Aggrenox

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antiplatelets (a type of blood thinner)  such as clopidogrel (Plavix), aspirin, prasugrel (Effient), ticagrelor (Brilinta), ticlopidine (Ticlid), abciximab (ReoPro), eptifibatide (Integrilin), tirofiban (Aggrastat), and cilostazol (Pletal)

• anticoagulant (blood thinner) medications such as warfarin (Coumadin, Jantoven), heparin, enoxaparin (Lovenox), fondaparinux (Arixtra), rivaroxaban (Xarelto), and apixaban (Eliquis)

• aspirin and other NSAIDs (nonsteroidal anti-inflammatory drugs) such as:

  • celecoxib (Celebrex)
  • diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others)
  • etodolac (Lodine)
  • ibuprofen (Advil, Motrin, Nuprin)
  • indomethacin (Indocin, Indocin SR)
  • ketoprofen (Orudis, Actron, Oruvail)
  • ketorolac (Toradol)
  • meloxicam (Mobic)
  • nabumetone (Relafen)
  • naproxen (Naprosyn)
  • naproxen sodium (Aleve, Anaprox, Naprelan)
  • oxaprozin (Daypro)
  • piroxicam (Feldene)

This is not a complete list of Aggrenox drug interactions. Ask your doctor or pharmacist for more information.

Before taking Aggrenox, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Are allergic to aspirin, dipyridamole or to any of its ingredients
• Have or have had a stroke
• Have liver problems
• Have kidney problems
• Have asthma or nasal polyps
• Have or have had problems with bleeding or bruising easily
• Are pregnant or breastfeeding

You should not use this medicine if you have asthma or polyps in your nose, or if you are allergic to aspirin or an NSAID (nonsteroidal anti-inflammatory drug).

This medicine can increase your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bleeding that will not stop, if you have black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take aspirin and dipyridamole with or without food.

Do not chew, break, or open an extended-release capsule. Swallow it whole.

Aspirin and dipyridamole may cause headaches when you first start taking it. Call your doctor at if these headaches are severe.

This medicine can make it easier for you to bleed, even from a minor injury such as a fall or a bump on the head. Contact your doctor or seek emergency medical attention if you fall or hit your head, or have any bleeding that will not stop.

If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using aspirin and dipyridamole. You may need to stop using the medicine for a short time before surgery to prevent excessive bleeding.

Do not stop taking aspirin and dipyridamole unless your doctor tells you to.

Store this medicine in its original container at room temperature, away from moisture and heat.

Taking the combination of aspirin and dipyridamole (Aggrenox) is not equivalent to taking each of the medications separately. Take only the medication your doctor has prescribed.

Drinking alcohol while taking this medicine can increase your risk of bleeding.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin, salicylates, or NSAIDs. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, naproxen, magnesium and/or choline salicylate.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• new or worsening chest pain;

• a light-headed feeling, like you might pass out;

• hearing problems, ringing in your ears;

• liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of stomach bleeding--stomach pain, severe heartburn, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

• signs of bleeding in the brain--confusion, memory problems, severe headache, fainting.

Common side effects may include:

• headache;

• heartburn, upset stomach;

• nausea, stomach pain; or

• diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Aspirin and dipyridamole combination is used to prevent you from having a stroke. Strokes occur when a blood vessel in the brain is blocked by blood clots. This medicine will thin the blood and help prevent blood clots from forming. It is only given when there is a high risk that these problems may occur.

This medicine is available only with your doctor's prescription.

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 Aggrenox. 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.

Aggrenox is not interchangeable with the individual components of aspirin and dipyridamole tablets.

The recommended dose of Aggrenox is one capsule given orally twice daily, one in the morning and one in the evening. Swallow capsules whole without chewing. Aggrenox can be administered with or without food.

  Alternative Regimen in Case of Intolerable Headaches

In the event of intolerable headaches during initial treatment, switch to one capsule at bedtime and low-dose aspirin in the morning. Because there are no outcome data with this regimen and headaches become less of a problem as treatment continues, patients should return to the usual regimen as soon as possible, usually within one week.

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".

Aggrenox capsules are supplied in unit-of-use bottles of 60 capsules (NDC 0597-0001-60).

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

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.

Common side effects of Aggrenox include: abdominal pain, diarrhea, and headache. See below for a comprehensive list of adverse effects.