Mocalm

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Mocalm

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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 Mocalm

Here is a quick overview of Mocalm's key attributes:

Property Description
Active Ingredient Flupentixol (low dose) and Melitracen
Form Oral Tablet
Pharmacological Class Combination Antipsychotic/Antidepressant
Common Use Mild to moderate mental disorders (e.g., anxiety, depression)
Status Prescription-only in most regions

Understanding Mocalm: Definition and Classification

Mocalm is a prescription-only combination medicine primarily classified as an anxiolytic and antidepressant, typically presented as an oral tablet. Unlike single-ingredient drugs, Mocalm combines two synthetic active compounds: a low dose of the antipsychotic Flupentixol and the tricyclic antidepressant Melitracen. This unique pairing positions Mocalm for the management of mild to moderate mental health conditions where both anxiety and low mood are present. The formulation's dual action on mood and anxiety is clinically recognized for its intended therapeutic role in many global markets, distinguishing it from general anxiety or sleep aids.


Mocalm's Specialized Composition and Role

Mocalm's specialized composition is its defining feature, utilizing low-dose compounds to achieve a balanced therapeutic effect. The inclusion of Melitracen, an antidepressant, works to help elevate mood, while the Flupentixol component is included at a low dosage to provide a calming, anti-anxiety effect. The active ingredients belong to distinct pharmacological classes, an approach for simultaneously addressing the interwoven symptoms of anxiety and depression. This blend is designed to be a comprehensive supportive therapy for a patient experiencing both nervous tension and associated mood changes.


Differentiated Therapeutic Focus

Mocalm's therapeutic focus is on patients experiencing a combination of psychological symptoms, such as mild anxiety and lack of motivation, which can often co-occur. A common neutral use scenario is to help a patient manage persistent, low-grade anxiety that is accompanied by noticeable changes in energy or mood. Due to its potent active ingredients and prescription status, Mocalm differs significantly from over-the-counter supplements and requires consultation and monitoring by a healthcare professional.

What side effects are possible with Mocalm?

Possible Side Effects and Safety Information

The safety profile for Mocalm, a combination product containing Flupentixol and Melitracen, is established through official regulatory documents, which classify potential adverse reactions primarily by frequency and the body system affected.

Official Side Effect Classification

Adverse effects are documented across multiple System-Organ Classes (SOCs), with reactions commonly reported in the Nervous System (e.g., tremor, dizziness) and Gastrointestinal Disorders (e.g., dry mouth, constipation). Effects on the Psychiatric System (insomnia, agitation, restlessness) are also classified as common. These classifications reflect how regulatory documents organize and communicate the medicine's potential impact.

Serious Safety Considerations and Regulatory Constraints

Specific serious adverse reactions, although typically rare, are officially documented in the drug's safety information. These include the risk of Neuroleptic Malignant Syndrome (NMS), severe Cardiovascular Risks such as a Prolonged QT interval, and specific Blood Disorders (e.g., agranulocytosis). Consistent with related medications, the risk of suicide or suicidal thoughts may persist or increase in the early stages of treatment.

Regulatory documents outline explicit safety limitations: Mocalm is contraindicated in certain severe heart conditions, such as the immediate recovery phase after a myocardial infarction or bundle-branch conduction defects, and must not be used concurrently with MAO inhibitors.

Population and Time-Related Safety Patterns

Specific safety warnings apply to certain populations: Older people with dementia taking related medicines have a documented small increased risk of death. Furthermore, exposure during the third trimester of pregnancy carries the potential for extrapyramidal and/or withdrawal symptoms in neonates. Regulatory information also notes that effects like extrapyramidal symptoms are often associated with the initial phase of treatment, while involuntary movements may be associated with long-term exposure.

Overdose and Emergency Response

Overdose and When to Seek Help

This section details the officially documented overdose manifestations and required emergency actions for Mocalm (Flupentixol/Melitracen) as specified in government regulatory documents.


Required Emergency Actions

If you or anyone else may have taken too many tablets, contact your doctor or nearest hospital casualty department immediately.

This action is mandatory even if there are no signs of discomfort or poisoning, due to the potential for delayed or severe effects. You must take the Mocalm container with you to the hospital or doctor to aid in proper management.


Documented Overdose Manifestations

Overdose effects are related to the drug's two components and can be severe, requiring immediate medical attention and monitoring. Officially documented manifestations may include:

System Documented Signs and Symptoms
Central Nervous System (CNS) Sleepiness (somnolence), unconsciousness, coma, convulsions (fits), irritability, hallucinations, extrapyramidal symptoms.
Cardiovascular System Fast heart rate (tachycardia), irregular heartbeat (arrhythmias), low blood pressure (hypotension), and circulatory collapse.
Autonomic/Other Dilated pupils, difficulty urinating (urinary retention), mucosal dryness, and changes in body temperature (hyperthermia or hypothermia).

Serious outcomes officially listed include coma, severe cardiac arrhythmias, and respiratory difficulties. No specific antidote is available; management focuses on supportive care, with consideration for gastric lavage and activated charcoal.

Therapeutic Uses of Mocalm

What Mocalm Treats: Main Uses and Benefits

Mocalm is considered relevant for symptomatic management in specific mental health contexts, particularly where mood and anxiety symptoms overlap and are generally mild to moderate in severity.

This medicine is relevant for managing emotional disorders. It is commonly used to address conditions marked by persistent co-occurring anxiety, low mood, and often related symptoms like nervous tension and lack of motivation. The medication is applied in clinical situations characterized by nervous tension or excessive worry that consistently appears alongside feelings of low spirits. The primary benefit provided is supportive relief that may help patients cope more steadily with the combined burden of emotional distress.

“The therapeutic focus is relevant for easing the interwoven symptoms of nervous tension and associated mood changes.”

The medication is commonly used to help with related symptoms such as asthenia, which involves psychological weakness, low energy, and lack of motivation. Addressing these symptoms may assist with easing the impact of persistent psychological strain on routine activities, supporting patients during episodes of heightened discomfort. It is commonly used in conditions marked by persistent, low-grade symptoms, rather than those presenting with severe symptomatic escalation, which may assist with easing the overall symptom load.


Quick Fact: Relief for Combined Psychological Symptoms
Primary Focus Used for managing symptoms in mild to moderate emotional disorders.
Symptom Type Anxiety, low mood, and lack of drive appearing together.
Context Supportive care for persistent, low-grade symptom patterns.

Eligibility and Restrictions for Use

Official Eligibility: Who Can and Cannot Use Mocalm?

The population eligibility for Mocalm (Flupentixol/Melitracen) is strictly determined by regulatory documentation, defining groups for whom use is allowed, restricted, or absolutely contraindicated.

Absolute Contraindications (Must Not Use)

Use of Mocalm is strictly prohibited for patients with a recent myocardial infarction (heart attack), specific cardiac rhythm disorders (e.g., atrioventricular block, coronary artery insufficiency), or those in a state of circulatory collapse or coma.

Additionally, Mocalm is contraindicated for individuals currently taking, or who have taken within the last 14 days, Monoamine Oxidase Inhibitors (MAOIs), as well as patients with phaeochromocytoma or pre-existing blood disorders.

Population Restrictions and Conditional Use

Population Group Eligibility Status (Regulatory Wording)
Age (Under 18) Not recommended (safety and efficacy not established).
Pregnancy Should not be administered unless benefit outweighs risk.
Lactation Not recommended (components pass into breast milk).
Older Adults (>65) Use requires caution.
Severe Depression Not recommended (e.g., cases requiring hospitalization).

Use is also advised with caution in patients with advanced hepatic disease, hyperthyroidism, untreated angle-closure glaucoma, or a history of convulsions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Mocalm is defined by documented regulatory constraints, primarily involving prohibited combinations and additive effects on the central nervous and cardiovascular systems, as defined by health authorities.

Prohibited and Restricted Combinations

  • Monoamine Oxidase Inhibitors (MAOIs) are strictly contraindicated due to the potential for severe, life-threatening reactions, including serotonin syndrome and hypertensive crisis. A mandatory separation period of 14 days is required after discontinuing non-selective MAOIs, and at least one day for selective inhibitors like Moclobemide or Selegiline.
  • Co-administration with drugs known to significantly prolong the QT interval (e.g., Class Ia and III antiarrhythmics) must be avoided to mitigate the increased risk of malignant arrhythmias.

Pharmacodynamic and Metabolic Constraints Mocalm's active components, a neuroleptic and a tricyclic antidepressant, are documented to mutually inhibit the metabolism of one another, which may increase the plasma concentration of both compounds. Pharmacodynamically, co-use with alcohol or other CNS depressants (e.g., opioids, barbiturates) results in an enhanced depressant response. Furthermore, Mocalm may reduce the therapeutic effect of certain antihypertensive agents and increase the risk of extrapyramidal disorders when combined with agents like metoclopramide.

Population Considerations Regulatory information states that in diabetic patients, co-administration may officially modify insulin and glucose responses, requiring adjustment of the antidiabetic therapy. Susceptible individuals with electrolyte disturbances also face heightened risk.

Mechanism of Action

The mechanism of action results from the concurrent engagement of two distinct molecular processes within central monoamine pathways. The Melitracen component operates through reuptake inhibition of both Norepinephrine (NE) and Serotonin (5-HT) by blocking their respective transporters. This increases the concentration and duration of these neurotransmitters in the synaptic cleft, initiating a molecular cascade that drives long-term alterations in synaptic density and neuronal signaling.

Simultaneously, the Flupentixol component engages in selective antagonism of central Dopamine D2 receptors and D2 autoreceptors. This targeted blockage disarms the inhibitory feedback mechanism, acutely increasing functional dopamine signaling in specific neural circuits.

This combined effect establishes complementary kinetic timing: the rapid dopamine modulation produces a swift shift in the activity of neural circuits that modulate motivation and autonomic arousal. This transient adjustment interacts with the slower, sustained physiological adaptation required for NE/ 5-HT enhancement, resulting in the integrated adjustment of both active and long-term signaling states within monoamine regulatory systems.

Dosage and Administration Information

How to Use Mocalm: Official Administration Guidelines

This section describes the high-level, standardized usage principles for Mocalm (Flupentixol 0.5 mg / Melitracen 10 mg), focusing strictly on administration and dosing patterns.


Administration and Dosage Principles

Mocalm is supplied as an oral film-coated tablet, which constitutes the sole approved route of administration. The tablets must be swallowed whole with a drink of water and should not be chewed. Administration is permitted with or without food.

Dosing Schedule and Timing

The frequency and timing of Mocalm are specifically constrained. Dosing is typically twice daily—once in the morning and again at noon. This schedule avoids late-day administration, which aligns with known usage patterns.

Population Starting/Usual Daily Regimen Maximum Recommended Daily Dose
Adults (General) 2 tablets (1 morning, 1 noon) 4 tablets
Older Adults (> 65 years) 1 tablet in the morning 2 tablets (in severe cases)

Usage Duration and Special Considerations

For the general adult population, the typical maintenance dose is one tablet in the morning. Standard instructions specify that if no effect is observed after approximately one week of treatment at the maximum recommended dose, the medication should be reassessed or discontinued.

Use in children and adolescents under 18 years of age is not recommended due to a lack of established clinical data. While dose adjustments are not explicitly required for patients with reduced renal or hepatic function, administration in these groups is based on standard adult or geriatric regimens.

Recent Clinical Evidence

Research evidence / Overview of Studies for Mocalm (Flupentixol/Melitracen)

Evidence for Use in Mild to Moderate Anxiety and Depression

Research on Mocalm's combination of Flupentixol and Melitracen has primarily involved Randomized Controlled Trials (RCTs). These short- and intermediate-term studies were used in research exploring how symptoms change over time in adults experiencing mild to moderate anxiety and depression simultaneously. To measure the impact, researchers used studies examining symptom intensity or variability via standardized scales such as the Hamilton Anxiety Rating Scale (HAM-A) and the Hamilton Depression Rating Scale (HAM-D).

Evidence for Use in Gastrointestinal and Other Symptom Management

Mocalm was studied for use in patient populations experiencing symptoms in contexts beyond mood and anxiety alone. For conditions like Functional Dyspepsia (FD), which involves patient-reported outcomes describing perceived discomfort in the stomach, research has explored whether the combination was associated with changes, often as an adjunct to other treatments. Similarly, the combination was studied for Refractory Chronic Cough (RCC)—a condition where cough persists despite multiple prior treatments. These short-term RCTs explored outcomes related to systemic or functional imbalance by monitoring changes in the Cough Symptom Score (CSS).

What Is Still Uncertain About Mocalm Research

The overall evidence landscape has several key areas where findings describe group patterns, not personal outcomes. One significant limitation is the lack of large, head-to-head comparative evidence; few trials have been conducted to definitively compare the combination against standard, single-ingredient treatments for mood and anxiety. Subgroup findings are uncertain due to limited data for certain groups, particularly special populations like older adults. Furthermore, the evidence quality varies across studies, and for applications like Persistent Idiopathic Facial Pain (PIFP), the reliance on retrospective analysis means the certainty remains low. Long-term effects are not fully established regarding how any measured changes are sustained when the combination is used over extended periods.

Frequently Asked Questions (FAQ)

Common questions about Mocalm (FAQ)

Q: What types of foods or drinks should be limited while taking Mocalm?

Official warnings strongly advise against consuming alcohol. This is because combining it with Mocalm can enhance depressant effects, potentially leading to increased dizziness or drowsiness. Regulatory guidance for Mocalm specifies that administration is permitted with or without food.

Q: Is Mocalm safe for older adults (seniors)?

Regulatory information advises that Mocalm should be used with caution in older adults. This is due to an increased sensitivity to potential side effects. Official guidance often suggests lower initial doses and careful monitoring for effects like anticholinergic responses or risk of falls.

Q: Has Mocalm been studied in different patient populations?

Regulatory-related research indicates that Mocalm has been studied in specific adult populations beyond its primary use in mild anxiety and depression. Studies have examined its use in patients with conditions like functional dyspepsia and refractory chronic cough to observe how symptoms change over time.

Q: Is Mocalm okay to take if I have a history of liver problems?

Use requires caution in patients who have a history of liver (hepatic) disease. Dose reduction may be necessary in some cases. Official product information notes that a healthcare professional must determine if the potential benefit of Mocalm outweighs the risk in this circumstance.

Q: Is it normal to feel a difference in the first week of using Mocalm?

Clinical experience indicates that some patients may begin to experience a noticeable change within 5 to 7 days of starting treatment. However, official information describes that the full intended effects often require sustained use, with changes observed after 2 to 4 weeks.

Q: How long does the effect of Mocalm last?

The duration of the medicine's effect is related to how long the active compounds remain in the body. For instance, the Flupentixol component has a relatively long elimination half-life, which is approximately 34 hours.

Q: Does Mocalm cause weight gain or weight loss?

Official safety information sometimes lists increased appetite as a common side effect. Official documents concerning weight change from the combination product may not be uniformly reported across all regulatory labels.

Q: Can Mocalm make you feel tired or drowsy?

Yes, official regulatory documents list fatigue and drowsiness or mild sedation as common side effects.

Q: Is Mocalm habit-forming or addictive?

Regulatory-consistent information states that the medicine is non-habit forming.

Q: What happens if I forget to take a dose of Mocalm?

Regulatory-consistent information states that a missed dose should be taken as soon as it is remembered. However, if the time for the next scheduled dose is close, the regulatory-consistent instruction is that the missed dose should be skipped.

Q: What is the risk of stopping Mocalm suddenly?

Regulatory safety information warns that abrupt discontinuation of Mocalm should be avoided. Stopping abruptly may lead to withdrawal symptoms. Official safety information notes that Mocalm should be discontinued under medical supervision.

Q: Does Mocalm affect your ability to drive or operate machinery?

Official warnings state that Mocalm may cause drowsiness or cognitive impairment. Patients are therefore advised to use caution when driving or operating machinery.

Q: Is there a generic version of Mocalm available?

Mocalm is one specific brand name for the combination of Flupentixol and Melitracen. The combination itself is available under multiple equivalent brand names and combination products from different manufacturers across various global regions.

Q: Does taking Mocalm affect blood pressure readings?

The melitracen component, a tricyclic antidepressant, is associated with a risk of hypotension (low blood pressure). For this reason, official guidance suggests that periodic blood pressure monitoring may be advised during treatment.

Q: What should be done if an allergic reaction to Mocalm is suspected?

Suspected serious adverse reactions, such as allergic reactions (e.g., rash or swelling), are considered a medical concern. Official guidance requires that any suspected serious adverse reactions, such as allergic reactions, be reported to a physician promptly.

Q: Is Mocalm safe for people with kidney issues?

Use requires caution in patients with kidney (renal) impairment. Official product information notes that a healthcare professional must determine if the potential benefit of Mocalm outweighs the risk in this patient population.

Q: Does Mocalm require regular blood tests?

Regulatory information advises periodic monitoring of certain parameters if the medicine is used for a prolonged period. This monitoring often includes parameters such as liver function tests and a cardiovascular assessment.

Q: What is the difference between Mocalm and a placebo in clinical trials?

Studies have examined how Mocalm performs against an inactive placebo in clinical trials. For example, studies in conditions like refractory chronic cough have noted a statistically significant difference in patient-reported outcomes compared to placebo.

Q: Is Mocalm associated with any reports of vision changes?

Regulatory safety documents list accommodation disorder as a common side effect. Accommodation disorder is a term for a problem with the eyes' ability to focus clearly on objects at different distances.

Q: Does Mocalm affect appetite?

Increased appetite is listed in some regulatory-consistent safety information as a common side effect.

How should Mocalm be stored and disposed of?

How to Store and Dispose of Mocalm?

The storage and disposal of Mocalm (Flupentixol/Melitracen) must comply strictly with official regulatory specifications to ensure product quality and public safety.

Official Storage Conditions

Mocalm tablets must be stored at a temperature not exceeding 30 C. The medicine requires protection from light and must be kept in a dry place to maintain its stability and labeled shelf-life. To prevent accidental ingestion, a mandatory requirement is to keep the product out of the sight and reach of children.

Disposal Instructions

Disposal of any unused or expired Mocalm tablets must be executed in accordance with local requirements for pharmaceutical waste, as instructed by regulatory bodies. This requirement prevents the improper disposal of medicine through ordinary household trash or wastewater systems.

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

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