Aspirin and dipyridamole

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Dipyridamole keeps platelets in your blood from sticking together to form clots.

Aspirin and dipyridamole is a combination medicine used to reduce the risk of stroke in people who have had blood clots or a "mini-stroke" (also called a transient ischemic attack or TIA).

Aspirin and dipyridamole may also be used for purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain
• vomiting

• Bleeding from the rectum
• bloody mucous or unexplained nosebleeds
• bloody or black, tarry stools
• confusion
• convulsions (seizures)
• difficulty with breathing
• difficulty with speaking
• double vision
• inability to move the arms, legs, or facial muscles
• inability to speak
• memory loss
• pale skin
• purple or red spots on skin
• slow speech
• tightness in the chest
• troubled breathing (exertional)
• unusual bleeding or bruising
• vomiting of blood or material that looks like coffee grounds

• Abdominal or stomach fullness
• blood in the urine
• chills
• clay-colored stools
• collection of blood under the skin
• cough
• deep, dark purple bruise
• gaseous abdominal or stomach pain
• itching, pain, redness, or swelling of the eye or eyelid
• loss of appetite
• nausea
• noisy breathing
• recurrent fever
• skin rash or hives (severe)
• watering of the eyes
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blurred vision
• continuing ringing or buzzing or other unexplained noise in the ears
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast or irregular heartbeat
• flushes
• hearing loss
• restlessness
• sweating
• unusual tiredness or weakness
• warm feeling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• diarrhea
• difficulty with moving
• headache
• heartburn
• indigestion
• muscle pain or stiffness
• pain, swelling, or redness in the joints
• stomach discomfort or upset

• Back pain
• burning feeling in the chest or stomach
• loss of strength or energy
• rectal pain or swelling
• sleepiness or unusual drowsiness
• taste loss
• tenderness in the stomach area

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

For all patients taking aspirin and dipyridamole:

• If you have an allergy to aspirin, dipyridamole, or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Asthma, bleeding problems, nose polyps, or rhinitis.
• If you have any of these health problems: Kidney disease or liver disease.
• If you have ever had ulcer disease.
• If you are taking another drug that has the same drug in it.
• If you are taking any other NSAID.
• If you are pregnant or may be pregnant. Do not take aspirin and dipyridamole if you are in the third trimester of pregnancy. You may also need to avoid this medicine at other times during pregnancy. Talk with your doctor to see when you need to avoid taking aspirin and dipyridamole during pregnancy.

Children:

• If your child or teenager has or is getting better from flu signs, chickenpox, or other viral infections. The risk of a very bad problem called Reye's syndrome may be raised. Do not give this medicine to a child or teenager who has or is getting better from a viral infection.

This is not a list of all drugs or health problems that interact with aspirin and dipyridamole.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Swallow whole. Do not chew, break, or crush.
• Take with a full glass of water.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Belly pain or heartburn.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Joint pain.
• Feeling tired or weak.
• Back pain.
• You may have headaches when you start taking aspirin and dipyridamole. Most of the time it gets better with time. Call your doctor if you have a headache that gets very bad, bothers you, or does not go away. There may be ways to lessen this side effect.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Stroke prevention: Oral: One capsule (dipyridamole extended release 200 mg/aspirin 25 mg) twice daily

Alternative regimen for patients with intolerable headache: Oral: One capsule (dipyridamole extended release 200 mg/aspirin 25 mg) at bedtime and low-dose aspirin in the morning. Return to usual dose (1 capsule twice daily) as soon as tolerance to headache develops (usually within a week).

Carotid artery stenosis, symptomatic (including recent carotid endarterectomy) (off-label use): Oral: One capsule (dipyridamole extended release 200 mg/aspirin 25 mg) twice daily (Guyatt 2012)

Hemodialysis graft patency (off-label use): Oral: One capsule (dipyridamole extended release 200 mg/aspirin 25 mg) twice daily

Administer with or without food. Capsule should be swallowed whole; do not crush or chew.

See individual agents.

>10%:

Central nervous system: Headache (39%; tolerance usually develops)

Gastrointestinal: Abdominal pain (18%), dyspepsia (18%), nausea (16%), diarrhea (13%)

1% to 10%:

Cardiovascular: Cardiac failure (2%), syncope (1%)

Central nervous system: Fatigue (6%), pain (6%), amnesia (2%), malaise (2%), seizure (2%), confusion (1%), drowsiness (1%)

Gastrointestinal: Vomiting (8%), gastrointestinal hemorrhage (1% to 4%), melena (2%), anorexia (1%), hemorrhoids (1%)

Hematologic & oncologic: Hemorrhage (3%), anemia (2%), rectal hemorrhage (2%), purpura (1%)

Neuromuscular & skeletal: Arthralgia (6%), back pain (5%), arthritis (2%), weakness (2%), arthropathy (1%), myalgia (1%)

Respiratory: Cough (2%), epistaxis (2%), upper respiratory tract infection (1%)

<1% (Limited to important or life-threatening): Ageusia, agitation, alopecia, anaphylaxis, angina pectoris, angioedema, antepartum hemorrhage, aplastic anemia, asthma, auditory impairment, blood coagulation disorder, bronchospasm, bruise, cardiac arrhythmia, cerebral edema, cerebral hemorrhage, changes in liver function, chest pain, cholelithiasis, coma, deafness, dehydration, disseminated intravascular coagulation, dizziness, dyspnea, ecchymoses, fever, flushing, gastritis, gastrointestinal perforation, gastrointestinal ulcer, gingival hemorrhage, hematemesis, hematoma, hematuria, hemoptysis, hepatic failure, hepatitis, hyperglycemia, hyperkalemia, hypersensitivity angiitis, hypersensitivity reaction, hyperventilation, hypoglycemia, hypokalemia, hypotension, hypothermia, increased thirst, interstitial nephritis, intracranial hemorrhage, jaundice, laryngeal edema, metabolic acidosis, migraine, palpitations, pancreatitis, pancytopenia, paresthesia, postpartum hemorrhage, prolonged prothrombin time, proteinuria, pruritus, pulmonary edema, renal failure, renal insufficiency, renal papillary necrosis, respiratory alkalosis, Reye's syndrome, rhabdomyolysis, skin rash, Stevens-Johnson syndrome, subarachnoid hemorrhage, supraventricular tachycardia, tachycardia, tachypnea, thrombocythemia, thrombocytopenia, tinnitus, urticaria, uterine hemorrhage

Applies to aspirin / dipyridamole: oral capsule, oral capsule extended release

Along with its needed effects, aspirin / dipyridamole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking aspirin / dipyridamole:

• Abdominal or stomach pain
• vomiting

• Bleeding from the rectum
• bloody mucous or unexplained nosebleeds
• bloody or black, tarry stools
• confusion
• convulsions (seizures)
• difficulty with breathing
• difficulty with speaking
• double vision
• inability to move the arms, legs, or facial muscles
• inability to speak
• memory loss
• pale skin
• purple or red spots on skin
• slow speech
• tightness in the chest
• troubled breathing (exertional)
• unusual bleeding or bruising
• vomiting of blood or material that looks like coffee grounds

• Abdominal or stomach fullness
• blood in the urine
• chills
• clay-colored stools
• collection of blood under the skin
• cough
• deep, dark purple bruise
• gaseous abdominal or stomach pain
• itching, pain, redness, or swelling of the eye or eyelid
• loss of appetite
• nausea
• noisy breathing
• recurrent fever
• skin rash or hives (severe)
• watering of the eyes
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking aspirin / dipyridamole:

• Blurred vision
• continuing ringing or buzzing or other unexplained noise in the ears
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast or irregular heartbeat
• flushes
• hearing loss
• restlessness
• sweating
• unusual tiredness or weakness
• warm feeling

Some side effects of aspirin / dipyridamole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• diarrhea
• difficulty with moving
• headache
• heartburn
• indigestion
• muscle pain or stiffness
• pain, swelling, or redness in the joints
• stomach discomfort or upset

• Back pain
• burning feeling in the chest or stomach
• loss of strength or energy
• rectal pain or swelling
• sleepiness or unusual drowsiness
• taste loss
• tenderness in the stomach area