Patient Information

Aspirin (AS-pir-in) and extended-release dipyridamole ( dye-pir-id-a-mole )   Capsules

Read this Patient Information before you start taking aspirin and extended-release dipyridamole capsule and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is Aspirin and extended-release dipyridamole capsule ?

Aspirin and extended-release dipyridamole capsule is a prescription medicine that contains aspirin and a medicine that is slowly released in your body, called dipyridamole. Aspirin and extended-release dipyridamole capsule is used to lower the risk of stroke in people who have had a “mini-stroke” (transient ischemic attack or TIA) or stroke due to a blood clot.

It is not known if aspirin and extended-release dipyridamole capsule is safe and effective in children. See “Who should not take aspirin and extended-release dipyridamole capsule?”

Who should not take Aspirin and extended-release dipyridamole capsule ?

Do not take Aspirin and extended-release dipyridamole capsule if you:

• are allergic to any of the ingredients in aspirin and extended-release dipyridamole capsule.  See the end of this leaflet for a list of ingredients in aspirin and extended-release dipyridamole capsule.
• are allergic to non-steroidal anti-inflammatory drugs (NSAIDs)
• have asthma in combination with runny nose and nasal polyps

Do not give  aspirin and extended-release dipyridamole capsule to a child or teenager with a viral illness. Reye syndrome, a life-threatening condition, can happen when aspirin (an ingredient in aspirin and extended-release dipyridamole capsule) is used in children and teenagers who have certain viral illnesses.

What should I tell my doctor before using aspirin and extended-release dipyridamole capsule?

Before taking aspirin and extended-release dipyridamole capsule, tell your healthcare provider if you:

• have stomach ulcers
• have a history of bleeding problems
• have heart problems
• have kidney or liver problems
• have low blood pressure
• have myasthenia gravis
• have any other medical conditions
• are pregnant or plan to become pregnant.You should not take aspirin and extended-release dipyridamole capsule during pregnancy without first talking to your healthcare provider. Tell your healthcare provider right away if you become pregnant while taking aspirin and extended-release dipyridamole capsule.
• are breast-feeding or plan to breast-feed. Aspirin and extended-release dipyridamole capsule can pass into your milk. Talk to your healthcare provider about the best way to feed your baby if you take aspirin and extended-release dipyridamole capsule.

Tell your doctor you are taking aspirin and extended-release dipyridamole capsules if you are scheduled to have a stress test for your heart.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Aspirin and extended-release dipyridamole capsule and other medicines may affect each other causing side effects. Aspirin and extended-release dipyridamole capsule may affect the way other medicines work, and other medicines may affect how aspirin and extended-release dipyridamole capsule works.

Especially tell your healthcare provider if you take:

• a medicine for high blood pressure, irregular heart beat, or heart failure
• acetazolamide [Diamox ®]
• any blood thinner medicines
• warfarin sodium [Coumadin ®, Jantoven ®]
• a heparin medicine
• anagrelide [Agrylin ®]
• a seizure medicine
• a medicine for Alzheimer’s disease
• a water pill

• methotrexate sodium [Trexall ®]
• aspirin or a non-steroidal anti-inflammatory drug (NSAIDs). You should not take NSAIDs during treatment with aspirin and extended-release dipyridamole capsule. Using these medicines with aspirin and extended-release dipyridamole capsule can increase your risk of bleeding.
• a medicine for diabetes
• probenecid [Probalan ®, Col-Probenecid ®]

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them and show your healthcare provider and pharmacist when you get a new medicine.

How should I take aspirin and extended-release dipyridamole capsule ?

• Take aspirin and extended-release dipyridamole capsule exactly as prescribed. Your healthcare provider will tell you how many aspirin and extended-release dipyridamole capsule to take and when to take them.
• Headaches are not uncommon when you first start taking aspirin and extended-release dipyridamole capsule, but often lessen as treatment continues. Tell your healthcare provider if you have a severe headache. Your healthcare provider may change the instructions for taking aspirin and extended-release dipyridamole capsule.
• Swallow aspirin and extended-release dipyridamole capsule whole. Do not crush or chew the capsules.
• You can take aspirin and extended-release dipyridamole capsule with or without food.
• If you miss a dose, take your next dose at the usual time. Do not take two doses at one time.
• If you take more aspirin and extended-release dipyridamole capsule (overdose) than prescribed, call your healthcare provider or Poison Control Center, or get emergency help right away.

Symptoms of an overdose of aspirin and extended-release dipyridamole capsule include:

• a warm feeling or flushing
• sweating
• restlessness
• weakness or dizziness
• a fast heart rate
• ringing in the ears

What should I avoid while using aspirin and extended-release dipyridamole capsule ?

• heavy alcohol use.People who drink three or more alcoholic drinks every day have a higher risk of bleeding during treatment with aspirin and extended-release dipyridamole capsule, because it contains aspirin.

What are the possible side effects of aspirin and extended-release dipyridamole capsule?

Aspirin and extended-release dipyridamole capsule may cause serious side effects, including:

• increased risk of bleeding.You may bleed more easily during aspirin and extended-release dipyridamole capsule treatment, and it may take longer than usual for bleeding to stop. This can include:
• bleeding into your brain (intracranial hemorrhage).This can be a medical emergency. Get medical help right away if you have any of these symptoms while taking aspirin and extended-release dipyridamole capsule:

• severe headache with drowsiness
• confusion or memory change
• pass out (become unconscious)

• bleeding in your stomach or intestine .

• stomach pain
• heartburn or nausea
• vomiting blood or vomit looks like “coffee grounds”
• red or bloody stools
• black stools that look like tar  

• n ew or worsening chest pain in some people with heart disease. Tell your healthcare provider if you have new chest pain or have any change in your chest pain during treatment with aspirin and extended-release dipyridamole capsule.
• liver problems, including increased liver function tests and liver failure. Tell your healthcare provider if you have any of these symptoms of a liver problem while taking aspirin and extended-release dipyridamole capsule:
• loss of appetite
• pale colored stool
• stomach area (abdomen) pain
• yellowing of your skin or whites of your eyes
• dark urine
• itching

Call your healthcare provider right away if you have any of the symptoms listed above.

The most common side effects of aspirin and extended-release dipyridamole capsule include:

• headache
• upset stomach
• diarrhea

These are not all the possible side effects of aspirin and extended-release dipyridamole capsule. Tell your healthcare provider or pharmacist if you have any side effect that bothers you or that does not go away.

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

How should I store aspirin and extended-release dipyridamole capsule ?

• Store aspirin and extended-release dipyridamole capsule at room temperature 59 ºF to 86 ºF (15 ºC to 30 ºC).
• Keep aspirin and extended-release dipyridamole capsules dry.

Keep aspirin and extended-release dipyridamole capsule  and all medicines out of the reach of children.

General information about aspirin and extended-release dipyridamole capsule

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information. Do not use aspirin and extended-release dipyridamole capsule for a condition for which it was not prescribed. Do not give aspirin and extended-release dipyridamole capsule to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information summarizes the most important information about aspirin and extended-release dipyridamole capsule. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about aspirin and extended-release dipyridamole capsule that is written for health professionals.

For more information call Micro Labs USA, Inc. at 1-855-839-8195

What are the ingredients in aspirin and extended-release dipyridamole capsule?

Active Ingredients:dipyridamole in an extended-release form and aspirin

Inactive Ingredients:caprylic/capric mono/diglycerides, D&C yellow #10 Aluminum Lake,  FD&C blue #1/brilliant blue FCF Aluminum Lake, glyceryl monostearate, hypromellose, methacrylic acid and methacrylate copolymer, microcrystalline cellulose, povidone K30, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc, tartaric acid, titanium dioxide, triacetin and triethyl citrate.

Each capsule shell contains gelatin, ferric oxide red, ferric oxide yellow, titanium dioxide and water.

Black imprint ink composition contains ferrosoferric oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

Manufactured by:

Micro Labs Limited

Goa-403 722, INDIA.

Manufactured for:

Micro Labs USA Inc.

Somerset, NJ 08873

Rev.10/2021