Engflag

Aceclo SR

Quick links to important sections

Aceclo SR

Aceclo SR_EN

Treatment option:

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 Aceclo SR

Quick Facts Description
Active Ingredient Aceclofenac
Form Sustained-Release Tablet (SR)
Pharmacological Class Non-steroidal Anti-inflammatory Drug (NSAID)
Common Use Symptomatic relief of Pain and Inflammation
Origin Synthetic

Aceclo SR: Classification as a Non-steroidal Anti-inflammatory Drug (NSAID)

Aceclo SR is a specific, synthetic, single-ingredient pharmaceutical preparation containing the active ingredient, Aceclofenac. This medication is classified pharmacologically as a Non-steroidal Anti-inflammatory Drug (NSAID), belonging specifically to the Phenylacetic acid derivative group. Its primary action involves acting as an inhibitor of the cyclooxygenase (COX) enzyme, a key step in the synthesis of prostaglandins.

The drug's properties allow it to control inflammatory responses by affecting the chemical messengers that drive them. This medication helps ease discomfort and swelling by interrupting the body's primary inflammatory process, positioning it as an established tool for systemic symptomatic relief.

What Does the Sustained-Release (SR) Designation Mean?

The SR in Aceclo SR indicates that the medicine is an oral dosage form designed as a Sustained-Release tablet, engineered for prolonged-action. This formulation is intended to continuously release the Aceclofenac into the bloodstream after the oral route of administration, which is the primary differentiating factor from standard immediate-release Aceclofenac formulations.

The design goal of this prolonged-action formulation is to maintain effective drug concentrations over an extended duration, which is suitable for continuous management of persistent symptoms, often allowing for less frequent dosing compared to immediate-release formulations. This engineering supports more stable, long-term symptomatic relief for the adult patient population.

General Purpose: Targeting Inflammation and Pain

The overall general purpose of Aceclo SR is to serve as an effective anti-inflammatory agent, analgesic (pain reliever), and antipyretic. The medication's physiological actions allow it to effectively modulate the inflammatory response and block pain signals throughout the body. This systemic effect means that a typical, neutral use scenario involves managing the discomfort, swelling, or stiffness associated with conditions where inflammation is a key factor.

What side effects are possible with Aceclo SR?

Possible Side Effects and Safety Information

The safety profile for Aceclofenac, classified as a Non-steroidal Anti-inflammatory Drug (NSAID), is documented based on the frequency and the System-Organ Class (SOC) affected. The most frequently reported adverse reactions are associated with Gastrointestinal disorders and Nervous System disorders.

Frequency-Classified Adverse Reactions

Classification Examples of Documented Effects
Common Dyspepsia, Abdominal pain, Nausea, Diarrhea, Dizziness, Elevated hepatic enzymes.
Uncommon Flatulence, Gastritis, Rash, Pruritus, Urticaria, Vomiting.
Rare Anemia, Hypersensitivity reactions, Anaphylactic reactions (including shock), Gastrointestinal bleeding, ulceration, or perforation.
Very Rare Serious skin reactions (e.g., Stevens-Johnson syndrome, Toxic Epidermal Necrolysis), Oedema, Hepatitis.

Serious Adverse Reactions and Safety Patterns

The official label highlights several potentially severe reactions. Gastrointestinal bleeding, ulceration, or perforation are documented as serious events that can occur at any time. Serious skin reactions are classified as Very Rare but potentially fatal, with the highest risk noted early in the course of therapy.

As a class effect of NSAIDs, epidemiological data suggest a possible small increased risk of Arterial Thrombotic Events (such as myocardial infarction or stroke), a risk that may increase with the dose and duration of exposure.

Population-Specific Safety Notes

The regulatory safety text provides specific considerations for patient populations. Elderly patients are noted to have an increased frequency of adverse reactions, particularly serious GI risks. The medication is contraindicated during the last trimester of pregnancy. Furthermore, close surveillance is required for patients with mild to moderate renal or hepatic impairment, and the use of this drug may impair female fertility.

Overdose and Emergency Response

Any confirmed or suspected overdosage of Aceclo SR (Aceclofenac) requires immediate medical attention. Regulators explicitly advise contacting a doctor immediately or proceeding to the nearest hospital casualty department, taking the medication information with you.

Documented manifestations of overdosage may involve the gastrointestinal system and the central nervous system. Symptoms formally documented include Headache, Nausea, Vomiting, Epigastric pain, Dizziness, Drowsiness, Confusion, Tinnitus, and Gastrointestinal irritation. Severe, life-threatening outcomes are possible in cases of significant poisoning. These documented severe outcomes include Acute renal failure, Liver damage, and serious complications such as Convulsions and Coma. Consequences of overdosage, such as severe gastrointestinal bleeding, may be more serious in the elderly.

The official regulatory profile confirms that no specific antidote is known for Aceclofenac poisoning; therefore, management is symptomatic and supportive. Intervention procedures documented in official labeling include considering activated charcoal or gastric lavage if ingested within the hour. Following acute poisoning, close monitoring of Renal function and Liver function is required. For prolonged or frequent convulsions, the official guidance states that intravenous diazepam should be administered.

Therapeutic Uses of Aceclo SR

What Aceclo SR Treats: Main Uses and Benefits

Aceclo SR is relevant for symptomatic management across domains involving chronic musculoskeletal conditions. The medication is used for the relief of pain and inflammation in Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis in adults.

Symptom Management and Clinical Contexts

This medication is applied in addressing conditions where persistent symptoms may intensify temporarily, such as chronic inflammatory joint disorders, including Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis. It is applied across conditions where persistent inflammation drives symptoms and may help improve day-to-day comfort and assist with maintaining functional stability during periods of heightened symptoms.

The support provided by Aceclo SR is relevant for easing symptom clusters associated with inflammatory or irritative states, used when groups of symptoms, such as joint swelling, tenderness, and symptoms that interfere with daily functioning, appear suddenly or fluctuate. It is relevant for easing stiffness, particularly morning stiffness, and can support patients during difficult episodes by helping to ease the overall symptom load.

The medication is also relevant in specific acute clinical scenarios, such as when short-term symptomatic assistance is needed for discomfort and swelling that arise post-operatively or following certain dental procedures, where it is used in settings where short-term symptom stabilization is important.

Quick Fact Relief for
Primary Domain Musculoskeletal Inflammation
Key Symptom Morning Stiffness
SR Benefit Continuous Symptom Control

Eligibility and Restrictions for Use

Eligibility Scope and Contraindications

Aceclo SR (Aceclofenac Sustained Release) is officially indicated for use in adults who do not have documented pre-existing high-risk conditions. Use is not recommended in children under 18 years due to a lack of sufficient clinical data.

Use is strictly contraindicated for the following populations and conditions, as stated in regulatory documents:

Classification Condition/Population
Hypersensitivity Known allergy to aceclofenac or any other non-steroidal anti-inflammatory drug (NSAID), including a history of asthma, urticaria, or acute rhinitis after taking aspirin or other NSAIDs.
Gastrointestinal Active or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding), or a history of GI bleeding/perforation related to previous NSAID therapy.
Cardiovascular Established congestive heart failure (NYHA Class II–IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease. Also contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Organ Failure Severe hepatic failure or severe renal failure.
Reproductive During the third trimester of pregnancy.

Eligibility-Related Restrictions

Caution/Surveillance is required for elderly patients and those with mild-to-moderate renal or hepatic impairment. The drug is not recommended for women who are attempting to conceive due to potential impairment of female fertility, or for use during the first two trimesters of pregnancy and lactation, unless compelling reasons exist.

What should I know about interactions with other medicines?

Aceclo SR (Aceclofenac sustained-release) can interact with several other medicines, potentially altering their effects or increasing the risk of adverse reactions. It is crucial to inform your healthcare provider about all prescription drugs, over-the-counter medicines, and herbal supplements you are currently taking.

Increased Risk of Bleeding and Ulcers

Co-administration with the following medications can significantly raise the risk of gastrointestinal bleeding and ulceration:

  • Other Non-Steroidal Anti-inflammatory Drugs (NSAIDs): Including aspirin, ibuprofen, naproxen, or COX-2 selective inhibitors.
  • Anticoagulants and Antiplatelet Agents: Such as warfarin, heparin, or clopidogrel, due to an enhanced effect on blood thinning.
  • Corticosteroids: Such as prednisone.
  • Selective Serotonin Reuptake Inhibitors (SSRIs): Certain antidepressants like citalopram or fluoxetine.

Potential for Altered Drug Efficacy and Toxicity

Aceclo SR may affect the action of other drugs:

  • Anti-hypertensive Medicines: Such as ACE inhibitors (enalapril), Angiotensin II Receptor Blockers (losartan), and diuretics (furosemide, hydrochlorothiazide); Aceclo SR may reduce their blood pressure-lowering effects and increase the risk of kidney problems.
  • Lithium and Digoxin: Aceclo SR may increase the plasma concentration of these drugs, leading to increased toxicity and requiring close monitoring.
  • Methotrexate: Use with caution, as Aceclo SR may increase its toxicity.
  • Ciclosporin or Tacrolimus: Combining with Aceclo SR may increase the risk of kidney toxicity.

Alcohol: Avoid consuming alcohol, as it may increase the risk of gastrointestinal side effects and excessive drowsiness.

Mechanism of Action

Primary Mechanism: COX-2 Enzyme Inhibition and Prostaglandin Suppression

Aceclofenac functions as a preferential inhibitor of the Cyclooxygenase-2 ( COX-2) enzyme. This interaction blocks the Arachidonic Acid Pathway, thereby suppressing the enzymatic conversion of arachidonic acid and subsequently reducing the systemic concentration of Prostaglandin E2 ( PGE2). The molecular consequence of reduced PGE2 is the modulation of pain signaling pathways via decreased nociceptor sensitization, along with the physiological limitation of vascular changes characteristic of an inflammatory response.

Secondary Modulation of Inflammatory Mediators and Tissue Enzymes

Beyond COX inhibition, Aceclofenac's active metabolite reduces the activity of Matrix Metalloproteinases ( MMPs), which are enzymes associated with tissue restructuring. The molecule also acts to suppress other elements of the inflammatory cascade, including the production of key inflammatory mediators such as Interleukin-1 beta ( IL-1beta). These mechanisms influence the systemic inflammatory response and demonstrate an effect on cellular enzymatic activity separate from PGE2 synthesis inhibition.

Sustained Duration of Mechanism

This sustained presence of the inhibitor molecule prolongs the duration of pathway modulation and facilitates prolonged interference with signaling within the affected physiological pathways.

Dosage and Administration Information

Official Administration Guidelines for Aceclo SR

This section outlines the standardized protocol for the administration and dosing of Aceclo SR (Aceclofenac Sustained-Release 200 mg).

Administration Scope

Instruction Detail
Route of administration: Oral route only, supplied as a sustained-release (SR) tablet or capsule.
Dosing schedule: The standard recommended daily dose for adults is 200 mg, taken as a single unit. This dose also represents the maximum daily dose.
Timing in relation to meals: Administration should occur preferably with or after food.
Preparation requirements: The tablet or capsule must be swallowed whole with sufficient liquid; it must not be chewed, crushed, or broken to maintain its prolonged-action properties.
Age-group administration rules: Pediatric: Not recommended for use due to a lack of clinical data. Elderly: No dose modification is typically necessary, but use should adhere to the lowest effective dose for the shortest duration.
Special procedural conditions: A dose reduction is indicated for adults with hepatic impairment; an initial daily dose of 100 mg is suggested in these patients.

Instruction Classifications

Classification Detail
Administration method type: Oral
Frequency pattern: Once daily (every 24 hours)
Use-context constraints: Administration is tied to food intake and specific patient hepatic status.

Resulting Procedural Structure

The official instructions establish the use of Aceclo SR as a once-daily oral regimen of 200 mg. The core procedural requirement is that the sustained-release unit must be swallowed intact for the formulation to function as intended. This use protocol is also structured by specific dose adjustments mandated for patients with impaired hepatic function, which requires reducing the dose to 100 mg daily.

Recent Clinical Evidence

Aceclo SR: Recent Clinical Evidence

This overview describes the types of clinical research that have examined the sustained-release formulation of aceclofenac (Aceclo SR) in conditions where it is studied. It summarizes what the research explored and what evidence gaps exist, based on regulatory and scientific reviews.

Evidence for Use in Chronic Musculoskeletal Conditions

Research for Aceclofenac has primarily involved short-term studies (Randomized Controlled Trials) applied in studies examining patient-reported experiences related to Osteoarthritis (OA), Rheumatoid Arthritis (RA), and Ankylosing Spondylitis (AS). These trials compared the medicine to a placebo or other active comparator treatments. Outcomes studied relate to physical discomfort, such as pain scores, joint swelling, and functional capacity. Findings describe patterns observed in the studies related to short-term symptom patterns in these adult populations.

Evidence for Use in Acute Pain Settings

Aceclo SR was evaluated in research exploring short-term symptom changes related to acute or disruptive episodes, such as pain following certain dental procedures. These very short-term studies monitored outcomes describing episodic or acute changes over periods of about 24 hours. Research examined the time until patients reported a need for additional medication in the context of acute pain. The evidence in this setting is highly specific and limited to the procedural models studied.

Research Gaps and Formulation Characteristics

Studies have been conducted to understand the Sustained-Release (SR) formulation's characteristics, showing release characteristics that differ from the immediate-release version. However, comparative evidence is lacking for patient outcomes when comparing the clinical efficacy of SR versus immediate-release Aceclofenac in all chronic conditions. A significant research limitation is that the follow-up durations were limited across many key studies, meaning long-term effects are not yet fully established, and long-term outcomes are not well characterized for continuous use.

Frequently Asked Questions (FAQ)

Common questions about Aceclo SR (FAQ)

Q: Why is Aceclo SR formulated as a sustained-release tablet?

The sustained-release (SR) design means the medicine is released slowly into the body over time. Official documents indicate that this prolonged action is intended to maintain a consistent amount of the active ingredient for continuous symptom management. This design is consistent with a once-daily regimen.

Q: Does Aceclo SR need to accumulate in the body over several days to work effectively?

Sustained-release formulations are designed to provide a controlled release of the medicine to maintain stable levels in the body. This consistent concentration is intended to help support a prolonged therapeutic effect suitable for the continuous management of symptoms.

Q: Are there any known issues with driving or operating machinery mentioned in official materials for Aceclo SR?

Official information advises avoiding driving or using machinery if specific side effects are experienced. This warning is in place because side effects such as dizziness, drowsiness, vertigo, tiredness, or difficulties with eyesight are documented potential effects of the medicine.

Q: Is there a risk of weight changes (gain or loss) associated with Aceclo SR use?

Official safety information documents water retention, or oedema, as a potential side effect. This is classified as a very rare effect. Oedema involves water retention and is documented in official patient information.

Q: Can I take non-prescription cold and flu medicine while using Aceclo SR?

Regulatory documents include warnings about interactions between Aceclo SR and other Non-Steroidal Anti-inflammatory Drugs (NSAIDs). Since many non-prescription cold and flu remedies may contain other NSAIDs, regulatory documents describe the potential for interaction with other NSAIDs.

Q: Can Aceclo SR be used for temporary, acute pain like a sprain?

Authorized indications for this medicine include the treatment of painful conditions. This covers a range of processes, such as dental pain and certain types of post-operative pain, as described in official documents.

Q: How is Aceclo SR different from other common over-the-counter pain relievers?

Aceclo SR is a prescription-only medicine belonging to the NSAID class of drugs. It differs from many common over-the-counter options because it is a sustained-release product, meaning it is designed for a prolonged effect, which aligns with its use for chronic conditions.

Q: Is feeling dizzy or drowsy a recognized side effect of Aceclo SR?

Regulatory safety information documents that dizziness is listed as a common side effect of this medicine. Drowsiness, or somnolence, is also listed as a potential, though very rare, side effect in official safety information.

Q: Can Aceclo SR cause headaches or ringing in the ears?

Official safety information lists headache and tinnitus (ringing in the ears) as potential adverse reactions. Both effects are documented as very rare.

Q: What is the expected duration of effect from a single dose of Aceclo SR?

The sustained-release formulation is designed to release the medicine over a longer time compared to standard tablets. This prolonged effect is consistent with the recommended dosing schedule of a once-daily regimen.

Q: Can the sustained-release tablet of Aceclo SR be crushed or broken for easier swallowing?

Official administration instructions state that the tablet must be swallowed whole with liquid. Crushing or breaking the tablet would damage the sustained-release coating, which is essential for the medicine’s prolonged-action properties.

Q: Are there any specific dietary restrictions mentioned for patients taking Aceclo SR?

Outside of the specific interaction warning related to alcohol, there are no general dietary restrictions listed in regulatory documents. The administration guidelines indicate that the tablet should be taken with or after food.

Q: Does Aceclo SR have any known effect on common blood test results?

The official safety profile documents that the medicine may affect certain blood test results. This includes potential increases in hepatic (liver) enzymes, which are common, and increases in blood urea and creatinine levels, which are uncommon.

Q: Where can I access the official patient information leaflet or package insert for Aceclo SR?

Official documents, such as the Summary of Product Characteristics (SmPC) or the Patient Information Leaflet (PIL), are public-facing documents. They are typically available from the website of the national drug regulatory authority in the country where the product is approved.

Q: Has research examined the use of Aceclo SR in conditions other than arthritis?

While the primary research focuses on chronic conditions like various forms of arthritis, studies have also examined its use in other painful and inflammatory conditions. This includes research related to dental pain and pain after certain procedures.

Q: Are there official studies that compare the safety profiles of different Aceclofenac formulations?

Research summaries note that evidence may be lacking regarding a direct comparison of the clinical efficacy between the sustained-release and immediate-release formulations. Official safety documentation typically refers to the overall NSAID drug class effects.

Q: Is it true that Aceclo SR must be taken at the exact same time every day?

The medicine is designed as a once-daily regimen, intended for use every 24 hours. Consistent administration timing is important for sustained-release medicines to help ensure stable drug levels are maintained in the body.

Q: What is the purpose of the color or specific shape of the Aceclo SR tablets?

Official packaging and information materials describe the physical characteristics of the tablet, such as its color and shape. These features are defined by the manufacturer and serve as a method for clear product identification.

How should Aceclo SR be stored and disposed of?

How to Store and Dispose of Aceclo SR

The storage and disposal of Aceclo SR (Aceclofenac Sustained-Release) must follow specific governmental regulatory guidelines to maintain product stability and ensure public safety.

Official Storage Requirements

Condition Requirement
Temperature Store below 30°C. Some official labeling specifies below 25°C.
Protection Keep the product in its original container, protected from light and moisture.
Child Safety Keep out of the sight and reach of children.

Disposal Instructions

Unused or expired Aceclo SR must not be thrown away via wastewater or household garbage. Disposal must be performed according to local regulations for pharmaceutical waste, which often involves returning the product to a pharmacy or designated collection point.

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

Equivalent of Aceclo SR found in:

A-Z Index: