Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PRASUGREL HYDROCHLORIDE
ELI LILLY (MALAYSIA) SDN. BHD.
PRASUGREL HYDROCHLORIDE
28Tablet Tablets
ELI LILLY & CO
EFFIENT ® FILM COATED TABLETS Prasugrel (5 dan 10mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Effient is used for 2. How Effient works 3. Before you use Effient 4. How to use Effient 5. While you are using it 6. Side effects 7. Storage and Disposal of Effient 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT EFFIENT IS USED FOR Effient is a prescription medicine used to treat people who: • have had a heart attack or severe chest pain that happens when your heart does not get enough oxygen, and • have been treated with a procedure to open a blocked artery in the heart, with or without a stent (small mesh tube) being placed in the artery Effient is used to lower your chance of having another serious problem with your heart or blood vessels, such as another heart attack, a stroke, blood clots in your stent, or death. HOW EFFIENT WORKS Effient, which contains the active substance prasugrel, belongs to a group of medicines called antiplatelet agents. Platelets are blood cells that help with normal blood clotting. Effient helps prevent platelets from sticking together and forming a clot that can block an artery or a stent. BEFORE YOU USE EFFIENT _- When you must not use it _ Do not take Effient If you are allergic (hypersensitive) to prasugrel or any of the other ingredients of Effient. An allergic reaction may be recognized as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor immediately. If you have a medical condition that is currently causing bleeding, such as bleeding from your stomach or intestines. If you have ever has a stroke or a transient ischaemic attack (TIA, also known as “mini-stroke”, where stroke symptoms [see section SIDE EFFECTS] happen suddenly and disappear within 24 hours). If you have severe liver disease. _- Before you start to use it _ Effient may not be right for you. Tell your doctor about all of your medical condi Pročitajte cijeli dokument
Effient PI_USPI Mar 2018_04 Apr 2018 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These hig hlights do not include all the informatio n nee ded to use Effient safely and effectively. See full prescribing information for Effient. Effient (prasugrel) tablets , for oral use WARNING: BLEEDING RISK See full prescribing information for complete boxed warning. • Effient can cause significant, sometimes fatal, bleeding (5.1, 5.2, 6.1). • Do not use Effient in patie nts with active pathological bleeding or a history of transient ischemic attack or stroke (4.1 , 4.2). • In patients ≥ 75 years of age, Effient is generally not recommended , except in high-risk patients (diabetes or prior MI), where its use may be c onsidered (8.5). • Do not start Effie nt in patients like ly to undergo urgent coronar y artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery (5.2) . • Additional risk factors for bleeding include: body weight < 60 kg; propensity to bleed; concomitant use of medications that increase the risk of bleeding (5.1) . • Suspect blee ding in any patie nt who is hypotensive and has recently undergone invasive or surgical procedures (5.1). • If possible, manage bleeding without discontinuing Effie nt. Sto pping Effient increases the risk of subsequent cardiovascular events (5.3). -------------------------INDICATIONS AND U SAGE------------------- Effient is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with PCI as follows: • Patients with u nstable angina or non -ST-elevation myocardial infarction (NSTEMI) (1.1). • Patients with ST-elevation myocardial infarction (STEMI) when mana ged with either primary or dela yed PCI (1.1). -------------------- DOSAGE AND ADMINISTRATION -------------- • Initiate treatment with a single 60 mg oral loading dose (2). • Continue at 10 mg once daily with or without food. Consider 5 mg Pročitajte cijeli dokument