aspirin 25 mg-dipyridamole 200 mg capsule,ext.release 12 hr multiphase

Generic name:
Aspirin/dipyridamole sustained-release - oral

Pronunciation
(AS-pir-in/DYE-pir-ID-a-mole)

Brand name(s)
Aggrenox

This medication is used to reduce the risk of stroke in patients who have had "mini-strokes" (transient ischemic attacks) or a previous stroke due to a blood clot and are at high risk for another stroke. It contains two medications: a very low dose of aspirin (25 milligrams per tablet) and dipyridamole in a slow-release form.

Low-dose aspirin and dipyridamole are antiplatelet drugs that work to keep blood flowing to the brain by stopping platelets from clumping together. This helps prevent the platelets from forming blood clots, which can lodge in the brain and cause a certain type of stroke (ischemic stroke).

Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually twice daily (morning and evening). Swallow the capsule whole. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects.

Take this medication with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise.

The dosage is based on your medical condition and response to treatment. If you have certain side effects (such as severe headache) when you first start taking this medication, your doctor may temporarily change your dose. Carefully follow your doctor's directions. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not try to replace this combination medication with aspirin and dipyridamole taken separately. You would not be able to get the right dose and slow-release dosage form, so the separate medications would not work as well as this combination medication. Consult your pharmacist for more information.

Headache, nausea, vomiting, diarrhea, abdominal pain, heartburn, and dizziness may occur. Talk with your doctor if you have a severe headache when you first start taking this medication. Your doctor may change your dose for the first week to lessen headache (see also How to Use section). If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor 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.

Tell your doctor right away if you have any serious side effects, including:

• easy bleeding/bruising
• uncontrolled bleeding from gums or nose
• fast/slow/irregular heartbeat
• loss of appetite
• dark urine
• yellowing eyes/skin
• unusual tiredness
• unusual weakness
• signs of kidney problems (such as change in the amount of urine)

This drug may rarely cause serious bleeding from the stomach or intestines. If you notice any of the following serious side effects, stop taking this medication and consult your doctor or pharmacist right away:

• stomach/abdominal pain that doesn't go away
• black stools
• vomit that looks like coffee grounds

Get medical help right away if you have any very serious side effects, including:

• fainting
• symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)
• signs of bleeding in the brain or stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion)

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:

• fever
• swollen lymph nodes
• 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor if you are allergic to dipyridamole; or to aspirin; or to other salicylates (such as choline salicylate); or to NSAIDs (such as ibuprofen, naproxen); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs)
• bleeding problems (such as hemophilia, vitamin K deficiency, low platelets)
• low blood pressure (hypotension)
• heart problems (such as angina, heart attack)
• stomach problems (such as ulcers, heartburn)
• kidney disease
• liver disease
• a certain muscle problem (myasthenia gravis)
• growths in the nose (nasal polyps)
• bleeding in the brain

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis).

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco while using this medicine may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Ask your doctor or pharmacist about how much alcohol you may safely drink.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may instruct you to stop aspirin/dipyridamole 10 days before surgery. Do not stop taking this medication without first talking with the doctor who prescribed it.

The amount of aspirin in this medication may not be enough to prevent heart attack. If you need aspirin to prevent heart attack, consult your doctor or pharmacist for more information.

This drug contains aspirin. Children and teenagers younger than 18 should not take aspirin if they have chickenpox, flu, or any undiagnosed illness or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness.

Older adults may be more sensitive to the side effects of this drug, especially dizziness and bleeding.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Aspirin and dipyridamole pass into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• corticosteroids (such as prednisone)
• mifepristone
• ginkgo biloba
• other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran)
• riociguat

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These drugs are similar to this medication and may increase your risk of side effects if taken together. However, if your doctor has told you to take low-dose aspirin to prevent heart attack (usually 81-162 milligrams a day), ask your doctor if you should keep taking the aspirin. The low dose of aspirin in this product may not be enough to protect against heart attack. Ask your doctor or pharmacist for more details.

This medication may interfere with certain medical/lab tests (such as chemical stress tests using adenosine/dipyridamole), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: ringing in the ears, flushing, sweating, restlessness, weakness, dizziness, fast heartbeat.

Do not share this medication with others.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.