Dolvex

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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 Dolvex

Quick Facts

Property Description
Active ingredient Nimesulide
Form Tablet, Capsule, Granules, Gel, Suppository
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Symptomatic relief of pain, inflammation, and fever
Origin Synthetic organic compound

What is Dolvex and What Pharmacological Class Does it Belong To?

Dolvex is a trade name for a medicinal product featuring the active substance Nimesulide, which is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). Its core function is providing symptomatic relief for acute pain, swelling, and elevated body temperature.

The active component, Nimesulide, is recognized for its unique chemical structure, belonging to the sulfonanilide chemical class within the broader NSAID group. This classification defines its utility as an analgesic agent. As a synthetic organic compound, its manufacturing ensures high consistency and quality control for the substance.


What is the Main Ingredient in Dolvex and How Does it Generally Help?

The therapeutic effects of Dolvex are entirely attributable to its single component, Nimesulide, which functions by selectively addressing the biological signals that amplify pain and cause swelling. The drug is a relatively selective inhibitor of cyclooxygenase-2 (COX-2), meaning it preferentially targets the enzyme responsible for creating inflammatory mediators.

This mechanism underpins the medicine's general purpose: to deliver simultaneous analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) effects. For instance, the medicine is commonly used for managing sudden, short-term painful episodes, confirming its established role in helping to suppress the body's acute inflammatory response.


What Forms is the Active Ingredient Nimesulide Available In?

The availability of Nimesulide in multiple pharmaceutical preparations is a key differentiating factor, enabling flexible administration methods. These preparations include common oral forms like tablets and capsules, as well as granules or powder intended for oral suspension to be taken by mouth. For local effects, the active ingredient is also incorporated into a topical gel or spray, facilitating cutaneous administration. The variety in these dosage forms dictates the specific base or vehicle that carries the Nimesulide, fully defining the physical nature of the drug entity.

What side effects are possible with Dolvex?

Possible Side Effects and Safety Information

The official safety profile for Dolvex, which contains Nimesulide, is organized based on affected body systems and the documented frequency of adverse reactions, as defined in regulatory documents like the European Medicines Agency (EMA) Summary of Product Characteristics (SmPC).

Documented Adverse Reaction Scope

Adverse Reaction Type System-Organ Classes Involved
Common (1 in 100 to 10) Gastrointestinal disorders (e.g., diarrhea, nausea, vomiting), Mild Hepatobiliary disorders (e.g., elevated liver enzymes).
Uncommon (1 in 1,000 to 100) Skin and subcutaneous tissue disorders (e.g., rash), Vascular disorders (e.g., hypertension), Edema.

Serious adverse reactions, though classified as Rare or Very Rare, include severe risks to vital organs. These officially documented serious risks include Severe Hepatic Failure (liver injury, including fatal cases), Gastrointestinal Bleeding, Ulceration, and Perforation, and Severe Cutaneous Adverse Reactions (such as Stevens-Johnson Syndrome).

Safety Constraints and Population Restrictions

Regulatory documents impose specific limitations on the use of Nimesulide. Treatment is restricted to the shortest possible duration (e.g., up to 15 days) due to safety concerns, particularly regarding the liver. Serious hepatic reactions have been reported even after short-term exposure.

The medicine is strictly contraindicated in several populations, including: children under 12 years of age, patients with severe hepatic or renal impairment, individuals with an active gastric or duodenal ulcer, and women in the third trimester of pregnancy.

This structure ensures that the primary risks—to the liver and the gastrointestinal tract—are clearly identified, defining the limitations and constraints for its prescription.

Overdose and Emergency Response

The regulatory documentation for Dolvex (Nimesulide) overdose details the acute clinical presentation and the required emergency response. Documented Overdose Presentations are often initially mild, including gastrointestinal symptoms like nausea, vomiting, and epigastric pain, alongside central nervous system effects such as lethargy and drowsiness. Physiological Systems Affected can include the gastrointestinal, renal (leading to acute renal failure), and central nervous systems (potentially leading to coma or respiratory depression). The officially noted severe risk profile includes fulminant hepatic failure. Population-specific Overdose Notes confirm that overdose severity is heightened in hepatic impairment, where the drug is contraindicated.

Emergency-response statements mandate that immediate medical attention is required for any suspected overdose or if severe symptoms occur. Urgent hospital treatment is necessary for severe manifestations. Official Overdose Statements confirm that no specific antidote is known for Nimesulide overdose, and management is therefore restricted to symptomatic and supportive treatment. Procedural management notes that activated charcoal may be considered for recent high-dose ingestion. This structure defines the official overdose profile based strictly on mandated actions and documented risks.

Therapeutic Uses of Dolvex

Dolvex is commonly used to help manage symptom clusters related to physical discomfort, inflammation, and systemic imbalance across several distinct clinical contexts. It is considered relevant for easing symptoms that interfere with daily functioning, providing short-term symptomatic assistance.

The medication is applied across domains where additional symptomatic support is needed, with common uses including addressing acute pain, the symptomatic management of painful osteoarthritis flares, and the relief of symptoms associated with primary dysmenorrhea (menstrual pain). It helps address symptom clusters that may become intense, contributing to easing discomfort during periods of heightened symptoms.

Acute Pain and Inflammatory Conditions

This domain is applicable within clinical settings that involve acute or disruptive symptom patterns, such as postoperative dental pain and discomfort from conditions involving inflammatory or irritative processes. It supports the patient during difficult episodes by easing distress and may assist in supporting functional stability.


Quick Fact: Symptomatic Relief for Acute Episodes Dolvex is commonly used when short-term symptomatic assistance is needed for conditions presenting with heightened symptoms like sudden pain or inflammatory episodes, supporting the patient during difficult episodes by easing distress.

Regulatory References

  1. European Medicines Agency Annex III on Nimesulide

Eligibility and Restrictions for Use

Who can and cannot use Dolvex?

Eligibility for Dolvex (Nimesulide) is strictly determined by governmental regulatory labeling, with numerous absolute contraindications based on age, organ function, and current health status. It is primarily permitted for adults and adolescents over 12 years of age for short-term, acute pain relief, and is officially restricted as second line treatment only. The maximum course of therapy is limited to 15 days.


Absolute Non-Eligibility (Contraindicated)

Dolvex is absolutely forbidden for patients who have any degree of hepatic impairment or severe renal impairment (creatinine clearance < 30 ml/min). It is also contraindicated in those with severe heart failure, severe coagulation disorders, or active gastrointestinal bleeding or ulcers. Use is strictly prohibited for children under 12 years of age and during the third trimester of pregnancy and lactation.

Use Restrictions

Use is not recommended during the first two trimesters of pregnancy or for women attempting to conceive. Furthermore, regulators no longer recommend its use for the symptomatic treatment of painful osteoarthritis.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information regarding Nimesulide (Dolvex) interactions is structured around pharmacokinetic and pharmacodynamic constraints, as documented by government health authorities.

Interaction Classifications and Restrictions

Interaction Type Interacting Agent(s) Official Regulatory Statement
Contraindicated Other NSAIDs (including Aspirin) Prohibited due to a documented increased risk of gastrointestinal adverse effects and hemorrhage.
Contraindicated Hepatotoxic Substances (e.g., Paracetamol) Prohibited due to the established risk of hepatotoxic reactions associated with Nimesulide.
Pharmacodynamic Oral Anticoagulants (e.g., Warfarin) Use carries an officially documented increased risk of bleeding due to additive antiplatelet effects.
Pharmacokinetic Lithium Reduces Lithium renal clearance, which results in elevated plasma levels and risk of toxicity.
Pharmacokinetic Methotrexate Co-administration may increase serum levels and enhance the toxicity of Methotrexate, especially when administered within a 24-hour window.
Pharmacodynamic Diuretics / ACE Inhibitors May decrease the antihypertensive/diuretic activities of these agents, requiring caution in susceptible patients.

Nimesulide is documented to have the potential for drug interaction with substances metabolized by the CYP2C9 enzyme. Furthermore, the official profile notes caution for the use of certain interacting substances in populations such as the elderly, dehydrated, or those with compromised renal function.

Mechanism of Action

Dolvex is a pharmaceutical preparation containing Mefenamic acid and Paracetamol (Acetaminophen). Its systemic modulation involves the distinct pharmacodynamic actions of these two components.

Mefenamic acid functions as a non-steroidal anti-inflammatory drug (NSAID) by acting as an inhibitor of Cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2. This inhibition prevents the metabolism of arachidonic acid, thereby reducing the intracellular biosynthesis and release of prostaglandins and thromboxanes. These eicosanoids are chemical mediators involved in cellular signaling related to local tissue injury and cellular activation, modulating vascular permeability and nerve sensitization. System-level consequences include the modification of local inflammatory responses and nociceptive signaling.

Paracetamol's precise mechanism is less fully elucidated but involves central action, likely through inhibition of central COX activity and potential interaction with descending serotonergic pathways. This leads to a modulation of thermoregulatory centers in the central nervous system, and a modification of central pain perception thresholds.

Dosage and Administration Information

Dolvex, containing the active substance Nimesulide, is intended for systemic use via the oral and rectal routes, and for local use via topical application (gel or ointment). The standard adult dose is 100 mg of Nimesulide, administered twice daily. The total daily intake for systemic formulations must not exceed 200 mg.

For oral preparations, such as tablets or granules for suspension, administration must consistently occur after meals. The administration protocol maintains that treatment duration for systemic forms is limited to a maximum of 15 days, utilizing the minimum effective dose for the shortest possible duration.

Usage rules are population-specific: The medicine is contraindicated in children under 12 years of age and in patients with severe hepatic or renal impairment. Conversely, no dose adjustment is typically required for older adults or those with mild-to-moderate renal impairment. If a scheduled dose is missed, the subsequent dose must not be doubled to compensate. This structured approach defines the standardized, time-bound usage pattern for the medication.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Dolvex (Nimesulide)

This overview summarizes the official clinical research and study landscape for Dolvex (Nimesulide), detailing the types of evidence that exist, the populations research examined, and what remains uncertain, based solely on authoritative sources.


Research Evidence for Acute Pain and Inflammatory Episodes

Research examined the effects of Dolvex in adult populations in conditions characterized by sudden, short-term painful manifestations, such as after surgical procedures or during sudden flares of musculoskeletal issues. The majority of the evidence comes from short-term, randomized controlled trials (RCTs). These studies were designed to compare the drug against an inactive substance or against other common pain relievers to observe how symptoms evolved during the study period.

Studies monitored patient-reported outcomes describing perceived discomfort and used measurements related to physical discomfort, assessing how quickly and to what degree pain scores were monitored over the first few days of treatment. This evidence contributes to understanding symptom patterns in research contexts involving fluctuating or unstable symptoms for conditions associated with acute or disruptive episodes.


Research Evidence for Primary Dysmenorrhea (Menstrual Pain)

Research conducted on Dolvex for primary dysmenorrhea primarily consists of short-term, cyclical randomized controlled trials. These trials were applied in studies examining patient-reported experiences in adult women with conditions involving periods of heightened symptoms.

Studies monitored outcomes capturing phases of heightened symptom activity, with researchers focusing on how outcomes related to physical discomfort evolved during the first few days of the menstrual cycle. As treatment is intended only for acute, self-limiting episodes, the follow-up durations were limited, typically assessing effects across just one or two menstrual cycles. Therefore, long-term effects are not fully established or relevant to its authorized use.


What Remains Uncertain: Evidence Gaps and Limitations

Long-term effects are not fully established for this medicine because regulatory bodies have restricted its use to a maximum of 15 consecutive days. This crucial limitation means that the evidence base does not provide context regarding sustained effects or the management of chronic conditions. Furthermore, while the medicine was studied for various acute conditions, the comparative evidence is limited for certain specific patient subgroups. Subgroup findings are uncertain in complex patients where evidence quality varies across studies.

Key Studies & References

  1. Nimesulide in dysmenorrhoea
  2. A Systematic Review and Meta-analysis Comparing the Efficacy of Nonsteroidal Anti-inflammatory Drugs, Opioids, and Paracetamol in the Treatment of Acute Renal Colic [Contextual RCT/Meta-analysis of NSAID class used]

Frequently Asked Questions (FAQ)

Common questions about Dolvex (FAQ)


Q: What is the main difference between Dolvex and a standard over-the-counter pain medicine?

Official information indicates that Dolvex (Nimesulide) belongs to the Non-Steroidal Anti-Inflammatory Drug (NSAID) class, but has a different mechanism compared to many common over-the-counter pain medicines.

It is recognized as a relatively selective COX-2 inhibitor, meaning it preferentially targets the enzyme responsible for creating inflammatory mediators in the body.


Q: Does Dolvex carry a Boxed Warning or Black Box Warning from the FDA or similar bodies?

Dolvex is not approved for use by the U.S. Food and Drug Administration (FDA) and therefore does not have an FDA-issued Boxed Warning.

However, regulatory agencies in countries where it is approved have placed severe restrictions on its use due to the officially documented risk of serious liver injury (hepatotoxicity). The safety constraints include restrictions on the maximum duration of use for the systemic formulation.


Q: What kind of allergic reactions are most commonly associated with Dolvex?

Official safety documents state that skin issues associated with the medicine range from rash (uncommon) to very serious, though rare, reactions.

These rare reactions are classified as Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson Syndrome, and are clearly identified in the safety profile.


Q: Does taking Dolvex with a meal change how the body absorbs it?

Official usage instructions mandate that the medicine should be taken after meals.

However, pharmacokinetic data available to regulatory bodies suggests that the presence of food has a negligible effect on the overall rate and extent of the medicine absorbed by the body.


Q: What is the current official safety classification (e.g., Pregnancy Category) for Dolvex?

Regulatory documents strictly contraindicate the use of this medicine during the third trimester of pregnancy.

Use during the first two trimesters and for women attempting to conceive is generally not recommended due to potential risks consistent with the NSAID class of drugs.


Q: What is the official indication for Dolvex in the European Union?

According to European regulatory documents, the official indications for Dolvex are limited to the symptomatic relief of acute pain, the symptoms of osteoarthritis, and primary dysmenorrhoea (period pain).

Treatment for any of these conditions is strictly subject to a maximum 15-day limit.


Q: Why might a patient need to have their blood checked when taking Dolvex?

Official warnings highlight the risk of liver injury and elevated liver enzymes.

For this reason, regulatory documents state that the presence of symptoms of liver problems or abnormal liver function test results necessitates the discontinuation of use.


Q: Does Dolvex have a generic or bioequivalent version currently available?

Yes, the active ingredient, Nimesulide, is widely available in many countries.

It is marketed both as various branded products and as generic medicines that contain the same active substance.


Q: Does consuming alcohol have a listed interaction with Dolvex?

Regulatory warnings generally caution against the simultaneous use of Dolvex and alcohol.

This caution is due to the potential for increased risk of gastrointestinal irritation and an additive strain on the liver, as both substances are processed by the body’s detoxification pathways.


Q: How long does it usually take for the effects of Dolvex to begin or feel noticeable?

Studies and official information indicate that Dolvex has a relatively rapid onset of action.

Initial onset of pain relief is typically noted within approximately 15 minutes of taking the systemic medicine.


Q: What is the typical half-life of Dolvex as reported in official documents?

Pharmacokinetic data available to regulatory agencies report that the elimination half-life of the medicine in the body is generally between 1.8 and 4.7 hours.

The half-life refers to the time it takes for half of the drug to be eliminated from the bloodstream.


Q: How long can the relief from a single dose of Dolvex be expected to last?

Official dosing protocols prescribe the medicine to be taken twice daily (every 12 hours).

This schedule suggests that the expected duration of effect aligns with the 12-hour dosing interval.


Q: Is the Dolvex tablet or capsule designed to be crushed, cut, or split?

Regulatory guidance indicates that crushing, cutting, or splitting the tablet or capsule is generally not recommended.

Studies have shown that dividing the medicine can lead to excessive variation in the drug content between the pieces, which may compromise the drug's action.


Q: Is Dolvex mentioned as appropriate or cautioned against for people with diabetes?

Regulatory studies related to interactions with sulfonylurea medicines, which are sometimes used for diabetes management, have not shown an influence on blood sugar or glucose tolerance in diabetic patients.


Q: Is it required to get a new prescription every time I need to fill Dolvex?

Yes, according to the official product information and legal status in approved regions, Dolvex is classified as a prescription-only medicine.

Therefore, obtaining this medicine requires a prescription from a qualified healthcare professional.


Q: Does the medicine come in different strengths?

Yes, the active ingredient Nimesulide is available in different strengths and forms.

These include standard 100 mg tablets, 200 mg capsules, and a liquid oral dosage form, such as a 50 mg/mL suspension.

How should Dolvex be stored and disposed of?

How to Store and Dispose of Dolvex: Official Regulatory Information

Official labeling for Dolvex outlines mandatory conditions necessary to maintain the drug's quality and stability. This information is critical for proper storage and safe disposal.

Storage Requirements

Condition Requirement
Temperature Store below 30 C (ambient temperature).
Container Integrity Keep in the original container or pack and ensure it is tightly closed.
Protection Store according to the instructions on the label to protect stability and shelf-life.
Child Safety Keep this medicine out of the reach of children.

Disposal Instructions

Official disposal guidelines require the safe discard of unused or expired Dolvex. Do not dispose of this medicine in household trash or wastewater (e.g., flushing down the toilet) unless specifically instructed to do so by a healthcare professional or an authorized governmental program. Safe disposal is mandatory to ensure the product is not consumed by pets, children, or other people.

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

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