Aspirin and Dipyridamole: Package Insert and Label Information (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Aspirin and extended-release dipyridamole capsules are available as a hard gelatin capsule, with a red cap and an ivory-colored body, containing yellow extended-release pellets incorporating dipyridamole and a round white tablet incorporating immediate-release aspirin. The capsule body is imprinted in red with the Boehringer Ingelheim logo and with “01A”.

Aspirin and Extended-Release Dipyridamole Capsules 25 mg/200 mg are supplied in unit-of-use bottles of 60 capsules (NDC 70436-092-05).

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from excessive moisture.

17  PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Risk of Bleeding
Inform patients that as with other antiplatelet agents, there is a general risk of bleeding including intracranial and gastrointestinal bleeding. Inform patients about the signs and symptoms of bleeding, including occult bleeding. Tell patients to notify their physician if they are prescribed any drug which may increase risk of bleeding.
Counsel patients who consume three or more alcoholic drinks daily about the bleeding risks involved with chronic, heavy alcohol use while taking aspirin.
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with aspirin and extended-release dipyridamole capsules [see Use in Specific Populations (8.1)].
Headaches
Some patients may experience headaches upon treatment initiation; these are usually transient. In case of intolerable headaches, tell patients to contact their physician.
Stress Test
Instruct patients who are scheduled to undergo a pharmacologic stress test to tell their healthcare provider that they are taking aspirin and extended-release dipyridamole capsules.
Dosage and Administration
Tell patients that aspirin and extended-release dipyridamole capsules should be swallowed whole, and not chewed or crushed. If you miss a dose, continue with your next dose on your regular schedule. Do not take a double dose.
Storage
Inform patients to protect aspirin and extended-release dipyridamole capsules from moisture.

Distributed by:
Slate Run Pharmaceuticals, LLC

Columbus, OH 43215 USA

Licensed from:

Boehringer Ingelheim International GmbH

Made in Germany

10011116/03 Revised March 2020

Patient Information

Aspirin and Extended-Release DipyridamoleCapsules

Read this Patient Information before you start taking aspirin and extended-release dipyridamole capsules 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 are aspirin and extended-release dipyridamole capsules?

Aspirin and extended-release dipyridamole capsules are a prescription medicine that contains aspirin and a medicine that is slowly released in your body, called dipyridamole. Aspirin and extended-release dipyridamole capsules are 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 capsules are safe and effective in children. See “Who should not take aspirin and extended-release dipyridamole capsules?”

Who should not take aspirin and extended-release dipyridamole capsules?

Do not take aspirin and extended-release dipyridamole capsules if you:

are allergic to any of the ingredients in aspirin and extended-release dipyridamole capsules. See the end of this leaflet for a list of ingredients in aspirin and extended-release dipyridamole capsules.
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 capsules 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 capsules) is used in children and teenagers who have certain viral illnesses.

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

Before taking aspirin and extended-release dipyridamole capsules, 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 capsules 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 capsules.
are breast-feeding or plan to breast-feed. Aspirin and extended-release dipyridamole capsules 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 capsules.

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 capsules and other medicines may affect each other causing side effects. Aspirin and extended-release dipyridamole capsules may affect the way other medicines work, and other medicines may affect how aspirin and extended-release dipyridamole capsules work.

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 capsules. Using these medicines with aspirin and extended-release dipyridamole capsules 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 capsules?

Take aspirin and extended-release dipyridamole capsules exactly as prescribed. Your healthcare provider will tell you how many aspirin and extended-release dipyridamole capsules to take and when to take them.
Headaches are not uncommon when you first start taking aspirin and extended-release dipyridamole capsules, 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 capsules.
Swallow aspirin and extended-release dipyridamole capsules whole. Do not crush or chew the capsules.
You can take aspirin and extended-release dipyridamole capsules 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 capsules (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 capsules 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 capsules?

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 capsules, because it contains aspirin.

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

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

increased risk of bleeding. You may bleed more easily during aspirin and extended-release dipyridamole capsules 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 capsules:
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
new 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 capsules.
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 capsules:
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 capsules include:

headache
upset stomach
diarrhea

These are not all the possible side effects of aspirin and extended-release dipyridamole capsules. 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 capsules?

Store aspirin and extended-release dipyridamole capsules at room temperature 68°F to 77°F (20°C to 25°C).
Keep aspirin and extended-release dipyridamole capsules dry.

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

General information about aspirin and extended-release dipyridamole capsules

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information. Do not use aspirin and extended-release dipyridamole capsules for a condition for which it was not prescribed. Do not give aspirin and extended-release dipyridamole capsules 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 capsules. 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 capsules that is written for health professionals.

For more information, call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or (TTY) 1-800-459-9906.

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

Active Ingredients: dipyridamole in an extended-release form and aspirin
Inactive Ingredients: acacia, aluminum stearate, colloidal silicon dioxide, corn starch, dimethicone, hypromellose, hypromellose phthalate, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, povidone, stearic acid, sucrose, talc, tartaric acid, titanium dioxide and triacetin. Each capsule shell contains gelatin, red iron oxide and yellow iron oxide, titanium dioxide, and water.

Distributed by:
Slate Run Pharmaceuticals, LLC

Columbus, OH 43215 USA

Licensed from:

Boehringer Ingelheim International GmbH

The other brands listed are trademarks of their respective owners.

Made in Germany

10011116/03 Revised March 2020

Aspirin and Extended-Release Dipyridamole Capsules
(60) 25 mg/200 mg CapsulesNDC: 70436-092-05

//druginserts.com/lib/images-rx/aspirin-and-dipyridamole-6/aspirin-dipyr-image1-253x300.jpg
(click image for full-size original)
ASPIRIN AND DIPYRIDAMOLE aspirin and dipyridamole capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-092
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
aspirin (aspirin) aspirin 25 mg
dipyridamole (dipyridamole) dipyridamole 200 mg
Product Characteristics
Color RED (red) , WHITE (ivory) Score no score
Shape CAPSULE (capsule) Size 24mm
Flavor Imprint Code 01A;
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-092-05 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (70436-092-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020884 08/23/2018
Labeler — Slate Run Pharmaceuticals, LLC (039452765)

Revised: 02/2020 Slate Run Pharmaceuticals, LLC

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