Седалгин Плюс

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Седалгин Плюс

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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 Седалгин Плюс

Property Description
Active Ingredients Metamizole Sodium, Caffeine, Thiamine Hydrochloride
Form Tablets (Solid oral preparation)
Pharmacological Class Analgesic and Antipyretic Combination
General Purpose Symptomatic relief of pain and fever
Origin Synthetic and Derived Components

Identity, Classification, and Composition of Седалгин Плюс

Седалгин Плюс is a fixed-dose combination product intended for oral administration, classified within the broad therapeutic category of analgesics and antipyretics. This medicinal entity is a synthetic and derived preparation supplied as tablets. Its composition is defined by the three distinct active ingredients: Metamizole Sodium, Caffeine, and Thiamine Hydrochloride (Vitamin B1). This unique formulation, integrating an analgesic with a stimulant and a vitamin, distinguishes it from simple, single-component pain relievers.

Metamizole Sodium is a Pyrazolone derivative, a non-narcotic agent that provides the primary pain-relieving and fever-reducing actions. Metamizole is recognized for its analgesic efficacy and is classified under the ATC code N02BB. This confirms that the drug's principal function is recognized in medical literature for managing discomfort.

The Therapeutic Rationale of a Triple Combination

The general purpose of this combination preparation is the effective symptomatic relief of discomfort, typically used for sudden onset symptoms like a severe headache or temporary fever. The rationale for this triple-component formulation is built on complementary actions that are clinically recognized for their synergistic effects.

Metamizole Sodium provides core analgesic and antipyretic effects. The inclusion of Caffeine is designed to enhance the analgesic effect and provides mild central nervous system support, which helps counteract the general lethargy often associated with symptomatic illness. Furthermore, Thiamine Hydrochloride is an essential nutrient used for cell function and nervous system health. This component contributes to supporting general well-being during symptomatic periods. This multi-component approach aims for comprehensive alleviation of common uncomfortable symptoms in a single tablet form.

Regulatory References

  1. NIH MedlinePlus Thiamine Information (Vitamin B1)
  2. NIH, MedlinePlus Thiamine Information

What side effects are possible with Седалгин Плюс?

Possible side effects and safety information

The official safety profile for this medicine, which contains Metamizole Sodium, Caffeine, and Thiamine Hydrochloride, is primarily defined by the risks associated with the Metamizole component. These risks are documented in regulatory labeling by their system-organ class and frequency.


Documented Adverse Reactions and Safety Concerns

The most significant and serious concerns are classified as rare or very rare in regulatory sources and primarily involve three major system-organ classes:

  • Blood and Lymphatic System Disorders: The most serious, though rare, reaction is Agranulocytosis, a severe decrease in white blood cells. Regulatory documents state the risk of this condition is not related to the dose used and can occur at any time during or shortly after treatment.
  • Immune System Disorders and Skin: The potential for rare, severe hypersensitivity reactions, including Anaphylactic Shock, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), is officially documented.
  • Hepatobiliary Disorders: There is a potential for Drug-induced Liver Injury (DILI), with regulatory reviews noting onset observed from a few days to months following treatment initiation.

Safety Constraints and Special Populations

Official regulatory documents establish definitive constraints on the medicine's use. If a prior episode of confirmed agranulocytosis or unexplained DILI occurs, the medicine must not be reintroduced. Furthermore, specific safety caution is required, and repeated high doses should be avoided in older adults and in patients with impaired renal or hepatic function due to documented concerns regarding the delayed clearance of drug metabolites. This official safety framework focuses on managing these rare but serious outcomes.

Overdose and Emergency Response

Overdose and When to Seek Help

The following information details the officially documented signs and required emergency actions for an overdose involving the active components of Седалгин Плюс (Metamizole Sodium and Caffeine), as specified in regulatory and government-approved medical sources.

Documented Overdose Manifestations

Manifestations of overdose are linked to the toxicity of both components. Symptoms may include dizziness, nausea, vomiting, and epigastric pain. Serious CNS effects documented are seizures, convulsions, agitation, and confusion. Cardiovascular signs include tachycardia (rapid heartbeat) and severe hypotension (shock), as well as tachydysrhythmia (abnormal heart rhythm).

Severe outcomes documented in official sources include acute renal failure, hepatic injury, and the risk of cardiogenic shock.

Emergency Actions

Immediate medical attention is required upon any suspicion of overdose. Regulatory bodies mandate that individuals seek immediate medical attention or call emergency services/Poison Help hotline right away. Due to the potential for life-threatening outcomes such as shock, seizures, and acute organ damage, a severe overdose should not be managed outside of a clinical setting.

There is no specific antidote for this combination overdose. Management is supportive care and may involve procedures like activated charcoal (if within one hour of ingestion), orogastric lavage, or the use of specific agents (e.g., benzodiazepines) to manage symptoms, alongside continuous hospital monitoring.

Therapeutic Uses of Седалгин Плюс

What Седалгин Плюс Treats: Main Uses and Benefits

The primary therapeutic role of Седалгин Плюс is to provide symptomatic relief across several key domains where acute pain and related discomfort may pose a challenge to daily stability. Such formulations are frequently used to manage heightened symptoms of pain and fever.

The medication is commonly used across conditions presenting with acute episodes of pain, including headache (tension or migrainous features), toothache, discomfort from nerve pain (neuralgia, radiculitis), muscle and joint pain (myalgia, arthralgia), and symptomatic fever (pyrexia). This application contributes to easing the overall symptom load during periods of heightened symptoms, and may help patients cope more steadily with symptom fluctuations.


Quick Fact: Relief for Episodic Pain

The medication is particularly relevant for managing symptoms that interfere with daily comfort, focusing on acute and recurrent manifestations. This application contributes to improved day-to-day comfort during periods of heightened symptoms, which supports general well-being during symptomatic phases.

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

The eligibility profile for Седалгин Плюс is strictly defined by regulatory classifications that specify who is approved for use and who is formally excluded. All eligibility statements reflect information documented in government-approved prescribing labels.

Contraindicated Populations (Must Not Use)

Use is formally contraindicated for several groups:

  • Individuals with known hypersensitivity or allergy to Metamizole, other pyrazolone derivatives, or any component of the medication.
  • Patients with impaired haematopoiesis (e.g., bone marrow suppression) or a history of drug-induced agranulocytosis.
  • Women during the third trimester of pregnancy and those who are breastfeeding.
  • Infants below the age of three months or those under five kilograms body weight.
  • Patients diagnosed with acute hepatic porphyria.

Age and Organ Function Restrictions

The medication is generally not recommended for children under the age of 15 years for the fixed-dose tablet strength. Use is approved for adults and eligible adolescents in the absence of contraindications. Furthermore, use is restricted and requires special consideration in populations with pre-existing renal impairment (kidney function) or hepatic impairment (liver function), as documented in regulatory guidelines.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Sedalgin Plus contains metamizole sodium, caffeine, and thiamine hydrochloride (vitamin B1), making its interactions complex. It is crucial to inform your healthcare provider about all medications, supplements, and herbal products you are taking.


️ Significant Drug Interactions

  • Other Pain Relievers: Co-administration with other non-steroidal anti-inflammatory drugs (NSAIDs) or metamizole-containing products increases the risk of side effects, particularly gastrointestinal issues and effects on the blood (e.g., agranulocytosis). Concomitant use with methotrexate may increase the toxicity of methotrexate due to reduced elimination.
  • Blood Thinners (Anticoagulants): Metamizole may enhance the effect of coumarin anticoagulants, such as warfarin, by affecting liver enzymes. This can lead to an increased risk of bleeding and requires close monitoring of blood clotting parameters.
  • Antihypertensives: The therapeutic effect of certain blood pressure medications, like captopril and other ACE inhibitors, may be reduced when taken with metamizole.
  • Cyclosporine: Metamizole can cause a decrease in blood levels of cyclosporine, which is used to prevent organ transplant rejection. This may necessitate monitoring of cyclosporine concentration.

Other Interactions

  • Alcohol: Consumption of alcohol should be avoided as it can intensify the central nervous system effects of the medicine and increase the risk of adverse reactions.
  • Central Nervous System Stimulants: Due to the caffeine content, use with other central nervous system stimulants should be approached with caution to prevent excessive stimulation or adverse cardiovascular effects.

Mechanism of Action

Pharmacodynamic Mechanism

Седалгин Плюс functions through the combined action of its primary components, targeting central and peripheral pathways. The main analgesic component is primarily understood to modulate signaling within the central nervous system (CNS), specifically by influencing the production and release of prostaglandins via interaction with specific enzyme systems in the brain and spinal cord. This central action modulates the intensity of ascending nociceptive signal transmission and adjusts the hypothalamic thermal regulatory set point.

Simultaneously, the drug engages a separate mechanism to influence pathways associated with smooth muscle hyper-contractility. It acts directly on the smooth muscle cells by modulating the intracellular processes that govern contraction, resulting in reduced smooth muscle tension (spasmolysis).

Additionally, the stimulant component modifies the overall pharmacodynamic profile by targeting the adenosine signaling system in the CNS. By acting as an adenosine receptor antagonist, it alters neural signaling dynamics related to arousal and pain perception, resulting in altered signaling dynamics related to the primary analgesic mechanism.

Dosage and Administration Information

Administration Guidelines for Седалгин Плюс

This section outlines the instructions for the proper administration of Седалгин Плюс (a combination product typically containing Metamizole, Caffeine, and Thiamine), based on established guidelines for its active components.

Administration Protocol

Feature Guideline
Route of Administration Oral. The tablets must be swallowed whole with a sufficient amount of liquid.
Standard Adult Dose The typical single dose is one tablet. Adults (ge 15 years and > 53 kg) should generally not exceed a single dose equivalent to 1,000 mg of Metamizole.
Dosing Frequency The medicine can be taken up to 3-4 times per day. A minimum interval of 6 to 8 hours must be maintained between subsequent doses to avoid accumulation and exceeding the maximum daily limit.
Maximum Daily Dose The maximum daily intake for adults should not exceed the equivalent of 4,000 mg of Metamizole.
Timing Relative to Meals While not strictly mandated, it may be taken with or immediately after food to minimize potential gastric discomfort.

Usage Constraints

Administration follows these procedural rules:

  • Lowest Effective Dose: The lowest dose necessary to manage symptoms is used.
  • Pediatric Use: Dosing for children and adolescents under 15 years old is determined by body weight and requires professional guidance, as standard adult doses do not apply.
  • Duration Limit: Self-treatment is limited to 5 days for pain and 3 days for fever. If symptoms persist beyond these limits, a physician must be consulted.

Summary of Use

The administration protocol describes the use of Седалгин Плюс as an as-needed oral therapy, defined by limits on the maximum single and total daily dosage. This protocol dictates precise time intervals between doses and specifies dose adjustments based on age and body weight, ensuring standardized use.

Recent Clinical Evidence

Research evidence / Overview of Studies for Седалгин Плюс

The research available for the combination product Седалгин Плюс (Metamizole, Caffeine, Thiamine) primarily relies on clinical trials and systematic reviews focused on its main component, Metamizole, and its dual combination with Caffeine. This overview summarizes how the medicine was evaluated in a research setting, what findings were observed, and where data remain insufficient or limited, particularly concerning the full triple combination.


Evidence for Acute Episodic Pain (Headache, Toothache, and Muscle Discomfort)

The use of Metamizole for pain management has been investigated through Randomized Controlled Trials (RCTs) and Systematic Reviews. Studies explored outcomes related to physical discomfort by measuring pain metrics usually within a few hours of administration. Findings describe patterns observed in the studies related to short-term differences in pain metrics in adults experiencing acute, moderate-to-severe pain, such as headache. Research consistency for Metamizole alone has been explored in studies referenced by regulatory bodies. However, comparative evidence is lacking regarding the precise contribution of the specific triple combination compared to the individual components.


Evidence for Symptomatic Fever

Research has explored the antipyretic (fever-related) properties of the primary active component, Metamizole, in studies examining temporary physiological imbalance. These trials were conducted during periods of increased symptom activity. Studies monitored outcomes related to systemic or functional imbalance by measuring changes in elevated body temperature from the baseline. Studies report how fever symptoms evolved in the observed populations, including both adults and pediatric groups, indicating patterns related to temperature decline. However, the existing research primarily describes Metamizole’s action as a monotherapy.


Evidence Gaps and Areas of Uncertainty

The rationale for the combination was examined in research exploring short-term outcomes observed when Metamizole was combined with other substances. However, evidence is limited for the precise interaction and combined outcome of the exact triple combination itself, as many findings were based on individual component studies or dual combinations. Research focusing on long-term use is generally limited, and the durability of any observed pattern beyond the initial study window is not fully established. Subgroup findings in special populations, such as pediatric or older adult populations, are uncertain, and data for certain comorbidity-defined groups remain insufficient.

Key Studies & References

  1. Analgesic Efficacy of Paracetamol in Combination with Metamizole and Caffeine for Acute Migraine Treatment

Frequently Asked Questions (FAQ)

Common questions about Седалгин Плюс (FAQ)


Q: How quickly does Седалгин Плюс usually start working?

Studies and official information indicate that the pain-relieving effect begins relatively quickly. Official documents describe the onset of the effect for the primary active component starting within approximately 30 minutes following oral administration.


Q: How long do the effects of Седалгин Плюс typically last?

Regulatory documents indicate that the duration of the analgesic effect from the active component persists for approximately 4 hours. This duration is the basis for the minimum interval specified in the official administration guidelines.


Q: Does taking Седалгин Плюс affect blood pressure?

Official safety information notes a potential for a temporary drop in blood pressure, known as hypotension, as an adverse event. This effect is particularly associated with the intravenous administration of the primary ingredient.


Q: Why are there warnings about consuming alcohol while taking Седалгин Плюс?

Official guidelines describe that alcohol consumption is to be avoided. This is based on the potential for alcohol to intensify the drug's effects on the central nervous system (CNS) and increase the overall risk of experiencing adverse reactions.


Q: Can people with liver issues use Седалгин Плюс?

Regulatory documentation specifies that use requires special consideration and caution for individuals with pre-existing impaired hepatic (liver) function. Furthermore, regulatory constraints state the drug is not to be reintroduced following a confirmed drug-induced liver injury (DILI).


Q: Can I use Седалгин Плюс if I have kidney problems?

Official guidelines state that use requires special caution for individuals with pre-existing impaired renal (kidney) function. This caution relates to the clearance of the drug’s metabolites (breakdown products) from the body.


Q: Are there specific laboratory tests that might be affected by Седалгин Плюс?

Regulatory documents mention that the primary active component may interfere with the results of certain laboratory tests that rely on colorimetric methods, such as those used to measure creatinine or uric acid levels.


Q: Is it safe to use Седалгин Плюс if I am taking blood thinning medication?

Regulatory documents include a warning that the primary component may increase the effect of certain blood-thinning medications (anticoagulants). This enhancement carries a documented risk of bleeding, and the medicine is generally described as necessitating close monitoring of blood clotting parameters by a healthcare professional.


Q: Is Седалгин Плюс considered a strong pain reliever?

The World Health Organization (WHO) and regulatory literature describe the primary component, Metamizole, as exhibiting potent analgesic efficacy (strong pain-relieving action). It is classified within the group of non-opioid pain relievers.


Q: Can Седалгин Плюс cause drowsiness or affect concentration?

The official safety profile includes possible side effects related to the nervous system. These documented effects include fatigue, headache, and problems with concentration or drowsiness.


Q: Are there common signs of an allergic reaction to Седалгин Плюс?

Official safety information documents the recommendation that patients contact a doctor immediately if certain severe signs develop. These signs, which may indicate a rare but serious blood disorder, include feeling generally unwell, having a persistent fever, or developing signs of infection or a sore throat.


Q: Is it possible for Седалгин Плюс to cause stomach upset?

The official safety profile lists disorders of the digestive system among the possible adverse reactions. These documented issues include nausea, vomiting, and feelings of discomfort or pain in the stomach area.


Q: Does Седалгин Плюс interact with common cold or flu medicines?

Regulatory documents specifically warn against the co-administration of this medicine with other products containing the same analgesic components or non-steroidal anti-inflammatory drugs (NSAIDs). This is due to an increased risk of combined side effects.


Q: Can certain foods or drinks affect how Седалгин Плюс works?

The official interaction profile is highly specific about avoiding alcohol consumption. While the medicine may be taken with or immediately after food, no specific food-drug interactions that affect the core function are documented in the general regulatory information.


Q: Is there any risk of dependency associated with Седалгин Плюс?

The official classification defines this product as a non-opioid analgesic. This classification is based on the fact that it is a non-opioid drug, meaning it is not associated with the same risks of dependency as opioid-based pain medications.


Q: What age group is Седалгин Плюс intended for, according to official information?

Regulatory guidelines state that the fixed-dose tablet strength is approved for use by adults and eligible adolescents. The medicine is generally not recommended for children under the age of 15.


Q: Is it true that Седалгин Плюс includes a mild stimulant?

Yes, the product contains Caffeine, which is documented in regulatory sources as a central nervous system stimulant. This component is included to enhance the overall pain-relieving effect and provide mild CNS support.


Q: Can Седалгин Плюс be taken at night?

Due to the inclusion of Caffeine, official information notes that the stimulant component has the potential to interfere with normal sleep patterns if the medicine is used close to bedtime.


Q: Is there an official list of substances that should not be taken with Седалгин Плюс?

Official documents detail specific substances and drug classes that have documented interactions, such as blood thinners, immunosuppressants, and other pain relievers. This information is typically grouped by drug class rather than presented as a single, comprehensive 'official list'.


Q: Is Седалгин Плюс widely available internationally?

The active component, Metamizole, is authorized for use in numerous countries across Europe, Latin America, and parts of Asia. However, its specific authorized use, branding, and availability vary significantly by individual nation.


Q: Are there documented cases of interactions between Седалгин Плюс and herbal supplements?

Regulatory guidance specifies that patients should inform their healthcare providers about all herbal products or supplements being used. This is because these substances can potentially affect the body’s clearance and potency of the medicine.


Q: Is it common to feel jittery after taking Седалгин Плюс?

Due to the inclusion of Caffeine, a central nervous system stimulant, the official safety profile notes the potential for side effects such as restlessness or agitation.


Q: Why is the drug not recommended for children under a certain age?

The restriction for children and adolescents under 15 years of age is primarily based on the difficulty of determining a safe, standardized weight-based dose for the fixed-dose tablet form. Use in younger populations requires specific professional guidance.


Q: What are the different strengths or formats of Седалгин Плюс available?

While this specific product is a tablet, the primary active component (Metamizole) is available in different formats. These include various oral forms such as tablets and syrups, in addition to injectable formulations used in specialized hospital settings.


Q: Is it normal to feel a change in appetite while using Седалгин Плюс?

Loss of appetite (anorexia) is listed in the official safety information as a potential sign associated with rare but serious adverse effects, such as drug-induced liver injury (DILI). This symptom is not generally described as a frequent occurrence in the safety profile.


Q: Is Седалгин Плюс suitable for managing chronic pain?

Regulatory guidelines restrict the duration of self-treatment for pain to a maximum of 5 days. The medicine is intended for the symptomatic relief of acute, sudden onset discomfort, and official guidelines mandate consultation with a physician if symptoms persist beyond the prescribed limit.


Q: Is there information on how Седалгин Плюс is cleared from the body?

Regulatory literature confirms that the primary component is rapidly metabolized into its active form, mainly in the liver. Its metabolites are then cleared from the body, predominantly through the kidneys.


Q: Is it common to experience temporary side effects with this medicine?

While the official safety profile focuses on rare and severe risks, other documented adverse effects that are generally considered milder and temporary include nausea, vomiting, and abdominal discomfort.


Q: Can Седалгин Плюс be used for period pain?

The medicine is officially classified as a general-purpose analgesic and antipyretic. Its stated use is for the symptomatic relief of discomfort, which includes various types of pain.


Q: What warnings are listed regarding driving or operating machinery while using Седалгин Плюс?

Due to the documented potential for side effects such as drowsiness, fatigue, and problems with concentration, official product labeling typically includes a warning advising caution when operating heavy machinery or driving.


How should Седалгин Плюс be stored and disposed of?

Official Storage and Disposal Requirements

Седалгин Плюс tablets must be stored according to strict regulatory conditions to ensure the stability of the active ingredients. The product must be stored below 25°C (77°F) and must not be frozen. To maintain its integrity, the medicine must be kept in its original container or carton, which should be tightly closed to protect it from both light and moisture. All medicine must be kept out of the sight and reach of children.

Disposal instructions mandate that unused or expired Седалгин Плюс must not be thrown away with household waste or disposed of via wastewater. Patients are required to consult a pharmacist to determine the proper method for discarding unused medicinal products, ensuring compliance with local environmental and pharmaceutical waste regulations.

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

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