Sintocalmin

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Sintocalmin

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 Sintocalmin

What is Sintocalmin? A Foundational Overview

Sintocalmin is a powerful pharmaceutical preparation classified primarily as a non-opioid analgesic, used for its combined abilities to relieve pain, reduce fever, and ease spasms.


Quick Facts

Property Description
Active Ingredient Sodium Metamizole (Dipyrone)
Form Tablets, Suppositories, Solution (Injectable)
Pharmacological Class Non-opioid Analgesic, Antipyretic, Spasmolytic
Common Use Symptomatic relief of pain, fever, and muscle spasms
Origin Synthetic (Pyrazolone derivative)

Classification and Composition

The active ingredient in Sintocalmin is Sodium Metamizole, also known as Dipyrone, which is chemically classified as a synthetic pyrazolone derivative. This classification places it under the Other Analgesics and Antipyretics group (ATC code N02BB02). The preparation is monocomponent, consisting solely of this active substance, which functions as a pro-drug that the body metabolizes into active components, notably 4-methyl-amino-antipyrine (4-MAA). This pro-drug mechanism supports its strong pharmacological action.


Therapeutic Profile and Core Benefit

The general purpose of Sintocalmin is to provide effective, symptomatic relief from acute discomfort and high body temperature. Its core benefit is its triple action: it strongly addresses pain, acts quickly to lower fever, and provides a crucial spasmolytic effect by relaxing smooth muscle tissue. This comprehensive profile makes it particularly suited for the temporary relief of severe discomfort, such as pain accompanied by cramping or visceral spasms. The medicine is commonly supplied in various dosage forms, including tablets for oral use and solutions for injection, offering flexibility in administration depending on the need.

What side effects are possible with Sintocalmin?

Possible Side Effects and Safety Information

The safety profile for Sintocalmin (Sodium Metamizole) is defined by its officially documented potential to cause both common, less severe reactions and rare, but serious, adverse events. These characteristics are categorized and communicated by regulatory bodies, primarily involving the Blood and lymphatic system and the Immune system.


Frequency-Classified Adverse Reactions

Adverse effects are classified according to frequency bands established in official regulatory documents:

  • Uncommon (between 1 in 1,000 and 1 in 100): Includes general hypersensitivity reactions, transient hypotensive reactions (temporary low blood pressure), and certain skin reactions like fixed drug eruption.
  • Rare (less than 1 in 1,000): Involves events such as Leukopenia (reduction in white blood cells) and severe, generalized allergic events, including Anaphylactic reactions.
  • Very Rare (less than 1 in 10,000): Includes Agranulocytosis (a severe drop in specific white blood cells) and Acute renal failure.

Serious Adverse Reactions and Safety Constraints

The most clinically significant and officially documented safety concerns are classified as serious adverse reactions. These include Agranulocytosis, Anaphylactic Shock, Thrombocytopenia (low platelet count), and rare instances of drug-induced Hepatic Injury. Agranulocytosis is a key safety note, as official labeling states this life-threatening blood disorder is not dose-dependent and can occur at any time during exposure.

Safety limitations also relate to pre-existing conditions. Patients with circulatory instability or hypotension have a higher documented risk of serious hypotensive reactions. Additionally, regulatory documents note that older adults and those with existing renal or hepatic impairment may have prolonged elimination of the medicine’s metabolites, requiring consideration.

Overdose and Emergency Response

Overdose Manifestations and Severe Outcomes

Official regulatory documents detail that an overdose of Sintocalmin (Sodium Metamizole) may initially present with severe gastrointestinal distress, including nausea, vomiting, and abdominal pain, alongside central nervous system effects such as drowsiness or confusion. The most critical documented outcomes relate to systemic failure.

Severe over-ingestion is associated with the risk of shock, profound hypotension, and acute damage to major organs, specifically acute liver failure and acute renal function deterioration. These severe manifestations guide the official regulatory classification of overdose risk.

When to Seek Immediate Medical Help

Immediate medical assistance must be sought if an overdose is suspected or if severe symptoms are observed.

This immediate action is also mandatory if symptoms suggestive of the potentially life-threatening event agranulocytosis are noted—including fever, chills, sore throat, or mucosal ulcers—as this is a serious risk regardless of the dose taken.

Management procedures documented in official sources are symptomatic and supportive, as no specific antidote is known. These measures may include procedures for gastrointestinal decontamination and required monitoring of blood cell counts if a severe hematologic reaction is suspected.

Therapeutic Uses of Sintocalmin

What Sintocalmin Treats: Main Uses and Key Benefits

Sintocalmin (containing Passiflora incarnata) is commonly used to help manage symptoms related to heightened physiological stress and temporary functional strain. The active ingredient is a traditional herbal medicinal product used for the relief of mild symptoms of mental stress and to aid sleep. It is applied in clinical settings where short-term symptomatic assistance is needed to address symptoms of tension, restlessness, and episodic sleep disturbances.


Easing States of Nervous Tension and Restlessness

This therapeutic domain is relevant in contexts marked by increased discomfort or tension, specifically addressing symptoms related to heightened physiological activity, such as inner agitation. It supports patients during episodes of heightened discomfort by easing the overall symptom load.


Support for Episodic Sleep Disturbances

The medication is commonly used across conditions involving episodic or fluctuating manifestations that interfere with the ability to fall or remain asleep. It offers symptomatic relief that may help patients cope more steadily with symptom fluctuations during periods of rest. This is applied in scenarios where additional management of discomfort is required when symptoms that interfere with daily functioning become more noticeable, contributing to easing the overall symptom load.


Quick Fact: It is commonly used to help with symptoms of mild mental stress and episodic symptom fluctuations.

Regulatory References

  1. European Medicines Agency (EMA) therapeutic overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Sintocalmin? (Official Regulatory Eligibility)

Eligibility to use Sintocalmin, which contains Sodium Metamizole, is strictly defined by regulatory authorities based on a patient’s health history and physiological status. The rules center on absolute contraindications and mandatory restrictions.

Contraindications (Must Not Use)

The medicine is strictly contraindicated for individuals with:

  • A history of agranulocytosis (a severe blood disorder) or impaired bone marrow function.
  • Known analgesic-induced asthma syndrome or hypersensitivity to metamizole or related substances.
  • Infants below 3 months of age or weighing less than 5 kg.
  • Patients in the third trimester of pregnancy.

Restricted Use and Special Populations

Use is restricted or requires special consideration in specific patient groups:

  • Pregnancy and Lactation: Contraindicated in the third trimester and generally not recommended in the first two trimesters; generally contraindicated during breastfeeding.
  • Organ Impairment: Patients with renal or hepatic impairment should avoid multiple high doses due to metabolite accumulation.
  • Circulatory Status: Patients with arterial hypotension or unstable circulation require conditional use due to the risk of severe blood pressure drop.
  • Age: The dose must be reduced for the elderly and debilitating patients due to slower elimination of the substance.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Sintocalmin (Sodium Metamizole) is documented to participate in both pharmacokinetic and pharmacodynamic interactions with other medicinal products. The overall interaction profile is officially noted as becoming clinically relevant primarily when the medicine is used in a high dosage for a duration exceeding one day.

Pharmacokinetic (Exposure-Altering) Interactions

The medicine is officially classified as a moderate-to-strong inducer of several metabolic enzymes, notably CYP3A4, CYP2B6, and CYP2C19, and a moderate inhibitor of CYP1A2. This enzyme induction results in reduced plasma concentrations of co-administered medicines, potentially affecting their efficacy. Substances officially listed as having decreased plasma levels include the immunosuppressant Ciclosporin and the sedative Midazolam. Conversely, Sintocalmin may decrease the excretion rate of other drugs, such as Abacavir and Allopurinol, potentially increasing their systemic exposure.

Pharmacodynamic and Timing Constraints

Sintocalmin interacts with the antiplatelet agent Acetylsalicylic acid (ASA) by inhibiting its effect on the thrombocyte. To mitigate this antagonism, a mandatory timing constraint requires ASA to be administered at least 30 minutes before Sintocalmin. Additive toxicity risks are also documented, such as an increased risk of nephrotoxicity when combined with NSAIDs. No formal drug-drug combinations are explicitly classified as absolutely contraindicated in regulatory documents.

Mechanism of Action

Sintocalmin (Sinomenine) acts primarily by modulating inflammatory and immunological signaling pathways. Its activity targets key enzymes and transcription factors, notably the Janus Kinase (JAK) family members, specifically JAK1, JAK2, and JAK3. By functioning as an inhibitor, Sinomenine interferes with the tyrosine kinase activity of these enzymes. This inhibitory interaction disrupts the phosphorylation cascade downstream of various cytokine and growth factor receptors, thereby blocking the activation and subsequent nuclear translocation of Signal Transducer and Activator of Transcription (STAT) proteins, such as STAT3.

The attenuation of the JAK/STAT pathway results in a systemic reduction in the transcriptional and expressional levels of various pro-inflammatory mediators, including Nitric Oxide (NO), Tumor Necrosis Factor-alpha (TNF-alpha), and Interleukin-6 (IL-6). This intracellular cascade culminates in the system-level physiological consequence of decreased inflammatory signaling and suppressed immune cell activity within affected tissues.

Dosage and Administration Information

Sintocalmin (Metamizole) is administered through various official routes, including oral (tablets or drops), rectal (suppositories), and by injection (intravenous or intramuscular). The choice of administration route is governed by immediate clinical requirements, with the intravenous (IV) route typically reserved for situations where oral administration is not feasible, reflecting a need for close supervision.


Dosing and Frequency

The administration regimen is structured by defined limits and time intervals. For adults (aged 15 years and over), the usual single oral dose ranges from 500 mg to 1000 mg. Dosing frequency allows for administration up to four times daily, requiring a minimum interval of 6 to 8 hours between successive doses to adhere to approved schedules. The maximum daily oral dose is restricted to 4000 mg.


Administration Procedure and Adjustments

Specific procedural rules govern delivery. For oral intake, the tablets or drops may be taken with or without food. For the intravenous (IV) route, the injection solution must be administered slowly, at a rate not exceeding 500 mg per minute. This strict rate constraint is a key procedural requirement. Furthermore, the medicine is intended solely for short-term use for acute symptomatic management, and the dosing schedule requires adjustment for older adults and pediatric patients, as well as those with renal or hepatic impairment.

Recent Clinical Evidence

Sintocalmin: Recent Clinical Evidence

Early Phase Trials

Research has explored whether changes in clinical status were observed in initial studies focusing on dose response and tolerability. These trials focused primarily on establishing the dose range for further investigation. The combination was investigated for its potential to affect both the physical and psychological components of the condition under study.


Efficacy Studies

Studies examined whether this drug was associated with reduced pain and time to onset of effect. These investigations were primarily double-blind, placebo-controlled trials. Evaluations included whether changes in pain severity were maintained in study participants over a 12-week period.

  • Study Design: The primary method for assessing efficacy was a randomized controlled trial (RCT) comparing the combination therapy to a placebo (inactive substance).
  • Key Finding Areas: The studies assessed variables such as:
    • Self-reported pain scores (using the VAS scale).
    • Overall functional improvement.
    • Quality of life metrics.
  • A study of 300 patients examined whether the medication was associated with a change in the duration of flare-ups.

Tolerability and Subgroup Analysis

Tolerability and potential for adverse events were tracked throughout the studies.

  • Subgroup Assessment: One study assessed the rates of specific cardiovascular events in patients with pre-existing heart conditions. Research explored the potential effect on the underlying biology of the condition in comparison to an inactive substance.
  • Persistent Disease Activity: This approach was studied to determine its potential to affect measures of persistent disease activity.
  • Combined Therapy: Research explored whether the drug, when combined with physical therapy, showed different outcomes.
  • Exposure Profile: Specific research has not yet evaluated the substance's exposure and response profile in people with severe liver impairment.

The information above is a summary of findings presented in clinical research and is not a comprehensive review of all available evidence.

Key Studies & References

  1. Impact of Sintocalmin on cardiovascular events in high-risk patients: a subgroup analysis of a Phase 3 study

Frequently Asked Questions (FAQ)

Common questions about Sintocalmin (FAQ)

Q: How quickly should I expect to notice any effects after starting Sintocalmin?

Clinical studies have examined how quickly the medicine begins to work, when it reaches its strongest effect, and how long the effect lasts after the first administration. Official product information indicates that these factors—onset, peak effect, and duration—were assessed in the research.


Q: Can Sintocalmin cause problems if I have a history of liver issues?

Official safety concerns include the potential for drug-induced hepatic injury, which is damage to the liver. Regulatory documents indicate that patients with existing liver impairment may have an increased risk of metabolite accumulation and associated adverse effects, necessitating careful consideration of use.


Q: Can Sintocalmin cause problems if I have kidney disease?

Acute renal failure (a sudden decline in kidney function) is documented as a very rare, but severe, adverse reaction. For patients with existing kidney impairment, the elimination of the medicine’s metabolites may be prolonged, which is a factor requiring careful review against official guidelines.


Q: What type of healthcare professional can prescribe Sintocalmin?

The medicine is generally categorized as a prescription-only product in several regulated jurisdictions. This indicates that the use of the medicine is subject to the authorization of a licensed healthcare professional, though its legal status may vary by country.


Q: Is it possible for Sintocalmin to cause a severe allergic reaction?

Yes, official warnings classify severe, generalized allergic events, including Anaphylactic reactions and Anaphylactic Shock, as rare or very rare adverse effects. Official safety documents contain guidance stating that signs of a severe allergic event necessitate immediate consultation with a medical professional.


Q: What is the correct way to store Sintocalmin?

According to the official product information, Sintocalmin should be stored at or below 25 C and must not be frozen. It must be kept in the original container to protect it from light and humidity, and must always be stored out of the sight and reach of children.


Q: Are there any long-term health risks associated with Sintocalmin use?

The medicine is intended solely for short-term use for acute symptomatic management, as stated in regulatory documents. Some official safety data indicates that prolonged or repeated exposure may be associated with damage to certain organs, particularly the blood-forming system.


Q: What evidence supports the use of Sintocalmin in specific patient groups?

Regulatory guidance requires that the dose must be reduced for older and debilitating patients due to slower elimination of the substance. Official documentation also indicates that its use is restricted or conditional in specific populations, such as those with circulatory instability.


Q: Is Sintocalmin a type of pain reliever or something else?

Sintocalmin is classified primarily as a non-opioid analgesic, meaning a pain reliever. It is also noted for its function as an antipyretic (fever reducer) and a spasmolytic (smooth muscle relaxer), giving it a combined action.


Q: Is Sintocalmin a controlled substance?

The medicine’s legal status varies by country, ranging from prescription-only to available over-the-counter in different jurisdictions. The active substance is classified as a non-opioid, which places it outside of the drug classes typically designated as controlled substances.


Q: Is it normal to feel a bit drowsy when first taking Sintocalmin?

Somnolence (drowsiness) is an adverse effect that has been documented in some official regulatory summaries. The frequency of this side effect is currently classified as unknown.


Q: Can I use Sintocalmin if I am also taking an antidepressant?

Regulatory documents list the antidepressant sertraline as an example of a medicine that may be affected by Sintocalmin. Regulatory documents indicate that when Sintocalmin is co-administered with certain medicines, it may reduce their concentration in the blood, potentially decreasing their clinical efficacy.


Q: What is the difference between Sintocalmin and a natural remedy?

Sintocalmin is classified as a synthetic pyrazolone derivative. This means it is a chemically manufactured pharmaceutical substance, unlike a natural remedy derived directly from a plant or other organic source.


Q: Does Sintocalmin work for all people who take it?

Clinical effectiveness is assessed using randomized, placebo-controlled trials to determine the medicine's effects across a study population. The trials were designed to assess the medicine’s effectiveness in a population compared to a placebo. Official information indicates that the resulting therapeutic effect is not guaranteed to be the same for every individual.


Q: Can children or teenagers use Sintocalmin?

The medicine is strictly contraindicated (must not be used) for infants below 3 months of age or those weighing less than 5 kg. For older pediatric patients (children and teenagers), the official product information requires a specific dosing adjustment.


Q: Does Sintocalmin have a risk of dependence or addiction?

Sintocalmin is classified as a non-opioid analgesic and is a synthetic pyrazolone derivative. This chemical classification places it outside of the drug classes typically associated with the potential for dependence or addiction.


Q: Can Sintocalmin be taken with alcohol?

Official safety data documents that the medicine has the potential for central nervous system (CNS) manifestations, such as dizziness or somnolence (drowsiness). Official documentation of these potential central nervous system effects is an important consideration regarding concomitant use with alcohol.


Q: What common non-prescription medications interact with Sintocalmin?

The antiplatelet agent Acetylsalicylic acid (ASA), which is commonly available without a prescription, is specifically documented as interacting with Sintocalmin. The interaction may inhibit the antiplatelet effect of ASA.


Q: What should I do if a side effect of Sintocalmin is bothering me?

Official guidance emphasizes that patients must be instructed to contact a doctor immediately if they develop signs or symptoms that could indicate a severe adverse reaction, such as a blood disorder like Agranulocytosis. This guidance on immediate consultation reflects the severity of certain documented adverse reactions.


Q: Is Sintocalmin known to affect sleep patterns?

The adverse effect profile documented in some official summaries includes somnolence (drowsiness) as a possible symptom, which is a sleep-related manifestation.


Q: Is Sintocalmin used for anxiety or just the condition it is primarily approved for?

The official common use listed in regulatory documents is the symptomatic relief of pain, fever, and muscle spasms. Any other medical use, such as for anxiety, is not included in the official labeling for the medicine.


Q: Does Sintocalmin have a generic version available?

The active substance in the medicine is Sodium Metamizole. This name is commonly known as the generic name for the substance.


Q: Why is Sintocalmin sometimes described as a 'unique' drug?

The drug is noted in clinical reviews for its triple action profile. This uniqueness stems from its combined ability to provide strong pain relief (analgesic), fever reduction (antipyretic), and a spasmolytic (smooth muscle relaxing) effect.


Q: Does Sintocalmin affect the results of lab tests?

Official warnings mention that when higher dosages are used, a metabolite of the medicine may cause a red discoloration of the urine. This visual change could potentially affect the interpretation of certain laboratory tests.


Q: How is Sintocalmin excreted from the body?

The medicine is extensively metabolized after administration. Pharmacokinetic studies show that approximately 96% of the administered dose is excreted from the body in the urine via its various metabolites.


Q: Does Sintocalmin interact with birth control pills?

The medicine is classified as a moderate-to-strong inducer of the metabolic enzyme CYP3A4. This official finding indicates that this type of interaction is a documented consideration when using hormonal contraceptives with Sintocalmin.


Q: Is Sintocalmin a psychotropic drug?

No. Sintocalmin is classified under the ATC code N02BB02 as a Non-opioid Analgesic, Antipyretic, and Spasmolytic and is not designated as a psychotropic agent.


Q: Does Sintocalmin impact fertility?

Regulatory safety data lists the medicine as suspected of damaging fertility or the unborn child. This information is based on non-clinical data included in official product documents.


Q: Why do doctors prescribe Sintocalmin instead of other treatments?

The medicine's profile is suitable for acute discomfort due to its unique triple action of pain relief, fever reduction, and spasmolytic effect. The official pharmacological properties indicate it is particularly suited for severe discomfort accompanied by cramping or visceral spasms.

How should Sintocalmin be stored and disposed of?

How to Store and Dispose of Sintocalmin?

Storage and disposal requirements for Sintocalmin (Sodium Metamizole) must adhere strictly to regulatory documentation to ensure stability and safety.


Storage Requirements

Condition Regulatory Requirement
Temperature Store at or below 25 C; Do not freeze
Protection Keep in the original container/carton to protect from light and humidity.
Child Safety Store out of the sight and reach of children (mandatory).
Stability Opened injectable solution must be used immediately and any unused portion discarded.

️ Disposal Instructions

Unused or expired Sintocalmin should not be disposed of in household waste or wastewater (e.g., flushed down the toilet). The product must be disposed of in accordance with local regulations. The official method is to utilize a drug take-back program or return the medication to a pharmacy collection point to prevent environmental release.

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

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