The incidence rate of all-cause mortality was 11.3% for AGGRENOX, 11.0% for aspirin alone, 11.4% for extended-release dipyridamole alone and 12.3% for placebo alone. The differences between the AGGRENOX, aspirin alone and extended-release dipyridamole alone treatment groups were not statistically significant. These incidence rates for AGGRENOX and aspirin alone are consistent with previous aspirin studies in stroke and TIA patients.
AGGRENOX 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”.
- 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.
Inform patients that aspirin is known to be harmful to fetuses and ask the patient to notify them if they are or become pregnant.
Some patients may experience headaches upon treatment initiation; these are usually transient. In case of intolerable headaches, tell patients to contact their physician.
- Dosage and Administration
Tell patients that AGGRENOX 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.
Inform patients to protect AGGRENOX from moisture.
Read this Patient Information before you start taking AGGRENOX 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.
AGGRENOX is a prescription medicine that contains aspirin and a medicine that is slowly released in your body, called dipyridamole. AGGRENOX 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.
- are allergic to any of the ingredients in AGGRENOX. See the end of this leaflet for a list of ingredients in AGGRENOX.
- are allergic to non-steroidal anti-inflammatory drugs (NSAIDs)
- have asthma in combination with runny nose and nasal polyps
Do not give AGGRENOX to a child or teenager with a viral illness. Reye syndrome, a life-threatening condition, can happen when aspirin (an ingredient in AGGRENOX) is used in children and teenagers who have certain viral illnesses.
- 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. AGGRENOX can harm your unborn baby, especially if you take it in the last (third) trimester of pregnancy. You should not take AGGRENOX during pregnancy without first talking to your healthcare provider. Tell your healthcare provider right away if you become pregnant while taking AGGRENOX.
- are breast-feeding or plan to breast-feed. AGGRENOX can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take AGGRENOX.
Tell your doctor about all the medicines you take , including prescription and non-prescription medicines, vitamins and herbal supplements. AGGRENOX and other medicines may affect each other causing side effects. AGGRENOX may affect the way other medicines work, and other medicines may affect how AGGRENOX works.
- 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 AGGRENOX. Using these medicines with AGGRENOX can increase your risk of bleeding.
- a medicine for diabetes
- probenecid [Probalan® , Col-Probenecid® ]
- Take AGGRENOX exactly as prescribed. Your healthcare provider will tell you how many AGGRENOX to take and when to take them.
- Headaches are not uncommon when you first start taking AGGRENOX, 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 AGGRENOX.
- Swallow AGGRENOX whole. Do not crush or chew the capsules.
- You can take AGGRENOX 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 AGGRENOX (overdose) than prescribed, call your healthcare provider or Poison Control Center, or get emergency help right away.
- a warm feeling or flushing
- weakness or dizziness
- a fast heart rate
- ringing in the ears
- heavy alcohol use. People who drink three or more alcoholic drinks every day have a higher risk of bleeding during treatment with AGGRENOX, because it contains aspirin.
- increased risk of bleeding. You may bleed more easily during AGGRENOX 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 AGGRENOX:
- 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
- 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 AGGRENOX:
- 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 AGGRENOX.
- 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
- loss of appetite
- pale colored stool
- stomach area (abdomen) pain
- yellowing of your skin or whites of your eyes
- dark urine
- upset stomach
- Store AGGRENOX at 59°F to 86°F (15°C to 30°C).
- Keep AGGRENOX capsules dry.
- Safely throw away medicine that is out of date or no longer needed.
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information. Do not use AGGRENOX for a condition for which it was not prescribed. Do not give AGGRENOX 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 AGGRENOX. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about AGGRENOX that is written for health professionals.
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.
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