Prasugrel Mylan

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Prasugrel Mylan 5 mg film-coated tablets 
Prasugrel Mylan 10 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Prasugrel Mylan 5 mg: 
Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel. 
 
Prasugrel Mylan 10 mg: 
Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel. 
 
Excipient with known effect 
Each tablet contains 0.016 mg of sunset yellow FCF aluminium lake (E110). 
 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
 
Prasugrel Mylan 5 mg: 
Yellow film-coated, capsule shaped, biconvex tablet, of dimensions 8.15 mm × 4.15 mm, debossed 
with ‘PH3’ on one side and ‘M’ on the other side. 
 
Prasugrel Mylan 10 mg: 
Beige film-coated, capsule shaped, biconvex tablet, of dimensions 11.15 mm × 5.15 mm, debossed 
with ‘PH4’ on one side and ‘M’ on the other side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Prasugrel Mylan, 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 
Prasugrel Mylan 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 Prasugrel Mylan should also take ASA daily (75 mg to 325 mg). 
 
In patients with acute coronary syndrome (ACS) who are managed with PCI, premature 
discontinuation of any antiplatelet agent, including Prasugrel Mylan, could result in an increased risk 



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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 Prasugrel Mylan is clinically indicated 
(see sections 4.4 and 5.1). 
 
Patients ≥75 years old 
The use of Prasugrel Mylan 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 
Prasugrel Mylan 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). Prasugrel Mylan is contraindicated in patients with 
severe hepatic impairment (Child Pugh class C). 
 
Paediatric population 
The safety and efficacy of Prasugrel Mylan 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 
 
Prasugrel Mylan is for oral use. It 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). The tablets should not be crushed or broken. 
 
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). 
 
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 prasugrel and ASA showed an increased risk of 
major and minor bleeding according to the TIMI classification system. Therefore, the use of prasugrel 
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). 



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• 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 prasugrel is 
required, platelet transfusion may be appropriate. 
 
The use of Prasugrel Mylan 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, Prasugrel Mylan 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. 
 
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. 
 
Morphine and other opioids 
Reduced prasugrel efficacy has been seen in patients co-administered prasugrel and morphine (see 
section 4.5). 
 
Prasugrel Mylan 5 mg contains sodium 



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This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 
‘sodium-free’. 
 
Prasugrel Mylan 10 mg contains sunset yellow FCF aluminium lake (E110) and sodium 
Sunset yellow FCF aluminium lake is an azo colouring agent, which may cause allergic reactions. 
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 
‘sodium-free’. 
 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Warfarin 
Concomitant administration of Prasugrel Mylan 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 Prasugrel Mylan should 
be co-administered with caution (see section 4.4). 
 
Prasugrel Mylan 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. Prasugrel Mylan 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, prasugrel 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 Prasugrel Mylan 
 
Acetylsalicylic acid 
Prasugrel Mylan 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 Prasugrel Mylan 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. 
 
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, prasugrel 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. 



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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 Prasugrel Mylan 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 Prasugrel Mylan 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). 
 
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, Prasugrel Mylan 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. 
 



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

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 
bleedingf 2.4 1.9 2.3 1.6 2.7 2.6 

 



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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. 
 
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). 
 



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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 

 
a Other standard therapies were used as appropriate. The clinical study protocol provided for all 

patients to receive aspirin and a daily maintenance dose of prasugrel. 
b Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in 

haemoglobin ≥5 g/dL. 
c Life-threatening is a subset of TIMI Major bleeding and includes the types indented below. Patients 

may be counted in more than one row. 
d ICH = intracranial haemorrhage. 
e Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL. 
 
Tabulated list 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   



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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. 
 
4.9 Overdose 
 
Overdose of Prasugrel Mylan 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: Antithrombotic agents, 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. 



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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. 
 
Clinical efficacy and safety 
 
Acute Coronary Syndrome (ACS) 
The phase 3 TRITON study compared 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 GP IIb/IIIa inhibitors, were administered at 
the discretion of the physician. Approximately 40% of patients (in each of the treatment groups) 
received GP IIb/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. 
 



12/43 

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 
Prasugrel 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 GP IIb/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 GP IIb/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. 
 
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 

Non fatal MI 7.0 9.1 0.757 (0.672, 0.853) <0.001 

Non fatal stroke 0.9 0.9 1.016 (0.712, 1.451) 0.930 



13/43 

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 

Non-fatal MI 7.1 9.2 0.761 (0.663,0.873) <0.001 

Non-fatal 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 

Non-fatal MI 6.7 8.8 0.746 (0.588,0.948) 0.016 

Non-fatal 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, 
non-fatal 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 prasugrel 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 prasugrel 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 prasugrel, 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). 
 



14/43 

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 teste 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. Prasugrel was administered without 
regard to food in TRITON. Therefore, prasugrel 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%. 
 
Biotransformation 
Prasugrel is not detected in plasma following oral administration. It is rapidly hydrolysed in 
theintestine 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 



15/43 

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 prasugrel, 
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). 
 
Pharmacokinetic 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/1.73 m²) 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. 
 
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. 
 



16/43 

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, repeat-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. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core 
Microcrystalline cellulose 
Mannitol 
Crospovidone 
Colloidal anhydrous silica 
Magnesium stearate 
 
Film-coating 
Polyvinyl alcohol 
Talc 
Titanium dioxide (E171) 
Glyceryl monocaprylocaprate 
Sodium lauryl sulfate 
Iron oxide yellow (E172) 
Sunset yellow FCF aluminium lake (E110) [only Prasugrel Mylan 10 mg] 
Iron oxide red (E172) [only Prasugrel Mylan 10 mg] 
 
6.2 Incompatibilities 
 
Not applicable. 
 



17/43 

6.3 Shelf life 
 
Blisters: 18 months. 
Bottles: 36 months. 
 
6.4 Special precautions for storage 
 
Prasugrel Mylan 5 mg: 
Do not store above 30°C. Store in the original package in order to protect from moisture. 
 
Prasugrel Mylan 10 mg: 
HDPE bottle: Do not store above 25°C. Store in the original package in order to protect from moisture. 
Blister packs: 
Do not store above 30°C. Store in the original package in order to protect from moisture. 
 
 
6.5 Nature and contents of container 
 
Prasugrel Mylan 5 mg: 
White opaque HDPE bottle closed with white opaque polypropylene screw cap and aluminium 
induction sealing liner wad. Each bottle contains a desiccant labelled “DO NOT EAT” and 28 or 30 
film-coated tablets. 
Each carton contains 1 bottle. 
OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 28, 30, 84 or 98 film-coated 
tablets. 
 
Prasugrel Mylan 10 mg: 
White opaque HDPE bottle closed with white opaque polypropylene screw cap and aluminium 
induction sealing liner wad. Each bottle contains a desiccant labelled “DO NOT EAT” and 28 or 30 
film-coated tablets. 
Each carton contains 1 bottle. 
OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 28, 30, 84, 90 or 98 film-
coated tablets. 
OPA/Aluminium/PE/Desiccant/PE- Aluminium perforated unit dose blister pack containing 30 x 1 or 
90 x 1 film-coated tablets. 
 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
117 Allee des Parcs, 69 800 Saint Priest, France 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
Prasugrel Mylan 5 mg: 
EU/1/18/1273/001 
EU/1/18/1273/003 
EU/1/18/1273/005 
EU/1/18/1273/006 
EU/1/18/1273/007 
EU/1/18/1273/008 



18/43 

 
Prasugrel Mylan 10 mg: 
EU/1/18/1273/002 
EU/1/18/1273/004 
EU/1/18/1273/009 
EU/1/18/1273/010 
EU/1/18/1273/011 
EU/1/18/1273/012 
EU/1/18/1273/013 
EU/1/18/1273/014 
EU/1/18/1273/015 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 16 May 2018 
 
 
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. 
  



19/43 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 
 
 



20/43 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
McDermott Laboratories t/a Gerard Laboratories t/a Mylan Dublin 
35/36 Baldoyle Industrial Estate 
Grange Road 
Dublin 13 
Ireland 
 
Mylan Hungary Kft./Mylan Hungary Ltd. 
Mylan utca 1 
2900 Komarom 
Hungary 
 
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. 

 
• 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. 
 



21/43 

The educational material should include: 
• A copy of the SPC 
• Emphasis that: 

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

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

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



22/43 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 
 
  



23/43 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 
 



24/43 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE 
PACKAGING 
 
BOTTLE CARTON AND BOTTLE LABEL OF 5 MG FILM-COATED TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Prasugrel Mylan 5 mg film-coated tablets 
prasugrel 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel. 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
28 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 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. Store in the original package in order to protect from moisture. 
 



25/43 

 
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 
 
Mylan S.A.S. 
117 Allee des Parcs, 69 800 Saint Priest, France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/18/1273/001 
EU/1/18/1273/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
prasugrel Mylan 5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
carton only: 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
carton only: 
PC 
SN 
NN 
 
  



26/43 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE 
PACKAGING 
 
BLISTER CARTON OF 5 MG FILM-COATED TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Prasugrel Mylan 5 mg film-coated tablets 
prasugrel 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel. 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
28 film-coated tablets 
30 film-coated tablets 
84 film-coated tablets 
98 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 
 
 



27/43 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. Store in the original package in order to protect from 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 
 
Mylan S.A.S. 
117 Allee des Parcs, 69 800 Saint Priest, France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/18/1273/005 
EU/1/18/1273/006 
EU/1/18/1273/007 
EU/1/18/1273/008 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
prasugrel Mylan 5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
carton only: 
2D barcode carrying the unique identifier included. 
 
 



28/43 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
carton only: 
PC 
SN 
NN 
 
  



29/43 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER CARTON OF 5 MG FILM-COATED TABLETS 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Prasugrel Mylan 5 mg film-coated tablets 
Prasugrel 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 

5. OTHER 
 
 
 



30/43 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE CARTON AND BOTTLE LABEL OF 10 MG FILM-COATED TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Prasugrel Mylan 10 mg film-coated tablets 
prasugrel 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sunset yellow FCF aluminium lake (E110). See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
28 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 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. Store in the original package in order to protect from moisture. 



31/43 

 
 
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 
 
Mylan S.A.S. 
117 Allee des Parcs, 69 800 Saint Priest, France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/18/1273/002 
EU/1/18/1273/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
prasugrel Mylan 10 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
carton only: 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
carton only: 
PC 
SN 
NN 
 
  



32/43 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BLISTER CARTON OF 10 MG FILM-COATED TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Prasugrel Mylan 10 mg film-coated tablets 
prasugrel 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sunset yellow FCF aluminium lake (E110). See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
28 film-coated tablets 
30 film-coated tablets 
30 x 1 film-coated tablets 
84 film-coated tablets 
90 film-coated tablets 
90 x 1 film-coated tablets 
98 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 
 
 
 



33/43 

8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. Store in the original package in order to protect from 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 
 
Mylan S.A.S. 
117 Allee des Parcs, 69 800 Saint Priest, France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/18/1273/009 
EU/1/18/1273/010 
EU/1/18/1273/011 
EU/1/18/1273/012 
EU/1/18/1273/013 
EU/1/18/1273/014 
EU/1/18/1273/015 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
prasugrel Mylan 10 mg 
 
 



34/43 

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



35/43 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER CARTON OF 10 MG FILM-COATED TABLETS 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Prasugrel Mylan 10 mg film-coated tablets 
Prasugrel 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 

5. OTHER 
 
 
 
  



36/43 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 



37/43 

Package leaflet: Information for the user 
 

Prasugrel Mylan 5 mg film-coated tablets 
Prasugrel Mylan 10 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 Prasugrel Mylan is and what it is used for 
2. What you need to know before you take Prasugrel Mylan 
3. How to take Prasugrel Mylan 
4. Possible side effects 
5. How to store Prasugrel Mylan 
6. Contents of the pack and other information 
 
 
1. What Prasugrel Mylan is and what it is used for 
 
Prasugrel Mylan, which contains the active substance prasugrel, belongs to a group of medicines 
called antiplatelet 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). 
 
Prasugrel Mylan inhibits the clumping of platelets and so reduces the chance of a blood clot forming. 
 
You have been prescribed Prasugrel Mylan 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. Prasugrel Mylan 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 antiplatelet agent. 
 
 
2. What you need to know before you take Prasugrel Mylan 
 
Do not take Prasugrel Mylan 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. 

– have a medical condition that is currently causing bleeding, such as bleeding from your stomach 
or intestines. 

– have ever had a stroke or a transient ischaemic attack (TIA). 
– have severe liver disease. 
 



38/43 

Warnings and precautions 
 
• Before you take Prasugrel Mylan: 
 
Talk to your doctor before taking Prasugrel Mylan. 
 
You should tell your doctor before taking Prasugrel Mylan 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 Prasugrel Mylan 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 Prasugrel Mylan 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 Prasugrel Mylan. If you then take 
Prasugrel Mylan 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 Prasugrel Mylan: 
 
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 
Prasugrel Mylan should not be used in children and adolescents below 18 years of age. 
 
Other medicines and Prasugrel Mylan 
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 Prasugrel Mylan 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 Prasugrel Mylan if your doctor tells you that you can. 
 
Pregnancy and breast-feeding 
If you are pregant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine. 
 



39/43 

Tell your doctor if you become pregnant or are trying to become pregnant while you are taking 
Prasugrel Mylan. You should use Prasugrel Mylan only after discussing with your doctor the potential 
benefits and any potential risks to your unborn child. 
 
If you are breast-feeding, ask your doctor or pharmacist for advice before taking any medicine. 
 
Driving and using machines 
Prasugrel Mylan is unlikely to affect your ability to drive or use machines. 
 
Prasugrel 5 mg Mylan contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’.  
 
Prasugrel Mylan 10 mg contains sunset yellow FCF aluminium lake (E110) and sodium 
Sunset yellow FCF aluminium lake is a colouring agent, which may cause allergic reactions. 
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’.  
 
 
3. How to take Prasugrel Mylan 
 
Always take Prasugrel Mylan exactly as your doctor has told you. You should check with your doctor 
or pharmacist if you are not sure. 
 
The usual dose of prasugrel 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 Prasugrel Mylan per 
day. Your doctor will also tell you to take acetylsalicylic acid, and (s)he will tell you the exact dose to 
take (usually between 75 mg and 325 mg daily). 
 
You may take Prasugrel Mylan 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 Prasugrel Mylan. 
 
If you take more Prasugrel Mylan 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 Prasugrel Mylan. 
 
If you forget to take Prasugrel Mylan 
If you miss your scheduled daily dose, take Prasugrel Mylan when you remember. If you forget your 
dose for an entire day, just resume taking Prasugrel Mylan at its usual dose the next day. Do not take 
two doses in one day. 
 
If you stop taking Prasugrel Mylan 
Do not stop taking Prasugrel Mylan without consulting your doctor; if you stop taking Prasugrel 
Mylan 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. 
 



40/43 

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 Prasugrel Mylan in 
patients who have never had a stroke or transient ischaemic attack (TIA). 
 
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 Prasugrel Mylan’) 

• 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 
Prasugrel Mylan’) 

 
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 Prasugrel Mylan. 
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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please 
tell you doctor or pharmacist. 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. 
 



41/43 

 
5. How to store Prasugrel Mylan 
 
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 bottle and carton after EXP. The 
expiry date refers to the last day of that month. 
 
Prasugrel Mylan 5 mg: Do not store above 30°C. Store in the original package in order to protect from 
moisture. 
 
Prasugrel Mylan 10 mg: Do not store above 25°C. Store in the original package in order to protect 
from moisture. 
Blister packs only: Do not store above 30°C. Store in the original package in order to protect from 
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 to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Prasugrel Mylan contains 
– The active substance is prasugrel. 
Prasugrel Mylan 5 mg: Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel. 
Prasugrel Mylan 10 mg: Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel. 
 
– The other ingredients are: 
Prasugrel Mylan 5 mg: microcrystalline cellulose, mannitol, crospovidone, silica colloidal anhydrous, 
magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), glyceryl monocaprylocaprate, 
sodium lauryl sulfate, iron oxide yellow (E172). 
 
Prasugrel Mylan 10 mg: microcrystalline cellulose, mannitol, crospovidone, silica colloidal anhydrous, 
magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), glyceryl monocaprylocaprate, 
sodium lauryl sulfate, iron oxide yellow (E172), sunset yellow FCF aluminium lake (E110) (see 
section 2, ‘Prasugrel Mylan 10 mg contains sunset yellow FCF aluminium lake’), iron oxide red 
(E172). 
 
What Prasugrel Mylan looks like and contents of the pack 
 
Prasugrel Mylan 10 mg film-coated tablets are beige film-coated, capsule shaped, biconvex tablets, of 
dimensions 11.15 mm × 5.15 mm, debossed with ‘PH4’ on one side of the tablet and ‘M’ on the other 
side. 
This medicine is available in plastic bottles containing a desiccant and 28 or 30 film-coated tablets and 
in blister packs containing 28, 30, 84, 90, 98 and in perforated blister packs containing 30 x 1 and 90 x 
1 film-coated tablets. 
 
Prasugrel Mylan 5 mg film-coated tablets are yellow film-coated, capsule shaped, biconvex tablets, of 
dimensions 8.15 mm × 4.15 mm, debossed with ‘PH3’ on one side of the tablet and ‘M’ on the other 
side. 
This medicine is available in plastic bottles containing a desiccant and 28 or 30 film-coated tablets and  
in blister packs containing 28, 30, 84 or 98 film-coated tablets. 
 
Do not eat or remove the desiccant contained in the bottle 
Not all pack sizes may be marketed. 
 



42/43 

Marketing Authorisation Holder 
Mylan S.A.S. 
117 Allee des Parcs, 69 800 Saint Priest, France 
 
Manufacturer 
Mylan Hungary Kft 
Mylan utca 1, Komárom, 2900, Hungary 
 
McDermott Laboratories Limited t/a Gerard Laboratories 
35/36 Baldoyle Industrial Estate, Grange State, Dublin 13, Ireland 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Mylan bvba/sprl 
Tél/Tel: + 32 (0)2 658 61 00 
 

Lietuva 
BGP Products UAB 
Tel: +370 5 205 1288 
 

България 
Майлан ЕООД 
Тел: +359 2 44 55 400 
 

Luxembourg/Luxemburg 
Mylan bvba/sprl 
Tel: + 32 (0)2 658 61 00 
(Belgique/Belgien) 
 

Česká republika 
Mylan Healthcare CZ s.r.o. 
Tel: + 420 222 004 400 
 

Magyarország 
Mylan EPD Kft 
Tel: + 36 1 465 2100 
 

Danmark 
Mylan Denmark ApS 
Tel: +45 28 11 69 32 

Malta 
V.J. Salomone Pharma Ltd 
Tel: + 356 21 22 01 74 
 

Deutschland 
Mylan Healthcare GmbH 
Tel: +49 800 0700 800 
 

Nederland 
Mylan BV 
Tel: +31 (0)20 426 3300 
 

Eesti 
BGP Products Switzerland GmbH 
Eesti filiaal 
Tel: + 372 6363 052 
 

Norge 
Mylan Healthcare Norge AS 
Tel: + 47 66 75 33 00 

Ελλάδα 
Generics Pharma Hellas ΕΠΕ 
Τηλ: +30 210 993 6410 
 

Österreich 
Arcana Arzneimittel GmbH 
Tel: +43 1 416 2418 
 

España 
Mylan Pharmaceuticals, S.L. 
Tel: + 34 900 102 712 
 

Polska 
Mylan Healthcare Sp. z o.o. 
Tel: + 48 22 546 64 00 
 

France 
Mylan S.A.S 
Tél : +33 4 37 25 75 00 
 

Portugal 
Mylan, Lda. 
Tel: + 351 21 412 72 56 
 

Hrvatska 
Mylan Hrvatska d.o.o. 
Tel: +385 1 23 50 599 
 

România 
BGP Products SRL 
Tel: + 40 372 579 000 
 



43/43 

Ireland 
Mylan Ireland Limited 
Tel: +353 (0) 87 1694982 
 

Slovenija 
Mylan Healthcare d.o.o. 
Tel: + 386 1 23 63 180 
 

Ísland 
Icepharma hf 
Tel: +354 540 8000 
 

Slovenská republika 
Mylan s.r.o. 
Tel: +421 2 32 199 100 
 

Italia 
Mylan Italia S.r.l. 
Tel: + 39 02 612 46921 
 

Suomi/Finland 
Mylan Finland OY 
Puh/Tel: + 358 20 720 9555 
 

Κύπρος 
Varnavas Hadjipanayis Ltd   
Τηλ: +357 2220 7700 

Sverige 
Mylan AB 
Tel: + 46 855 522 750 
 

Latvija 
 Mylan Healthcare SIA 
Tel: +371 676 055 80 
 

United Kingdom 
Generics [UK] Ltd 
Tel: +44 1707 853000 
 

 
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. 
 


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