Anzet

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Anzet

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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 Anzet

What is Anzet? A Foundational Definition

Property Description
Active Ingredients Flupentixol, Melitracen (Prescription Required)
Form Oral Tablet (Fixed-Dose Combination)
Pharmacological Class Combined anxiolytic and antidepressant
General Purpose Managing mixed anxiety-depression and asthenia
Origin Synthetic

Anzet: Identity and Composition Differentiators

Anzet is a prescription-only drug defined as a Fixed-Dose Combination (FDC) product used to manage conditions where anxiety and depression occur together. This medication is presented as an oral tablet and is derived entirely from synthetic compounds. The drug is classified pharmacologically as a combined anxiolytic and antidepressant, an approach for addressing overlapping emotional and mood disturbances.

Its composition features two distinct active ingredients: Flupentixol (a stabilizing neuroleptic agent) and Melitracen (an activating tricyclic antidepressant). This specific dual-agent structure is a key differentiating feature that aims to provide both mood-elevating and tension-reducing effects simultaneously. This formulation is used to address both depressive and anxious symptoms by combining two agents intended to treat both anxiety and low mood.


Therapeutic Profile and Dual-Action Benefit

The primary therapeutic profile of Anzet is to provide relief for mixed anxiety-depression, depressive neuroses, and mood disturbances accompanied by fatigue. The medication's dual structure is designed to address the chemical balance required for both emotional uplift and mental calm. This approach is utilized in the management of emotional disorders to address both the mood and accompanying physical symptoms of distress.

By addressing both the feelings of tension and the associated lack of energy (often characterized as asthenia), Anzet supports the improvement of psychological function. The combination is typically positioned for patients who present with mild to moderate symptoms that include a component of low drive or general malaise.

What side effects are possible with Anzet?

Possible Side Effects and Safety Information

The following information on adverse reactions and safety constraints is based strictly on governmental regulatory documents for the Flupentixol and Melitracen combination product.

Adverse Reactions by Frequency and System

Adverse reactions are officially documented across several System-Organ Classes (SOCs), with frequency categories established by regulatory standards:

Frequency Common Adverse Reactions (Examples)
Common Dry mouth, Constipation, Dizziness, Insomnia, Agitation, Tremor, Fatigue.
Uncommon Extrapyramidal symptoms.
Rare Thrombocytopenia, Agranulocytosis, Tardive dyskinesia.

Additional affected systems include Gastrointestinal, Psychiatric, Cardiac, Blood and Lymphatic, and Vascular disorders.

Serious Adverse Reactions and Key Warnings

Official labeling highlights the risk of Suicide-Related Events (thoughts or attempts), requiring close monitoring, particularly early in treatment. Serious cardiac events, including QTc prolongation and Ventricular Arrhythmias, are documented, particularly in overdose. Neuroleptic Malignant Syndrome is listed as a very rare, serious potential outcome.

Safety Constraints and Population Notes

The medicine is subject to defined regulatory restrictions and warnings:

  • Contraindications: Use is strictly prohibited in cases such as the immediate recovery phase after myocardial infarction, bundle-branch conduction defects, or within two weeks of receiving a MAO-inhibitor.
  • Neonatal Risk: Exposure during the third trimester of pregnancy carries a risk of extrapyramidal or withdrawal symptoms in the newborn.
  • Time-Related Pattern: Extrapyramidal effects are noted to occur, especially in the initial phase of treatment.

Patients should also be advised of the potential for drowsiness/dizziness and the official recommendation to limit or avoid alcohol.

Overdose and Emergency Response

The official regulatory profile for an overdose of Anzet (Flupentixol/Melitracen) highlights the potential for severe, life-threatening effects primarily involving the cardiovascular and central nervous systems. Due to the high risk of delayed complications such as ventricular arrhythmias, QT prolongation, cardiac arrest, and circulatory collapse, governmental guidance mandates that individuals seek immediate medical attention or contact emergency services following any suspected overdose, even if there are no immediate signs of discomfort or poisoning.

Documented overdose manifestations often include CNS effects ranging from drowsiness and confusion to profound somnolence that may progress to coma, convulsions, and respiratory depression. Other clinical signs include anticholinergic symptoms such as mydriasis and urinary retention, alongside possible acute extrapyramidal reactions.

Treatment for overdose is defined as symptomatic and supportive. Required procedural steps documented in the label include immediate management of the airway, consideration of activated charcoal, and continuous cardiac monitoring. The regulatory documentation states that no specific antidote is known for the combination product.

Therapeutic Uses of Anzet

What Anzet Treats: Main Uses and Benefits

The combination of Flupentixol and Melitracen (Anzet) may be part of symptomatic management applied in contexts involving certain distressing symptoms arising from emotional and mood disorders. Its core therapeutic use is for addressing conditions where mood and anxiety symptoms overlap.

This combination may assist with managing symptoms in conditions presenting with mild to moderate symptoms, including mixed anxiety-depression, depressive neuroses, and emotional components of psychosomatic affections. It is relevant for easing symptoms that become more disruptive during flare-ups, such as asthenia (fatigue and low drive), inner tension, worry, and dysphoria. The treatment contributes to improved comfort during difficult episodes and supports general well-being during symptomatic phases.

“The dual action is considered relevant for individuals experiencing the dual burden of persistent low mood and generalized anxiety.”


Quick Fact: Relief for Low Drive and Fatigue

Quick Fact: Relief for Asthenia Anzet is applied across domains where patients may benefit from symptomatic assistance for low psychological drive, malaise, and fatigue that accompanies their emotional distress. It assists with maintaining functional stability by addressing this critical component of symptom clusters.

Regulatory References

  1. Malta Medicines Authority's Summary of Product Characteristics

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Anzet — Official Regulatory Information

The eligibility profile for Anzet (Flupentixol/Melitracen) is strictly defined by regulatory documents, establishing absolute prohibitions and specific restrictions for certain populations.


Category Official Regulatory Statement
Populations for whom use is allowed Adults for approved indications (mixed anxiety-depression, asthenia). Older people (>65 years) are permitted, often with lower initial dosing.
Populations for whom use is not recommended Children and adolescents under 18 years due to insufficient data. Excitable or overactive patients. Patients with severe depression requiring hospitalization or ECT.
Populations for whom use is contraindicated Patients with known hypersensitivity to components. Patients with recent myocardial infarction, atrioventricular block, coronary artery insufficiency, or circulatory collapse. Patients with blood disorders or phaeochromocytoma.
Concomitant Drug Restriction Contraindicated in patients receiving MAOIs (Monoamine Oxidase Inhibitors) or within 14 days of MAOI discontinuation.
Pregnancy and Lactation Status Pregnancy: Should not be administered unless maternal benefit outweighs fetal risk. Lactation: Not recommended as Flupentixol is present in milk, and Melitracen excretion is unknown.
Conditional Use (Caution Required) Use with caution in patients with advanced hepatic disease, organic brain syndrome, history of convulsion, hyperthyroidism, or urinary retention.

This structure rigorously delineates who is officially permitted to use the medicine under standard conditions versus who is restricted or forbidden from use, based on severe comorbidities, age limitations, and reproductive status, as defined by the Summary of Product Characteristics (SmPC).

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section summarizes interaction patterns for Anzet (Flupentixol/Melitracen) as documented in official government regulatory sources.


Contraindicated Combinations and Restrictions

The co-administration of Anzet is strictly contraindicated with Monoamine Oxidase Inhibitors (MAOIs), including non-selective, selective A (Moclobemide), and selective B (Selegiline). A mandatory separation period is required: Anzet must not be given to a patient who has received an MAO-inhibitor within the preceding two weeks (14 days). The medicine is also contraindicated in cases of depressed consciousness due to acute intoxication involving alcohol, barbiturates, or opiates. Epinephrine (Adrenaline) must not be used for symptomatic support in Anzet overdosage.

Documented Pharmacodynamic Effects

Pharmacodynamic interactions are defined by the medicine’s potentiating effects. Co-administration with other CNS depressants or alcohol may enhance the depressant response. The medicine may potentiate the cardiovascular effects of Sympathomimetic Agents and increase the risk of effects when combined with Anticholinergic Agents. Anzet may reduce the antihypertensive effect of drugs like Adrenergic Neurone Blockers. Caution is also required with General Anaesthetics during surgery.

Exposure Modification and Specific Cautions

The Flupentixol component may inhibit the metabolism of other Tricyclic Antidepressants, which can lead to increased serum concentrations. A population-specific consideration notes that Anzet may impair control of diabetes in patients using antidiabetic therapy, necessitating careful monitoring and potential adjustment of that therapy.

Mechanism of Action

Dual Action on Monoamine Systems for Activation and Drive

The drug's mechanism is founded on the simultaneous modulation of Norepinephrine ( NE), Serotonin ( 5-HT), and Dopamine ( DA) systems. One component works as a reuptake inhibitor, blocking the transporters for NE and 5-HT, which increases their availability in the synapse to increase the modulation of pathways associated with arousal and drive. The other component uniquely boosts DA availability by antagonizing presynaptic D2 autoreceptors, directly enhancing the psychomotor drive and activation circuits.

Receptor Blockade for Neurochemical Stabilization

A crucial part of the mechanism involves the antagonism of specific post-synaptic receptors, primarily Dopamine D2 and Serotonin 5- HT2A receptors. This receptor blockade acts as a dampening mechanism on overactive neural circuits. This mechanism induces neurochemical stabilization, contributing to the dampening of hyperactive signaling in circuits related to internal restlessness.

Mechanistic Synergy for Combined Modulation

The two core mechanisms function synergistically: the activation mechanism (via reuptake inhibition and DA release) is balanced by the stabilization mechanism (via receptor antagonism). This coordinated action on multiple monoamine pathways leads to a combined modulation of CNS tone, which dictates the drug’s physiological effects on central activation and neural signaling.

Dosage and Administration Information

Administration Guidelines for Anzet (Flupentixol/Melitracen)

The usage of this fixed-dose combination is based on established parameters defining the appropriate route and dose administration.

Entity Instruction
Route of administration Oral ingestion only, as a film-coated tablet.
Dosing schedule Usual Daily Dose: Two tablets, typically administered in a divided schedule (morning and noon). Maximum Dosing: The dose may be increased for severe cases, with a maximum limit of four tablets daily.
Timing in relation to meals Administration can occur independently of meal times (with or without food).
Preparation requirements The tablet must be swallowed whole with water and is not intended for crushing or dilution.
Age-group administration rules Older Adults (> 65 years): Starting dose is typically limited to one tablet in the morning. Children/Adolescents (< 18 years): Use is not recommended due to a lack of established data on safety and efficacy.
Missed-dose rules If a scheduled dose is missed, the next dose should be taken at the usual time; doubling the next dose to compensate is discouraged.
Special procedural conditions Gradual discontinuation is required; the medicine must not be stopped suddenly. Previous use of tranquilizers should be withdrawn gradually before initiation.

Procedural Structure and Protocol

Standardized administration sequence:

  • The usual daily treatment begins with one tablet in the morning and one tablet at noon.
  • Swallow the prescribed film-coated tablet whole with water.
  • Follow the dose adjustment rules set for older adults, if applicable.
  • Conclude treatment only via a gradual reduction or tapering protocol.

The administration instructions establish a standardized, daytime-focused regimen for Anzet's oral intake, defining precise numerical limits for daily intake for adults. This structured protocol ensures the medicine is taken as a divided dose during waking hours and provides specific guidelines for initiating therapy in older adults. Furthermore, the protocol requires a gradual tapering phase to complete the course of treatment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Anzet

Evidence for Use in Mixed Anxiety and Depressive Symptoms

Research has explored the combination of flupentixol and melitracen in individuals experiencing overlapping, mild to moderate symptoms of anxiety and low mood. The available evidence largely comes from short-term, randomized controlled trials (RCTs) that compared the combination agent either against a placebo or against an existing treatment. These studies monitored how symptoms changed over defined time intervals. Research examined adult populations where anxiety and depression was observed in the context of other chronic medical conditions. Research describes patterns related to measurement change on the scales, including observed response or remission rates, during the short study period.

Evidence for Use in Functional Somatic Disorders

The combination agent was evaluated in research exploring its use as an adjuvant therapy for specific conditions characterized by functional limitations, such as certain chronic digestive issues (like Functional Dyspepsia) and Refractory Chronic Cough. In these trials, research examined patient-reported outcomes describing perceived discomfort and the overall impact on daily life. Studies report patterns related to measured shifts in both the physical symptoms and the co-occurring anxiety and depression scores.

What is Still Uncertain About Anzet's Research Profile

A key characteristic of the research base is that it consists mainly of short-term studies observing responses over defined time intervals, often lasting only a few weeks. These follow-up durations were limited. Consequently, long-term effects are not fully established, and there is limited information for long-term outcomes regarding the sustained symptomatic shift. Furthermore, comparative evidence against monotherapy (single-agent treatment) is lacking in many populations. Certainty is limited regarding the long-term clinical utility and the necessary duration of use. The research highlights what is known — and what is still uncertain — about the combination agent's profile.

Key Studies & References

  1. Summary of Product Characteristics (SPC) - Flupentixol/Melitracen
  2. Flupentixol: a review of its clinical efficacy in patients with depressive disorders (Indian J Pharmacol. 2008)

Frequently Asked Questions (FAQ)

Common questions about Anzet (FAQ)


Q: What happens if I forget to take Anzet?

According to the official administration guidelines, if a dose is missed, the regulatory guidance is to take the next dose at the usual time. Official instructions explicitly discourage taking a double dose to compensate for the one missed.


Q: Is Anzet safe for older adults to use?

Official documentation indicates that use in older adults (generally over 65 years) is allowed. However, the schedule typically begins with a restriction to a lower daily amount, such as one tablet in the morning.


Q: Can Anzet be taken with vitamins or supplements?

Official product information describes documented interactions with certain prescription medications and alcohol. While vitamins and general supplements are not specifically listed, official information notes potential interaction risks with agents that share similar effects on the body.


Q: Can I take Anzet if I am also taking blood pressure medicine?

Regulatory documents indicate that Anzet may affect the performance of some blood pressure medicines. Specifically, it may reduce the pressure-lowering effect of drugs categorized as Adrenergic Neurone Blockers.


Q: Can Anzet cause dizziness or affect driving?

Official safety documents note that potential adverse reactions include drowsiness and dizziness. Because of this, regulatory documents recommend awareness regarding the medicine's effect on the ability to safely operate vehicles or machinery.


Q: What is the difference between a side effect and a precaution for Anzet?

In official documents, 'side effects' are referred to as 'Adverse Reactions' and describe documented unwanted effects of the drug. 'Precautions' or 'Warnings' refer to special situations or patient groups that require extra attention, monitoring, or caution before or during treatment.


Q: What do official sources say about stopping Anzet?

Official administration instructions state that the medicine is not intended to be stopped suddenly. Official instructions specify that a gradual reduction or tapering protocol is necessary for treatment cessation.


Q: How quickly does Anzet typically start to work?

Studies and clinical data have examined a relatively rapid onset of effects for the components of Anzet. Some clinical trials have examined early response, where anti-depressive effects were indicated within the first few days after administration.


Q: Can Anzet be used long-term?

Official research summaries note that available studies on the drug combination primarily consist of short-term trials. As a result, sustained long-term effects regarding symptomatic change are not fully established in the existing evidence base.


Q: Does Anzet affect sleep patterns?

Insomnia (difficulty sleeping) is listed as a common adverse reaction in official documentation. Furthermore, clinical data indicates that the medicine may affect certain sleep parameters, which can result in reduced sleep efficiency.


Q: Is it common to feel tired when taking Anzet?

Official regulatory documentation classifies fatigue (a feeling of tiredness) as a 'Common' adverse reaction. This means it is one of the more frequently observed effects documented in patients using the medicine.


Q: Are there any foods or drinks I need to avoid while on Anzet?

Official administration instructions state that Anzet tablets can be taken independently of meal times (with or without food). However, alcohol is a substance that should be avoided or limited due to documented interaction risk.


Q: Has Anzet been studied in children?

Official documentation states that use is not recommended in children and adolescents under 18 years. This is due to a lack of established data on the safety and effectiveness of the combination medicine for this age group.


Q: Can people with liver problems use Anzet?

Official documents indicate that the medicine is used with caution in patients with advanced hepatic disease (severe liver disease). This reflects official concerns regarding how the drug is processed in the body.


Q: Is Anzet a narcotic or habit-forming medicine?

The medicine is not classified as a narcotic. While official labeling may not use the exact term 'habit-forming,' the possibility of dependence or use disorder is a known area of study for medicines affecting the central nervous system.


Q: Why is Anzet sometimes prescribed for a few different problems?

The primary purpose defined in official documents is for mixed anxiety-depression and asthenia (lack of energy). Research has also explored its use as an adjuvant therapy—meaning it is used in addition to other treatments—for specific functional conditions characterized by physical limitations.


Q: Is Anzet known to cause weight gain or loss?

Official regulatory documentation lists 'Increased appetite and weight' as an adverse reaction. This reaction is categorized under the system-organ-class of metabolism and nutrition disorders.


Q: How does Anzet affect my mood?

The medication is officially described as a combined anxiolytic (tension-reducing) and antidepressant (mood-elevating) agent. It is intended to affect the mood by modulating multiple chemical pathways in the brain to help restore a balance required for emotional uplift and mental calm.


Q: Is Anzet a 'new' medicine or has it been around for a while?

Regulatory overviews and historical data indicate that the combination medicine was first marketed globally around the early 1970s. It is therefore considered a medicine that has been available for a significant period.


Q: What types of allergic reactions are listed for Anzet?

Official documentation uses the term 'hypersensitivity' to the components as a contraindication. This is the official medical term for an allergic reaction, strictly prohibiting use in affected individuals.


Q: What does it mean if the official documents mention a 'contraindication' for Anzet?

A contraindication is a regulatory term for a situation where the medicine is strictly prohibited from being used. Official documents indicate that the patient must not take the medicine because the potential risk outweighs any possible therapeutic benefit.


Q: What is the purpose of the boxed warning, if Anzet has one?

Official labeling highlights serious risks, such as Suicide-Related Events and serious cardiac events like QTc prolongation. These are the types of serious safety concerns that regulatory bodies flag with the highest level of alert.


Q: How long does Anzet stay in your system after stopping?

Official pharmacokinetic data provides information on how long the components stay in the body. For the Flupentixol component, the elimination half-life is noted as approximately 35 hours following oral administration (this is the time it takes for half the drug to be eliminated).

How should Anzet be stored and disposed of?

How to Store and Dispose of Anzet (Flupentixol/Melitracen)

Anzet tablets must be stored according to strict regulatory requirements to maintain product stability.

Official Storage Requirements

Storage Component Requirement
Temperature Store at a temperature not exceeding 30°C (86°F).
Protection Keep in a dry place and protect from light.
Packaging Must be kept in the original container (e.g., blister pack).

Safety and Disposal

It is a mandatory regulatory instruction that this medication must be kept out of the sight and reach of children at all times.

Disposal: Any unused or expired Anzet must be safely disposed of in accordance with local and national regulations for pharmaceutical waste. Do not dispose of expired medication in household trash or wastewater unless specifically instructed by local authorities.

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

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