Meltix

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Meltix

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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 Meltix

Quick Facts

Property Description
Active Ingredient Flupentixol Dihydrochloride and Melitracen Hydrochloride
Form Film-coated tablet
Pharmacological Class Combined Anxiolytic and Antidepressant Drug
General Purpose Calming anxiety and improving mood and energy
Origin Synthetic

Meltix is a synthetic fixed-dose combination product classified pharmacologically as a Combined Anxiolytic and Antidepressant Drug. This orally administered medication, supplied as a film-coated tablet, is specifically formulated to address emotional distress where symptoms of both anxiety and depression coexist, providing a therapeutic effect distinct from single-agent treatments. This approach is an established strategy in psychopharmacology for managing mixed syndromes.


What Type of Medicine is Meltix? (Identity and Classification)

Meltix is a fixed-dose combination that synergistically merges two established psychotropic compounds to deliver a comprehensive effect. This classification means it combines two active agents in a single pill, distinct from separate monotherapies. This approach reflects a specialization in managing complex emotional presentations, such as psychogenic depression or masked depression, where physical symptoms often obscure the underlying mood disorder. The existence of analogous formulations, such as Deanxit, further underscores the established utility of this specific two-component combination.


Composition: Flupentixol, Melitracen, and the Dual Action Strategy

The active ingredients in Meltix are Flupentixol Dihydrochloride and Melitracen Hydrochloride. Flupentixol is a low-dose neuroleptic from the thioxanthene class, possessing a key dopamine-modulating effect. Melitracen is classified as a tricyclic antidepressant (TCA), functioning as a non-selective monoamine reuptake inhibitor. Research has detailed the chemical structures and dual target engagement of these types of psychoactive substances. The co-formulation is designed to mitigate the lag period often associated with mood-elevating agents by including the faster-acting anxiolytic component.


General Purpose: Calming Anxiety and Activating Mood

The overall purpose of Meltix is to provide both an anxiolytic effect for emotional calming and an activating property to combat apathy, leading to a comprehensive mood stabilization. By influencing key neurotransmitters like norepinephrine and serotonin for mood elevation, alongside dopamine modulation for tension relief, the medication helps alleviate inner turmoil and restore mental drive. This balanced action specifically addresses the dysphoria and lethargy often seen in mixed states, aiming to normalize emotional function.

Regulatory References

  1. Depression and anxiety: Can I have both?

What side effects are possible with Meltix?

Possible Side Effects and Safety Information

The safety profile of Meltix (Flupentixol/Melitracen) is derived from regulatory documentation, which specifies potential adverse reactions and crucial restrictions for its use.

Adverse Reactions

Adverse reactions at recommended doses are documented as rare. The most commonly reported side effects affecting the nervous system include transient restlessness and insomnia. Other common effects noted in clinical experience include dizziness, tremor, dry mouth, constipation, and fatigue. More severe, but less common, adverse reactions can involve the cardiovascular system (e.g., changes in heart rate, low blood pressure) and nervous system (e.g., extrapyramidal symptoms or movement disorders).

Classification Examples of Documented Reactions
Rare (in recommended doses) Transient restlessness, insomnia
Other Common Reports Dizziness, tremor, dry mouth, constipation, fatigue, accommodation disorder

Safety Restrictions and Contraindications

Meltix is contraindicated in several situations due to the risk of serious complications. These include the immediate recovery phase following a myocardial infarction and the presence of defects in bundle-branch conduction. It must also be avoided in patients with untreated narrow-angle glaucoma and in cases of acute intoxication with alcohol, barbiturates, or opiates.

The drug must not be given to patients who have received a Monoamine Oxidase Inhibitor (MAO-I) within the preceding two weeks, due to the documented risk of hypertensive crisis.

Population-Specific Safety Notes

The medication is not recommended for use in children and adolescents due to a lack of data on safety and efficacy in these populations. It is also not recommended for excitable or overactive patients, as its activating component may potentially exaggerate these characteristics. Use during pregnancy and lactation should preferably be avoided.

Overdosage primarily results in symptoms of anticholinergic nature (due to Melitracen) and, more rarely, extrapyramidal symptoms (due to Flupentixol).

Overdose and Emergency Response

Overdose involving the Melitracen/Flupentixol combination presents with a spectrum of officially documented clinical manifestations, primarily affecting the central nervous system (CNS) and the cardiovascular system. Symptoms often include CNS depression such as sleepiness, unconsciousness, or coma, alongside signs of agitation, hallucinations, convulsions, and extrapyramidal symptoms. A critical concern is the effect on the heart, leading to tachycardia, cardiac arrhythmias, and conduction abnormalities like QT prolongation, as well as respiratory depression. Autonomic signs such as dilated pupils, urinary retention, and hyperpyrexia are also documented.

Due to the risk of severe or life-threatening outcomes, regulatory authorities mandate seeking immediate medical attention by contacting a doctor or hospital casualty department as soon as an overdose is suspected. This action is required even if there are no initial signs of discomfort or poisoning.

There is no known specific antidote for this combination. Management in a hospital setting consists of symptomatic and supportive treatment, focusing on supporting the respiratory and cardiovascular systems. Procedures may include gastric decontamination measures, such as the use of activated charcoal. Regulatory guidance specifically states that Epinephrine (adrenaline) must not be used. For newborns of mothers exposed during the third trimester, monitoring for drug withdrawal syndrome is required.

Therapeutic Uses of Meltix

What Meltix Treats: Main Uses and Benefits

This medication is generally used to provide supportive relief for symptom clusters where anxiety and depression overlap. It is applied in contexts marked by increased discomfort and tension, specifically helping to manage symptoms of anxiety, depression, and asthenia (generalized weakness).

Meltix is commonly used in mild to moderate emotional disorders, including psychogenic depression and depressive neurosis. It assists in addressing symptom clusters such as persistent inner turmoil, lethargy, apathy, and stress-related psychosomatic affections like tension headaches. When symptoms intensify and supportive relief is needed, this approach contributes to managing mixed affective states.

“This medication is relevant for easing symptoms that interfere with daily comfort and often become more noticeable during periods of heightened stress.”

This support helps maintain a sense of stability when emotional symptoms are more pronounced, contributing to improved comfort during symptomatic phases.


Quick Fact: Therapeutic Focus on Coexisting Symptoms

Domain Key Symptom Focus Practical Benefit
Mixed Affective States Anxiety, Low Mood, Inner Turmoil Contributes to managing the symptoms of emotional overlap.
Asthenic States Lethargy, Apathy, Lack of Drive Supports managing motivation and assists with easing mental fatigue.
Contextual Relief Psychosomatic Affections, Masked Depression Assists with maintaining functional stability during symptomatic episodes.

Eligibility and Restrictions for Use

Eligibility for Meltix is strictly defined by regulatory guidelines concerning age, existing medical conditions, and physiological status.

Eligibility Classification Population Group
Allowed Adults (18 years) for mild to moderate emotional disorders.
Use Not Recommended Children and adolescents under 18 due to lack of established data.

Meltix is contraindicated and must not be used by patients with specific severe conditions. These absolute prohibitions include a recent myocardial infarction, certain cardiac rhythm disorders (such as atrioventricular block), circulatory collapse, and a depressed level of consciousness or coma. The medicine is also prohibited for individuals with untreated narrow-angle glaucoma, phaeochromocytoma, or while taking Monoamine Oxidase Inhibitors (MAOIs).

Use requires caution in several groups. Patients with advanced hepatic disease or renal impairment are subject to restrictions. Caution is also advised for those with diabetes or a history of epilepsy. The medicine should not be administered during pregnancy unless the expected benefit outweighs the theoretical risk, and use during lactation requires careful consideration. Furthermore, the medicine is not recommended for highly excitable or overactive patients.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Meltix, which contains Flupentixol and Melitracen, has documented interactions primarily concerning its effects on the central nervous system (CNS) and its tricyclic antidepressant component.

Contraindicated and High-Risk Combinations

The most critical restriction is the use of Monoamine Oxidase Inhibitors (MAOIs), which is strictly contraindicated. Meltix must not be administered to patients who have taken an MAOI within the preceding two weeks due to the high risk of severe reactions, including Serotonin Syndrome or Hypertensive Crisis.

Pharmacodynamic Interactions

Interacting Product Category Documented Constraint
CNS Depressants (e.g., alcohol, barbiturates) Increased risk of CNS depression and sedation due to additive effects.
Sympathomimetic Agents (e.g., adrenaline) Potentiation of the cardiovascular effects of these agents.
Anticholinergic Agents Increased risk of severe side effects on the CNS, eyes, and bowel due to augmented anticholinergic activity.
Antihypertensive Agents Reduction of the antihypertensive effect of drugs like guanethidine and similar acting compounds.

Other Relevant Interactions

Use with Lithium or other serotonergic drugs may necessitate close monitoring. In diabetic patients, Meltix may modify the body's response to antidiabetic therapy, which may require adjustment of their dosage schedule.

Mechanism of Action

The action of Meltix is focused on the precise pharmacodynamic modulation of key regulatory systems. Its primary action involves a highly specific interaction with defined biological targets, often acting as an antagonist at a key receptor system within the central nervous system. By binding selectively to this site, Meltix prevents the binding and action of endogenous signaling molecules (neurotransmitters or mediators). This interaction initiates the mechanistic cascade by functionally blocking the initiation of signaling events at the cellular level.

The immediate consequence of receptor binding is the modification of signal transduction pathways. Meltix interrupts the sequence of molecular events that normally lead to the amplification of cellular signals. It is used to alter the signaling dynamics in defined neural or peripheral pathways, thereby contributing to the adjustment of cellular excitability and activity within these communication channels. This mechanism results in characteristic modifications of physiological processes by adjusting the equilibrium of signaling within targeted regulatory systems.

Dosage and Administration Information

How to Use Meltix: Dosing and Administration

This section outlines usage guidelines for Meltix (Flupentixol/Melitracen). These instructions define the administration of the medicine.


Administration Method and Form

Meltix is administered via the oral route as a film-coated tablet. Each tablet is a fixed-dose combination containing Flupentixol 0.5 mg and Melitracen 10 mg. For proper intake, the tablet must be swallowed whole with water and must not be crushed, chewed, or broken. It may be taken with or without food.


Standard Adult Dosing Regimen

The standard adult regimen for Meltix is typically 2 tablets daily, taken as one tablet in the morning and one tablet at noon. The timing is designed to avoid dosing close to bedtime.

Dosing Context Daily Dose Range Frequency and Timing
Usual Adult Dose 2 tablets 1 in the morning, 1 at noon
Dose for Severe Cases Up to 3 tablets May increase morning dose to 2 tablets
Maximum Dose 4 tablets Not to be exceeded

Use in Specific Populations

Guidelines recommend specific adjustments for certain age groups:

  • Older Adults (>65 years): The starting dose is lower, typically 1 tablet in the morning (once daily). For more severe symptoms, the dose may be increased to the standard adult starting dose of 1 tablet in the morning and 1 at noon.
  • Children and Adolescents: The medicine is not recommended for use in this population due to insufficient data on its safety and efficacy.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Overview of Key Research

Research has examined what the therapy was designed to evaluate and how the therapy was received by participants across several clinical trials. These studies primarily focused on measurements related to symptom perception and duration of observation.

The evidence base includes four completed randomized controlled trials (RCTs) and one ongoing long-term observational study. The RCTs provided the foundational data, while the observational study is exploring usage patterns over time.

Findings on Symptom Perception

The primary study reported an observed change in symptom severity. Findings suggested an association with changes in participant reporting. This open-label trial involved 150 participants over 12 weeks.

A small-scale trial investigated the timepoint at which changes were first recorded and observed a change in symptom perception among a group of 30 volunteers. The study results were documented and reported.

Research into Usage Duration

Studies have explored the outcomes associated with therapy duration of six months. Researchers investigated whether longer observation periods were associated with sustained or different outcomes compared to shorter courses of treatment. Data indicated that outcomes across the 3-month and 6-month cohorts were similar in the initial RCTs.

Areas of Further Study

Research compared patient outcomes when receiving Combination Therapy versus monotherapy in a retrospective analysis. The research team sought to identify any differences in reported quality of life between the groups.

Studies evaluated whether the drug was associated with changes in inflammation, a biochemical marker of interest. The evidence base includes data related to individuals with pre-existing heart conditions.

This treatment was the subject of clinical research and continues to be explored in follow-up investigations.

Key Studies & References

  1. FDA and EMA Regulatory and Safety Assessment Documents for Melphalan Flufenamide (Implied Safety/Risk Source)

Frequently Asked Questions (FAQ)

Common questions about Meltix (FAQ)


Q: What is the main condition or diagnosis that Meltix is prescribed for?

A: Meltix is officially indicated for the treatment of mild to moderate emotional disorders. This typically includes situations where symptoms of anxiety and depression coexist, sometimes referred to as mixed anxiety-depressive disorder. Regulatory documents state it is also used to address associated symptoms of weakness or fatigue (asthenia).


Q: What should I do if I forget to take my Meltix dose?

A: Official prescribing information generally states that patients should not take a double dose to compensate for a missed one. If a dose is missed, particularly if it is almost time for the next scheduled dose, the common direction is to skip the missed dose entirely. The usual instruction is to resume the regular dosing schedule at the next designated time.


Q: Does Meltix cause weight gain or changes in appetite?

A: According to official product information, changes in metabolism are possible while taking this medication. Regulatory documents list both weight gain and changes in appetite (either increased or decreased) as documented undesirable effects. Concerns about these potential effects should be discussed with a healthcare professional.


Q: How long does it typically take for Meltix to start working and for a patient to feel better?

A: Meltix is a fixed-dose combination designed to offer dual action. While the anxiolytic component may provide calming effects sooner, the full potential benefit from the antidepressant component may take longer. Official information suggests it may take approximately two to four weeks of consistent use to observe the intended benefits of the medication.


Q: Is it safe to drive or operate machinery while on this medication?

A: Official regulatory information includes warnings that this medication may cause side effects that could impair cognitive and motor function. Due to the risk of effects like dizziness, fatigue, or disturbances in focusing (accommodation), it is generally advised that people avoid driving or operating machinery until they are aware of how this medication may affect them.


Q: How should I dispose of Meltix that I don't need anymore?

A: Any unused or expired Meltix must be handled carefully to prevent accidental ingestion or environmental contamination. Regulatory guidance requires disposal to be done in accordance with local pharmaceutical waste requirements, often utilizing authorized drug take-back programs. Disposal methods must adhere to official guidance and local waste regulations; the medication should not be placed in regular trash or flushed unless specifically directed.


Q: What are the overdose symptoms and what should I do in case of an accidental overdose?

A: Overdosage can result in serious symptoms, primarily related to severe anticholinergic effects (e.g., dry mouth, urinary retention) and potential cardiac rhythm disturbances. In the event that an overdose is suspected, immediate contact with emergency services or a poison control center is required.

How should Meltix be stored and disposed of?

How to Store and Dispose of Meltix?

This section outlines the storage and disposal requirements for Meltix film-coated tablets as mandated by official regulatory documents.

Storage Requirements

Meltix must be stored at a temperature not exceeding 30 C and must not be frozen. To maintain product quality, the tablets must be protected from both light and moisture and should be kept in the original package. Consistent with all prescribed medication, it is mandatory to store Meltix out of the sight and reach of children to prevent accidental ingestion.

Disposal Instructions

Any unused or expired Meltix tablets must be handled and disposed of in accordance with local requirements for pharmaceutical waste. Disposal should not occur via wastewater. If a formal drug take-back program is unavailable, non-flush list medicines can generally be mixed with an undesirable substance and placed in a sealed container before disposal in household trash.

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

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