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Description

Diclofenac is used to reduce pain, swelling, and joint stiffness from arthritis. Diclofenac is known as a nonsteroidal anti-inflammatory drug (NSAID). Misoprostol protects the stomach from diclofenac's irritating effects. This combination medication is used to treat arthritis in people at high risk of getting stomach/intestinal ulcers and complications from the ulcers (such as bleeding).

If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. 

Read the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this medication.

Swallow the tablets whole. Do not crush, chew, or dissolve the tablets. Doing so can increase the risk of side effects. Do not take tablets that are broken.

Take this medication with food to prevent stomach upset and to reduce the chances of diarrhea. Avoid taking antacids that contain magnesium while using this medication because they may worsen diarrhea. If you need an antacid, consult your doctor or pharmacist to help you choose a product.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or use this drug more often or for longer than prescribed. For ongoing conditions such as arthritis, keep taking this medication as directed. Discuss the risks and benefits with your doctor or pharmacist.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. It may take up to 2 weeks of taking this drug regularly before you get the full benefit.

Tell your doctor if your condition does not get better or if it gets worse.

Cautions

Do not use Arthrotec if you are pregnant. Misoprostol can cause birth defects, miscarriage, premature labor, or rupture of the uterus. You must have a negative pregnancy test within 2 weeks before you start taking Arthrotec. You may need to start taking this medicine only on the 2nd or 3rd day of a normal menstrual period. Use effective birth control while you are using Arthrotec.

Diclofenac can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use Arthrotec just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

You should not use Arthrotec if you have active bleeding in your stomach or intestines.

Diclofenac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using diclofenac, especially in older adults. You should not use Arthrotec if you have active bleeding in your stomach or intestines.

Diclofenac can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking Arthrotec.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Diclofenac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using diclofenac, especially in older adults.

You should not use Arthrotec if you are allergic to diclofenac or misoprostol, or:

  • if you have active bleeding in your stomach or intestines;
  • if you are pregnant; or
  • if you have a history of asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure Arthrotec is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
  • a history of heart attack, stroke, or blood clot;
  • a history of stomach ulcers or bleeding;
  • asthma;
  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
  • liver or kidney disease; or
  • fluid retention.

You will need to have a pregnancy test within 2 weeks before you start taking Arthrotec. You may need to start taking this medicine only on the 2nd or 3rd day of a normal menstrual period.

It is not known whether diclofenac and misoprostol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Side Effects

Diarrhea and stomach/abdominal pain may occur within a few weeks after you start taking this medication, and usually last for about one week. Nausea, heartburn, gas, upset stomach, drowsiness, and dizziness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Diarrhea that is severe or doesn't stop may result in a serious loss of body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.

Tell your doctor right away if you have any serious side effects, including: difficult/painful swallowing, hearing changes (such as ringing in the ears), mental/mood changes (such as depression), easy bruising/bleeding, unusual/heavy vaginal bleeding, menstrual problems/irregular periods, symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).

Get medical help right away if you have any very serious side effects, including: signs of kidney problems (such as change in the amount of urine), unexplained stiff neck, seizures.

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

FAQs

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
  • kidney disease
  • liver disease
  • 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
  • breast-feeding

 

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.

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