Аулин

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Аулин

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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 Аулин

What is Аулин? (What is Aulin?)

Property Description
Active ingredient Nimesulide
Form Tablet, granules for oral suspension
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common purpose Symptomatic relief from pain, inflammation, and fever
Origin Synthetic (Sulfonanilide derivative)

Аулин: Composition and Origin

Аулин is the trade name for a medicinal product that contains Nimesulide as its single active ingredient. This core substance is a synthetic compound structurally categorized as a sulfonanilide derivative. It is designed for prescription-only use and is typically administered orally, available as a standard tablet or in the form of granules for oral suspension (sachets). The pharmaceutical preparation focuses on the Nimesulide molecule to provide consistent therapeutic delivery.

What class of medicine does Aulin belong to?

Аулин is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID), a general category of medications used for discomfort management. Its functional distinction lies in its categorization as a selective cyclooxygenase-2 inhibitor (COX-2 selective NSAID). The active ingredient Nimesulide preferentially modulates the COX-2 enzyme, which is linked to the production of inflammatory signals. This differentiation sets its mechanism apart from traditional non-selective NSAIDs.

What is the general purpose of Aulin?

The overarching role of Аулин is to provide symptomatic relief by exerting three primary physiological actions: it functions as an anti-inflammatory agent, an analgesic (pain reliever), and an antipyretic (fever reducer). Nimesulide is used for the symptomatic treatment of acute pain. This combination of effects is intended for managing general discomfort, such as the aches and pains that accompany acute inflammatory conditions.

What side effects are possible with Аулин?

The safety profile of Аулин (Nimesulide) is defined by official regulatory documents, classifying possible adverse reactions by frequency and the body system affected. These classifications differentiate between common, generally less severe effects and serious, rare events.

Adverse Reactions by Frequency

Side effects are categorized according to standardized frequency bands (e.g., EMA SmPC classifications):

Frequency Common Examples
Common (1 in 100 to 1 in 10) Diarrhoea, nausea, vomiting, elevated liver enzymes (transaminases).
Uncommon (1 in 1,000 to 1 in 100) Gastritis, constipation, dizziness, oedema, hypertension.
Rare (1 in 10,000 to 1 in 1,000) Anaemia, hypersensitivity reactions, haemorrhage, tachycardia, malaise.
Very Rare (less than 1 in 10,000) Fulminant hepatitis, gastrointestinal perforation, renal failure, anaphylaxis, Stevens-Johnson Syndrome.

Serious Safety Considerations

The most serious adverse reactions documented in regulatory sources primarily involve the gastrointestinal and hepatobiliary systems. These include potentially severe events such as gastrointestinal haemorrhage, ulceration, and fulminant hepatitis. Severe cutaneous reactions, including Toxic Epidermal Necrolysis (TEN), are also classified as very rare but serious.

Population and Duration Constraints

Official safety statements note that older adults may be more susceptible to adverse effects, particularly those affecting the renal, hepatic, and gastrointestinal systems. Nimesulide is contraindicated in individuals with severe hepatic or renal impairment. Furthermore, the risk of serious gastrointestinal events is associated with the duration of treatment. Due to safety concerns, the regulatory documents restrict use to the shortest possible duration, typically not exceeding 15 days, and designate it as a second-line treatment option.

Overdose and Emergency Response

Aulin (nimesulide) is an NSAID, and overdose symptoms are generally consistent with that drug class. While the majority of NSAID overdoses are minor and self-limiting, high doses can lead to severe and potentially life-threatening toxicity. There is no specific antidote for nimesulide overdose; treatment focuses on supportive care.

Overdose Symptoms

Symptoms of a nimesulide overdose can vary, but commonly reported signs include:

  • Gastrointestinal Effects: Nausea, vomiting, diarrhea, epigastric pain, and potentially gastrointestinal bleeding.
  • Central Nervous System Effects: Drowsiness, lethargy, headache, dizziness, and, in severe cases, seizures or coma.
  • Other Potential Effects: Acute kidney failure, metabolic acidosis, and hypertension.

When to Seek Emergency Help

Immediate emergency medical attention is required if an overdose is suspected or if severe symptoms develop. Call for emergency medical services immediately if the patient experiences any of the following:

  • Severe respiratory distress (e.g., shallow or difficult breathing).
  • Loss of consciousness or profound confusion.
  • Seizures or convulsions.
  • Signs of severe gastrointestinal bleeding (e.g., vomiting blood or passing black, tarry stools).

If an overdose is suspected, even without severe symptoms, contact a poison control center or seek medical advice right away. Provide the medical professional with the patient's age, weight, the name and strength of the product, and the estimated amount and time of ingestion.

Therapeutic Uses of Аулин

What Аулин Treats: Main Uses and Benefits

Аулин is commonly used to provide supportive symptomatic relief by addressing pronounced physical manifestations associated with acute conditions. The medication is utilized in situations where supportive symptom management is appropriate for acute episodes of pain and inflammation.

It is generally applied across therapeutic domains involving heightened discomfort or tension, such as pain from recent musculoskeletal injuries like sprains and strains, discomfort following dental procedures, and the pain and cramping of primary dysmenorrhoea. This use helps address symptom clusters that may become intense or disruptive, and is intended to support comfort during periods of heightened symptoms.

This medication is considered relevant for easing distress in situations where acute pain and inflammation may interfere with daily functioning.

Quick Fact: Relief for Acute Discomfort

  • Symptom Focus: Helps manage symptoms related to physical discomfort, inflammatory states, and systemic imbalance (fever).
  • Conditions: Applicable in conditions presenting with acute or disruptive episodes, including painful osteoarthritis flare-ups.
  • Patient Benefit: Provides support that assists with maintaining functional stability and helps patients cope with symptom fluctuations.

Regulatory References

  1. European Medicines Agency: Nimesulide Annex III

Eligibility and Restrictions for Use

Eligibility Scope

Populations for whom use is allowed: The medicine is designated for use only by adults and adolescents aged 12 years and older.

Populations for whom use is contraindicated: Aулин is strictly prohibited in several key populations, including children under 12 years of age. Use is contraindicated in patients with any degree of hepatic impairment or a history of hepatotoxic reactions to the drug. It is also prohibited for those with severe renal impairment (creatinine clearance < 30 mL/min), severe heart failure, and active peptic ulceration or GI bleeding. Contraindications also apply to individuals with severe coagulation disorders or those presenting with fever and/or flu-like symptoms.

Pregnancy and Lactation Eligibility Status: Use is contraindicated during the third trimester of pregnancy and throughout lactation/breastfeeding. Use is not recommended for women attempting to conceive due to potential impairment of fertility.

Eligibility-Related Restrictions: Regulatory rules mandate that the medicine must only be prescribed as second-line treatment—meaning after other therapies have failed—and for a maximum duration of 15 days.


Eligibility Classifications (High-Level)

Eligibility severity classification: Contraindicated (absolute prohibition) based on multi-organ system risks.

Regulatory basis: European Medicines Agency (EMA) reviews.

Eligibility-context constraints: Second-line use, time-limited use (15 days maximum).

What should I know about interactions with other medicines?

Interactions with other medicines and products

Category Official Regulatory Statement/Entities
Medicinal product categories with documented interactions: NSAIDs, Anticoagulants, Anti-platelet agents, Diuretics, ACE Inhibitors, Angiotensin II Receptor Antagonists, Methotrexate, Lithium, Cyclosporines.
Mechanistic basis of interactions (only if stated in label): Inhibition of the CYP2C9 enzyme; Reduced renal clearance of co-administered drugs; Pharmacodynamic synergy (increasing risk of bleeding or renal damage).
Interaction-related restrictions: Alcohol abuse must be avoided; Co-administration with other NSAIDs is not recommended; Co-administration with Anticoagulants is not recommended.

The official interaction profile for Nimesulide is structured around its metabolic and pharmacodynamic properties. The drug is documented as an inhibitor of the CYP2C9 enzyme, which can increase the plasma concentration and exposure of certain co-administered substrates like Warfarin. Due to the risk of reduced clearance, Nimesulide can lead to elevated plasma levels of both Lithium and Methotrexate, the latter requiring caution if doses are taken less than 24 hours apart. Furthermore, the combination with Diuretics and ACE Inhibitors can reduce their therapeutic efficacy and increase the risk of acute renal compromise, especially in the elderly or those with pre-existing impairment. These interaction patterns are categorized to guide appropriate co-administration constraints.

Mechanism of Action

The mechanism of action for the active ingredient, Nimesulide, is defined by its ability to modulate specific pathways within the inflammatory response, resulting in key physiological adjustments.

Preferential COX-2 Inhibition and Mediator Modulation

This core action involves the preferential inhibition of the Cyclooxygenase-2 (COX-2) enzyme at the molecular level, reducing the synthesis of pro-inflammatory mediators like Prostaglandin E2 ( PGE2). This primary mechanistic domain initiates a sequence that results in reduced inflammatory signaling and decreased sensitization of peripheral nociceptors.

Complementary Cellular and Oxidative Pathway Control

In addition to COX-2 modulation, the drug engages secondary mechanisms by inhibiting specific inflammatory cell enzymes such as Matrix Metalloproteinases (MMPs) and Myeloperoxidase (MPO). This domain contributes to the cascade by inhibiting tissue-degrading enzyme activity and scavenging free radicals, contributing to the modulation of the cellular inflammatory process.

Central Pathway Modulation for Thermoregulation

The drug also acts on the pathways governing body temperature by reducing PGE2 levels within the hypothalamus. This central mechanistic action modulates the elevated set point for core body temperature, leading directly to the resulting physiological effect of lowering the elevated core body temperature.

Dosage and Administration Information

Administration Guidelines for Аулин (Nimesulide)

The use of systemic Nimesulide, marketed as Аулин, is characterized by parameters that specify the route, dosage, frequency, and maximum duration of treatment. The lowest effective dose is used for the shortest duration necessary.

Administration Scope Parameter
Route of Administration The product is indicated for oral use, available as 100 mg tablets or granules for oral suspension.
Standard Dosing Schedule The standard adult dose is 100 mg Nimesulide, taken twice daily (bid). The total daily dose must not exceed 200 mg.
Timing in Relation to Meals Each dose is administered after a meal (post prandially).
Preparation Requirements Granules for oral suspension are dissolved in a small amount of water immediately prior to administration.
Maximum Treatment Duration The maximum duration for a single course of treatment does not exceed 15 days.

Population-Specific Usage Rules

There are specific parameters for use for certain populations. The product is contraindicated in children under 12 years of age. For adolescents (12–18 years) and older adults, no routine dosage adjustment is required based on age alone. However, the medicine is contraindicated in individuals with severe renal impairment (creatinine clearance < 30 mL/min) or any degree of hepatic impairment.

Procedural Structure

The established procedure dictates that the 100 mg dose is taken two times a day following food intake. This regimen adheres to the constraint that treatment is limited to the shortest possible duration, with an absolute ceiling of 15 days for this NSAID.

Recent Clinical Evidence

Research Evidence for Acute Pain

Research has explored Nimesulide (Аулин) in study settings involving conditions characterized by acute or disruptive episodes of pain, such as discomfort following dental or minor orthopedic procedures, or pain from recent injuries like strains and sprains. The evidence base for this type of condition includes short-term randomized controlled trials (RCTs). These studies were designed to compare outcomes when using Nimesulide against both an inactive substance (placebo) and other standard non-steroidal anti-inflammatory drugs (NSAIDs).

In these research scenarios, investigators used validated measurement tools to monitor patient-reported outcomes describing perceived discomfort. Findings describe patterns observed in the studies where outcomes related to physical discomfort were observed and measured over short time intervals. The studies relevant for acute pain were designed to monitor outcomes over defined time intervals, typically lasting no more than 15 consecutive days, which is the maximum duration mandated by regulatory bodies for this medicine.


Research Evidence for Primary Dysmenorrhoea (Menstrual Pain)

Research has also explored Nimesulide in study settings involving conditions characterized by fluctuating or episodic manifestations, such as primary dysmenorrhoea (common menstrual pain). These studies were structured as cyclical RCTs, typically double-blind, where the medicine was applied in research contexts involving fluctuating or unstable symptoms. These trials aimed to contextualize how patients reported their experience when compared against an inactive substance and other NSAID comparators used in the studies.


Research on Treatment Duration and Long-Term Follow-up

The available research base used to support the approved uses of Nimesulide is strictly limited to short-term studies. The treatment protocols observed in the trials typically involved administration for no longer than 15 consecutive days. Therefore, there is limited information for long-term outcomes, meaning the long-term effects are not fully established. The evidence base contributes to understanding symptom patterns for temporary, episodic use, but the research does not provide data related to the durability of outcomes when used repeatedly beyond the study durations.

Frequently Asked Questions (FAQ)

Common questions about Аулин (FAQ)


Q: How does the action of Аулин compare to non-selective pain relievers?

Official information describes Аулин's active ingredient as a relatively selective inhibitor of the COX-2 enzyme. This mechanism is distinct from non-selective NSAIDs. Studies have shown that in the short-term use for which it is indicated, the drug offers comparable gastrointestinal tolerability.


Q: Are there any major food or diet restrictions while using Аулин?

According to the official product information, the medicine is advised to be taken after a meal. The use of alcohol during treatment is generally discouraged by official warnings. Regulatory documents do not typically specify other major diet restrictions.


Q: Is long-term use of Аулин associated with a need for liver function monitoring?

The drug is only approved for short-term use, with a strict maximum duration of 15 days, which is intended to mitigate liver risks. Elevated liver enzymes are a common side effect, and the medicine is strictly contraindicated in individuals with existing hepatic impairment. Use beyond the prescribed duration is not supported by regulatory guidance.


Q: How is the active ingredient in Аулин processed and broken down by the body?

The active ingredient, Nimesulide, is rapidly absorbed by the body. It then undergoes extensive metabolism, or breakdown, primarily in the liver. This process forms 4-hydroxynimesulide, which is also a biologically active compound.


Q: Can a person with a history of high blood pressure generally take Аулин?

Official information states that the medicine is contraindicated in severe or non-controlled heart failure. While hypertension (high blood pressure) is listed as an uncommon side effect, caution is generally advised in the product label for patients with cardiac impairment.


Q: What are the main differences between the granules and the tablet forms of Аулин?

Both the granules and the tablets contain the same standard dose of 100 mg of the active ingredient. The key difference in administration is that the granules for oral suspension are required to be dissolved in a small amount of water immediately prior to administration.


Q: What are the warning signs of a severe allergic reaction to Аулин?

Severe allergic reactions are rare adverse events. Regulatory documents list symptoms that can include general hypersensitivity, difficulty breathing (bronchospasm), hives (urticaria), and very rare but serious skin reactions like Stevens-Johnson Syndrome (SJS).


Q: Is there a reported impact of Аулин on kidney function?

The drug is strictly contraindicated in patients who have severe kidney impairment. Renal dysfunction, though a rare event, is a documented risk, especially when combined with other interacting drugs.


Q: What does it mean for Аулин to be a 'COX-2 selective inhibitor'?

This term means that the drug preferentially targets the Cyclooxygenase-2 (COX-2) enzyme in the body. The COX-2 enzyme is the one primarily responsible for producing the specific chemical signals that lead to pain and inflammation.


Q: Why is the treatment duration often strictly limited in the professional prescribing information?

The duration of treatment is strictly limited to a maximum of 15 days to minimize the risk of serious adverse reactions. Official documents indicate that risks, particularly those affecting the gastrointestinal tract and liver, are linked to longer treatment courses.


Q: Can Аулин be used for muscle soreness after exercise?

The oral form is indicated for the symptomatic relief of acute pain, which covers many short-term issues. The topical gel form (where available) is specifically indicated for local relief of pain from soft tissue injuries, strains, and sprains.


Q: Why is there discussion about the drug's impact on the cardiovascular system?

The class of medicines known as NSAIDs has been generally linked to an increased risk of serious cardiovascular side effects, such as heart attack and stroke. For this reason, official information states that the drug is contraindicated in patients with severe heart failure.


Q: Does Аулин commonly cause side effects like drowsiness or affect alertness?

Official documents list somnolence (drowsiness) and dizziness as potential side effects. As a result, patients are generally advised in the product information to use caution when driving or operating heavy machinery if they experience these effects.


Q: How quickly does the pain-relieving effect of Аулин typically begin to work?

The medicine has a relatively rapid onset of action following administration. Studies and official information indicate that meaningful reductions in pain are often observed within 15 minutes of taking the dose.


Q: Is Аулин generally suitable for people with a history of asthma or respiratory issues?

Official documents strictly contraindicate (prohibit) the medicine in patients who have a history of allergic reactions induced by aspirin or other NSAIDs. Such reactions include rhinitis, urticaria (hives), or bronchospasm (sudden airway narrowing).


Q: What should be done if a patient realizes they have forgotten to take a dose?

If a dose is forgotten, general medical guidelines advise against taking a double dose to make up for the missed one. Official information typically advises patients to resume the regular dosing schedule with the next planned dose.


Q: Why is the medicine sometimes available in a topical gel formulation?

The active ingredient is manufactured in a topical gel formulation to provide localized treatment. This form is indicated for the specific purpose of achieving local relief from pain and inflammation associated with soft tissue injuries, strains, and sprains.


Q: Does Аулин have a reported interaction with antacid medications?

Regulatory information indicates that studies found no clinically significant interaction when Nimesulide was co-administered with a common combination antacid. This antacid combination contained aluminium and magnesium hydroxide.


Q: Are there differences in the type or frequency of side effects reported for the tablet versus the gel form?

When the gel is applied topically to the skin, the amount of the drug entering the bloodstream results in much lower plasma concentrations than with oral intake. For this reason, the risk of systemic adverse reactions, such as gastrointestinal upset, is significantly lower with the gel.


Q: Does Аулин cause weight changes?

While specific weight gain or loss is not listed in the adverse event profile, the side effect of oedema (fluid retention) is listed as an uncommon adverse reaction associated with the medicine.


Q: Are headaches a reported side effect of Аулин?

Yes, headaches are listed in the official documents as a potential side effect associated with the use of the drug.


Q: How long after stopping the drug does it completely leave the system?

Nimesulide has a half-life of 2 to 5 hours, and its active metabolite's half-life is 3 to 9 hours. Pharmacokinetic data suggests that the drug and its active metabolite are typically cleared from the system within approximately 40 to 45 hours of the last dose.


Q: Is there an increased sensitivity to sunlight when taking Аулин?

The official product information includes a warning against exposure to direct sunlight and solarium sunlight. This measure is necessary to reduce the risk of photosensitivity, particularly when the topical gel formulation is being used.

How should Аулин be stored and disposed of?

Official Storage and Disposal Requirements for Аулин (Nimesulide)

The storage and disposal of Аулин must adhere strictly to the conditions specified in official regulatory labeling to ensure product stability and safety.

Storage Conditions

  • Temperature: The product must be stored at a temperature below 25°C.
  • Protection: To protect against moisture, the medicine must be kept in its original package.
  • Child Safety: It is a mandatory regulatory requirement to keep Аулин out of the sight and reach of children.

Disposal Instructions

Expired or unused Аулин must be discarded in accordance with local pharmaceutical requirements.

  • Prohibited Methods: The medicine should not be disposed of via wastewater or mixed with regular household waste.
  • Environmental Mandate: These procedures are necessary to protect the environment and comply with official drug disposal mandates.

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

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