Berlosin

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Berlosin

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 Berlosin

Property Description
Active ingredient Sodium Metamizole (Dipyrone)
Form Tablet, Oral liquid (Drops), Suppository, Solution for injection
Pharmacological class Non-opioid Analgesic, Antipyretic, Spasmolytic
Common purpose Relief of pain, fever, and muscle spasms
Origin Synthetic organic compound

What Type of Medication is Berlosin?

Berlosin is a medicinal product whose active substance is the powerful non-opioid analgesic and antipyretic compound, Sodium Metamizole, also known internationally as Dipyrone. Metamizole is a synthetic organic compound categorized as a pyrazolone derivative. The triple pharmacological profile—analgesic, antipyretic, and spasmolytic—characterizes this compound. This profile shows that Metamizole is recognized not only for pain and fever relief, but also for its ability to relax painful involuntary muscle contractions.


What is Sodium Metamizole Used For?

The primary purpose of Sodium Metamizole is to provide effective relief from acute, elevated body temperature and pain, offering a distinct alternative to conventional painkillers. The use of Sodium Metamizole for potent pain relief occurs in numerous countries for conditions that include severe headache or renal colic, which is a typical use scenario. A key feature of Metamizole is its spasmolytic effect, which acts directly on the smooth muscles of internal organs to relieve painful involuntary contractions. The medicine’s core function is to address moderate to severe discomfort and high fevers that may be poorly responsive to more common over-the-counter options.


Available Forms and Composition

Berlosin, containing Sodium Metamizole Monohydrate, is available in multiple high-level dosage forms, including the oral, rectal, and parenteral routes of administration, often positioned for use in both adults and children over 10 years of age. The medication is commercially prepared as an oral tablet, an oral liquid (drops) for easier adjustment of intake, suppositories, and a sterile solution for injection (intramuscular or intravenous use). The composition is defined by the active ingredient, Sodium Metamizole, combined with basic, inert vehicles or solid excipients appropriate for the specific form, ensuring proper physical presentation. This diverse range of preparations offers flexibility, which is a defining feature of Metamizole-based medicines like Berlosin.

What side effects are possible with Berlosin?

Possible Side Effects and Safety Information

The official safety profile of Berlosin, which contains Sodium Metamizole, is primarily characterized by the risk of certain serious, though very rare, adverse reactions that are documented in regulatory labeling across various international health authorities.


Adverse Reaction Classification

Classification Examples of Officially Listed Adverse Reactions
Very Rare Agranulocytosis, Aplastic Anaemia, Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), Acute renal failure.
Rare Leukopenia, Maculopapular exanthema, Anaphylactic/Anaphylactoid reactions.
Uncommon Hypersensitivity reactions (skin rash), Hypotension (particularly following injection).

The most clinically significant safety concerns are related to blood and lymphatic system disorders, specifically the risk of agranulocytosis, a severe reduction in white blood cells, and aplastic anaemia. Regulatory documents specify that the risk of agranulocytosis is not dose-dependent and can occur at any time during treatment or shortly after stopping the medicine.


Regulatory Safety Notes

Official labeling includes specific restrictions for certain patient populations. The use of Berlosin is generally contraindicated during the last trimester of pregnancy due to documented risks to the fetus and is restricted in patients with severe pre-existing renal or hepatic impairment. A non-serious, expected effect noted in official documents is the reddish discoloration of the urine, caused by a harmless metabolite, which is not indicative of blood or kidney damage. The regulatory framework emphasizes that the serious risks, though infrequent, define the safety structure of the medicine.

Overdose and Emergency Response

Overdose and When to Seek Help

The official overdose profile for Sodium Metamizole (Berlosin) is structured around the immediate identification of severe manifestations and the subsequent mandated emergency actions as described in regulatory documentation.

Overdose may present with serious manifestations involving the cardiovascular system (e.g., severe hypotension and shock) and the central nervous system (e.g., convulsions and coma). Less severe initial manifestations may include nausea, vomiting, and abdominal pain. Life-threatening outcomes documented in regulatory sources include circulatory collapse and respiratory paralysis.

Required Emergency Actions

If overdose is suspected or if symptoms indicative of severe adverse reactions occur, such as signs of blood dyscrasia (fever, sore throat, painful mucosal changes), the patient must discontinue treatment immediately and seek urgent medical assistance.

Management and Monitoring

No specific antidote is known for Metamizole overdose. Management is based on symptomatic and supportive treatment. Procedural steps documented in official labeling may include gastrointestinal decontamination (e.g., stomach lavage) and forced diuresis to enhance metabolite clearance. Continuous monitoring of vital signs, including blood pressure, is required during the risk period.

Population Considerations

Regulatory documentation notes that the elimination rate is reduced in patients with renal or hepatic impairment, making these groups susceptible to drug accumulation. Therefore, multiple high doses must be avoided to mitigate the risk of toxicity.

Therapeutic Uses of Berlosin

What Berlosin Treats: Main Uses and Benefits

Berlosin is commonly used to help with symptoms related to physical discomfort and systemic imbalance when other supportive measures are considered insufficient. The medication is applied across domains where additional symptomatic support is needed.

This medication is considered relevant for easing moderate to severe pain, which includes discomfort following surgery, traumatic injury, and chronic conditions like neoplastic pain. It is also utilized for symptoms linked to muscle spasms, particularly in conditions involving episodic or fluctuating manifestations such as renal or biliary colic, and for supporting symptomatic relief of high, persistent fever.

“Applied in scenarios where symptoms create noticeable functional strain, it provides supportive relief when symptoms interfere with routine activities.”

By addressing these clusters, Berlosin supports the patient during difficult episodes by easing distress and assists with maintaining functional stability.


Supports Management of Pain Linked to Spasms

Eligibility and Restrictions for Use

Eligibility Profile for Berlosin (Sodium Metamizole)

Official regulatory documents define strict population eligibility criteria for the use of Berlosin, based on age, specific medical history, and physiological status. The medicine is primarily approved for use in adults and adolescents from 15 years of age and in children from 3 months of age (minimum 5 kg body weight).


Absolute Contraindications

Use is prohibited for patients with:

  • Known hypersensitivity to Metamizole or other pyrazolone derivatives.
  • A history of agranulocytosis (a severe blood disorder) or impaired bone marrow function.
  • Specific metabolic disorders, including acute intermittent hepatic porphyria and G6PD deficiency.
  • Analgesic-induced asthma syndrome or severe analgesic intolerance.
  • Use during the last three months (third trimester) of pregnancy is strictly contraindicated.

Conditional Use and Restrictions

Population Regulatory Status
Pregnancy (First 6 Months) Not recommended (Use restricted)
Lactation (Breastfeeding) Not recommended
Severe Organ Dysfunction Contraindicated (Hepatic or Renal)
Circulatory Instability Restricted use (Requires monitoring)

Infants under 3 months (or under 5 kg) are contraindicated from using the medicine. Patients with existing hepatic or renal impairment must avoid multiple high doses.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Berlosin, containing Sodium Metamizole, is primarily defined by its effects on drug metabolism and specific pharmacodynamic actions, as outlined in regulatory documents.

Berlosin is officially classified as an inducer of specific Cytochrome P450 (CYP) enzymes, notably CYP2B6 and CYP3A4. This pharmacokinetic interaction results in a significant reduction in the plasma concentration and potentially decreased efficacy of numerous co-administered medications that are substrates for these enzymes. This list includes immunosuppressants such as Ciclosporin and Tacrolimus, as well as other drugs like Bupropion, Methadone, and Midazolam.

Pharmacodynamic and Timing Constraints

Metamizole exhibits a pharmacodynamic interaction with low-dose Acetylsalicylic acid (ASA), which may inhibit the antiplatelet effect of ASA. To address this, regulatory information specifies a mandatory timing requirement: ASA must be administered at least 30 minutes before Metamizole to minimize competitive inhibition.

Regulatory restrictions also advise against the co-administration of Metamizole with other NSAIDs and COX-2 inhibitors due to a documented additive risk of severe toxic effects, including acute renal and hepatic injury. Furthermore, co-administration with Methotrexate is restricted, especially at high doses, due to an increased risk of blood toxicity.

Mechanism of Action

Central Suppression of Prostaglandin Synthesis and Signaling

The action of Berlosin is driven by its active metabolites, which primarily target the central nervous system ( CNS). The metabolites inhibit the COX-3 enzyme and modulate key neuronal receptors ( CB1 and K ATP channels). This collectively limits the synthesis of pyrogenic and algesic chemical messengers ( PGE2) and limits the transmission of excessive nerve signals in the CNS. This cascade results in the systemic effect of altered nociception (pain transmission) and the resetting of the hypothalamic temperature set point.

Modulation of Smooth Muscle Tone

This domain describes the drug's effect on involuntary muscles in organs like the gastrointestinal tract. The metabolites interfere with the release of calcium ions ( Ca^2+) inside muscle cells, which are essential for muscle contraction. This action promotes the relaxation of smooth muscle fibers and decreases the incidence or magnitude of spasmodic contractions.

Multi-Target Cascade and Metabolic Dependence

Its activity is dependent on the body's metabolic conversion to form the active metabolites ( MAA and AA), which initiate this multi-target signaling cascade involving both COX inhibition and direct receptor modulation.

Dosage and Administration Information

Official Instructions for Use

Berlosin (metamizole) is an orally administered medication that must be used strictly according to the prescribed dosing regimen to maintain safety and effectiveness.

Dosage and Frequency

Patient Group Single Dose Limit Maximum Daily Dose Dosing Interval
Adults and Adolescents (≥ 15 years, > 53 kg) 1,000 mg 4,000 mg 6 to 8 hours (up to 4 times daily)
Children and Adolescents (< 15 years) 8–16 mg per kg body weight Dose limit based on weight/age 6 to 8 hours (up to 4 times daily)

Core Administration Rules

  1. Lowest Effective Dose: Treatment must be initiated with the lowest dose that achieves the intended effect. The dose should only be increased if necessary and if it remains within the prescribed limits.
  2. Administration Timing: The medicine can be taken with or without food.
  3. Weight-Based Calculation: For all patients under 15 years of age, the single dose must be calculated based on their body weight (milligrams per kilogram) to ensure accurate administration.
  4. Missed Dose: If an administration is missed, do not take a double dose to compensate. The patient should take the next scheduled dose at the regular time and not deviate from the mandatory time interval.

Procedural Summary

The structured use of Berlosin requires the determination of the lowest effective dose, followed by a check on the patient's age and weight for dose calculation. The single dose must not exceed 1,000 mg, and the total dose in a 24-hour period must not exceed 4,000 mg (for patients ≥ 15 years) and must always observe a minimum interval of 6 hours between administrations.

Recent Clinical Evidence

Berlosin, which contains the active substance metamizole, is a potent painkiller (analgesic) and fever reducer (antipyretic) belonging to the pyrazolone class of medicines. In certain countries, it is indicated for the treatment of severe acute pain following injury or surgery, colic, tumor pain, other acute or chronic severe pain when other treatments are not suitable, and high fever unresponsive to other measures.

Efficacy and Tolerability

Recent clinical data, including a 2015 meta-analysis, support metamizole's effectiveness and favorable tolerability profile, particularly for short-term hospital use, compared to some other widely used analgesics. Unlike many non-steroidal anti-inflammatory drugs (NSAIDs), metamizole appears to have a lower risk of causing gastrointestinal or cardiovascular toxicity. It also possesses spasmolytic (anti-spasm) properties, contributing to its use in treating painful colics.

Safety Profile and Regulatory Updates

Clinical and post-marketing surveillance data continue to focus on the known, albeit rare, risk of agranulocytosis—a sharp, sudden decrease in white blood cells which can lead to life-threatening infections. Regulatory bodies, such as the European Medicines Agency (EMA), have reviewed the safety data and concluded that the benefits of metamizole generally outweigh its risks when used according to approved indications.

To minimize the risk of serious outcomes from agranulocytosis, regulatory measures have recently emphasized the following patient safety warnings:

  • Immediate Discontinuation: Patients must stop taking Berlosin and seek urgent medical attention if symptoms like fever, chills, sore throat, or painful mucosal sores (mouth, nose, throat, or genital/anal areas) occur, as these can be signs of agranulocytosis.
  • Contraindications: Use is strictly contraindicated in patients with a history of metamizole- or pyrazolone-induced agranulocytosis, impaired bone marrow function, or in the last trimester of pregnancy due to potential fetal risks.

Frequently Asked Questions (FAQ)

Common questions about Berlosin (FAQ)

Q: Is Berlosin the same type of drug as other common treatments for the condition?

A: Official information describes the active ingredient, Metamizole, as belonging to the pyrazolone class of medicines. It is categorized as a non-opioid pain reliever and fever reducer. Unlike common NSAIDs, Metamizole works mainly on the central nervous system to relieve pain and is noted for its minimal anti-inflammatory effects.

Q: Is Berlosin considered a long-term treatment or a short-term course?

A: Regulatory documents generally recommend that this medicine be used for the shortest duration necessary, usually for short-term treatments. For use beyond approximately seven days, official guidance suggests that close monitoring, particularly blood monitoring (hematological), is prudent for mitigating potential adverse effects.

Q: Why is Berlosin only available by prescription?

A: The drug’s status as prescription-only is a regulatory requirement established to support patient safety and medical supervision. This is due to the known, though rare, potential for severe adverse reactions, such as agranulocytosis (a serious blood disorder). Medical supervision is required for the early detection and management of any such risks.

Q: Can Berlosin be safely stopped abruptly, or should use be tapered?

A: Official guidance on this medicine focuses on prompt action if signs of a serious problem occur. Regulatory information indicates that the medicine should be stopped immediately if symptoms like fever or a sore throat occur, as these may signal a severe blood disorder. There is no general information in regulatory documents recommending a tapering schedule upon cessation.

Q: What are the most commonly reported side effects of Berlosin?

A: Official sources classify potential adverse effects based on how frequently they are reported, such as Common, Uncommon, or Rare. Official adverse event information, which varies by specific product label, notes that effects such as dizziness, nausea, vomiting, or headache may be reported.

Q: Does Berlosin typically cause drowsiness or affect alertness?

A: Some medical summaries list somnolence, which is the medical term for drowsiness, as a possible adverse event. This means that taking the medicine may potentially affect a person's alertness.

Q: Does taking Berlosin affect the quality of sleep?

A: Since official safety information includes somnolence (drowsiness) as a reported adverse event, this is related to a person’s level of alertness and, therefore, may influence the sleep-wake cycle.

Q: Is stomach upset a common experience for users starting Berlosin?

A: Medical summaries indicate that common adverse effects can include nausea and upset stomach. Official information notes the drug’s profile regarding gastrointestinal tolerability.

Q: Do older individuals experience side effects from Berlosin differently?

A: Regulatory warnings highlight that older individuals have an increased risk of experiencing certain adverse effects. This includes a focus on the potential for kidney (renal toxicity).

Q: Can Berlosin be taken alongside commonly used vitamins or herbal supplements?

A: The active ingredients are known to interact with certain liver enzymes, called CYP enzymes, that process many other substances, including various vitamins and herbal supplements. For any combination not specifically studied, official warnings draw attention to the potential for enzyme induction to change how fast other substances are processed.

Q: Are there any known interactions between Berlosin and medications for blood pressure?

A: Official interaction summaries indicate that the active ingredient may reduce the blood-pressure-lowering effects of certain medications used to treat high blood pressure. Co-administration may require medical attention or monitoring.

Q: Is there official guidance on specific foods or beverages to avoid while on Berlosin?

A: Official product information includes a warning that patients who exhibit an intolerance to alcohol are associated with a potential for severe hypersensitivity reactions when using the drug. This is related to a potential underlying condition called analgesic-induced asthma syndrome.

Q: Does Berlosin have any documented interaction with oral contraceptives?

A: The active metabolite is known to induce an enzyme ( CYP3A4) that helps break down many oral contraceptives. Because induction increases how quickly the body processes these substances, there is a theoretical potential for the effectiveness of hormonal contraceptives to be reduced.

Q: What types of over-the-counter cold remedies are officially listed as potential interactions?

A: Official safety information draws attention to co-administration with other NSAIDs (non-steroidal anti-inflammatory drugs) or COX-2 inhibitors. This is due to a documented increased risk of toxicity. Many common over-the-counter cold remedies contain ingredients belonging to these classes.

Q: Are there any known interactions between Berlosin and alcohol consumption?

A: Official drug information notes that patients who exhibit an intolerance to alcohol, sometimes signaled by a severe facial flush after small amounts, are associated with a potential for a severe hypersensitivity condition. This potential for severe reaction is what is highlighted in the safety documents regarding alcohol.

Q: How quickly should a person expect Berlosin to start providing an effect?

A: According to official product information on pharmacokinetics, a clear effect is generally expected to begin approximately 30 to 60 minutes after the oral form of the medicine is taken.

Q: Is Berlosin generally intended for continuous use, or is a break recommended?

A: Regulatory guidance recommends that the medicine be used for the shortest possible duration. Unsupervised use is often limited to a maximum of seven days, as continuous use requires careful medical and laboratory monitoring.

Q: What is the maximum duration of use that Berlosin has been studied for in clinical trials?

A: While an absolute maximum duration studied is not quantified in the official regulatory documents, clinical practice often limits unsupervised use to about seven days. This duration reflects the typical length of use in short-term studies for acute conditions.

Q: When is the full benefit of Berlosin typically expected to be noticed?

A: Official product information indicates that the onset of a clear, noticeable effect generally occurs within 30 to 60 minutes after the oral administration of the medicine.

Q: Are there special warnings or dosage considerations for the elderly using Berlosin?

A: Official guidance indicates that lower doses are generally applied for the elderly due to this population's potential for increased risk of adverse effects, particularly related to kidney function. The lowest effective dose should be used for the shortest time possible.

Q: Is Berlosin considered safe for people who also have high blood pressure?

A: Official information notes that co-administration may require medical attention or monitoring due to the potential reduction in the blood-pressure-lowering activity of the co-administered medicine.

Q: Where can I find the most current official prescribing information or patient leaflet for Berlosin?

A: The most current official prescribing information, often called the Summary of Product Characteristics or patient leaflet, is published by the national regulatory agency. These documents can be found on the websites of the relevant government health or medicines authorities in the country where the drug is sold.

Q: What is the difference between the generic and the brand name forms of Berlosin?

A: The key difference is the name and manufacturer, but the medicine itself is the same. The active ingredient in the brand-name product is the generic substance Sodium Metamizole, meaning both forms contain the identical medicinal compound.

Q: How long has Berlosin been commercially available since its initial approval?

A: The active ingredient, Metamizole, has a long history of use, having been commercially available for approximately a century. However, official information notes that its regulatory status and availability have varied significantly across countries over that time.

How should Berlosin be stored and disposed of?

Official Storage and Disposal Requirements for Berlosin

Official regulatory information dictates specific conditions for storing and disposing of Berlosin to ensure product integrity and safety.

Storage Component Requirement
Temperature Store at controlled room temperature, typically between 20 C and 25 C (68 F and 77 F). Do not freeze.
Protection Keep the medicine in its original container and protect it from both light and moisture.
Handling Keep the product out of the sight and reach of children. Do not refrigerate unless the label specifically directs refrigeration.
Stability Adhere strictly to the expiration date. If the product is opened or reconstituted, follow the specific, shorter 'in-use' stability period documented on the label.
Disposal Do not dispose of unused or expired Berlosin by flushing it down a toilet or throwing it in household trash. Return the medicine to a pharmacy or an authorized drug take-back collection point.

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

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