Diclofenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.
Misoprostol reduces stomach acid and replaces protective substances in the stomach that are reduced by NSAIDs.
The combination of diclofenac and misoprostol is used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers.
Diclofenac and misoprostol may also be used for other purposes not listed in this medication guide.
Misoprostol can cause birth defects, miscarriage, premature labor, or rupture of the uterus if the medication is taken during pregnancy. Diclofenac can cause birth defects if it is taken during the last 3 months of pregnancy. Do not use diclofenac and misoprostol if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.
This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use diclofenac. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.
This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking diclofenac. Older adults may have an even greater risk of these serious gastrointestinal side effects.
Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.Do not drink alcohol while taking diclofenac and misoprostol. Alcohol can increase the risk of stomach bleeding caused by diclofenac.
Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.Do not use this medication if you are allergic to diclofenac (Cataflam) or misoprostol (Cytotec), or if you have a history of allergic reaction to aspirin or other NSAIDs.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely take diclofenac and misoprostol.
FDA pregnancy category X. Misoprostol can cause birth defects, miscarriage, premature labor, or rupture of the uterus if the medication is taken during pregnancy. Diclofenac can cause birth defects if it is taken during the last 3 months of pregnancy. Do not use diclofenac and misoprostol if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. You will need to have a pregnancy test within 2 weeks before you start taking diclofenac and misoprostol. Diclofenac and misoprostol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
a history of heart attack, stroke, or blood clot;
heart disease, congestive heart failure, high blood pressure;
a history of stomach ulcers or bleeding;
- liver or kidney disease,
polyps in your nose;
a bleeding or blood clotting disorder;
if you smoke; or
drink more than three alcoholic beverages a day.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.Take this medicine with a full glass of water. Swallow the diclofenac and misoprostol tablet whole. Do not crush, break, or chew the pill. Take diclofenac and misoprostol with food or milk to lessen stomach upset. Do not share this medication with anyone else, even if they have the same symptoms you have. Store diclofenac and misoprostol at room temperature away from moisture and heat.
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include drowsiness, confusion, muscle weakness, nausea, vomiting, stomach pain, shallow breathing, feeling light-headed, or fainting.
Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb diclofenac and misoprostol.Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to diclofenac (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking diclofenac and misoprostol. Alcohol can increase the risk of stomach bleeding caused by diclofenac. Avoid prolonged exposure to sunlight. Diclofenac may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and seek medical attention or call your doctor at once if you have any of these serious side effects:
chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
black, bloody, or tarry stools;
coughing up blood or vomit that looks like coffee grounds;
swelling or rapid weight gain;
urinating less than usual or not at all;
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
bruising, severe tingling, numbness, pain, muscle weakness; or
fever with headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).
Less serious side effects may include:
mild stomach pain, nausea, diarrhea, bloating, gas;
dizziness, drowsiness, headache;
blurred vision, ringing in your ears; or
unusual vaginal bleeding.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before taking diclofenac and misoprostol, tell your doctor if you are taking any of the following drugs:
a blood thinner such as warfarin (Coumadin);
cyclosporine (Neoral, Sandimmune);
diuretics (water pills) such as furosemide (Lasix);
insulin or diabetes medicine you take by mouth;
lithium (Eskalith, Lithobid);
methotrexate (Rheumatrex, Trexall);
phenobarbital (Luminal, Solfoton);
steroids (prednisone and others);
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), and others; or
an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others.
This list is not complete and there may be other drugs that can interact with diclofenac and misoprostol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
- Your pharmacist can provide more information about diclofenac and misoprostol.
Copyright 1996-2006 Cerner Multum, Inc. Version: 4.01. Revision Date: 05/27/2009 3:04:41 PM.;
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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