Efient

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Efient 10 mg film-coated tablets. 
Efient 5 mg film-coated tablets. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Efient 10 mg: 
Each tablet contains 10 mg prasugrel (as hydrochloride). 
 
Excipient(s) with known effect 
Each tablet contains 2.1 mg lactose monohydrate. 
 
Efient 5 mg: 
Each tablet contains 5 mg prasugrel (as hydrochloride). 
 
Excipient(s) with known effect 
Each tablet contains 2.7 mg lactose monohydrate. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
 
Efient 10 mg: 
Beige and double-arrow shaped tablets, debossed with “10 MG” on one side and “4759” on the other. 
 
Efient 5 mg: 
Yellow and double-arrow shaped tablets, debossed with “5 MG” on one side and “4760” on the other. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of 
atherothrombotic events in adult 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). 
 
For further information please refer to section 5.1. 
 
4.2. Posology and method of administration 
 
Posology 
Adults 
Efient 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 
Efient should also take ASA daily (75 mg to 325 mg). 



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In patients with acute coronary syndrome (ACS) who are managed with PCI, premature 
discontinuation of any antiplatelet agent, including Efient, could result in an increased risk of 
thrombosis, myocardial infarction or death due to the patient’s underlying disease. A treatment of up 
to 12 months is recommended unless the discontinuation of Efient is clinically indicated (see sections 
4.4 and 5.1). 
 
Patients ≥ 75 years old 
The use of Efient in patients ≥ 75 years of age is generally not recommended. If, after a careful 
individual benefit/risk evaluation by the prescribing physician (see section 4.4), treatment is deemed 
necessary in the patients age group ≥ 75 years, then following a 60 mg loading dose a reduced 
maintenance dose of 5 mg should be prescribed. Patients ≥ 75 years of age have greater sensitivity to 
bleeding and higher exposure to the active metabolite of prasugrel (see sections 4.4, 4.8, 5.1 and 5.2). 
 
Patients weighing < 60 kg 
Efient should be given as a single 60 mg loading dose and then continued at a 5 mg once daily dose. 
The 10 mg maintenance dose is not recommended. This is due to an increase in exposure to the active 
metabolite of prasugrel, and an increased risk of bleeding in patients with body weight < 60 kg when 
given a 10 mg once daily dose compared with patients ≥ 60 kg (see sections 4.4, 4.8 and 5.2). 
 
Renal impairment 
No dose adjustment is necessary for patients with renal impairment, including patients with end stage 
renal disease (see section 5.2). There is limited therapeutic experience in patients with renal 
impairment (see section 4.4). 
 
Hepatic impairment 
No dose adjustment is necessary in subjects with mild to moderate hepatic impairment (Child Pugh 
class A and B) (see section 5.2). There is limited therapeutic experience in patients with mild and 
moderate hepatic dysfunction (see section 4.4). Efient is contraindicated in patients with severe 
hepatic impairment (Child Pugh class C). 
 
Paediatric population 
The safety and efficacy of Efient in children below age 18 has not been established. Limited data are 
available in children with sickle cell anaemia (see section 5.1). 
 
Method of administration 
For oral use. Efient may be administered with or without food. Administration of the 60 mg prasugrel 
loading dose in the fasted state may provide most rapid onset of action (see section 5.2). Do not crush 
or break the tablet. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Active pathological bleeding. 
History of stroke or transient ischaemic attack (TIA). 
Severe hepatic impairment (Child Pugh class C). 



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4.4 Special warnings and precautions for use 
 
Bleeding risk 
In the phase 3 clinical trial (TRITON) key exclusion criteria included an increased risk of bleeding; 
anaemia; thrombocytopaenia; a history of pathological intracranial findings. Patients with acute 
coronary syndromes undergoing PCI treated with Efient and ASA showed an increased risk of major 
and minor bleeding according to the TIMI classification system. Therefore, the use of Efient in 
patients at increased risk of bleeding should only be considered when the benefits in terms of 
prevention of ischaemic events are deemed to outweigh the risk of serious bleedings. This concern 
applies especially to patients: 
• ≥ 75 years of age (see below). 
• with a propensity to bleed (e.g. due to recent trauma, recent surgery, recent or recurrent 

gastrointestinal bleeding, or active peptic ulcer disease) 
• with body weight < 60 kg (see sections 4.2 and 4.8). In these patients the 10 mg maintenance dose 

is not recommended. A 5 mg maintenance dose should be used. 
• with concomitant administration of medicinal products that may increase the risk of bleeding, 

including oral anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs), and 
fibrinolytics. 

 
For patients with active bleeding for whom reversal of the pharmacological effects of Efient is 
required, platelet transfusion may be appropriate. 
 
The use of Efient in patients ≥75 years of age is generally not recommended and should only be 
undertaken with caution after a careful individual benefit/risk evaluation by the prescribing physician 
indicates that benefits in terms of prevention of ischaemic events outweigh the risk of serious 
bleedings. In the phase 3 clinical trial these patients were at greater risk of bleeding, including fatal 
bleeding, compared to patients <75 years of age. If prescribed, a lower maintenance dose of 5 mg 
should be used; the 10 mg maintenance dose is not recommended (see sections 4.2 and 4.8). 
 
Therapeutic experience with prasugrel is limited in patients with renal impairment (including ESRD) 
and in patients with moderate hepatic impairment. These patients may have an increased bleeding risk. 
Therefore, prasugrel should be used with caution in these patients. 
 
Patients should be told that it might take longer than usual to stop bleeding when they take prasugrel 
(in combination with ASA), and that they should report any unusual bleeding (site or duration) to their 
physician. 
 
Bleeding Risk Associated with Timing of Loading Dose in NSTEMI 
In a clinical trial of NSTEMI patients (the ACCOAST study), where patients were scheduled to 
undergo coronary angiography within 2 to 48 hours after randomization, a prasugrel loading dose 
given on average 4 hours prior to coronary angiography increased the risk of major and minor 
peri-procedural bleeding compared with a prasugrel loading dose at the time of PCI. Therefore, in 
UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the 
loading dose should be given at the time of PCI. (see sections 4.2, 4.8 and 5.1). 
 
Surgery 
Patients should be advised to inform physicians and dentists that they are taking prasugrel before any 
surgery is scheduled and before any new medicinal product is taken. If a patient is to undergo elective 
surgery, and an antiplatelet effect is not desired, Efient should be discontinued at least 7 days prior to 
surgery. Increased frequency (3-fold) and severity of bleeding may occur in patients undergoing 
CABG surgery within 7 days of discontinuation of prasugrel (see section 4.8). The benefits and risks 
of prasugrel should be carefully considered in patients in whom the coronary anatomy has not been 
defined and urgent CABG is a possibility. 



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Hypersensitivity including angioedema 
Hypersensitivity reactions including angioedema have been reported in patients receiving prasugrel, 
including in patients with a history of hypersensitivity reaction to clopidogrel. Monitoring for signs of 
hypersensitivity in patients with a known allergy to thienopyridines is advised (see section 4.8). 
 
Thrombotic Thrombocytopaenic Purpura (TTP) 
TTP has been reported with the use of prasugrel. TTP is a serious condition and requires prompt 
treatment. 
 
Lactose 
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-
galactose malabsorption should not take this medicine. 
 
Morphine and other opioids 
Reduced prasugrel efficacy has been seen in patients co-administered prasugrel and morphine (see 
section 4.5). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Warfarin: 
Concomitant administration of Efient with coumarin derivatives other than warfarin has not been 
studied. Because of the potential for increased risk of bleeding, warfarin (or other coumarin 
derivatives) and prasugrel should be co-administered with caution (see section 4.4). 
 
Non-steroidal anti-inflammatory drugs (NSAIDs): 
Concomitant administration with chronic NSAIDs has not been studied. Because of the potential for 
increased risk of bleeding, chronic NSAIDs (including COX-2 inhibitors) and Efient should be co-
administered with caution (see section 4.4). 
 
Efient can be concomitantly administered with medicinal products metabolised by cytochrome P450 
enzymes (including statins), or medicinal products that are inducers or inhibitors of cytochrome P450 
enzymes. Efient can also be concomitantly administered with ASA, heparin, digoxin, and medicinal 
products that elevate gastric pH, including proton pump inhibitors and H2 blockers. Although not 
studied in specific interaction studies, Efient has been co-administered in the phase 3 clinical trial with 
low molecular weight heparin, bivalirudin, and GP IIb/IIIa inhibitors (no information available 
regarding the type of GP IIb/IIIa inhibitor used) without evidence of clinically significant adverse 
interactions. 
 
Effects of other medicinal products on Efient 
Acetylsalicylic acid: 
Efient is to be administered concomitantly with acetylsalicylic acid (ASA). Although a 
pharmacodynamic interaction with ASA leading to an increased risk of bleeding is possible, the 
demonstration of the efficacy and safety of prasugrel comes from patients concomitantly treated with 
ASA. 
 
Heparin: 
A single intravenous bolus dose of unfractionated heparin (100 U/kg) did not significantly alter the 
prasugrel-mediated inhibition of platelet aggregation. Likewise, prasugrel did not significantly alter 
the effect of heparin on measures of coagulation. Therefore, both medicinal products can be 
administered concomitantly. An increased risk of bleeding is possible when Efient is co-administered 
with heparin. 
 
Statins: 
Atorvastatin (80 mg daily) did not alter the pharmacokinetics of prasugrel and its inhibition of platelet 
aggregation. Therefore, statins that are substrates of CYP3A are not anticipated to have an effect on 
the pharmacokinetics of prasugrel or its inhibition of platelet aggregation. 



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Medicinal products that elevate gastric pH: 
Daily co-administration of ranitidine (an H2 blocker) or lansoprazole (a proton pump inhibitor) did not 
change the prasugrel active metabolite’s AUC and Tmax, but decreased the Cmax by 14% and 29%, 
respectively. In the phase 3 clinical trial, Efient was administered without regard to co-administration 
of a proton pump inhibitor or H2 blocker. Administration of the 60 mg prasugrel loading dose without 
concomitant use of proton pump inhibitors may provide most rapid onset of action. 
 
Inhibitors of CYP3A: 
Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4 and CYP3A5, did not affect 
prasugrel-mediated inhibition of platelet aggregation or the prasugrel active metabolite’s AUC and 
Tmax, but decreased the Cmax by 34% to 46%. Therefore, CYP3A inhibitors such as azol antifungals, 
HIV protease inhibitors, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin, 
and grapefruit juice are not anticipated to have a significant effect on the pharmacokinetics of the 
active metabolite. 
 
Inducers of cytochromes P450: 
Rifampicin (600 mg daily), a potent inducer of CYP3A and CYP2B6, and an inducer of CYP2C9, 
CYP2C19, and CYP2C8, did not significantly change the pharmacokinetics of prasugrel. Therefore, 
known CYP3A inducers such as rifampicin, carbamazepine, and other inducers of cytochromes P450 
are not anticipated to have significant effect on the pharmacokinetics of the active metabolite. 
 
Morphine and other opioids: 
A delayed and decreased exposure to oral P2Y12 inhibitors, including prasugrel and its active 
metabolite, has been observed in patients with acute coronary syndrome treated with morphine. This 
interaction may be related to reduced gastrointestinal motility and apply to other opioids. The clinical 
relevance is unknown, but data indicate the potential for reduced prasugrel efficacy in patients co-
administered prasugrel and morphine. In patients with acute coronary syndrome, in whom morphine 
cannot be withheld and fast P2Y12 inhibition is deemed crucial, the use of a parenteral P2Y12 
inhibitor may be considered. 
 
Effects of Efient on other medicinal products 
Digoxin: 
Prasugrel has no clinically significant effect on the pharmacokinetics of digoxin. 
 
Medicinal products metabolised by CYP2C9: 
Prasugrel did not inhibit CYP2C9, as it did not affect the pharmacokinetics of S-warfarin. Because of 
the potential for increased risk of bleeding, warfarin and Efient should be co-administered with 
caution (see section 4.4). 
 
Medicinal products metabolised by CYP2B6: 
Prasugrel is a weak inhibitor of CYP2B6. In healthy subjects, prasugrel decreased exposure to 
hydroxybupropion, a CYP2B6-mediated metabolite of bupropion, by 23%. This effect is likely to be 
of clinical concern only when prasugrel is co-administered with medicinal products for which 
CYP2B6 is the only metabolic pathway and have a narrow therapeutic window 
(e.g. cyclophosphamide, efavirenz). 



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4.6 Fertility, pregnancy and lactation 
 
No clinical study has been conducted in pregnant or breast-feeding women. 
 
Pregnancy 
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal 
development, parturition or postnatal development (see section 5.3). Because animal reproduction 
studies are not always predictive of a human response, Efient should be used during pregnancy only if 
the potential benefit to the mother justifies the potential risk to the foetus. 
 
Breast-feeding 
It is unknown whether prasugrel is excreted in human breast milk. Animal studies have shown 
excretion of prasugrel in breast milk. The use of prasugrel during breastfeeding is not recommended. 
 
Fertility 
Prasugrel had no effect on fertility of male and female rats at oral doses up to an exposure 240 times 
the recommended daily human maintenance dose (based on mg/m2). 
 
4.7 Effects on ability to drive and use machines 
 
Prasugrel is expected to have no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
Safety in patients with acute coronary syndrome undergoing PCI was evaluated in one clopidogrel-
controlled study (TRITON) in which 6741 patients were treated with prasugrel (60 mg loading dose 
and 10 mg once daily maintenance dose) for a median of 14.5 months (5802 patients were treated for 
over 6 months, 4136 patients were treated for more than 1 year). The rate of study drug 
discontinuation due to adverse events was 7.2% for prasugrel and 6.3% for clopidogrel. Of these, 
bleeding was the most common adverse reaction for both drugs leading to study drug discontinuation 
(2.5% for prasugrel and 1.4% for clopidogrel). 
 
Bleeding 
Non-Coronary Artery Bypass Graft (CABG) related bleeding 
In TRITON, the frequency of patients experiencing a non-CABG related bleeding event is shown in 
Table 1. The incidence of Non-CABG-related TIMI major bleeding, including life-threatening and 
fatal, as well as TIMI minor bleeding, was statistically significantly higher in subjects treated with 
prasugrel compared to clopidogrel in the UA/NSTEMI and All ACS populations. No significant 
difference was seen in the STEMI population. The most common site of spontaneous bleeding was the 
gastrointestinal tract (1.7% rate with prasugrel and 1.3% rate with clopidogrel); the most frequent site 
of provoked bleeding was the arterial puncture site (1.3% rate with prasugrel and 1.2% with 
clopidogrel). 



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Table 1: Incidence of Non-CABG related bleedinga (% Patients) 

a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria. 
b Other standard therapies were used as appropriate.  
c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL. 
d Life-threatening bleeding is a subset of TIMI major bleeding and includes the types indented below. Patients may be 

counted in more than one row. 
e ICH=intracranial haemorrhage. 
f Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL. 
 
Patients ≥ 75 years old  
Non-CABG-related 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) 

*TRITON study in ACS patients undergoing PCI 
**TRILOGY-ACS study in patients not undergoing PCI (see 5.1): 

a 10 mg prasugrel; 5 mg prasugrel if <60 kg 
 
Patients < 60 kg 
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) 
≥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 
<60kg (N=1391)** 1.4% (0.1% fatal) 2.2% (0.3% fatal) 

*TRITON study in ACS patients undergoing PCI 
**TRILOGY-ACS study in patients not undergoing PCI (see 5.1): 

a 10 mg prasugrel; 5 mg prasugrel if  ≥75 years of age 
 
Patients ≥60 kg and age <75 years 
In patients ≥60 kg and age <75 years, non-CABG-related TIMI major or minor bleeding rates were 
3.6% for prasugrel and 2.8% for clopidogrel; rates for fatal bleeding were 0.2% for prasugrel and 0.1% 
for clopidogrel. 
 

Event All ACS UA/NSTEMI STEMI 
Prasugrelb 

+ASA 
(N = 6741) 

Clopidogrelb 
+ASA 

(N = 6716) 

Prasugrelb 
+ASA 

(N = 5001) 

Clopidogrelb 
+ASA 

(N = 4980) 

Prasugrelb 
+ASA 

(N = 1740) 

Clopidogrelb 
+ASA 

(N = 1736) 
TIMI major 
bleedingc 

2.2 1.7 2.2 1.6 2.2 2.0 

Life-threateningd 1.3 0.8 1.3 0.8 1.2 1.0 
Fatal 0.3 0.1 0.3 0.1 0.4 0.1 
Symptomatic 
ICHe 

0.3 0.3 0.3 0.3 0.2 0.2 

Requiring 
inotropes 

0.3 0.1 0.3 0.1 0.3 0.2 

Requiring 
surgical 
intervention 

0.3 0.3 0.3 0.3 0.1 0.2 

Requiring 
transfusion (≥ 4 
units) 

0.7 0.5 0.6 0.3 0.8 0.8 

TIMI minor 
bleeding f 

2.4 1.9 2.3 1.6 2.7 2.6 



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CABG-related bleeding 
In the phase 3 clinical trial, 437 patients underwent CABG during the course of the study. Of those 
patients, the rate of CABG-related TIMI major or minor bleeding was 14.1% for the prasugrel group 
and 4.5% in the clopidogrel group. The higher risk for bleeding events in subjects treated with 
prasugrel persisted up to 7 days from the most recent dose of study drug. For patients who received 
their thienopyridine within 3 days prior to CABG, the frequencies of TIMI major or minor bleeding 
were 26.7% (12 of 45 patients) in the prasugrel group, compared with 5.0% (3 of 60 patients) in the 
clopidogrel group. For patients who received their last dose of thienopyridine within 4 to 7 days prior 
to CABG, the frequencies decreased to 11.3% (9 of 80 patients) in the prasugrel group and 3.4% (3 of 
89 patients) in the clopidogrel group. Beyond 7 days after drug discontinuation, the observed rates of 
CABG-related bleeding were similar between treatment groups (see section 4.4). 
 
Bleeding Risk Associated with Timing of Loading Dose in NSTEMI 
In a clinical study of NSTEMI patients (the ACCOAST study), where patients were scheduled to 
undergo coronary angiography within 2 to 48 hours after randomization, patients given a 30 mg 
loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at 
the time of PCI had an increased risk of non-CABG peri-procedural bleeding and no additional benefit 
compared to patients receiving a 60 mg loading dose at the time of PCI (see sections 4.2 and 4.4). 
Non-CABG- related TIMI bleeding rates through 7 days for patients were as follows: 
 

 
Adverse Reaction 

Prasugrel Prior to 
Coronary 

Angiographya 
(N=2037) 

% 

Prasugrel At 
time of PCIa  

 
(N=1996) 

% 

TIMI Major bleedingb 1.3 0.5 
Life-threateningc 0.8 0.2 

Fatal 0.1 0.0 
Symptomatic ICHd 0.0 0.0 
Requiring inotropes 0.3 0.2 
Requiring surgical intervention 0.4 0.1 
Requiring transfusion (≥4 units) 0.3 0.1 

TIMI Minor bleedinge 1.7 0.6 
 

aOther standard therapies were used as appropriate. The clinical study protocol provided for all patients to receive 
aspirin and a daily maintenance dose of prasugrel. 
bAny intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL. 
cLife-threatening is a subset of TIMI Major bleeding and includes the types indented below. Patients may be counted in 
more than one row. 
dICH=intracranial haemorrhage. 
eClinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL. 

 



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Tabulated summary of adverse reactions 
Table 2 summarises haemorrhagic and non-haemorrhagic adverse reactions in TRITON, or that were 
spontaneously reported, classified by frequency and system organ class. Frequencies are defined as 
follows: 
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100);  
rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the 
available data). 
 
Table 2: Haemorrhagic and Non-haemorrhagic adverse reactions 
System Organ 
Class 

Common Uncommon Rare Not Known 

Blood and 
Lymphatic System 
disorders  

Anaemia  Thrombocytopaenia Thrombotic 
thrombocytopaenic 
purpura (TTP) -see 
section 4.4 

Immune system 
disorders 

 Hypersensitivity 
including 
angioedema 

  

Eye disorders  Eye haemorrhage   
Vascular Disorders Haematoma    
Respiratory, 
thoracic and 
mediastinal 
disorders 

Epistaxis 
 

Haemoptysis   

Gastrointestinal 
disorders 

Gastrointestinal 
haemorrhage 

Retroperitoneal 
haemorrhage 
Rectal haemorrhage 
Haematochezia  
Gingival bleeding 

  

Skin and 
subcutaneous tissue 
disorders 

Rash 
Ecchymosis 

   

Renal and urinary 
disorders 

Haematuria    

General disorders 
and administration 
site conditions 

Vessel puncture site 
haematoma 
Puncture site 
haemorrhage 

   

Injury, poisoning 
and procedural 
complications 

Contusion Post-procedural 
haemorrhage 

Subcutaneous 
haematoma 

 

 
In patients with or without a history of TIA or stroke, the incidence of stroke in the phase 3 clinical 
trial was as follows (see section 4.4): 
 

History of TIA or stroke Prasugrel Clopidogrel 
Yes (N=518) 6.5% (2.3% ICH*) 1.2% (0% ICH*) 
No (N=13090) 0.9% (0.2% ICH*) 1.0% (0.3% ICH*) 

* ICH=intracranial haemorrhage. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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4.9 Overdose 
 
Overdose of Efient may lead to prolonged bleeding time and subsequent bleeding complications. No 
data are available on the reversal of the pharmacological effect of prasugrel; however, if prompt 
correction of prolonged bleeding time is required, platelet transfusion and/or other blood products may 
be considered. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC22. 
 
Mechanism of action / Pharmacodynamic effects 
Prasugrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its 
active metabolite to the P2Y12 class of ADP receptors on platelets. Since platelets participate in the 
initiation and/or evolution of thrombotic complications of atherosclerotic disease, inhibition of platelet 
function can result in the reduction of the rate of cardiovascular events such as death, myocardial 
infarction, or stroke. 
 
Following a 60 mg loading dose of prasugrel, inhibition of ADP-induced platelet aggregation occurs at 
15 minutes with 5 µM ADP and 30 minutes with 20 µM ADP. The maximum inhibition by prasugrel 
of ADP-induced platelet aggregation is 83% with 5 µM ADP and 79% with 20 µM ADP, in both cases 
with 89% of healthy subjects and patients with stable atherosclerosis achieving at least 50% inhibition 
of platelet aggregation by 1 hour. Prasugrel-mediated inhibition of platelet aggregation exhibits low 
between-subject (9%) and within-subject (12%) variability with both 5 µM and 20 µM ADP. 
Mean steady-state inhibition of platelet aggregation was 74% and 69% respectively for 5 µM ADP and 
20 µM ADP, and was achieved following 3 to 5 days of administration of the 10 mg prasugrel 
maintenance dose preceded by a 60 mg loading dose. More than 98% of subjects had ≥ 20% inhibition 
of platelet aggregation during maintenance dosing. 
 
Platelet aggregation gradually returned to baseline values after treatment in 7 to 9 days after 
administration of a single 60 mg loading dose of prasugrel and in 5 days following discontinuation of 
maintenance dosing at steady-state. 
 
Switching data: Following administration of 75 mg clopidogrel once daily for 10 days, 40 healthy 
subjects were switched to prasugrel 10 mg once daily with or without a loading dose of 60 mg. 
Similar or higher inhibition of platelet aggregation was observed with prasugrel. Switching directly to 
prasugrel 60 mg loading dose resulted in the most rapid onset of higher platelet inhibition. 
Following administration of a 900 mg loading dose of clopidogrel (with ASA), 56 subjects with ACS 
were treated for 14 days with either prasugrel 10 mg once daily or clopidogrel 150 mg once daily, and 
then switched to either clopidogrel 150 mg or prasugrel 10 mg for another 14 days. Higher inhibition 
of platelet aggregation was observed in patients switched to prasugrel 10 mg compared with those 
treated with clopidogrel 150 mg. In a study of 276 ACS patients managed with PCI, switching from an 
initial loading dose of 600 mg clopidogrel or placebo administered upon presentation to the hospital 
prior to coronary angiography to a 60 mg loading dose of prasugrel administered at the time of 
percutaneous coronary intervention, resulted in a similar increased inhibition of platelet aggregation 
for the 72 hour duration of the study. 



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Clinical efficacy and safety 
 
Acute Coronary Syndrome (ACS) 
The phase 3 TRITON study compared Efient (prasugrel) with clopidogrel, both co-administered with 
ASA and other standard therapy. TRITON was a 13,608 patient, multicentre international, 
randomised, double blind, parallel group study. Patients had ACS with moderate to high risk UA, 
NSTEMI, or STEMI and were managed with PCI. 
 
Patients with UA/NSTEMI within 72 hours of symptoms or STEMI between 12 hours to 14 days of 
symptoms were randomised after knowledge of coronary anatomy. Patients with STEMI within 
12 hours of symptoms and planned for primary PCI could be randomised without knowledge of 
coronary anatomy. For all patients, the loading dose could be administered anytime between 
randomisation and 1 hour after the patient left the catheterisation lab. 
 
Patients randomised to receive prasugrel (60 mg loading dose followed by 10 mg once daily) or 
clopidogrel (300 mg loading dose followed by 75 mg once daily) were treated for a median of 
14.5 months (maximum of 15 months with a minimum of 6 months follow-up). Patients also received 
ASA (75 mg to 325 mg once daily). Use of any thienopyridine within 5 days before enrolment was an 
exclusion criterion. Other therapies, such as heparin and GPIIb/IIIa inhibitors, were administered at 
the discretion of the physician. Approximately 40% of patients (in each of the treatment groups) 
received GPIIb/IIIa inhibitors in support of PCI (no information available regarding the type of GP 
IIb/IIIa inhibitor used). Approximately 98% of patients (in each of the treatment groups) received 
antithrombins (heparin, low molecular weight heparin, bivalirudin, or other agent) directly in support 
of PCI. 
 
The trial’s primary outcome measure was the time to first occurrence of cardiovascular (CV) death, 
non-fatal myocardial infarction (MI), or non-fatal stroke. Analysis of the composite endpoint in the All 
ACS population (combined UA/NSTEMI and STEMI cohorts) was contingent on showing statistical 
superiority of prasugrel versus clopidogrel in the UA/NSTEMI cohort (p < 0.05). 
 
All ACS population:  
Efient showed superior efficacy compared to clopidogrel in reducing the primary composite outcome 
events as well as the pre-specified secondary outcome events, including stent thrombosis 
(see Table 3). The benefit of prasugrel was apparent within the first 3 days and it persisted to the end 
of study. The superior efficacy was accompanied by an increase in major bleeding (see sections 4.4 
and 4.8). The patient population was 92% Caucasian, 26% female, and 39% ≥ 65 years of age. 
The benefits associated with prasugrel were independent of the use of other acute and long-term 
cardiovascular therapies, including heparin/low molecular weight heparin, bivalirudin, intravenous 
GPIIb/IIIa inhibitors, lipid-lowering medicinal products, beta-blockers, and angiotensin converting 
enzyme inhibitors. The efficacy of prasugrel was independent of the ASA dose (75 mg to 325 mg once 
daily). The use of oral anticoagulants, non-study antiplatelet medicinal products and chronic NSAIDs 
was not allowed in TRITON. In the All ACS population, prasugrel was associated with a lower 
incidence of CV death, non-fatal MI, or non-fatal stroke compared to clopidogrel, regardless of 
baseline characteristics such as age, sex, body weight, geographical region, use of GPIIb/IIIa 
inhibitors, and stent type. The benefit was primarily due to a significant decrease in non-fatal MI 
(see Table 3). Subjects with diabetes had significant reductions in the primary and all secondary 
composite endpoints. 
 
The observed benefit of prasugrel in patients ≥ 75 years was less than that observed in patients 
< 75 years. Patients ≥ 75 years were at increased risk of bleeding, including fatal (see sections 4.2, 4.4, 
and 4.8). Patients ≥ 75 years in whom the benefit with prasugrel was more evident included those with 
diabetes, STEMI, higher risk of stent thrombosis, or recurrent events. 
 
Patients with a history of TIA or a history of ischaemic stroke more than 3 months prior to prasugrel 
therapy had no reduction in the primary composite endpoint. 
 



13 

Table 3: Patients with Outcome Events in TRITON Primary Analysis 

Outcome Events 

Prasugrel 
+ ASA 

 

Clopidogrel 
+ASA 

 

Hazard Ratio (HR) 
(95% CI) 

p-value 

All ACS 
(N = 6813) 

% 
(N = 6795) 

% 
 
 

0.812 (0.732, 0.902) 

 
 

< 0.001 Primary Composite Outcome Events 
Cardiovascular (CV) death, non fatal MI, 
or non fatal stroke 

9.4 11.5 

Primary Individual Outcome Events 
CV death 2.0 2.2 0.886 (0.701, 1.118) 0.307 
Nonfatal MI 7.0 9.1 0.757 (0.672, 0.853) < 0.001 
Nonfatal stroke 0.9 0.9 1.016 (0.712, 1.451) 0.930 

UA/NSTEMI 
Primary Composite Outcome Events 

(N = 5044) 
% 

(N = 5030) 
% 

  

CV death, nonfatal MI, or nonfatal stroke 9.3 11.2 0.820 (0.726, 0.927) 0.002 
CV death 1.8 1.8 0.979 (0.732,1.309) 0.885 
Nonfatal MI 7.1 9.2 0.761 (0.663,0.873) < 0.001 
Nonfatal stroke 0.8 0.8 0.979 (0.633,1.513) 0.922 

STEMI 
Primary Composite Outcome Events 

(N = 1769) 
% 

(N = 1765) 
% 

  

CV death, nonfatal MI, or nonfatal stroke 9.8 12.2 0.793 (0.649, 0.968) 0.019 
CV death 2.4 3.3 0.738 (0.497,1.094) 0.129 
Nonfatal MI 6.7 8.8 0.746 (0.588,0.948) 0.016 
Nonfatal stroke 1.2 1.1 1.097 (0.590,2.040) 0.770 

 
In the All ACS population, analysis of each of the secondary endpoints showed a significant benefit 
(p < 0.001) for prasugrel versus clopidogrel. These included definite or probable stent thrombosis at 
study end (0.9% vs 1.8%; HR 0.498; CI 0.364, 0.683); CV death, nonfatal MI, or urgent target vessel 
revascularisation through 30 days (5.9% vs 7.4%; HR 0.784; CI 0.688,0.894); all cause death, nonfatal 
MI, or nonfatal stroke through study end (10.2% vs 12.1%; HR 0.831; CI 0.751, 0.919); CV death, 
nonfatal MI, nonfatal stroke or rehospitalisation for cardiac ischaemic event through study end 
(11.7% vs 13.8%; HR 0.838; CI 0.762, 0.921). Analysis of all cause death did not show any significant 
difference between prasugrel and clopidogrel in the All ACS population (2.76% vs 2.90%), in the 
UA/NSTEMI population (2.58% vs 2.41%), and in the STEMI population (3.28% vs 4.31%). 
 
Prasugrel was associated with a 50% reduction in stent thrombosis through the 15 month follow-up 
period. The reduction in stent thrombosis with Efient was observed both early and beyond 30 days for 
both bare metal and drug eluting stents. 
 
In an analysis of patients who survived an ischaemic event, prasugrel was associated with a reduction 
in the incidence of subsequent primary endpoint events (7.8% for prasugrel vs 11.9% for clopidogrel). 
 
Although bleeding was increased with prasugrel, an analysis of the composite endpoint of death from 
any cause, nonfatal myocardial infarction, nonfatal stroke, and non-CABG-related TIMI major 
haemorrhage favoured Efient compared to clopidogrel (Hazard ratio, 0.87; 95% CI, 0.79 to 0.95; 
p = 0.004). In TRITON, for every 1000 patients treated with Efient, there were 22 fewer patients with 
myocardial infarction, and 5 more with non–CABG-related TIMI major haemorrhages, compared with 
patients treated with clopidogrel. 
 
Results of a pharmacodynamic/pharmacogenomic study in 720 Asian ACS PCI patients demonstrated 
that higher levels of platelet inhibition are achieved with prasugrel compared to clopidogrel, and that 
prasugrel 60-mg loading dose/10-mg maintenance dose is an appropriate dose regimen in Asian 
subjects who weigh at least 60 kg and are less than 75 years of age (see section 4.2). 



14 

 
In a 30 month study (TRILOGY–ACS) in 9326 patients with UA/NSTEMI ACS medically managed 
without revascularisation (non-licensed indication), prasugrel did not significantly reduce the 
frequency of the composite endpoint of CV death, MI or stroke compared to clopidogrel. Rates of 
TIMI major bleeding (including life threatening, fatal and ICH) were similar in prasugrel and 
clopidogrel treated patients. Patients ≥75 years old or those below 60 kg (N=3022) were randomized 
to 5 mg prasugrel. As in the < 75 years old and ≥60 kg patients treated with 10 mg prasugrel, there 
was no difference between 5 mg prasugrel and 75 mg clopidogrel in CV outcomes. Rates of major 
bleeding were similar in patients treated with 5 mg prasugrel and those treated with 75 mg clopidogrel. 
Prasugrel 5 mg provided greater antiplatelet effect than clopidogrel 75 mg. Prasugrel should be used 
with caution in patients ≥ 75 years old and in patients weighing <60 kg (see sections 4.2, 4.4 and 4.8). 
 
In a 30-day study (ACCOAST) in 4033 patients with NSTEMI with elevated troponin who were 
scheduled for coronary angiography followed by PCI within 2 to 48 hours after randomization, 
subjects who received prasugrel 30 mg loading dose on average 4 hours prior to coronary angiography 
followed by a 30 mg loading dose at the time of PCI (n=2037) had an increased risk of non-CABG 
peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading 
dose at the time of PCI (n=1996).  Specifically, prasugrel did not significantly reduce the frequency of 
the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, urgent 
revascularization (UR), or glycoprotein (GP) IIb/IIIa inhibitor bailout through 7 days from 
randomization in subjects receiving prasugrel prior to coronary angiography compared to patients 
receiving the full loading dose of prasugrel at the time of PCI, and the rate of the key safety objective 
for all TIMI major bleeding (CABG and non-CABG events) through 7 days from randomization in all 
treated subjects was significantly higher in subjects receiving prasugrel prior to coronary angiography 
versus patients receiving the full loading dose of prasugrel at the time of PCI. Therefore, in 
UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the 
loading dose should be given at the time of PCI. (See sections 4.2, 4.4, and 4.8) 
 
Paediatric population 
Study TADO tested the use of prasugrel (n=171) vs placebo (n=170) in patients, ages 2 to less than 
18 years of age, with sickle cell anaemia for reduction of vaso occlusive crisis in a phase III study. 
The study failed to meet any of the primary or secondary endpoints. Overall, no new safety findings 
were identified for prasugrel as monotherapy in this patient population. 
 
5.2 Pharmacokinetic properties 
 
Prasugrel is a prodrug and is rapidly metabolised in vivo to an active metabolite and inactive 
metabolites. The active metabolite’s exposure (AUC) has moderate to low between-subject (27%) and 
within-subject (19%) variability. Prasugrel’s pharmacokinetics are similar in healthy subjects, patients 
with stable atherosclerosis, and patients undergoing percutaneous coronary intervention. 
 
Absorption 
The absorption and metabolism of prasugrel are rapid, with peak plasma concentration (Cmax) of the 
active metabolite occurring in approximately 30 minutes. The active metabolite’s exposure (AUC) 
increases proportionally over the therapeutic dose range. In a study of healthy subjects, AUC of the 
active metabolite was unaffected by a high fat, high calorie meal, but Cmax was decreased by 49% and 
the time to reach Cmax (Tmax) was increased from 0.5 to 1.5 hours. Efient was administered without 
regard to food in TRITON. Therefore, Efient can be administered without regard to food; however, the 
administration of prasugrel loading dose in the fasted state may provide most rapid onset of action 
(see section 4.2). 
 
Distribution 
Active metabolite binding to human serum albumin (4% buffered solution) was 98%. 



15 

 
Biotransformation 
Prasugrel is not detected in plasma following oral administration. It is rapidly hydrolysed in the 
intestine to a thiolactone, which is then converted to the active metabolite by a single step of 
cytochrome P450 metabolism, primarily by CYP3A4 and CYP2B6 and to a lesser extent by CYP2C9 
and CYP2C19. The active metabolite is further metabolised to two inactive compounds by 
S-methylation or conjugation with cysteine. 
 
In healthy subjects, patients with stable atherosclerosis, and patients with ACS receiving Efient, there 
was no relevant effect of genetic variation in CYP3A5, CYP2B6, CYP2C9, or CYP2C19 on the 
pharmacokinetics of prasugrel or its inhibition of platelet aggregation. 
 
Elimination 
Approximately 68% of the prasugrel dose is excreted in the urine and 27% in the faeces, as inactive 
metabolites. The active metabolite has an elimination half-life of about 7.4 hours (range 2 to 
15 hours). 
 
Pharmacokinetics in special Populations 
Elderly: 
In a study of healthy subjects between the ages of 20 and 80 years, age had no significant effect on 
pharmacokinetics of prasugrel or its inhibition of platelet aggregation. In the large phase 3 clinical 
trial, the mean estimated exposure (AUC) of the active metabolite was 19% higher in very elderly 
patients (≥ 75 years of age) compared to subjects < 75 years of age. Prasugrel should be used with 
caution in patients ≥ 75 years of age due to the potential risk of bleeding in this population 
(see sections 4.2 and 4.4). In a study in subjects with stable atherosclerosis, the mean AUC of the 
active metabolite in patients ≥75 years old taking 5 mg prasugrel was approximately half that in 
patients < 65 years old taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was reduced but was 
non-inferior compared to 10 mg. 
 
Hepatic impairment: 
No dose adjustment is necessary for patients with mild to moderate impaired hepatic function 
(Child Pugh Class A and B). Pharmacokinetics of prasugrel and its inhibition of platelet aggregation 
were similar in subjects with mild to moderate hepatic impairment compared to healthy subjects. 
Pharmacokinetics and pharmacodynamics of prasugrel in patients with severe hepatic impairment 
have not been studied. Prasugrel must not be used in patients with severe hepatic impairment 
(see section 4. 3). 
 
Renal impairment: 
No dosage adjustment is necessary for patients with renal impairment, including patients with end 
stage renal disease (ESRD). Pharmacokinetics of prasugrel and its inhibition of platelet aggregation 
are similar in patients with moderate renal impairment (GFR 30<50 ml/min/1.73m2) and healthy 
subjects. Prasugrel-mediated inhibition of platelet aggregation was also similar in patients with ESRD 
who required haemodialysis compared to healthy subjects, although Cmax and AUC of the active 
metabolite decreased 51% and 42%, respectively, in ESRD patients. 
 
Body weight: 
The mean exposure (AUC) of the active metabolite of prasugrel is approximately 30 to 40% higher in 
healthy subjects and patients with a body weight of < 60 kg compared to those weighing ≥ 60 kg. 
Prasugrel should be used with caution in patients with a body weight of < 60 kg due to the potential 
risk of bleeding in this population (see section 4.4).  In a study in subjects with stable atherosclerosis, 
the mean AUC of the active metabolite in patients <60 kg taking 5 mg prasugrel was 38% lower than 
in patients ≥60 kg taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was similar to 10 mg. 



16 

 
Ethnicity: 
In clinical pharmacology studies, after adjusting for body weight, the AUC of the active metabolite 
was approximately 19% higher in Chinese, Japanese, and Korean subjects compared to that of 
Caucasians, predominantly related to higher exposure in Asian subjects < 60 kg. There is no difference 
in exposure among Chinese, Japanese, and Korean subjects. Exposure in subjects of African and 
Hispanic descent is comparable to that of Caucasians. No dose adjustment is recommended based on 
ethnicity alone. 
 
Gender: 
In healthy subjects and patients, the pharmacokinetics of prasugrel are similar in men and women. 
 
Paediatric population: 
Pharmacokinetics and pharmacodynamics of prasugrel have not been evaluated in a paediatric 
population (see section 4.2). 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction.  
 
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the 
maximum human exposure indicating little relevance to clinical use. 
 
Embryo-foetal developmental toxicology studies in rats and rabbits showed no evidence of 
malformations due to prasugrel. At a very high dose (> 240 times the recommended daily human 
maintenance dose on a mg/m2 basis) that caused effects on maternal body weight and/or food 
consumption, there was a slight decrease in offspring body weight (relative to controls). In pre- and 
post-natal rat studies, maternal treatment had no effect on the behavioural or reproductive 
development of the offspring at doses up to an exposure 240 times the recommended daily human 
maintenance dose (based on mg/m2). 
 
No compound-related tumours were observed in a 2-year rat study with prasugrel exposures ranging to 
greater than 75 times the recommended therapeutic exposures in humans (based on plasma exposures 
to the active and major circulating human metabolites). There was an increased incidence of tumours 
(hepatocellular adenomas) in mice exposed for 2 years to high doses (> 75 times human exposure), but 
this was considered secondary to prasugrel-induced enzyme-induction. The rodent-specific association 
of liver tumours and drug-induced enzyme induction is well documented in the literature. The increase 
in liver tumours with prasugrel administration in mice is not considered a relevant human risk. 
 



17 

 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet Core: 
Microcrystalline cellulose 
Mannitol (E421) 
Croscarmellose sodium 
Hypromellose (E464) 
Magnesium stearate 
 
Film-Coat: 
Lactose monohydrate 
Hypromellose (E464) 
Titanium dioxide (E171) 
Triacetin (E1518)  
Iron oxide red (E172) {only Efient 10 mg} 
Iron oxide yellow (E172)  
Talc 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
Efient 10 mg: 
3 years. 
 
Efient 5 mg: 
2 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special temperature storage conditions. Store in the 
original package in order to protect from air and moisture. 
 
6.5 Nature and contents of container 
 
Aluminium foil blisters in cartons of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Daiichi Sankyo Europe GmbH 
Zielstattstrasse 48 
81379 Munich 
Germany 



18 

 
8. MARKETING AUTHORISATION NUMBER(S) 
 
Efient 5 mg: EU/1/08/503/001 – 007, 015 
Efient 10 mg: EU/1/08/503/008 – 014, 016 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 25 February 2009 
Date of latest renewal: 13 November 2013 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 

RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 



20 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer responsible for batch release 
 
Daiichi Sankyo Europe GmbH 
Luitpoldstrasse 1 
85276 Pfaffenhofen 
Germany 
 
Lilly S.A. 
Avda de la Industria 30 
E-28108 Alcobendas (Madrid) 
Spain 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
Medicinal product subject to medical prescription. 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 

 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE 
USE OF THE MEDICINAL PRODUCT 

 
• Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 
marketing authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new 
information being received that may lead to a significant change to the benefit/risk profile or as 
the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 



21 

 
• Additional risk minimisation measures   
 
The MAH should provide educational material to all physicians who may be involved in treating 
patients with prasugrel. The format and means of dissemination, of this material should be discussed 
with the appropriate learned societies. The results of the discussion, and where appropriate the 
material, should be agreed with the national competent authority and be available prior to launch in 
each member state. 
 
The educational material should include: 

• A copy of the SPC 
• Emphasis that: 

o Severe haemorrhagic events are more frequent in patients ≥ 75 years of age (including 
fatal events) or those weighing < 60 kg 

o Treatment with prasugrel is generally not recommended for patients of ≥ 75 years of 
age. 

o If, after a careful individual benefit/risk evaluation by the prescribing physician, 
treatment is deemed necessary in the ≥ 75 years age group then following a loading 
dose of 60 mg, a reduced maintenance dose of 5 mg should be prescribed. 

o Patients weighing < 60 kg should have a reduced maintenance dose of 5 mg 
 



22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 
 
 
 
 
 
 
 
 
 
 
 
 



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



24 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON OF 5mg FILM-COATED TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Efient 5 mg film-coated tablets 
prasugrel 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 5 mg prasugrel (as hydrochloride) 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
28 film-coated tablets 
30x1 film-coated tablet 
56 film-coated tablets 
84 film-coated tablets 
90x1 film-coated tablet 
98 film-coated tablets 
30 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



25 

9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from air and moisture. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Daiichi Sankyo Europe GmbH 
81366 Munich 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/08/503/001 14 film-coated tablets 
EU/1/08/503/002 28 film-coated tablets 
EU/1/08/503/003 30x1 film-coated tablet 
EU/1/08/503/004 56 film-coated tablets 
EU/1/08/503/005 84 film-coated tablets 
EU/1/08/503/006 90x1 film-coated tablet 
EU/1/08/503/007 98 film-coated tablets 
EU/1/08/503/015 30 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Efient 5 mg 
 



26 

 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



27 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER OF 5 mg FILM-COATED TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Efient 5 mg film-coated tablets 
prasugrel 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Daiichi-Sankyo (Logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
<MON, TUE, WED, THU, FRI, SAT, SUN> 
 
 



28 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON OF 10 mg FILM-COATED TABLETS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Efient 10 mg film-coated tablets 
prasugrel 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 10 mg prasugrel (as hydrochloride) 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
28 film-coated tablets 
30x1 film-coated tablet 
56 film-coated tablets 
84 film-coated tablets 
90x1 film-coated tablet 
98 film-coated tablets 
30 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



29 

9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from air and moisture. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Daiichi Sankyo Europe GmbH 
81366 Munich 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/08/503/008 14 film-coated tablets 
EU/1/08/503/009 28 film-coated tablets 
EU/1/08/503/010 30x1 film-coated tablet 
EU/1/08/503/011 56 film-coated tablets 
EU/1/08/503/012 84 film-coated tablets 
EU/1/08/503/013 90x1 film-coated tablet 
EU/1/08/503/014 98 film-coated tablets 
EU/1/08/503/016 30 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Efient 10 mg 
 



30 

 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



31 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER OF 10 mg FILM-COATED TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Efient 10 mg film-coated tablets 
prasugrel 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Daiichi-Sankyo (Logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
<MON, TUE, WED, THU, FRI, SAT, SUN> 
 
 



32 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



33 

Package Leaflet: Information for the user 
 

Efient 10 mg film-coated tablets  
Efient 5 mg film-coated tablets 

prasugrel 
 

Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Efient is and what it is used for 
2. What you need to know before you take Efient 
3. How to take Efient 
4. Possible side effects 
5. How to store Efient 
6. Contents of the pack and other information 
 
 
1. What Efient is and what it is used for  
 
Efient, which contains the active substance prasugrel, belongs to a group of medicines called anti-
platelet agents. Platelets are very small cell particles that circulate in the blood. When a blood vessel is 
damaged, for example if it is cut, platelets clump together to help form a blood clot (thrombus). 
Therefore, platelets are essential to help stop bleeding. If clots form within a hardened blood vessel 
such as an artery they can be very dangerous as they can cut off the blood supply, causing a heart attack 
(myocardial infarction), stroke or death. Clots in arteries supplying blood to the heart may also reduce 
the blood supply, causing unstable angina (a severe chest pain). 
 
Efient inhibits the clumping of platelets and so reduces the chance of a blood clot forming. 
 
You have been prescribed Efient because you have already had a heart attack or unstable angina and 
you have been treated with a procedure to open blocked arteries in the heart. You may also have had 
one or more stents placed to keep open a blocked or narrowed artery supplying blood to the heart. 
Efient reduces the chances of you having a further heart attack or stroke or of dying from one of these 
atherothrombotic events. Your doctor will also give you acetylsalicylic acid (e.g. aspirin), another anti-
platelet agent. 
 
 
2. What you need to know before you take Efient 
 
Do not take Efient 
- If you are allergic to prasugrel or any of the other ingredients of this medicine (listed in 

section 6). An allergic reaction may be recognised 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 had a stroke or a transient ischaemic attack (TIA). 
- If you have severe liver disease. 
 



34 

Warnings and precautions 
 
• Before you are taking Efient: 
 
Talk to your doctor before taking Efient. 
 
You should tell your doctor before taking Efient if any of the situations mentioned below apply to you: 
• If you have an increased risk of bleeding such as: 

-  age of 75 years or older. Your doctor should prescribe a daily dose of 5 mg as there is a 
greater risk of bleeding in patients older than 75 years 

-  a recent serious injury 
-  recent surgery (including some dental procedures) 
-  recent or recurrent bleeding from the stomach or intestines (e.g. a stomach ulcer or colon 

polyps) 
-  body weight of less than 60 kg. Your doctor should prescribe a daily dose of 5 mg of Efient 

if you weigh less than 60 kg 
- renal (kidney) disease or moderate liver problems 
- taking certain types of medicines (see ‘Taking other medicines’ below) 
- planned surgery (including some dental procedures) in the next seven days. Your doctor 

may wish you to stop taking Efient temporarily due to the increased risk of bleeding 
• If you have had allergic reactions (hypersensitivity) to clopidogrel or any other anti-platelet 

agent please tell your doctor before starting treatment with Efient. If you then take Efient and 
experience allergic reactions that may be recognised as a rash, itching, a swollen face, swollen 
lips or shortness of breath you need to tell your doctor immediately. 

 
• While you are taking Efient: 
 
You should tell your doctor immediately if you develop a medical condition called Thrombotic 
Thrombocytopaenic Purpura (or TTP) that includes fever and bruising under the skin that may appear 
as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin 
or eyes (jaundice) (see section 4 ‘Possible side effects’). 
 
Children and adolescents 
Efient should not be used in children and adolescents below 18 years of age. 
 
Other medicines and Efient 
Tell your doctor if you are taking, have recently taken or might take any other medicines, including 
medicines obtained without a prescription, dietary supplements and herbal remedies.  
 
It is particularly important to tell your doctor if you are being treated with: 

• clopidogrel (an anti-platelet agent), 
• warfarin (an anti-coagulant), 
• “non steroidal anti inflammatory drugs” for pain and fever (such as ibuprofen, naproxen, 

etoricoxib). 
If given together with Efient these medicines may increase the risk of bleeding. 
 
Tell your doctor if you are taking morphine or other opioids (used to treat severe pain). 
 
Only take other medicines while you are on Efient if your doctor tells you that you can. 
 
Pregnancy and breast-feeding 
Tell your doctor if you become pregnant or are trying to become pregnant while you are taking Efient. 
You should use Efient only after discussing with your doctor the potential benefits and any potential 
risks to your unborn child. 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 



35 

Driving and using machines 
Efient is unlikely to affect your ability to drive or use machines. 
 
Efient contains lactose  
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product. 
 
 
3. How to take Efient  
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure.  
 
The usual dose of Efient is 10 mg per day. You will start the treatment with a single dose of 60 mg. 
If you weigh less than 60 kg or are more than 75 years of age, the dose is 5 mg Efient per day. 
Your doctor will also tell you to take acetylsalicylic acid- (s)he will tell you the exact dose to take 
(usually between 75 mg and 325 mg daily). 
 
You may take Efient with or without food. Take your dose at around the same time every day. Do not 
break or crush the tablet. 
 
It is important that you tell your doctor, dentist and pharmacist, that you are taking Efient. 
 
If you take more Efient than you should 
Contact your doctor or hospital straight away, as you may be at risk of excessive bleeding. You should 
show the doctor your pack of Efient. 
 
If you forget to take Efient 
If you miss your scheduled daily dose, take Efient when you remember. If you forget your dose for an 
entire day, just resume taking Efient at its usual dose the next day. Do not take a double dose to make 
up for a forgotten dose. For the 14, 28, 56 84 and 98 tablet pack sizes, you can check the day on which 
you last took a tablet of Efient by referring to the calendar printed on the blister. 
 
If you stop taking Efient 
Do not stop taking Efient without consulting your doctor; if you stop taking Efient too soon, your risk 
of a heart attack may be higher.  
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects  
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Contact your doctor immediately if you notice any of the following: 

• Sudden numbness or weakness of the arm, leg or face, especially if only on one side of the 
body. 

• Sudden confusion, difficulty speaking or understanding others. 
• Sudden difficulty in walking or loss of balance or co-ordination. 
• Sudden dizziness or sudden severe headache with no known cause. 

All of the above may be signs of a stroke. Stroke is an uncommon side effect of Efient in patients who 
have never had a stroke or transient ischaemic attack (TIA). 



36 

 
Also contact your doctor immediately if you notice any of the following: 

• Fever and bruising under the skin that may appear as red pinpoint dots, with or without 
unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice). 
(see section 2 ‘What you need to know before you take Efient’). 

• A rash, itching, or a swollen face, swollen lips/tongue, or shortness of breath. These may be 
signs of a severe allergic reaction (see section 2 ‘What you need to know before you take 
Efient’). 

 
Tell your doctor promptly if you notice any of the following: 
 

• Blood in your urine. 
• Bleeding from your rectum, blood in your stools or black stools. 
• Uncontrollable bleeding, for example from a cut. 

 
All of the above may be signs of bleeding, the most common side effect with Efient. Although 
uncommon, severe bleeding can be life-threatening. 
 
Common side effects (may affect up to 1 in 10 people) 
• Bleeding in the stomach or bowels 
• Bleeding from a needle puncture site 
• Nose bleeds 
• Skin rash 
• Small red bruises on the skin (ecchymoses) 
• Blood in urine  
• Haematoma (bleeding under the skin at the site of an injection, or into a muscle, causing 

swelling) 
• Low haemoglobin or red blood cell count (anaemia) 
• Bruising 

 
Uncommon side effects (may affect up to 1 in 100 people) 
• Allergic reaction (rash, itching, swollen lips/tongue, or shortness of breath) 
• Spontaneous bleeding from the eye, rectum, gums or in the abdomen around the internal organs 
• Bleeding after surgery 
• Coughing up blood 
• Blood in stools 

 
Rare side effects (may affect up to 1 in 1,000 people) 
• Low blood platelet count 
• Subcutaneous haematoma (bleeding under the skin causing a swelling) 

 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


37 

 
5. How to store Efient 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date, which is stated on the blister and carton after EXP. The 
expiry date refers to the last day of that month. 
 
Store in the original package in order to protect from air and moisture. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Efient contains 
- The active substance is prasugrel. 
 Efient 10 mg: Each tablet contains 10 mg of prasugrel (as hydrochloride). 
 Efient 5 mg: Each tablet contains 5 mg of prasugrel (as hydrochloride). 

 
- The other ingredients are: 

 
Microcrystalline cellulose, mannitol (E421), croscarmellose sodium, hypromellose (E464) 
magnesium stearate, lactose monohydrate, titanium dioxide (E171), triacetin (E1518), iron 
oxide red (10 mg tablets only) (E172), iron oxide yellow (E172) and talc. 

 
What Efient looks like and contents of the pack 
Efient 10 mg: The tablets are beige and double-arrow-shaped, with “10 MG” debossed on one side and 
“4759” on the other. 
 
Efient 5 mg: The tablets are yellow and double-arrow-shaped, with “5 MG” debossed on one side and 
“4760” on the other. 
 
Efient is available in packs of 14, 28, 30, 56, 84, 90 and 98 tablets. 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Daiichi Sankyo Europe GmbH 
Zielstattstrasse 48 
81379 Munich 
Germany 
 
 
Manufacturer: 
Daiichi Sankyo Europe GmbH 
Luitpoldstrasse 1 
85276 Pfaffenhofen 
Germany 
 
Lilly S.A. 
Avda. de la Industria 30 
28108 Alcobendas 
Madrid 
Spain 



38 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
Belgique/België/Belgien 
Daiichi Sankyo Belgium N.V.-S.A 
Tél/Tel: +32-(0) 2 227 18 80 

Lietuva 
Daiichi Sankyo Europe GmbH 
Tel. +49 (0) 89 7808 0 

България 
Алвоген Фарма България ЕООД 
тел. +359 24417136 

Luxembourg/Luxemburg 
Daiichi Sankyo Belgium N.V.-S.A 
Tél/Tel: +32-(0) 2 227 18 80 

Česká republika 
Zentiva, k.s. 
Tel: +420 267 241 111 

Magyarország 
Aramis Pharma Kft 
Tel: +36 1 299 1058 

Danmark 
Daiichi Sankyo Nordics ApS 
Tlf: +45 (0) 33 68 19 99 

Malta 
Daiichi Sankyo Europe GmbH 
Tel: +49 (0) 89 7808 0 

Deutschland 
Daiichi Sankyo Deutschland GmbH 
Tel. +49 (0) 89 7808 0 

Nederland 
Daiichi Sankyo Nederland B.V. 
Tel: +31 (0) 20 4 07 20 72 

Eesti 
Daiichi Sankyo Europe GmbH 
Tel: +49 (0) 89 7808 0 

Norge 
Daiichi Sankyo Nordics ApS 
Tlf: +47 (0) 21 09 38 29 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 

Österreich 
Daiichi Sankyo Austria GmbH 
Tel: +43 (0) 1 485 86 42 0 

España 
Daiichi Sankyo España, S.A. 
Tel: +34 91 539 99 11 

Polska 
Daiichi Sankyo Europe GmbH 
Tel: +49 (0) 89 7808 0  

France 
Daiichi Sankyo France SAS 
Tél: +33 (0) 1 55 62 14 60 

Portugal 
Daiichi Sankyo Portugal, Unip. LDA 
Tel: +351 21 4232010 

Hrvatska 
Daiichi Sankyo Europe GmbH 
Tel: +49 (0) 89 7808 0 

România 
Daiichi Sankyo Europe GmbH 
Tel: +49 (0) 89 7808 0 

Ireland 
Daiichi Sankyo Ireland Ltd  
Tel: +353-(0) 1 489 3000 

Slovenija 
Apta Medica Internacional d.o.o. 
Tel: +386 41 301 360 

Ísland 
Daiichi Sankyo Nordics ApS 
Sími: +45 (0) 33 68 19 99 

Slovenská republika 
Zentiva, a.s. 
Tel: +421 2 3918 3010 

Italia 
Daiichi Sankyo Italia S.p.A. 
Tel: +39-06 85 2551 

Suomi/Finland 
Daiichi Sankyo Nordics ApS 
Puh/Tel: +358 (0) 9 3540 7081 

Κύπρος 
Daiichi Sankyo Europe GmbH 
Τηλ: +49 (0) 89 7808 0 

Sverige 
Daiichi Sankyo Nordics ApS 
Tel: +46 (0) 40 699 2524 

Latvija 
Daiichi Sankyo Europe GmbH 
Tel: +49 (0) 89 7808 0 

United Kingdom 
Daiichi Sankyo UK Ltd 
Tel: +44 (0) 800 028 5122 

 
This leaflet was last revised in {MM/YYYY}. 
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET