Lemesil

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Medically reviewed

Laura Arias

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 Lemesil

Quick Facts about Lemesil

Property Description
Active Ingredient Nimesulide (a sulfonanilide derivative)
Form Granules for oral suspension, tablets
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID), selective COX-2 inhibitor
General Purpose Symptomatic relief of pain, fever, and inflammation
Origin Synthetic compound

Identity, Class, and Composition

Lemesil is a proprietary medicine that contains the active substance Nimesulide, which is a synthetic compound derived from the sulfonanilide chemical family. It is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID) and is recognized as a single-active-ingredient product. Unlike older, non-selective NSAIDs, Nimesulide functions as a selective COX-2 inhibitor, a characteristic that differentiates its action profile.


Action Profile and General Purpose

The general therapeutic purpose of Lemesil is to provide symptomatic relief by exerting a three-pronged action profile: it is anti-inflammatory (reduces swelling), analgesic (relieves pain), and antipyretic (lowers fever). This combined capability makes it suitable for managing short-term acute discomfort. The preparation as granules for oral suspension is a common presentation, intended for oral administration and systemic delivery of the active ingredient.

Nimesulide is used for managing acute pain states, providing pain relief for conditions such as post-operative discomfort. It is also used for the treatment of acute pain and primary dysmenorrhoea, reflecting its pharmacological properties.

Regulatory References

  1. European Medicines Agency (EMA)
  2. [EMA: Nimesulide Review]

What side effects are possible with Lemesil?

Possible Side Effects and Safety Information

This section describes the officially documented adverse reactions and high-level safety constraints for Nimesulide (Lemesil's active substance), as classified by government regulatory authorities.

Adverse Reactions by System and Frequency

Regulatory documentation groups possible effects by physiological system, using frequency terms like Common (occurring in 1 to 10 users in 100), Uncommon, Rare, and Very Rare (less than 1 in 10,000 users).

System-Organ Class (SOC) Common Adverse Reactions (Examples) Serious Adverse Reactions (Very Rare)
Hepatobiliary Disorders Transient liver enzyme elevation Fulminant hepatic failure, Liver transplant
Gastrointestinal Disorders Diarrhea, Nausea, Vomiting Bleeding, Ulceration, Perforation
Skin Disorders Pruritus, Rash (Uncommon) Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN)
Vascular Disorders Hypertension (Uncommon) Arterial thrombotic events (e.g., myocardial infarction, stroke)

Safety Constraints and Risk Patterns

The most significant safety focus in the regulatory profile is on hepatotoxicity (liver injury). Treatment is officially contraindicated in patients with any evidence of hepatic impairment and in those with severe renal impairment. Use is also contraindicated in children under 12 years of age.

Official labeling notes that the risk of serious skin reactions is highest within the first month of treatment. Furthermore, immediate discontinuation of treatment is mandated if symptoms consistent with liver injury, such as dark urine or unexplained fatigue, develop. The risk of serious gastrointestinal and cardiovascular events may increase with duration of use.

Overdose and Emergency Response

Overdose Manifestations and Emergency Action

An acute overdose of Lemesil (Nimesulide) is managed strictly according to the officially documented toxicological profile for Nonsteroidal Anti-inflammatory Drugs. Immediate medical attention is required in all cases of suspected overdose.

Documented Clinical Manifestations

The most common initial signs of overdose are related to the gastrointestinal and central nervous systems. These documented manifestations include epigastric pain, nausea, and vomiting. Affected individuals may also experience systemic symptoms such as lethargy and drowsiness. These symptoms are generally limited in scope and considered reversible with the provision of supportive care.

Severe Systemic Outcomes

Although less common, the regulatory documentation outlines potential severe systemic outcomes that necessitate urgent monitoring. These include gastrointestinal bleeding, acute renal failure, and cardiovascular effects like hypertension. In rare instances, more critical effects such as respiratory depression or coma have been noted. Hospital monitoring may be required to manage these serious manifestations.

Official Management and Antidote Status

The officially mandated therapeutic response to a Nimesulide overdose consists only of symptomatic and supportive care. Specific interventions like gastric lavage or the administration of activated charcoal are considered within this supportive framework. It is explicitly documented in official labeling that no specific antidote for this overdose is known.

Therapeutic Uses of Lemesil

Lemesil is a medication generally used for symptomatic relief, which provides support that helps ease the overall symptom burden related to heightened physiological activity across several acute conditions. The active substance is utilized to provide symptomatic support in situations involving specific distressing symptoms. It is applied across domains where additional symptomatic support is needed.

Commonly used in clinical settings that involve acute pain, inflammation, and fever, it is used for easing symptom clusters that may become intense or disruptive. It is utilized for symptoms associated with conditions that involve heightened systemic burden, such as soft tissue discomfort and pain from acute or recurrent episodes. It is also used for managing symptoms of primary dysmenorrhoea and acute flare-ups of painful osteoarthritis.

“It supports the patient during difficult episodes by easing distress and may assist with maintaining functional stability when symptoms are more noticeable.”


Quick Fact: Relief for Acute Pain

  • Target Symptoms: Symptoms related to physical discomfort, systemic imbalance, and inflammatory states.
  • Usage Context: Applied in scenarios where supportive symptom management is appropriate for acute or recurrent episodes.
  • Patient Benefit: Contributes to improved day-to-day comfort during periods of heightened symptoms.

Regulatory References

  1. European Medicines Agency (EMA) therapeutic overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Lemesil?

Lemesil (Nimesulide) eligibility is strictly defined by government regulatory documents based on age, medical history, and physiological status. The medicine is permitted for use only by adults and adolescents aged 12 years and older. Its use is absolutely contraindicated in children under 12 years of age.

Official labeling states that the medicine must not be used by individuals with existing hepatic impairment or a history of hepatotoxic reactions to Nimesulide. Contraindications also extend to those with severe renal impairment, severe heart failure, or those with active gastric or duodenal ulcers or a history of recurrent gastrointestinal bleeding. Individuals with known hypersensitivity to aspirin or other Non-Steroidal Anti-inflammatory Drugs (NSAIDs) are likewise ineligible.

Use is contraindicated during the third trimester of pregnancy and during lactation (breastfeeding). Even when eligible, use is strictly limited to a maximum duration of 15 days and is designated as a second-line treatment. Older adults are permitted to use the medicine but should undergo appropriate clinical monitoring.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section details officially documented interaction patterns based on government regulatory information.

Interaction Scope

Classification Documentation Point
Hepatotoxic Restriction Avoidance of alcohol abuse and co-administration with other potentially hepatotoxic substances is required by regulatory documents.
Pharmacokinetic Effect Nimesulide is a documented inhibitor of the CYP2C9 enzyme. This action may increase the plasma concentrations of co-administered medicines that are substrates of this enzyme.
Exposure Modification Non-Steroidal Anti-inflammatory Drugs (NSAIDs) reduce the clearance of Lithium, potentially resulting in elevated plasma levels and risk of toxicity. Close monitoring is required.
Renal Function The combination of Nimesulide with Diuretics, ACE Inhibitors, or Angiotensin II Antagonists may reduce the efficacy of these agents and poses a risk of renal function deterioration, particularly in patients with reduced renal function.
Pharmacodynamic Risk Co-administration with Anti-coagulants (e.g., Warfarin), Oral Corticosteroids, Anti-platelet agents, or Selective Serotonin Reuptake Inhibitors (SSRIs) may enhance the risk of bleeding complications or gastrointestinal ulceration.

Timing-Based Separation Rule

Caution is formally required if Nimesulide is administered less than 24 hours before or after treatment with Methotrexate, as this may increase the serum level and toxicity of Methotrexate. The regulatory profile establishes these constraints to define necessary administration restrictions.

Mechanism of Action

Selective Inhibition of Fungal Sterol Synthesis

Lemesil's mechanism is defined by its action as a non-competitive inhibitor of the fungal-specific enzyme squalene epoxidase. This targeted interaction blocks a critical early step in the ergosterol biosynthesis pathway, preventing the fungus from manufacturing its essential cell membrane component, ergosterol. This enzyme inhibition initiates a mechanistic cascade that contributes to the drug's effects by resulting in altered cell membrane permeability and structural properties.


Dual Action: Membrane Destabilization and Intracellular Toxicity

The enzyme blockade triggers a dual physiological consequence within the fungal cell. First, the lack of sufficient ergosterol destabilizes the fungal cell membrane. Second, the precursor substance, squalene, is forced to accumulate to toxic levels inside the cell, interfering with internal metabolic processes. This combination of structural defect and metabolic toxicity ultimately leads to the impairment of fungal cell viability and function.

Dosage and Administration Information

How to Use Lemesil: Administration Guidelines

The administration of Lemesil (Nimesulide) is defined to ensure appropriate use, focusing on the shortest possible duration of treatment. Administration follows established parameters.

Standard Dosage and Frequency

Administration Scope Instruction
Route Oral (Systemic) via tablets or granules.
Standard Dose 100 mg per dose for adults and adolescents (12–18 years).
Frequency Twice daily (bid), leading to a maximum daily dose of 200 mg.
Timing Must be taken after a meal.

Duration and Preparatory Instructions

Lemesil is intended for acute, short-term symptomatic relief only. The use protocol involves specific time constraints:

  • Maximum Duration: The total treatment course must not exceed 15 days under any circumstances, and treatment should be for the shortest possible duration.
  • Preparation: Granules for oral suspension must be dissolved in a small quantity of water before administration.

Population-Specific Rules

Specific rules regarding age and health status include:

  • Adolescents (12–18 years): No dosage adjustment is necessary.
  • Children (under 12 years): Use is contraindicated.
  • Older Adults (Elderly): No specific dosage adjustment is required.

Use is contraindicated in patients with severe kidney impairment or any form of liver impairment.

Recent Clinical Evidence

The clinical data for Lemesil (Nimesulide) is built upon research primarily consisting of short-term Randomized Controlled Trials (RCTs), comparative studies, and comprehensive scientific reviews and meta-analyses. This evidence base, which is used by major regulatory bodies, examines how the active substance was studied for specific, acute symptomatic conditions. The findings describe group patterns observed in these studies and provide context on how symptoms were measured and evolved in the study populations.

Evidence for Short-Term Acute Pain Management

Research for this indication examined scenarios where symptoms become more noticeable, such as post-operative pain or acute musculoskeletal discomfort. The studies were designed to examine outcomes related to physical discomfort during periods of increased symptom activity. Researchers primarily examined two key elements in adults and adolescents: the measurement of pain intensity and the speed of measured symptomatic change after administration. Research explored how these outcomes aligned with those documented in similar studies involving other Nonsteroidal Anti-inflammatory Drugs (NSAID). A key limitation is that the research available for current licensed use is restricted to a maximum treatment duration of 15 days.

Evidence for Primary Dysmenorrhoea (Menstrual Pain)

Lemesil was evaluated in clinical trials focusing on conditions characterized by fluctuating or episodic manifestations during the menstrual cycle. The studies, primarily short-term RCTs, examined symptom patterns in adult and adolescent women. Research examined outcomes describing episodic or acute changes, such as the measurement of pain intensity and overall symptom reporting during the symptomatic phase of the cycle. Findings highlight changes measured during the study period.

Evidence for Acute Osteoarthritis Flare-ups

The research structure for osteoarthritis is specific, focused on studies examining acute flare-ups in adult patients. Studies examined outcomes reflecting daily functioning or activity level (such as the WOMAC scale), and monitored how patients with conditions presenting with cycles of stability and flare-ups reported their experience during periods of increased symptom activity. Data show patterns related to measured physical function and discomfort levels over the acute, short-term treatment intervals.

Research on Study Duration and Data Gaps

The regulatory evidence is focused on research exploring short-term symptom changes. Long-term effects are not fully established or characterized by the regulatory research record for any indication. Additionally, research is still emerging regarding the durability of observed symptom changes or patterns of use beyond acute treatment windows in the official evidence base.

Frequently Asked Questions (FAQ)

Common questions about Lemesil (FAQ)

Q: Is Lemesil the same type of medicine as [similar common drug name]?

Official information states that the active ingredient in Lemesil, Nimesulide, is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). It is specifically identified as a selective COX-2 inhibitor, which is a subtype of NSAID. This classification defines its action profile and distinguishes it from non-selective NSAIDs.

Q: How quickly am I supposed to feel the effects of Lemesil?

According to the official pharmacokinetic data, the medicine is noted for its rapid absorption in the body. The highest concentration of the active substance in the bloodstream is typically reached within approximately one to three hours after taking the granules or tablets. This timeline provides an indication of the expected onset of symptomatic change.

Q: Does taking Lemesil require any special blood tests?

Regulatory documents place a significant focus on the potential for liver enzyme elevation. While routine blood tests for all users may not be explicitly mandated, official information advises appropriate clinical monitoring, especially for older adults. Official information states that immediate discontinuation is required if tests show abnormal liver function.

Q: If I miss a dose of Lemesil, what is the official guidance?

The regulatory guidance for a forgotten dose states that the dosage should not be doubled at the next scheduled time. Official guidance states that the maximum daily dosage is not permitted to be exceeded. Patients are advised that if a dose is missed, they should revert to their regular schedule as originally prescribed.

Q: What is the scientific term for the main action of Lemesil in the body?

Lemesil is pharmacologically classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). Its primary action is described as the preferential inhibition of the cyclooxygenase-2 (COX-2) enzyme, which is the mechanism behind its anti-inflammatory, pain-relieving, and fever-reducing properties.

Q: Can Lemesil affect a person's ability to drive or operate machinery?

Official prescribing information includes a caution regarding activities that require full alertness. The official caution states that refraining from driving or operating machinery is advised for patients who experience side effects such as dizziness, vertigo, or somnolence (drowsiness). This is a standard safety measure noted in official documentation.

Q: Is it normal to feel a mild headache when first starting Lemesil?

Official adverse reaction data indicates that headache is a possible, though very rare, adverse effect of the medicine. Regulatory documents classify all side effects by their expected frequency, based on data collected from clinical studies.

Q: What is the evidence theme regarding long-term side effects in research on Lemesil?

The regulatory evidence base for Lemesil is specifically concentrated on research exploring short-term symptomatic changes. Official documentation explicitly notes that long-term effects are not fully established or characterized by the regulatory research record for any approved indication.

Q: What kinds of non-prescription supplements are listed as possible interactions with Lemesil?

Official documents note that caution is advised regarding the co-administration of other non-prescription pain relievers with this medicine. Furthermore, official regulatory sources note that co-administration is to be avoided for other potentially hepatotoxic substances or those that could increase the risk of bleeding complications.

Q: I heard Lemesil can make you tired; is this a common experience?

The feeling of tiredness or drowsiness (somnolence) is listed in regulatory documents as a very rare, adverse reaction. However, unexplained fatigue is also listed as a symptom that could suggest potential liver injury, which is a condition where immediate medical attention and discontinuation are mandated by official labeling.

Q: Is there a generic version of Lemesil available, and is it comparable?

The active substance, Nimesulide, is available globally as both branded and generic medicines in various authorized countries. Generic medicines are approved by regulatory authorities and must meet specific bioequivalence standards. This means they are expected to work the same way as the original branded product.

Q: Are there any specific demographic groups where Lemesil's effects are known to differ?

Official documentation specifically notes that older adults (the elderly) are particularly susceptible to the adverse effects associated with NSAIDs. Due to this potential increased risk, appropriate clinical monitoring is formally advised for this specific patient group.

Q: What steps are usually recommended if someone suspects a serious side effect from Lemesil?

Immediate discontinuation of the medicine is mandated if a patient develops symptoms that suggest a serious reaction, particularly related to the liver (such as unexplained fatigue, dark urine, or vomiting). Official labeling states that informing a doctor immediately or seeking emergency help is mandated if symptoms suggesting a serious reaction occur.

How should Lemesil be stored and disposed of?

Official Storage and Disposal Instructions

Lemesil (Nimesulide) must be stored and disposed of according to official regulatory labeling to maintain product stability and safety.

Storage Conditions

Requirement Description
Temperature Store below 30 C. Do not freeze.
Protection Keep in the original package to protect from moisture and light.
Child Safety Keep out of the sight and reach of children.

Disposal Requirements

Used or expired Lemesil must not be disposed of via household waste or wastewater, as mandated by regulatory documents to protect the environment. The correct procedure for discarding unused medicine is to consult a pharmacist, who can advise on local collection programs.

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

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