Effient can cause severe and sometimes fatal bleeding. It should not be used in patients who have an active bleeding problem or a history of stroke or transient ischemic attack (TIA; "mini-stroke"). Effient is usually not recommended in patients over 74 years old, except in high-risk situations (eg, diabetes, history of heart attack); the risk of severe side effects may be increased.
Do not use Effient if you will be having bypass heart surgery (coronary artery bypass graft [CABG]). Tell your doctor that you take Effient if you have recently had or will be having any type of surgery. If possible, Effient should be stopped for at least 7 days before surgery.
Tell your doctor if you have risk factors for bleeding, including a body weight of less than 132 lbs (60 kg) or a history of easy or persistent bleeding. Tell your doctor if you take a medicine that may increase your risk of bleeding, such as warfarin, heparin, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or fibrinolytic agents (eg, alteplase).
Tell your doctor if dizziness occurs while you take Effient . Do not suddenly stop Effient without checking with your doctor. This may increase the risk of severe heart problems or death.
Reducing the risk of having another serious heart or blood vessel problem (eg, heart attack, stroke, blood clots in your stent, death). It is intended for use in patients who have had a heart attack, angina, or a procedure called angioplasty.
Effient is a platelet aggregation inhibitor. It works by slowing or stopping platelets from clumping together to form clots.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Effient . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Effient . Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Effient may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Effient as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Effient .
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Back pain; cough; diarrhea; mild bruising or bleeding; nausea; nosebleeds; tiredness.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; change in the amount of urine; chest pain; confusion; coughing up blood; dark or bloody urine; dizziness; fast or irregular heartbeat; fever, chills, or persistent sore throat; one-sided weakness; pale skin; purple spots on the skin; seizure; severe or persistent headache; severe or persistent nosebleeds; shortness of breath; speech problems; stomach pain; unusual bruising; unusual or severe bleeding (eg, excessive bleeding from cuts , increased menstrual bleeding, unexplained vaginal bleeding, unusual bleeding from the gums when brushing); unusual tiredness or weakness; vision changes; vomit that contains blood or looks like coffee grounds; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.Proper storage of Effient :
Store Effient at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the original container with the lid tightly closed. Do not remove the desiccant (gray cylinder) from the bottle. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Effient out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Effient . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.