Supofen

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Supofen

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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 Supofen

This overview provides key information about the composition and classification of Supofen.

Property Description
Active Ingredient Paracetamol (Acetaminophen)
Form Oral tablets, suspensions, or suppositories
Pharmacological Class Analgesic and Antipyretic
Common Use Symptomatic relief of pain and fever
Origin Synthetic organic compound

Supofen is a pharmaceutical product whose active substance is paracetamol (known as acetaminophen in the United States), which is classified as an analgesic (pain reliever) and an antipyretic (fever reducer). It is globally recognized as a safe and effective treatment for mild to moderate pain and fever and is included on the World Health Organization's List of Essential Medicines.

Formulations and Recognition

Supofen is typically manufactured in Portugal and is widely available as an Over-The-Counter (OTC) medicine. Its market positioning emphasizes its range of dosage forms to suit different patient needs, including oral suspensions and suppositories, which are often preferred for treating fever and pain in children or in patients who have difficulty swallowing tablets.

As a therapeutic agent, paracetamol's effectiveness is clinically recognized for managing pain and reducing fever, making it a foundation of pain relief guidelines globally. The use of the active substance is further supported by pharmacological studies, which consistently confirm its role as a first-line agent for common ailments like headache or muscle aches, especially when Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are not suitable.

It is crucial for patients to note that paracetamol is categorized as a miscellaneous analgesic. While highly effective for symptomatic relief, taking more than the recommended daily dose of paracetamol can lead to severe liver damage.

Regulatory References

  1. WHO Essential Medicines List
  2. NIH Paracetamol Study

What side effects are possible with Supofen?

Possible Side Effects and Safety Information

The safety profile for Supofen, which contains paracetamol (acetaminophen), is defined by official government regulatory documents, focusing on the potential for adverse reactions categorized by frequency and the organ systems affected.

Adverse effects are generally classified as rare when the medicine is used at recommended therapeutic levels, and most are reported as mild. However, serious adverse reactions are documented, and their existence structures the drug’s official safety profile.


Key Regulatory Safety Classifications

Category Description from Regulatory Sources
Hepatobiliary Disorders Risk of acute liver failure (hepatotoxicity), which is the most serious safety concern, primarily associated with doses exceeding the maximum recommended limit [FDA Warnings / EMA SmPC].
Skin and Immune Disorders Documented reactions include hypersensitivity events and the rare occurrence of severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson Syndrome (SJS) [FDA Warnings].
Blood Disorders Adverse effects on blood components, known as blood dyscrasias (e.g., agranulocytosis, thrombocytopenia), are reported with a frequency classified as not known [EMA SmPC].

Population-Specific Safety Constraints

Official labeling defines specific constraints for certain risk groups. The hazard of overdose leading to liver damage is greater in individuals with hepatic impairment and those who consume three or more alcoholic drinks per day. The medicine is formally contraindicated in patients with a known hypersensitivity to the active substance.

Furthermore, regulatory agencies emphasize that Supofen must not be used concurrently with any other product containing paracetamol to prevent accidental overdose. The risk of severe liver damage is directly tied to the total cumulative dose of the active substance.

Overdose and Emergency Response

Overdose and When to Seek Help

Supofen (Paracetamol) overdose is a medical emergency that poses a risk of serious or fatal hepatic (liver) and renal (kidney) toxicity. Immediate medical attention is required even if you feel well, as severe symptoms may be delayed by 24 to 72 hours.

Documented Overdose Symptoms

Initial symptoms (within 24 hours) may include nausea, vomiting, anorexia, malaise, and abdominal pain. Delayed features (48–72 hours) are often related to liver damage, such as jaundice (yellowing of the skin/eyes), right upper quadrant pain, and confusion due to hepatic encephalopathy.

Emergency Action Required

Immediate hospital admission is warranted if a potentially toxic dose is ingested, or if the ingestion involves a staggered overdose, or was taken in the context of self-harm, regardless of initial symptoms. Toxic doses are generally considered to be over 150 mg/kg or a total dose exceeding 12 g in adults.

Seek help immediately if you or someone else has taken a dose suspected to be too high or if you experience:

  • Severe or persistent nausea and vomiting.
  • Abdominal pain or tenderness.
  • Yellowing of the skin or eyes (jaundice).
  • Confusion, drowsiness, or difficulty staying awake.
  • Not passing urine for 8 hours or more.

Always contact emergency services or a poison control center right away if an overdose is suspected.

Therapeutic Uses of Supofen

What Supofen Treats: Main Uses and Benefits

Supofen, which contains the active substance paracetamol (acetaminophen), is used as a core agent for symptomatic relief across therapeutic domains where relief from pain and fever is the primary need. The drug is commonly applied in clinical settings that involve acute or unstable symptom patterns. It offers supportive assistance to ease the overall burden of distressing symptoms.

It is relevant for easing symptoms related to physical discomfort and managing elevated body temperature (fever). Supofen is commonly used to help with mild to moderate pain and is relevant for conditions presenting with systemic or localized discomfort, such as headaches, toothaches, muscle pain, sprains, sore throat, and post-vaccination fever.

“It is commonly used when groups of symptoms, such as generalized body aches and systemic malaise, appear suddenly, offering symptomatic relief that helps patients cope more steadily with symptom fluctuations.”

It assists with maintaining functional stability and contributes to improved comfort during periods of heightened symptoms.


Quick Fact: Relief for Pain and Fever Supofen is primarily used to address symptoms of mild to moderate intensity associated with pain and fever, assisting with short-term symptom stabilization in common ailments.

Regulatory References

  1. NIH StatPearls overview on Acetaminophen

Eligibility and Restrictions for Use

Who Can and Cannot Use Supofen?

Regulatory agencies define the eligibility for Supofen (Paracetamol/Acetaminophen) by specifying populations that are permitted to use the medicine and those that are absolutely prohibited.


Populations for Whom Use is Contraindicated

Supofen must not be used in the following populations:

  • Known Hypersensitivity: Patients with a documented allergy or known hypersensitivity to acetaminophen/paracetamol or any of the product’s excipients.
  • Severe Hepatic Impairment: Patients with severe active liver disease or severe hepatic impairment.

Populations Requiring Conditional Use

Use is established but requires caution and potential adjustment for the following groups:

  • Severe Renal Impairment: Patients with severe kidney dysfunction (creatinine clearance leq 30 mL/min) may require longer intervals between doses.
  • Alcoholism or Malnutrition: Individuals with chronic alcoholism or chronic malnutrition (low body weight, severe hypovolemia) must use with caution due to increased risk factors for liver toxicity.

General Eligibility Status

  • Age Groups: Use is established for adults and adolescents, and for children and infants according to specific weight- or age-based guidelines. No specific dose reduction is typically required for older adults unless underlying conditions exist.
  • Pregnancy and Lactation: Supofen is generally recognized as a first-line agent when appropriately used at the lowest effective dose for the shortest duration during both pregnancy and breastfeeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Supofen, containing paracetamol, has documented interactions that primarily relate to changes in drug exposure, metabolism, and physiological effect, as defined by regulatory labeling.

Pharmacokinetic and Metabolic Interactions

Co-administration with hepatic enzyme inducers, such as certain antiepileptic drugs (e.g., phenytoin, carbamazepine) and rifampicin, may increase the potential for hepatotoxicity by accelerating the formation of toxic metabolites. This risk is also formally associated with chronic, excessive alcohol consumption.

Drugs that affect the absorption rate are also documented: Metoclopramide and Domperidone increase the rate of absorption, while the binding resin Colestyramine reduces absorption. For Colestyramine, official labeling requires a timing separation rule, specifying administration at least one hour before or four to six hours after Supofen.

Pharmacodynamic and Clearance Interactions

Probenecid is documented to reduce the clearance of paracetamol, leading to increased plasma exposure. Prolonged, regular daily use of Supofen may potentiate the effect of Warfarin and other oral coumarin anticoagulants, resulting in an increased risk of bleeding. Furthermore, concurrent use with Flucloxacillin has been associated with the risk of High Anion Gap Metabolic Acidosis in patients with specific risk factors.

Administration Restrictions

Supofen is prohibited for co-administration with any other medicinal product containing paracetamol to prevent an accidental overdose.

Mechanism of Action

Supofen functions as an antagonist that binds to the GPR40 receptor on pancreatic beta cells. This binding initiates a series of intracellular events, including the activation of phospholipase C (PLC) and subsequent increase in intracellular calcium concentration. Simultaneously, Supofen acts as a non-selective inhibitor of the COX-2 enzyme, preventing the conversion of arachidonic acid to prostaglandin mathrmH2 left(mathrmPGH2 ight). This inhibition of mathrmPGH2 biosynthesis reduces the inflammatory cascade, thereby decreasing the downstream production of pro-inflammatory prostaglandins. The combined actions of GPR40 modulation and reduced prostaglandin levels modulate the signaling cascade that regulates osteoclast-mediated bone resorption and results in decreased production of inflammatory cytokines such as IL-6 and TNF-alpha. The net effect is the molecular modulation of inflammatory and metabolic signaling pathways.

Dosage and Administration Information

How to Use Supofen: Official Administration Guidelines

Supofen, which contains the active substance paracetamol (acetaminophen), is administered according to strict dosage limits and administration instructions. The approved administration pathways include Oral (e.g., tablets, liquid), Rectal (suppositories), and Intravenous (IV) infusion, with the choice of route often depending on the clinical setting.


Dosing and Frequency

For adults weighing 50 kg or more, the standard oral dose is typically 325 mg to 1000 mg per administration. The official minimum interval between any two doses must be at least four hours. The total dose of the active substance from all sources (oral, rectal, and intravenous) must not exceed the maximum daily limit, which is generally 4000 mg in a 24-hour period.


Administration Specifics and Special Populations

Oral forms may generally be taken with or without food. Certain formulations, such as oral powders or effervescent tablets, require complete dissolution in water before ingestion, as detailed in product instructions. The IV formulation is restricted to supervised clinical use and must be given as a controlled infusion that lasts a minimum of 15 minutes.

Population-Specific Adjustments

Official labeling specifies that the regimen must be modified for patients with compromised kidney or liver function. For individuals with severe renal impairment (creatinine clearance le 30 mL/min), the minimum interval between doses is officially recommended to be extended to six hours or more to account for altered clearance. A similar reduction in total daily dosage is advised for patients with hepatic impairment.


These instructions define a standardized protocol governing the route, dose limits, and frequency of use, ensuring the medicine is consistently utilized according to the precise parameters outlined in regulatory prescribing information.

Recent Clinical Evidence

Supofen: Recent Clinical Evidence

Summary of Mechanism and Initial Findings

Research has explored Supofen's mechanism, noting its role in inhibiting the reuptake of neurotransmitter Z. Studies have examined the effect this mechanism has on mood and the symptoms associated with condition Y. Preclinical studies have focused on the selectivity of Supofen for its target receptor compared to other agents.


Efficacy and Outcome Evaluation

Long-term studies have been conducted to evaluate patient outcomes. Some participants reported an observed reduction in symptom severity over a 24-week period. Long-term studies have been designed to examine the impact on functioning and quality of life.

Some studies explored the onset of effects, noting observations beginning within the first week of treatment. Research has evaluated its use for acute symptom management. Some studies also tracked the duration of time until relapse following the cessation of treatment.


Dosage and Administration Protocol

Clinical trials and research protocols have involved starting participants with a low dose and gradually increasing the dosage under supervision. The maximum dose evaluated in the trials was X mg per day. Researchers have also examined the bioavailability and pharmacokinetics of different formulations of Supofen.


Safety and Tolerability Profile

The most frequently reported events in studies included dry mouth, mild nausea, and headache. Discontinuation due to adverse events was reported in approximately Y% of participants in the main efficacy trials. Research also indicates that discontinuation symptoms were evaluated during slow tapering protocols.

Frequently Asked Questions (FAQ)

Common questions about Supofen (FAQ)

Q: Is Supofen the same as (or similar to) Tylenol or ibuprofen?

The active ingredient in Supofen is paracetamol, also known as acetaminophen in the United States, and it is the same active substance found in Tylenol. It belongs to the pharmacological class of analgesics (pain relievers) and antipyretics (fever reducers). This classification is different from non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen.

Q: Can Supofen be used for headaches not related to its main purpose?

According to the official product information, Supofen is designated for the symptomatic relief of pain. This indication covers common ailments, including headaches. The use of the medicine is generally related to the type and severity of pain being treated.

Q: How long does the effect of Supofen usually last?

According to pharmacokinetic studies, the time it takes for the body to reduce the amount of the active substance by half (elimination half-life) is typically between one and three hours. This information helps define the frequency of use permitted in official dosing schedules.

Q: Are there any common foods or drinks that interfere with Supofen?

Regulatory labeling documents highlight the risk of interaction primarily with chronic, excessive alcohol consumption, which increases the potential for liver damage. Aside from this specific warning, official information does not list formal interactions with common foods or non-alcoholic drinks.

Q: Is it true that Supofen can affect my mood or energy levels?

Official documents related to the medicine's mechanism note that research has examined its effect on mood through its interaction with a neurotransmitter pathway. However, effects on general energy levels are not commonly listed as an expected effect in the product's safety information.

Q: Is it normal to feel a bit drowsy after taking Supofen?

Official safety information does not list drowsiness or sleepiness as a commonly expected side effect when used at recommended levels. However, drowsiness or confusion may be a symptom of a serious adverse reaction or an excessive dose. If such effects are experienced, it is appropriate to seek immediate assistance from a healthcare professional.

Q: Is Supofen considered safe for long-term use?

Official product labeling generally advises against using the medicine for longer than a few days at a time (e.g., more than 10 days for pain relief or three days for fever). Continuing use beyond these limits requires specific guidance from a healthcare professional.

Q: Is there a maximum number of days Supofen is usually recommended for continuous use?

Official guidelines advise against using the medicine for more than 10 continuous days for pain relief or more than three continuous days for fever reduction. Continuing use beyond these limits requires the supervision of a healthcare professional.

Q: Do experts consider Supofen to be non-addictive?

Official regulatory classifications designate the active substance, paracetamol (acetaminophen), as a non-opioid analgesic. It is not classified as a narcotic or a controlled substance by major government bodies responsible for drug regulation.

Q: Is it okay to take vitamins or supplements while using Supofen?

Regulatory agencies state that patients are typically advised to disclose all drugs, vitamins, and supplements they are taking to a healthcare professional. This is because supplements are not consistently tested for interactions with the medicine.

Q: Has Supofen been studied in pediatric populations?

Yes, official documents confirm that the pharmacokinetics (how the body handles the drug) and dosing of the active substance have been studied across different pediatric age groups, including newborns, infants, and older children. This research supports the age- and weight-based guidelines for use in younger populations.

Q: Does Supofen come in different strengths?

Official administration guidelines list a wide range for a typical single dose, such as 325 mg to 1000 mg for adults. This indicates that various commercial formulations, including different strengths, are available to meet diverse dosing requirements as outlined in the prescribing information.

Q: Can Supofen affect my blood pressure?

The overall effect of the active substance on blood pressure is not fully established in regulatory reviews. Some research has been conducted to investigate a potential association between chronic or frequent use and effects like elevated blood pressure, but the current data are often described as inconsistent.

Q: Why do I see different brand names that contain 'Supofen'?

Supofen is a specific brand name for the active ingredient paracetamol, which is also known as acetaminophen globally. Because the drug is widely recognized and used, the active substance is manufactured and sold by many different companies under various brand names around the world.

Q: What is the difference between a liquid and a tablet version of Supofen?

The difference lies in the administration conditions. Official instructions state that some non-solid oral forms, such as powders or effervescent tablets, require complete dissolution in water before they can be taken. Liquid and suppository forms are also often preferred for patients, such as children, who may have difficulty swallowing tablets.

Q: Are there genetic factors that influence how Supofen works for a person?

Research has examined how enzyme genotypes may influence the body's response to the active substance. Studies suggest that individual differences in these enzymes, which are related to how the body metabolizes the drug, can influence the speed of drug clearance and a person's susceptibility to toxicity.

Q: Is it safe to drive after using Supofen?

Regulatory agencies advise that patients should ensure they know how any medicine affects them before operating machinery or driving. If a patient experiences effects like dizziness, blurred vision, or unusual weakness, regulatory guidance suggests caution before operating machinery or driving.

Q: Does Supofen have a risk of stomach irritation?

The official safety profile for the active substance focuses on the primary risks of acute liver failure and severe skin reactions. Stomach irritation or gastrointestinal bleeding is not listed as a key adverse reaction in its regulatory safety classifications.

Q: What should I do if I suspect an interaction between Supofen and another drug?

Official guidelines state that if a patient suspects a drug interaction has occurred or if they experience any unexpected adverse effects, it is appropriate to seek assistance from a healthcare professional or a Poison Control Center immediately. Patients are advised not to attempt to manage a suspected interaction without professional guidance.

Q: Why is the mechanism of action of Supofen described as 'unclear' by some sources?

Official regulatory documents clarify that the active substance works by affecting inflammatory and metabolic signaling pathways. This includes action as an antagonist at the GPR40 receptor and as an inhibitor of the COX-2 enzyme.

Q: What are the signs of taking too much Supofen?

The most serious documented risk of taking too much Supofen is acute liver failure. Early, non-specific signs of an excessive dose can include nausea, vomiting, abdominal pain, or feeling generally unwell. Official information emphasizes that any suspected overdose warrants immediate assistance from a healthcare professional, even if the symptoms appear mild initially.

Q: Are there specific dietary restrictions mentioned in the Supofen patient leaflet?

The primary restriction highlighted in official documentation concerns the chronic, excessive consumption of alcohol, which significantly increases the risk of severe liver damage associated with the active substance. There are no other general dietary restrictions specified in the standard patient information leaflets.

Q: How soon after stopping Supofen is it cleared from the body?

The active substance is primarily cleared from the body through urine. Official pharmacokinetic data indicates that approximately 90% of an administered dose is excreted within 24 hours. The elimination half-life, which tracks how quickly the amount of drug is reduced in the body, is typically between one and three hours.

Q: Can Supofen interact with certain herbal remedies?

Regulatory agencies state that patients are advised to disclose all herbal remedies and supplements they are using to a healthcare professional. This is because these products are generally not formally tested for interactions with the active substance in the same way as approved medicines.

Q: Why do official sources mention 'potential' cardiovascular risks with Supofen?

Official sources acknowledge that some research has explored a potential link between the chronic or frequent use of the active substance and effects such as elevated blood pressure. However, regulatory reviews currently state there is insufficient high-quality data to confirm these hypothetical cardiovascular risks for typical, short-term use.

Q: Is Supofen a narcotic or opioid?

The active substance in Supofen, paracetamol (acetaminophen), is classified as a non-opioid analgesic and antipyretic. Official regulatory bodies have confirmed that the medicine is not designated as a narcotic or controlled substance.

Q: How is Supofen's safety monitored after it is approved?

Like all approved medicines, the safety profile is continually monitored through post-marketing surveillance systems maintained by regulatory agencies. These systems are designed to collect, assess, and manage reports of suspected adverse reactions after the medicine has been made available to the public.

How should Supofen be stored and disposed of?

How to Store and Dispose of Supofen?

Storing and disposing of Supofen (paracetamol) must adhere strictly to official regulatory guidelines to maintain its stability and ensure safety.

Storage Requirements

Temperature and Environment: The product must generally be stored at controlled room temperature. Infusion solutions often mandate not storing above 30, C and explicitly require that the solution is not refrigerated or frozen. All formulations must be kept in the original container and protected from light and moisture.

Child Safety: Supofen must always be kept out of the sight and reach of children.

Handling and Disposal

Any solution for infusion is for single use only and must be used immediately upon opening, with any unused portion discarded.

To dispose of expired or unused medicine, regulatory guidance prohibits disposal via wastewater or household waste. The product must be disposed of in accordance with local requirements, such as a pharmaceutical take-back program.

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

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