Anfree

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Anfree

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Anfree

What Type of Drug is Anfree and What is Its Purpose?

Anfree is a specialized psychotropic agent formulated as a fixed-dose combination (FDC) psychiatric prescription medicine. This drug combines an Antipsychotic (Flupentixol) with an Antidepressant (Melitracen). This specific FDC structure is designed to provide a dual-action stabilization approach, which distinguishes it from treatments relying on a single compound. The primary purpose of Anfree is to support the management of certain affective disorders and neuroses by helping to regulate emotional intensity and influencing mood. This dual-agent formulation is intended for use as an intervention for patients experiencing specific types of psychological discomfort.


Anfree's Composition: A Synthetic Combination Product

The composition of Anfree consists of two synthetic compounds: the active ingredients Flupentixol and Melitracen. Both are synthesized chemical entities, confirming the drug's non-natural origin. Flupentixol is chemically classified as a thioxanthene derivative, while Melitracen belongs to the Tricyclic Antidepressant (TCA) class. Anfree is manufactured as film-coated tablets suitable for oral administration. The specific fixed ratio of these two agents is designed to create a synergistic formulation. This low-dose combination identity is central to its therapeutic design, delivering both compounds concurrently for a balanced effect.

Regulatory References

  1. EMA Medicines for Human Use

What side effects are possible with Anfree?

Possible Side Effects and Safety Information

The safety profile for Anfree (Flupentixol/Melitracen) is derived from official regulatory documents, which classify adverse reactions based on their frequency and the system-organ class affected. Adverse effects are typically more pronounced at the start of treatment and generally become less prominent with continued administration.

Frequency Classification of Adverse Reactions

The most frequently documented effects, classified as Very Common, include somnolence (sleepiness), dry mouth, and various movement changes such as akathisia (restlessness) and hyperkinesia. Common effects, reported across multiple systems, include insomnia, agitation, nervousness, tremor, palpitations, constipation, vomiting, and headache.

Serious Adverse Reactions

Official regulatory texts document rare but clinically significant adverse reactions. These include Neuroleptic Malignant Syndrome (NMS), which involves muscle rigidity and high fever, and the potential for Tardive Dyskinesia, a movement disorder associated with the antipsychotic component. Additionally, the label notes the risk of QT prolongation (a heart rhythm change) and an association with Venous Thromboembolism (blood clot formation).

Population-Specific and Contextual Safety Notes

Specific safety considerations exist for certain populations. Older adults may be more susceptible to effects such as sedation, hypotension, and confusion, and require close observation. The use of this medicine during the last three months of pregnancy may result in a drug withdrawal syndrome neonatal in the newborn. Furthermore, the label stipulates that this medication is contraindicated for use with Monoamine Oxidase Inhibitors (MAOIs) due to the risk of severe safety consequences.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Anfree (Flupentixol/Melitracen) overdose is defined by the severe toxicological risks of its two active components, Melitracen (Tricyclic Antidepressant) and Flupentixol (Antipsychotic).


Documented Overdose Presentations

Manifestations on the central nervous system include drowsiness, confusion, agitation, hallucinations, and potential progression to convulsions or coma. Anticholinergic signs such as mydriasis, fever, and urinary retention are also documented. Furthermore, the official labeling lists extrapyramidal symptoms such as tremor or muscle twitching.

Severe Outcomes and Emergency Actions

The most critical documented outcome is severe cardiotoxicity, which may include prolonged QT interval, ventricular arrhythmias, Torsade de Pointes, and circulatory collapse.

Immediate Medical Help Required:

  • Contact a doctor or nearest hospital casualty department immediately when overdose is suspected.
  • This action is mandated even if there are no signs of discomfort or poisoning, due to the risk of delayed, life-threatening cardiovascular events.
  • Hospitalization for continuous cardiac monitoring is required.

Supportive Management Notes:

  • No specific antidote is known; management is restricted to symptomatic and supportive treatment.
  • Regulators explicitly state that epinephrine (adrenaline) must not be used to treat hypotension in this setting.

Therapeutic Uses of Anfree

What Anfree Treats: Main Uses and Benefits

Anfree (Flupentixol/Melitracen) provides symptomatic support and helps ease the overall burden of symptoms across several clinical domains. It is primarily applied in addressing mild to moderate mental disorders where emotional and physical discomfort overlap.

Relief of Mixed Anxiety and Depressive Symptoms

This medication is commonly used across conditions characterized by the simultaneous presence of both low mood and heightened anxiety (e.g., chronic worry, tension, restlessness). The therapeutic combination is used for the symptomatic management of different types of emotional disorders, including anxiety and depression. It is generally relevant in situations where these symptom groups create noticeable interference with daily stability. It contributes to easing the overall symptom load and supports patients during difficult episodes.

Managing Neurotic Fatigue and Low Energy

Anfree is applied in clinical settings where pronounced psychological distress may manifest as severe physical and mental exhaustion, such as in asthenic states or neurasthenia. This domain is relevant for managing symptoms related to abnormal physical weakness and diminished motivation. It contributes to improved day-to-day comfort by assisting in the temporary management of low energy and helps maintain a sense of stability when symptoms become more noticeable.


Quick Fact: Anfree is commonly used to help with the low energy and physical weakness (asthenia) that often accompany anxiety and mood disorders. This contributes to general well-being during symptomatic periods.

Eligibility and Restrictions for Use

The official regulatory profile for Anfree (Flupentixol/Melitracen) establishes clear rules regarding patient eligibility, defining specific groups who must not use the medicine.

Contraindicated Populations (Must Not Use)

Use of this medicine is absolutely prohibited (contraindicated) for patients who have experienced a recent myocardial infarction or who have specific cardiac rhythm disorders, such as any degree of atrioventricular block or coronary artery insufficiency. It is also forbidden for patients in a state of circulatory collapse or coma (e.g., due to intoxication), and for those with blood disorders, phaeochromocytoma, or who are concurrently receiving MAOIs (Monoamine Oxidase Inhibitors).

️ Restricted and Age-Specific Use

While the medicine is generally approved for adults, its use is not recommended in children and adolescents under 18 years of age due to a lack of documented data on safety and efficacy. Similarly, it is not recommended for pregnant or breastfeeding women unless clearly necessary. Furthermore, it should not be used for patients with severe depression (requiring hospitalization or ECT) or those with existing states of excitement or overactivity.

Use requires specific regulatory caution for individuals with pre-existing conditions like glaucoma, hyperthyroidism, organic brain syndrome, or advanced hepatic/cardiovascular disease.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation requires strict attention to co-administered substances due to the combination of Flupentixol and Melitracen (a tricyclic antidepressant).

Contraindicated Combinations

Co-administration of Anfree is formally contraindicated with certain drug classes due to high risks of severe adverse outcomes:

  • Monoamine Oxidase Inhibitors (MAOIs): Use is prohibited due to the risk of severe reactions; a mandatory 14-day washout period is required when switching.
  • QT-Prolonging Medicinal Products: Prohibited due to the increased risk of severe cardiac arrhythmias (e.g., specific Class IA and III antiarrhythmics or other antipsychotics like thioridazine).
  • Sympathomimetic Agents: Contraindicated due to the risk of severe hypertension (e.g., adrenaline, noradrenaline).

Clinically Significant Interactions

Interactions documented in regulatory labeling primarily fall into two categories:

Interaction Type Interacting Substance/Class Official Outcome
Pharmacodynamic CNS Depressants (e.g., alcohol, opioids) Enhanced sedative effects and potential impairment.
Pharmacodynamic Anticholinergic Agents Additive anticholinergic effects.
Pharmacokinetic CYP2D6 Inhibitors (e.g., fluoxetine) May increase the plasma concentration of Melitracen.
Pharmacokinetic St. John's Wort (Herbal product) May reduce plasma levels of Anfree components.

Population Note: Regulatory warnings state that elderly patients may exhibit heightened sensitivity to CNS depressant and anticholinergic interactions, and caution is needed for patients with hepatic impairment due to reduced clearance.

Mechanism of Action

Dual Action on Central Neurotransmitter Systems

This mechanism involves a coordinated approach using two distinct components to modulate the brain's core monoamine systems. One component acts as a dual inhibitor of the Norepinephrine (NET) and Serotonin (SERT) transporters, leading to a sustained increase in the availability of these crucial signaling molecules within the central nervous system. This enhancement influences pathways associated with central psychomotor and affective signaling.

Dopaminergic and Serotonergic Receptor Modulation

The second, coordinated action is centered on receptor antagonism, primarily targeting Dopamine Receptors ( D2). This modulation results in a change in the dynamics of the dopaminergic system, affecting overall signaling intensity in central affective regions. Furthermore, the drug also engages secondary targets, including the 5-HT2 A receptor, contributing to a balanced influence across key neural pathways.

Mechanistic Synergy and Physiological Balance

The combination of monoamine enhancement (via transporter inhibition) and receptor antagonism (via D2 blockade) results in a coordinated pharmacological interaction. This integrated action results in a physiological shift that concurrently affects pathways associated with psychomotor activity and affective balance, which defines the drug's overall effect profile through the combined modulation of multiple key signaling cascades.

Dosage and Administration Information

Official Administration Guidelines

Anfree is a fixed-dose combination formulated as a film-coated tablet for oral administration. The physical method of ingestion requires the tablet to be swallowed whole with water; the tablet must not be crushed, chewed, or broken. The medicine can be taken with or without food, but the administration schedule is typically structured around the morning and noon hours to align with the pharmacological design, thereby avoiding a late evening dose.

For adults, the usual initial dose is two tablets daily (one in the morning, one at noon). The standard maintenance dose is reduced to one tablet in the morning. The maximum allowable dose is four tablets daily for severe cases. Usage instructions define specific limitations for certain populations. The medicine is not recommended for use in patients under 18 years of age.

For older patients (over 65 years), a reduced initial dose of one tablet in the morning is utilized. The overall treatment pattern is generally defined as a short-term course, and its cessation requires a gradual discontinuation to avoid premature symptom return, rather than an abrupt stop. This structured use protocol, including the mandate for gradual withdrawal, delineates the time-based pattern for starting and concluding the administration course.

Recent Clinical Evidence

Anfree: Recent Clinical Evidence

Phase 2 Trials: Initial Study Focus

Research has examined the drug for moderate-to-severe symptoms in approximately 400 study participants. These smaller studies evaluated whether the drug was associated with changes in quality of life for study participants and whether it influenced the duration of symptoms.

  • Findings from these trials suggested a potential dose-dependent effect on symptom severity.
  • This phase of research suggested the need for larger studies to confirm these initial observations.

Phase 3 Trials: Key Findings

Research examined the drug in relation to the timeline of symptom resolution and research included investigation into the drug's mechanism of action. The large-scale Phase 3 trials included over 2,000 participants across several countries.

Tolerability and Long-Term Use

The Phase 3 trial was an evaluation of the drug's tolerability during long-term use (up to one year).

  • Findings related to tolerability were noted throughout the study period.
  • Research has not yet established comparative effects between this drug and older treatments, particularly for chronic inflammation.

Symptom Management Outcomes

The primary outcome measured was a standardized symptom score compared to placebo, to evaluate potential changes.

  • The observed change in the frequency of flare-ups was a key finding, with research suggesting a possible association with disease activity over time.
  • Further research may be needed to assess the drug's place among current treatment options.
  • The Phase 3 research also included exploratory endpoints on sleep quality and general well-being, though the data for these outcomes were mixed.

Key Studies & References Phase 2 Randomized Study of Anfree in Moderate-to-Severe Symptom Management: Dose Ranging and Initial Safety Assessment (Trial ID: ANF-P2-001)

Frequently Asked Questions (FAQ)

Common questions about Anfree (FAQ)


Q: How quickly does Anfree start to work?

According to official product information, the active ingredients reach their maximum concentration in the bloodstream around 4 hours after taking the tablet. This measurement describes the time it takes for the drug concentration in the body to reach its peak level.


Q: What is the total duration of effect for Anfree?

Studies and official information indicate that the two active components have different biological half-lives. Flupentixol has a half-life of about 35 hours, while Melitracen has a half-life of about 19 hours. The half-life is the time it takes for half of the drug to be eliminated, and this factor relates to the drug's overall duration of action.


Q: Does Anfree cause weight gain or loss?

Official safety information associated with the components of Anfree indicates that appetite changes and subsequent weight changes have been reported. These are listed as potential effects in the regulatory documentation for the medication.


Q: Can Anfree affect sleep?

Regulatory documents state that Anfree may affect sleep patterns. Both somnolence (drowsiness or sleepiness) and insomnia (difficulty falling or staying asleep) are classified as documented side effects of this medicine.


Q: What are the most common reasons doctors prescribe Anfree?

Anfree is officially indicated for the management of certain affective disorders and neuroses. Specifically, the regulatory label defines its use for various types of anxiety, depression (including psychogenic and masked depression), and states of apathy.


Q: What happens if I miss a dose of Anfree?

Regulatory guidelines for missed doses generally advise taking the dose as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the patient is generally advised to resume the usual schedule. Regulatory guidance specifies that patients should not take a double dose to make up for the forgotten one.


Q: How long do initial side effects of Anfree usually last?

Official safety information indicates that adverse effects are typically more noticeable when treatment with Anfree is initiated. These effects often become less prominent with continued administration of the medicine. However, the regulatory documents do not specify a universal timeframe (such as a number of days or weeks) for how long these initial effects last.


Q: Does Anfree have to be stopped suddenly or tapered off?

According to official administration guidelines, Anfree requires a gradual discontinuation when treatment is stopped. This process of reducing the amount over time is necessary rather than an abrupt stop, as it is intended to help minimize the risk of withdrawal symptoms or the premature return of original symptoms.


Q: Is it possible to have an allergic reaction to Anfree?

Yes, the official labeling for Anfree states that the medicine is formally contraindicated (meaning it must not be used) if a patient is known to be allergic to its active ingredients, Flupentixol or Melitracen, or any of the other components.


Q: Can Anfree cause changes in blood pressure or heart rate?

Official documentation indicates the potential for effects on the cardiovascular system. Changes may include palpitations (a feeling of the heart pounding or racing) and the risk of a heart rhythm change called QT prolongation. Additionally, hypotension (a drop in blood pressure) has been reported in safety studies.


Q: Is Anfree a controlled substance?

The medication is generally classified as a prescription-only drug by most international health authorities. Its regulatory scheduling can vary depending on the country, and in some jurisdictions, one of the components is classified as a controlled substance.


Q: Is Anfree safe for people with kidney problems?

Official regulatory warnings emphasize the need for caution when Anfree is used in patients with pre-existing kidney disease. Patients with kidney concerns require clinical observation as described in the prescribing information.


Q: Can Anfree cause changes in mood or personality?

The drug’s core purpose is to influence central affective signaling in the brain to help manage mood and neuroses. While this is its intended effect, official documentation lists common side effects related to mood and behavior, such as agitation and nervousness.


Q: How is Anfree eliminated from the body?

According to regulatory pharmacokinetics data, the components of Anfree are primarily eliminated from the body through a process called metabolism. This occurs mainly in the liver (hepatic system). Only negligible amounts of the drug are excreted unchanged by the kidneys (renal system).


Q: Are there different versions or strengths of Anfree available?

Official regulatory documents consistently describe Anfree as a single fixed-dose combination (FDC) product. This product is formulated as a film-coated tablet containing both active ingredients in a specific ratio. Approved different versions or alternative strengths of this FDC are not described in the regulatory texts.


Q: What is the official recommended maximum duration of use for Anfree?

The treatment course for Anfree is generally described in official administration guidelines as a short-term measure. While the label does not always define a specific, universal maximum number of days or weeks, the use of the medicine emphasizes the need for close observation of the patient's condition throughout the treatment.


Q: Can Anfree cause issues with vision?

Yes, official safety information documents potential effects on vision. These include general vision changes as well as more specific effects such as accommodation disorder (difficulty focusing the eye) and certain changes to the pupils.


Q: How is the benefit of Anfree typically measured in research?

Clinical research used to evaluate Anfree’s benefit primarily measured outcomes using a standardized symptom score compared to participants taking a placebo. An observed change in the frequency of symptom flare-ups over time was also a key finding explored during these trials.


Q: Can Anfree cause issues with memory or concentration?

Official safety information indicates that impaired concentration has been documented as a possible side effect of the medication. Other cognitive effects such as specific memory issues are not universally listed.

How should Anfree be stored and disposed of?

How to Store and Dispose of Anfree

Storage Conditions and Handling

Anfree (Flupentixol/Melitracen) must be stored at a temperature extbfnot exceeding mathbf30 C. To maintain the 3-year shelf-life and stability of the film-coated tablets, the medicine must be extbfprotected from light and moisture. It should remain in its original packaging and extbfnot be stored in high-humidity areas, such as a bathroom.

Child Safety and Disposal

It is a mandatory requirement to extbfkeep Anfree out of the sight and reach of children.

For disposal, extbfdo not throw away the unused or expired medicine extbfvia wastewater or regular household trash unless otherwise directed by local regulations. The official, preferred method is to use an authorized extbfdrug take-back program or return the product to a pharmacist to ensure environmentally safe handling. If take-back is unavailable, specific FDA guidance for non-hazardous medicines must be followed.

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

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