Диклотол

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Диклотол

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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

Overview of Диклотол

Quick Facts

Property Description
Active Ingredient Aceclofenac
Form Tablets (Film-coated)
Pharmacological Class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common Purpose Relief of pain, inflammation, and fever
Origin Synthetic (Phenylacetic acid derivative)

What Type of Medicine is Диклотол? (Classification and Origin)

Диклотол is a prescription medicine whose active component is Aceclofenac, classifying it as a Non-Steroidal Anti-Inflammatory Drug (NSAID). Aceclofenac is a synthetic compound that belongs to the phenylacetic acid derivative group. The substance has a documented benefit-risk profile for its intended use, which supports its clinical classification.

The official global classification for Aceclofenac when used for systemic purposes is M01AB16 under the WHO Anatomical Therapeutic Chemical (ATC) code system. Диклотол is generally marketed as a single-ingredient product, focusing the entire therapeutic effect on the actions of the Aceclofenac compound.

The Core Purpose of Aceclofenac

The general purpose of Aceclofenac is to provide systemic symptomatic relief by functioning simultaneously as an anti-inflammatory agent, an analgesic agent (pain reliever), and an antipyretic agent (fever reducer). It is typically used for the effective management of pain and swelling stemming from inflammatory processes.

Aceclofenac is recognized as an effective agent for pain management, with a reliable analgesic effect. Its function as an anti-inflammatory agent means it addresses the source of discomfort rather than simply masking the pain. This dual action is the drug’s primary benefit.

Form and Composition of the Drug

Диклотол is formulated for the oral route of administration and is supplied as solid dosage forms, specifically tablets that are commonly film-coated. This formulation is necessary for the substance to be properly absorbed into the bloodstream for widespread systemic treatment. The use of a film-coated tablet is a distinctive feature, designed to optimize stability and release characteristics.

The composition consists solely of the Aceclofenac compound, serving as the active ingredient, integrated into the tablet matrix and the outer base/vehicle components.

Regulatory References

  1. Public Assessment Report (PAR)

What side effects are possible with Диклотол?

Possible Side Effects and Safety Information

Диклотол, containing the active ingredient diclofenac (a Nonsteroidal Anti-inflammatory Drug or NSAID), can cause side effects ranging from common and mild to rare and serious.


Common Side Effects

The most frequently reported side effects are generally gastrointestinal in nature. These may include:

  • Nausea, vomiting, diarrhea, or constipation
  • Indigestion, heartburn, or abdominal pain
  • Bloating or gas

Central Nervous System effects like headache, dizziness, and tinnitus (ringing in the ears) are also possible.


Serious Warnings and Precautions

As with all systemic NSAIDs, diclofenac carries Boxed Warnings regarding serious risks. Patients should seek immediate medical attention if they experience symptoms related to the following:

  • Cardiovascular Risk: NSAIDs can increase the risk of serious thrombotic events (heart attack or stroke), which can be fatal. This risk may be higher with prolonged use and in individuals with pre-existing heart disease or risk factors (like high blood pressure).
  • Gastrointestinal Risk: There is an increased risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. This can occur without warning symptoms.
  • Other Serious Effects include severe allergic reactions, liver problems (jaundice, dark urine), and kidney issues (changes in urine output, swelling).

Diclofenac is generally contraindicated for treating pain right before or after coronary artery bypass graft (CABG) surgery, and caution is advised for pregnant individuals, especially late in pregnancy. It is recommended to use the lowest effective dose for the shortest duration necessary to manage symptoms.

Overdose and Emergency Response

Overdose and when to seek help

The information below summarizes the officially documented descriptions of overdose for Aceclofenac (Диклотол) and the required emergency actions, strictly based on government regulatory labeling.

Overdose scope

Category Description
Documented overdose presentations Gastrointestinal effects (nausea, vomiting, epigastric pain, diarrhea, gastrointestinal bleeding) and Central Nervous System (CNS) disturbances, including headache, drowsiness, disorientation, excitation, and convulsions [Source 1.1]. Other signs include dizziness, tinnitus, hypotension, and respiratory depression [Source 1.1].
Physiological systems affected (as stated in label) Gastrointestinal system, Nervous System, Renal system (Acute Renal Failure), Hepatic system (Liver Damage), and Cardiovascular system [Source 1.1].
Population-specific overdose notes (if applicable) The elderly have an increased risk for serious gastrointestinal reactions, such as bleeding and perforation, which may be fatal [Source 1.3].
When immediate medical help is required (label-derived phrasing only) Urgent medical attention must be sought for the management of significant poisoning and the appearance of severe or life-threatening symptoms [Source 1.1].

Resulting overdose structure

Official overdose statements:

  • When a potentially toxic amount is ingested, management must be symptomatic and supportive [Source 1.4].
  • No specific antidote is known, and elimination procedures like dialysis or haemoperfusion are noted as being unlikely to be helpful due to high protein binding [Source 1.1].
  • Immediate supportive measures include considering the administration of activated charcoal within one hour, and patients must be observed for at least four hours following the ingestion of potentially toxic amounts [Source 1.1].
  • In the event of frequent or prolonged convulsions, regulatory instructions specify treatment with intravenous diazepam [Source 1.1].

Note: The content above reflects specific information documented in government-authorized prescribing information, where [Source 1.1] refers to the Aceclofenac SmPC/Prescribing Information provided by national regulatory authorities, [Source 1.3] refers to warnings on NSAID use in the elderly, and [Source 1.4] refers to the general management of Aceclofenac overdose.

Therapeutic Uses of Диклотол

What Диклотол Treats: Main Uses and Benefits

Диклотол (Aceclofenac) is generally applied across therapeutic domains that involve symptoms related to physical discomfort, systemic imbalance, and symptoms that interfere with daily functioning. The primary uses are aligned with addressing symptoms of increased neurological or muscular activity associated with inflammatory joint conditions. Its primary utility is to provide systemic symptomatic relief in situations where discomfort and swelling interfere with physical comfort and daily stability.

The medication is commonly used to help with symptoms related to inflammatory or irritative states of chronic joint diseases, specifically including Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis. It is also applied across domains where additional symptomatic support is needed for painful inflammatory states outside the major joints, such as Low Back Pain and soft tissue rheumatism like scapulohumeral periarthritis.

“It helps address symptom clusters that may become intense or disruptive, including persistent joint pain, localized tenderness, and stiffness.”

This supportive relief is also relevant when short-term symptomatic assistance is needed to help manage acute manifestations, for instance, following minor physical trauma or specific dental procedures. By easing the overall symptom load, the medication contributes to improved comfort during periods of heightened symptoms and assists with maintaining functional support.


Quick Fact: Therapeutic support for Inflammatory Discomfort

Eligibility and Restrictions for Use

Диклотол, which contains the active ingredient diclofenac, is a non-steroidal anti-inflammatory drug (NSAID) primarily used by adults for the relief of pain and inflammation associated with conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It is generally advised to use the lowest effective dose for the shortest necessary duration.


Contraindications (Who Cannot Use Диклотол)

This medication is not suitable for everyone. Do not use Диклотол if you have:

  • A known allergy to diclofenac, aspirin, or any other NSAID.
  • A history of severe allergic reactions (e.g., asthma, angioedema, urticaria) after taking aspirin or other NSAIDs.
  • Active or recurrent stomach/intestinal ulcers, bleeding, or perforation.
  • Severe heart failure.
  • Established ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease.
  • Severe liver or kidney disease.
  • In the setting of coronary artery bypass graft (CABG) surgery (perioperative period).
  • Are in the last three months of pregnancy, as it may cause harm to the fetus and complications during delivery.

Cautions (Use with Caution)

Discuss your medical history with a doctor before use, as caution is advised for patients with high blood pressure, fluid retention, asthma (non-aspirin related), Crohn's disease, ulcerative colitis, or during the first six months of pregnancy and while breastfeeding. Elderly patients are also at a higher risk of serious side effects, particularly gastrointestinal bleeding and kidney problems.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The regulatory profile for Диклотол (Aceclofenac) outlines specific constraints regarding co-administration with other medicines, substances, and certain conditions. The profile is primarily structured around interactions that increase risk, modify drug exposure, or reduce therapeutic efficacy.

Official Interaction Statements

Co-administration with other NSAIDs, including COX-2 selective inhibitors and high-dose Aspirin, is restricted due to a significantly increased risk of gastrointestinal bleeding.

The product may enhance the effects of Anticoagulants (e.g., Warfarin) and other antiplatelet agents, leading to an increased risk of bleeding.

Aceclofenac may inhibit the elimination of Lithium and Methotrexate, which can result in elevated plasma concentrations and increased toxicity of those medicines.

Concomitant use with Antihypertensives (e.g., ACE-inhibitors, Angiotensin II Receptor Antagonists) may result in a reduced antihypertensive effect and an increased risk of acute renal insufficiency, especially in patients with compromised renal function.

Timing separation is required for Mifepristone; Aceclofenac should not be used for 8 to 12 days following its administration, as it can reduce the effect of Mifepristone.

Combination with Ciclosporin or Tacrolimus carries an increased risk of nephrotoxicity. Caution is advised with Alcohol, as it may increase the risk of stomach bleeding.

Mechanism of Action

The mechanism of action for Диклотол (Aceclofenac/Diclofenac) is centered on its ability to interfere with key enzyme activity that regulate specific biochemical pathways.

Targeting the Eicosanoid Pathway

The drug's primary action involves inhibiting cyclooxygenase (COX) enzymes, particularly the inducible COX-2 isoform. This enzyme inhibition prevents the conversion of arachidonic acid into prostaglandins and other eicosanoids, which are chemical mediators involved in local signal transduction and physiological responses.

Attenuating Inflammatory Responses

By suppressing the production of these key mediators, the drug initiates a mechanistic cascade that leads to a reduction in local chemical signaling associated with pathway activation. This results in the suppression of pathway activation at the cellular and tissue level, which alters signal dynamics within the targeted pathways.

Modulating Sensory and Thermal Signals

The reduction of prostaglandin concentration impacts the sensitivity of peripheral nerve endings and affects the hypothalamus's thermal regulation. This modulating effect on peripheral and central signaling contributes to predictable physiological adjustments. This modulation restricts the influence of mediator activity on sensory transduction and hypothalamic thermal regulation.

Dosage and Administration Information

Official Administration Guidelines: How to Use Diclotol (Aceclofenac 100 mg)

These instructions outline the guidelines for using Diclotol (Aceclofenac 100 mg film-coated tablets) and should be followed.

Administration Scope Official Instruction
Route of Administration Oral (by mouth)
Standard Daily Dose The recommended total daily dose is 200 mg.
Dosing Frequency The 200 mg dose must be split into two separate doses of 100 mg each, typically taken morning and evening.
Duration Constraint Use the lowest effective dose for the shortest duration necessary to manage symptoms.

Procedural and Population Rules

Administration Conditions: The film-coated tablet must be swallowed whole with sufficient liquid. It is required to take the tablet preferably with or immediately after food to minimize gastrointestinal upset. The tablet must not be crushed or chewed.

Population-Specific Adjustments:

  • Hepatic Impairment: For patients with mild to moderate liver function impairment, the suggested initial daily dose must be reduced to 100 mg (one tablet per day).
  • Children (<18 years): Use of Aceclofenac is not recommended in children and adolescents due to a lack of sufficient clinical data.
  • Elderly Patients: While no specific dose modification is required, use the lowest effective dose for the shortest duration due to increased risk of adverse reactions.

This structure ensures the medication is delivered correctly and according to its established safety profile.

Recent Clinical Evidence

Research evidence / Overview of studies for Диклотол

Evidence for use in Chronic Joint Conditions

This section describes the structure of the research that has examined Aceclofenac, focusing on adult patients with long-term inflammatory joint diseases. The evidence base includes large-scale research projects, such as Randomized Controlled Trials (RCTs) and meta-analyses, which studies explored using patient-reported experiences to monitor how symptoms change over time during the study periods.

Research Focus for Osteoarthritis (OA)

Research for Osteoarthritis (OA), a condition marked by functional limitations, has primarily used short-term RCTs and reviews of those trials. The studies examined outcomes related to physical discomfort, specifically measuring pain intensity scores and changes in physical function indices like the WOMAC Index. Studies report how symptoms evolved in the observed populations during the short-term observation windows, with reported outcomes focused on the initial 4 to 12 weeks of observation. However, the evidence quality varies across studies, and some analyses have noted that the sample sizes were modest in a number of the original trials, leading to a degree of heterogeneity in the findings.

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

Aceclofenac was studied for Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS), which are conditions characterized by fluctuating or episodic manifestations. The research primarily utilized comparative clinical studies that explored outcomes related to systemic or functional imbalance. These studies monitored widely accepted metrics, such as disease activity scores and the measured count of tender and swollen joints, as well as patient-reported outcomes describing perceived discomfort. Studies describe patterns observed in these group measurements, comparing how the outcomes evolved in the observed populations relative to comparator medications.

Evidence for use in Musculoskeletal and Soft Tissue Pain

The evidence for outcomes related to physical discomfort stemming from conditions like Low Back Pain (LBP) and other extra-articular rheumatic conditions was evaluated in double-blind multicenter studies and other RCTs. These studies were evaluated in populations dealing with both acute and chronic phases of these conditions, which are often marked by functional limitations. Research monitored changes in pain intensity scores and functional status metrics over relatively short time frames. The studies monitored patterns related to symptom evolution over these short, defined intervals, with most follow-up durations being limited to only about 10 days to 2 weeks.

Frequently Asked Questions (FAQ)

Common questions about Диклотол (FAQ)

Q: What is the information about using Диклотол during pregnancy?

Official labeling notes that the drug should be avoided starting at 30 weeks of pregnancy because of the risk of causing harm to the developing fetus's circulatory system. For use earlier in pregnancy, official documents state that caution is advised.

Q: What is the information about using Диклотол while breastfeeding?

Official sources advise caution regarding use while breastfeeding. While no specific information is readily available on the amount of medicine that passes into breast milk, official information indicates that use during breastfeeding is generally not recommended due to potential risks to the infant.

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

According to the official product information (pharmacokinetic studies), the medicine is absorbed relatively quickly. Peak concentrations in the bloodstream are typically reached approximately 1.25 to 3 hours after the tablet is swallowed.

Q: How long does the effect of Диклотол last after taking it?

Official pharmacokinetic data indicates that the medicine has an elimination half-life of approximately 4 hours. This refers to the time it takes for half of the drug to be eliminated from the bloodstream.

Q: What happens if I miss a scheduled amount of Диклотол?

Regulatory patient information describes procedures for a missed amount, stating it can be taken as soon as it is remembered. However, if it is nearly time for the next scheduled amount, the missed amount is described as being skipped entirely. Official documents caution that double amounts should not be taken to replace a missed amount.

Q: Are there known interactions between Диклотол and herbal supplements?

Official regulatory guidance emphasizes the importance of reporting all medicines, supplements, herbs, and vitamins to a healthcare provider. This is essential to prevent potential interactions that could affect how the medicine works or increase the risk of side effects.

Q: What is the purpose of the coatings on some Диклотол tablets?

The tablets are supplied as film-coated tablets, which is a feature of the formulation. This coating is designed to help optimize the stability of the medicine and regulate its release characteristics, and supports the absorption of the active ingredient for systemic treatment.

Q: Is Диклотол available without a prescription?

Official regulatory sources classify this medicine as a prescription-only medicine (POM or Rx-only) in many jurisdictions. This classification means it is only available when supplied by a registered practitioner.

Q: Is there any information on Диклотол for people with diabetes?

Yes, official documents note that the medicine may alter the effects of anti-diabetic medicines (specifically oral hypoglycemic agents). Regulatory information indicates that dosage adjustments for the anti-diabetic medicine may be considered during co-administration.

Q: How is Диклотол different from other common pain relief medicines?

The drug is officially classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). Its core purpose is to provide relief by functioning simultaneously as an anti-inflammatory agent, an analgesic (pain reliever), and an antipyretic (fever reducer).

Q: Is Диклотол the same type of medicine as ibuprofen?

Official classification indicates that both medicines belong to the same pharmacological class. They are both classified as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Q: Can Диклотол interact with blood pressure medications?

Yes. According to official interaction statements, the medicine may reduce the effect of certain blood pressure medications (Antihypertensives, such as ACE-inhibitors). The combination also carries an increased risk of acute renal insufficiency (a type of kidney problem).

Q: Does Диклотол interact with alcohol?

Official documents advise caution regarding co-administration with alcohol. Taking the medicine with alcohol may increase the risk of gastrointestinal (stomach) bleeding.

Q: Does Диклотол affect the blood clotting process?

Official regulatory information indicates that the medicine may enhance the effects of anticoagulants and other antiplatelet agents. This effect on these types of medications results in an increased risk of bleeding.

Q: What is the recommendation for taking Диклотол before surgery?

Official documentation identifies that the medicine is contraindicated (not permitted for use) for pain relief right before or immediately following coronary artery bypass graft (CABG) surgery.

Q: Why do official documents warn about fluid retention with Диклотол?

Fluid retention and swelling (edema) have been reported in association with this class of medicine in clinical observations. This warning is relevant for patients, especially those with a history of high blood pressure or mild to moderate heart failure.

How should Диклотол be stored and disposed of?

How to Store and Dispose of Diklotol (Aceclofenac)

Official regulatory labeling outlines specific environmental conditions necessary to maintain the integrity and stability of Diklotol tablets. The medication must be stored at a temperature below 30°C and kept in a dry place. It is mandatory to protect the tablets from both light and moisture throughout storage.

Safety and Disposal Requirements

For household safety, the medicine must be kept out of the sight and reach of children at all times. The labeled shelf-life of the unopened product is typically three years, provided the required storage conditions are met.

Disposal instructions reflect the product's environmental classification. Unused or expired Diklotol should not be released into drains or water courses due to its aquatic toxicity. Disposal must follow official guidelines, often requiring transfer to an approved waste disposal plant or adherence to specific FDA-recommended procedures for household trash.

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

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