Аэртал

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Аэртал

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Medically reviewed

Marina Burgos

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 Аэртал

What is Аэртал? The Drug Identity

Property Description
Active ingredient Aceclofenac
Primary Forms Film-coated tablet, Topical cream, Oral suspension powder
Pharmacological Class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General Purpose Symptomatic relief of pain and inflammation
Origin Synthetic, derived from phenylacetic acid

What Type of Drug is Аэртал? The Core Identity and Classification

Аэртал is a medicinal product defined by its active ingredient, Aceclofenac, and is categorized as a Non-Steroidal Anti-Inflammatory Drug (NSAID). The substance itself is a synthetic compound that is a phenylacetic acid derivative, chemically related to diclofenac. The pharmacological classification places it among the NSAIDs, a group of agents sharing the core function of modulating the body’s response to inflammation and pain. Aceclofenac is designed to provide anti-inflammatory and pain-relieving effects, helping to reduce swelling and ease general discomfort associated with conditions such as joint stiffness. This structural identity characterizes Aceclofenac as a dual-acting agent providing both anti-inflammatory and analgesic effects.

Aceclofenac: General Purpose and Available Forms

The general purpose of Aceclofenac is to provide effective symptomatic relief by addressing the processes that cause discomfort and swelling. Its function is achieved through the inhibition of cyclooxygenase (COX) enzymes, thereby limiting the production of prostaglandins, which are key chemical messengers responsible for initiating pain and inflammation signals. Preparations containing Aceclofenac are utilized for managing pain and inflammation related to rheumatic conditions, providing both a general easing of pain and reduction of inflammatory symptoms. A differentiating factor for Aceclofenac is the comprehensive range of pharmaceutical preparations provided: film-coated tablets and a powder for oral suspension for internal (systemic) action, as well as a topical cream formulation intended for direct local application. The availability of these distinct dosage forms allows the anti-inflammatory and pain-relieving effects of the drug to be applied appropriately for either widespread or localized conditions.

What side effects are possible with Аэртал?

Possible Side Effects and Safety Information

The safety profile of Aertal (aceclofenac), an NSAID, is structured by regulatory authorities based on system-organ classes and frequency of occurrence.

Frequency Examples of Adverse Reactions (by System-Organ Class)
Common (ge 1/100 to <1/10) Gastrointestinal (e.g., Nausea, Diarrhea, Dyspepsia, Abdominal pain), Nervous System (e.g., Dizziness), Hepatobiliary (e.g., increased liver enzymes).
Uncommon (ge 1/1,000 to <1/100) Gastrointestinal (e.g., Flatulence, Constipation, Vomiting, Gastritis), Skin (e.g., Rash, Pruritus, Urticaria), Renal (e.g., increased blood urea).
Rare (ge 1/10,000 to <1/1,000) Immune System (e.g., Anaphylactic reaction, Hypersensitivity), Gastrointestinal (e.g., Ulceration, Gastrointestinal haemorrhage, Melaena), Eye (e.g., Visual disturbance).
Very Rare (<1/10,000) Haematological (e.g., Bone marrow depression), Skin (e.g., Serious mucocutaneous skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis), Cardiac (e.g., Palpitations, Congestive heart failure).

Serious Adverse Reactions and Restrictions

Official regulatory documents highlight the potential for serious adverse events and impose limitations on use. The most critical risks associated with the drug include potentially fatal Gastrointestinal bleeding, ulceration, or perforation. Use is officially contraindicated in patients with active or recurrent peptic ulcer/haemorrhage, severe heart, hepatic, or renal failure, and established Ischaemic Heart Disease, Peripheral Arterial Disease, or Cerebrovascular Disease.

Cardiovascular Risks: The risk of serious arterial thrombotic events (such as myocardial infarction or stroke) is officially stated to increase with higher dosage and longer duration of treatment. The lowest effective dose for the shortest possible duration is recommended to minimize risks.

Population-Specific Caution: Elderly patients are at an officially increased risk of experiencing more severe consequences from adverse reactions, particularly GI bleeding and perforation. The drug is contraindicated in the third trimester of pregnancy.

Overdose and Emergency Response

An overdose of Aceclofenac (Аэртал), a Non-Steroidal Anti-Inflammatory Drug (NSAID), necessitates seeking immediate medical attention due to the potential for severe, officially documented systemic outcomes. Patients must contact a doctor immediately or go to the nearest hospital casualty department in the event of suspected overdosage.

Documented clinical manifestations of overdosage include symptoms such as headache, nausea, vomiting, epigastric pain, dizziness, drowsiness, and disorientation. The regulatory labeling notes that severe or potentially life-threatening outcomes can occur, including gastrointestinal bleeding, hypotension, convulsions, and the possibility of acute renal failure or liver damage in cases of significant poisoning. Coma is also an officially recognized risk.

Management is strictly supportive and symptomatic treatment, as regulatory documents confirm that no specific human data is available on the consequences of Aceclofenac overdosage, meaning no specific antidote is officially listed. Procedural actions officially described include the consideration of administering activated charcoal or performing gastric lavage in adults if a potentially toxic or life-threatening amount was ingested within one hour of seeking professional help. This official structure mandates urgent, professionally managed intervention based on the presenting regulatory profile.

Therapeutic Uses of Аэртал

What Аэртал Treats: Main Uses and Benefits

The primary therapeutic benefit of Aceclofenac is to provide supportive relief by addressing the symptomatic core of painful and inflammatory conditions. This generally helps patients cope more steadily with difficult episodes. As a non-steroidal anti-inflammatory drug (NSAID), it is commonly used for managing symptoms related to pain and inflammation in certain chronic joint conditions. It is indicated for providing relief in these settings.


Therapeutic Scope and Patient Benefit

This medication is commonly applied in the management of conditions characterized by periods of heightened symptoms, including major inflammatory joint disorders like Osteoarthritis (OA), Rheumatoid Arthritis (RA), and Ankylosing Spondylitis (AS). It is also relevant for easing symptoms associated with Low Back Pain, inflammation of soft tissues surrounding the joints, painful dental manifestations (odontalgia), and specific painful gynecological manifestations. This symptomatic assistance is offered when symptoms create noticeable physiological strain and when short-term supportive relief is needed. It is commonly used to help provide supportive relief that assists with easing the overall symptom burden.

“This medication is applied across domains where additional symptomatic support is needed, and is relevant for managing symptoms that interfere with daily comfort.”


Quick Fact: Relief for Pain and Inflammation

The medication is relevant for easing symptoms related to inflammatory or irritative states and is commonly used in settings marked by temporary physiological imbalance. It may assist with the symptoms that interfere with daily functioning, such as joint discomfort and stiffness.

Eligibility and Restrictions for Use

Who Can and Cannot Use Аэртал (Aceclofenac)

Official regulatory guidelines strictly define the eligible patient population for Aceclofenac. Use is generally permitted for adults but is prohibited or restricted based on pre-existing health conditions and age.


Absolute Prohibitions (Contraindications)

Regulatory documents state that use is absolutely contraindicated for patients with:

  • Severe failure of the liver (hepatic), kidneys (renal), or heart (NYHA Class II–IV).
  • Active or recurrent gastrointestinal bleeding/ulceration or a history of perforation related to NSAID use.
  • Documented hypersensitivity to Aceclofenac or cross-reactivity to aspirin/other NSAIDs (precipitating asthma, rhinitis, or angioedema).
  • Women in the third trimester of pregnancy.

Conditional Use and Restrictions

  • Pediatric Use: Use is not recommended in children and adolescents under 18 years of age due to insufficient clinical data.
  • Organ Function: Patients with mild to moderate liver or kidney impairment may use the medicine but require close medical surveillance and potential dose adjustments.
  • Older Adults: The geriatric population is eligible but must be treated with explicit caution due to an increased risk of serious adverse reactions.
  • Pregnancy/Lactation: Use is not recommended during the first two trimesters, and should be avoided while breastfeeding or attempting to conceive.

What should I know about interactions with other medicines?

Interactions with other medicines and products — Official Regulatory Information for Aceclofenac

Aceclofenac's official interaction profile, documented in regulatory sources, establishes restrictions and monitoring requirements for co-administration with multiple substance classes.

Classification Interacting Agents / Classes Regulatory Constraint
Combination Avoidance Other NSAIDs (including Aspirin/COX-2 inhibitors) Avoid concomitant use; increases risk of adverse effects, specifically gastrointestinal bleeding/ulceration.
Exposure Elevation Lithium, Digoxin, Methotrexate May increase plasma concentrations of these agents due to reduced clearance, necessitating monitoring of drug levels to prevent toxicity.
Risk Enhancement Anticoagulants (Warfarin), Corticosteroids, SSRIs Enhances the effects of anticoagulants and other agents affecting hemostasis/mucosa, resulting in a heightened risk of bleeding.
Organ Toxicity Risk Diuretics, Ciclosporin, Tacrolimus Increases the risk of nephrotoxicity; requires monitoring of renal function, especially in the elderly and patients with pre-existing impairment.
Efficacy Reduction Antihypertensives (ACE-inhibitors, ARBs), Mifepristone Reduces the effect of antihypertensives; use with Mifepristone should be avoided for 8–12 days following its administration to prevent reduced efficacy.

The regulatory profile also notes that concomitant use with Oral Antidiabetic Agents may result in isolated hypo- or hyperglycemic effects, requiring consideration for dosage adjustment of the antidiabetic drug. Interaction risks with multiple agents are heightened in elderly patients and those with impaired renal, cardiac, or hepatic function.

Mechanism of Action

How Аэртал works

Targeting the Cyclooxygenase (COX) Enzyme System

Aertal acts primarily by inhibiting the cyclooxygenase (COX) enzymes, particularly the COX-2 isoform, which becomes highly expressed in response to inflammatory stimuli. This mechanism works by blocking the enzyme responsible for converting arachidonic acid into prostanoids. This inhibition acts to disrupt the molecular steps that contribute to the modulation of physiological responses.

⬇️ Attenuation of Prostanoid Synthesis

The inhibition of COX enzymes leads directly to a reduction in the synthesis of pro-inflammatory mediators, such as certain prostaglandins, at the cellular level. By limiting the availability of these signaling molecules, Aertal alters peripheral and central sensory signaling dynamics, thereby modulating the intensity of the pathway activation and influencing the subsequent physiological activity within the pathway.

Dosage and Administration Information

Instruction Map: How to use Аэртал — Administration Guidelines


Administration Scope

Route of administration: The medicine is administered orally (as film-coated tablets or powder for oral suspension) and topically (as a cream/gel).

Dosing schedule: The standard oral dose for adults is 200 mg daily. For the immediate-release tablet form, this is typically administered as 100 mg twice daily, one dose in the morning and one in the evening. The maximum oral dose should not exceed 200 mg per day.

Timing in relation to meals (if applicable): Oral forms should be taken with or immediately after food, as this affects the rate but not the overall extent of absorption.

Preparation requirements (if applicable): Powder for oral suspension must be dissolved in approximately 40–60 ml of water and consumed immediately after preparation.

Age-group administration rules: Use is not recommended in children under 18 years of age due to insufficient clinical data. For older adults, no modification to the dose or frequency is generally considered necessary.

Missed-dose rules: If a dose is missed, it should be taken as soon as it is remembered. However, if it is nearly time for the next scheduled dose, the missed dose should be skipped; do not double the dose.

Special procedural conditions: The medication is administered using the lowest effective dose for the shortest possible duration. For patients with mild to moderate hepatic impairment, the initial daily dose is reduced to 100 mg once daily. Tablets must be swallowed whole and should not be crushed or chewed.


Instruction Classifications (High-Level)

Administration method type (oral / IV / topical / inhaled / etc.): Oral and Topical.

Frequency pattern (daily / weekly / as-needed, etc.): Twice daily (for IR form) or Once daily (for CR form).

Regulatory basis: Based on standard pharmacological specifications.

Use-context constraints: Use is constrained by the principle of lowest dose and shortest duration.


Resulting Procedural Structure

Step sequence:

  • Administer the oral dose as 100 mg twice daily, or 200 mg once daily for controlled-release forms, ensuring the 200 mg daily limit is not exceeded.
  • Take the dose with or immediately after food.
  • Swallow all tablets whole with liquid, without crushing.
  • If using the suspension, dissolve the powder sachet contents in the prescribed amount of water and take immediately.
  • Periodically reassess the need for continued treatment.

Connection to the overall use protocol (2–4 sentences): The instructions define a maximum daily limit of 200 mg and specify the administration method, requiring tablets to be swallowed whole and oral suspension to be properly reconstituted. This protocol follows the principle of treating conditions with the lowest effective dose for the briefest duration necessary. Dose adjustments are defined for patients with mild hepatic impairment.

Recent Clinical Evidence

Research Evidence for Managing Osteoarthritis (OA) Symptoms

The evidence base examining Aceclofenac's application in Osteoarthritis (OA), a condition characterized by functional limitations, includes Randomized Controlled Trials (RCTs) and systematic reviews, which are used to evaluate the symptomatic profile. These studies were used in research exploring how symptoms change over time. The populations observed were generally adults between the ages of 40 and 75 with chronic OA.

In these research scenarios, studies focused on measuring patient-reported outcomes describing perceived discomfort. Researchers utilized metrics like the Visual Analog Scale (VAS) to track outcomes related to physical discomfort. They also monitored changes in the WOMAC Index, a composite measure reflecting daily functioning and activity level. The documented outcomes described patterns of measurement when compared to other active comparators or placebo. However, most follow-up durations were limited, typically spanning only up to three months, meaning long-term effects are not fully established.


Research Evidence for Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS)

Aceclofenac was studied for its use in two other chronic conditions: Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS). Research included comparative trials and RCTs applied in studies examining patient-reported experiences in adults.

For RA, studies explored outcomes related to systemic or functional imbalance, specifically monitoring changes in composite scores like the DAS28. For AS, studies monitored outcomes reflecting spinal mobility and morning stiffness. The research durations (typically 8 and 12 weeks) are short when viewed in the context of the chronic nature of these conditions, and the overall evidence for long-term status over many years is less extensive.


What Research Gaps and Uncertainties Exist for Aceclofenac

A critical limitation across all studied indications is that follow-up durations were consistently limited, providing minimal long-term outcomes data. Data for certain groups, including children or pregnant individuals, remain insufficient within the primary evidence base. Some scientific reviews note that evidence quality varies across studies, and comparative evidence against every newer class of drug now available for these conditions is often lacking.

Frequently Asked Questions (FAQ)

Common questions about Аэртал (FAQ)


Q: How quickly does Аэртал start working for pain?

Official product information indicates that after oral administration, the highest concentration of the active ingredient in the bloodstream is usually reached in approximately 1.25 to 3 hours. This measurement, known as the Tmax, provides an indication of the timeframe for the drug's initial systemic effect.


Q: How long does the effect of Аэртал last?

The drug has a mean elimination half-life of about 4 hours, which means half of the substance is typically cleared from the plasma within this time. This pattern is consistent with the drug’s typical administration frequency outlined in regulatory documents.


Q: Is it true that Аэртал should not be taken with alcohol?

Regulatory guidance for this class of medicine, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), suggests caution. Official documentation cautions against alcohol consumption because combining the medication with alcohol may increase the risk of serious side effects, particularly affecting the gastrointestinal system, such as stomach bleeding.


Q: Is Аэртал addictive?

No, official regulatory classifications indicate that Аэртал (Aceclofenac) is not classified as an addictive substance. As a Non-Steroidal Anti-Inflammatory Drug (NSAID), it works through a fundamentally different mechanism than controlled substances like opioids and does not carry the regulatory classification of an addictive substance.


Q: How long after stopping Аэртал does it stay in the body?

The plasma elimination half-life of the drug is approximately 4 hours. Based on this measure, the majority of the administered dose is typically eliminated from the body within about 24 hours of the last dose.


Q: Is there a difference in how different people react to Аэртал?

Yes, official regulatory information specifies that certain pre-existing conditions can increase the risk of adverse effects. Patients with impaired liver, kidney, or heart function are considered to be at a higher risk and may necessitate close monitoring by a healthcare professional.


Q: Are there any dietary restrictions while using Аэртал?

No specific restrictions on diet are typically noted in the regulatory documents for this drug. However, official documents suggest taking the oral form with or immediately after food, a condition often associated with reducing gastrointestinal discomfort.


Q: What is the difference in how Аэртал affects the body compared to opioids?

The two types of drugs have fundamentally different mechanisms of action. Аэртал, an NSAID, works primarily by inhibiting the Cyclooxygenase (COX) enzyme to limit the production of inflammation and pain signals at the source. Opioids, in contrast, work on opioid receptors in the central nervous system to change the brain's perception of pain.


Q: Can I take Аэртал if I am recovering from surgery?

Official regulatory warnings state that for all NSAIDs, use is contraindicated following coronary artery bypass graft (CABG) surgery. For recovery from other types of surgery, these situations necessitate evaluation by a qualified healthcare professional regarding the risks of bleeding and cardiovascular events.


Q: What research is currently being done on the uses of Аэртал?

Governmental registries that track medical studies provide information on ongoing research involving the drug. Recently registered clinical trials have explored topics such as its interaction with other specific medications and studies designed to check the bioequivalence of different formulations.


Q: Why do official sources sometimes mention the potential for fluid retention with Аэртал?

Official regulatory documents mention fluid retention, known as edema, because NSAIDs can influence certain processes in the kidney. This effect could contribute to the exacerbation of pre-existing conditions such as hypertension or heart failure.

How should Аэртал be stored and disposed of?

Storage and Disposal of Airtal (Aceclofenac)

Official regulatory guidelines establish specific requirements for the storage and disposal of Airtal film-coated tablets to ensure product stability and safety.

Storage Requirements

The medicine must be stored at a temperature below 30 C and must not be stored in a refrigerator.

Storage Constraint Required Condition
Temperature Below 30 C (Do not refrigerate)
Protection Store in original package and keep tightly closed to protect from moisture
Child Safety Keep out of the sight and reach of children
Stability Shelf-life is 3 years when stored under these conditions

Disposal Instructions

Unused or expired Airtal should be disposed of via a drug take-back program whenever possible. If such a program is not available, the medicine may be discarded in household trash after being mixed with an undesirable substance (like coffee grounds or dirt) and sealed in a container. The product is not on the official flush list for disposal via wastewater.

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

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