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|Arthrotec

Arthrotec

Arthrotec is used for:

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.

Arthrotec 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.

Do NOT use Arthrotec if:

• you are allergic to any ingredient in Arthrotec or other prostaglandins
• you are pregnant
• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin or an NSAID (eg, ibuprofen, naproxen, celecoxib)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Arthrotec :

Some medical conditions may interact with Arthrotec . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of kidney or liver problems, the blood disease porphyria, bleeding problems, lupus, heart disease, ulcer problems, or high blood pressure
• if you have asthma; bone marrow depression; canker sores; or a hole, bleeding, or destruction of tissue in the stomach or intestines; or you are dehydrated
• if you drink alcohol

Some MEDICINES MAY INTERACT with Arthrotec . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine) because the risk of side effects, such as bleeding, may be increased
• Cyclosporine or methotrexate because the risk of toxicity may be increased
• Lithium because the risk of its side effects may be increased by Arthrotec
• Quinolone antibiotics (eg, ciprofloxacin) because the risk of side effects, such as seizures, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Arthrotec 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.

How to use Arthrotec :

Use Arthrotec as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Arthrotec comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Arthrotec refilled.
• Take Arthrotec by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Do not take magnesium-containing antacids while taking Arthrotec . If an antacid is needed, use one with calcium or aluminum.
• If you miss a dose of Arthrotec , 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.

Ask your health care provider any questions you may have about how to use Arthrotec .

Important safety information:

• Arthrotec may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Arthrotec with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Arthrotec may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Arthrotec . Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Diabetes patients - Arthrotec may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Women who are able to become pregnant should use effective birth control while they are taking Arthrotec . Talk with your doctor if you are unsure of effective birth control methods.
• Lab tests, including complete blood cell counts, liver function tests, and electrolytes, may be performed while you use Arthrotec . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Arthrotec should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Arthrotec if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Arthrotec is found in breast milk. Do not breast-feed while taking Arthrotec .

Possible side effects of Arthrotec :

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; swelling; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bleeding and ulcers in the stomach and intestines; dark urine; fever; heart failure; increase in asthma attacks; increased liver injury; loss of appetite; severe diarrhea; sore throat; trouble breathing; unusual bleeding or bruising; vaginal bleeding after menopause; vision or hearing problems; vomit that looks like coffee grounds; 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), 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.

Store Arthrotec 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 Arthrotec out of the reach of children and away from pets.

General information:

• If you have any questions about Arthrotec , please talk with your doctor, pharmacist, or other health care provider.
• Arthrotec is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Arthrotec . 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.