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Arthrotec

Last reviewed on RxList: 10/27/2017

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Arthrotec Patient Information Including Side Effects

Brand Names: Arthrotec

Generic Name: diclofenac and misoprostol (Pronunciation: dye KLOE fen ak and mye so PROST ole)

What is diclofenac and misoprostol (Arthrotec)?

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). 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 purposes not listed in this medication guide.

What are the possible side effects of diclofenac and misoprostol (Arthrotec)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using diclofenac and misoprostol and call your doctor at once if you have a serious side effect such as:

  • 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, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

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.

What is the most important information I should know about diclofenac and misoprostol (Arthrotec)?

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 may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use diclofenac and misoprostol just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking diclofenac and misoprostol, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol. It may increase your risk of stomach bleeding caused by diclofenac.

Arthrotec Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking diclofenac and misoprostol (Arthrotec)?

Do not use diclofenac and misoprostol just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking diclofenac and misoprostol, especially in older adults.

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.

To make sure you can safely take diclofenac and misoprostol, tell your doctor if you have any of these other conditions:

  • 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,
  • asthma;
  • polyps in your nose;
  • porphyria;
  • a bleeding or blood clotting disorder;
  • if you smoke; or
  • drink more than three alcoholic beverages a day.

Diclofenac and misoprostol can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using 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.

How should I take diclofenac and misoprostol (Arthrotec)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. 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.

If you use this medication long-term, your liver function may need to be checked with frequent blood tests. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

Arthrotec Patient Information including If I Miss a Dose

What happens if I miss a dose (Arthrotec)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Arthrotec)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, confusion, muscle weakness, nausea, vomiting, stomach pain, shallow breathing, feeling light-headed, or fainting.

What should I avoid while taking diclofenac and misoprostol (Arthrotec)?

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb diclofenac and misoprostol.

Ask a doctor or pharmacist before using any other cold, allergy, or pain medicine. NSAIDs are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain type of drug. Check the label to see if a medicine contains asprin, ibuprofen, ketoprofen, or naproxen.

Avoid drinking alcohol. It may increase your risk of stomach bleeding caused by diclofenac.

Avoid exposure to sunlight or tanning beds. Diclofenac and misoprostol can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect diclofenac and misoprostol (Arthrotec)?

Tell your doctor about all other medicines you use, especially:

  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • cyclosporine (Neoral, Gengraf, Sandimmune);
  • digoxin (Lanoxin);
  • a diuretic (water pill);
  • insulin or diabetes medicine you take by mouth;
  • lithium (Eskalith, Lithobid);
  • methotrexate (Rheumatrex, Trexall);
  • phenobarbital (Luminal, Solfoton);
  • steroids (prednisone and others);
  • voriconazole (Vfend);
  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or
  • an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

This list is not complete and other drugs may interact with diclofenac and misoprostol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about diclofenac and misoprostol.


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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