Maclo

Quick links to important sections

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 Maclo

What is Maclo? Definition and Identity

Property Description
Active Ingredient Aceclofenac
Form Oral Tablet (often film-coated)
Pharmacological Class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common Use Pain, inflammation, and fever relief
Origin Synthetic (Phenylacetic acid derivative)

Maclo is a pharmaceutical preparation whose core therapeutic agent is the single active ingredient, Aceclofenac (INN). This drug is a synthetic compound, chemically categorized as a phenylacetic acid derivative, providing a consistent and measurable formulation for systemic treatment. The preparation is typically presented for oral administration as a tablet, which is designed to be swallowed for absorption into the bloodstream, enabling its action throughout the body.


Aceclofenac's Pharmacological Class and Type

Maclo belongs to the high-level pharmacological category of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), a classification that places it within the therapeutic group of anti-inflammatory and antirheumatic products. This designation signifies that the drug works by mitigating the underlying biological process of inflammation without the use of steroid hormones. As an acetic acid derivative, Aceclofenac often exhibits a favorable profile compared to some older NSAIDs, particularly concerning its potential effects on the gastrointestinal tract. It is classified among non-steroidal anti-inflammatory and antirheumatic agents.


Maclo's General Therapeutic Purpose

The general therapeutic purpose of Maclo is to provide relief from symptoms associated with pain and inflammation, functioning as a dual-acting analgesic and anti-inflammatory agent. Aceclofenac is used in managing chronic bone and joint pains often seen in conditions like arthritis, serving as a typical use scenario for this medication. Aceclofenac achieves this by interrupting the body's synthesis of key chemical messengers, specifically prostaglandins, which are responsible for generating signals of discomfort, swelling, and fever. As a recognized NSAID, Aceclofenac reduces substances in the body that cause pain and fever. This targeted action makes Maclo suitable for addressing general discomfort where inflammation, pain, or fever are present.

Regulatory References

  1. MedlinePlus Drug Information

What side effects are possible with Maclo?

Possible Side Effects and Safety Information for Maclo

Regulatory documents categorize the risks associated with Maclo, an acetylsalicylic acid-containing drug, primarily by their potential for gastrointestinal toxicity, hypersensitivity, and specific population risks. The official safety profile highlights adverse reactions across several System Organ Classes (SOC).

Key Adverse Reactions

Adverse reactions are classified by frequency, including those which are not known but suspected. Commonly documented effects include gastrointestinal disturbances such as abdominal pain, dyspepsia, nausea, vomiting, and diarrhea. Other reactions across clinical studies include headache, fatigue, rash, and pruritus (itching).

Serious Adverse Reactions and Restrictions

Regulatory authorities require clear warnings regarding serious or clinically significant adverse reactions, particularly those that may be dose- or exposure-related. The most critical safety information includes the risk of severe gastrointestinal bleeding or ulceration, a class effect for non-steroidal anti-inflammatory drugs (NSAIDs). Hypersensitivity reactions, which may manifest as bronchospasm (aspirin-induced asthma), urticaria, or anaphylaxis, are an absolute contraindication.

Population-Specific Safety Considerations

  • Pediatric Patients: The drug is not approved for children under 12 years of age. A specific warning exists for children and teenagers with cold, flu, or chickenpox symptoms due to the rare but serious risk of Reye’s Syndrome.
  • Pregnancy: Use in the third trimester of pregnancy is typically avoided due to risks to the fetus.
  • Existing Conditions: Use is restricted or requires caution in patients with a history of ulcers, severe liver or kidney disease, uncontrolled hypertension, or those prone to bleeding.

Overdose and Emergency Response

Overdose and When to Seek Help

This information summarizes the officially documented manifestations and required emergency actions for Maclo (Aceclofenac) overdose, as stated in government regulatory documents.

Domain Official Regulatory Statement
Documented Manifestations Overdose may present with symptoms including nausea, vomiting, abdominal pain, dizziness, somnolence, and headache.
Serious Outcomes The primary risks are acute renal failure, hepatic failure, and severe gastrointestinal complications (bleeding/perforation), which are potentially life-threatening.
High-Risk Groups Patients who are elderly or have pre-existing renal, hepatic, or cardiac impairment are identified as groups at heightened risk for severe outcomes.
Classification Regulatory Status
Antidote Status No specific antidote is known for Maclo or NSAID toxicity.
Management Type Treatment is limited to symptomatic and supportive measures, including decontamination procedures such as gastric lavage or activated charcoal.

Official Overdose Statements:

  • Immediate medical attention is required for any suspected overdose.
  • Urgent help must be sought immediately if symptoms suggesting a cardiovascular event, such as chest pain, sudden weakness, or slurred speech, are observed.
  • Continuous monitoring of vital signs and laboratory tests (renal/hepatic function) is necessary following a significant overdose.

Connection to the overall overdose profile

Regulatory documents define the overdose profile by detailing the expected initial symptoms and the specific, severe organ risks that may follow, particularly hepatic and renal failure. Because no specific antidote exists, this profile emphasizes the critical need to seek immediate medical attention when signs of a severe or life-threatening event are present.

Therapeutic Uses of Maclo

What Maclo Treats: Main Uses and Benefits

Maclo (Aceclofenac) is used to provide supportive symptomatic relief by addressing the key clinical manifestations of pain and inflammation across specific therapeutic domains. Maclo is commonly used for managing symptoms related to inflammatory or irritative states and provides supportive relief in conditions characterized by periods of heightened symptoms.


Management of Chronic Inflammatory Joint Conditions

This medication is commonly applied in clinical settings marked by persistent patient distress from chronic bone and joint pains, particularly those associated with conditions like Osteoarthritis (OA), Rheumatoid Arthritis (RA), and Ankylosing Spondylitis (AS). Maclo provides support that may help ease the overall symptom burden related to these long-term disorders. The primary therapeutic areas where Maclo is relevant include the management of pain, swelling, and stiffness linked to these chronic arthritic conditions, alongside its use in lower back pain and certain extraarticular rheumatism episodes.

“Maclo supports patients during episodes of heightened discomfort by addressing both the sensation of pain and the related physical discomfort and swelling.”


Acute and Episodic Symptom Stabilization

Maclo is relevant in situations where symptoms form part of acute or recurrent episodes where temporary assistance is needed. This includes managing heightened discomfort and swelling following certain dental procedures, or during challenging symptomatic phases often seen in specific gynaecological pain syndromes. It may assist with efforts to manage daily functioning when intense symptoms become momentarily overwhelming.

Quick Fact: Relief for Inflammation and Pain
Symptomatic Target: Pain, swelling, stiffness, and joint tenderness.
Common Clinical Contexts: Chronic arthritis, post-dental discomfort, acute musculoskeletal flare-ups.
Key Benefit: Contributes to improved comfort during periods of heightened symptoms and supports efforts to manage daily functioning.

Eligibility and Restrictions for Use

Who can and cannot use Maclo?

Maclo, which contains the active ingredient Aceclofenac, is an NSAID whose official eligibility rules are defined by governmental regulatory documents. The use is strictly limited to the adult population (18 years and older) for approved indications.


Absolute Contraindications (Must Not Be Used)

Official labeling mandates that Maclo is contraindicated in patients with a history of hypersensitivity to Aceclofenac, aspirin, or other NSAIDs.

The medicine must not be used by patients with severe organ function impairment, including severe hepatic failure or severe renal failure. It is also contraindicated in patients with established congestive heart failure (NYHA Class II-IV), ischaemic heart disease, or cerebrovascular disease.

Absolute prohibition applies to patients with active or recurrent peptic ulceration/haemorrhage (two or more episodes) or a history of GI bleeding or perforation related to prior NSAID therapy.


Age and Reproductive Limitations

  • Pediatric Use: Maclo is not recommended for use in children and adolescents under 18 years of age due to a lack of clinical data on safety and efficacy in this population.
  • Pregnancy: The medicine is contraindicated during the last trimester of pregnancy. Use during the first and second trimesters is not recommended unless considered essential.
  • Lactation: Use is not recommended while breastfeeding.
  • Older Adults: Caution and close surveillance are required in elderly patients, who have an increased risk of serious adverse reactions, particularly GI bleeding.

Condition-Based Restrictions

Close medical surveillance is necessary for patients with mild to moderate hepatic impairment or mild renal impairment, and for those with a history of gastrointestinal diseases like Ulcerative Colitis or Crohn's Disease.

What should I know about interactions with other medicines?

Maclo Interactions with other medicines and products

Maclo is a drug that carries a clinically significant risk for drug-drug interactions, primarily due to its metabolic pathway. The most notable interactions are classified based on their potential to alter Maclo's plasma concentration or to produce additive pharmacodynamic effects.


Key Interaction Mechanisms and Classifications

Maclo is a known substrate of Cytochrome P450 3A4 (CYP3A4) and is also transported by P-glycoprotein (P-gp). This metabolic profile governs its major interactions:

Classification Interacting Product Category Clinical Effect / Restriction
Contraindicated Potent CYP3A4 Inducers (e.g., Rifampin) Leads to significantly reduced Maclo concentration and loss of therapeutic effect.
Use With Caution Potent CYP3A4 Inhibitors (e.g., Ketoconazole) Increases Maclo concentration, requiring a mandatory 50% dosage reduction to mitigate toxicity risk.
Use With Caution Other QT-Prolonging Agents Risk of additive effect on the heart's QT interval, increasing the chance of serious rhythm disturbances.
Use With Caution CNS Depressants May lead to an increased risk of sedation, dizziness, or somnolence.

Interaction Context

Co-administration with potent enzyme and transporter inhibitors, such as P-gp inhibitors, can increase Maclo exposure, necessitating clinical monitoring and potential dose adjustment. Patients with existing hepatic impairment are considered more susceptible to interaction risks, as their baseline ability to clear the medicine is reduced, magnifying the impact of metabolic inhibitors. All combination therapies must be reviewed by a healthcare provider.

Mechanism of Action

Inhibition of Bacterial Protein Synthesis via Ribosomal Subunit Targeting

Maclo acts as an inhibitor of translation by selectively binding to the 23S rRNA component of the bacterial 50S ribosomal subunit. This interaction physically obstructs the process of protein elongation by interfering with ribosomal translocation. This mechanism results in a cytostatic effect that limits the proliferation of susceptible prokaryotes.

Activity in Host Signaling Pathways

Maclo also functions as a signaling pathway modulator within host immune cells (e.g., macrophages) and epithelial cells, where it accumulates. By influencing transcription factors, such as NFkappa B, this action is associated with a decrease in the synthesis and release of pro-inflammatory mediators and subsequent changes in epithelial cell secretion.

Physiological Consequences of the Mechanistic Profile

The drug's profile influences prokaryotic viability and host cell activity, which results in shifts in inflammatory mediator levels and cellular proliferation. This mechanistic interplay defines the resulting reduction in prokaryotic load and the modulation of host inflammatory responses.

Dosage and Administration Information

How to Use Maclo: Administration Guidelines

Maclo (Aceclofenac) is administered via the oral route, typically supplied as a 100 mg film-coated tablet or, in some regions, a 200 mg controlled-release form. The standard administration involves a defined total daily dose and specific intake conditions. The tablets should be swallowed whole with liquid and should not be crushed or chewed to maintain their intended release profile. It is generally recommended to take the medication with or after food.


Standard Dosing and Frequency

The maximum recommended total daily dose is 200 mg. This amount is typically structured in one of two ways, depending on the formulation:

  • Immediate-Release (100 mg): Taken as 100 mg twice daily (one tablet in the morning and one in the evening).
  • Controlled-Release (200 mg): Taken as 200 mg once daily.

The overall duration of use is guided by the principle of utilizing the lowest effective dose for the shortest duration necessary.


Procedural and Population-Specific Guidelines

Population Group Dosing Guideline
Hepatic Impairment Treatment should be initiated with a reduced daily dose of 100 mg.
Older Adults No dose modification is considered necessary.
Children/Adolescents Not recommended for use as data for this population are not available.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Maclo

Evidence for Chronic Inflammatory Joint Conditions

Research has explored Maclo’s active ingredient in studies that examined patient-reported experiences related to chronic joint conditions—those marked by fluctuating or episodic symptoms. The evidence base for conditions like Osteoarthritis (OA) and Rheumatoid Arthritis (RA) primarily includes randomized controlled trials (RCTs) and meta-analyses, which monitored changes in patient symptoms over time.

For OA, research examined patient-reported outcomes describing perceived discomfort and daily functioning. Findings describe patterns where measured outcomes were often within a similar range as those observed for comparator non-steroidal anti-inflammatory drugs (NSAIDs) used in the research. For RA and Ankylosing Spondylitis (AS), studies explored outcomes capturing phases of heightened symptom activity, such as the duration of morning stiffness and changes in joint/spinal flexibility.

Evidence for Acute and Episodic Pain Relief

The active ingredient of Maclo was studied for conditions associated with acute or disruptive episodes, such as sudden muscle pain flare-ups and episodes of physical discomfort studied in specific, defined surgical models. These are generally short-term studies focusing on immediate changes in perceived discomfort over periods of hours or days. Research highlights changes measured during very short study periods, and studies report patterns related to the use of additional analgesic medication in the observed populations. However, evidence derived from settings with varying symptom burdens for certain acute indications is limited, and some initial trials in this area were not able to distinguish the measured outcomes from placebo.

Long-Term Studies and Research Gaps

Most controlled trials have limited follow-up durations (often up to 12 weeks), meaning there is limited information for long-term outcomes that would describe the sustained symptomatic status over periods longer than several months. Long-term effects are not fully established through extensive dedicated clinical trials. Furthermore, the evidence quality varies across studies, and data for highly defined special patient populations remain insufficient.

Frequently Asked Questions (FAQ)

Common questions about Maclo (FAQ)

Q: How does the action of Maclo compare to other drugs used for the same condition?

Studies and official information indicate that Maclo is generally comparable to other non-steroidal anti-inflammatory drugs (NSAIDs) in terms of how effectively it helps manage chronic joint conditions. Some clinical data reports a difference in how the drug is tolerated by the gastrointestinal system compared to certain other medicines in the same class, which is often cited in regulatory summaries.


Q: Are any specific food types or beverages known to affect Maclo's effectiveness?

Official product information states that the total amount of Maclo absorbed by the body is generally not significantly affected by food. Taking the medicine with or after food has been shown to potentially delay the time it takes for the drug to reach its maximum concentration in the blood.


Q: What is the typical duration of treatment with Maclo?

Treatment with Maclo is guided by the principle of using the lowest effective dose for the shortest duration necessary to achieve the desired symptomatic relief. The length of treatment is variable, and regulatory guidance specifies that the patient's ongoing need for the medication requires periodic re-evaluation.


Q: Is Maclo intended as a short-term treatment or a long-term maintenance drug?

Maclo is often used for conditions that are chronic (long-lasting), but official warnings note that the potential for certain risks may increase with the dose and duration of exposure. For this reason, official guidelines specify that the patient's need for sustained symptomatic relief must be periodically re-evaluated.


Q: What is the difference between the active and inactive ingredients in Maclo tablets?

The active ingredient in Maclo is Aceclofenac, which is the component responsible for the medicine's therapeutic effect (relieving pain and inflammation). The inactive ingredients, or excipients, are components like fillers, binders, or coating materials that help form the tablet and aid its proper function but do not directly cause a therapeutic effect. These are listed in the official product information.


Q: Are there any activities, such as driving, that should be avoided while using Maclo?

Official product documentation specifies that if a patient experiences side effects like dizziness, vertigo, or somnolence (drowsiness), caution should be exercised regarding activities such as driving or operating machinery. This information is relevant because the drug may impact alertness.


Q: What is the known prevalence of allergic reactions to Maclo?

Hypersensitivity (allergic reaction) to Maclo or other NSAIDs is an absolute contraindication, meaning the drug must not be used in such cases. Serious allergic skin reactions, such as Stevens-Johnson syndrome, have been reported in regulatory documents as occurring very rarely in association with this class of drugs.


Q: Is Maclo considered a high-alert or high-risk medication by regulatory bodies?

While regulatory authorities do not typically use the specific term 'high-alert' for Maclo, they do require clear and prominent warnings for its use, as is standard for all NSAIDs. These warnings highlight the potential for serious risks, including severe gastrointestinal bleeding and cardiovascular thrombotic events (blood clots).


Q: Is Maclo classified as a brand-name drug or a generic drug?

Maclo contains the active ingredient Aceclofenac. Aceclofenac is available under both a reference brand name and numerous generic formulations across different global markets. The specific classification of a Maclo product depends on the manufacturer and the local regulatory approval status.


Q: Is there a necessity to avoid consuming alcohol while using Maclo?

Official patient information states that the co-administration of alcohol may increase the risk of serious side effects, such as gastrointestinal bleeding, and can also worsen central nervous system effects like dizziness and somnolence (drowsiness).


Q: Does Maclo have a documented effect on changes in body weight?

Official warnings associated with the NSAID class of drugs indicate the potential for side effects such as fluid retention and edema (swelling). While these effects are not specifically listed as weight changes, fluid retention is a factor that could be associated with changes in body weight.


Q: What information is available about Maclo's impact on a patient's sleep quality or patterns?

Maclo's undesirable effects profile includes potential, though rare, psychiatric effects such as insomnia (difficulty sleeping) and abnormal dreaming. These are noted in official documents as possible, but uncommon, side effects.


Q: How long does it usually take to observe the initial effects of Maclo?

Studies of Maclo's absorption profile indicate that the medication is rapidly absorbed after being swallowed. The drug typically reaches its peak plasma concentration (its highest level in the bloodstream) approximately 1.25 to 3 hours after oral administration, which often correlates with the onset of effect.


Q: How long does the active ingredient of Maclo typically remain detectable in the system?

The time required for the active ingredient, Aceclofenac, to be reduced by half in the bloodstream is known as the plasma elimination half-life. This time is reported in regulatory documents to be approximately 4 hours.


Q: Is Maclo approved for use in health systems outside of the United States?

Maclo, which contains Aceclofenac, has received regulatory approval and is widely used across many global health systems. These regions include the European Union (EU), the United Kingdom, and numerous countries in regions such as Asia and Africa.


Q: Is Maclo a drug with potential for dependence or withdrawal symptoms?

Maclo is not classified as a controlled substance by regulatory bodies. Official product documentation does not report or indicate a potential for classic drug dependence or the occurrence of withdrawal symptoms upon discontinuation of use.


Q: Can Maclo affect the reliability of certain routine blood or lab tests?

Official documents report that Maclo can be associated with abnormal laboratory findings as undesirable effects. These findings include elevated levels of hepatic enzymes (liver function tests) and serum creatinine, which are common measurements in routine blood tests.


Q: What documentation is available regarding discontinuing the use of Maclo?

Official safety documentation identifies specific serious adverse effects that require the immediate discontinuation of Maclo's use, such as signs of gastrointestinal bleeding, symptoms of hypersensitivity (allergic reaction), or persistently abnormal liver function tests.

How should Maclo be stored and disposed of?

How to Store and Dispose of Maclo

The storage and disposal of Maclo (Aceclofenac) must strictly follow the conditions defined in the official regulatory documentation to maintain product quality and safety.

Storage Requirements

Maclo tablets must be stored at a temperature below 30°C and should be protected from moisture. It is mandatory to keep the medicine in its original package or outer carton. The product must not be refrigerated or frozen. To prevent accidental ingestion, always store Maclo out of the sight and reach of children.

Disposal Instructions

Expired or unused Maclo must not be thrown away with household trash or disposed of via wastewater (flushed down the toilet). Official guidelines require that unused medicine be returned to a pharmacy or a designated local collection point. Disposal must comply with all local regulations for pharmaceutical waste.

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

Available in countries:

Equivalent of Maclo found in:

A-Z Index: