Aggrenox Extended-Release Capsules

Reducing the risk of stroke in patients who have previously had a stroke due to a blood clot in the brain. It is also used to reduce the risk of stroke in patients who have had transient ischemic attacks (TIAs) (eg, "warning stroke" or "mini-stroke" that produces stroke-like symptoms but no lasting damage).

Aggrenox Extended-Release Capsules is an antiplatelet combination. It works by preventing clots from forming in the blood.

• you are allergic to any ingredient in Aggrenox Extended-Release Capsules
• you have bleeding problems
• you are younger than 18 years of age and have the flu, chicken pox, or shingles
• you have had a severe allergic reaction (eg, a severe rash, hives, breathing difficulties, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)

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

Some medical conditions may interact with Aggrenox Extended-Release Capsules. 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 asthma; peptic ulcers; stomach problems; liver problems; a blood clotting disorder; the flu; chicken pox; shingles; hives, rash, or intense itching; Kawasaki syndrome; tumors in the nose; or vitamin K deficiency; or bleeding in the brain

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

• Anticoagulants (eg, heparin, warfarin) or NSAIDs (eg, celecoxib, naproxen) because the risk of their side effects, including risk of bleeding, may be increased by Aggrenox Extended-Release Capsules
• Adenosine, acetazolamide, hydantoins (eg, phenytoin), methotrexate, oral antidiabetic medicines (eg, glyburide), or valproic acid because the risk of their actions and side effects may be increased by Aggrenox Extended-Release Capsules
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), cholinesterase inhibitors (eg, pyridostigmine), diuretics (eg, hydrochlorothiazide), probenecid, or sulfinpyrazone because their effectiveness may be decreased by Aggrenox Extended-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aggrenox Extended-Release Capsules 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 Aggrenox Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Aggrenox Extended-Release Capsules by mouth with or without food.
• Swallow Aggrenox Extended-Release Capsules whole. Do not break, crush, or chew before swallowing.
• DO NOT lie down for 15 to 30 minutes after taking Aggrenox Extended-Release Capsules to help prevent irritation to the esophagus.
• Do not substitute this form of aspirin for any other form of aspirin.
• If you miss a dose of Aggrenox Extended-Release Capsules, 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 Aggrenox Extended-Release Capsules.

• Aggrenox Extended-Release Capsules may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Aggrenox Extended-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Aggrenox Extended-Release Capsules may cause dizziness or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Talk to your doctor before you take Aggrenox Extended-Release Capsules if you drink more than 3 drinks with alcohol per day. Serious stomach ulcers or bleeding can occur with the use of Aggrenox Extended-Release Capsules. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Aggrenox Extended-Release Capsules with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
• Aspirin has been linked to a serious illness called Reye syndrome. Do not give Aggrenox Extended-Release Capsules to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
• Tell your doctor or dentist that you take Aggrenox Extended-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
• Diabetes patients - Aggrenox Extended-Release Capsules may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Use Aggrenox Extended-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.
• Aggrenox Extended-Release Capsules should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aggrenox Extended-Release Capsules while you are pregnant. Aggrenox Extended-Release Capsules is not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. Aggrenox Extended-Release Capsules is found in breast milk. If you are or will be breast-feeding while you use Aggrenox Extended-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

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:

Constipation; diarrhea; dizziness; headache; heartburn; indigestion; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the hands, mouth, face, lips, eyes, throat, or tongue); bloody or black, tarry stools; chest pain; convulsions; dark urine or pale stools; hoarseness; memory loss; nausea; severe stomach pain; stroke; unusual fatigue; vomiting with or without blood; 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 atIf OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control centeror emergency room immediately. Symptoms may include dizziness; fast heartbeat; flushing; restlessness; ringing in the ears; sweating; weakness.

Store Aggrenox Extended-Release Capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aggrenox Extended-Release Capsules out of the reach of children and away from pets.

• If you have any questions about Aggrenox Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Aggrenox Extended-Release Capsules 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 Aggrenox Extended-Release Capsules. 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.

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