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Sertralina Cinfa

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Medically reviewed

Laura Arias

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.

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Overview of Sertralina Cinfa

Quick Facts

Property Description
Active ingredient Sertraline (hydrochloride)
Form Film-coated tablets
Pharmacological class Selective Serotonin Reuptake Inhibitor (SSRI)
General purpose Supports mood stability and neurological balance
Origin Synthetic compound
Status Prescription-only (Rx)

What Type of Medicine is Sertralina Cinfa?

Sertralina Cinfa is a strictly prescription-only medication manufactured by Laboratorios Cinfa S.A. and is classified as a Selective Serotonin Reuptake Inhibitor (SSRI). This places it within the broader group of antidepressant agents used to modulate key aspects of brain chemistry. The active ingredient, Sertraline (INN), is a synthetically produced compound characterized by its targeted action against the serotonin reuptake mechanism. This drug is utilized for its focused approach to managing conditions related to emotional balance.

Composition, Form, and Differentiation

The pharmaceutical preparation is a single-ingredient product featuring the synthetic active substance, Sertraline (as the hydrochloride salt). Sertralina Cinfa is manufactured as an oral, solid preparation, specifically in the form of film-coated tablets designed for ingestion via the oral route. Unlike certain other SSRI formulations, this product is consistently presented as a film-coated tablet, offering a standard and easily recognizable form. The composition includes typical pharmaceutical excipients, such as lactose monohydrate and microcrystalline cellulose, which provide structure and stability to the solid dosage form.

General Therapeutic Purpose of an SSRI

The fundamental goal of this medication is to influence the brain chemical serotonin (5-HT), which is a key messenger in pathways regulating mood. The drug achieves this by temporarily blocking the mechanism that reabsorbs serotonin back into nerve cells. By inhibiting this presynaptic serotonin reuptake, the medicine increases the functional amount of serotonin available between neurons. This chemical adjustment serves the general purpose of supporting emotional equilibrium and stabilizing mood, which is why SSRIs are commonly utilized in the management of related neurological issues.

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What side effects are possible with Sertralina Cinfa?

Possible Side Effects and Safety Information

Sertralina Cinfa's safety profile is formally classified by regulatory authorities, detailing potential adverse reactions according to frequency and the body systems affected. These classifications are strictly derived from official government prescribing documents.

Frequency-Classified Adverse Reactions

The medicine is associated with reactions categorized by frequency in clinical trials:

Classification Common Examples Affected System-Organ Class
Very Common (ge 1/10) Nausea, Dry Mouth, Diarrhea, Insomnia Gastrointestinal, Psychiatric
Common (ge 1/100 to <1/10) Dizziness, Tremor, Increased Sweating Nervous System, Skin

Serious Adverse Reactions and Safety Notes

Regulatory warnings highlight the potential for serious adverse reactions, which are officially documented but rare. These include the risk of developing Serotonin Syndrome and the potential for increased suicidal thoughts and behavior, particularly in pediatric, adolescent, and young adult patients, requiring close monitoring during treatment initiation and dose changes. The label also notes risks for Abnormal Bleeding and Hyponatremia (low blood sodium).

Use is contraindicated with Monoamine Oxidase Inhibitors (MAOIs) due to the risk of Serotonin Syndrome and with the concomitant use of Pimozide. Population-specific notes require caution for older adults (due to increased risk of hyponatremia) and for patients with hepatic impairment, as the drug's clearance may be reduced.

This structural framework establishes the official risk landscape by defining the likelihood of common effects and emphasizing the potential for severe, rare events, as mandated by the regulatory authority.

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Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

Official labeling for Sertraline overdose documents a range of potential symptoms, and mandates immediate medical intervention due to the risk of severe complications.

Feature Official Regulatory Statement
Documented Overdose Presentations Symptoms often include somnolence, nausea, vomiting, tachycardia (rapid heartbeat), dizziness, agitation, and tremor (shaking).
Physiological Systems Affected Effects are noted on the Central Nervous System (CNS), cardiovascular system, and gastrointestinal system.
Dose-Related Factors Severe outcomes, including fatalities, have been reported, primarily when Sertraline was taken in combination with other drugs and/or alcohol.
Emergency Actions Required Seek immediate medical attention or call emergency services immediately for any suspected overdose.

The most serious documented manifestations include Serotonin Syndrome, convulsions (seizures), and severe cardiac events such as QTc prolongation and Torsade de Pointes.

No specific antidote is known for Sertraline overdosage. Management is strictly symptomatic and supportive, which involves maintaining a patent airway, ensuring adequate oxygenation, and continuous monitoring of cardiac and vital signs (e.g., ECG monitoring). Activated charcoal may be considered as a decontamination measure, but induction of emesis (vomiting) is not recommended. Patients with pre-existing hepatic impairment may be at increased risk of increased overdose severity.

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Therapeutic Uses of Sertralina Cinfa

What Sertralina Cinfa Treats: Main Uses and Benefits

Sertralina Cinfa is used to provide symptomatic support across several therapeutic domains. It is applied in contexts where symptoms interfere with daily functioning and stability. Clinical indications for this medication include Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Panic Disorder, Post-Traumatic Stress Disorder (PTSD), Social Anxiety Disorder (SAD), and Premenstrual Dysphoric Disorder (PMDD).

The medication is commonly used during phases of increased distress or discomfort, often when symptoms are more noticeable. It helps address symptom clusters that may become intense or disruptive, such as prolonged sadness, recurring episodes of intense fear, or unwanted, intrusive thoughts.

“This supportive benefit may assist with easing the overall symptom load, helping patients cope more steadily with symptom fluctuations.”

This supportive treatment is relevant across acute therapeutic contexts and supports general well-being during symptomatic phases, assisting with the maintenance of comfort during routine activities.


Quick Fact: Relief for Obsessive and Anxiety-Driven Symptoms

Domain Symptom Clusters Common Benefit
Mood/Affective Persistent sadness, loss of pleasure, cyclical irritability (PMDD) Supports emotional equilibrium and stability.
Anxiety/Fear Panic attacks, social avoidance, chronic worry (SAD, PD) Contributes to reduced fear intensity and avoidance behaviors.
Intrusive/Compulsive Unwanted thoughts, ritualized behaviors (OCD, PTSD) Helps lessen symptom interference with functional capacity.
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Eligibility and Restrictions for Use

Who can and cannot use Sertralina Cinfa?

The official regulatory profile for Sertralina Cinfa outlines specific eligibility and non-eligibility requirements based on age, concurrent medication use, and existing medical conditions.

Absolute Contraindications (Prohibited Use)

The medicine is contraindicated and must not be used by patients with a known hypersensitivity to the active substance or any excipients. Additionally, concurrent use with Monoamine Oxidase Inhibitors (MAOIs), requiring a mandatory 14-day washout period, is prohibited. Co-administration with Pimozide is also strictly contraindicated.

Age and Use Restrictions

Population Eligibility Status (Regulatory)
Adults (18+ years) Approved for all labeled indications.
Children (6–17 years) Approved only for Obsessive-Compulsive Disorder (OCD). Use for other indications is not recommended.
Children (<6 years) Safety and effectiveness have not been established.

Conditional Use (Organ Function and Comorbidity)

Use is not recommended for patients with moderate or severe hepatic (liver) impairment due to significantly reduced clearance. Patients with mild hepatic impairment may be eligible but require a reduced starting dose. Use should be avoided in patients with unstable epilepsy and used with caution in those with a history of mania or hypomania.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Sertralina Cinfa (Sertraline) interacts with various medicines through both shared mechanisms in the body (pharmacodynamics) and effects on drug processing by the liver (pharmacokinetics).

Interacting Product Category Key Interaction Context/Risk
Monoamine Oxidase Inhibitors (MAOIs), including linezolid and intravenous methylene blue Contraindicated. Combining these medicines can lead to Serotonin Syndrome, a potentially life-threatening condition. A 14-day washout period is required when switching between Sertraline and an MAOI.
Other Serotonergic Drugs (e.g., Triptans, SNRIs, Fentanyl, Tramadol, Tryptophan, St. John’s Wort) Increased risk of Serotonin Syndrome. Use of these combinations should be closely monitored by a healthcare professional.
Drugs Affecting Bleeding/Platelet Function (e.g., Warfarin, NSAIDs, Aspirin, other antiplatelet drugs) Increased risk of bleeding events or hemorrhage due to Sertraline's effect on platelet function. Patients taking Warfarin require careful monitoring of their international normalized ratio (INR).
Pimozide Contraindicated due to the potential for serious heart rhythm problems.
CYP2D6 Substrates Sertraline is a weak inhibitor of the CYP2D6 liver enzyme, potentially increasing the plasma levels and effects of drugs metabolized by this pathway. Dosage adjustments of the co-administered drug may be necessary.
Phenytoin (and other highly protein-bound drugs) Co-administration may affect the body’s levels of either drug due to high protein binding; careful monitoring of drug plasma levels is required, especially for Phenytoin.
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Mechanism of Action

How Sertralina Cinfa Works

Selective Modulation of the Serotonergic System

Sertralina Cinfa's mechanism is the selective inhibition of the sodium-dependent serotonin transporter (SERT) in the brain. By blocking this presynaptic reuptake mechanism, the drug ensures an immediate increase in the functional concentration of serotonin (5- HT) within the neuronal synapse. This action targets key central pathways that rely on serotonin for signaling, thereby initiating the molecular steps that lead to the establishment of new steady-state 5- HT levels.

Time-Dependent Neural Adaptation and Tone Enhancement

The immediate rise in synaptic 5- HT is followed by a slower, crucial adaptive process: the desensitization and downregulation of presynaptic 5- HT1A autoreceptors. This mechanism overrides the neuron's self-regulatory feedback, leading to a sustained enhancement of serotonergic signaling and neuronal firing over several weeks. This delayed physiological consequence is a necessary physiological step for the establishment of sustained functional changes within CNS circuitry.

Influence on Neuroplasticity and Secondary Targets

Beyond its primary reuptake blockade, chronic use of Sertraline is associated with downstream modulation of neuroplasticity pathways, including the upregulation of factors like Brain-Derived Neurotrophic Factor (BDNF), a key protein involved in neural structure and viability. The drug also engages the Sigma-1 (sigma1) receptor and exhibits weak inhibitory action on the dopamine transporter (DAT), contributing to its observed physiological effect profile beyond simple 5- HT elevation.

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Dosage and Administration Information

How to Use Sertralina Cinfa

Sertralina Cinfa is an oral medication that follows a structured administration protocol. The film-coated tablets are taken once daily and may be administered with or without food. Although the exact timing is flexible (morning or evening), consistency in daily intake is generally followed.


Dosing and Adjustment Patterns

Sertraline therapy typically begins with a low starting dose that is subsequently adjusted. The usual initial dose for Major Depressive Disorder and Obsessive-Compulsive Disorder is 50 mg per day. For anxiety-related conditions such as Panic Disorder, Post-Traumatic Stress Disorder, and Social Anxiety Disorder, the starting dose is 25 mg per day, which is then increased to 50 mg after one week.

Dosing Parameter Standard Specification
Therapeutic Range 50 mg to 200 mg per day
Maximum Daily Dose 200 mg per day
Adjustment Interval Increments of 25 mg or 50 mg at at least one-week intervals

Contextual and Population Use

Usage instructions include guidance for specific populations. For patients with mild hepatic impairment, a starting and maximum dosage reduction to half the normal recommended amount is specified. No specific dosage adjustment is required for individuals with renal impairment.

A key procedural aspect of administration is that abrupt discontinuation must be avoided. When treatment is concluded, the dosage should be gradually reduced over a period of at least one to two weeks to manage the cessation process. In the event of a missed daily dose, the recommended protocol is to skip the missed dose entirely and resume the regular schedule the following day.

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Recent Clinical Evidence

Sertralina Cinfa: Recent Clinical Evidence

The available research on Sertraline is based on a structured clinical evaluation, primarily involving randomized controlled trials (RCTs) and meta-analyses that research examined how symptoms change over defined time intervals. These studies contribute to the broader evidence landscape by examining various outcomes related to symptom intensity, daily functioning, and overall condition. The findings describe group patterns and reflect the specific conditions under which they were conducted.


Evidence for Use in Major Depressive Disorder (MDD) and Obsessive-Compulsive Disorder (OCD)

Research for MDD included short-term RCTs, typically lasting 6 to 12 weeks, which was studied for how symptoms change over time in adult outpatients. These studies monitored outcomes by measuring scores on standardized rating scales, such as the Hamilton Depression Rating Scale (HDRS). In the adult populations studied, the findings reported measurable score changes on standardized instruments in the treatment groups compared to control groups.

For OCD, short-term controlled trials were applied in research contexts involving fluctuating or unstable symptoms. The research examined patient-reported outcomes describing perceived discomfort (ritualized behaviors and unwanted thoughts) using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).


Evidence in Special Populations and Uncertainties

Specific evaluations have been performed to understand how the medicine was studied for different age groups. The research for the pediatric group (ages 6–17) was evaluated in the context of OCD. For MDD in this age group, regulatory assessments have highlighted that the data for certain groups remain insufficient regarding long-term safety and overall effectiveness. Additionally, long-term effects are not fully established; there is limited information for outcomes related to continuous use over many years for the SSRI class generally.

For conditions like Panic Disorder (PD) and Post-Traumatic Stress Disorder (PTSD), regulatory concerns were noted regarding that follow-up durations were limited for assessing recurrence risk, and for PTSD, some studies reported patterns related to measured symptom change while others were mixed.

Key Studies & References

  1. Sertraline for Posttraumatic Stress Disorder (PTSD): An Overview of the Evidence and Treatment Guidelines
  2. National Institute for Health and Care Excellence (NICE) Clinical Guideline [CG123] - Depression in adults: recognition and management
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Frequently Asked Questions (FAQ)

Common questions about Sertralina Cinfa (FAQ)


Q: How long does it take for Sertralina Cinfa to start working and improve my symptoms?

Studies and official information indicate that the medicine's mechanism involves a delayed process of nerve cell adaptation that takes place over several weeks of continuous use. For this reason, clinical trials assessing changes in symptoms typically monitor effects over short-term periods, such as 6 to 12 weeks. Response times can vary. Patients are generally advised to follow the treatment regimen as prescribed to allow time for the drug's effects to become established.


Q: Are there any known foods or drinks I should avoid while taking this medication?

Regulatory guidance indicates that the use of alcohol should be avoided during treatment with this medicine. In terms of food, the drug may generally be taken with or without it. Official product information also highlights the importance of avoiding certain drug and herbal interactions, such as those with St. John's Wort.


Q: What should I do if I have been taking this drug for a long time and want to stop?

Official administration instructions emphasize that abrupt discontinuation must be avoided. When it is time to conclude treatment, the official instructions define that the dosage should be gradually reduced. This gradual reduction is done over a period of at least one to two weeks to help manage the overall cessation process.


Q: Can I use Sertralina Cinfa if I have liver or kidney problems?

Official prescribing information includes specific guidance for patients with impaired organ function. For those with mild liver impairment, a reduced starting and maximum dosage is specified. Use is not recommended in cases of moderate or severe liver impairment. For kidney impairment, no specific dosage adjustment is required.


Q: What are the common signs or symptoms of Serotonin Syndrome?

Serotonin Syndrome is a serious, potentially life-threatening condition associated with this class of medication. Official documents describe signs and symptoms that may include changes in mental status (like agitation or hallucinations), autonomic changes (like a fast heart rate or blood pressure changes), and neuromuscular changes (like tremor or overactive reflexes). Official documentation advises that individuals who suspect this condition should seek immediate medical attention.


Q: What should I do if I experience a serious or severe side effect while taking Sertralina Cinfa?

Serious adverse reactions are rare but officially documented, including the risk of severe abnormal bleeding and suicidal thoughts or behavior. Government health resources consistently advise that patients experiencing severe side effects should seek immediate medical attention. This guidance is provided to facilitate timely assessment.


Q: Are there different strengths (e.g., 25mg, 50mg, 100mg) of Sertralina Cinfa tablets available?

According to official product labeling, the medicine is manufactured as film-coated tablets in multiple strengths. These typically include 25 mg, 50 mg, and 100 mg tablets. These strengths are available to cover the full therapeutic dosing range.

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How should Sertralina Cinfa be stored and disposed of?

Storage & Disposal Map: How to Store and Dispose of Sertraline — Official Regulatory Information

Item Regulatory Statement
Labeled storage temperature requirements Store at room temperature, typically specified as 15 C to 30 C (59 F to 86 F) [1.5].
Light/moisture protection requirements Store away from excess heat and moisture and out of direct sunlight [1.5].
Packaging-related storage rules Keep the medication in the container it came in and the container must be kept tightly closed [4.3].
Child-protection storage requirements Keep this medication out of sight and reach of children [4.2]. Always lock safety caps and secure in a safe location [4.2].
Disposal instructions (as documented in government sources) Disposal is best done via a drug take-back location or prepaid mail-back envelope [2.1]. If unavailable, remove from the container, mix with an undesirable substance (e.g., coffee grounds), and place in a sealed bag/container before discarding in the household trash [2.1].
Environmental or controlled-waste disposal requirements The substance is classified as very toxic to aquatic life [3.5]. Avoid release to the environment (P273) and dispose of contents/container through an approved waste disposal plant (P501) [3.3, 3.5].

The regulatory profile defines that the tablets must be stored at room temperature, protected from heat and moisture, and kept in their original, tightly closed packaging, strictly away from children [1.5, 4.2]. Official disposal procedures prioritize take-back programs or a secure, non-divertible method for household trash, with explicit warnings against environmental release due to the compound's toxicity to aquatic life [2.1, 3.5].

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

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