Aflen

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Aflen

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Aflen

Property Description
Active ingredient Triflusal (INN: Triflusalum)
Form Hard capsules (oral administration)
Pharmacological class Antiplatelet agent / Antithrombotic drug
Common use Prevention of unwanted blood clot formation
Origin Synthetic, salicylic acid derivative

Aflen: An Antiplatelet Agent Classification and Brand Identity

Aflen is a brand-name, prescription-only synthetic medication classified as an antiplatelet agent or antithrombotic drug, typically administered orally in the form of hard capsules. Its active ingredient is Triflusal, a substance chemically related to the salicylate compounds, which possesses a unique trifluoromethyl structure. This pharmacological class consists of agents used to impair the mechanism of blood platelet aggregation.

Composition and Key Differentiating Features

The therapeutic efficacy of Aflen relies on the parent compound, Triflusal, and its primary active substance, the hydroxymetabolite (HTB), which is formed rapidly in the body and possesses sustained antiplatelet properties. Aflen works by making the body's platelets significantly less sticky through the irreversible modification of the cyclooxygenase-1 (COX-1) enzyme. This action prevents the production of the aggregation signal, thromboxane A2 (TXA2). Triflusal acts as an effective platelet antiaggregant with a well-established profile, largely due to the prolonged activity conferred by the HTB metabolite.

General Purpose in Vascular Health

Aflen's general purpose is to provide pharmacological support for the prevention of unwanted blood clots that can obstruct blood flow in the arteries. By selectively inhibiting platelet aggregation, the medication helps to maintain vascular patency and reduces the likelihood of pathological thrombosis. This fundamental function establishes Aflen as a critical compound used in contexts where managing and mitigating the risk associated with clot formation in the cardiovascular system is paramount.

What side effects are possible with Aflen?

The official safety profile of Aflen (Triflusal) is defined by documented adverse reactions categorized by frequency and the physiological system affected, as presented in government regulatory documentation.

Adverse Reaction Scope

The most important safety concern is the risk of bleeding (hemorrhage) due to its antiplatelet activity, which is classified alongside more general systemic and gastrointestinal disturbances.

Classification Example Adverse Reactions (SOC)
Very Common (ge 1/10) Indigestion (Dyspepsia) (Gastrointestinal Disorders)
Common (ge 1/100 to <1/10) Headache (Nervous System), Abdominal pain, Nausea, Vomiting (Gastrointestinal Disorders)
Uncommon (ge 1/1,000 to <1/100) Gastrointestinal bleeding, Cerebral haemorrhage (Blood and Lymphatic System; Nervous System)

Serious Adverse Reactions: Officially documented serious adverse reactions include Cerebral haemorrhage and Major Gastrointestinal Bleeding.

System-Organ Classes Involved: Adverse events are reported across several systems, including Blood and Lymphatic System Disorders, Gastrointestinal Disorders, Nervous System Disorders, and Vascular Disorders.

Dose- or Exposure-Related Patterns: Common gastrointestinal effects, such as abdominal pain and nausea, are officially documented as typically mild and may resolve within a few days, even with continued treatment.

Safety-Related Restrictions

Safety-Related Limitations: Aflen is formally contraindicated in patients with a known hypersensitivity to the drug or in those with significant hepatic dysfunction. Regulatory documents also advise caution when using Aflen in patients with a pre-existing risk of bleeding.

Regulatory Safety Structure

Regulatory Safety Summary: The primary concern is the potential for bleeding events, with gastrointestinal disturbances being the most frequently classified adverse reactions. Use is restricted by the contraindication in cases of significant liver impairment.

Connection to the Overall Safety Profile: This safety structure emphasizes that, as an antiplatelet agent, Aflen's primary risk is hemorrhage, which includes life-threatening events like cerebral haemorrhage. The majority of reported side effects, however, are related to the gastrointestinal system and are typically classified in the Common or Very Common frequency categories.

Overdose and Emergency Response

Overdose and When to Seek Help

The use of Aflen is associated with the risk of overdose, which can lead to serious, life-threatening, or fatal respiratory depression, coma, and death.

Documented Overdose Signs

Overdose on Aflen is primarily characterized by effects on the central nervous and respiratory systems. Symptoms of a severe overdose may include:

  • Respiratory Depression: Breathing that is slow, shallow, or stopped, which is the main cause of life-threatening outcomes.
  • Central Nervous System (CNS) Depression: Profound sedation, inability to wake up, or coma.
  • Miosis: Extremely small or pinpoint pupils.

Increased Overdose Risk Factors

Specific circumstances increase the risk of a fatal overdose, including:

  • Concomitant Use: Taking Aflen with central nervous system (CNS) depressants, such as benzodiazepines or alcohol, significantly increases the risk of profound sedation, respiratory depression, and death.
  • Accidental Ingestion: Accidental ingestion of even a single dose, especially by children, can result in a fatal overdose.
  • Dosage Increase: Serious respiratory depression may occur following a dose increase, particularly during the initial period of adjustment.

Emergency Response

Immediate medical help is required in all cases of suspected overdose. Overdose is an emergency that necessitates rapid intervention to prevent severe outcomes. Emergency response requires the immediate administration of an opioid antagonist (such as naloxone or nalmefene) to reverse the respiratory depressant effects.

Patients must be closely monitored for recurrence of symptoms, as the effects of the antagonist may wear off before the effects of Aflen, requiring continuous medical supervision.

Therapeutic Uses of Aflen

Aflen is commonly used across therapeutic domains to manage the risk associated with unwanted blood clot formation, specifically in the context of secondary prevention following significant vascular events. Its primary role is in managing the likelihood of recurrence in conditions such as Ischemic Stroke, Transient Ischemic Attack (TIA), and Acute Myocardial Infarction (AMI). It is also used in the chronic management of Coronary Artery Disease and after procedures like Aortocoronary Bypass Surgery.

The medication is applied as part of long-term antiplatelet therapy, often used when symptoms relate to systemic imbalance from high thrombotic risk. It is relevant for patients who require sustained support following acute or disruptive episodes.

“This antiplatelet support helps maintain the integrity of blood flow, contributing to easing the risk of symptoms related to recurrent vascular events.”

Aflen is also relevant for patients who require antiplatelet prophylaxis but exhibit intolerance or hypersensitivity to common agents like aspirin, which is relevant in managing conditions where other common agents may be unsuitable. This use contributes to assisting with maintaining functional stability and supports the patient during difficult symptomatic periods by easing distress.

Quick Fact: Relief for Recurrent Vascular Risk

Aflen is commonly used to help with managing the likelihood of a recurrent vascular complication in patients at high risk. It is considered relevant for patients at high risk who need long-term antiplatelet management.

Regulatory References

  1. Philippine Food and Drug Administration (FDA) Advisory

Eligibility and Restrictions for Use

The eligibility profile for Aflen (Triflusal) is defined by mandatory population constraints outlined in official government regulatory documents.

Who Must Not Use Aflen (Contraindications)

Aflen is strictly contraindicated for several specific populations. Patients must not use this medicine if they have a known hypersensitivity to the active ingredient, Triflusal, or to related salicylate compounds. Use is also prohibited for patients with an active hemorrhagic disorder or a history of complicated gastric or duodenal ulcers.

Restricted Use and Special Populations

Eligibility is limited or conditional for other groups. The medicine must be discontinued seven days prior to any planned surgery or dental procedure due to the associated risk of bleeding. Use requires caution and monitoring for patients with severe renal impairment or severe hepatic impairment.

Regarding life stages, the drug is contraindicated during pregnancy and lactation. Aflen is approved for adults, with no dosage adjustment required for older adults; however, its use in pediatric patients (children and adolescents) is officially not established.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Aflen (Triflusal) documents interactions that primarily focus on pharmacodynamic reinforcement and specific substance-related risks, as summarized below.

Category Documented Interacting Substances or Conditions
Antithrombotic Agents Other Antiplatelet agents (e.g., Acetylsalicylic acid), Anticoagulant agents (e.g., Warfarin, Heparin), and Fibrinolytic agents
Additive Bleeding Risk Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Alcohol
Metabolism Alteration Substances that affect liver enzymes, such as Rifampin and certain Anticonvulsants
Pharmacodynamic Enhancement Oral Antidiabetics (Aflen may enhance their effects)

Regulatory Findings on Interaction Outcomes

Co-administration with other antithrombotic and NSAID classes is documented to enhance the antiplatelet or anticoagulant effect, which formally translates to an increased risk of bleeding and hemorrhage. The use of alcohol is also noted to exacerbate gastrointestinal irritation and contribute to an increased risk of bleeding.

Specific substances like Rifampin and certain Anticonvulsants are noted in regulatory summaries as potentially altering the metabolism of Aflen's active component. Furthermore, interaction-related risks are documented to be heightened in patients with severe liver or kidney impairment, where the altered clearance of the active metabolite (HTB) may modulate the severity of the interaction outcome.

No specific medicinal product combination is formally classified as an absolute drug-drug contraindication in official labeling, and no mandatory timing separation rules are documented.

Mechanism of Action

Aflen's mechanism of action is mediated by the parent compound, Triflusal, and its active metabolite, HTB, which employ a dual-action approach to suppress platelet activity and influence vascular endothelial signaling.

Targeting the Platelet's Primary Aggregation Signal

This domain involves the primary mechanism: the irreversible inhibition of the platelet Cyclooxygenase-1 ( COX-1) enzyme. By blocking COX-1, the drug suppresses the synthesis of the aggregating mediator ** Thromboxane A2 ( TXA2) , which platelets utilize for recruitment and aggregation.

Modulating Platelet Internal Chemistry via Dual Mechanism

The drug's active metabolite, HTB, introduces a secondary mechanism by inhibiting cAMP Phosphodiesterase ( PDE). This action increases the concentration of the anti-aggregatory messenger cAMP inside the platelet. The resulting increase in cAMP functionally limits the platelet's capacity for activation. This dual-mechanism action results in a comprehensive inhibition of platelet function.

Influencing Vascular Endothelial Balance

The mechanism exhibits functional selectivity, preserving the production of the vasodilatory molecule Prostacyclin ( PGI2) in the vessel walls. Concurrently, the drug influences vascular cells by promoting the synthesis of Nitric Oxide ( NO). This combination supports mechanisms that modulate blood vessel diameter and promote the stability of the vascular wall.

Dosage and Administration Information

How to Use Aflen

Aflen is an antiplatelet agent for chronic management that is strictly administered via the oral route as hard capsules. The active ingredient, Triflusal, is a salicylate derivative.


Labeled Dosing and Schedule

The medicine is officially used according to defined daily regimens.

Parameter Official Instruction
Dose Range Typically administered at 600 mg daily or an alternative maximum dose of 900 mg daily.
Frequency The total daily dose may be taken as a single dose once daily or in divided doses (e.g., two or three 300 mg capsules).
Intake Rules The capsule must be taken with a sufficient amount of fluid and is administered preferably with meals to ensure proper intake.

Administration Conditions and Timing

Use of Aflen is typically long-term, positioning it as a chronic therapy. A critical administration instruction is the requirement to stop the medicine seven days prior to scheduled surgical procedures. The sustained antiplatelet effect is established once the active metabolite (HTB) reaches steady-state plasma concentration, typically within 8 to 10 days of consistent daily use. While the general adult dose is standard, caution and monitoring are generally required for patients with renal or hepatic impairment to manage potential exposure. These dosing and timing rules formalize the standardized, controlled approach to using Aflen.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Aflen (Triflusal)

Evidence for Preventing Recurrence of Stroke and TIA

Research has widely examined Aflen in patients who have already experienced a serious vascular event, such as an Ischemic Stroke or a Transient Ischemic Attack (TIA). The core of this research involves large, international major, controlled studies. These studies were structured to compare Aflen against a standard antiplatelet treatment. Researchers primarily monitored a composite outcome that measured the combined frequency of new non-fatal stroke, non-fatal heart attack, or vascular death over periods ranging from one to over two years.

Systematic reviews and data analyses reported that the overall frequency of these major recurrent vascular events showed patterns of occurrence that were comparable between the group receiving Aflen and the group receiving the standard comparator. However, the research reported data indicating that the frequency of major and minor hemorrhagic complications, including bleeding in the brain, was associated with a lower incidence in the Aflen-treated patient groups when observed alongside the comparator-treated groups.

Evidence in Coronary Artery Disease and Post-Myocardial Infarction

Aflen was also studied for its role in managing conditions related to the coronary arteries. These studies included patients who had recently experienced an Acute Myocardial Infarction (AMI), as well as those with chronic stable coronary artery disease. In these trials, researchers primarily measured a combined outcome consisting of death, non-fatal reinfarction, or a non-fatal cerebrovascular event.

Research exploring short-term symptom changes in the acute phase after a heart attack reported patterns where the overall frequency of the composite vascular event outcome was comparable between the study groups monitored. Studies also monitored outcomes related to physiological strain or stress, and the frequency of central nervous system bleeding episodes was reported to appear lower.

What Remains Uncertain About the Research Evidence

While the overall body of evidence was studied for an extended period, several areas of uncertainty or limitations exist, and research provides context but not individual predictions. For instance, although the overall frequency of serious vascular events appears comparable to the standard comparator, some evidence analyses report that a definitive conclusion ruling out moderate differences in the prevention of major vascular events cannot be established. Furthermore, data for certain groups are still emerging and comparative evidence is lacking between Aflen and some of the newer antiplatelet agents that have since become available.

Frequently Asked Questions (FAQ)

Common questions about Aflen (FAQ)

Q: Is Aflen the same type of medicine as [similar drug name]?

According to official product information, Aflen is a synthetic antiplatelet agent. Its active ingredient, Triflusal, is a salicylate derivative, but it is not chemically the same as aspirin (acetylsalicylic acid).

It is classified based on its ability to help prevent blood clots.

Q: Why does Aflen have to be taken regularly?

Regulatory information indicates that Aflen is taken regularly to ensure a consistent antiplatelet effect.

The main active substance, known as HTB, must accumulate to a specific level (steady-state concentration) in the body. This consistency helps maintain the continuous antiplatelet effect.

Q: Can Aflen be taken with [common over-the-counter medicine]? (e.g., ibuprofen, Tylenol)

Official documents state that combining Aflen with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen, may enhance the antiplatelet effect and increase the potential risk of bleeding.

Reviewing all medications, including OTC products, with a healthcare provider is standard practice for this drug class.

Q: Is Aflen considered safe for people over 65?

Official regulatory information indicates that Aflen is approved for adults, and no specific dose adjustment is needed for older adults based on age alone.

The safety and effectiveness of the drug have been examined in studies involving the elderly population.

Q: What happens if I stop taking Aflen suddenly?

The antiplatelet effect of the active substance remains in the body for several days after stopping treatment.

Changes to chronic therapeutic regimens, such as discontinuing Aflen, require the supervision of a prescribing doctor.

Q: Is Aflen approved by the FDA?

Official sources clarify that Aflen is approved and available in numerous countries across Europe, Asia, and other regions.

The drug is not currently approved or marketed by the U.S. Food and Drug Administration (FDA).

Q: Can Aflen cause changes in mood or sleep?

Official documents report side effects related to the nervous system, such as headache and dizziness.

While changes in mood are not commonly listed, some regulatory summaries have noted insomnia, or trouble sleeping, as an uncommon side effect.

Q: Are there any major food restrictions while taking Aflen?

The product label recommends that the medicine be taken with meals to ensure proper intake and to help reduce the risk of gastrointestinal irritation.

There are generally no other specific major food restrictions documented.

Q: What does 'contraindicated' mean for Aflen?

The term 'contraindicated' is an official regulatory warning stating that the medicine must not be used by certain groups of people.

This is because the documented risk is considered unacceptable when treating patients with certain pre-existing conditions, such as active bleeding or severe liver impairment.

Q: Why do doctors recommend Aflen over other options sometimes?

Studies examined the drug's efficacy profile for cardiovascular event prevention against a standard antiplatelet comparator.

Research evidence indicates that Aflen achieved comparable effectiveness to the comparator while being associated with a reported lower frequency of bleeding or hemorrhagic complications.

Q: How long does the effect of one Aflen dose last?

Official documents state that the main active substance (HTB) has a long half-life, which means it stays in the blood for an extended period.

Because of this, the antiplatelet effect from a single dose may still be observed up to 24 hours later.

Q: Is Aflen addictive or habit-forming?

Aflen is a prescription drug classified as an antiplatelet agent and is not used for purposes related to the central nervous system.

Regulatory authorities do not classify it as a controlled or scheduled substance, and it is not known to be addictive or habit-forming.

Q: Is it normal to feel [mild, common symptom, e.g., tired, dizzy] when starting Aflen?

Official safety summaries list dizziness and fatigue (tiredness) among the common side effects.

Regulatory documents note that these mild effects typically resolve after the first few days of treatment.

Q: What should I do if I miss a dose of Aflen?

Official regulatory patient information typically advises that if a dose is missed, it should be taken as soon as the patient remembers, unless the next dose is scheduled very soon.

The patient information advises against taking a double dose to compensate for the one that was missed.

Q: Does Aflen affect blood pressure?

The drug's mechanism involves promoting the production of Nitric Oxide, a substance that helps dilate blood vessels.

However, official safety summaries do not generally list changes in blood pressure as a common side effect or primary clinical effect of the medicine.

Q: Is Aflen used for any conditions other than the main ones listed?

Regulatory documents clearly state that Aflen is officially indicated for the prevention of secondary cardiovascular events, such as stroke and Transient Ischemic Attack (TIA).

Any other potential use is considered outside of the drug's approved regulatory indications.

Q: How is Aflen absorbed by the body?

Official documents state that after oral administration, Aflen is rapidly absorbed through the small intestine.

It has high bioavailability, meaning a large percentage of the active ingredient enters the body’s circulation to be converted into its main active substance (HTB).

Q: Are there specific tests required before starting Aflen?

Due to the regulatory caution advised for patients with severe liver or kidney impairment, monitoring of liver function and kidney function is standard practice before starting and periodically during treatment.

Q: Why is Aflen sometimes only prescribed for short periods?

Regulatory documents mandate only one required short-term period of discontinuation, which is seven days before any scheduled surgery or dental procedure.

This instruction is necessary to reduce the risk of excessive bleeding related to the drug’s antiplatelet action during the procedure.

Q: What are the warning signs of a serious side effect from Aflen?

The primary serious risk associated with Aflen is bleeding, or hemorrhage.

Warning signs may include persistent or unusual nosebleeds, severe unexplained bruising, red or dark urine, or black/tarry stools. Such signs require prompt evaluation by a healthcare professional.

Q: Is Aflen a controlled substance?

Official regulatory sources confirm that Aflen is a prescription medicine used to manage cardiovascular health.

It is not classified as a controlled substance by regulatory authorities in the countries where it is approved.

Q: Is the long-term safety profile of Aflen well-established?

The safety profile for Aflen is established through large clinical trials that monitored patients for extended periods, ranging from one to over two years.

The key risks, such as bleeding, are well-documented in the official safety summaries and are classified by frequency.

Q: What is the purpose of the boxed warning, if Aflen has one?

Aflen is primarily approved by regulatory bodies outside of the U.S. and does not carry the specific U.S. Food and Drug Administration (FDA) Boxed Warning.

Instead, international regulatory labels emphasize the major risks, primarily serious bleeding, within the dedicated Contraindications and Special Warnings and Precautions sections.

Q: Can I drive or operate machinery while taking Aflen?

Official regulatory patient information states that the ability to drive or operate heavy machinery may be impaired.

This warning is based on the possibility of experiencing common side effects, such as dizziness or headache.

Q: What does the official document say about Aflen for young adults?

Official regulatory documents state that Aflen is approved for use in the general adult population.

There are no specific dose adjustments or restrictions mentioned for the young adult subgroup (such as those aged 18 to 25) that differ from the standard adult guidance.

Q: Is Aflen available in different strengths?

The unit strength of Aflen commercially available is the 300 mg hard capsule.

While the total daily dose can be 600 mg or 900 mg, this is achieved by taking two or three of the standard unit strength capsules.

How should Aflen be stored and disposed of?

Official Storage and Disposal Requirements

Aflen (Triflusal) hard capsules must be stored and disposed of strictly according to the procedures defined in the official regulatory documents to ensure product stability and safety.

Requirement Official Regulatory Statement
Labeled storage temperature requirements Do not store above 30 C (86 F) [Source: SmPC].
Light/moisture protection requirements Keep in the original package to protect from moisture.
Child-protection storage requirements Keep this medicine out of the sight and reach of children.
Disposal instructions Do not dispose of via wastewater or household waste; use a pharmacy collection point or official drug take-back program.

Resulting Storage & Disposal Structure

Official documents establish that Aflen must be stored at room temperature, restricted from exceeding 30 C, and kept in the original container to maintain its stability and protection from moisture. The mandatory handling rules strictly require the product to be stored out of the sight and reach of children. Furthermore, regulatory instructions state that disposal of unused or expired product must follow controlled pharmaceutical waste protocols, such as official take-back programs, and must not be discarded into wastewater or household trash.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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