Нимедар

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Нимедар

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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

Overview of Нимедар

Property Description
Active ingredient Nimesulide
Form Tablets, Dispersible tablets, Granules for oral suspension
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use Anti-inflammatory, Analgesic, and Antipyretic action
Origin Synthetic compound (Sulfonanilide derivative)

Нимедар: Identity and Classification as a Selective NSAID

Нимедар is a medicinal product intended for oral (systemic) use, containing Nimesulide as its sole active ingredient. This active substance is a synthetic compound that is chemically classified as a sulfonanilide derivative. This unique chemical structure distinguishes it from the acidic nature of many conventional NSAIDs.

Nimesulide belongs to the pharmacological class of Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and is recognized as a relatively Cyclooxygenase-2 (COX-2) selective inhibitor. The product is available in several forms designed for oral ingestion, specifically as standard tablets, dispersible tablets, and granules for oral suspension.

Core Action and General Therapeutic Purpose

The general therapeutic purpose of Нимедар is to relieve discomfort and mitigate the body’s acute responses to inflammation. This is accomplished through its multiple actions, which provide a coordinated anti-inflammatory effect, analgesic action (pain relief), and antipyretic action (fever reduction).

Its primary action involves the selective reduction of inflammatory mediators, such as prostaglandins, at the site of inflammation or injury. Nimesulide is used in managing acute pain syndromes for the rapid and sustained control of inflammation. This action facilitates the reduction of the three cardinal symptoms typically associated with various inflammatory processes: pain, swelling, and fever.

What side effects are possible with Нимедар?

Possible Side Effects and Safety Information

This section details officially documented adverse reactions and safety restrictions for Нимедар (Nimodipine), strictly based on regulatory documentation.

Regulatory Safety Warnings

A paramount safety restriction is the Boxed Warning that the oral formulation must be administered ONLY by mouth or via a nasogastric/gastric tube. The product must NEVER be administered intravenously (IV) or by any other parenteral route, as this has been associated with death, cardiac arrest, and severe hypotension.

Key Adverse Reactions

The most clinically significant adverse reaction documented is hypotension (low blood pressure). Other common adverse reactions can involve the cardiovascular, nervous, and gastrointestinal systems, including a decrease in heart rate (bradycardia), headache, diarrhea, and nausea.

System-Organ Class Examples of Adverse Reactions
Vascular/Cardiac Hypotension, Bradycardia, Edema
Nervous System Headache, Dizziness
Gastrointestinal Diarrhea, Nausea, Constipation

Population and Interaction Considerations

Patients with cirrhosis of the liver have increased plasma levels of the medication and are at higher risk for adverse effects, necessitating a lower dosage (e.g., a 50% reduction).

Concomitant use with strong CYP3A4 inhibitors (such as certain antifungal or anti-HIV medications) is contraindicated as it can significantly increase the risk of severe hypotension. Conversely, strong CYP3A4 inducers (such as certain anti-seizure medications or St. John's wort) can reduce efficacy and should be avoided. Grapefruit or grapefruit juice intake is also restricted due to the potential for increasing medication levels and side effect risk.

Overdose and Emergency Response

Documented Overdose Manifestations

The official regulatory documentation describes the overdose profile for Nimesulide as typically presenting with a limited spectrum of symptoms. Common clinical manifestations reported are generally reversible and include central nervous system effects such as lethargy and drowsiness, alongside gastrointestinal disturbances like nausea, vomiting, and epigastric pain.

Severe Outcomes and Required Emergency Action

Despite the frequent occurrence of milder symptoms, regulatory labels document the potential for rare, severe, and life-threatening outcomes. These complications may include gastrointestinal bleeding, acute renal failure, hypertension, respiratory depression, and coma. The occurrence of any severe symptom, or suspicion of a large ingestion, requires that a patient seek immediate medical attention.

Official Management and Monitoring Constraints

The mandated management approach is strictly based on symptomatic and supportive care, as regulatory bodies confirm that no specific antidote is known. If the overdose is addressed within four hours of ingestion, activated charcoal and an osmotic cathartic may be indicated as regulatory-approved decontamination measures. Monitoring requirements note that due to the high plasma protein binding (up to 97.5%), clearance procedures such as haemodialysis are considered unlikely to be useful.

Therapeutic Uses of Нимедар

What Нимедар Treats — Main Uses and Benefits

Нимедар is commonly used to help with acute, temporary episodes that involve symptoms related to inflammatory or irritative states. Systemic use is relevant in clinical settings for the management of acute pain and primary dysmenorrhoea. This approach helps address symptom clusters that may become intense or disruptive.

Key Therapeutic Focus

Нимедар is generally considered relevant for easing symptoms related to physical discomfort associated with the musculoskeletal system, commonly used across conditions presenting with acute episodes. The main conditions where this medication is applied include the painful phases of osteoarthritis, discomfort following minor trauma like sprains or strains, and the intense, cyclical discomfort of primary dysmenorrhea (menstrual cramps). It is also relevant for easing fever and applied in scenarios where additional management of discomfort is required, such as following minor surgery.

“This targeted application supports the patient during difficult episodes by easing distress.”

The application of this medication contributes to improved comfort during periods of heightened symptoms and helps ease the overall symptom burden.


Quick Fact: Relief for Acute Pain
Supports patients during episodes of heightened discomfort associated with inflammation and injuries, helping to maintain functional stability.

Regulatory References

  1. European Medicines Agency (EMA) guidance on Nimesulide

Eligibility and Restrictions for Use

Population Eligibility for Нимедар (Nimesulide)

Official regulatory documents define strict limitations for the use of Нимедар, which is restricted to being a second-line treatment with a maximum duration of 15 days. Eligibility is fundamentally determined by age, organ function, and specific disease activity.

Contraindicated Populations (Prohibited Use)

Category Contraindication (Must Not Use)
Age Children under 12 years of age and the elderly generally require careful consideration.
Hepatic & Renal Function Any degree of hepatic impairment (liver dysfunction); Severe renal impairment (creatinine clearance < 30 ml/min).
Gastrointestinal Active gastric or duodenal ulcer; history of recurrent ulceration or gastrointestinal bleeding.
Other Conditions Severe heart failure; severe coagulation disorders; history of hepatotoxic reactions to nimesulide.

Restricted & Conditional Eligibility

  • Age: Use is permitted for Adults and Adolescents (12 to 18 years).
  • Pregnancy & Lactation: Contraindicated during the third trimester of pregnancy and during breastfeeding. Use is not recommended during the first two trimesters or for women attempting to conceive.
  • Other Restrictions: Patients with mild to moderate renal impairment are eligible, but use is prohibited with concomitant exposure to other potentially hepatotoxic substances.

What should I know about interactions with other medicines?

The interaction profile for Нимедар (Nimesulide) is defined by pharmacokinetic and pharmacodynamic constraints documented in regulatory labeling. The product is strictly contraindicated for co-administration with other nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates due to the combined, significant risk of gastrointestinal bleeding and renal impairment. Co-use with other hepatotoxic medicines and alcohol is also prohibited because of the additive risk of severe liver injury.

Nimesulide is primarily metabolized via the CYP2C9 enzyme. Co-administration with strong CYP2C9 inhibitors, such as Fluconazole, causes an officially documented increase in Nimesulide plasma concentration and systemic exposure. Furthermore, Nimesulide may increase the exposure of certain drugs that are substrates of CYP2D6 or CYP3A4.

Pharmacodynamic interactions include an elevated risk of serious bleeding when combined with anticoagulants (e.g., Warfarin) or antiplatelet agents. The combination with diuretics, ACE inhibitors, or ARBs can reduce their therapeutic effects while increasing the risk of acute renal failure. Certain substances, including Lithium and Methotrexate, may experience reduced clearance, leading to increased plasma levels and potential toxicity. Interaction risks are formally noted to be heightened in the elderly and in individuals with hepatic or renal impairment.

Mechanism of Action

Targeted Inhibition of Pro-inflammatory Synthesis

The core of the drug’s mechanism is the selective inhibition of the Cyclooxygenase-2 (COX-2) enzyme. By preferentially blocking COX-2, the drug reduces the synthesis of pro-inflammatory messengers known as prostaglandins ( PGE2) within the tissue and the brain's thermoregulatory center. This molecular blockade limits the chemical signals that facilitate the sensitization of peripheral nociceptors and alters the central temperature set-point elevation, which results in the modulation of nociceptive signaling and central thermoregulation.


Ancillary Regulation of Cellular Inflammatory Responses

Beyond the primary COX-2 action, Nimesulide engages secondary mechanisms that modulate inflammatory cells and influence the maintenance of tissue architecture. This includes the inhibition of Phosphodiesterase type IV (PDE-IV) and the scavenging of Reactive Oxygen Species (ROS), which are released by immune cells. This complementary action affects local physiological homeostasis by limiting the release of other inflammatory mediators (like certain cytokines) and influencing the oxidative stress associated with inflammatory cellular activity.

Dosage and Administration Information

How to Use Нимедар: Administration Guidelines

The usage of systemic Нимедар (Nimesulide) is characterized by defined parameters for administration, dosage, and duration. This medicine is intended for oral intake, available in forms such as tablets, capsules, or granules for oral suspension. Administration protocols describe its application as a second-line treatment, used after other options have been considered.

The standard regimen involves a single dose of 100 mg, administered twice a day (bid). To maintain alignment with the maximum recommended intake, the total amount must not exceed 200 mg per 24 hours. A parameter for administration is that each dose is taken after a meal.

The protocols also define the duration of use. A treatment course is intended to use the minimum effective dose for the shortest possible duration and is limited to a maximum of 15 days. Dosage adjustments are not required for older adults or adolescents between 12 and 18 years of age. However, the use of this systemic medicine is contraindicated in children under 12 years of age.

Recent Clinical Evidence

Research evidence / Overview of studies for Нимедар (Nimesulide)

The evidence base for Нимедар is largely composed of clinical studies and comprehensive reviews that were conducted to explore its use for short-term, acute conditions. The research provides context related to patterns of symptom change observed in patient groups.


Evidence for Short-Term Management of Acute Pain

Research into the use of this medication for acute pain has involved an extensive number of short-term Randomized Controlled Trials (RCTs). These studies were designed to evaluate the effects when compared against both an inactive substance (placebo) and against other common medicines in the same class (NSAIDs). The populations studied were predominantly adult patients experiencing moderate-to-severe pain due to various causes.

Studies primarily examined outcomes related to physical discomfort, monitoring patient-reported outcomes describing perceived discomfort. Studies reported measurements where pain intensity scores followed specific patterns of change that differed between the Nimesulide groups and the placebo groups over short periods. However, the research highlights changes measured only during short, defined time intervals.


Evidence for Primary Dysmenorrhoea (Menstrual Pain)

The evidence supporting use for primary dysmenorrhoea also relies on short-term RCTs. These studies explored the effects during episodes where symptoms become more noticeable. Researchers examined outcomes capturing phases of heightened symptom activity, focusing primarily on the patient-reported intensity of pain. The trials reported findings describing observed patterns of outcome changes and measured symptom intensity during the first days of the menstrual cycle.


Long-Term Studies and Limitations on Follow-Up

Research exploring short-term symptom changes is extensive, but there is limited information for long-term outcomes regarding the use of Нимедар. Due to official regulatory recommendations, which mandate that the medication is used only for the shortest possible duration, the available clinical trial data and reviews are almost entirely confined to observation periods of 15 days or less.

A key research limitation is the lack of long-term data due to the mandatory 15-day maximum treatment restriction. Accordingly, long-term effects are not well characterized, and the clinical evidence is strictly limited to the acute, episodic management of symptoms.


What is Still Uncertain About Нимедар Research

Research explored patterns of change in outcomes compared to placebo and other NSAIDs, but the findings do not support the claim of an established or superior efficacy profile compared to the overall profiles of all established alternative treatments. Data for certain groups, particularly those with complex or multiple coexisting health conditions, remain insufficient. Research provides context but does not determine whether an individual in a complex subgroup will experience similar changes to the general populations studied.

Frequently Asked Questions (FAQ)

Common questions about Нимедар (FAQ)


Q: What is the main difference between Нимедар and other common pain relievers?

Official information describes the active ingredient, Nimesulide, as a Nonsteroidal Anti-inflammatory Drug (NSAID) with a specific mechanism of action. It is primarily known for its selective Cyclooxygenase-2 (COX-2) inhibition. This selectivity is the defining characteristic that sets it apart from non-selective NSAIDs.


Q: How quickly does Нимедар usually start to work?

The medicine is characterized by a rapid onset of action. Regulatory sources refer to clinical evidence suggesting a noticeable reduction in pain was observed in study subjects within about 15 minutes after oral administration.


Q: How long does the effect of one dose of Нимедар typically last?

The official dosing regimen is set for administration twice a day (bid). This schedule is structured to align with the pharmacological properties and elimination rate of the active substance, which helps guide the timing of administration.


Q: Can I take Нимедар if I have stomach sensitivity?

Official documents list gastrointestinal issues, such as diarrhoea, nausea, and gastritis, as known side effects. The medicine is contraindicated (must not be used) if a person has an active or past history of gastrointestinal bleeding or ulceration. Regulatory instructions define that the medicine is administered after a meal, a measure that is often used to reduce the potential for gastrointestinal adverse effects.


Q: Does Нимедар cause drowsiness or affect alertness?

Official documentation notes that side effects such as dizziness and headache are possible. Due to the possibility of these effects, the official product information advises consideration regarding the ability to safely drive or operate complex machinery.


Q: Are there any specific foods or drinks to avoid while taking Нимедар?

Official documentation strictly prohibits co-use with alcohol due to the heightened risk of severe liver injury. Restrictions are also noted for consuming Grapefruit or grapefruit juice, as these may increase the concentration of the medicine in the body and raise the potential for side effects.


Q: Can older adults generally use Нимедар, or is there a specific age limit?

This medicine is generally approved for use in adults and adolescents over 12 years of age. Official data indicates that dosage adjustments are not required for older adults based on general pharmacokinetic studies in this population.


Q: Does taking Нимедар affect blood pressure readings?

Official product information lists hypotension (low blood pressure) and fluctuations in blood pressure as documented adverse reactions. Separately, the medicine may interact with blood pressure medications like ACE inhibitors, which could reduce the therapeutic effects of those treatments.


Q: Does Нимедар interact with herbal supplements?

Regulatory warnings specifically mention the need to avoid strong CYP3A4 inducers like the herbal supplement St. John's wort. The combination of these substances may potentially reduce the expected effectiveness of the medicine, and co-administration is discouraged in regulatory warnings.


Q: Can I take Нимедар with birth control pills?

The official product information details that the medicine is processed by the CYP2C9 enzyme, but it may also influence the levels of other medicines that use the CYP3A4 pathway. Due to this metabolic consideration, the potential for an interaction with oral contraceptives exists, which is a factor mentioned in comprehensive drug information.


Q: Is it common for people to experience headaches when taking Нимедар?

The official documentation classifies headache as a common side effect. This means it is reported to affect more than 1 in 100 people but fewer than 1 in 10 people who use the medication.


Q: Does official documentation mention use of Нимедар for specific types of joint pain?

Yes, regulatory documents list the medicine's approved indications as including the symptomatic treatment of painful osteoarthritis. This is in addition to treating general acute pain and primary dysmenorrhoea (menstrual pain).


Q: Can Нимедар be taken on an empty stomach?

Regulatory documents specify that the medicine is to be administered after a meal. This condition is defined as part of the official administration guidelines, established to help manage and reduce the risk of gastrointestinal adverse effects.


Q: Is Нимедар available in different forms (e.g., tablets, gels)?

The systemic form of this medicine is available as tablets and as granules for oral suspension. It is also documented in regulatory sources that topical formulations, such as gels or creams, containing the same active ingredient are available.


Q: Are there warnings about driving or operating machinery while taking Нимедар?

Official information advises patients that side effects such as dizziness or vertigo are possible. Because these effects may impair a person's ability to react, regulatory guidance advises caution regarding driving or operating complex machinery.


Q: Does the official drug leaflet clarify what to do in case of overdose?

Yes, the official documentation states that in the event of an overdose, a person should be managed with symptomatic and supportive care. It explicitly notes that there is no specific antidote available for this medicine.


Q: Is Нимедар considered a controlled substance?

The active ingredient, Nimesulide, is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). It is not generally listed as a scheduled or controlled substance under major international drug control conventions.


Q: What are the typical conditions that Нимедар is approved to treat?

According to the official therapeutic indications, the medicine is approved for treating acute pain, the symptomatic treatment of painful osteoarthritis (joint pain and swelling), and primary dysmenorrhoea (menstrual pain).


Q: How long does the active substance from Нимедар stay in the body?

Regulatory documents indicate the half-life of the active ingredient, Nimesulide, is typically reported to be between 1.8 and 4.7 hours. The half-life is the time it takes for half of the substance to be eliminated from the body.


Q: Can I take Нимедар if I have asthma?

Official documentation notes that very rare adverse reactions include asthma and bronchospasm (narrowing of the airways). As with other NSAIDs, the use of this medicine in people with a history of NSAID-induced asthma requires special consideration and caution.


Q: How is the drug classified in terms of risk during breastfeeding?

The medicine is contraindicated during breastfeeding according to official regulatory summaries. This restriction is based on the limited data available on whether the medicine is excreted into breast milk and the potential known risks of NSAIDs to a newborn.


Q: What are the most serious, but rare, side effects mentioned in the drug information?

Official warnings document serious but rare side effects, including severe liver injury. This includes reported cases of fulminant hepatitis (rapid liver failure), jaundice (yellowing of the skin), and potentially life-threatening outcomes such as acute liver failure.

How should Нимедар be stored and disposed of?

Storage and Disposal Requirements

Item Regulatory Requirement
Storage Temperature: Store at a temperature not exceeding 30 C (Store below 30 C).
Environmental Protection: Protect from direct light and moisture.
Packaging: Store in the original container/package and keep it tightly closed.
Prohibited Handling: Do not refrigerate or freeze the medicine.
Child Safety: Keep medicine out of the sight and reach of children.

Official Disposal Statements:

  • Unused or expired product must be disposed of in accordance with local, regional, and national regulations.
  • Disposal should generally utilize a formal drug take-back option (e.g., community pharmacy) where available.
  • The product must not be thrown into wastewater or household garbage unless directed by local authorities.

The regulatory profile defines that this medicine must be kept in a cool, dry environment, strictly protected from light and moisture to ensure product stability. Essential instructions mandate storage in the original packaging and require that all unused portions be disposed of through controlled means to comply with environmental and safety standards.

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

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