Asec

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

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 Asec

Property Description
Active ingredient Aceclofenac
Form Oral film-coated tablet
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
General purpose Anti-inflammatory, analgesic, antipyretic relief
Origin Synthetic

Asec is a synthetic medicinal product characterized by its systemic capacity to address pain and inflammation throughout the body. The active compound in the medicine is Aceclofenac (INN), which is structurally classified as a phenylacetic acid derivative.

This places Asec squarely within the established pharmacological class of Nonsteroidal Anti-inflammatory Drugs (NSAIDs), a designation that confirms its fundamental action involves modulating the body's inflammatory response. The compound Aceclofenac is chemically related to diclofenac, having been developed as an analogue. It possesses systemic action and efficacy as an analgesic and anti-inflammatory agent, which functions to help ease discomfort by reducing both pain and the underlying inflammation associated with various musculoskeletal conditions.

Composition, Form, and General Therapeutic Purpose

The active ingredient, Aceclofenac, is most commonly administered in the form of an oral film-coated tablet, representing the standard dosage form for achieving systemic therapeutic action. The oral route of administration is typical for Asec, distinguishing it from preparations designed for localized dermal absorption.

As a core NSAID, Asec's general therapeutic purpose is to provide relief by simultaneously delivering anti-inflammatory, analgesic (pain relief), and antipyretic (fever reduction) actions. This comprehensive symptomatic effect is achieved by disrupting the chemical processes involving the cyclooxygenase enzyme that are responsible for causing swelling, tissue tenderness, and elevated body temperature. This action defines the medicine's identity and confirms its use for general symptomatic management of pain and inflammation, such as the generalized discomfort experienced during acute flares.

What side effects are possible with Asec?

Possible side effects and safety information

The official safety information for Asec (Aceclofenac) is structured by regulatory bodies to classify documented adverse reactions and specific safety patterns. The drug's safety profile is consistent with its classification as a Nonsteroidal Anti-inflammatory Drug (NSAID), with risks primarily documented across several major organ systems.

Frequency-Classified Adverse Reactions

Adverse reactions are classified by occurrence rate based on regulatory data. Officially documented reactions classified as Common (ge 1/100 to < 1/10) include gastrointestinal disturbances such as dyspepsia, abdominal pain, nausea, and diarrhea, alongside central nervous system effects such as dizziness. Laboratory findings of increased hepatic enzymes are also classified as Common. Uncommon reactions include gastritis, constipation, rash, and increased blood urea or creatinine. Serious hypersensitivity reactions, including anaphylactic shock, are classified as Rare.

System-Organ Safety Concerns

The most frequently observed adverse reactions are those related to the Gastrointestinal disorders and Nervous system disorders. However, the regulatory documentation highlights potential for effects in other System-Organ Classes, including the hepatobiliary, renal, and cardiovascular systems.

Serious Adverse Reactions and Safety Constraints

The label explicitly documents risks of serious, life-threatening events, which can occur at any time during treatment. These include Gastrointestinal Hemorrhage, Ulceration, and Perforation, as well as the risk of Arterial Thrombotic Events, such as myocardial infarction and stroke, which may increase with higher doses and long-term use. This profile necessitates explicit safety constraints, defining contraindications for patients with existing severe cardiac, renal, or hepatic failure, or a history of recurrent gastrointestinal bleeding.

Population-Specific Safety Statements

Official labeling includes explicit warnings regarding use in certain groups. Older adults are documented to have an increased frequency of adverse reactions, particularly serious gastrointestinal complications. Furthermore, Asec is contraindicated in patients with established cardiovascular disease, such as congestive heart failure (NYHA class II–IV) or ischaemic heart disease.

Overdose and Emergency Response

The official regulatory profile for Asec overdose details a spectrum of potential clinical manifestations involving multiple organ systems. These documented presentations commonly include gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and internal bleeding (Melaena or Haematemesis). Central Nervous System effects like dizziness, somnolence, confusion, and convulsions (seizures) are also officially noted.

The regulatory risk profile centers on the potential for severe, life-threatening outcomes. These explicitly documented complications include acute renal failure, significant hepatic injury (Jaundice), and potentially fatal gastrointestinal perforation or ulceration. Furthermore, official government warnings for the NSAID class mandate seeking help for potential serious cardiovascular events, such as myocardial infarction or stroke.

Treatment is explicitly defined as symptomatic and supportive, as no specific antidote is known for this toxicity. Management requires hospital monitoring and laboratory investigations to evaluate renal and liver function. Authorities mandate that individuals must seek immediate medical attention for any suspected overdose. Emergency services must be contacted immediately if a patient exhibits symptoms like sudden chest pain, trouble breathing, or sudden weakness, which are indicative of a severe outcome. The elderly and patients with pre-existing renal or hepatic impairment are noted to be at increased risk for precipitated renal failure in an overdose situation.

Therapeutic Uses of Asec

What Asec Treats: Main Uses and Benefits

Asec is commonly used to help with the relief of symptoms related to physical discomfort and symptoms related to inflammatory or irritative states. The active compound is generally relevant in conditions that involve the management of chronic and acute inflammation. Asec is considered relevant in contexts that involve heightened systemic burden for the symptomatic management of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in adult patients.


Therapeutic Scope and Patient Benefit

This medication is applied across domains where additional symptomatic support is needed, such as in conditions characterized by periods of heightened symptoms. It is relevant for easing symptoms that create noticeable physiological strain, and is considered relevant for easing the persistent joint pain, tenderness, and stiffness. Applied in scenarios where additional management of discomfort is required, it supports general well-being during symptomatic phases.

“Asec is relevant in clinical settings marked by increased discomfort, often used during phases when symptoms become more noticeable due to chronic or localized inflammation.”

In addition to chronic conditions, Asec is also commonly used to manage acute, fluctuating symptoms related to localized inflammation, such as low back pain or extraarticular rheumatism. It may assist with maintaining functional stability and contributes to easing the overall symptom load, providing supportive relief when symptoms interfere with routine activities.


Quick Fact: Symptomatic Relief for Joint Pain, Stiffness, and Swelling

Eligibility and Restrictions for Use

Asec (Aceclofenac) is subject to strict eligibility rules based on regulatory labeling to ensure appropriate use. Eligibility is defined by age, organ function, and specific pre-existing health conditions.

Who Must Not Use Asec (Contraindications)

Use is contraindicated and must be avoided in populations with specific severe conditions:

  • Severe Organ Failure: Patients with severe hepatic (liver) or severe renal (kidney) failure.
  • Cardiovascular Disease: Individuals with established congestive heart failure (NYHA functional class II–IV), ischemic heart disease, or cerebrovascular disease.
  • Gastrointestinal History: Patients with active, or a history of recurrent, peptic ulcer/haemorrhage, or a history of GI bleeding related to previous NSAID therapy.
  • Allergy: Known hypersensitivity to Aceclofenac, or a history of asthma, rhinitis, or urticaria precipitated by aspirin or other NSAIDs.
  • Pregnancy: Women in the third trimester of pregnancy.

Age and Special Population Restrictions

Population Eligibility Status (Regulatory Wording)
Children/Adolescents Not recommended (under 18 years) due to a lack of clinical data.
Elderly Patients Use is permitted but requires caution and close surveillance due to increased risk.
Mild to Moderate Impairment Requires surveillance and caution in mild to moderate hepatic or renal impairment.
Lactation Not recommended / Use should be avoided.

Use during the first and second trimesters of pregnancy is generally restricted to the lowest effective dose for the shortest duration, and only if clearly necessary.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Asec (Aceclofenac) is officially documented by regulatory authorities, focusing on combinations that affect pharmacological safety or product exposure. The most significant restrictions involve mandatory avoidance and interactions that alter substance levels or physiological effects.

Mandatory Avoidance and Timing Separation

Restriction Type Interacting Substance(s) Official Constraint
Contraindicated Co-use Other Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including Aspirin (analgesic doses) Co-administration must be avoided due to the increased risk of severe adverse effects.
Timing Separation Mifepristone Use of Asec must be avoided for 8 to 12 days following administration.

Pharmacodynamic and Exposure Interactions

Official labeling describes interactions resulting from effects on substance concentrations or additive physiological risk:

  • Increased Plasma Concentrations: Asec may inhibit the renal clearance of substances like Lithium and Digoxin, potentially leading to increased plasma levels of these co-administered medicines.
  • Enhanced Bleeding Risk: Co-administration with Anticoagulants (e.g., Warfarin), Antiplatelet agents, Systemic Corticosteroids, or SSRIs may enhance the risk of bleeding.
  • Reduced Therapeutic Effect: Asec may antagonize the effects of Antihypertensives and Diuretics, potentially reducing their efficacy and increasing the risk of nephrotoxicity.

Furthermore, regulatory information notes that close medical surveillance is warranted when Asec is used with Alcohol, due to the potential for exaggerated side effects.

Mechanism of Action

Inhibition of Prostaglandin Synthesis via COX-2 Selectivity

The primary mechanism of Aceclofenac involves the preferential inhibition of the Cyclooxygenase-2 (COX-2) enzyme, which is responsible for the localized, inducible production of pro-inflammatory mediators, primarily Prostaglandin E2 ( PGE2). This molecular interaction interrupts the arachidonic acid cascade, which is a primary process generating mediators that contribute to inflammatory and nociceptive signaling.


Dampening of Central and Peripheral Signaling

The reduction in PGE2 synthesis modulates physiological signaling sequences in both peripheral and central pathways. Peripherally, the drug decreases the chemical sensitization of pain receptors, contributing to the modulation of nociceptive input. Centrally, the mechanism modulates PGE2 activity within the hypothalamus, altering the central thermal setpoint.


Modulation of Cartilage Homeostasis

Beyond the classical anti-inflammatory pathway, Aceclofenac and its active metabolites engage a distinct mechanism by modulating the production and activity of specific pro-inflammatory cytokines, such as Interleukin-1beta ( IL-1beta). This action influences the metabolic balance within joint tissues by supporting the synthesis of essential structural components like glycosaminoglycans in articular cartilage.

Dosage and Administration Information

How to Use Asec: Administration Guidelines

Asec (Aceclofenac) is administered via the oral route as a 100 mg film-coated tablet. The usage protocol focuses on standardized dosing, proper technique, and specific adjustments for certain populations.


Standard Dosage and Frequency

The standard protocol for adults requires a total daily dose of 200 mg, which is achieved by taking one 100 mg tablet twice daily (approximately every 12 hours). This frequency ensures that the intended therapeutic levels are maintained throughout the day.


Administration Technique

The film-coated tablet must be swallowed whole with a sufficient quantity of liquid and must not be crushed, broken, or chewed. To align with proper administration conditions, the medicine is taken preferably with or immediately after food.


Usage Duration and Patient-Specific Rules

Usage of Asec is governed by the principle that the lowest effective dose should be used for the shortest duration necessary to address the condition; the need for continued treatment must be re-evaluated periodically.

Population Group Labeled Administration Principle
Hepatic Impairment The initial daily dose is reduced to 100 mg (one tablet once daily).
Older Adults No mandatory dose modification, but caution is advised, and the lowest effective dose should be maintained.
Pediatric Population (<18 years) Use is not recommended due to a lack of clinical data.

These parameters define the process for utilizing the medicine, ensuring consistent administration practice across varying patient profiles.

Recent Clinical Evidence

Asec: Recent Clinical Evidence

Research evidence / Overview of studies

Evidence in Select Populations

Research has explored whether this investigational compound may affect patient outcomes in specific populations. Studies have investigated the compound’s role in affecting chronic symptom severity. The investigational data is complex, and analysis is ongoing to determine the full range of effects.

Safety and Tolerability Profile

Clinical trials have focused on the compound's safety profile across different age groups. Long-term study data examined the potential effects of continuous use in chronic cases. The findings generally report on the types and frequency of side effects observed during the trial period.

Molecular Interaction Research

Research focused on how the compound interacts with specific receptors. Research assessed the compound's effects on relevant biological markers in laboratory and clinical settings.

Trial Findings and Outcomes

Phase 3 trials reported associations with outcomes in a majority of trial participants. The trials evaluated the duration of changes in symptom frequency. Data also suggests researchers examined the onset of effect relative to other study compounds. These findings describe effects observed in controlled, monitored research settings. Results from these trials do not imply individual suitability for treatment or predictable outcomes.

Key Studies & References

  1. AACE/ACE Consensus Statement: Comprehensive Management of Dyslipidemia and Prevention of Cardiovascular Disease

Frequently Asked Questions (FAQ)

Common questions about Asec (FAQ)

Q: Does Asec interact with common painkillers like ibuprofen or acetaminophen?

Regulatory documents state that co-administration of Asec with other Nonsteroidal Anti-inflammatory Drugs (, NSAIDs), such as ibuprofen, must be avoided due to the increased risk of severe adverse effects. For non-, NSAID pain relievers, like acetaminophen, the official documentation suggests that the possibility of interaction should be considered, especially regarding the risk of hepatic toxicity with high doses or in certain patient populations.

Q: Do I need to eat food when I take Asec?

Official product information indicates that the administration of the tablet is preferably with or immediately after food. This recommendation is made to help minimize potential gastrointestinal side effects, such as upset stomach or indigestion. Studies show that taking the medicine with food may slow down the rate at which the medicine is absorbed into the bloodstream, but it does not change the total amount absorbed.

Q: How long does it usually take to notice anything after starting Asec?

Based on the pharmacological data, the onset of action for the active ingredient is typically reported to occur within one to two hours following administration. The peak levels of the medicine in the bloodstream are generally reached around 1.25 to 3 hours after a dose. This time frame gives a general indication of when the body begins processing the medicine.

Q: Are there any widely known 'food interactions' people talk about with Asec?

Official regulatory documents, such as the Summary of Product Characteristics, focus primarily on interactions with other medicines that may affect safety or drug levels. They do not commonly list specific food-based interactions like grapefruit juice for this medication. A patient’s overall need for symptomatic relief and their response to therapy should be evaluated regularly.

Q: Is feeling more tired than usual a side effect of Asec?

Official safety documents list central nervous system effects, such as dizziness and somnolence (drowsiness), among the documented side effects. Fatigue is also explicitly listed as a common or occasional side effect in some regulatory summaries. Official warnings suggest that if central nervous system effects are experienced, activities requiring concentration may be affected.

Q: Why do some people say Asec gave them a headache?

Headache is officially documented as a potential adverse reaction in the medicine’s safety information. The majority of reported adverse reactions in clinical data are generally noted to be reversible and minor in nature.

Q: Is Asec safe to take if I have mild kidney issues?

Regulatory guidance indicates that no mandatory dosage changes are specified for patients with mild renal (kidney) impairment. However, as is the case with many Nonsteroidal Anti-inflammatory Drugs, caution should be exercised and surveillance is recommended in these cases. Use in moderate to severe renal failure is listed as an official contraindication.

Q: Are there any specific activities to avoid while taking Asec?

Official warnings state that Asec may cause central nervous system effects such as dizziness, vertigo, or visual disturbances in some patients. The official documentation cautions that if a patient experiences these effects, the ability to drive or operate machinery may be impaired.

Q: Is it normal to feel a slight upset stomach when starting Asec?

Gastrointestinal disturbances are among the commonly documented side effects of the medicine based on regulatory data. These reactions include dyspepsia (indigestion), abdominal pain, nausea, and diarrhea. Official administration instructions indicate that the medicine is preferably taken with or immediately after food.

Q: Do you need to take Asec long-term, or is it just a short course?

The official protocol is that the medicine should be used for the shortest duration necessary to control symptoms, using the lowest effective dose. Due to potential risks, particularly cardiovascular ones that may increase with the dose and duration, the need for continued treatment requires periodic re-evaluation by a healthcare professional.

Q: Is Asec addictive or habit-forming?

The medicine is chemically classified as a Nonsteroidal Anti-inflammatory Drug (, NSAID). , NSAIDs are not categorized as controlled substances by regulatory bodies and are generally not associated with the potential for drug dependency or habit formation.

Q: Can Asec cause any unusual skin reactions?

The safety profile documents skin reactions as potential adverse effects. These include less common effects like pruritus (itching), rash, dermatitis, and urticaria (hives). It is also noted that severe mucocutaneous (skin and mucous membrane) reactions may rarely occur.

Q: Is Asec studied for uses beyond its primary approved purpose?

Regulatory documents refer to the active compound as an 'investigational compound' where research is ongoing. Studies have been conducted to examine the compound's potential effects on outcomes in various specific patient populations beyond the conditions for which it is primarily approved.

Q: If I miss a dose of Asec, what are the general guidelines people follow?

General patient information for twice-daily medication suggests that if a dose is missed, the patient should continue with the next scheduled dose at the usual time. Regulatory guidance consistently advises against doubling a dose to make up for a missed one.

Q: Does Asec need to be taken at a specific time of day?

The standardized protocol for adults is to take the medicine in two doses, resulting in a total daily dose of 200 mg. This is specified as twice daily or approximately every 12 hours, which is intended to maintain consistent therapeutic levels throughout the day.

Q: Can Asec affect my ability to drive or operate machinery?

Official warnings note that the medicine may cause adverse effects like dizziness, vertigo, or visual disturbances. Regulatory documentation cautions that if a patient experiences central nervous system effects, the ability to drive or operate machinery may be impaired.

Q: Can Asec affect blood sugar levels, according to the documents?

The official interaction profile notes that the possibility of requiring dosage adjustment for oral anti-diabetic agents exists when the two medicines are administered concurrently. This indicates a potential effect on the regulation of blood sugar.

Q: Is Asec considered a 'new' drug, or has it been around for a while?

The active compound is a Nonsteroidal Anti-inflammatory Drug (, NSAID) that is chemically related to diclofenac, an older medicine. The compound has been developed as an analogue, and its efficacy is supported by long-standing pharmacological studies, with regulatory filings and updates taking place over a long period.

Q: What happens if Asec is taken past its expiration date?

Regulatory guidelines specify that the medicine must not be used past its labeled expiration date. This rule exists because using outdated products may compromise the quality, strength, and purity of the medication. Expired products must be properly removed from stock.

Q: Is Asec available in different strengths?

The medicine is primarily described in regulatory documents and administered as a 100 mg film-coated tablet, which is the standard dosage form for systemic therapeutic action. The official Summary of Product Characteristics may also list information on other available fixed-dose combinations with other active ingredients.

Q: Can women who are planning pregnancy use Asec?

Official information states that the use of this medicine may potentially impair female fertility. Consequently, the use of the medicine is not recommended for women who are actively attempting to conceive. For women undergoing investigation for infertility or who have difficulties conceiving, the official information suggests that discontinuation may be appropriate.

Q: Why is Asec sometimes prescribed for different conditions?

As a Nonsteroidal Anti-inflammatory Drug (, NSAID), the core purpose of the medicine is to provide relief through a triple action: anti-inflammatory, analgesic (pain relief), and antipyretic (fever reduction). This makes it generally suitable for the symptomatic management of various musculoskeletal and inflammatory conditions that involve pain and swelling.

Q: Are there common reasons why a doctor might decide Asec is not the right fit for a patient?

The official label lists multiple conditions that make the medicine unsuitable for certain patients (contraindications). Common reasons include existing severe organ failure (like severe cardiac, hepatic, or renal failure), a history of recurrent gastrointestinal bleeding, or a known hypersensitivity to the drug or other , NSAIDs.

Q: What are the non-active ingredients in Asec?

The complete list of non-active ingredients, also known as excipients, is required to be disclosed in the official regulatory documents, specifically within the pharmaceutical particulars section of the Summary of Product Characteristics (, SmPC). These ingredients do not contribute to the medicine's primary effect.

Q: Is Asec part of a common treatment plan or usually a last resort?

The medicine is a verified agent within the pharmacological class of Nonsteroidal Anti-inflammatory Drugs (, NSAIDs). Its systemic capacity to address pain and inflammation confirms its use for general symptomatic management, placing it within standard treatment protocols for various pain and inflammatory conditions.

Q: How quickly is Asec cleared out of the body?

The speed at which the medicine is processed and removed from the body is described in the regulatory documents under pharmacokinetics. The plasma half-life of the active compound is stated to be approximately four hours, which is the time it takes for the concentration of the medicine in the blood to reduce by half.

Q: What studies exist about Asec use in patients with heart conditions?

Regulatory information highlights the potential for arterial thrombotic events, such as myocardial infarction and stroke, which may increase with higher doses and long-term use. Consequently, the medicine is officially contraindicated in patients with established cardiovascular disease, such as ischemic heart disease.

Q: Do official sources mention Asec interacting with grapefruit juice?

Official drug interaction sections are focused on combinations with other medicines, such as anticoagulants and diuretics. They do not typically list specific common food substances like grapefruit juice as having a known interaction with this medicine.

Q: How is the safety of Asec tracked after it is approved?

The ongoing safety of the medicine is continuously monitored by regulatory authorities through a process called pharmacovigilance. This involves the systematic collection and assessment of reports on adverse drug reactions after the product has been approved and made available to the public.

How should Asec be stored and disposed of?

Asec must be stored and handled according to the official requirements specified in its regulatory labeling to maintain its quality, strength, and purity.

Official Storage Conditions

  • Temperature: Store at the temperature designated on the product label, or at controlled room temperature if no specific requirement is provided in the labeling.
  • Protection: The product container must protect Asec from contamination and deterioration, which may require protection from light and moisture as specified in the official documents.
  • Container Security: Keep the drug in a clean, orderly, and secure location, ensuring it is segregated from other items and protected from unauthorized access.

Disposal and Stability

  • Expiration Date: Do not use the drug past its labeled expiration date, as products must be removed from stock when they become outdated or damaged.
  • Disposal: The disposal of unused, expired, or adulterated Asec must follow established procedures, including specific protocols for controlled or hazardous substances, to ensure the product is rendered non-retrievable and cannot be diverted, as mandated by federal and local regulations.

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

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