Prasugrel EQL Pharma: Uses, Dosage & Side Effects

What Is Prasugrel EQL Pharma and What Is It Used For?

Prasugrel EQL Pharma contains the active substance prasugrel, a third-generation thienopyridine antiplatelet agent developed by Daiichi Sankyo and Eli Lilly and originally marketed under the brand name Efient (Effient in the United States). It belongs to the class of P2Y12 receptor antagonists, which are medications that prevent blood clot formation (thrombosis) by inhibiting the activation and aggregation of platelets. Platelets are small, disc-shaped blood cells that play a central role in normal haemostasis (stopping bleeding from injured vessels), but they can also contribute to the formation of dangerous arterial blood clots, particularly at sites where atherosclerotic plaques have ruptured or where metallic coronary stents have been placed.

As a generic medicinal product, Prasugrel EQL Pharma is manufactured to be pharmaceutically and therapeutically equivalent to the reference product Efient. In accordance with the European Medicines Agency's Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1), generic medicines must demonstrate that they deliver the same amount of active substance to the bloodstream over the same period of time as the originator. This is established through bioequivalence studies showing that the 90% confidence intervals for the ratios of the test and reference product for the pharmacokinetic parameters (AUC, Cmax) fall within the conventional acceptance range of 80–125%. Once approved, a generic medicine can be prescribed interchangeably with the originator product and is expected to produce the same clinical response.

Prasugrel itself is a prodrug, meaning it must undergo metabolic conversion in the body before becoming pharmacologically active. After oral ingestion, prasugrel is rapidly absorbed from the gastrointestinal tract and is hydrolysed by intestinal and plasma esterases to a thiolactone intermediate. This intermediate is then metabolised in the liver to the active thiol metabolite (designated R-138727), primarily by cytochrome P450 enzymes CYP3A4 and CYP2B6, with smaller contributions from CYP2C9 and CYP2C19. Unlike clopidogrel, which requires a two-step hepatic conversion heavily dependent on CYP2C19, prasugrel's more efficient activation pathway produces faster onset, greater maximum platelet inhibition, and significantly less inter-individual variability in antiplatelet response. Peak plasma concentrations of the active metabolite are reached approximately 30 minutes after dosing, with a terminal elimination half-life of around 7 hours.

The active metabolite of prasugrel binds irreversibly to the P2Y12 subtype of adenosine diphosphate (ADP) receptor on the platelet surface. ADP is a potent platelet agonist released from activated platelets and damaged vascular tissue that amplifies platelet activation and drives the formation of stable platelet aggregates. By blocking the P2Y12 receptor, prasugrel prevents ADP from triggering the intracellular signalling cascade that leads to conformational change of the glycoprotein IIb/IIIa (GPIIb/IIIa) receptor on the platelet surface. Activated GPIIb/IIIa binds fibrinogen and von Willebrand factor, cross-linking adjacent platelets to form a platelet plug. Because prasugrel binding is irreversible, its antiplatelet effect lasts for the entire remaining lifespan of each affected platelet (approximately 7 to 10 days), meaning that platelet function recovery depends on the generation of new platelets in the bone marrow.

Prasugrel EQL Pharma is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI). Acute coronary syndrome is a clinical umbrella term encompassing a spectrum of conditions caused by a sudden reduction or cessation of blood flow to the heart muscle:

• Unstable angina (UA): Chest pain or discomfort that occurs at rest or with minimal exertion, typically caused by partial, intermittent obstruction of a coronary artery by an unstable atherosclerotic plaque with superimposed platelet-rich thrombus.
• Non-ST-elevation myocardial infarction (NSTEMI): A heart attack characterised by elevation of cardiac biomarkers (troponin) without persistent ST-segment elevation on the electrocardiogram (ECG), indicating partial or intermittent coronary artery occlusion with myocardial necrosis.
• ST-elevation myocardial infarction (STEMI): A heart attack with persistent ST-segment elevation on the ECG, indicating complete occlusion of a coronary artery and requiring urgent revascularisation, most often by primary PCI.

In all three presentations, PCI (coronary angioplasty with stent placement) is frequently performed to restore blood flow through the blocked or severely narrowed coronary artery. During PCI, an interventional cardiologist advances a balloon-tipped catheter through the arteries to the culprit lesion. The balloon is inflated to compress the atherosclerotic plaque against the arterial wall, and a metallic stent (typically a drug-eluting stent) is deployed to maintain vessel patency. However, the stent represents a foreign body within the vascular lumen and is a potent trigger for platelet activation and thrombus formation. Without adequate and sustained antiplatelet therapy, the risk of stent thrombosis, which can present as sudden cardiac death or acute myocardial infarction, is unacceptably high.

The evidence base for prasugrel is primarily derived from the TRITON-TIMI 38 trial (Trial to Assess Improvement in Therapeutic Outcomes by Optimising Platelet Inhibition with Prasugrel–Thrombolysis in Myocardial Infarction 38), a landmark randomised, double-blind, phase III trial published in the New England Journal of Medicine in 2007. This pivotal trial enrolled 13,608 patients with moderate-to-high-risk ACS scheduled for PCI and compared prasugrel (60 mg loading dose followed by 10 mg daily) with clopidogrel (300 mg loading dose followed by 75 mg daily), both in combination with aspirin, over a median follow-up of 14.5 months.

The primary efficacy endpoint was the composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. Prasugrel significantly reduced this composite endpoint by a relative 19% compared with clopidogrel (9.9% vs. 12.1%; hazard ratio 0.81; 95% confidence interval 0.73–0.90; p < 0.001). The benefit was driven primarily by a significant reduction in non-fatal myocardial infarction (7.3% vs. 9.5%), including a striking 52% relative reduction in definite or probable stent thrombosis (1.1% vs. 2.4%). These efficacy gains were partially offset by a statistically significant increase in non-CABG-related TIMI major bleeding (2.4% vs. 1.8%; p = 0.03), with life-threatening bleeding occurring in 1.4% versus 0.9% and fatal bleeding in 0.4% versus 0.1% of patients, respectively.

Importantly, the TRITON-TIMI 38 trial identified three patient subgroups in which prasugrel did not show a net clinical benefit: patients aged 75 years or older, patients weighing less than 60 kg, and patients with a prior history of stroke or transient ischaemic attack. The latter group showed net clinical harm from prasugrel and led to an absolute contraindication, while the first two groups prompted the development and recommended use of the 5 mg reduced maintenance dose, which is the strength supplied by Prasugrel EQL Pharma in the 5 mg presentation.

Prasugrel was first approved by the U.S. Food and Drug Administration (FDA) in July 2009 and by the European Medicines Agency (EMA) in February 2009. Following expiry of the originator's patent and supplementary protection certificates in Europe, multiple bioequivalent generic prasugrel products, including Prasugrel EQL Pharma, have entered the market, substantially improving access to this therapy and reducing treatment costs for healthcare systems. Prasugrel, together with ticagrelor (a reversible P2Y12 inhibitor from a different chemical class), represents a newer, more potent generation of P2Y12 inhibitors that has largely replaced clopidogrel as the preferred agent for patients with ACS undergoing PCI in current European Society of Cardiology (ESC) and American College of Cardiology/American Heart Association (ACC/AHA) guidelines.

What Should You Know Before Taking Prasugrel EQL Pharma?

Contraindications

Prasugrel EQL Pharma must not be used in the following situations, which represent absolute contraindications based on efficacy and safety data from clinical trials and post-marketing surveillance:

• Hypersensitivity: Known allergy to prasugrel or to any of the excipients listed in the tablet formulation (see the section on composition).
• Active pathological bleeding: Patients with ongoing bleeding, including bleeding peptic ulcer, intracranial haemorrhage, or any other clinically significant active bleeding, must not receive prasugrel as it will worsen the haemorrhage and may be life-threatening.
• History of stroke or transient ischaemic attack (TIA): In the TRITON-TIMI 38 trial, patients with a history of cerebrovascular events experienced net clinical harm from prasugrel therapy, with a significant increase in intracranial haemorrhage that outweighed the ischaemic benefit. This is the single most important contraindication after active bleeding.
• Severe hepatic impairment: Patients with severe liver disease (Child-Pugh class C) should not take Prasugrel EQL Pharma due to limited safety data, potentially altered metabolism of prasugrel, and the intrinsic coagulopathy associated with advanced hepatic dysfunction.

Warnings and Precautions

Before starting Prasugrel EQL Pharma, your doctor should carefully assess the following conditions and clinical circumstances, as they may affect the safety and appropriateness of treatment:

• Age 75 years or older: In the TRITON-TIMI 38 trial, the subgroup of patients aged 75 years and older treated with prasugrel 10 mg daily did not achieve a net clinical benefit, and the rate of fatal bleeding was higher compared with clopidogrel. Prasugrel is therefore generally not recommended in this age group. However, if the prescribing physician determines after individual assessment (considering ischaemic risk factors such as diabetes or prior myocardial infarction) that the benefit outweighs the risk, a reduced maintenance dose of 5 mg daily should be used after the 60 mg loading dose. The 5 mg strength of Prasugrel EQL Pharma is specifically formulated for this purpose.
• Body weight below 60 kg: Patients weighing under 60 kg show higher plasma exposure to the active metabolite of prasugrel, with a correspondingly increased bleeding risk demonstrated in clinical trials. A reduced maintenance dose of 5 mg once daily, as provided by Prasugrel EQL Pharma 5 mg, is recommended for these patients, following the standard 60 mg loading dose.
• Propensity to bleed: Conditions that inherently elevate bleeding risk include recent trauma, recent surgery (especially coronary artery bypass grafting), active gastrointestinal ulceration, thrombocytopenia or other disorders of haemostasis, and concurrent use of anticoagulants or non-steroidal anti-inflammatory drugs (NSAIDs). All bleeding risk factors should be openly discussed with your doctor so that the ischaemic-versus-bleeding balance can be individualised.
• Planned elective surgery: If elective surgery is anticipated, prasugrel should generally be discontinued at least 7 days before the procedure to allow sufficient recovery of platelet function through turnover of new platelets. This recommendation applies to both major surgical procedures and significant dental procedures. Always inform your surgeon, anaesthesiologist, and dentist that you are taking an antiplatelet medication. Do not stop prasugrel without first consulting your cardiologist, who must weigh the thrombotic risk of interrupting therapy against the bleeding risk of the planned procedure.
• Renal impairment: No dose adjustment is necessary in patients with renal impairment, including those with end-stage renal disease requiring dialysis. However, clinical experience in patients with severe renal disease is limited, and general caution is advised.
• Moderate hepatic impairment: No dose adjustment is required for patients with mild to moderate liver disease (Child-Pugh class A or B). However, prasugrel should be used with caution in these patients because of their potentially increased intrinsic bleeding risk and limited specific clinical experience in this population.
• Lactose and gluten: Prasugrel EQL Pharma tablets contain lactose as an excipient in some formulations. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Always check the current patient information leaflet supplied with the product for the precise excipient composition.

Pregnancy and Breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, you must inform your doctor before taking Prasugrel EQL Pharma. Animal reproduction studies (in rats and rabbits) have not demonstrated direct harmful effects on embryonic or fetal development, but there are no adequate and well-controlled studies of prasugrel in pregnant women. Because of the antiplatelet mechanism of action, prasugrel may increase the risk of bleeding in the mother during pregnancy and particularly at the time of delivery, as well as potentially increase the risk of bleeding in the fetus or newborn. As a precaution, Prasugrel EQL Pharma should not be used during pregnancy unless the potential benefit to the mother clearly justifies the potential risk to the fetus. Women of childbearing potential should use effective contraception throughout the treatment period.

It is not known whether prasugrel or its metabolites are excreted in human breast milk. Studies in lactating rats have shown that prasugrel and its metabolites do pass into animal breast milk. A risk to the breastfed infant therefore cannot be excluded. The decision whether to breastfeed while taking Prasugrel EQL Pharma should be made jointly with your doctor, taking into account the benefits of breastfeeding for the child, the importance of continued antiplatelet therapy for the mother, and the potential risk to the infant.

Driving and Operating Machinery

Prasugrel EQL Pharma has no known or negligible influence on the ability to drive and use machines. In clinical trials, dizziness was reported uncommonly. If you experience dizziness, lightheadedness, or any other adverse effect that could impair your ability to drive or operate machinery, refrain from these activities until the symptoms have fully resolved.

Generic Substitution

Because Prasugrel EQL Pharma is a bioequivalent generic of the originator Efient, your pharmacist may, in many jurisdictions, legally substitute one prasugrel product for another if the prescription is written by international non-proprietary name (INN) or if generic substitution is permitted by national regulations. In such cases, the clinical effect is expected to be equivalent. If you have concerns about switching between different prasugrel products, or if you notice any change in the appearance of your tablets, speak with your pharmacist or doctor. Never change or stop your antiplatelet medication without medical advice because of the risk of stent thrombosis.

How Does Prasugrel EQL Pharma Interact with Other Drugs?

The drug interaction profile of Prasugrel EQL Pharma is primarily defined by its pharmacodynamic effects, that is, additive or synergistic increases in bleeding risk when combined with other medications that affect haemostasis, rather than by pharmacokinetic interactions. Prasugrel's active metabolite is formed through hepatic CYP enzymes (primarily CYP3A4 and CYP2B6), but clinically important metabolic drug interactions are uncommon because the activation is distributed across multiple redundant enzymes.

The following table summarises the key drug interactions to be aware of when taking Prasugrel EQL Pharma:

Major Interactions

The most clinically important interactions with Prasugrel EQL Pharma involve other medications that impair haemostasis. The combination of prasugrel with oral anticoagulants, whether vitamin K antagonists (warfarin, phenprocoumon) or direct oral anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban), represents a particularly high-risk scenario, sometimes referred to as "triple antithrombotic therapy" when aspirin is also continued. This combination may be clinically necessary in patients who have both ACS requiring PCI and atrial fibrillation requiring anticoagulation, or other indications for chronic anticoagulation. However, triple therapy carries a substantially elevated risk of major bleeding. Current ESC guidelines recommend that when triple therapy is needed, the total duration should be kept as short as possible (typically from 1 week up to 1 month), followed by a step-down to dual therapy consisting of an oral anticoagulant plus a single antiplatelet agent (most commonly clopidogrel rather than prasugrel, or aspirin alone).

Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, or COX-2 inhibitors in combination with Prasugrel EQL Pharma and aspirin significantly increases the risk of gastrointestinal bleeding and should be avoided whenever possible. If an NSAID is genuinely necessary for pain or inflammation, the shortest possible duration at the lowest effective dose should be used, ideally together with a proton pump inhibitor for gastric protection. Paracetamol (acetaminophen) is generally preferred as a first-line analgesic in patients receiving DAPT.

Concomitant administration of prasugrel with fibrinolytic agents such as alteplase, tenecteplase, reteplase, or urokinase is not recommended outside specific acute-care protocols due to the markedly increased risk of bleeding, including fatal intracranial haemorrhage.

Minor Interactions and Clinically Favourable Features

An important practical advantage of prasugrel over clopidogrel is that it is not clinically affected by proton pump inhibitors (PPIs). Omeprazole, esomeprazole, and related PPIs are CYP2C19 inhibitors that have been shown to reduce the antiplatelet effect of clopidogrel, creating ongoing clinical debate about their concomitant use with clopidogrel. Because prasugrel's metabolic activation does not meaningfully depend on CYP2C19, PPIs do not reduce its antiplatelet efficacy. This property is particularly relevant because many patients on DAPT are co-prescribed PPIs for gastric protection, and the combination of prasugrel plus PPI plus aspirin therefore provides both effective platelet inhibition and reduced gastrointestinal bleeding risk compared with omitting the PPI.

Prasugrel also lacks clinically significant pharmacokinetic interactions with statins (atorvastatin, rosuvastatin, simvastatin), angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, calcium channel blockers, and diuretics, all of which are routinely prescribed in cardiovascular patients. No dose adjustments of these concomitant medications are required when starting Prasugrel EQL Pharma.

Unlike clopidogrel, prasugrel's clinical efficacy is not substantially affected by common genetic polymorphisms in the CYP2C19 gene. Patients who are CYP2C19 "poor metabolisers" show reduced conversion of clopidogrel to its active metabolite and therefore reduced antiplatelet effect and higher ischaemic event rates. This pharmacogenetic concern does not apply to prasugrel, making it a particularly attractive option in patients known or suspected to have impaired CYP2C19 function.

What Is the Correct Dosage of Prasugrel EQL Pharma?

Prasugrel EQL Pharma should always be taken exactly as prescribed by your doctor. The dosage regimen for prasugrel consists of a single oral loading dose to rapidly achieve adequate platelet inhibition, followed by a daily oral maintenance dose to sustain the antiplatelet effect throughout the treatment period. All patients receiving prasugrel must also receive low-dose aspirin (75–325 mg daily, with 75–100 mg daily preferred for long-term maintenance according to current European guidelines).

Adults

The dosing of prasugrel is individualised according to age, body weight, and clinical risk profile. The following table summarises the recommended regimens for adult patients:

The 60 mg loading dose is typically administered at the time of the PCI procedure or as soon as the decision to perform PCI has been made. In patients presenting with STEMI, the loading dose may be given immediately upon presentation, because primary PCI is the definitive treatment and time to platelet inhibition is critical. In patients with unstable angina or NSTEMI, the timing of the loading dose depends on the clinical situation and planned intervention strategy; current ESC guidelines suggest that in these non-STEMI ACS scenarios, the loading dose should generally be given once the coronary anatomy is known and PCI is planned, rather than at the time of initial presentation. This approach, known as avoidance of routine pretreatment, helps minimise bleeding risk in patients who may ultimately require coronary artery bypass graft (CABG) surgery instead of PCI.

Prasugrel EQL Pharma 5 mg tablets can be taken with or without food. The tablet should be swallowed whole with a glass of water. Do not crush, split, or chew the tablet, as this may alter absorption. There is no strict requirement to take prasugrel at a specific time of day, but taking it at approximately the same time each day (for example, with breakfast) helps maintain consistent platelet inhibition and improves long-term adherence.

It is worth noting that because Prasugrel EQL Pharma is supplied as a 5 mg tablet, it is particularly suited to the reduced maintenance-dose indications (patients aged 75 years or older, patients weighing less than 60 kg) rather than to the 10 mg standard regimen. Patients requiring the 10 mg maintenance dose must obtain a product containing that strength; two 5 mg tablets should not be routinely substituted for a 10 mg tablet unless specifically instructed by the prescribing physician, because dosing intervals, bioequivalence testing, and patient-acceptability considerations are based on the approved single-tablet strength.

Children and Adolescents

Prasugrel EQL Pharma is not indicated for use in children and adolescents under 18 years of age. There are no adequate safety or efficacy data available on the use of prasugrel in paediatric patients, and acute coronary syndrome requiring PCI is exceedingly rare in this age group. Accordingly, no dosing recommendations can be made for paediatric patients. Use of prasugrel in any paediatric indication (including very rare inherited or acquired cardiovascular disorders) should be restricted to specialist paediatric cardiology settings.

Elderly Patients

In the TRITON-TIMI 38 trial, subgroup analysis of patients aged 75 years and older showed no net clinical benefit from the standard prasugrel 10 mg daily maintenance regimen when compared with clopidogrel, and the risk of fatal bleeding and intracranial haemorrhage was significantly higher in elderly patients. For this reason, prasugrel is generally not recommended for patients aged 75 years or older. However, if after careful individual assessment (taking into account both ischaemic risk factors, such as diabetes or prior myocardial infarction, and bleeding risk factors, such as prior gastrointestinal bleeding or anaemia) the prescribing physician determines that the anticipated benefit outweighs the risk, a reduced maintenance dose of 5 mg once daily should be used following the 60 mg loading dose. Prasugrel EQL Pharma 5 mg is specifically suitable for this reduced-dose indication.

Missed Dose

If you forget to take a dose of Prasugrel EQL Pharma, take it as soon as you remember on the same day. If you do not realise until the following day, simply take your normal dose at the usual time and do not take a double dose to compensate for the missed tablet. Taking a double dose does not provide additional antiplatelet protection but does increase the bleeding risk. Frequent missed doses, however, can significantly reduce the effectiveness of antiplatelet protection and may increase your risk of stent thrombosis. If you find it difficult to remember your daily tablet, consider using a weekly pill organiser or setting a recurring daily alarm on your mobile phone. Discuss persistent adherence problems with your doctor or pharmacist.

Overdose

If you have taken more Prasugrel EQL Pharma than prescribed, contact your doctor, nearest emergency department, or national poisons information centre immediately. Overdose of prasugrel may result in prolonged bleeding time and subsequent bleeding complications, which in severe cases may be life-threatening. There is no specific antidote for prasugrel. If rapid reversal of the antiplatelet effect is required (for example, in the event of life-threatening bleeding or need for emergency surgery), platelet transfusion may be considered, although the effectiveness of platelet transfusion in reversing prasugrel's antiplatelet effect has not been formally established in clinical trials and benefit may be limited during the first hours after ingestion, when active metabolite is still present in plasma. The active metabolite of prasugrel is not expected to be dialysable due to its extensive protein binding (approximately 98%).

What Are the Side Effects of Prasugrel EQL Pharma?

Like all medicines, Prasugrel EQL Pharma can cause side effects, although not everybody will experience them. Because Prasugrel EQL Pharma is a bioequivalent generic of the originator Efient, its safety profile is considered equivalent to that of the originator product at comparable daily doses. The most significant side effects are related to the primary pharmacological action of inhibiting platelet aggregation, which inherently increases the risk of bleeding. In the TRITON-TIMI 38 trial, the overall rate of non-CABG-related TIMI major bleeding was 2.4% in the prasugrel group versus 1.8% in the clopidogrel group. Life-threatening bleeding occurred in 1.4% versus 0.9% of patients, and fatal bleeding in 0.4% versus 0.1%, respectively. For patients using the 5 mg reduced maintenance dose (as in elderly or low-weight patients), bleeding rates are generally lower than with the 10 mg dose, but remain elevated compared with clopidogrel.

The following frequency categories are based on clinical trial data and post-marketing surveillance for prasugrel-containing medicinal products, using the standard EMA convention:

It is important to understand that some degree of minor bleeding (such as easier bruising, slightly prolonged bleeding from small cuts, or occasional minor nosebleeds) is an expected consequence of effective antiplatelet therapy and does not, on its own, mean that the medication must be stopped. However, any episode of significant, prolonged, or unexplained bleeding should be promptly reported to your healthcare provider so that investigations can be arranged and, where appropriate, preventive measures (such as a proton pump inhibitor for gastric protection or evaluation of occult bleeding sources) can be implemented.

Skin rash has been reported in approximately 2–3% of patients taking prasugrel in clinical trials. Most rashes are mild to moderate in severity and resolve spontaneously or with standard treatment; however, rash occasionally leads to permanent discontinuation of prasugrel. The types of rash reported include erythematous (redness), macular (flat), papular (raised), maculopapular, and urticarial (hive-like) rashes. Rare cases of more severe skin reactions, including Stevens-Johnson syndrome, have been reported in post-marketing surveillance. Any rapidly spreading rash, blistering, or involvement of mucous membranes should prompt immediate medical evaluation.

If you experience any side effects, including those not listed above, speak with your doctor or pharmacist. You can also report side effects directly to your national adverse drug reaction reporting system (for example, the Yellow Card Scheme in the United Kingdom, MedWatch in the United States, EudraVigilance in the European Union, or the corresponding national pharmacovigilance system in your country). By reporting side effects, you help to generate better information about the safety of this medicine and support ongoing pharmacovigilance across generic and originator products.

How Should You Store Prasugrel EQL Pharma?

Proper storage of Prasugrel EQL Pharma is essential to ensure that the medication retains its pharmaceutical quality and therapeutic effectiveness throughout the entire treatment period. The following storage guidelines should be observed carefully:

• Temperature: Store below 30°C (86°F) in a dry place. Do not refrigerate or freeze the tablets, and avoid storing them in bathrooms, near kitchen sinks, or in other locations where they may be exposed to humidity or temperature fluctuations.
• Moisture protection: Keep the tablets in the original blister packaging until the moment you are ready to take a dose. The aluminium-based blister packaging is specifically designed to protect the tablets from moisture, which can accelerate degradation of the active ingredient. Do not transfer tablets to a separate pill organiser more than 1–2 weeks in advance.
• Light protection: Avoid exposing the tablets to direct sunlight or strong artificial light for prolonged periods. The film coating of the tablet provides some light protection, but prolonged exposure should still be avoided.
• Expiry date: Do not use Prasugrel EQL Pharma after the expiry date printed on the blister and carton packaging (indicated by "EXP" followed by a month and year). The expiry date refers to the last day of the stated month. Medicines used after expiry may have reduced potency or altered pharmaceutical properties.
• Child safety: Keep Prasugrel EQL Pharma out of the sight and reach of children. Store the medication in a secure location such as a locked cabinet, as accidental ingestion by a child could cause serious bleeding complications. If accidental ingestion occurs, contact your national poisons information centre immediately.
• Environmental disposal: Do not dispose of Prasugrel EQL Pharma via household waste or wastewater systems. Return unused, damaged, or expired tablets to your pharmacy for safe disposal in accordance with local regulations. This helps protect the environment and prevents accidental ingestion or misuse by other parties.

If your tablets appear discoloured, damaged, show signs of moisture exposure (such as softening, swelling, or crumbling), or have developed an unusual odour, do not take them. Contact your pharmacist for a replacement supply. Never take a tablet from a damaged or opened blister that you cannot conclusively identify as being from your current prescription.

What Does Prasugrel EQL Pharma Contain?

Understanding the complete composition of your medication is important, particularly if you have allergies or intolerances to specific excipients. Generic medicinal products such as Prasugrel EQL Pharma contain the same active substance at the same strength as the originator product, but may contain different excipients (inactive ingredients). Bioequivalence studies ensure that these excipient differences do not meaningfully affect the bioavailability or clinical effect of the active substance.

Active Substance

The active ingredient is prasugrel, present as prasugrel hydrochloride. Prasugrel hydrochloride is a white to off-white crystalline powder that is practically insoluble in water at pH 2 and freely soluble in methanol and dichloromethane. Each Prasugrel EQL Pharma 5 mg tablet contains 5 mg of prasugrel (corresponding to 5.49 mg of prasugrel hydrochloride salt).

Inactive Ingredients (Excipients)

The tablet core typically contains the following excipients (the exact formulation may vary by manufacturing site; always check the patient information leaflet supplied with your specific pack):

• Microcrystalline cellulose – a bulking and binding agent that provides tablet structure
• Mannitol (E421) – a sugar alcohol used as a filler and sweetener; suitable for diabetic patients
• Croscarmellose sodium – a disintegrant that helps the tablet break apart after ingestion
• Hypromellose (hydroxypropyl methylcellulose) – a binder and film-forming agent
• Magnesium stearate – a lubricant used during tablet compression
• Lactose monohydrate (where present) – a common tablet filler; patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should avoid formulations containing lactose

The film coating typically contains:

• Hypromellose – film-forming agent
• Titanium dioxide (E171) – a white pigment providing opacity
• Talc – an anti-adherent agent
• Triacetin or Macrogol/polyethylene glycol – plasticiser
• Iron oxide yellow (E172) – colouring agent specific to the 5 mg strength of many prasugrel generics

Tablet appearance varies by manufacturer, but Prasugrel EQL Pharma 5 mg tablets are typically yellow or beige-coloured, elongated film-coated tablets, embossed or debossed with an identifier on one or both sides. The tablets are supplied in blister packs. For the precise appearance, embossing, and full excipient list of your specific pack, always consult the patient information leaflet supplied with the product.

If you have known intolerances or allergies to any of the listed ingredients, inform your doctor or pharmacist before starting treatment so that a suitable alternative formulation can be identified if necessary.