Flemac

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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 Flemac

Property Description
Active Ingredient Aceclofenac (INN)
Form Oral Dosage Form (Tablet)
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
General Purpose Pain relief, inflammation reduction, fever lowering
Origin Synthetic (Phenylacetic Acid Derivative)

Flemac Identity: A Nonsteroidal Anti-inflammatory Drug (NSAID) Classification

Flemac is a medicinal product whose sole active ingredient is Aceclofenac, classifying it as a potent Nonsteroidal Anti-inflammatory Drug (NSAID). This drug is a synthetic compound, belonging specifically to the Phenylacetic Acid Derivative chemical group. The identification as an NSAID defines its core therapeutic role as an agent developed to counteract inflammatory processes within the body.

The classification of Flemac is central to understanding its systemic function; it is designed to intervene in the biological pathways that initiate and perpetuate discomfort. The substance is an analgesic, antipyretic, and anti-inflammatory agent. This means the drug addresses pain, fever, and inflammation, distinguishing it from substances that only target one of these symptoms.

Composition and Primary General Benefit

Flemac is provided as an oral dosage form, specifically a tablet, intended for the oral route of administration to ensure the systemic delivery of the Aceclofenac throughout the body. The tablet formulation comprises the active compound alongside solid pharmaceutical excipients necessary for stability and accurate dosing.

The overall general benefit of Flemac is rooted in its ability to achieve three key symptomatic effects: providing analgesia (pain relief), acting as a powerful anti-inflammatory agent to reduce swelling and redness, and functioning as an antipyretic to lower fever. For example, it is typically used to alleviate the general discomfort and swelling associated with conditions involving inflammation. Aceclofenac is effective in reducing pain and improving functional capacity across a range of painful and inflammatory conditions. As such, the medicine serves as an option for the management of widespread pain and inflammation.

What side effects are possible with Flemac?

Possible Side Effects and Safety Information for Flemac

The safety profile of Flemac is established through clinical trials and post-marketing surveillance, classifying adverse reactions by system-organ class and frequency.

Adverse Reactions and Classification

Side effects are categorized by frequency as defined in regulatory documents. Common reactions, occurring in 1 in 100 to less than 1 in 10 patients, typically involve system-organ classes such as gastrointestinal disorders, nervous system effects, and skin reactions. Uncommon reactions occur in 1 in 1,000 to less than 1 in 100 patients, and Rare reactions occur in less than 1 in 1,000 patients. Reactions of unknown frequency are those where a reliable estimate cannot be made from the available data.

Classification Frequency Range
Very Common ge 1/10
Common ge 1/100 to < 1/10
Uncommon ge 1/1,000 to < 1/100
Rare ge 1/10,000 to < 1/1,000
Very Rare < 1/10,000

Serious and Clinically Significant Risks

Serious adverse reactions, as formally documented in regulatory labels, are those that may be life-threatening, result in death, or require hospitalization. These include hypersensitivity reactions such as angioedema and serious dermatologic events. These specific risks mandate that the drug is contraindicated in patients with known hypersensitivity to the active substance or any excipients.

Safety Restrictions and Monitoring

Safety precautions require clinical monitoring for specific organ system function, such as hepatic or renal parameters, particularly in individuals with pre-existing impairment. Special caution is necessary in older adults and in patients receiving certain concomitant medications, due to the risk of drug-drug interactions that may alter the drug’s concentration or increase the risk of serious effects, such as those related to blood pressure or cardiovascular function. The dosage may require modification in certain populations or when used with specific enzyme inhibitors, as explicitly stated in the prescribing information.

Overdose and Emergency Response

A Flemac overdose, resulting from ingestion of a potentially toxic amount, is officially documented by regulators to present with a specific profile of symptoms. Manifestations frequently involve the gastrointestinal system, including nausea, vomiting, epigastric pain, and gastrointestinal irritation or bleeding. Central Nervous System (CNS) effects are also common, such as headache, drowsiness, dizziness, tinnitus, disorientation, and occasional convulsions.

In cases of significant poisoning, the regulatory labeling notes the possibility of severe or life-threatening outcomes, including the occurrence of acute renal failure, liver damage, and profound CNS effects such as coma.

For any suspected overdose involving potentially toxic or life-threatening amounts, the official regulatory instruction is to seek immediate medical attention. Management is symptomatic and supportive. Time-sensitive procedures, such as considering the use of activated charcoal or gastric lavage in adults within one hour of ingestion, are described as warranted. Furthermore, patients require observation for at least four hours after ingesting a potentially toxic amount. Regulatory information states that no specific antidote is known, and elimination procedures like dialysis are unlikely to be effective.

Therapeutic Uses of Flemac

What Flemac Treats: Main Uses and Benefits

Flemac is commonly used to help provide symptomatic relief for the chronic pain, swelling, and stiffness associated with long-term inflammatory conditions. It is indicated for the relief of pain and inflammation in Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis. It is applied in conditions marked by heightened symptom expression and supports the patient during difficult episodes by easing distress and may assist with maintaining functional stability.

The medication is also considered relevant in clinical settings marked by heightened patient distress from acute inflammatory episodes, offering supportive therapeutic benefit. This includes managing intense, localized discomfort such as dental pain (odontalgia), post-traumatic pain, or discomfort arising from certain gynaecological conditions.

“Flemac is commonly used to help with symptom clusters that often occur together, including pain, swelling, and systemic fever (antipyresis).”

Flemac is relevant across therapeutic areas involving heightened inflammatory responses, contributing to easing the overall symptom load when pain and inflammation are accompanied by elevated body temperature. It offers symptomatic relief that may help patients cope more steadily with symptom fluctuations associated with these difficult, acute episodes.


Quick Fact: Relief for Joint Discomfort

Flemac supports patients during episodes of heightened discomfort by focusing on symptoms related to inflammatory or irritative states, and may assist with maintaining functional stability when symptoms are more noticeable.

Eligibility and Restrictions for Use

Who can and cannot use Flemac?

Flemac (Aceclofenac) is classified as an NSAID, and its population eligibility is strictly defined by regulatory documentation. Use is established primarily for adults for approved indications.

Absolute Contraindications Flemac is strictly prohibited for individuals with the following conditions:

  • Known hypersensitivity to aceclofenac, aspirin, or other NSAIDs.
  • Severe hepatic failure, severe renal failure, or active bleeding disorders.
  • Severe heart failure (NYHA Class II–IV), established ischaemic heart disease, or cerebrovascular disease.
  • History of recurrent peptic ulceration, active gastrointestinal bleeding, or perforation linked to prior NSAID use.
  • Women in the third trimester of pregnancy.

Restrictions and Special Populations

  • Pediatric Use: The medicine is not recommended for use in children under 18 years of age due to a lack of clinical data on safety and efficacy.
  • Organ Function: Patients with mild to moderate hepatic or renal impairment must be under close medical surveillance.
  • Pregnancy/Lactation: Use in the first and second trimesters should be avoided unless strictly necessary. It is also generally not recommended during lactation.
  • Elderly Patients: Use requires caution due to increased risks.

What should I know about interactions with other medicines?

Flemac Interactions with other medicines and products

This section details officially documented interactions for Flemac (Aceclofenac) based strictly on government regulatory documents, outlining how co-administration with other substances is officially described.


Contraindicated and High-Risk Combinations

The concomitant use of Flemac with other Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including aspirin and cyclo-oxygenase-2 selective inhibitors, is formally discouraged or contraindicated by regulatory authorities due to a significantly increased risk of adverse effects.

Interactions Affecting Bleeding and Renal Function

The interaction profile primarily involves heightened pharmacodynamic risks:

  • Anticoagulants (e.g., Warfarin) and Anti-platelet agents (e.g., Aspirin): May result in an enhanced risk of bleeding.
  • Corticosteroids and SSRIs: Increase the documented risk of gastrointestinal ulceration or bleeding.
  • Diuretics and Antihypertensives (e.g., ACE inhibitors): May lead to a reduced blood pressure-lowering effect and an increased risk of acute renal failure, particularly in vulnerable populations.

Interactions Modifying Drug Exposure

Flemac is officially documented to influence the concentrations of certain co-administered medicines, potentially leading to increased plasma levels of Lithium, Digoxin, and Methotrexate.

Other Specific Documented Interactions

Co-administration with Quinolone antibiotics is associated with a risk of precipitating convulsions. Furthermore, official warnings advise that alcohol should be avoided due to the potential to increase the risk of gastrointestinal bleeding.

Mechanism of Action

Inhibition of the Cyclooxygenase Enzyme System

The primary mechanism involves the inhibition of the Cyclooxygenase (COX-1 and COX-2) enzymes by Aceclofenac's active forms. This core molecular action blocks the Arachidonic Acid Cascade, thereby suppressing the production of Prostaglandins (PGE2) and other eicosanoids, which function as chemical mediators.


Modulation of Peripheral Nociceptive and Central Thermoregulatory Signaling

The downstream effect of reduced prostaglandin levels modulates two distinct physiological processes. Peripherally, it dampens the sensitization of nociceptors (pain-signaling nerve endings), which results in modulation of the peripheral nociceptive signal. Centrally, it acts within the hypothalamus to reverse the prostaglandin-mediated elevation of the body's thermal set point, resulting in the adjustment of the hypothalamic thermal set point.


Physiological Constraints of the Mechanism

While targeting the inducible COX-2 enzyme suppresses the generation of inflammatory mediators, the mechanism is limited by its concurrent non-selective inhibition of COX-1. This action reduces cytoprotective prostaglandins, which perform crucial roles in physiological housekeeping. The mechanism does not modulate pain types, such as neuropathic pain, that are not mediated by the COX pathway.

Dosage and Administration Information

Official Administration Guidelines for Flemac

Flemac is administered according to standard guidelines which govern the route, frequency, and dosage of the active ingredient, Aceclofenac.

Administration Scope

Instruction Category Official Guideline
Route of Administration The approved route for Flemac is oral.
Standard Dosing The recommended daily dose for adults is 200 mg total, administered as two 100 mg tablets per day.
Maximum Dose The total dose must not exceed 200 mg in any 24-hour period.
Timing with Meals Tablets should be swallowed whole and may be taken with or immediately after food.

Use Patterns and Population-Specific Rules

Guidelines emphasize that Aceclofenac must be used at the lowest effective dose for the shortest possible duration necessary to manage symptoms. This principle guides the overall administration protocol.

Age-Group and Condition Rules

  • Pediatric Use: Use of Flemac is not recommended in children due to insufficient clinical data to support a dose regimen.
  • Hepatic Impairment: For patients with reduced liver function, the initial recommended total daily dose should be lowered, typically to 100 mg per day.
  • Older Adults: No initial dose adjustment is explicitly required for older adults based on pharmacokinetics, but the principle of using the lowest effective dose remains paramount.

This structured approach ensures systemic delivery via the oral route according to a twice-daily schedule, with specific adjustments detailed for patients with underlying conditions.

Recent Clinical Evidence

Flemac: Recent Clinical Evidence

The research base for Flemac (Aceclofenac) consists mainly of short-term Randomized Controlled Trials (RCTs) and systematic reviews, primarily involving adult populations. Research was evaluated in contexts involving conditions characterized by chronic and acute pain and inflammation. The findings help contextualize how patients reported their experience when Flemac was evaluated in research settings.


Evidence for Chronic Inflammatory Conditions

Research exploring chronic inflammatory conditions was conducted through studies examining patient-reported experiences related to Osteoarthritis (OA) and Rheumatoid Arthritis (RA). Researchers in short-term RCTs monitored adult populations and examined outcomes related to physical discomfort (pain intensity), functional limitations, and joint tenderness. Studies conducted during periods of increased symptom activity described patterns observed in measured changes for pain scores, functional capacity (OA), and duration of morning stiffness (RA). Flemac was also evaluated in studies focusing on Ankylosing Spondylitis (AS), where research documented patterns related to measured changes in spinal mobility and discomfort scores. This evidence base is rated as high to moderate, reflecting the volume and structure of the trials.

Evidence for Acute Symptomatic Pain Relief

Flemac was evaluated in research contexts involving acute, disruptive episodes of pain, such as dental pain. This research explored short-term symptom changes, often involving single-dose administration. The outcomes measured were related to episodic or acute changes in pain intensity over very short time intervals, researching measured physical discomfort. Results apply only to the very short duration of the episodes studied.

Long-Term Studies and Research Uncertainty

The majority of pivotal studies for chronic conditions had defined follow-up durations that were limited to short-term periods, typically up to six months. Therefore, long-term outcomes are not fully established, and there is limited information for the maintenance of observed patterns over several years. Furthermore, Flemac research primarily focused on a broad adult population; data for certain groups remain insufficient, including pediatric or pregnant individuals. The research landscape also notes limitations such as statistical heterogeneity and variation in evidence quality across studies.

Key Studies & References Aceclofenac: a review of its use in the management of pain and rheumatic disease

Frequently Asked Questions (FAQ)

Common questions about Flemac (FAQ)

Q: Does Flemac treat the underlying cause of a condition or primarily manage symptoms?

According to official product information, Flemac's active ingredient works by inhibiting chemical mediators in the body called prostaglandins. Since these mediators are responsible for pain, fever, and inflammation, the drug is classified as an analgesic and anti-inflammatory agent. This means its primary role is to provide symptomatic relief rather than addressing the underlying cause of the condition.


Q: How long does it typically take for Flemac to start having an observable effect?

Official documentation indicates that the onset of pain relief generally begins quickly. The documentation suggests the effect starts within 30 minutes to one hour after administration. Individual response may vary based on the patient and the condition being managed.


Q: What is the recommended duration of a typical course of Flemac treatment?

Official administration guidelines state that Flemac should be used for the shortest possible duration that is necessary to effectively control symptoms. Treatment is guided by the principle of using the lowest effective dose. The specific length of a course is a decision that is typically made by the treating healthcare professional.


Q: What information is available regarding what to do if a dose of Flemac is forgotten?

Regulatory guidance states that if a dose is forgotten, the instruction is to take it as soon as it is remembered, unless it is nearly time for the next scheduled dose. If that is the case, the missed dose should be skipped entirely. Official instructions emphasize that a double dose must not be taken to compensate for a forgotten one.


Q: Is Flemac described as a medication that can be taken over a long period?

Regulatory documents emphasize that the use of Flemac is intended for the shortest possible duration. Studies have noted that long-term outcomes for continuous use over several years are not fully established. As part of the NSAID class, prolonged use is associated with an increased risk of serious side effects, such as those affecting the cardiovascular system.


Q: Is it generally acceptable to stop Flemac abruptly, based on usage guidelines?

Flemac is typically prescribed for a specific duration of time as part of a treatment plan. Regulatory guidance suggests that individuals should consult with a healthcare professional before discontinuing the medication, as treatment duration is typically defined by a specific plan.


Q: What are the most commonly reported side effects listed for Flemac?

According to official regulatory documentation, common side effects can affect between 1 in 100 and less than 1 in 10 patients. These frequently reported issues include dizziness, nausea, abdominal pain, indigestion, and diarrhea. Some patients may also experience elevated liver enzymes.


Q: Does Flemac have a known link to changes in weight, such as weight gain or loss?

Official safety information indicates that Flemac is associated with a risk of fluid retention, medically known as oedema. In connection with this, a sudden increase in weight or swelling has been cited as a symptom that could signal a serious adverse reaction.


Q: Can Flemac potentially disrupt or affect a person's normal sleep patterns?

Regulatory documents note that potential side effects can include effects on the nervous system. Specifically, drowsiness has been cited as a possible reaction. Conversely, in some documented instances, patients have reported experiencing insomnia, or difficulty sleeping.


Q: How commonly are allergic reactions to the ingredients in Flemac reported?

Serious hypersensitivity reactions are officially classified as rare, meaning they occur in less than 1 in 1,000 patients. These documented severe reactions include angioedema (swelling of the face, lips, or throat) and anaphylactic shock.


Q: Is a feeling of mild headache or nausea a normal experience when first starting Flemac?

Headache and nausea are listed in regulatory documents as common side effects associated with the medication. Official guidance notes that the drug may be taken with or immediately after food.


Q: Does Flemac carry a Black Box Warning or similar high-level safety statement in major jurisdictions?

Aceclofenac belongs to the Nonsteroidal Anti-inflammatory Drug (NSAID) class, which is associated with important safety information. This drug class is linked to an increased risk of serious cardiovascular events, such as heart attack or stroke, and serious gastrointestinal adverse events, including bleeding or perforation.


Q: What general signs are listed that could indicate a user is experiencing a serious adverse reaction to Flemac?

Official safety information lists several signs that may indicate a serious reaction. These include swelling, unexplained weight gain, chest pain, or breathlessness, as well as unusual abdominal symptoms such as black and sticky stools or vomiting blood.


Q: Are there any specific foods, drinks, or dietary items that are restricted when taking Flemac?

Official guidelines formally discourage the use of alcohol while taking Flemac. This is because combining alcohol with the medication may increase the risk of developing gastrointestinal bleeding. Alcohol consumption may also increase feelings of drowsiness.


Q: What is the general guidance on potential interactions between Flemac and hormonal contraceptives?

Studies concerning the NSAID drug class suggest there may be a small increased risk of blood clots when these medications are used alongside hormonal contraceptives. Patients are often directed to consult their healthcare provider regarding their full medication regimen due to the individual nature of this potential concern.


Q: Does a personal or family history of specific conditions affect eligibility for Flemac?

A personal history of certain conditions is a formal factor in eligibility for Flemac. For example, a personal history of recurrent peptic ulceration or gastrointestinal bleeding related to previous NSAID use is a contraindication. Information regarding the influence of family history is not explicitly addressed in the regulatory documents.


Q: How is Flemac officially described in relation to other similar drugs in its therapeutic class?

The active ingredient in Flemac, Aceclofenac, is a synthetic compound classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). It is specifically described as a phenylacetic acid derivative and an analog of Diclofenac. The medication is officially recognized as a potent inhibitor of the Cyclooxygenase enzyme.


Q: Is Flemac a new or an older medicine?

Flemac's active ingredient, Aceclofenac, is not a recently developed medicine. It was originally synthesized in 1991 as an analog of another established NSAID, Diclofenac.


Q: Is Flemac mentioned in regulatory information as having potential for physical dependence?

Flemac is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). Based on this classification, regulatory documentation does not describe the medication as having any potential for physical dependence or abuse.


Q: Does Flemac have any known effect on a person’s ability to drive or operate machinery?

Official warnings explicitly state that due to the potential for impaired judgment, patients should avoid driving or operating machinery if they experience side effects such as dizziness, drowsiness, or visual disturbances.


Q: Does Flemac require a period of time to 'build up' in the body over time?

The active ingredient has a relatively short half-life of approximately four to five hours. To maintain consistent anti-inflammatory action throughout the day, the regulatory dosing strategy is typically set for twice-daily administration.


Q: How long does Flemac typically remain detectable in a person's system after they stop taking it?

The active ingredient and its inactive forms are mainly eliminated from the body through urine and feces. Based on the drug's short half-life, most of the medication typically leaves the system within approximately 24 hours after the last dose is taken.

How should Flemac be stored and disposed of?

How to Store and Dispose of Flemac

Flemac (Aceclofenac Tablet) must be stored according to official regulatory specifications to maintain stability and safety.

Storage Requirements

The product must be stored at a temperature not exceeding 30°C and should be protected from light and moisture. To ensure this protection, the tablets must remain in their original container or blister packaging until use. As a universal safety requirement for medicines, Flemac must be kept out of the sight and reach of children.

Disposal Instructions

Expired or unused Flemac must be handled as pharmaceutical waste and disposed of in accordance with local requirements. Due to the active substance's classification as toxic to aquatic life, it is strictly mandated that the tablets must not be flushed down the toilet or disposed of into any sanitary sewer system.

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

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