Algifen Neo

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Algifen Neo

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Medically reviewed

Marina Burgos

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 Algifen Neo

Quick Facts

Property Description
Active ingredient Metamizole sodium, Pitofenone hydrochloride
Form Solution for injection (ampoules), Tablets
Pharmacological class Combined analgesic-antispasmodic (Pyrazolone derivative + Musculotropic spasmolytic)
General purpose Relief of pain associated with smooth muscle spasm (visceral pain)
Origin Synthetic substance

What is the Core Identity of Algifen Neo?

Algifen Neo is a synthetic, combined preparation classified as a Fixed-Dose Combination (FDC) medicinal product, strategically formulated to address pain accompanied by spasm. The preparation is composed of two principal synthetic substance ingredients: the non-opioid analgesic Metamizole sodium (also widely recognized as Dipyrone) and the musculotropic spasmolytic Pitofenone hydrochloride. This specific pairing, featuring the potent analgesic properties of the pyrazolone derivative Metamizole with the smooth muscle relaxing effects of Pitofenone, is clinically recognized for its synergistic action in treating conditions where pain and spasm are intertwined. This FDC format ensures that both essential therapeutic components are delivered concurrently.

What Pharmacological Class Does Algifen Neo Belong To?

Algifen Neo belongs to the pharmacological class of combined analgesic-antispasmodic agents, integrating a pyrazolone derivative with a musculotropic spasmolytic. This classification arises from the established roles of its active ingredient(s); Metamizole sodium is utilized for its strong analgesic effect and is characterized as a pyrazolone derivative. The inclusion of Pitofenone hydrochloride ensures direct action against spasm, a property differentiating the combination from simple, single-ingredient pain relievers. This combined pharmacological approach is implemented to achieve the general therapeutic purpose of providing relief for moderate to severe pain, such as the cramping discomfort seen in various forms of colic, a typical use scenario where both pain and spasm must be managed.

What Dosage Forms and Administration Types Are Associated with Algifen Neo?

Algifen Neo is typically available as a solution for injection and as tablets, providing the option for both parenteral and oral administration routes. The liquid formulation, contained in ampoules, is prepared for parenteral administration (e.g., intramuscular or intravenous use), which is essential when a rapid onset of the combined analgesic and spasmolytic action is necessary. The availability of tablets allows for routine oral administration. The inclusion of the injectable form represents a key differentiating factor, supporting its positioning for acute, intense episodes that require quicker intervention than standard oral medications.

What side effects are possible with Algifen Neo?

Possible Side Effects and Safety Information

This section outlines the adverse reactions and safety characteristics of the medicine, which is a fixed-dose combination dominated by the well-documented safety profile of Metamizole sodium, as classified in official regulatory documents.

Adverse Reaction Scope Official Regulatory Statement
Key Adverse Reactions The most significant regulatory concern involves Hematological Disorders and Hypersensitivity Reactions.
Frequency Classification Agranulocytosis and severe anaphylactic reactions are officially classified as Rare or Very Rare events.
Serious Adverse Reactions Listed serious reactions include Agranulocytosis (a severe blood disorder), Aplastic Anemia, Anaphylactic Shock, and severe cutaneous reactions such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
System-Organ Classes Effects are listed across the Blood and Lymphatic System, Immune System, Skin and Subcutaneous Tissue, and Vascular systems. Common, non-serious effects may include mild Gastrointestinal complaints.
Dose- or Time-Related Patterns Agranulocytosis can occur at any time during treatment or shortly after cessation and is not related to the dose. Severe hypotensive reactions are more likely following too rapid intravenous injection.

Population-Specific Safety Considerations

The official label includes specific constraints for certain patient groups:

  • Organ Impairment: Caution is noted for elderly patients and those with reduced renal or hepatic function; long-term, high-dose use must be avoided due to the risk of prolonged elimination of the drug's metabolic products.
  • Pregnancy and Lactation: The use is officially contraindicated during the third trimester of pregnancy due to the potential for adverse effects on the fetus. Use during lactation is also advised against as drug metabolites are excreted in breast milk.
  • Pre-Existing Conditions: The medicine is formally contraindicated in patients with a history of metamizole-induced agranulocytosis or pre-existing bone marrow or hematopoietic system problems.

These restrictions and classifications reflect how government regulatory documents organize and communicate the medicine’s risk profile.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

The officially documented presentations of overdose for this combined preparation relate primarily to the effects of Metamizole sodium on major body systems. Severe overdose is classified as a potentially life-threatening situation by regulatory authorities.

Overdose Scope Documented Regulatory Data
Documented overdose presentations Symptoms may include nausea, vomiting, abdominal pain, vertigo, and central nervous system effects such as somnolence, convulsions, or coma. The Pitofenone component may contribute anticholinergic effects like tachycardia and visual disturbances.
Physiological systems affected Cardiovascular system (e.g., severe hypotension and shock); Central Nervous System (e.g., coma and convulsions); and Renal system (e.g., acute renal failure due to impaired renal function).
Emergency-response statements Seek immediate medical attention. Urgent medical assistance is mandatory for severe symptoms, including signs of severe hypotension, loss of consciousness, or convulsions. Treatment is symptomatic and supportive. No specific antidote is known.

Official overdose management procedures listed in regulatory documents may include reducing absorption via gastric lavage or activated charcoal if administered shortly after ingestion. Measures to accelerate elimination, such as forced diuresis or haemodialysis, are cited for the Metamizole component. Close hospital monitoring of vital functions and renal status is required.

Therapeutic Uses of Algifen Neo

What Algifen Neo Treats: Main Uses and Benefits

The medication is applied to address symptoms of pain and muscle cramping. It is commonly used when short-term symptomatic assistance is needed for acute discomfort. The therapeutic domain includes the symptomatic management of conditions involving painful spasms and moderate to severe pain. The medication (containing Metamizole) is relevant in contexts involving heightened systemic burden requiring symptomatic relief.

Targeted Relief for Intense Pain and Cramping

This medication is generally used to provide symptomatic relief for acute, intense pain, particularly when discomfort is related to muscle tension or cramping. It is applied across domains where additional symptomatic support is needed to address pronounced pain manifestations.

Common Scenarios: The medication is relevant for easing symptomatic phases such as intense headaches, discomfort following minor procedures, and spasms related to organ-specific functional stress.

“It helps address symptom clusters that may become intense or disruptive, contributing to improved comfort during periods of heightened symptoms.”

Easing Spasm-Related Discomfort (Colic)

The medicine is commonly used to help with symptoms linked to organ-specific functional stress, such as sharp, fluctuating pain and spasms. It can contribute to easing the overall symptom load and may assist with maintaining functional stability. This makes it applicable in scenarios where the symptomatic burden is significant, such as painful episodes of colic or intense menstrual pain.

Quick Fact: Relief for Acute Discomfort
The medication provides supportive relief when symptoms interfere with routine activities, and may help patients cope more steadily with symptom fluctuations.

Regulatory References

  1. European Medicines Agency Metamizole Review

Eligibility and Restrictions for Use

The eligibility for using Algifen Neo (Metamizole/Pitofenone FDC) is strictly defined by regulatory contraindications and restrictions, primarily based on the Metamizole component.


Populations for Whom Use is Contraindicated

Use is absolutely prohibited for individuals with a previous episode of agranulocytosis induced by Metamizole or related drugs, and in those with impaired bone marrow function or diseases of the haematopoietic system. Use is also prohibited in patients with acute hepatic porphyria or known hypersensitivity to the medicine.

Age and Physiological Restrictions

The medicine is generally approved for adults and adolescents 15 years of age or older. It is contraindicated in women during the third trimester of pregnancy due to risks of fetal renal impairment. It is also not recommended during the first and second trimesters, or while breastfeeding. Certain formulations are contraindicated for infants below the age of 3 months or those under 5 kg body weight.

Conditional Use and Comorbidities

Use is generally advised against or requires caution in the elderly population and in patients with renal (kidney) or hepatic (liver) impairment.

What should I know about interactions with other medicines?

Algifen Neo contains metamizole, pitofenone, and fenpiverinium bromide. Interactions are primarily related to the metamizole component and the anticholinergic properties of fenpiverinium. Always inform your healthcare provider about all medicines, supplements, and herbal products you are taking before starting Algifen Neo.

Potential Major Interactions

  • Aspirin (taken for vascular protection): Metamizole may reduce the antiplatelet effect of low-dose aspirin. This is a critical interaction for patients with cardiovascular risk; separation of dosing times may be required.
  • Methotrexate: The combination can increase the concentration of methotrexate in the blood, raising the risk of severe blood-related toxicity.
  • Ciclosporin (Cyclosporine): Metamizole may lower the blood levels of ciclosporin, which can reduce its effectiveness. Close monitoring of ciclosporin levels is necessary.
  • Other NSAIDs/Pyrazolones: Concurrent use increases the risk of gastrointestinal side effects and potential kidney toxicity. Avoid taking other non-steroidal anti-inflammatory drugs or similar pain relievers.

Other Significant Interactions

Drug Class Interaction Risk Mechanism / Effect
Anticoagulants (e.g., Warfarin) Increased bleeding risk Metamizole may enhance the effect of some blood thinners, requiring adjustment of the anticoagulant dose.
Chlorpromazine Increased risk of hypothermia Combination may cause a significant and dangerous drop in body temperature.
Antihypertensives Reduced blood pressure control Metamizole may counteract the effect of some blood pressure-lowering drugs, such as ACE inhibitors.
Alcohol Increased drowsiness/side effects Alcohol intake may worsen the central nervous system effects of Algifen Neo and should be avoided.

Fenpiverinium's anticholinergic effects mean that taking Algifen Neo with other medicines that have similar effects (e.g., tricyclic antidepressants, some antipsychotics, or anti-Parkinsonian drugs) can increase the risk of side effects like dry mouth, constipation, or urinary retention.

Mechanism of Action

Central Pain Blockade and Antipyresis

The metamizole component primarily works by modulating signaling within the Central Nervous System (CNS). It targets the enzyme COX-3 to suppress the production of PGE2 and also engages the body's natural opioidergic and endocannabinoid pathways. This central action modulates the perception and transmission of nociceptive signals and influences the hypothalamic thermoregulatory set point.


Dual Peripheral Spasmolysis

The combination includes two components, pitofenone and fenpiverinium bromide, that collaboratively modulate smooth muscle tissue contraction. Fenpiverinium provides a neurotropic effect by blocking muscarinic receptors on the muscle surface, thereby inhibiting the neural signal that causes contraction. Pitofenone provides a myotropic effect by inhibiting PDE enzymes, which raises cAMP levels within the muscle cell to induce direct relaxation. This dual mechanism results in the modulation of overactive smooth muscle contraction in visceral organs.


Synergistic Mechanistic Action

The mechanistic characteristic of this combination is its synergy: metamizole modulates nociceptive signaling centrally, while pitofenone and fenpiverinium influence smooth muscle contraction peripherally. The simultaneous action on central nociceptive pathways and peripheral smooth muscle tone constitutes a multifaceted mechanistic approach.

Dosage and Administration Information

How to Use Algifen Neo: Official Administration Guidelines

The administration of Algifen Neo is governed by specific regulatory guidelines that establish the route, dosage limits, and timing intervals. The medicine is available for oral use (tablets or drops) and for parenteral administration via either the intramuscular (IM) or intravenous (IV) routes (solution for injection). This dual availability allows for use in both routine outpatient settings and acute care environments.


Dosing and Frequency

The standard administration schedule defines both a maximum single dose and a maximum daily limit, based on the Metamizole component. For adults and adolescents (aged 15 years and older), the maximum single oral dose is 1,000 mg, and this may be repeated up to 4 times daily, provided a minimum interval of 6 to 8 hours is observed between doses. The maximum daily oral dose must not exceed 4,000 mg. Use is primarily constrained to short-term treatment of acute symptoms.


Population-Specific Use

Administration protocols include high-level population-specific requirements: Dosing for pediatric patients is determined based on body weight (typically 8–16 mg per kg body weight). Additionally, in older adults and patients with renal or hepatic impairment, official instructions advise initiating treatment with a lower dose. The overarching procedural principle requires all treatments to commence at the lowest recommended dose, increasing only if therapeutically necessary.

Recent Clinical Evidence

Research evidence / Overview of studies for Algifen Neo

Evidence for use in Spasm-Related Acute Pain (Colic)

Research focusing on the Metamizole/Pitofenone combination primarily examined its use in conditions characterized by acute, functional discomfort, such as colic. Conditions associated with acute or disruptive episodes, like pain from spasms in the digestive, biliary, or urinary tracts, was studied for outcomes related to physical discomfort.

The evidence base is founded on Randomized Controlled Trials (RCTs) designed to examine patient response patterns following a single dose, complemented by systematic reviews and meta-analyses compiling results from multiple short-term studies. These trials generally include adults (18-65 years) who are observed in clinical settings, such as emergency departments, during periods of increased symptom activity. The findings describe patterns observed in the studies regarding the speed and degree of change in pain intensity. Some trials specifically research examined whether the addition of the spasmolytic component (Pitofenone) provides different patterns observed in the studies compared to Metamizole used on its own.

Study Designs and Outcomes Examined in Trials

The clinical research often uses short-term, single-dose designs relevant in trials assessing episodic symptom patterns. Research examined how pain intensity evolved in the observed populations, typically by asking patients to rate their discomfort using visual or numerical scales (VAS/NRS) at defined time intervals.

Other outcomes describing episodic or acute changes that studies monitored include the rate at which patients required supplemental pain medication; these findings contribute to understanding short-term changes. Furthermore, studies sometimes incorporated global evaluations of treatment effect, where both patients and physicians reported their perceived experience, contributing to the broader evidence landscape.

Research Gaps and Unanswered Questions

Research exploring short-term symptom changes has been conducted, but several areas of uncertainty remain. Limited information for long-term outcomes is noted in the research limitation frames. Comparative evidence is lacking in large-scale studies designed to explore how the fixed Metamizole/Pitofenone combination compares to Metamizole monotherapy.

Furthermore, evidence quality varies across studies, with some being noted as having sample sizes were modest, which is a factor to consider, as findings describe group patterns, not personal outcomes. This means that while research highlights what is known about the drug's use in acute spasm-related pain, it also transparently points to where more focused studies are needed to address these existing research limitation frames.

Key Studies & References Prescribing and use of metamizole/pitofenone combination products in Finland during the years 2017-2022 (Provides direct context for the Metamizole/Pitofenone combination product and specific populations/usage patterns)

Frequently Asked Questions (FAQ)

Common questions about Algifen Neo (FAQ)

Q: What is Algifen Neo used for?

Algifen Neo is primarily indicated for the management of certain types of pain and spasm. Official product information describes its use in situations where a strong antispasmodic and analgesic effect may be required, such as in cases of renal, biliary, or gastrointestinal colic.

Q: What should I know about taking Algifen Neo during pregnancy or breastfeeding?

It is generally advised that Algifen Neo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and this decision should be made in consultation with a healthcare provider. The official labeling recommends caution. Similarly, because the drug’s components may pass into breast milk, a healthcare professional should be consulted to weigh the risks and benefits before using this medication while breastfeeding.

Q: Can Algifen Neo be taken with alcohol?

The official product information advises caution when using Algifen Neo concurrently with alcohol. Alcohol can potentially increase the sedative effects of some components in the medication. It is safest to discuss the use of alcohol with a doctor or pharmacist while taking this drug.

Q: How should Algifen Neo be stored?

Algifen Neo should be stored according to the instructions provided on the packaging and patient information leaflet. Typically, medications should be kept at room temperature, away from moisture and heat, and out of the reach of children and pets. Do not use the medication past its expiration date.

Q: Are there any specific warnings about driving or operating machinery while taking Algifen Neo?

Some components of Algifen Neo may cause side effects like drowsiness or blurred vision. These effects could impair the ability to drive safely or operate complex machinery. Patients are generally advised to determine how the medication affects them before engaging in such activities.

How should Algifen Neo be stored and disposed of?

Storage Conditions and Requirements

Regulatory documents for Algifen Neo define specific mandatory conditions to maintain its stability and quality:

  • Temperature: Store the medicinal product at a temperature that does not exceed 25 C.
  • Protection: The product must be stored in the original package to ensure it is protected from light.
  • Prohibition: The medication must not be frozen.
  • Child Safety: Keep the medicine out of the sight and reach of children.
  • Stability: The product must not be used after the expiry date printed on the label.

Official Disposal Instructions

Disposing of unused or expired Algifen Neo requires adherence to authorized environmental and local waste regulations:

  • Household Waste Restriction: Do not dispose of the unused product or waste material via wastewater or household waste.
  • Authorized Disposal: Discard the product according to the local/regional/national regulations for pharmaceutical waste, often requiring return to a pharmacy or authorized collection point.

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

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