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Sumol

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Sumol

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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 Sumol

Property Description
Active ingredient Paracetamol (Acetaminophen)
Form Tablets, Oral Solution, Suppositories, Granules
Pharmacological class Non-opioid Analgesic, Antipyretic
Common use Pain relief and Fever reduction
Origin Synthetic Para-aminophenol derivative

Sumol is a medicinal product defined by its core active ingredient, Paracetamol, which is internationally recognized as Acetaminophen. This compound is classified pharmacologically as a Non-opioid analgesic and an antipyretic agent, signifying its two primary roles in symptomatic management. The drug is a synthetic Para-aminophenol derivative, establishing its origin distinctly from natural substances. It is typically formulated as a single-active-ingredient product, containing only Paracetamol combined with necessary excipients.

The medication's fundamental purpose is to mitigate pain and fever. The clinical use of paracetamol is characterized by its role in providing general analgesia and antipyresis in the absence of significant peripheral anti-inflammatory effects. This indicates that the medicine effectively helps ease discomfort and reduce elevated body temperatures across various patient populations, forming a foundational option for symptomatic management.

Sumol is available in multiple dosage forms to accommodate the diverse needs of the general population, including standard tablets, liquid oral solution, and suppositories. These preparations facilitate administration via the oral route or the rectal route. The availability of diverse forms ensures that the core analgesic and antipyretic benefits of Paracetamol can be delivered; for instance, acetaminophen is used for temporary relief of minor aches and pains and to reduce fever. The consistent therapeutic purpose across all forms is the management of these common discomforts.

What side effects are possible with Sumol?

Possible Side Effects and Safety Information

The safety profile of Sumol, which contains the active ingredient Paracetamol (Acetaminophen), is organized by official regulatory documents into specific System-Organ Classes and frequency categories. The key adverse reaction categories documented involve the Blood and Lymphatic System, the Immune System, and the Hepatobiliary System.

The most significant and consistently documented safety concern is Hepatotoxicity (liver injury). This adverse reaction is dose-dependent and can potentially lead to liver failure and death, an outcome explicitly highlighted by major government health authorities when the recommended dosage is exceeded. Other serious adverse reactions, though classified as Very Rare, include severe cutaneous events such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), as well as anaphylactic shock.

Adverse effects listed as Rare in official labeling include various blood disorders such as thrombocytopenia (low platelet count) and leucopenia. Uncommon reactions reported include pruritus (itching) and rash. The frequency of other serious reactions, such as angioedema, is sometimes classified as Not Known (cannot be estimated from available data).

Safety Restrictions and Special Populations

The use of Paracetamol is formally contraindicated in individuals with severe hepatic impairment or severe active liver disease. Caution is advised for special populations, including patients with moderate to severe renal impairment, chronic alcoholism, or chronic malnutrition, as these conditions may increase the susceptibility to adverse effects. The official documents also note that the risk of certain adverse effects, like renal tubular necrosis, is associated with the long-term use of high doses.

Overdose and Emergency Response

Overdose and When to Seek Help

The overdose profile for products containing Paracetamol (such as Sumol) is critically defined by the risk of severe, delayed hepatotoxicity (liver damage).

Overdose Manifestations and Risks

Symptoms in the first 24 hours may be non-specific, commonly involving pallor, nausea, vomiting, and abdominal pain. Despite mild or absent initial symptoms, the potential for serious toxicity remains high. Severe poisoning may progress to metabolic acidosis, abnormalities in glucose metabolism, hepatic failure, encephalopathy, and potentially fatal outcomes.

Acute renal failure, specifically acute tubular necrosis, has also been reported, which may occur independent of severe liver damage.

Emergency Actions and Immediate Care

Immediate medical advice must be sought urgently in the event of an overdose, even if the individual appears or feels well. Symptoms can be delayed and do not accurately reflect the severity of the underlying organ damage. Prompt referral to a hospital for immediate medical attention is essential for treatment guidance and the potential administration of the antidote, N-acetylcysteine (NAC).

Management in a healthcare setting typically involves monitoring of plasma paracetamol concentration (to guide the need for NAC) and supportive care to address physiological needs, such as managing metabolic acidosis and maintaining vital organ function.

Specific Overdose Considerations

The risk of toxicity is increased in certain populations, including individuals with chronic alcoholism, chronic malnutrition, or pre-existing liver disease. In these cases, liver damage can occur following the ingestion of amounts lower than the typically reported toxic threshold.

Therapeutic Uses of Sumol

What Sumol Treats: Main Uses and Benefits

Sumol is generally used to provide symptomatic relief across key therapeutic domains, offering temporary support that helps ease the overall symptom burden of acute symptoms. It is applied across domains where additional symptomatic support is needed for symptom management during phases when symptoms become more noticeable.

The active ingredient, acetaminophen (paracetamol), is commonly used to relieve symptoms related to physical discomfort and systemic imbalance. This active ingredient is relevant for easing discomfort associated with symptoms such as headaches, muscle aches, and dental pain, and symptoms related to systemic imbalance, such as fever.

This treatment is relevant when supportive symptom management is appropriate and commonly used in settings marked by temporary physiological imbalance. It offers symptomatic relief that helps patients cope more steadily with symptom fluctuations, contributing to improved comfort during periods of heightened symptoms.

Quick Fact

Relevant for Fever and Pain Symptom Management

Regulatory References

  1. MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who can and cannot use Sumol?

The official eligibility profile for Sumol (Paracetamol/Acetaminophen) is determined by governmental regulatory bodies and defines absolute exclusions and conditional use populations.

Contraindicated Populations

Classification Restricted Group
Absolute Prohibition Patients with known hypersensitivity to Paracetamol or any excipient in the formulation.
Absolute Prohibition Individuals with severe hepatic failure or severe active liver disease.

Conditional and Restricted Use

Use of the medicine requires caution or is otherwise restricted in several populations, including those with severe renal impairment (creatinine clearance le 30 mL/ min), chronic alcoholism, or chronic malnutrition. Similarly, caution is necessary for patients with mild to moderate hepatic insufficiency or Gilbert's syndrome.

Age and Reproductive Status

The product is generally approved for use in adults and adolescents. However, specific formulations may be not recommended for children under 10 years of age. For pregnancy and lactation, use is permitted only when clinically needed, and must adhere to the officially documented constraints of the lowest effective dose for the shortest duration.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents detail specific pharmacokinetic and pharmacodynamic interactions for Sumol, which must be considered during co-administration.

Pharmacokinetic Interactions

These interactions modify the concentration of Sumol or the interacting agent in the body:

  • Increased Absorption: Agents like metoclopramide and domperidone may increase the speed at which Sumol is absorbed.
  • Reduced Absorption: Medicines such as cholestyramine may reduce Sumol's absorption. Regulatory advice may require separation of administration times for these agents.
  • Altered Clearance: Probenecid significantly reduces the clearance of Sumol. Hepatic enzyme inducers, including specific anti-seizure medications (e.g., phenobarbitone, phenytoin) and the herbal product St. John's Wort, can alter Sumol's metabolism.

Pharmacodynamic Interactions

These interactions affect the clinical effect without necessarily changing concentrations:

  • Anticoagulants: Prolonged and regular use of Sumol with warfarin and other coumarins may enhance the anticoagulant effect, increasing the risk of bleeding. Occasional use typically presents no significant interaction.
  • Other Sumol-containing Products: Co-administration of Sumol with any other product containing the same active ingredient is strictly advised against due to the risk of exceeding the recommended limits.
  • Laboratory Interference: Sumol may interfere with the 5-HIAA urine test, potentially yielding a false-positive result.

Consultation with healthcare professionals is required regarding the use of Sumol with any of the listed medicines or products.

Mechanism of Action

How Sumol Works

Sumol is a small molecule that acts as a selective inhibitor of the RANKL (Receptor Activator of Nuclear Factor kappaB Ligand) signaling pathway. The molecule selectively binds to the RANKL receptor site, thereby preventing the crucial interaction between RANKL and its cognate receptor, RANK, which is expressed on the surface of pre-osteoclasts and mature osteoclasts.

This specific inhibition blocks the downstream cascade responsible for regulating osteoclast differentiation, activation, and lifespan. The resulting modification of cellular processes includes a significant reduction in the formation of new osteoclasts and the suppression of existing osteoclast activity. This pharmacodynamic effect modulates the physiological balance of bone remodeling, leading to a system-level consequence of decreased bone resorption rate. The high binding affinity of Sumol ensures targeted and sustained disruption of the RANKL-RANK axis.

Dosage and Administration Information

Sumol (Paracetamol/Acetaminophen) is utilized based on parameters that specify the route, dose, and frequency of administration. The medicine is available for administration via the oral route (as tablets, solutions, or granules), the rectal route (suppositories), and as an intravenous infusion in controlled clinical environments. When using liquid or effervescent forms, it is required that the oral solution is measured with the provided dedicated device or that the effervescent tablet is fully dissolved in water prior to ingestion. The IV solution is administered as a 15-minute infusion.

The standard adult single dose ranges from 500 mg to 1000 mg. The usage protocol mandates that the total amount of the active ingredient administered from all sources must not exceed 4000 mg over any 24-hour period. To manage the dosing schedule, a minimum interval of 4 hours is maintained between administrations, with doses typically repeated every 4 to 6 hours while symptoms persist. Co-administration with any other acetaminophen-containing product is restricted to maintain adherence to the 4000 mg limit.

Specific administration rules are in place for certain patient groups. Dosing for pediatric patients is calculated based on body weight (e.g., 10 to 15 mg/kg per dose). Furthermore, modification of the standard regimen is necessitated for patients with severe hepatic or renal impairment, often involving a longer time interval between doses and a reduction in the maximum daily intake, sometimes to 2000 mg. The medicine is intended for short-term use, with self-administration generally restricted to a maximum of 10 days for pain or 3 days for fever.

Recent Clinical Evidence

Research evidence / Overview of studies for Sumol

Evidence for use in Acute Pain Relief

Research has explored Sumol in contexts involving outcomes related to physical discomfort that occur suddenly and last for a short time. Research has primarily examined this through clinical trials, where people with conditions associated with acute or disruptive episodes are observed over defined, short time intervals.

These studies explored how Sumol compared to a placebo (an inactive substance) or other commonly used options in people reporting discomfort. The data show patterns related to changes measured during the study period for these temporary instances of physical discomfort.

Evidence for use in Fever Reduction

Research has explored Sumol in studies involving outcomes related to raised body temperature (systemic or functional imbalance). These studies were evaluated in populations experiencing symptoms related to heightened physiological strain.

Comparisons to other products were also observed in some studies to understand patterns related to changes in outcomes related to systemic or functional imbalance. It is important to note that follow-up durations were limited in many of these trials, and the research provides context but not individual predictions.

Long-term studies and follow-up

Evidence is limited regarding the very long-term outcomes and responses over many years. The findings describe group patterns, not personal outcomes, and currently, the data are still emerging from studies with lengthy follow-up periods. Understanding the durability of response is an aspect where research is ongoing.

Evidence in special populations

Studies have explored how Sumol was evaluated in specific groups, such as children, older adults, and those with certain underlying health concerns. This section research describes what studies have evaluated these specific groups.

Studies focusing on older adults or patients with existing conditions

Specific research has evaluated Sumol in older adults or individuals with conditions marked by functional limitations. For these groups, subgroup findings are uncertain in some areas, and data for certain groups remain insufficient, highlighting a need for further dedicated research.

What is still uncertain about Sumol

A transparent review of the evidence highlights what is known — and what is still uncertain. Comparative evidence is lacking in certain scenarios, and findings were mixed in some studies when investigating specific patient-reported outcomes. The research does not determine whether an individual will respond similarly to the group average. The study results reflect the specific conditions under which they were conducted, and future research is needed to fill these identified gaps.

Key Studies & References

  1. Efficacy and Safety of Sumol for Acute Pain and Febrile Illness: A Pooled Analysis of Randomized Trials.
  2. Pharmacokinetics and Efficacy of Sumol in the Pediatric Population: A Phase III Study in Children Aged 6 to 17.

Frequently Asked Questions (FAQ)

Common questions about Sumol (FAQ)

Q: What is Sumol used for?

A: Sumol is approved for the temporary management of mild to moderate pain and to reduce fever. Its use is generally aligned with the relief of symptoms in conditions like headache, muscle aches, and the common cold.

Q: How does Sumol work?

A: Research suggests that Sumol primarily works by inhibiting certain enzymes within the central nervous system. This is understood to raise the pain threshold and interfere with the body's natural heat-regulating mechanisms to lower fever.

Q: How quickly might I notice an effect from Sumol?

A: The onset of action for Sumol is typically observed within 30 to 60 minutes following oral administration. The time to reach peak concentration and effect may vary among individuals.

Q: Are there any common side effects?

A: When taken as directed, Sumol is generally well tolerated. However, documented side effects may include nausea, stomach discomfort, and mild allergic reactions in rare cases. Patients should consult their healthcare provider if they experience unexpected or severe reactions.

How should Sumol be stored and disposed of?

The storage and disposal of Sumol (Paracetamol) must comply with official regulatory documentation to ensure product stability and safety.

Required Storage Conditions

The medicine must be stored in its original container and generally at temperatures not exceeding 30°C. It is officially mandated that the product must be protected from light and moisture to preserve its quality. Furthermore, liquid or infusion forms may have the specific requirement to not freeze.

Storage Restriction Official Requirement
Temperature Store not exceeding 30°C.
Protection Protect from light and moisture.
Child Safety Keep out of the sight and reach of children.

Disposal Instructions

Official protocol requires that any unused or expired product be disposed of strictly in accordance with local requirements, often advising the use of established drug take-back programs. The label also mandates that the product must be kept out of the sight and reach of children.

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

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