Aceclofenac Ecloare

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Aceclofenac Ecloare

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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 Aceclofenac Ecloare

Property Description
Active ingredient Aceclofenac
Form Oral tablet/capsule, topical cream
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Pain, inflammation, and fever relief
Origin Synthetic (phenylacetic acid derivative)

Aceclofenac Ecloare: Definition and Pharmacological Class

Aceclofenac Ecloare is a medicine containing the active substance Aceclofenac (INN), which belongs to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). This classification identifies it as a synthetic systemic agent designed primarily to manage symptomatic discomfort. The chemical structure of Aceclofenac is recognized as an arylalkanoic acid derivative, distinguishing it as an NSAID utilized for its analgesic and anti-inflammatory properties. The medicine works to reduce both pain and inflammation.

Composition, Form, and General Purpose

Aceclofenac is the single active ingredient in the Ecloare formulation, which is most commonly presented as an oral tablet or capsule for systemic relief, though it is also available in topical cream form for localized application. This duality of available forms represents a differentiating feature, allowing for flexible application against general systemic pain or targeted relief. Aceclofenac-containing products are used for their general therapeutic function, characterized by a specific effectiveness and safety profile.

The medication's core purpose is to provide integrated symptomatic relief: the reduction of inflammation, the alleviation of pain, and the management of fever. This triple effect stems from its fundamental mechanism of interrupting the production of inflammatory mediators, allowing the drug to mitigate general physical discomfort associated with inflammatory responses.

What side effects are possible with Aceclofenac Ecloare?

Possible side effects and safety information

The safety profile of Aceclofenac is structured and communicated by regulatory authorities based on the nature, frequency, and organ systems involved, alongside specific administration constraints. This framework is derived strictly from official government prescribing information, such as the Summary of Product Characteristics (SmPC) and FDA labels.


Frequency-Classified Adverse Reactions

Adverse reactions are categorized by frequency of occurrence as documented in regulatory sources:

Classification Examples of Listed Effects
Common Dizziness, dyspepsia, abdominal pain, nausea, diarrhea, hepatic enzyme increased.
Uncommon Flatulence, gastritis, rash, pruritus, mouth ulceration, blood creatinine increased.
Rare Anaemia, anaphylactic reaction (including shock), visual disturbance, gastrointestinal haemorrhage or ulceration, cardiac failure, hypertension.
Very Rare Severe mucocutaneous skin reaction (SJS/TEN), renal failure, hepatic injury, depression.

These effects are classified across several System-Organ Classes, with the Gastrointestinal tract, Nervous System, and Hepatobiliary system being key areas of documented risk.


Serious Adverse Reactions and Safety Constraints

Official regulatory documents note the potential for serious adverse reactions, which may be fatal. These include gastrointestinal bleeding, perforation, and ulceration, and rare, severe immune and dermatological reactions like anaphylactic shock and Stevens-Johnson Syndrome. As an NSAID, use is associated with a potential small increased risk of arterial thrombotic events (e.g., myocardial infarction, stroke).

Safety Restrictions: Use of Aceclofenac is contraindicated in individuals with active or a history of recurrent peptic ulcer/haemorrhage, severe heart failure, severe hepatic failure, or severe renal failure. The official labeling also states that cardiovascular risks may increase with dose and duration of exposure, and use in the third trimester of pregnancy is restricted due to risk to the fetus.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation for Aceclofenac Ecloare, an NSAID, emphasizes the need for emergency action in the event of suspected overdosage, as no specific antidote is known.

Overdose manifestations, based on the documented NSAID toxicity profile, commonly involve gastrointestinal and central nervous system effects.

Documented Clinical Manifestations

System Documented Signs and Symptoms
Gastrointestinal Nausea, vomiting, epigastric pain, gastro-intestinal irritation
Central Nervous System Lethargy, drowsiness, convulsions (rare)

Severe Outcomes and Emergency Action

A suspected overdose requires patients to seek immediate medical attention due to the potential for rare, severe complications. These complications, documented in regulatory profiles, include acute renal failure, gastrointestinal bleeding, hypotension, and respiratory depression.

Management is strictly symptomatic and supportive. Official guidance outlines that procedures such as forced diuresis or hemodialysis are generally considered ineffective due to the drug’s high degree of protein binding. Activated charcoal may be considered for recent ingestion, with dosage instructions provided specifically for both adults and pediatric patients.

Therapeutic Uses of Aceclofenac Ecloare

What Aceclofenac Ecloare Treats: Main Uses and Benefits

Aceclofenac Ecloare is commonly used for managing symptoms related to physical discomfort, inflammation, and joint stiffness associated with various musculoskeletal conditions and acute inflammatory episodes. It is generally applied across domains where additional symptomatic support is needed, and may assist with addressing symptom clusters that become intense or disruptive.

This medication is commonly used for managing conditions characterized by periods of heightened symptoms, which include major long-term disorders like Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis, as well as acute episodes of low back pain, dental pain, and menstrual cramps (dysmenorrhea).

“It is relevant for addressing symptoms related to inflammatory or irritative states and contributes to improved comfort during periods of heightened symptoms.”

It is relevant for addressing symptoms related to inflammatory or irritative states and symptoms that interfere with daily functioning, and is often used during phases when symptoms become more noticeable. In addition to managing localized discomfort, it is applied in addressing systemic imbalance, such as fever that may accompany inflammatory states, and helps maintain a sense of stability when symptoms are more noticeable.


Quick Fact: Used for managing Joint Pain, Stiffness, and Inflammation Aceclofenac Ecloare is considered relevant for symptomatic management across multiple domains, supporting patients with chronic joint pain and acute inflammatory flares by contributing to easing the overall symptom load.

Eligibility and Restrictions for Use

This section explains, based strictly on official regulatory documentation, the mandatory limitations for the use of Aceclofenac Ecloare.

Contraindicated Populations (Must Not Use)

Use of this medicine is contraindicated (strictly prohibited) in individuals who have:

  • Known Hypersensitivity: Allergy to aceclofenac or other Non-Steroidal Anti-inflammatory Drugs (NSAIDs), including those who experience asthma, rhinitis, or urticaria after taking aspirin or other NSAIDs.
  • Gastrointestinal Conditions: Active or a history of recurrent peptic ulceration/hemorrhage, or a history of gastrointestinal bleeding/perforation related to prior NSAID therapy.
  • Severe Organ Failure: Severe hepatic failure, severe renal failure, or established congestive heart failure (New York Heart Association Class II–IV).
  • Established Vascular Disease: Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
  • Bleeding Disorders: Active bleedings or known bleeding disorders.

Restricted and Non-Recommended Use

  • Pregnancy and Lactation: The drug is contraindicated during the last trimester of pregnancy and is generally not recommended throughout pregnancy or during lactation.
  • Age: It is not recommended for use in the pediatric population (children) due to insufficient clinical data. Elderly patients are at an increased risk of serious adverse reactions and require caution.
  • Impaired Function: Patients with mild-to-moderate hepatic or renal impairment or mild-to-moderate congestive heart failure (NYHA I) require close medical monitoring and special consideration before use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Aceclofenac's official regulatory profile documents specific interaction patterns that impose restrictions or require precautions with co-administered substances. All interaction information is based strictly on government-mandated product labeling.

Contraindicated Combinations and Timing Restrictions

Concomitant use with other NSAIDs or analgesic doses of Aspirin is restricted, as these combinations are noted to significantly increase the risk of gastrointestinal adverse effects. A mandatory timing constraint exists for Mifepristone; Aceclofenac must not be used for 8–12 days following its administration.

Pharmacodynamic and Exposure-Modifying Interactions

Aceclofenac may alter the plasma concentration of certain co-administered drugs by reducing their renal clearance. This may result in increased plasma levels of agents such as Lithium, Digoxin, and Methotrexate, raising the potential for toxicity of those agents. When co-administered with Anticoagulants, SSRIs, or Systemic Corticosteroids, the risk of bleeding is formally augmented. Co-administration with ACE-inhibitors or Diuretics may reduce the efficacy of those medications while increasing the documented risk of acute renal insufficiency.

Population-Specific Interaction Cautions

Official labeling specifies that the risks of interaction-related renal insufficiency and gastrointestinal bleeding are heightened in elderly patients and individuals with compromised renal function.

Mechanism of Action

Aceclofenac Ecloare exerts its physiological effects by intervening in the biochemical pathways that regulate tissue response. The primary mechanism involves competitive inhibition of cyclo-oxygenase (COX) enzymes, specifically targeting the COX-2 isoform with preference over COX-1. This action, largely mediated by the active metabolite Diclofenac, prevents the conversion of arachidonic acid into pro-inflammatory mediators such as Prostaglandin E2 ( PGE2) . This interference in the chemical signaling cascade reduces the sensitization of peripheral nociceptors and affects the thermal regulatory set-point in the central nervous system. Independently, the mechanism includes suppression of pro-inflammatory cytokines ( IL-1beta and TNFalpha), which modulates the systemic inflammatory response. Additionally, at the tissue level, the drug modulates the metabolic activity of cells within articular cartilage, demonstrated by the stimulation of glycosaminoglycan (GAG) synthesis, a process that affects the composition of the joint matrix.

Dosage and Administration Information

How to Use Aceclofenac Ecloare: Official Administration Principles

Aceclofenac Ecloare, containing the active substance Aceclofenac, is administered according to established principles that govern its route, dosage, and intake conditions. This medicine is generally prescribed at the lowest effective dose for the shortest possible duration necessary to manage symptoms, a principle consistent across all non-steroidal anti-inflammatory drugs (NSAIDs).


Approved Administration and Dosing

The medicine is available for oral administration as 100 mg tablets and is also found in a topical cream formulation for localized application. The oral tablets must be swallowed whole with liquid and should not be crushed or chewed, ensuring the intended delivery of the active substance.

Administration Component Administration Details
Standard Oral Dosing 200 mg daily administered as a 100 mg dose twice daily (morning and evening).
Timing of Intake Tablets should be taken with or immediately after food.
Maximum Daily Dose The dose must not exceed 200 mg per 24 hours.

Population-Specific Use and Missed Doses

Administration protocols include adjustments for specific patient groups. For individuals with mild hepatic impairment, the daily oral dose is reduced to 100 mg. Conversely, no routine dose modification is specified for older adults.

If a dose of the oral tablet is missed, the instruction is to skip the missed dose entirely and resume the regimen at the next scheduled time; a double dose must not be taken to compensate. The need for continued treatment is re-evaluated by the prescriber on a periodic basis.

Recent Clinical Evidence

Aceclofenac Ecloare: Recent Clinical Evidence

Clinical research evaluates the drug's properties in managing pain and inflammation related to various musculoskeletal conditions. Studies typically focus on the drug's influence on symptoms and functional capacity in different patient populations.


Efficacy and Acute Pain Research

Studies examined whether the drug was associated with changes in acute pain levels following administration, particularly in episodes of dental pain, low back pain, and other painful inflammatory processes. Research investigated the drug's influence on reported pain intensity scores and functional improvement in participants with short-term, high-intensity pain.

Research on Chronic Conditions

Clinical trials explored the drug’s potential influence on symptoms associated with chronic inflammatory conditions, such as osteoarthritis (OA) and rheumatoid arthritis (RA). Investigators assessed outcomes like joint stiffness, duration of morning stiffness, and daily activity levels (e.g., using the WOMAC index) over extended periods, often up to 12 weeks. Several studies assessed how different dosing schedules correlated with changes in patient experience and inflammatory biomarkers.


Tolerability Profile and Comparative Studies

Studies assessed the drug's tolerability profile, including the incidence and severity of commonly reported adverse events, with a primary focus on gastrointestinal (GI) issues. Research has investigated the drug's outcomes in older adults, particularly in relation to renal function, and in individuals with pre-existing liver conditions.

Some clinical trials compared the drug's effect on pain and function against that of other nonsteroidal anti-inflammatory drugs (NSAIDs) or standard analgesics. The body of evidence also evaluated potential interactions between the drug and other commonly used agents.

Key Studies & References

  1. Pharmacokinetics and tolerability of aceclofenac in elderly patients and those with mild to moderate renal impairment.

Frequently Asked Questions (FAQ)

Common questions about Aceclofenac Ecloare (FAQ)


Q: Is Aceclofenac Ecloare a type of steroid medicine?

No, official regulatory documents classify Aceclofenac, the active substance in this medicine, as belonging to the group of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). NSAIDs work through a different mechanism than steroids to manage pain and inflammation.


Q: What is the difference between NSAIDs and drugs like Aceclofenac Ecloare?

The medicine is categorized as an NSAID, meaning it belongs to that class of anti-inflammatory and antirheumatic products. NSAIDs work by blocking certain chemicals in the body that cause inflammation and pain. Aceclofenac Ecloare is one such medicine within the official NSAID classification.


Q: Why is Aceclofenac Ecloare sometimes prescribed instead of other similar drugs?

Official information indicates that the medicine's mechanism involves a preferential targeting of the COX-2 enzyme. This characteristic is noted in product information as a factor that differentiates the medicine and is associated with a reported more favorable gastrointestinal tolerability profile compared to some other NSAIDs.


Q: Is the 'Ecloare' component a slow-release or modified-release feature?

The active substance, Aceclofenac, is manufactured in various types of formulations. This includes both conventional tablets and Controlled Release (CR) forms, which are designed to manage the release of the active substance over a set period.


Q: How is Aceclofenac Ecloare different from ibuprofen or naproxen?

The mechanism of Aceclofenac involves a degree of selective preference for inhibiting the COX-2 enzyme. Official product descriptions indicate that this selectivity may contribute to a lower incidence of gastrointestinal side effects compared to some non-selective NSAIDs, such as ibuprofen or naproxen.


Q: What is the main difference between Aceclofenac Ecloare and regular aceclofenac tablets?

Aceclofenac is available in different formats, typically a conventional 100 mg tablet (Immediate Release) and a Controlled Release (CR) formulation. The difference lies in how the drug is released into the body over time, as the CR formulation is designed to allow the active substance to be released over a longer period of time.


Q: Can Aceclofenac Ecloare be used for general back pain?

Official indications cover the relief of pain and inflammation associated with musculoskeletal conditions. These indications specifically include conditions such as osteoarthritis and ankylosing spondylitis.


Q: How long does it usually take for Aceclofenac Ecloare to start working?

According to official pharmacokinetic data, the medicine is rapidly absorbed after oral administration. Peak concentrations in the bloodstream are typically reached within approximately 1.25 to 3.00 hours.


Q: Does Aceclofenac Ecloare have a risk of stomach upset?

Gastrointestinal disorders such as nausea, indigestion, and abdominal pain are listed among the common adverse effects reported in official documents. Official guidance on administration includes taking the medicine with or immediately after food.


Q: What should I avoid eating or drinking while using Aceclofenac Ecloare?

Official warnings note that the consumption of alcohol should be avoided while using this medicine. This is because alcohol intake can increase the risk of gastrointestinal bleeding.


Q: Are there any known long-term side effects from using Aceclofenac Ecloare?

Official guidance emphasizes that any potential risks are more likely with high doses and prolonged treatment. Official bodies have documented a potential small increased risk of cardiovascular and blood vessel problems in people taking anti-inflammatory painkillers for extended periods.


Q: Is it normal to feel a bit dizzy after starting Aceclofenac Ecloare?

Dizziness is a symptom that is listed among the common side effects reported for the medicine in official product information. Official warnings advise that caution should be exercised when engaging in activities such as driving if this symptom occurs.


Q: What is the connection between Aceclofenac Ecloare and kidney function?

The medicine is generally contraindicated for use in patients who have established moderate to severe renal impairment. Additionally, official data indicates the medicine can cause an increase in levels of blood urea and creatinine, which are indicators of kidney function.


Q: Does Aceclofenac Ecloare cause sleepiness or drowsiness?

Drowsiness is listed in official documents as a potential side effect. Official product information notes that if this symptom occurs, activities requiring attention, such as driving or operating heavy machinery, should be approached with caution.


Q: Can I use Aceclofenac Ecloare for pain caused by a sprain?

The medicine is officially indicated for the relief of pain and inflammation associated with a range of musculoskeletal disorders. These indications include conditions such as extraarticular rheumatism (rheumatism affecting soft tissues).


Q: How long do the effects of Aceclofenac Ecloare last?

The pain-relieving effect generally lasts long enough to support the standard twice-daily dosing regimen. The mean plasma elimination half-life is around 4 hours, and this duration supports the common twice-daily dosing regimen described in product information.


Q: Is Aceclofenac Ecloare safe for people with asthma?

Official product information advises that the medicine is generally contraindicated or requires caution for use in patients with a history of asthma or other allergic disorders. This is because NSAIDs can potentially cause an allergic reaction or worsen respiratory symptoms.


Q: What are the current research findings on the long-term use of Aceclofenac Ecloare?

Official guidance stresses using the drug at the lowest effective dose for the shortest duration necessary to control symptoms. Official product information states that the need for continued treatment requires periodic re-evaluation by a healthcare professional.


Q: Can a person develop a tolerance to Aceclofenac Ecloare over time?

Official warnings and information state that there are no known potential for dependence or habit-forming tendencies reported for this medicine.


Q: Is Aceclofenac Ecloare approved for use in children or teenagers?

The medicine is not recommended for use in children and adolescents (typically under 18 years of age). Official information indicates that safety and efficacy data for this age group have not been established.


Q: Is it common for Aceclofenac Ecloare to cause skin reactions or rashes?

Skin rash is listed as a common or uncommon adverse effect in official product information. Official product information notes that the medicine should be discontinued at the first appearance of a skin rash or other signs of hypersensitivity, which should then be reported to a healthcare professional.


Q: Does taking Aceclofenac Ecloare affect liver enzyme levels?

Elevated liver enzymes are listed as a common adverse effect associated with the use of this medicine. Official documentation notes that monitoring of liver function may be necessary during treatment.


Q: Can I use Aceclofenac Ecloare for menstrual pain relief?

The therapeutic effects of the active substance include analgesic (pain-relieving) action. Official indications and clinical data support its use for the treatment of pain associated with various conditions, including menstrual pain (dysmenorrhea).


Q: What information is available about Aceclofenac Ecloare and pregnancy/breastfeeding?

Official information states the medicine is not recommended during the first six months of pregnancy and is contraindicated (should not be used) during the last three months. It is also generally not recommended for use while breastfeeding.


Q: What types of pain is Aceclofenac Ecloare generally described as most effective for?

The medicine is indicated for the relief of pain and inflammation associated with chronic inflammatory conditions. These include osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.


Q: Are there clinical trials suggesting Aceclofenac Ecloare has better absorption than standard aceclofenac?

Official pharmacokinetic data states that the medicine is rapidly and completely absorbed. While food intake may affect the rate at which the drug is absorbed, the total amount absorbed (extent of bioavailability) is not significantly affected.


Q: What should I do if I notice unusual bruising while taking Aceclofenac Ecloare?

The medicine can increase the risk of bleeding disorders or prolong blood clotting time. Official patient information notes that any signs of internal bleeding, such as passing blood or black stools, should be brought to the attention of a healthcare professional.


Q: Is Aceclofenac Ecloare typically prescribed for short-term or long-term issues?

Official guidance states that the medicine should be used at the lowest effective dose for the shortest duration necessary to control symptoms. This emphasizes a principle of short-term use, with long-term use requiring periodic medical re-evaluation.


Q: Is Aceclofenac Ecloare a prescription-only medicine?

Official product information refers to the necessity of a prescription and medical direction for the use and continued treatment with this medicine. This classification is consistent with its status as an NSAID in many jurisdictions.


Q: Does Aceclofenac Ecloare have a known potential for dependence?

Official warnings state that there are no known potential for dependence or habit-forming tendencies reported for this medicine.


Q: Is it required to take Aceclofenac Ecloare with a meal?

Official instructions advise that the medicine should be taken preferably with or immediately after food. This recommendation is intended to help reduce the potential for stomach upset and irritation.


Q: What are the general population limitations for using Aceclofenac Ecloare?

Official contraindications (situations where the drug should not be used) include patients with active gastrointestinal ulceration, severe heart failure, established cardiovascular disease (e.g., ischemic heart disease), moderate to severe renal or hepatic impairment, and women in the last three months of pregnancy.

How should Aceclofenac Ecloare be stored and disposed of?

How to Store and Dispose of Aceclofenac Ecloare

Official regulatory information defines specific environmental and handling constraints to maintain the medicine's stability and ensure safety.

Mandatory Storage Requirements

Requirement Official Instruction
Temperature Store below 30 C (or 25 C, depending on formulation).
Protection Keep in the original container; Protect from light and moisture.
Accessibility Keep out of the reach and sight of children.

Disposal Rules

To discard expired or unused Aceclofenac, follow local pharmaceutical waste regulations. The medicine should not be disposed of in wastewater or household trash due to its documented classification as being potentially toxic to aquatic life. Unused product must be returned to a pharmacy or utilized in a community drug take-back program as instructed by local government authorities.

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

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