDITIONAL MONITORING OF
YOUR DOSE OR CONDITION may be needed if you are taking "blood thinners" (such as
warfarin), corticosteroids (such as prednisone), "water pills" (such as
hydrochlorothiazide or furosemide), ACE inhibitors (such as lisinopril),
serotonin reuptake blocker medicines such as fluoxetine or citalopram,
aminoglycoside antibiotics, bisphosphonates such as alendronate or risedronate,
cyclosporine, aspirin, lithium, or methotrexate. DO NOT START OR STOP any
medicine without doctor or pharmacist approval. Inform your doctor of any other
medical conditions, including eye disease, heart problems (such as heart failure
or history of heart attack), swelling of the hands, feet, or ankles (edema),
high blood pressure, history of stroke, blood clotting problems, stomach or
bowel problems (such as bleeding or ulcers), history of tobacco use or alcohol
use, kidney problems, liver problems, blood or bleeding problems (such as
anemia), asthma, growths in the nose (nasal polyps), any allergies - especially
aspirin/NSAID allergy (e.g., ibuprofen, celecoxib), pregnancy, or
breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of
anemia or conditions of low platelets or white blood cells. USE OF THIS MEDICINE
IS NOT RECOMMENDED if you have history of severe kidney disease or if you are
going to have or have recently had coronary artery "heart bypass" (CABG)
surgery. Contact your doctor or pharmacist if you have any questions or concerns
about taking this medicine.
Follow the directions for using this medicine provided by your doctor. SWALLOW
WHOLE. Do not break, crush, or chew before swallowing. THIS MEDICINE MAY BE
TAKEN WITH FOOD if it upsets your stomach. Taking it with food may not decrease
the risk of stomach or bowel problems (such as bleeding or ulcers) that may
occur while taking this medicine. Talk with your doctor or pharmacist if you
experience persistent stomach upset. STORE THIS MEDICINE at room temperature
below 77 degrees F (25 degrees C) in a tightly-closed container, away from heat
and light. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If
it is almost time for your next dose, skip the missed dose and go back to your
regular dosing schedule. Do NOT take 2 doses at once.
THIS MEDICINE INCREASES YOUR RISK OF SERIOUS STOMACH OR BOWEL PROBLEMS (such as
ulcers and bleeding). This risk is increased if you are elderly or are in poor
health, if you have a history of smoking or drinking alcohol, if you take
corticosteroid medicines (such as prednisone) or "blood thinners" (such as
warfarin), or if you take this medicine for a long period of time. THIS MEDICINE
MAY ALSO INCREASE YOUR RISK for certain serious heart and blood vessel problems
(such as heart attack and stroke). TAKE THIS MEDICINE EXACTLY AS PRESCRIBED BY
YOUR DOCTOR, at the lowest possible dose for the shortest time needed. Talk with
your doctor or pharmacist for further information. DO NOT TAKE THIS MEDICINE IF
YOU HAVE HAD A SEVERE ALLERGIC REACTION to aspirin or any medicine containing
aspirin or to a nonsteroidal anti-inflammatory drug (such as Feldene, Motrin,
Naprosyn, Clinoril, Voltaren). A severe reaction includes a severe rash, hives,
breathing difficulties, or dizziness. If you have a question about whether you
are allergic to this medicine or if a certain medicine is a nonsteroidal
anti-inflammatory drug, contact your doctor or pharmacist. IF YOU EXPERIENCE
difficulty breathing or tightness of chest; swelling of eyelids, face, or lips;
or develop a rash or hives, tell your doctor immediately. Do not take any more
of this medicine unless your doctor tells you to do so. Laboratory and/or
medical tests, including blood counts, liver function tests, and kidney function
tests, may be performed to monitor your progress or to check for side effects,
especially if you are taking this medicine for a long period of time. KEEP ALL
DOCTOR AND LABORATORY APPOINTMENTS while you are taking this medicine. DO NOT
DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you
know how you react to this medicine. Using this medicine alone, with other
medicines, or with alcohol may lessen your ability to drive or to perform other
potentially dangerous tasks. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either
prescription or over-the-counter, check with your doctor or pharmacist. This
includes any non-prescription pain relievers or magnesium-containing antacids.
CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be
more sensitive to the effects of this medicine, especially the risk of stomach
or bowel effects (such as bleeding or ulcers), or kidney effects. FOR WOMEN: DO
NOT USE THIS MEDICINE if you are pregnant. IF YOU SUSPECT THAT YOU COULD BE
PREGNANT, contact your doctor immediately. THIS MEDICINE IS EXCRETED IN BREAST
MILK. DO NOT BREAST-FEED while taking this medicine. IF YOU HAVE DIABETES, this
medicine may affect your blood sugar. Check blood sugar levels closely and ask
your doctor before adjusting the dose of your diabetes medicine.
SIDE EFFECTS, that may go away during treatment, include nausea, vomiting,
diarrhea, gas, heartburn, constipation, dizziness, drowsiness, or headache. If
they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR
AS SOON AS POSSIBLE if you experience diarrhea which lasts longer than 1 week,
unusual bleeding or bruising, loss of appetite, weight loss, or hearing
problems. CONTACT YOUR DOCTOR IMMEDIATELY if you experience sharp or crushing
chest pain; sudden shortness of breath; sudden leg pain; sudden severe headache,
vomiting, dizziness, or fainting; changes in vision; numbness of an arm or leg;
slurred speech; one-sided weakness; sudden unexplained weight gain; change in
amount of urine produced; severe or persistent stomach pain; vomit that looks
like coffee grounds; black tarry stools; itching, reddened, swollen, blistered,
painful, or peeling skin; yellowing of the skin or eyes; dark urine; right-sided
tenderness; severe or persistent tiredness; fever, chills, or sore throat;
severe or persistent nausea; swelling of hands, ankles, feet, face, lips, eyes,
throat, or tongue; difficulty swallowing or breathing; or hoarseness. AN
ALLERGIC REACTION TO THIS MEDICINE is unlikely, but seek immediate medical
attention if it occurs. Symptoms of an allergic reaction include rash, itching,
swelling, severe dizziness, or trouble breathing. If you notice other effects
not listed above, contact your doctor, nurse, or pharmacist.
Drug interactions can result in unwanted side effects or prevent a medicine from
doing its job. Use our drug interaction checker to find out if your medicines
interact with each other.
If overdose is suspected, contact your local poison control center or emergency
room immediately. Symptoms of overdose may include sleepiness, tremor,
convulsions, difficulty breathing, stomach pain, diarrhea, fever, and unusually
fast or slow heart rate.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT
USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the
reach of children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain
refills before your supply runs out.
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