Land: Israel
Språk: engelska
Källa: Ministry of Health
PRASUGREL AS HYDROCHLORIDE
ELI LILLY ISRAEL LTD
B01AC
FILM COATED TABLETS
PRASUGREL AS HYDROCHLORIDE 10 MG
PER OS
Required
LILLY S.A., SPAIN
PLATELET AGGREGATION INHIBITORS, EXCL. HEPARIN
Effient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome ( i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI] undergoing primary or delayed percutaneous coronary intervention (PCI). The increased efficacy should be balanced with the increased risk in patients with bleeding tendencyin those who had TIA/CVA in the past and in those above the age of 75 or weight below 60 kg.
2015-01-31
Page 1 of 6 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only EFFIENT 10 MG Coated tablets EACH TABLET CONTAINS: Prasugrel (as Hydrochloride) 10 mg EFFIENT 5 MG Coated tablets COMPOSITION: EACH TABLET CONTAINS: Prasugrel (as Hydrochloride) 5 mg For the list of inactive ingredients and allergens, please see section “Additional information about the ingredients of this medicine” and section 6 “Additional information”. The medication contains lactose and may cause an allergy in people who are sensitive to lactose. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please contact your doctor or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. EFFIENT is not intended for children and adolescents below 18 years of age, since there is no information about the efficacy and safety of this medicine in this age group. 1. WHAT IS THIS MEDICINE INTENDED FOR? EFFIENT, co-administered with acetylsalicylic acid, is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (unstable angina, acute myocardial infarction) who are undergoing initial or elective catheterization, with or without stent implantation. THERAPEUTIC GROUP: Platelet aggregation inhibitors. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients contained in this medicine (see section 6). An allergic reaction may appear as a rash, itching, swelling of the face and lips or shortness of breath. • You suffer from active bleeding (such as bleeding from a peptic ulcer) • You have ever had a stroke or a transient ischemic attack (TIA). • You have severe li Läs hela dokumentet
X EFFITB A 05 _This leaflet format was set by MOH and its content has been reviewed and approved on _ _March 2016 and updated according to the guidelines of the Ministry of Health on January 2019. _ EFFIENT 1. NAME OF THE MEDICINAL PRODUCT Effient 5 mg film-coated tablets. Effient 10 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mg tablet contains: 5 mg prasugrel (as hydrochloride). Excipient with known effect: Each tablet contains 2.7 mg lactose. Each 10 mg tablet contains: 10 mg prasugrel (as hydrochloride). Excipient with known effect: Each tablet contains 2.1 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. The 5 mg tablets are: Yellow and double-arrow-shaped tablets, debossed with “5 MG” on one side and “4760” on the other. The 10 mg tablets are: Beige and double-arrow shaped tablets, debossed with “10 MG”on one side and “4759” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Effient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI). The increased efficacy should be balanced with the increased risk in patients with bleeding tendency in those who had TIA/CVA in the past and in those above the age of 75 or weight below 60 kg. For further information please refer to section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Page 2 of 16 Posology _Adults _ Effient should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day. In UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should only be given at the time of PCI (see sections 4.4, 4.8 and 5.1). Patients taking Effient should also take ASA daily (75 mg to Läs hela dokumentet