Effient (Prasugrel)

EFFIENT increases the risk of bleeding.

• In patients 75 years of age or older, use is not recommended because of the increased risk of fatal bleeding and bleeding from blood vessels inside the head.
• In patients with body weight of less than 60 kg, use is not recommended because of the increased risk of major bleeding.

BEFORE you use EFFIENT, talk to your doctor, nurse or pharmacist if you:

• have a history of bleeding conditions, stomach ulcers, diverticulitis or liver problems.
• have had a recent severe injury or recent surgery (including dental procedures).
• have allergies to medications including if you have had an allergic reaction to clopidogrel or ticlopidine.
• are planning to have a surgical or dental procedure. Your doctor or dentist may ask you to temporarily stop taking EFFIENT 7 days prior to surgery due to the risk of increased bleeding. Do not stop taking EFFIENT without talking to your cardiologist.
• are breastfeeding, pregnant, or are planning to get pregnant.
• are less than 18 years old.
• have kidney disease or damage.
• have one of the following rare hereditary diseases:
  • galactose intolerance,
  • Lapp lactase deficiency,
  • glucose-galactose malabsorption.
• because lactose is a nonmedical ingredient in EFFIENT.

If you experience any allergic reaction including symptoms such as swelling mainly of the face and throat (angioedema), stop taking EFFIENT and seek immediate medical attention.

It is important that you tell all of your healthcare professionals that you are taking EFFIENT.

Like all antiplatelet medications, EFFIENT can increase the risk of bleeding. While taking EFFIENT, you may notice that you bruise more easily, are more likely to have nose bleeds, or have cuts that take longer to stop bleeding. Unlike these types of bleeding, some bleeding can be serious, even fatal. Bleeding, such as rectal bleeding or coughing up blood, should be investigated by your doctor as it may be a sign of an unsuspected tumour.

Tell your doctor about a rash that bothers you or that does not go away. If you notice any undesirable effects, especially during the first few weeks of treatments.

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you regularly take, including prescription and non-prescription medicines, vitamins, minerals, natural supplements, or alternative medicines.

Drugs that may interact with EFFIENT include:

• Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen (Advil, Motrin), naproxen (Naprosyn, Aleve)
• Oral anticoagulants (blood thinners) such as warfarin (Coumadin)
• Fibrinolytics (drugs used to dissolve blood clots during treatment for a heart attack or lung clot). Examples include streptokinase, tissue plasminogen activators (tPAs) and tenecteplase (TNKase)

It is important to take EFFIENT exactly as prescribed by your doctor. It is also important to get your refills on time so you do not run out of medicine.

Usual dose:

Your doctor will prescribe the right dose of EFFIENT for you. EFFIENT is usually started with a single 60 mg loading dose. Then, the usual dose is 10 mg daily.

• Take EFFIENT once a day by mouth, with or without food.
• Do not break your EFFIENT tablet. Talk to your healthcare professional if you have trouble swallowing pills.
• Continue taking acetylsalicylic acid (ASA) as directed by your doctor.
• Your doctor will decide how long you should take EFFIENT. Stopping EFFIENT without informing your doctor may increase the chance of a heart attack or stroke or a clot forming in your stent. Therefore you should inform your doctor immediately if you stop taking EFFIENT.

Overdose:

Warning:

If you think you have taken too much EFFIENT, contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you miss your scheduled daily dose, take EFFIENT when you remember. If you forget your dose for an entire day, just resume taking EFFIENT at its usual dose the next day. Do not take two doses on the same day.