Prasugrel G.L. Pharma 5 mg

What Is Prasugrel G.L. Pharma and What Is It Used For?

Prasugrel G.L. Pharma contains the active substance prasugrel, which belongs to a group of medicines called antiplatelet agents – more specifically, the thienopyridine class of P2Y12 receptor antagonists. Platelets are very small cells in the blood that play an essential role in the formation of blood clots. When a blood vessel is injured, platelets stick together to plug the wound and stop bleeding. While this process is protective in normal circumstances, blood clots that form inside diseased coronary arteries or on the surface of an implanted stent can completely block blood flow to the heart and trigger a life-threatening cardiovascular event.

When a clot forms inside a coronary artery, it can cause a myocardial infarction (heart attack). Clots can also cause unstable angina (severe chest pain at rest from reduced coronary blood flow) or, if a fragment travels to the brain, an ischaemic stroke. After a heart attack or unstable angina, many patients are treated with percutaneous coronary intervention (PCI), a procedure in which the blocked artery is reopened and one or more stents (small mesh tubes) are placed to keep the artery open. The stent surface, however, remains a target for new clot formation until it becomes covered by the artery's own lining – a process called endothelialisation. During this period, dual antiplatelet therapy is essential to prevent stent thrombosis.

Prasugrel works by irreversibly blocking the P2Y12 receptor on the surface of platelets. This receptor normally responds to adenosine diphosphate (ADP), a chemical released from damaged tissue and from already-activated platelets that amplifies the clotting cascade. By irreversibly disabling P2Y12, prasugrel prevents new platelets from being recruited and activated, which substantially reduces the chance of a pathological clot forming in a stented or atherosclerotic coronary artery. Because the binding is irreversible, the antiplatelet effect lasts for the lifetime of the platelet (approximately 7–10 days), which is why prasugrel must be stopped well in advance of any planned major surgery.

Prasugrel G.L. Pharma is prescribed to patients who have been treated with PCI for an acute coronary syndrome – including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or unstable angina – and is always taken in combination with low-dose aspirin (acetylsalicylic acid). This combination, known as dual antiplatelet therapy (DAPT), is the cornerstone of secondary prevention after PCI and is recommended by all major cardiology guidelines, including those of the European Society of Cardiology (ESC) and the American Heart Association/American College of Cardiology (AHA/ACC).

The clinical evidence for prasugrel is anchored in the landmark TRITON-TIMI 38 trial (Wiviott et al., New England Journal of Medicine, 2007), which randomised more than 13,600 patients with acute coronary syndromes undergoing PCI to either prasugrel or clopidogrel on top of aspirin. Prasugrel reduced the composite endpoint of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke by 19% relative to clopidogrel, with a particularly striking reduction in stent thrombosis (52% relative reduction). However, the trial also identified subgroups in which the benefit was offset or outweighed by an increased bleeding risk – notably patients aged 75 years or older, those weighing less than 60 kg, and those with a history of stroke or TIA. This trial defined the modern dosing strategy and the contraindications that continue to govern prasugrel use today.

Prasugrel G.L. Pharma is a generic medicine, meaning it contains the same active substance, in the same dose and formulation, as the originator product (Efient/Effient). It has demonstrated bioequivalence to the reference product and is therapeutically interchangeable. Other generic prasugrel products available internationally include Prasugrel Krka, Prasugrel Viatris and Prasugrel Mylan.

What Should You Know Before Taking Prasugrel G.L. Pharma?

Contraindications

There are several situations in which Prasugrel G.L. Pharma must not be used. Recognising these contraindications is essential for safe treatment, and your doctor will check them carefully before prescribing. Do not take Prasugrel G.L. Pharma if any of the following apply:

• You are allergic to prasugrel or any of the other ingredients in this medicine. An allergic reaction may include skin rash, itching, swelling of the face, lips or tongue, or shortness of breath. Severe allergic reactions (anaphylaxis) require immediate emergency medical attention.
• You have active pathological bleeding, such as bleeding from a peptic ulcer or active intracranial haemorrhage. Because prasugrel inhibits the body's ability to form clots, it can dramatically worsen any existing bleeding source.
• You have ever had a stroke or transient ischaemic attack (TIA). This is one of the most important contraindications. The TRITON-TIMI 38 trial identified that patients with prior cerebrovascular events suffered a net clinical harm from prasugrel due to a markedly increased risk of intracranial bleeding. In this group, an alternative P2Y12 inhibitor (ticagrelor or clopidogrel) is used instead.
• You have severe hepatic (liver) impairment, classified as Child-Pugh class C. Severe liver disease is itself associated with a bleeding tendency, and there is insufficient data to support safe use of prasugrel in this population.

Warnings and Precautions

Before starting treatment, discuss your full medical history with your doctor or pharmacist. The 5 mg dose of Prasugrel G.L. Pharma is itself a precautionary measure for patients at higher bleeding risk, but additional caution is needed in the following situations.

Increased risk of bleeding: Several factors raise your bleeding risk while taking prasugrel. Your doctor will weigh the benefit of preventing thrombotic events against the bleeding risk if you:

• Are 75 years of age or older. Elderly patients have thinner blood vessels, more comorbidities, and a higher absolute risk of intracranial and gastrointestinal bleeding. The 5 mg maintenance dose – which is the only strength of Prasugrel G.L. Pharma – is the recommended dose specifically because of this risk.
• Weigh less than 60 kg. Low body weight increases drug exposure relative to plasma volume. The 5 mg daily dose is similarly recommended for this group.
• Have had a recent serious injury or have undergone surgery within the past few weeks, including dental procedures, eye surgery or biopsies.
• Have a history of gastrointestinal bleeding, peptic ulcer disease or oesophagitis. Co-prescription of a proton pump inhibitor is often appropriate to reduce gastrointestinal bleeding risk.
• Have moderate kidney or liver impairment (not classified as severe). No dose adjustment is required, but bleeding risk may be slightly increased.
• Are taking other medicines that affect bleeding, including anticoagulants (warfarin, DOACs), NSAIDs, SSRIs and SNRIs (see the drug interactions section below).

Planned surgery: If you are scheduled for any surgery or invasive procedure in the next seven days, tell the surgeon or dentist you are taking Prasugrel G.L. Pharma. The ESC recommends discontinuing prasugrel at least 7 days before elective surgery to allow new, unaffected platelets to be produced. For non-elective or urgent procedures, platelet transfusion may be considered to restore haemostasis. Never stop prasugrel on your own – the decision must always involve your cardiologist, because the risk of stent thrombosis must be balanced against bleeding risk.

Previous hypersensitivity to thienopyridines: If you have previously had an allergic reaction (rash, angio-oedema, anaphylaxis) to clopidogrel or ticlopidine, inform your doctor. Cross-reactivity is uncommon but possible, and an alternative P2Y12 inhibitor (such as ticagrelor, which has a different chemical structure) may be safer.

Pregnancy, Breastfeeding and Fertility

If you are pregnant, breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. There are no adequate, controlled studies of prasugrel in pregnant women. Animal studies have not shown direct harmful effects on pregnancy or development, but as a precaution prasugrel should only be used during pregnancy if the potential benefit clearly outweighs the potential risk. The clinical scenarios in which prasugrel is prescribed (post-PCI for acute coronary syndrome) are extremely uncommon during pregnancy.

It is not known whether prasugrel or its metabolites are excreted in human breast milk. Animal studies have shown excretion of prasugrel-related compounds in milk. A decision should be made either to stop breastfeeding or to stop the medicine, taking into account the importance of treatment for the mother. There are no known effects of prasugrel on human male or female fertility.

Driving and Operating Machinery

Prasugrel is not expected to affect your ability to drive or use machines. However, if you experience dizziness, lightheadedness or other symptoms that could impair alertness – particularly during the first few days of treatment – do not drive or operate heavy machinery until the symptoms have resolved.

How Does Prasugrel G.L. Pharma Interact with Other Drugs?

Drug interactions are an important consideration with any antiplatelet therapy. Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take in the near future – including prescription products, over-the-counter painkillers, herbal remedies and dietary supplements. Some commonly used medications can either substantially increase your risk of bleeding or interfere with prasugrel's antiplatelet effect.

Major Interactions

The following interactions are clinically significant and require medical supervision, dose adjustment or avoidance:

Minor Interactions and Co-Prescription Notes

Many medicines used in cardiovascular disease are routinely co-prescribed with prasugrel without clinically meaningful interactions:

• Proton pump inhibitors (PPIs) – omeprazole, pantoprazole, esomeprazole. Unlike clopidogrel, prasugrel's metabolic activation is not meaningfully affected by CYP2C19 inhibition. Co-administration with a PPI is therefore safe and is often recommended to reduce gastrointestinal bleeding risk.
• Statins – atorvastatin, rosuvastatin, simvastatin. No clinically significant interaction. Statins are virtually always co-prescribed after PCI for plaque stabilisation and LDL reduction.
• ACE inhibitors and ARBs – ramipril, perindopril, losartan, valsartan. No significant interaction. Standard component of post-MI therapy in patients with reduced left-ventricular function.
• Beta-blockers – bisoprolol, metoprolol, carvedilol, nebivolol. No clinically relevant interaction. Routinely used together as part of guideline-directed medical therapy.
• Mineralocorticoid receptor antagonists – spironolactone, eplerenone. No significant interaction.
• Heparins – unfractionated and low-molecular-weight heparins are routinely co-administered during the acute PCI period under close monitoring.

Only take medicines together with Prasugrel G.L. Pharma that your doctor has approved. Even apparently harmless over-the-counter painkillers (especially ibuprofen, naproxen and aspirin-containing combination products) and herbal remedies (such as ginkgo biloba, garlic supplements, fish oil and St John's wort) can affect bleeding risk or drug exposure. Always carry an up-to-date medication list and present it to any new healthcare provider, including dentists, before they prescribe new treatment or perform a procedure.

What Is the Correct Dosage of Prasugrel G.L. Pharma?

Always take Prasugrel G.L. Pharma exactly as your doctor or pharmacist has told you. Do not change the dose or stop the medicine without consulting your doctor first. Prasugrel is always given as part of dual antiplatelet therapy (DAPT) in combination with low-dose aspirin (acetylsalicylic acid).

Adults (Standard Dosing)

The full prasugrel regimen consists of two components: a single high-dose loading dose and a daily maintenance dose. The loading dose – 60 mg given as a one-off – is administered in the hospital setting at the time of PCI to achieve rapid, near-maximal platelet inhibition within 1–2 hours. The maintenance dose, taken daily for the prescribed duration, sustains that inhibition.

Because Prasugrel G.L. Pharma is only marketed in the 5 mg strength, it is intended specifically for the elderly and low-body-weight maintenance regimens. Standard adult patients receiving the 10 mg maintenance dose will use a different prasugrel-containing product. The 60 mg loading dose itself is typically administered in hospital using twelve 5 mg tablets, six 10 mg tablets, or whichever strength the hospital pharmacy stocks – the brand name does not influence the loading-dose strategy.

Children and Adolescents

Prasugrel G.L. Pharma must not be used in children and adolescents under 18 years of age. The safety and efficacy of prasugrel have not been established in this population, and acute coronary syndromes requiring PCI are exceptionally rare in paediatrics. In the few paediatric conditions associated with arterial thrombosis (such as Kawasaki disease), other therapies are preferred.

Elderly Patients (75 Years and Older)

Patients aged 75 or older are the principal target population for the 5 mg strength. The TRITON-TIMI 38 trial showed that elderly patients had a higher rate of major and fatal bleeding on the standard 10 mg dose, including a worrying signal of intracranial haemorrhage. Subsequent pharmacokinetic and pharmacodynamic studies (including the GENERATIONS study) showed that 5 mg once daily in elderly patients produces platelet inhibition similar to 10 mg in younger adults, while substantially reducing bleeding risk. The 60 mg loading dose remains unchanged.

The decision to start prasugrel in patients aged 75 or older should always include a careful assessment of frailty, cognitive function, fall risk, and competing causes of bleeding. In some elderly patients, an alternative P2Y12 inhibitor (such as clopidogrel) may be preferred.

Renal and Hepatic Impairment

Renal impairment: No dose adjustment is required for any degree of renal impairment, including end-stage renal disease. However, experience in patients on dialysis is limited, and bleeding risk may be higher.

Hepatic impairment: No dose adjustment is required for mild or moderate hepatic impairment (Child-Pugh class A or B). Prasugrel is contraindicated in severe hepatic impairment (Child-Pugh class C).

Missed Dose

Overdose

Stopping Treatment

Do not stop taking Prasugrel G.L. Pharma without first discussing it with your doctor. Premature discontinuation of antiplatelet therapy – particularly within the first 12 months after stent implantation – substantially increases the risk of stent thrombosis, an often catastrophic event with mortality of around 30–40%. If you need to stop prasugrel for surgery, dental work, suspected bleeding, or any other reason, the decision must be made together with your cardiologist, who will weigh the timing carefully and may consider bridging strategies in selected high-risk cases.

Make sure all healthcare providers you encounter – including emergency-department clinicians, dentists, optometrists and pharmacists – know that you are taking prasugrel. Carrying a wallet card or wearing a medical identification bracelet during the high-risk first year after PCI can be helpful in unexpected situations.

What Are the Side Effects of Prasugrel G.L. Pharma?

Like all medicines, Prasugrel G.L. Pharma can cause side effects, although not everyone gets them. Because prasugrel works by reducing platelet activity, bleeding is by far the most frequently reported adverse event. Most bleeding is mild or moderate, but serious and occasionally life-threatening haemorrhage can occur. Side effects are most likely during the first months of therapy and tend to be more frequent in the patient groups for whom the 5 mg dose was developed (elderly, low body weight).

Side Effects by Frequency

The following side effects are listed using standard MedDRA frequency categories from the European Medicines Agency Summary of Product Characteristics. No "very common" (greater than 1 in 10) effects are reported separately for prasugrel beyond those listed under "common".

Understanding Your Bleeding Risk on the 5 mg Dose

The 5 mg maintenance dose was specifically developed to reduce bleeding while preserving anti-ischaemic protection. In the GENERATIONS pharmacodynamic study, elderly patients on prasugrel 5 mg achieved platelet inhibition equivalent to younger adults on 10 mg. In real-world registries and follow-up studies, bleeding rates with the 5 mg dose are substantially lower than with the 10 mg dose in the same population, while ischaemic event rates remain low.

In the original TRITON-TIMI 38 trial (which used 10 mg in all patients), major bleeding occurred in approximately 2.4% of prasugrel-treated patients versus 1.8% on clopidogrel. Heart attack reduction was substantial (7.3% vs 9.5%), giving an overall net clinical benefit in most patient subgroups. By using the 5 mg dose, modern practice aims to retain that ischaemic benefit in vulnerable populations while bringing bleeding rates closer to those seen with clopidogrel.

If you notice any unusual or prolonged bleeding while on Prasugrel G.L. Pharma – including prolonged bleeding from a small cut, gum bleeding when brushing teeth, heavier-than-normal menstrual periods, frequent nosebleeds or unexplained bruises – tell your doctor. Most minor events can be managed with local measures, gastroprotection, or temporary dose modification, but early reporting is important to catch potentially serious bleeding before it progresses.

Reporting Side Effects

Reporting suspected side effects after a medicine has been authorised is important. It allows continuous monitoring of the benefit–risk balance. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to their national pharmacovigilance authority – for example the MHRA Yellow Card Scheme in the United Kingdom, the FDA MedWatch programme in the United States, or the relevant EU national competent authority listed on the EMA website.

How Should You Store Prasugrel G.L. Pharma?

Correct storage of Prasugrel G.L. Pharma ensures that the tablets remain effective and safe throughout their shelf life. Follow these storage instructions carefully:

• Temperature: Store at no more than 30°C (86°F). Do not refrigerate or freeze.
• Packaging: Keep the tablets in the original blister packaging to protect them from moisture and light. Prasugrel is moisture-sensitive, and exposure to humidity can degrade the active ingredient.
• Children: Keep this medicine out of the sight and reach of children. Accidental ingestion by a child can cause severe bleeding and is a medical emergency.
• Expiry date: Do not use Prasugrel G.L. Pharma after the expiry date printed on the carton and blister after "EXP". The expiry date refers to the last day of the stated month.
• Disposal: Do not throw any medicines into wastewater or household rubbish. Return unused or expired tablets to your community pharmacy or local medicines take-back scheme. These measures help protect the environment and prevent accidental ingestion by others.

What Does Prasugrel G.L. Pharma Contain?

Active Substance

Each film-coated tablet contains 5 mg of prasugrel, present as prasugrel hydrochloride. Prasugrel is a thienopyridine prodrug that is rapidly hydrolysed in the intestine and converted in the liver (predominantly by CYP3A4 and CYP2B6, with minor contributions from CYP2C19 and CYP2C9) to its active thiol metabolite. This active metabolite then irreversibly binds to and inactivates the P2Y12 receptor on the platelet surface for the lifetime of the platelet (approximately 7–10 days).

Other Ingredients (Excipients)

Tablet core: Microcrystalline cellulose, mannitol (E421), low-substituted hydroxypropylcellulose, hypromellose, croscarmellose sodium, magnesium stearate.

Film coating: Hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin, yellow iron oxide (E172) (responsible for the characteristic yellow tint of the 5 mg tablet).

Patients with rare hereditary intolerance to galactose, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Appearance and Pack Sizes

5 mg tablets: Pale brownish-yellow, oval, biconvex, film-coated tablets. Available in aluminium/aluminium blister packs typically containing 14, 28, 30, 56, 84, 90 or 100 tablets.

Not all pack sizes may be marketed in all countries.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria.

Manufacturer: G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria.

Prasugrel G.L. Pharma is a generic medicine that contains the same active substance as the originator brand Efient/Effient and is therapeutically interchangeable with other authorised prasugrel products such as Prasugrel Krka, Prasugrel Mylan and Prasugrel Viatris.

References

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2. Byrne RA, Rossello X, Coughlan JJ, et al. 2023 ESC Guidelines for the management of acute coronary syndromes. European Heart Journal. 2023;44(38):3720–3826.
3. Levine GN, Bates ER, Bittl JA, et al. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease. Journal of the American College of Cardiology. 2016;68(10):1082–1115.
4. European Medicines Agency (EMA). Prasugrel – Summary of Product Characteristics. Available at: ema.europa.eu
5. National Institute for Health and Care Excellence (NICE). Prasugrel with percutaneous coronary intervention for treating acute coronary syndromes. Technology appraisal guidance [TA317]. 2014.
6. Valgimigli M, Bueno H, Byrne RA, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease. European Heart Journal. 2018;39(3):213–260.
7. Erlinge D, Varenhorst C, Braun OO, et al. Patients with poor responsiveness to thienopyridine treatment or with diabetes have lower levels of circulating active metabolite, but their platelets respond normally to active metabolite added ex vivo. Journal of the American College of Cardiology. 2008;52(24):1968–1977.
8. Erlinge D, Gurbel PA, James S, et al. Prasugrel 5 mg in the very elderly attenuates platelet inhibition but maintains noninferiority to prasugrel 10 mg in non-elderly patients: the GENERATIONS trial, a pharmacodynamic and pharmacokinetic study in stable coronary artery disease patients. Journal of the American College of Cardiology. 2013;62(7):577–583.
9. Roe MT, Armstrong PW, Fox KAA, et al. Prasugrel versus Clopidogrel for Acute Coronary Syndromes without Revascularization (TRILOGY ACS). New England Journal of Medicine. 2012;367(14):1297–1309.
10. World Health Organization (WHO). Model List of Essential Medicines – 23rd list, 2023. Geneva: WHO; 2023.
11. British National Formulary (BNF). Prasugrel monograph. London: Joint Formulary Committee. Accessed via bnf.nice.org.uk.

Medical Editorial Team

This article has been written and reviewed by the iMedic Medical Editorial Team, comprising board-certified physicians specialising in cardiology, clinical pharmacology and internal medicine. Our content follows the GRADE evidence framework and is based exclusively on peer-reviewed research and current international clinical guidelines.

Evidence Level: This article is based on Level 1A evidence, including systematic reviews, meta-analyses and landmark randomised controlled trials (TRITON-TIMI 38, GENERATIONS, TRILOGY ACS). Last reviewed: May 10, 2026.