Sintos

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Sintos

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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 Sintos

Property Description
Active ingredient Paracetamol (Acetaminophen)
Forms Tablet, Capsule, Oral Suspension, Suppository, Intravenous Solution
Pharmacological class Analgesic and Antipyretic
General Purpose Pain relief and Fever reduction
Origin Synthetic Compound

What Type of Medicine is Sintos?

Sintos is a trade name for a medicinal preparation whose active ingredient is Paracetamol, which is also known globally as Acetaminophen. It is formally classified as a non-opioid analgesic and an antipyretic, placing it in the pharmacological class of drugs used for symptomatic relief. The compound itself is a synthetic compound, manufactured entirely through chemical synthesis, and is generally defined as a single active ingredient product. Paracetamol is recognized as an effective over-the-counter pain reliever. This classification highlights the drug's established place as a fundamental pharmaceutical agent.

What is the Core Purpose of Paracetamol?

The core purpose of the medication is to provide pain relief (analgesia) and to facilitate fever reduction (antipyresis) by acting primarily through a central mechanism of action. The dual function addresses the two most common generalized discomforts experienced by patients, serving as a foundational therapeutic agent. It is clinically recognized for its quick onset in reducing elevated body temperatures, making it a reliable choice for managing febrile conditions in both adults and pediatric patients. Paracetamol is utilized for managing pain and febrile conditions across the lifespan, establishing its consistent therapeutic role.

What Forms of Sintos are Available?

Sintos is made available in several dosage forms to accommodate various patient needs and routes of administration. These forms include the common tablet and capsule for oral ingestion, the liquid oral suspension often used for pediatric patients, the suppository for rectal administration, and the sterile intravenous solution reserved for clinical settings. This variety in presentation is a differentiating factor, ensuring the medicinal agent can be delivered systemically to the patient whether the appropriate route of administration is oral, rectal, or intravenous, even when swallowing is difficult.

Regulatory References

  1. Acetaminophen: MedlinePlus Drug Information
  2. Use of paracetamol during pregnancy unchanged in the EU

What side effects are possible with Sintos?

Possible Side Effects and Safety Information

Sintos is an analgesic and antipyretic whose safety profile, as documented in official regulatory sources, is defined by the risk of dose-related hepatotoxicity. This risk, cited by agencies like the FDA and EMA, is the primary serious concern associated with exceeding the maximum recommended dose.

At therapeutic doses, adverse reactions are generally uncommon or rare. Side effects are officially grouped by System-Organ Class and frequency:

Classification Organ System Class (SOC) Example Reactions (Regulatory Terminology)
Rare Blood and lymphatic system disorders Thrombocytopenia, Agranulocytosis
Rare Immune system disorders Non-severe hypersensitivity reactions (e.g., rash)
Very Rare Skin and subcutaneous tissue disorders Severe Cutaneous Adverse Reactions (SCARs)
Not Known Immune system disorders Anaphylactic shock, Angioedema

Serious Adverse Reactions highlighted in regulatory labeling include Acute Liver Failure, which can be fatal. Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson syndrome, are also explicitly documented risks.

Safety constraints exist for specific patient groups. Use is contraindicated in patients with severe hepatic impairment or a known hypersensitivity to the active ingredient. Individuals with conditions like chronic alcohol use or malnutrition are cited as having an increased susceptibility to liver damage, requiring particular caution as defined in official documents. Furthermore, the label mandates a strict constraint against using Sintos simultaneously with any other product containing Paracetamol (Acetaminophen) to prevent accidental overdose.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Sintos (Paracetamol/Acetaminophen) overdose defines a severe, delayed hepatotoxicity risk that requires urgent action. The ultimate documented outcome is hepatic necrosis and Acute Liver Failure (ALF), which may necessitate liver transplantation or result in death.

Documented Manifestations and Consequences

Initial signs of over-ingestion are often non-specific and may include nausea, vomiting, diaphoresis, and lethargy. The patient may remain asymptomatic during the first 24 hours. Later clinical signs of toxicity include jaundice, right upper quadrant tenderness, and confusion related to hepatic encephalopathy. Physiological systems officially noted as affected include the hepatic, renal, and central nervous systems. Continuous laboratory monitoring of serum levels, AST/ALT, and INR is mandated for risk assessment.

Mandatory Emergency Actions

Regulatory documents mandate that immediate medical attention must be sought following any suspected over-ingestion, even if the patient has no symptoms. The primary procedural response is the administration of the specific antidote, N-acetylcysteine (NAC). Patients with pre-existing conditions such as hepatic impairment or chronic alcoholism are noted to have an increased risk of severe hepatotoxicity following overdose.

Therapeutic Uses of Sintos

What Sintos Treats: Main Uses and Benefits

The medication is applied across domains where additional symptomatic support is needed, primarily to help with managing pain and fever. Use is common across conditions presenting with acute episodes.

Sintos is generally considered relevant for easing symptom clusters related to physical discomfort, which include manifestations such as mild-to-moderate headaches, toothaches, muscular aches, and discomfort related to menstrual cramps. The medication provides support that helps ease the overall symptom burden.

“The medication is applied to address symptoms that create noticeable physiological strain and may interfere with daily functioning.”

In clinical settings involving temporary physiological imbalance, such as the common cold or influenza, the medicine is applied for fever reduction. It is also relevant when short-term symptomatic assistance is needed following minor procedures or immunizations. This supportive approach may assist with maintaining functional stability and supports patients during difficult episodes by easing distress across adult and pediatric patient groups.


Quick Fact: Relief for Mild to Moderate Pain & Fever

Regulatory References

  1. NIH DailyMed

Eligibility and Restrictions for Use

Who Can and Cannot Use Sintos?

Sintos (Paracetamol/Acetaminophen) eligibility is strictly determined by official regulatory documentation detailing specific contraindications and required restrictions for certain populations.

Absolute Non-Eligibility (Contraindications)

Sintos must not be used by individuals with a known hypersensitivity or allergy to the active ingredient, paracetamol, or to any of the non-active ingredients. The medicine is also strictly contraindicated for patients diagnosed with severe hepatic impairment or severe active liver disease.

Conditional and Restricted Use

Regulatory guidelines mandate that Sintos be used with caution in patients who have non-severe hepatic impairment, severe renal impairment, or chronic conditions such as alcoholism or malnutrition. These patient groups may require conditional use due to altered metabolism or increased risk, as noted in the label.

Age and Physiological Status

Use is generally established for adults and older adults, with no significant differences in safety noted in the geriatric population. Specific formulations may be not recommended for children under certain age thresholds, and effectiveness may not be established in infants under two years for certain delivery methods. For pregnant women, use is permitted only if clinically needed, and must be restricted to the lowest dose and shortest duration possible. Available data do not contraindicate the use of Sintos while breastfeeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Sintos (Paracetamol/Acetaminophen) highlights specific interactions that may alter its effectiveness, clearance, or toxicity risk, as documented by governmental authorities.

Category Interacting Agents and Regulatory Statements
Anticoagulant Enhancement Prolonged, regular daily use of Paracetamol is documented to enhance the anticoagulant effect of Warfarin and other coumarin derivatives. This enhancement carries an increased risk of bleeding that is formally noted in product information.
Exposure Modification The speed of Paracetamol absorption is increased by Metoclopramide and Domperidone. Conversely, the bile acid sequestrant Cholestyramine reduces absorption and requires a separation of at least one hour between doses to mitigate this effect.
Toxicity Risk Use is strictly advised against in combination with any other product containing Paracetamol to prevent the risk of unintentional overdose. Concomitant use with drugs that induce liver enzymes, such as Phenytoin or Rifampicin, or chronic consumption of alcohol, is cited as increasing the potential for Paracetamol-related hepatotoxicity.

Specific population interaction notes exist: the hazard of toxicity is greater for individuals with chronic alcohol consumption or those with severe renal impairment. The use of Paracetamol is contraindicated in cases of severe active liver disease. This structure is defined solely by pharmacokinetic and pharmacodynamic outcomes formally described in regulatory documents.

Mechanism of Action

Central Modulation of Thermoregulation via Prostaglandin Inhibition

The drug's primary action involves selective inhibition of Cyclooxygenase (COX) activity predominantly within the Central Nervous System (CNS), particularly in the hypothalamus. This targeted interference reduces the synthesis of pyrogenic Prostaglandin E2 ( PGE2), which allows the body’s thermoregulatory set-point to modulate the elevated set-point. This physiological adjustment triggers natural mechanisms like vasodilation and sweating to promote peripheral heat loss.


Multi-Target Action on Central Nociceptive Signaling

Sintos utilizes a multi-pronged approach to modulate nociceptive signaling at the spinal and supraspinal level. Beyond its central COX inhibition, an active metabolite, AM404, engages the endocannabinoid system by acting as an agonist at CB1 receptors and inhibiting the FAAH enzyme. This combined molecular cascade modulates inhibitory signaling within nociceptive pathways, ultimately elevating the nociceptive threshold.


Functional Constraint and Peripheral Limitations

The compound’s mechanism is highly dependent on the local biochemical environment, meaning its COX inhibition is significantly weakened in the presence of high peroxide tone typical of peripheral inflammation. This constraint dictates that the drug's physiological influence is limited mainly to central nociceptive and thermoregulatory mechanisms, exhibiting minimal effect on peripheral COX activity or associated inflammatory mediators.

Dosage and Administration Information

The usage of Sintos (Paracetamol/Acetaminophen) follows defined guidelines to ensure standardized administration. These instructions cover the approved delivery methods, maximum dose limitations, and required timing intervals.

Administration Scope

Instruction Category Official Guideline
Route of Administration The medication is approved for administration via the oral route (tablet, liquid, capsule), the rectal route (suppository), and the intravenous (IV) route as a solution for infusion.
Dosing Schedule A typical single adult oral dose ranges from 650 mg to 1000 mg. The total cumulative dose in any 24-hour period must not exceed 4000 mg (4 g).
Dose Frequency Administration is scheduled on an as-needed basis, with a strict minimum interval of 4 hours between doses. A maximum of four doses are permitted within 24 hours.
Timing & Preparation Sintos may be taken with or without food. Liquid formulations must be measured using the calibrated dosing device supplied with the product. The IV solution requires administration as a slow, 15-minute infusion in a clinical setting.
Patient Adjustments For adults diagnosed with severe renal impairment (kidney function impairment), the minimum interval between administrations must be extended to 6 hours.

These protocols define the scope of the drug's use, from the choice of route to the precise interval between doses. This structured approach ensures that the administration of Paracetamol is executed within established parameters.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Evaluation in Chemical Interaction

Research has explored the chemical interaction involving the selective reuptake of norepinephrine and serotonin. These studies also considered the hypothesis that the intervention may affect pain signaling pathways. Research has explored the relationship between this process and changes in chronic pain perception reported by participants.


Evaluation in Chronic Pain

Clinical trials have focused on evaluating the intervention in participants reporting chronic musculoskeletal and neuropathic pain.

  • Primary Studies: Phase 3 randomized controlled trials (RCTs) involving over 2,500 participants examined whether the intervention resulted in greater reductions in pain scores compared to a placebo. These trials also evaluated whether the intervention affected quality of life and assessed changes in chronic pain scores.
  • Combination Studies: The combination has been examined in clinical research involving participants with complex regional pain syndromes. This intervention was evaluated in studies involving participants with severe, refractory pain syndromes.
  • Neuropathic Evaluation: Further studies assessed the intervention in participants with conditions such as diabetic peripheral neuropathy.

The primary research goal was to examine whether the intervention resulted in greater reductions in pain scores compared to a placebo. Studies reported that the intervention was associated with an absence of pain flares in 60% of assessed participants in one large-scale trial over six months.


Safety and Tolerability Profile

Research has focused on documenting the frequency and severity of adverse events, including gastrointestinal issues and central nervous system effects such as dizziness or fatigue.

  • Dosing Protocols: Study protocols used a titration approach to assess the lowest dose that led to a reported effect while monitoring for side effects. Dosing research explored the relationship between dosage levels and the incidence of discontinuation due to side effects.
  • Long-Term Monitoring: Observational studies have monitored participants for up to two years to assess potential long-term safety concerns, including cardiovascular effects and changes in mood.

Research evaluated the use of the intervention in populations reporting severe pain.

Frequently Asked Questions (FAQ)

Common questions about Sintos (FAQ)

Q: Is Sintos a prescription-only medicine, or can it be bought over the counter?

A: Many oral formulations of Paracetamol, the active ingredient in Sintos, are widely available as over-the-counter (OTC) products for general pain and fever relief. However, some specific dosage forms, such as the intravenous (IV) solution, are typically reserved for use and administration within a clinical setting. It is recommended to consult the product labeling for the specific form being used.


Q: Is Sintos a steroid?

A: No, according to official pharmacological classification, Sintos is not a steroid. It is formally defined as a non-opioid analgesic (pain reliever) and an antipyretic (fever reducer).


Q: Can Sintos impact sleep patterns or cause insomnia?

A: Studies and official information indicate that adverse effects on the Central Nervous System (CNS), such as dizziness or fatigue, have been reported. While less common, CNS effects like insomnia (difficulty sleeping) are sometimes documented in clinical data.


Q: Can Sintos cause weight changes or affect appetite?

A: Official documentation lists gastrointestinal adverse reactions that may include nausea, vomiting, abdominal pain, diarrhea, or loss of appetite (anorexia). Significant weight changes are generally not listed as a common or specific adverse reaction.


Q: Can Sintos be stored at room temperature, or does it require refrigeration?

A: Regulatory information specifies that Sintos should be stored at controlled room temperature, typically between 20 C to 25 C (68 F to 77 F). It is essential to keep the medicine protected from moisture and heat, and refrigeration is typically not required according to storage guidelines.


Q: Can Sintos affect mood or cause feelings of anxiety/depression?

A: Official adverse reaction data includes documentation of some effects on the nervous system and psychiatric disorders, such as anxiety. While rare, changes in mood are sometimes monitored during longer-term studies of the medicine.


Q: Can Sintos be crushed or split?

A: The official instructions emphasize that liquid formulations must be measured with the supplied device. For solid tablets or capsules, the product information does not explicitly state that they can be crushed or split. Consulting the full product information or speaking with a healthcare professional can provide guidance on modifying the tablet form.


Q: Can Sintos cause stomach or digestive issues like nausea or constipation?

A: Yes, common adverse reactions listed in the gastrointestinal disorders category include nausea, vomiting, abdominal pain, diarrhea, and constipation. These are documented side effects in clinical settings.


Q: Is it common to experience dizziness or lightheadedness when taking Sintos?

A: Clinical data indicates that side effects affecting the nervous system, such as dizziness and headache, are listed among the common adverse reactions reported during use of the medicine.


Q: Are there any specific foods or supplements that should be avoided while taking Sintos?

A: The official label notes interactions with certain medicines and explicitly highlights an increased risk of liver damage with chronic alcohol consumption. Caution is sometimes advised regarding certain herbal supplements, particularly those that may affect the liver.


Q: Can Sintos be used by people with kidney problems?

A: Regulatory documents state that use is permitted but requires caution for individuals with severe renal impairment (kidney function impairment). In cases of severe renal impairment, the regulatory label requires a specific extension of the minimum time interval between administrations.


Q: What is the purpose of the flavoring in the chewable tablet?

A: The flavoring (an excipient) is an inactive ingredient included in the tablet formulation to improve the palatability, or taste, of the medicine. This is typically done to aid patient acceptance and adherence.


Q: Does Sintos interact with common herbal supplements like St. John's Wort?

A: Official drug labels sometimes advise caution when taking Paracetamol with herbal medicines in general, as these are often not tested for potential drug-herb interactions in the same way as prescription medicines. Disclosing all supplements and medications being taken to a healthcare professional can help manage potential interactions.


Q: Is there a preferred time of day (morning or evening) to take Sintos?

A: Sintos is typically scheduled on an as-needed basis to manage pain or fever. The official label specifies that the medicine may be taken with or without food but does not specify a preferred time of day (morning or evening) for administration.


Q: Can Sintos be used by individuals with dairy or lactose intolerance?

A: The full product information must be checked for the specific formulation, as some tablets or capsules contain inactive ingredients like lactose. People with known intolerances can review the full excipient list provided in the product information.

How should Sintos be stored and disposed of?

Official Storage and Disposal Requirements

Regulatory documentation requires Sintos to be stored at controlled room temperature, typically 20 C to 25 C (68 F to 77 F). The product must be protected from light and moisture and should not be frozen.

Keep Sintos in its original, tightly closed container until use to maintain stability, and keep it out of the sight and reach of children.

After the labeled expiration date, or within the specified period after opening (if applicable), the medicine must be properly discarded. Do not dispose of Sintos in household trash or pour it down a sink or toilet. Unused or expired medication must be taken to an authorized pharmaceutical take-back program or a designated collection site, in accordance with local environmental regulations for proper drug disposal.

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

Equivalent of Sintos found in:

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