Diclofenac/Misoprostol is contraindicated in pregnant women because the misoprostol component can cause abortion. Misoprostol has been shown to cause the uterus to tear in pregnant women if it is used to induce labor or to cause an abortion after the first trimester of pregnancy. Diclofenac/Misoprostol should only be given to women of childbearing age when nonsteroidal anti-inflammatory drug (NSAID) therapy is required and the patient is at high risk of developing stomach ulcers or complications from stomach ulcers. Diclofenac/Misoprostol may be prescribed only if the patient has had a negative pregnancy test within 2 weeks before beginning therapy; is capable of using hormonal birth control (eg, birth control pills); has received oral and written warnings of the serious side effects associated with misoprostol, the risk of failed birth control, and the danger to women of childbearing age who take Diclofenac/Misoprostol by mistake; and will begin taking Diclofenac/Misoprostol only the second or third day of the next normal menstrual period.Diclofenac/Misoprostol is to be used only by the patient for whom it is prescribed. Do not share it with others.
Diclofenac/Misoprostol contains a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Diclofenac/Misoprostol for a long time. Do not use Diclofenac/Misoprostol right before or after bypass heart surgery.
Diclofenac/Misoprostol may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.
Treating joint swelling, pain, and stiffness caused by osteoarthritis or rheumatoid arthritis in patients who are at a high risk of developing NSAID-induced ulcers or their complications. It may also be used for other conditions as determined by your doctor.
Diclofenac/Misoprostol is an NSAID and prostaglandin analog combination. The prostaglandin maintains prostaglandin activity needed to protect the lining of the stomach and reduce acid secretion, reducing the risk of ulcers. The NSAID decreases prostaglandins that cause pain and inflammation, relieving joint pain.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Diclofenac/Misoprostol . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Diclofenac/Misoprostol . Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Diclofenac/Misoprostol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Diclofenac/Misoprostol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Diclofenac/Misoprostol .
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; dizziness; drowsiness; gas; headache; indigestion; nausea; stomach pain or upset; vomiting.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry stools; bleeding and ulcers in the stomach and intestines; chest pain; change in the amount of urine produced; dark urine; dizziness or blurred vision; fast or irregular heartbeat; loss of appetite; mental or mood changes; one-sided weakness; pale stools; persistent loss of appetite; red, swollen, blistered, or peeling skin; seizures; severe diarrhea or stomach pain; severe headache and stiff neck; severe nausea and vomiting; sudden or unexplained weight gain; swelling of the hands, legs, or feet; symptoms of infection (eg, chills, fever, sore throat); trouble breathing or shortness of breath; unusual bleeding or bruising; vaginal bleeding after menopause; vision, hearing, or speech problems; vomit that looks like coffee grounds; weakness, fatigue, fainting; weight loss; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include confusion; convulsions; diarrhea; difficulty breathing; dizziness; drowsiness; fever; lightheadedness; nausea; sleepiness; stomach pain; tremor; unusually fast or slow heartbeat.Proper storage of Diclofenac/Misoprostol :
Store Diclofenac/Misoprostol at 77 degrees F (25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Diclofenac/Misoprostol out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Diclofenac/Misoprostol . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.