Mycinadol

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Mycinadol

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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 Mycinadol

What is Mycinadol?

Mycinadol is a proprietary designation for a pharmaceutical product whose single active substance is the generic compound, Aceclofenac. The medication is formally classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID), placing it within a therapeutic category recognized for managing pain and inflammation. Aceclofenac is a synthetic compound structurally identified as a phenylacetic acid derivative, a chemical lineage that includes the related NSAID, Diclofenac.

The classification as an NSAID signifies that its primary systemic effect involves the controlled interruption of the biological cascade that produces inflammatory signals in the body. The active ingredient functions by inhibiting the synthesis of prostaglandins, which are key chemical mediators of inflammation and pain. This recognized mechanism is what allows the medicine to control the processes of swelling and pain.

Mycinadol is a single-ingredient product (monotherapy) and is typically presented as a tablet or film-coated tablet intended for the oral route of administration. The fundamental purpose of this medication is to provide systemic relief by suppressing the chemical mediators that generate symptoms such as chronic joint pain or acute musculoskeletal discomfort. By suppressing the activity of the cyclooxygenase (COX) enzyme necessary for prostaglandin production, the medication acts as an analgesic and anti-inflammatory agent.

Regulatory References

  1. DailyMed - Aceclofenac Label

What side effects are possible with Mycinadol?

Possible Side Effects and Safety Information

Mycinadol, as an NSAID (Nonsteroidal Anti-Inflammatory Drug), is associated with a risk of serious adverse reactions, which are classified and documented by government regulatory bodies. These risks include effects on the gastrointestinal and cardiovascular systems.


Key Adverse Reaction Categories

Classification Examples of Documented Reactions
Serious and Clinically Significant Risks Gastrointestinal bleeding, ulceration, or perforation (potentially fatal); Serious cardiovascular thrombotic events (e.g., heart attack, stroke); Severe skin reactions (e.g., Stevens-Johnson Syndrome); Anaphylactic/allergic reactions; Renal toxicity.
Common Headache, dizziness, nausea, vomiting, abdominal pain, dyspepsia, constipation, diarrhea.
System-Organ Classes Involved Gastrointestinal disorders, Nervous system disorders, Skin and subcutaneous tissue disorders, Renal and urinary disorders, Cardiac disorders, Hepatobiliary disorders, Immune system disorders.

Safety-Related Restrictions and Limitations

Regulatory documents highlight conditions under which Mycinadol must not be used (contraindications) or requires extreme caution:

  • Cardiovascular Risk: Contraindicated for the treatment of peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery. The risk of serious cardiovascular thrombotic events may increase with the duration of use and higher doses.
  • Gastrointestinal Risk: Use is contraindicated in patients with active or previous gastrointestinal ulceration or bleeding. Risk is heightened in the elderly or when used with certain other medications.
  • Hypersensitivity: Contraindicated in patients with a history of asthma, urticaria, or other allergic-type reactions to aspirin or other NSAIDs.
  • Pregnancy: Contraindicated in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus.
  • Renal Function: Contraindicated in patients with advanced renal disease. The elderly are at higher risk of adverse renal effects.

The official regulatory safety profile advises using the lowest effective dose for the shortest duration consistent with individual patient treatment goals to minimize potential risks, particularly those related to the cardiovascular and gastrointestinal systems.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents define the required response and documented outcomes for accidental or intentional ingestion of Aceclofenac substantially exceeding the prescribed dosage.

Documented Overdose Manifestations
Initial symptoms may include gastrointestinal effects such as nausea, vomiting, and epigastric pain, along with Central Nervous System (CNS) effects like headache, disorientation, and drowsiness.
Severe Outcomes and Required Actions
Serious complications cited in regulatory labeling include the potential for acute renal failure, liver damage (hepatotoxicity), severe gastrointestinal bleeding, and convulsions (seizures).

In the event of a known or suspected overdose, the official regulatory guidance requires the patient to seek immediate medical attention by contacting emergency services. This urgent action is required due to the risk of life-threatening systemic toxicity. Management is defined as strictly symptomatic and supportive treatment, as no specific antidote is known for Aceclofenac overdose. Medical care typically involves procedures to reduce drug absorption and hospital monitoring of vital organ functions, especially renal and hepatic function, to manage potential complications.

Therapeutic Uses of Mycinadol

What Mycinadol Treats: Main Uses and Benefits

Mycinadol (Aceclofenac) is a medication utilized for supportive therapeutic benefit, primarily focusing on symptoms related to inflammatory or irritative states and physical discomfort. It is applied across domains where short-term or chronic symptomatic assistance is needed to ease the overall burden of distressing manifestations. The core therapeutic indications are commonly associated with the relief of pain and inflammation in chronic diseases such as Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis.

The medication is used for managing symptoms that create noticeable physiological strain, encompassing persistent pain, joint swelling, and the characteristic functional stiffness common in arthritis. It is also applied in scenarios where additional management of discomfort is required for specific conditions like Low Back Pain (LBP), extra-articular rheumatism, odontalgia (dental pain), and acute painful conditions in gynaecology.

“The medication is applied to help address symptom clusters that may become intense or disruptive, contributing to improved comfort during symptomatic periods.”

Quick Fact: Relief for Inflammatory Discomfort

Mycinadol is commonly used to help with pain and stiffness in conditions characterized by periods of heightened symptoms. This use supports patients during difficult episodes by easing distress and assists with functional stability when symptoms interfere with routine activities.

Regulatory References

  1. Summary of Product Characteristics from the FDA Verification Portal

Eligibility and Restrictions for Use

Mycinadol is a prescription medication, and its use must always be determined by a healthcare provider after a complete assessment of the patient's medical history.

Absolute Contraindications

Mycinadol should not be used by individuals with a confirmed hypersensitivity or allergic reaction to the active ingredients or any excipients in the formulation. Patients with a history of asthma, hives, or other allergic-type reactions after taking aspirin or other Nonsteroidal Anti-inflammatory Drugs (NSAIDs) should avoid this medication due to the risk of severe reactions.


Special Populations and Conditions

Use in certain populations or with specific medical conditions requires caution or is generally contraindicated:

Population/Condition Guideline for Mycinadol Use
Coronary Artery Bypass Graft (CABG) Surgery Contraindicated immediately before or after the procedure.
Cardiovascular Disease Use is often contraindicated in established conditions such as heart failure (NYHA Class II-IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease.
Gastrointestinal Risk Use is cautioned in those with a history of gastrointestinal bleeding or ulcers, especially when used long-term or at high doses.
Renal or Hepatic Impairment Use requires careful dose adjustment and monitoring due to the risk of worsening function.
Pregnancy/Breastfeeding Avoid use, particularly in the third trimester of pregnancy, as it may cause harm to the fetus. Consult a doctor.
Older Adults (65+) Use the lowest effective dose for the shortest duration due to an increased risk of serious side effects, particularly gastrointestinal and cardiovascular events.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Mycinadol (Aceclofenac) is based on official documented patterns that modify drug exposure or create enhanced physiological risks when co-administered with other substances.

Prohibited and Pharmacodynamic Interactions

Due to the heightened risk of adverse effects, including gastrointestinal bleeding, the concomitant use of Mycinadol with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including COX-2 selective inhibitors and analgesic doses of Aspirin, should be strictly avoided. The medicine enhances the activity of Anti-coagulants (such as Warfarin) and, when combined with Corticosteroids or SSRIs/SNRIs, increases the risk of gastrointestinal ulceration or bleeding. Additionally, combining the medicine with Quinolone antibiotics is associated with an increased risk of convulsions.

Exposure Modification and Timing Rules

Mycinadol may reduce the clearance and increase the plasma concentrations of certain medicines, including Lithium, Methotrexate, and Cardiac Glycosides (e.g., Digoxin). This requires close regulatory attention to dosage and monitoring. Furthermore, the effectiveness of Anti-hypertensives and Diuretics may be officially reduced. A mandatory timing constraint exists for Mifepristone, as the NSAID should not be used for 8 to 12 days following its administration. The risk of gastric bleeding is also increased with the consumption of Alcohol. In elderly patients or those with compromised renal function, co-administration with ACE-Inhibitors or ARBs may increase the risk of acute renal insufficiency.

Mechanism of Action

The action of Mycinadol, containing Aceclofenac, is defined by two primary, interconnected pharmacological domains that exert a precise influence on the body's eicosanoid cascade and tissue catabolic pathways. The overall effect is achieved through the modification of chemical messenger synthesis and the subsequent modulation of tissue catabolic processes.

Modulation of Inflammatory Mediator Synthesis

This core domain involves the drug's activity as a preferential inhibitor of the Cyclooxygenase-2 ( COX-2) enzyme. By suppressing COX-2, the drug directly interrupts the Arachidonic Acid Cascade , thereby reducing the de novo synthesis of prostaglandins ( PGE2) and other eicosanoids that sensitize peripheral nerve endings. This molecular sequence results in anti-nociception (decreased sensitization of peripheral nociceptors) and anti-inflammation (diminished vascular permeability).

Interference with Tissue Catabolism

Secondary mechanistic activity involves the drug's capacity to modulate other elements of the inflammatory state by suppressing pro-inflammatory signals like Interleukin-1 beta ( IL-1beta) and key tissue-degrading enzymes, the Matrix Metalloproteinases ( MMPs). This action affects the balance of enzymes governing joint tissue and contributes to the modulation of cartilage homeostasis, shifting the local balance of catabolic and anabolic processes. The mechanism is physiologically constrained by its incomplete COX-2 selectivity, causing an interaction with constitutive COX-1 functions such as gastric cytoprotection and vascular autoregulation in a dose-dependent manner.

Dosage and Administration Information

How to Use Mycinadol

The following information describes the standardized way the medicine is taken.

Administration

The route of administration is oral (by mouth). The medication is typically available as a tablet that must be swallowed whole. It should not be crushed, cut, or chewed. Each dose is taken with food to minimize potential digestive discomfort.

Dosing Schedule and Rules

For adults (18 years of age and older), the recommended starting dose is X mg, taken once daily. The dose may be adjusted by a healthcare provider up to a maximum dose of Y mg once daily.

Administration Element Standard Instruction
Route/Form Oral tablet, swallowed whole
Frequency Once daily
Timing Must be taken with food
Adult Dose Starting: X mg once daily; Maximum: Y mg once daily
Age Group Adults (18 years and older)

Missed Dose Instructions

If a dose of Mycinadol is missed, take the forgotten dose as soon as you remember, unless it is closer to the time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Two doses must not be taken at the same time to make up for the missed dose.

Recent Clinical Evidence

The research evidence available for Mycinadol (Aceclofenac) consists primarily of studies designed to assess what research explored about outcomes related to physical discomfort and daily functioning in different patient groups. This overview describes the research landscape according to official regulatory and scientific sources, without offering any clinical advice.


Evidence for Use in Chronic Inflammatory Arthritis

The evaluation of Mycinadol in Osteoarthritis (OA), Rheumatoid Arthritis (RA), and Ankylosing Spondylitis (AS) has been the focus of numerous Randomized Controlled Trials (RCTs), Systematic Reviews, and Meta-analyses. Studies examined how symptoms were measured in adults with confirmed diagnoses, collecting data on patient-reported pain intensity and scores reflecting daily functioning or activity level. Findings describe patterns observed in the studies, suggesting that research highlights changes measured in pain and functional scores. Comparative trials generally explored how its performance stood up against established NSAID comparators, though available data often focuses on short-term changes.


Evidence for Use in Localized and Acute Pain Conditions

Research has explored research scenarios involving conditions associated with acute or disruptive episodes, such as Low Back Pain (LBP), Odontalgia (dental pain), and discomfort linked to gynaecological conditions. This evidence was studied for use in targeted Randomized Controlled Trials, focusing on measurements related to episodic or acute changes in discomfort. Reported findings indicate patterns observed in the studies related to short-term changes in pain intensity. The overall volume of research specifically examining each individual acute localized pain indication is less extensive compared to the major chronic inflammatory diseases.


Study Limitations and Research Gaps

A substantial portion of the research involved comparative studies, with many core trials designed as non-inferiority trials where the goal was evaluated in settings designed to assess similarity to an active comparator, rather than to placebo. The documented observation periods typically ranged up to long-term (6 months) follow-up in key trials, but long-term effects are not fully established beyond this duration. Research was studied for use primarily in the general adult population, and data for certain groups remain insufficient, including those with specific severe comorbidities. A key limitation is that follow-up durations were limited in many trials, and subgroup findings are uncertain in specific complex groups. Findings describe group patterns, not personal outcomes.

Key Studies & References

  1. IPAR HEALTH PRODUCTS REGULATORY AUTHORITY - HPRA: Clinical Efficacy and Safety of Aceclofenac
  2. A Review of Aceclofenac: Analgesic and Anti-Inflammatory Effects on Musculoskeletal Disorders

Frequently Asked Questions (FAQ)

Common questions about Mycinadol (FAQ)

Q: What is the main reason doctors prescribe Mycinadol?

A: Mycinadol is prescribed for the relief of pain and inflammation. The official approved uses listed in regulatory documents focus on chronic inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. This classification defines the main patient groups for whom the medicine is intended.

Q: Is Mycinadol used to treat more than one condition?

A: Yes, according to official regulatory documentation, Mycinadol is approved to address pain and inflammation for more than one condition. These conditions include chronic inflammatory joint diseases such as Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis.

Q: Is there a generic version of Mycinadol available?

A: Yes, the active component of Mycinadol is the generic compound, Aceclofenac. Following standard regulatory processes, the generic version of Aceclofenac is officially available from various manufacturers in regulated markets.

Q: What is the difference between Mycinadol and similar over-the-counter medicines?

A: Mycinadol is classified as a prescription-only medicine (POM) and is a specific type of Non-Steroidal Anti-Inflammatory Drug (NSAID). While it belongs to the same class as some over-the-counter pain relievers, it is a chemically distinct compound, Aceclofenac, and requires a healthcare provider's authorization for use.

Q: How long does Mycinadol usually take to start working?

A: Studies examined the medicine's absorption rate, finding that the active component reaches its highest concentration in the bloodstream approximately 1.25 to 3 hours after being taken orally. This measurement is related to the time frame when the effect begins to be observed. However, the full anti-inflammatory benefit for chronic conditions may take longer to develop.

Q: Will I feel a difference immediately after starting Mycinadol?

A: While studies indicate the medicine is absorbed and reaches peak concentration in the blood within a few hours, the full therapeutic benefit for chronic inflammatory conditions may not be immediately apparent. Official information suggests that the full anti-inflammatory effect may take several days of regular use to be fully observed.

Q: If Mycinadol is taken for pain, how quickly does the pain relief typically occur?

A: Studies indicate that the concentration of the active ingredient in the bloodstream peaks within 1.25 to 3 hours after being taken. This peak level correlates with the onset of the medicine's effect, though individual response and full pain relief can vary.

Q: Is Mycinadol taken once a day or multiple times?

A: According to the official regulatory prescribing information for adults, the recommended dosing schedule is typically once daily. The documentation notes that use of the medicine is not recommended for individuals under the age of 18.

Q: How long can a person safely stay on Mycinadol?

A: Regulatory documents state that to minimize the potential for serious adverse events, the medicine is typically intended to be used at the lowest effective dose for the shortest duration necessary. This guidance reflects the need to minimize exposure consistent with individual treatment goals.

Q: Can Mycinadol cause any long-term health issues?

A: Regulatory warnings note that long-term use may increase the risk of serious cardiovascular issues, such as thrombotic events (like heart attack or stroke). It can also increase the risk of serious gastrointestinal events, including bleeding, ulceration, and perforation.

Q: What is the likelihood of a severe side effect from Mycinadol?

A: Regulatory documents categorize the severe side effects, such as serious gastrointestinal bleeding or ulceration, as uncommon (affecting less than 1 in 100 people) or rare (affecting less than 1 in 1,000 people). This information provides a general estimate of their likelihood.

Q: Is it common to feel tired or drowsy after taking Mycinadol?

A: Official regulatory documents list dizziness as a common side effect. Regarding tiredness or drowsiness, these effects are classified as less common or infrequent adverse reactions. This means that while possible, they are not among the most frequently reported side effects.

Q: Is it normal to experience a headache when starting Mycinadol?

A: Yes, regulatory documents list headache as a common side effect. Common side effects are those that are frequently reported during clinical research and post-marketing surveillance.

Q: Can Mycinadol affect mood or cause any mental changes?

A: Yes, official documents list nervous system disorders as a class of possible reactions. Reported side effects include dizziness, depression, and insomnia. These effects are documented in the medicine's safety profile.

Q: Does taking Mycinadol affect my ability to drive or operate machinery?

A: Regulatory product information states that if side effects such as dizziness, vertigo, or drowsiness occur, patients may have impaired mental and physical ability. The official guidance notes that engaging in activities like driving or operating machinery should be avoided under these circumstances.

Q: Can Mycinadol make you sensitive to sun exposure?

A: Yes, official regulatory documents list photosensitivity reactions as a rare documented adverse reaction. Photosensitivity describes an increased sensitivity to sunlight that can result in a skin reaction.

Q: Does Mycinadol cause weight gain or weight loss?

A: Official regulatory documents list edema, which is swelling caused by fluid retention, as an infrequent documented adverse reaction. While not a direct weight gain claim, this fluid retention could potentially lead to a minor weight change.

Q: Can Mycinadol cause allergic reactions, and what are the signs?

A: Yes, Mycinadol is associated with a risk of serious allergic or hypersensitivity reactions. According to regulatory documents, the signs of a serious reaction can include difficulty breathing, swelling of the face, tongue, or throat, or the presence of hives or a severe rash. These symptoms are noted in the official safety profile.

Q: Is Mycinadol safe to use while breastfeeding?

A: Official regulatory information indicates that available human data regarding the use of Mycinadol while breastfeeding is limited. Due to this, use of the medicine is generally not recommended during this period. Official documents state that a healthcare provider is required to evaluate the benefits versus the risks of use.

Q: Is it safe to drink alcohol while taking Mycinadol?

A: Regulatory warnings explicitly state that consuming alcohol while using Mycinadol increases the risk of serious gastrointestinal adverse events, such as bleeding or ulceration. This combination is noted to heighten the risk profile.

Q: Are there any specific organs (like the liver or kidneys) that Mycinadol might affect?

A: Yes, regulatory documents specifically note that adverse reactions can involve major organ systems. These classes of documented reactions include those related to the Renal (kidneys), Hepatobiliary (liver), and Cardiac (heart) systems.

Q: Does Mycinadol affect the results of any common lab tests (blood work)?

A: Yes, regulatory guidance notes that the medicine may affect the results of certain lab tests. Specifically, official documents report that it can increase serum levels of substances like creatinine, liver enzymes, and potassium. These changes are factors evaluated by a healthcare professional.

Q: Does Mycinadol have a known risk for dependency or addiction?

A: Official regulatory documentation does not classify the active ingredient in Mycinadol as a drug with potential for abuse, dependence, or addiction. This information is consistent with its classification as a Non-Steroidal Anti-Inflammatory Drug (NSAID).

Q: Is Mycinadol classified as a controlled substance in any country?

A: According to government classification agencies, the active ingredient in Mycinadol is not listed as a controlled substance. This means it is not associated with the same potential for dependency or abuse as medications designated as controlled.

Q: Are there different restrictions for children versus adults taking Mycinadol?

A: Yes, official regulatory documents state that Mycinadol is not recommended for use in children and adolescents under 18 years of age. This restriction is based on the lack of sufficient data to establish safety and effectiveness for individuals in this age group.

Q: Do you need a prescription to get Mycinadol?

A: Yes, Mycinadol is officially classified as a Prescription-Only Medicine (POM) in most major regulatory regions. It requires authorization from a licensed healthcare provider to be obtained.

Q: What are the main findings from the research evidence on Mycinadol?

A: Research evidence examined the effects of Mycinadol on patient-reported outcomes. Studies looked at how the medicine modulated pain intensity and measured improvements in physical function scores compared to baseline in individuals with chronic inflammatory arthritis.

How should Mycinadol be stored and disposed of?

How to Store and Dispose of Mycinadol

Mycinadol (Aceclofenac) tablets must be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F), with permitted excursions up to 30 C. The medication must be kept in the original container, tightly closed, and should be protected from moisture. Storage environments like bathrooms should be avoided.

For safety, Mycinadol must be stored out of the sight and reach of children and pets. Do not use the tablets after the expiration date printed on the packaging.

Disposal of unused or expired medicine must follow local requirements for pharmaceutical waste. The product should not be disposed of by flushing it down the toilet or pouring it into a drain.

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

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