ASACOL

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, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, naproxen, celecoxib)
• you have recently had or will be having bypass heart surgery
• you have liver problems (eg, hepatic porphyria)

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, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)
• if you have a history of swelling or fluid buildup, seizures, lupus, asthma, or growths in the nose (nasal polyps)
• if you have high blood pressure, blood problems (eg, anemia, porphyria, low blood platelets), bleeding or clotting problems, heart problems (eg, heart failure), blood vessel disease, or inflammatory bowel disease, seizures, or if you are at risk for any of these diseases
• if you are dehydrated or if you drink alcohol, or have a history of alcohol abuse, or smoke

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, aspirin, clopidogrel, rivaroxaban, or selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, paroxetine) because the risk of bleeding may be increased
• Oral diabetic medicines (eg, glipizide) or insulin because the risk of high or low blood sugar may be increased
• Quinolone antibiotics (eg, levofloxacin) because the risk of seizures may be increased
• Probenecid because it may increase the risk of Arthrotec’s side effects
• Cyclosporine, digoxin, lithium, methotrexate, or tenofovir because the risk of their side effects may be increased by Arthrotec
• Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril) and diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Arthrotec

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 dizziness, drowsiness, or blurred vision. These effects 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, blood electrolyte levels, and liver function, 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. 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 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.

If OVERDOSE is suspected:

Contact your local Poison Control 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 Arthrotec:

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.
• Check with your pharmacist about how to dispose of unused medicine.

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.