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Effient 10 Mg 28 Tablets ingredient Prasugrel

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Active substance: Prasugrel in each tablet (as hydrochloride) .... 10 mg

Excipients: Lactose monohydrate in each tablet ... ............... 2.1 mg Mannitol ................................ ...... 67.21 mg Croscarmellose sodium ................ 11.2 mg For

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BRIEF PRODUCT INFORMATION

1. NAME OF HUMAN MEDICINAL PRODUCT

EFFIENT® 10 mg film coated tablet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

excipients, see 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablet

Beige and double-arrow film-coated tablets with ”10 MG renk on one side and” 4759 “on the other.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications EFFİENT, together with acetylsalicylic acid (ASA), should be treated with primary or late percutaneous coronary intervention (PCI) with acute coronary syndrome (ACS) [e.g. unstable angina is indicated for the prevention of atherothrombotic events in patients with ST-segment elevation myocardial infarction (UA / NSTEMI) or ST-segment elevation myocardial infarction (STEMI)].

4.2 Posology and method of administration Posology / frequency and duration of administration: Treatment with EFFIENT should be initiated with a single loading dose of 60 mg and then continued with 10 mg once daily. In patients undergoing UA / NSTEMI and who underwent coronary angiography within 48 hours of hospitalization, the loading dose should be given only during PCI (see Sections 4.4, 4.8 and 5.1). Patients receiving EFFIENT should also take ASA (75 mg - 325 mg) daily.

Early discontinuation of antiplatelet therapy, including EFFİENT, in patients treated with PCI; Thrombosis may result in an increased risk of death due to myocardial infarction or patient's underlying disease. Effient to the discontinuation of clinical treatment continued for 12 months of treatment, except as indicated, which is suggested. (See Section 4.4 and 5.1)

Method of administration will be oral. EFFİENT can be used before or after meals. A 60 mg prasugrel loading dose may lead to rapid onset of action when administered on an empty stomach (see Section 5.2). Do not crush or crush the tablet.

Additional information on specific populations: Renal failure: No dose adjustment is required for patients with renal failure, including patients with end-stage renal disease (see section 5.2). There is limited therapeutic experience of patients with renal impairment (see section 4.4).

Hepatic impairment No dose adjustment is required in patients with mild to moderate hepatic impairment (Child Pugh Class A and B) (see section 5.2). There is limited therapeutic experience of mild to moderate hepatic dysfunction (see section 4.4). Contraindicated in severe liver failure (Child Pugh class C).

Pediatric population: Due to insufficient data on safety and efficacy, EFFIENT is not recommended for children under 18 years of age.

Geriatric population: Use in patients 75 years and older: EFFİENT should not be used in patients aged 75 years and older. Patients over 75 years of age exhibit high sensitivity to bleeding and high exposure to active metabolite of prasugrel (see Sections 4.4, 4.8, 5.1 and 5.2).

4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients (see section 6.1). Active pathological bleeding. Stroke or transient ischemic attack (TIA) history Severe hepatic insufficiency (Child Pugh class C) should not be used in patients over 75 years or under 60 kg.

4.4 Special warnings and precautions for use Bleeding risk: In phase 3 clinical trial (TRITON), the main exclusion criteria include increased risk of bleeding, anemia, thrombocytopenia, and pathological intracranial findings. Patients with acute coronary syndrome who underwent percutaneous coronary intervention (PCI) with EFFIENT and ASA showed an increased risk of major and minor bleeding compared to the TIMI classification system. Therefore, the use of EFFIENT in patients with increased risk of bleeding should be taken into consideration if the benefit in preventing ischemic events against the risk of serious bleeding is greater. This concern should be taken into consideration in particular for the following patients:

• Patients over 75 years of age (see below).

• Patients with a tendency to bleeding (eg recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding, active peptic ulcer disease, severe hepatic impairment, or moderate to severe renal impairment).

• Patients weighing less than 60 kg: EFFİENT should not be used in patients under 60 kg. (see Sections 4.8 and 5.2).

• Co-administration of drugs that can increase the risk of bleeding, including oral anticoagulants, clopidogrel, nonsteroidal anti-inflammatory drugs (NSAIDs) and fibrinolytics.

If the pharmacological effects of EFFIENT need to be recycled in patients with active bleeding, platelet transfusion may be appropriate.

The therapeutic experience of Prasugrelle is limited in patients with renal failure (including end stage renal failure) and moderate liver failure. These patients may have an increased risk of bleeding. Therefore, prasugrel should be used with caution in these patients.

EFFİENT should not be used in patients over 75 years of age. In phase 3 clinical trials, these patients are at great risk for fatal bleeding, especially when compared to those under 75 years of age. (see Sections 4.2 and 4.8).

When patients take prasugrel (with ASA), they should be warned that it may take longer to stop bleeding and should report any unusual bleeding (region or duration) to their physician.

Bleeding risk associated with timing of loading dose in patients undergoing NSTEMI: A clinical trial (NAC) of patients underwent coronary angiography in 2 saat48 hours after randomization, with a median dose of 4 min prior to coronary angiography with prasugrel loading dose compared with administration of prasugrel loading dose during PCI major and minor procedural bleeding has been shown to increase the risk. Therefore, for patients undergoing UA / NSTEMI and undergoing coronary angiography within 48 hours of hospitalization, the loading dose should be given during PCI (see Chapters 4.2, 4.8 and 5.1).

Surgery: Patients are required to undergo any surgical intervention before taking any new medication. prasugrel should inform about their use. If the patient is undergoing elective surgery and antiplatelet effect is not desired, EFFİENT should be discontinued at least 7 days before surgery. In patients undergoing coronary artery bypass graft (CABG) surgery within 7 days after the discontinuation of prasugreline, the frequency of the bleeding (3 times) and the intensity may increase (see section 4.8). The risk and benefits of prasugrelin should be carefully evaluated in patients with unexplained coronary anatomy and emergency CABG surgery.

Thrombotic Thrombocytopenic Purpura (TTP) has been reported with the use of TTP prasugrel. TTP is a serious condition and requires immediate treatment.

Lactose: Patients with rare inherited galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption problems should not use this drug.

Sodium: EFFIENT contains less than 23 mg of sodium per dose, so it is not expected to affect patients on a controlled sodium diet.

Mannitol: EFFIENT contains trace amounts of mannitol. It is not expected to have an effect on mannitol in patients using EFFİENT.

Hypersensitivity to angioedema: Hypersensitivity reactions, including angioedema, have been reported in patients receiving prasugrel, including patients with a history of hypersensitivity to clopidogrel. It is recommended that patients with known allergies to thienopyridines are observed for signs of hypersensitivity.

4.5 Interactions with other medicinal products and other forms of interaction

Warfarin: The use of EFFIENT with coumarin derivatives other than warfarin has not been investigated. Caution should be exercised when co-administration of warfarin (or other coumarin derivatives) and EFFIENT, due to the potential for increased bleeding risk (see section 4.4).

Non-steroidal anti-inflammatory drugs (NSAIDs): Use with chronic NSAIDs has not been investigated. Caution should be exercised when coexistent with chronic NSAIDs (including COX-2 inhibitors) and EFFIENT, due to an increased potential for bleeding risk (see section 4.4).

EFFİENT (including statins) can be administered with drugs that are metabolised by cytochrome P450 enzymes or with drugs that are inducers or inhibitors of cytochrome P450 enzymes. EFFİENT ASAheparin, digoxin and also proton pump inhibitors and H

can also be given in combination with drugs that increase gastric pH, such asblockers. Although it has not been investigated in specific interaction studies, EFFİENT was applied in phase 3 clinical trial without clinical evidence of adverse reaction with low molecular weight heparin, bivalirudin and GP IIb / IIIa inhibitors (information on the type of GP IIb / IIIa inhibitors used).

Effects of other medicinal products on EFFİENT:

Acetylsalicylic acid: should be used with EFFİENT ASA. Although the pharmacodynamic interaction with ASA leads to an increased risk of bleeding, the efficacy and safety of prasugrelin is associated with the treatment of patients with ASA.

Heparin: A single dose of intravenous bolus non-fractionated heparin (100 U / kg) did not significantly change the prasugrel-mediated inhibition of platelet aggregation. As such, prasugrel did not significantly alter the effect of heparin on coagulation measurements. Therefore, both medicinal products can be administered together. When EFFİENT is used with heparin, the risk of bleeding may increase.

Statins: Atorvastatin (80 mg per day) did not alter the pharmacokinetics of prasugrel and its inhibition of platelet aggregation. Therefore, statins with CYP3A substrates are not expected to have an effect on the pharmacokinetics of prasugrelin or its inhibition of platelet aggregation.

4-blocker) Gastric pH-boosting drugs:ranitidine (a H

co-administration ofor lansoprazole (a proton pump inhibitor) every day did not alter the EAA and Tactive metabolite of prasugrelin

max

values ​​of thebutC

max

decreasedby 14% and 29%, respectively. in three clinical studies effient proton pumpsinhibitors or H

being applied regardlessblockers handling. 60 mg prasugrel loading dose ensures that proton pump inhibitors are being used with the rapid onset of.

CYP3A inhibitors: selective and potent CYP3A4 and CYP3A5 inhibitor ketoconazole (400 mg daily)prasugrel-mediated platelet aggregation inhibition or EAA and Tactive metabolite of prasugrelin

max

did not affectvalue of thebutC

max

decreasedvalue by 34% to 46%. and grapefruit juice i CYP3A inhibitors are not expected to have a significant effect on the pharmacokinetics of the active metabolite.

Cytochrome P450 inducers: A potent inducer of CYP3A and CYP2B6 and rifampicin (600 mg per day), which is an inducer of CYP2C9, CYP2C19 and CYP2C8, did not significantly alter the pharmacokinetics of prasugrel and its inhibition of platelet aggregation. Thus, known CYP3A inducers such as rifampicin, carbamazepine and other cytochrome P450 inducers are not expected to have a significant effect on the pharmacokinetics of the active metabolite.

Effects of EFFIENT on other medicinal products:

Digoxin: Prasugrelin has no clinically significant effect on the pharmacokinetics of digoxin.

Drugs metabolized by CYP2C9: Prasugrel did not inhibit CYP2C9 as it did not affect the pharmacokinetics of S-warfarin. Warfarin and EFFİENT should be administered with caution because of the potential for increased bleeding risk (see section 4.4).

Drugs metabolized by CYP2B6: Prasugrel is a weak inhibitor of CYP2B6. In healthy subjects, prasugrel reduced the exposure to hydroxyibupropion, a CYP2B6-mediated metabolite of bupropion by 23%. The clinical significance of this effect is likely to be the use of prasugrel in combination with drugs (eg cyclophosphamide, efavirenz) where CYP2B6 is the only metabolic pathway and with a narrow therapeutic window (eg, cyclophosphamide, efavirenz).

Additional information on special populations No interaction studies have been conducted.

Pediatric population No interaction study has been performed.

4.6 Pregnancy and lactation General advice Pregnancy category: B

Women with childbearing potential / Contraception No adequate data available.

Pregnancy The EFFİENT should always be used only when the potential benefit to the mother is greater than the potential risk to the fetus, since animal reproductive studies do not always provide foresight for human response.

For Prasugrel, there is no clinical data on exposure to pregnancies.

Animal studies do not show any direct or indirect adverse effects related to pregnancy / embryonal / fetal development / birth or postnatal development. (see section 5.3).

Pregnant women should be cautious when giving.

Lactation There is insufficient information about the elimination of the active metabolite of Prasugrel by human or animal milk. It cannot be excluded that there is a risk to the child in the breast. When deciding whether to stop breastfeeding or whether or not treatment of EFFİENT should be avoided, the benefit of breastfeeding for the child and the benefit of EFFİENT for the breastfeeding mother should be taken into account. Prasugrel is not recommended during breastfeeding.

Reproductive ability / Fertility Prasugrel up to 240-fold exposure of the daily recommended human maintenance dose (in mg / m 2) did not affect fertility in male and female rats.

4.7 Effects on ability to drive and use machines No work has been carried out on the effectiveness of the ability to drive and use machines. Prasugrel is expected to have no effect on the ability to use vehicles or machines, or these effects are expected to be negligible.

4.8 Undesirable effects

a. The tabulated summary of adverse reactions is summarized in Table 2 according to the TRITON study or spontaneously reported, haemorrhagic and non-hemorrhagic adverse reactions, frequency and organ class. Frequencies are defined as follows:

Very common (≥ 1/10); common (≥ 1/100 to <1/10); non-common (≥ 1 / 1,000 to <1/100); infrequently (≥ 1 / 10,000 - <1 / 1,000); very rare (<1 / 10.000); unknown (unpredictable data)

Table 1: Hemorrhagic and non-hemorrhagic adverse reactions

System Organ Class Common Uncommon Uncommon Infrequent Unknown Blood and lymphatic system disorders

Anemia Thrombocytopenia Thrombotic

thrombocytopenic purpura (TTP) - see P <0.05. Section 4.4

Angioedema my immune system

including disorders

Hypersensitivity Eye disorders Eye haemorrhage Vascular disorders Hematoma Respiratory, thoracic and mediastinal disorders

Epistaxis Hemoptysis

Gastrointestinal disorders

retroperitoneal hemorrhage, rectal hemorrhage Hematokez of gingival bleeding, Skin and subcutaneous tissue disorders

gastrointestinal hemorrhage

Rash Ecchymosis Renal and urinary disorders

Haematuria

General Disorders of the

vascular area Hematoma at the site of the vessel Injury, intoxication and procedural complications

Contusion Post-procedural

hemorrhage

Subcutaneous hematoma The

incidence of stroke in a phase 3 study is as follows in patients with or without a history of TIA or stroke (see section 4.4) :

TIA or stroke history Prasugrel Clopidogrel Yes (N = 518) 6.5% (2.3% IKK *) 1.2% (0% IKK *) No (N = 13090) 0.9% (0.2% IKK *) 1.0% (0.3% IKK *) IKK = intracranial hemorrhage.

b. Safety profile summary The safety of patients with planned acute coronary syndrome with PCI was evaluated in a clopidogrel-controlled study (TRITON). In this study, 6741 patients received prasugrel for a median of 14.5 months (60 mg loading dose and 10 mg maintenance once daily) (5802 patients were treated for 6 months and 4136 patients were treated for more than 1 year). The incidence of discontinuation of the study drug due to adverse events was 6.3% for prasugrel and 7.2% for clopidogrel. Of these, bleeding is the most common adverse reaction leading to discontinuation of the study drug for both drugs (2.5% for prasugrel and 1.4% for clopidogrel).

Bleeding

Coronary artery bypass graft (CABG) -related bleeding In a TRITON study, the incidence of patients with a non-CABG-related bleeding event is shown in Table 2. TIMI major bleeding or TIMI minor hemorrhage not associated with CABG, UA / NSTEMI and prasugrel in all ACS populations were significantly higher in patients treated with prasugrel than in clopidogrel. There was no significant difference in the STEMI population. The most frequent place of spontaneous bleeding is gastrointestinal system (ratio with prasugrel is 1.7% and clopidogrel with 1.3%);

most frequent site of bleeding withinterventions is the arterial puncture site (1.3% with prasugrel and 1.2% with clopidogrel).

Table 2: Incidence of non-CABG related hemorrhage (% of patients)

Event All ACS UA / NSTEMI STEMI

Prasugrelb + ASA (N = 6741)

Events that are centrally judged according to criteria defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group. b Other standard treatments were used where appropriate. c Open clinical hemorrhage or an intracranial hemorrhage with decreased hemoglobin ≥ 5 g / dL d Life-threatening bleeding is a subgroup of TIMI major hemorrhage and includes the following types. Patients maycounted in more than one line

be. e ICH = intracranial bleeding. f Obvious clinical bleeding with hemoglobin ≥3 g / dL but <5 g / dL reduction

Patients older than 75 years of age with non-CABG TIMI major or minor bleeding rates:

Age Prasugrel 10 mg Clopidogrel 75 mg ≥ 75 years (N = 1785 ) * 9.0% (1.0% fatal) 6.9% (0.1% fatal) <75 years (N = 11672) * 3.8% (0.2% fatal) 2.9% (0.1% fatal) <75 years (N = 7180) **% 2.0 (0.1% fatal) a 1.3% (0.1% fatal)

Prasugrel 5 mg Clopidogrel 75 mg ≥ 75 years (N = 2060) ** 2.6% (0.3% fatal) 3.0% (0.5% fatal) * In the TRITON study, PKG planned Patients with ACS ** In TRILOGY-ACS study, PKG unplanned patients (see section 5.1) a 10 mg prasugrel;60 kg of 5 mg prasugrel if

Patients with less thanless than 60 kg Patients with non-CABG related TIMI major or minor bleeding rates:

Weight Prasugrel 10 mg Clopidogrel 75 mg <60 kg (N = 664) * 10.1% (0% fatal ) 6.5% (0.3% fatal)

Klopidogrelb + ASA (N = 6716)

Prasugrelb + ASA (N = 5001)

Klopidogrelb + ASA (N = 4980)

Prasugrelb + ASA (N = 1740)

Klopidogrelb + ASA (N = 1736) TIMI major kanamac

2.2 1.7 2.2 1.6 2.2

Life-life

threateningthreat

1.3 1.3 1.3 1.3 1.2 1.2

Fatal 0.3 0.1 0.3 0.1 0.4 0.1 Symptomatic IKKe

0.3 0.3 0.3 0.3 0.2 0.2

Requires inotrope

0.3 0.1 0.3 0.1 0.3 0.2

Requires surgical intervention

0.3 0.3 0.3 0.3 0.1 0.2

Requires transfusion (≥ 4 units)

0.7 0.5 0.6 0.3 0.8 0.8

TIMI minor bleed

2.4 1.9 2.3 1.6 2.7 2.6

8

≥ 60 kg (N = 12672) * 4.2% (0.3% fatal) 3.3% (0.1% fatal) ≥ 60 kg (N = 7845) ** 2.2% (0.2% fatal) a 1.6% (0.2% fatal)

Prasugrel 5 mg Clopidogrel 75 mg <60 kg (N = 1391) ** 1.4% (0.1% fatal) 2.2% (0.3% fatal) * In the TRITON study, we planned a patient with PCI. ** In the TRILOGY-ACS study, PKG unplanned patients (cf. Section 5.1) a 10 mg of prasugrel; If the patient isPRA

over 75 years old, patients withover 60 kg and under 75 years of age are more than 60 kg and patients under 75 years of age do not have CABG related bleeding rates are 3.6% for prasugrel and 2.8% for clopidogrel. Fatal bleeding rates were 0.2% for prasugrel and 0.1% for clopidogrel.

CABG-related bleeding In a Phase 3 clinical trial, 437 patients underwent CABG during the study. In these patients, the rate of TIMI major or minor bleeding related to CABG was 14.1% in the prasugrel group and 4.5% in the clopidogrel group. The higher risk of bleeding in patients treated with Prasugrel lasted up to 7 days after the last dose of the study drug. In patients who received thienopyridine within 3 days prior to CABG, the frequency of TIMI major and minor bleeding was 26.7% in the prasugrel group (12 in 45 patients) and 5% in the clopidogrel group (3 in 60 patients). In patients who received the last dose of thienopyridine in the last 4-7 days before CABG, the frequency was 11.3% in the prasugrel group (9 in 80 patients) and 3.4% in the clopidogrel group (3 in 89 patients). CABG-associated hemorrhages after 7 days after discontinuation of the drug were the same in the treatment groups (see section 4.4).

Bleeding risk associated with timing of loading dose in patients undergoing NSTEMI A clinical trial with NSTEMI patients scheduled for 2-48 hours after randomization (ACCOAST study) was performed 30 minutes before coronary angiography and 30 mg in patients given a loading dose of 30 mg during PCI. There is an increase in the risk of procedural bleeding not associated with the patient and it has been shown that this has no additional benefit compared to patients receiving loading dose of 60 mg during PCI (see sections 4.2 and 4.4). The 7-day non-CABG-related TIMI bleeding rates in patients are as follows:

Adverse Reaction

During PKG Prasugrela (N = 1996)

% TIMI major kanamab

1.3 0.5 Life-threatening disposition

0.8 0.2 Fatal

0.1 0.0 Symptomatic IKKd

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