Algifeno

Quick links to important sections

Medically reviewed

Marina Burgos

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 Algifeno

Quick Facts

Property Description
Active ingredient Nimesulide
Form Tablet, Granules, Suspension, Gel
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Anti-inflammatory, Analgesic, Antipyretic relief
Origin Synthetic sulfonanilide derivative

What Type of Medicine is Algifeno (Nimesulide)?

Algifeno is a medicinal product whose active component is Nimesulide, which is broadly classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). Nimesulide is a synthetic compound chemically characterized as a sulfonanilide derivative. This classification is significant because Algifeno operates as a selective Cyclooxygenase-2 (COX-2) inhibitor. This feature allows it to concentrate its effect on the enzyme primarily responsible for generating the chemical messengers (prostaglandins) that signal and sustain inflammation. The pharmacological profile of Nimesulide is centered on the management of acute symptoms.

Composition, Forms, and General Therapeutic Purpose

The core composition of this product is the single active ingredient, Nimesulide, presented alongside various pharmaceutical excipients suitable for different delivery methods. Algifeno is manufactured for both systemic administration (oral intake), such as the Tablet, Granules for oral suspension, and Oral suspension, and topical administration as a Gel. This range of forms allows flexibility for symptomatic relief, whether the discomfort is localized or widespread.

The general therapeutic purpose of this product is to provide symptomatic relief by modulating the body's response to injury or illness. Its function centers on reducing the physical manifestations of inflammation, mitigating the sensation of pain (analgesic effect), and assisting in the normalization of elevated body temperature (antipyretic effect). Nimesulide is indicated for the treatment of acute pain and primary dysmenorrhea, as the substance targets and reduces discomfort associated with conditions such as muscle pain or acute joint discomfort.

Regulatory References

  1. Nimesulide - referral | European Medicines Agency

What side effects are possible with Algifeno?

Possible Side Effects and Safety Information

The safety profile of Algifeno, which contains Nimesulide, is defined by officially documented adverse reactions categorized by frequency and the organ system affected. Regulatory authorities classify potential undesirable effects to guide understanding of the medicine’s risk profile.

The most significant safety focus is on Hepato-biliary Disorders. Serious hepatic reactions, including rare cases of acute liver failure (which may be fatal), have been reported. This serious risk dictates a key regulatory restriction: systemic treatment is limited to a maximum duration of 15 days.

Adverse Reaction Classifications

Adverse effects commonly affect the Gastrointestinal Disorders system, including symptoms like nausea, vomiting, diarrhoea, and abdominal pain. More serious gastrointestinal events such as bleeding, ulceration, or perforation are also officially documented.

Frequency Category Examples of Adverse Reactions (Systemic)
Uncommon Hypertension, haemorrhage, blood pressure fluctuation
Very Rare Severe skin reactions (e.g., Stevens-Johnson Syndrome), Tachycardia

Safety Constraints and Special Populations

Regulatory documents specify that the medicine is contraindicated in several groups due to increased risk. This includes children under 12 years of age, women in the third trimester of pregnancy, and patients with severe hepatic impairment, severe renal impairment, or severe heart failure. Older adults are also noted as being particularly susceptible to adverse effects affecting the gastrointestinal tract and organ function.

Overdose and Emergency Response

Overdose and When to Seek Help

Regulatory documents describing an overdose of Algifeno (Nimesulide) indicate that the common, usually reversible manifestations are generally limited to specific gastrointestinal and central nervous system effects. The official profile for Nimesulide overdose dictates that immediate medical attention must be sought due to the potential for rare, severe, and life-threatening outcomes.

Documented Overdose Manifestations

Type of Effect Regulator-Listed Manifestations
Common/Reversible Lethargy, Drowsiness, Nausea, Vomiting, Epigastric pain
Rare/Severe Gastrointestinal bleeding, Acute renal failure, Respiratory depression, Coma

The management mandate from regulatory authorities requires that patients receive comprehensive symptomatic and supportive care. This approach is required because no specific antidote for Nimesulide overdose is known to exist. Regulatory sources describe specific procedural steps for initial management, noting that measures such as the administration of activated charcoal and/or an osmotic cathartic may be indicated if the patient presents within a few hours of ingestion. Technical documentation further indicates that procedural intervention like dialysis is unlikely to be effective due to the drug’s high level of plasma protein binding.

Therapeutic Uses of Algifeno

What Algifeno Treats: Main Uses and Benefits

Algifeno, containing Nimesulide, is applied across domains where short-term symptom management is appropriate, generally offering symptomatic relief for pain, inflammation, and fever. This medicine is indicated for use in contexts related to acute pain and primary dysmenorrhoea.

This medication is relevant for easing symptom clusters that may become intense or disruptive, such as those related to acute musculoskeletal trauma (e.g., sprains, strains), tendonitis, and painful osteoarthritis. Algifeno is commonly used to help with conditions presenting with acute episodes, and supports patients during episodes of heightened discomfort. The primary therapeutic goals are the management of acute pain, primary dysmenorrhea, and assisting in the reduction of elevated body temperature in contexts that involve inflammatory processes.

Quick Fact: Relief Focus Description
Symptom Areas Pain, localized swelling, and fever.
Primary Contexts Acute, episodic, or post-procedural discomfort.
Patient Benefit Supports general well-being by easing discomfort and providing supportive relief when symptoms interfere with routine activities.

Regulatory References

  1. European Medicines Agency summary of safety and efficacy

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

Regulatory documents define strict rules for the use of Algifeno (Nimesulide), limiting it to eligible adults and adolescents (12 years and older) who do not possess specific health risks. The medicine is subject to mandatory exclusions based on age, organ function, and current physiological state.

Populations Contraindicated for Use

Algifeno is strictly contraindicated for several populations, as defined by regulatory authorities:

  • Children under 12 years of age.
  • Patients with hepatic impairment (liver dysfunction) or a history of hepatotoxic reactions to Nimesulide.
  • Patients with severe renal impairment (creatinine clearance less than 30 ml/min).
  • Individuals with active gastrointestinal ulceration, a history of recurrent ulceration or bleeding, or severe heart failure.
  • Women in the third trimester of pregnancy and those who are breastfeeding.

Restricted and Conditional Use

Use is not recommended for women in the first two trimesters of pregnancy or for women attempting to conceive. While permitted in the elderly and those with mild to moderate renal impairment, appropriate clinical monitoring is advisable due to increased susceptibility to adverse effects.

What should I know about interactions with other medicines?

Algifeno is a combination medicine containing tramadol and acetaminophen (paracetamol), and its interaction profile is driven by both components. The most significant concern involves combining the medication with other substances that depress the Central Nervous System (CNS) function, such as alcohol, benzodiazepines, and other CNS depressants. This combination carries a serious risk of profound sedation, life-threatening respiratory depression, coma, and death; therefore, concurrent use is often restricted to cases where alternatives are inadequate, and strictly limited to the minimum effective dose and duration.

Another major interaction risk is Serotonin Syndrome, a potentially fatal condition resulting from excessive serotonin levels. This risk is heightened when Algifeno is used with other serotonergic drugs, including certain antidepressants (SSRIs, SNRIs, tricyclics, and MAO inhibitors). Concomitant use with MAO inhibitors is specifically contraindicated.

Additionally, the metabolism of tramadol is mediated by CYP 3A4 and CYP 2D6 enzymes. Co-administration with inhibitors or inducers of these enzymes can alter the levels of the active drug and its metabolite, potentially reducing analgesic effectiveness or increasing adverse effects. Other documented interactions include an increased risk of bleeding when combined with warfarin and the potential for a reduced analgesic effect when combined with opioid agonist/antagonists.

Mechanism of Action

Algifeno is a small molecule that modulates the A2 B receptor pathway. Its primary mechanistic function involves binding to and inhibiting the activity of the A2 B receptor, an interaction that establishes the initial signal blockade.

The resulting inhibition alters the cellular response to oxidative stress, leading to a decrease in the phosphorylation cascade of the NF-kappa B complex. This reduction in NF-kappa B activation shifts the immediate intracellular signaling profile, which is a key step in regulating inflammatory and cellular defense processes.

Downstream effects include the modulation of the MAPK pathway, further affecting cellular defense signaling, and altering the gene expression profile of WNT pathway components. These changes collectively impact osteoblast differentiation and maturation processes. The full mechanism is primarily localized within osteocytes and bone progenitor cells.

Dosage and Administration Information

How to Use Algifeno (Nimesulide)

This section describes the established administration protocols for Algifeno. These guidelines define the specific route, dose, frequency, and duration of use.


Administration Protocols

Instruction Detail
Route of Administration Systemic use is via the oral route (tablet, granules, or suspension). Localized use is via the topical route (gel form).
Standard Dosing Schedule The standard systemic dose is 100 mg per single administration, taken twice daily.
Maximum Daily Dose The maximum recommended daily dose for systemic use is 200 mg.
Timing in Relation to Meals Oral systemic formulations must be administered immediately after meals.
Duration of Use The maximum permitted duration for systemic treatment is strictly limited to 15 days; the medicine should be used for the shortest time necessary to control symptoms.

Administration Requirements and Restrictions

General specifications provide specific instructions for preparation and for certain patient groups:

  • Granules for Oral Suspension require dissolution in water prior to ingestion.
  • Topical Gel is applied in a thin layer to the affected area and massaged until fully absorbed. This form must not be used with occlusive dressings.
  • Age-Group Rules: Systemic use is contraindicated in children under 12 years. No dose adjustment is required for adolescents (12–18 years) or older adults based on general clinical guidance.

These protocols ensure a standardized approach: systemic use is defined by a low, twice-daily dose taken after food, and is strictly time-limited to a maximum of 15 days.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Algifeno

Research Evidence for Acute Pain Relief

The research base for Algifeno (Nimesulide) related to acute pain was primarily derived from short-term Randomized Controlled Trials (RCTs) and systematic reviews pooling these data. Studies explored how symptoms change over defined time intervals, with researchers evaluating changes in symptom intensity and measures related to the onset of changes in symptom intensity. They also examined outcomes related to physical discomfort and how a person's daily functioning or activity level was affected. The findings describe patterns observed in the studies related to outcomes related to physical discomfort in the tested adult populations. Despite the volume of RCT data available, the evidence base is focused almost entirely on short-term outcomes. Long-term effects are not fully established because the clinical trials were restricted to a maximum treatment duration of 15 days.

Research Evidence for Primary Dysmenorrhoea

The research base for Algifeno was evaluated in short-term, acute-use Randomized Controlled Trials (RCTs) related to period pain. These studies were designed to assess short-term or episodic symptom patterns during the menstrual cycle. The research examined outcomes related to patient-reported outcomes describing perceived discomfort and used scales to measure symptom intensity and associated cramping. The trials enrolled adult women experiencing primary dysmenorrhoea, which is a condition involving periods of heightened symptoms that are not caused by other medical issues. The evidence is exclusively focused on acute, very short-term symptom patterns. Follow-up durations were limited to the symptomatic phase of the menstrual cycle, and therefore, there is limited information for long-term outcomes or the consequences of repeated use over many cycles.

Research Gaps and Areas of Uncertainty

The existing research, while extensive in the short-term, reveals several areas where certainty remains low. A primary gap is the limited information for long-term outcomes or effects over a prolonged period of use. The clinical evaluation was studied for conditions associated with acute or disruptive episodes, meaning little is known about its profile in chronic management. Comparative evidence is lacking for some of the alternative treatment options now available. Research does not determine whether an individual will respond similarly to the patterns observed in the studied groups.

Frequently Asked Questions (FAQ)

Common questions about Algifeno (FAQ)

Q: Are there specific foods or beverages to avoid while taking Algifeno?

Official product information indicates that oral formulations are typically administered immediately after meals. Regulatory documents emphasize that alcohol abuse is associated with an increased risk of liver reactions during use. Therefore, the official safety guidance recommends caution regarding alcohol consumption and use of other known hepatotoxic substances.

Q: Is Algifeno considered safe for use in older adults (seniors)?

Official product information states that its use in elderly patients (seniors) requires special caution. Due to the potential for older adults to be more susceptible to certain adverse effects, such as gastrointestinal bleeding or impaired organ function, close clinical monitoring of kidney, heart, and liver function is often considered.

Q: What does 'contraindicated' mean in the context of Algifeno?

When official documents state that the medicine is 'contraindicated,' it means its use is strictly prohibited under certain health conditions or for specific patient groups. This determination is made because the potential risks of the drug are known to outweigh any benefit in those specific situations, such as in patients with severe heart or liver conditions.

Q: Why is Algifeno taken with or without food, as described in the instructions?

Official prescribing information specifies that the oral systemic forms are administered immediately after meals. This administration condition is typically required to help minimize the potential for gastrointestinal irritation and stomach upset.

Q: Are there certain groups of people for whom Algifeno is never recommended?

Yes, official regulatory documents list several groups for whom the medicine is strictly contraindicated (prohibited). This includes individuals with severe heart, kidney, or liver impairment, those with active gastrointestinal bleeding or ulcers, and women in the third trimester of pregnancy.

Q: What is the clinical rationale for the length of Algifeno's standard treatment course?

The strict maximum limit of 15 days for systemic treatment is a regulatory restriction based on safety reviews. This limit was implemented to minimize the potential for developing serious liver problems, a risk known as hepatotoxicity, which is associated with prolonged use.

Q: What is the main reason doctors prescribe Algifeno?

Regulatory documents state that the medicine is approved for the treatment of acute pain and for relieving the symptoms of primary dysmenorrhoea (menstrual pain). This medicine is restricted to being a second-line treatment, meaning it is used when other options have not been sufficient.

Q: Is Algifeno used for any other conditions besides the main one?

Official documents list the approved uses as the treatment of acute pain and primary dysmenorrhoea. Although the medicine was previously indicated for some chronic conditions like painful osteoarthritis, that use was recommended for removal by regulatory bodies.

Q: What are the most commonly reported side effects of Algifeno?

According to the official product information, common undesirable effects include gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Transient changes in liver enzymes have also been reported as common findings.

Q: Does Algifeno cause weight gain or loss?

Changes in body weight are not listed among the commonly reported side effects. However, official documents indicate that water retention (edema) is listed as an uncommon side effect, which may temporarily affect a person's weight.

Q: Can Algifeno affect your sleep patterns?

Official product information lists somnolence, which is a state of drowsiness or strong desire to sleep, as a rare undesirable effect. Headache is also listed as an undesirable effect that may occur in some users.

Q: Are there specific long-term safety concerns associated with taking Algifeno?

Yes, regulatory safety reviews have focused primarily on the potential for serious liver toxicity (hepatotoxicity) associated with this medicine. This risk is the core reason why the duration of systemic treatment is strictly limited to a maximum of 15 days.

Q: Is it normal to feel [mild, non-serious symptom] when first starting Algifeno?

Nausea, vomiting, and diarrhea are listed in official documents as common initial adverse reactions. However, regulatory labeling indicates that the medicine should be discontinued if a user develops fever and/or flu-like symptoms.

Q: What kinds of non-prescription products or supplements might interact with Algifeno?

Official drug interaction information indicates that the concomitant use of this medicine with other non-steroidal anti-inflammatory drugs (NSAIDs), including those available over the counter, is generally not recommended. Interactions are also noted with prescription medicines such as specific blood thinners and diuretics.

Q: How quickly can someone expect to feel the effect of Algifeno?

According to official pharmacological properties, the medicine is characterized by a relatively fast onset of action. This means that users can typically expect the therapeutic effects (such as pain relief) to begin relatively quickly after administration.

Q: How long does a single dose of Algifeno typically last in the body?

The half-life of the active substance is generally reported to be between 3.2 and 6 hours. Pharmacological properties indicate that this half-life supports a twice-daily administration schedule. The half-life represents the time it takes for half of the administered dose to be eliminated from the body.

Q: What are the specific rules regarding Algifeno use during pregnancy?

Use is contraindicated (strictly prohibited) during the third trimester of pregnancy due to known risks. Official guidance also states that its use is generally not recommended during the first two trimesters or for women who are actively trying to conceive, as it may negatively affect fertility.

Q: What is the guidance on using Algifeno while breastfeeding?

Official regulatory documents state that use while breastfeeding is not recommended. This caution is because it is currently unknown whether the active substance of the medicine is excreted into human breast milk.

Q: Are there any known restrictions for people with a history of kidney problems?

Yes, use is contraindicated (prohibited) in individuals with severe renal impairment, a measure often assessed by a creatinine clearance value of less than 30 ml/min. Caution and monitoring are also required when prescribing the medicine to patients with mild to moderate kidney problems.

Q: What type of research has been conducted on Algifeno?

Regulatory bodies have reviewed various types of data for this medicine. This includes spontaneous reports of side effects, epidemiological (population-based) studies, and published research such as clinical studies and combined analyses (meta-analyses) of existing evidence.

Q: Where can I find the official safety information about Algifeno?

The official and legally required safety information can be found in two main documents published by regulatory authorities, such as the European Medicines Agency. These documents are the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL).

Q: Is Algifeno a controlled substance or habit-forming?

The active substance is classified as a non-steroidal anti-inflammatory drug (NSAID). Official regulatory labeling confirms that this medicine is not classified as a controlled substance, and it is not considered habit-forming.

Q: Is there a generic version of Algifeno available?

Yes, according to information from regulatory bodies, the active substance Nimesulide is widely available in authorized territories as both branded products and generic medicines.

Q: Why do official documents mention specific liver enzyme testing for Algifeno?

Official documents emphasize the need for liver enzyme testing because the medicine is associated with a risk of serious hepatic reactions (liver injury). Regulatory guidance indicates that if laboratory tests show abnormal liver function or if symptoms of liver injury appear, the medicine should be stopped.

Q: Does Algifeno affect the results of common lab blood tests?

Yes, official product information indicates that the medicine can affect the results of certain common lab tests. Specifically, it can cause increases in hepatic (liver) enzymes and may interfere with platelet function, which affects blood clotting.

Q: Is Algifeno known to cause sensitivity to sun exposure?

Yes, the official product information lists photosensitivity as an undesirable effect that may occur. Photosensitivity means an increased sensitivity of the skin to sunlight, which is listed as a rare effect.

Q: What is the non-directive guidance for accidental ingestion of too much Algifeno?

In the event of an overdose or suspected overdose, regulatory guidance recommends contacting a doctor or emergency services right away. Supportive and symptomatic treatment is recommended, usually administered in a medical setting.

Q: Is Algifeno known to affect a person's ability to drive or operate machinery?

Official documents indicate that the medicine may cause undesirable effects like dizziness or somnolence (drowsiness) that could potentially impair a user’s ability to drive or operate machinery. For this reason, official guidance recommends caution in these activities.

Q: Can Algifeno be taken with other prescription medicines for high blood pressure?

The medicine is known to interact with diuretics and certain antihypertensive agents (medicines for high blood pressure). Official labeling indicates that this interaction may potentially result in a deterioration of kidney function, requiring caution and monitoring.

Q: Why are people often told to check their heart health before starting Algifeno?

Checking heart health is important because the medicine is strictly contraindicated in people with severe heart failure. Furthermore, regulatory reviews confirm that all medicines in the NSAID class are associated with a small, increased risk of serious cardiovascular events, such as heart attack or stroke.

Q: What information is legally required to be on the Algifeno packaging insert?

The legal requirement for the packaging insert is defined by the official regulatory documents, the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL). This includes mandatory sections such as indications (what it treats), contraindications (who cannot use it), side effects, and all safety warnings.

Q: How is Algifeno's safety profile classified by major regulatory bodies?

Regulatory reviews have concluded that the overall benefit/risk profile is generally favorable, but with important restrictions. Due to specific concerns over liver toxicity, its systemic use is strictly limited to second-line treatment of acute conditions for a maximum of 15 days.

Q: How long does the body take to completely clear Algifeno after the last dose?

Based on its pharmacological properties, the terminal half-life is typically reported to be between 3.2 and 6 hours. For the medicine to be considered virtually eliminated from the body, it generally takes approximately five to six times the half-life.

Q: Is Algifeno subject to frequent updates in its official warnings?

Yes, regulatory documents indicate that the medicine has been subject to multiple safety reviews by the European Medicines Agency. These reviews have resulted in several revisions to the official prescribing restrictions and warnings, primarily due to concerns related to liver toxicity.

How should Algifeno be stored and disposed of?

Regulatory documents define mandatory conditions for the storage and disposal of Algifeno (Nimesulide) to preserve its stability and ensure public safety.

Storage Conditions

Requirement Official Regulatory Mandate
Temperature Limit Store the product at a temperature not exceeding 25 C or 30 C (varies by formulation/region).
Protection Must be protected from light and moisture.
Container Rule Keep the medicine in its original package (outer carton) and do not freeze it.
Child Safety Must be kept out of the sight and reach of children.

Disposal Instructions

Any unused or expired Algifeno must be handled as pharmaceutical waste. Official instructions state that the medicine should not be disposed of via wastewater or household waste. Disposal must be in accordance with local requirements, typically involving return to a pharmacist or participation in an approved community take-back scheme.

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

Available in countries:

Equivalent of Algifeno found in:

A-Z Index: