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Andep (fluoxetine)

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Andep (fluoxetine)

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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.

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Overview of Andep (fluoxetine)

Quick Facts

Property Description
Active ingredient Fluoxetine Hydrochloride
Form Capsules, Tablets, Oral Solution
Pharmacological class Selective Serotonin Reuptake Inhibitor (SSRI)
General purpose Supports mood stability and emotional balance
Origin Synthetic compound

What is Andep (Fluoxetine)?

What Type of Medicine is Andep (Fluoxetine)?

Andep is a synthetic antidepressant medication containing the active ingredient Fluoxetine Hydrochloride. It is classified as a Selective Serotonin Reuptake Inhibitor (SSRI), a group of psychotropic drugs recognized worldwide as essential pharmacotherapy for mood stabilization. This authoritative designation confirms the drug's critical role in supporting mental health management. Unlike older pharmacological agents, the SSRI classification signifies a highly targeted therapeutic action, concentrating primarily on one key brain chemical. Fluoxetine is further distinguished within the SSRI class due to the long half-life of both the substance and its active metabolite, a property clinically recognized for supporting stable drug levels.

Compositional Identity and Pharmaceutical Forms

The medication is a single-ingredient product manufactured through chemical synthesis, assuring consistency and purity of the compound. Fluoxetine is administered via the oral route and is commonly available in several forms, which typically include standard capsules, tablets, and a liquid oral solution. This availability in liquid form offers flexibility for patients who may require alternatives to solid oral medication. The composition relies solely on Fluoxetine Hydrochloride, combined with necessary pharmaceutical excipients or a solvent vehicle for safe and effective systemic delivery.

General Purpose of Serotonin Modulation

The overarching purpose of Andep is to restore and sustain a functional equilibrium of the neurotransmitter serotonin (5-HT) within the brain. This is achieved by its selective action of inhibiting the reuptake of serotonin by presynaptic neurons, resulting in an increased availability of serotonin in the synaptic cleft. Its primary activity involves the high-affinity blockade of the serotonin transporter. This targeted neurochemical enhancement supports the broader therapeutic aim of facilitating neurochemical adjustments, which are essential for stabilizing mood, reducing psychological distress, and improving emotional regulation.

Regulatory References

  1. Fluoxetine MedlinePlus Drug Information
  2. Fluoxetine Mechanism of Action
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What side effects are possible with Andep (fluoxetine)?

Possible Side Effects and Safety Information

The safety profile of Andep (fluoxetine) is formally documented by regulatory authorities, which classify reported effects by frequency and the body's system or organ class. This descriptive framework is based on clinical trial and post-marketing data from government labels.


Official Adverse Reaction Listings and Frequency

Adverse reactions are classified according to frequency, typically using the WHO/ICH convention. Very Common (1/10) effects generally include headache, insomnia, nausea, and diarrhea. Effects listed as Common (1/100 to < 1/10) span several body systems and include anxiety, tremor, dry mouth, loss of appetite (anorexia), and various forms of sexual dysfunction.


Serious Adverse Reactions and Systemic Safety Concerns

Official labeling outlines several serious conditions associated with fluoxetine. These include the risk of Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions. An increased risk of Suicidal Thoughts and Behavior is documented in short-term studies for children, adolescents, and young adults (up to age 24), requiring close monitoring during initial treatment and dose changes. The medication may also be associated with Cardiac Arrhythmias, specifically QT interval prolongation.


Contextual and Population Safety Notes

The occurrence of certain effects is linked to the timing of use; for instance, akathisia (restlessness) is often noted in the first few weeks of treatment. Population-specific considerations are documented, such as the need for a lower or less frequent dosage for patients with hepatic impairment due to the liver's role in metabolism. Furthermore, regulatory documents specify the requirement for monitoring growth and pubertal development in the pediatric population throughout and after treatment.

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Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for fluoxetine overdose describes a spectrum of documented manifestations and high-risk scenarios. Common clinical presentations include nausea, vomiting, dizziness, tremor, CNS excitation, restlessness, hypomania, and fever. More severe neurological findings, such as seizures (convulsions), are also officially noted.

Overdose has the potential for serious or life-threatening outcomes affecting the Central Nervous System and Cardiovascular system. These complications include Serotonin Syndrome and significant cardiac toxicity, specifically QTc interval prolongation and Torsade de Pointes (TdP), which can lead to ventricular arrhythmia and cardiac arrest. The risk of severe outcomes is increased by the co-ingestion of other drugs. Elderly patients are noted in official labeling as a population with an increased risk of severe complications.

Immediate medical attention must be sought for any suspected overdose. Regulators mandate that management should begin by consulting a Poison Control Center or local emergency medical service. Since no specific antidote is known, treatment is symptomatic and supportive. Officially described management procedures involve ensuring adequate airway and ventilation, continuous cardiac monitoring, and the consideration of activated charcoal administration.

Official Regulatory Summary

The profile is defined by the dual risk of neurological toxicity and severe cardiovascular events, necessitating urgent emergency response. The official documents strictly direct immediate help-seeking to manage these life-threatening risks, with treatment focused entirely on supportive care and observation.

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Therapeutic Uses of Andep (fluoxetine)

What Andep (Fluoxetine) Treats: Main Uses and Benefits

Andep is commonly used to help manage symptoms related to mood, behavior, and anxiety, in conditions characterized by episodic or fluctuating symptom manifestations that interfere with daily functioning. It is generally applied across domains where additional symptomatic support is needed and provides support that helps ease the overall symptom burden.

The medication is considered relevant for a range of conditions, including Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Bulimia Nervosa, Panic Disorder, and Premenstrual Dysphoric Disorder (PMDD). It is often used when symptoms intensify, with the core benefit being to contribute to emotional balance. “This support assists with maintaining functional stability by easing the intensity of acute, distressing manifestations.”


Quick Fact: Relief for Obsessive and Compulsive Symptoms

Category Description
Symptom Focus Persistent sadness, intrusive thoughts, compulsive rituals, severe cyclical mood changes, and acute panic.
Clinical Contexts Conditions involving recurrent or episodic manifestations, such as MDD, OCD, and PMDD.
Primary Benefit Contributes to the stabilization of emotional balance and supports general well-being during symptomatic phases.

Regulatory References

  1. NIH MedlinePlus overview of Fluoxetine
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Eligibility and Restrictions for Use

Eligibility Scope

The eligibility for using fluoxetine is defined by official regulatory documents, specifying populations who are permitted, restricted, or prohibited from use.

Category Official Regulatory Status
Populations for whom use is allowed Adults for all approved indications. Adolescents (8–18 years) for Major Depressive Disorder and Children (7–17 years) for Obsessive-Compulsive Disorder are permitted [FDA Label].
Populations for whom use is contraindicated Patients with known Hypersensitivity to fluoxetine. Co-administration is prohibited with Monoamine Oxidase Inhibitors (MAOIs), pimozide, or thioridazine [FDA Label].

Condition-Specific and Physiological Restrictions

Fluoxetine use is subject to specific limitations for certain physiological states and co-occurring conditions:

  • Hepatic Impairment: Patients with liver dysfunction require a lower or less frequent dosage due to the risk of drug accumulation [FDA Label].
  • Renal Impairment: Caution is generally advised, and a reduced dose may be considered in severe cases.
  • Pregnancy and Lactation: Use during pregnancy is conditional and only permitted if the potential benefit justifies the risks. Breastfeeding is not recommended as the medication is excreted in human milk [FDA Label].
  • Other Restrictions: Use requires caution in older adults, and in patients with a history of seizures or conditions that may predispose to QT prolongation [FDA Label].
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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation identifies several categories of drugs and products that interact with fluoxetine. These interactions are primarily structured around the drug’s role as a potent inhibitor of the CYP2D6 enzyme and its effect on serotonin levels.

Contraindicated Combinations

Fluoxetine is contraindicated for use with Monoamine Oxidase Inhibitors (MAOIs), including linezolid and intravenous methylene blue. A washout period of at least 14 days is required when switching from an MAOI to fluoxetine, and a period of 5 weeks is required when switching from fluoxetine to an MAOI. Co-administration with the antipsychotic medicines pimozide and thioridazine is also contraindicated due to the risk of cardiac effects.

Clinically Significant Interactions

Interaction Domain Affected Products/Classes Required Constraint
Serotonergic Activity Triptans, TCAs, Tramadol, Lithium, St. John's Wort Close monitoring for Serotonin Syndrome
Enzyme Inhibition Drugs metabolized by CYP2D6 (e.g., certain tricyclic antidepressants) Monitoring of the co-administered drug’s plasma levels
Bleeding Risk Warfarin, NSAIDs, Aspirin Monitoring for increased risk of bleeding

Fluoxetine can significantly increase the concentration of drugs that are substrates for the CYP2D6 enzyme. The co-administration of fluoxetine with other serotonergic medicines necessitates vigilance, especially when initiating treatment or increasing the dose, due to the potential for excessive serotonin activity.

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Mechanism of Action

Selective Blockade of Serotonin Reuptake

Fluoxetine's primary mechanism involves the inhibition of the Serotonin Transporter (SERT), a protein located on presynaptic neurons. By binding to the SERT, the drug prevents the reabsorption of serotonin (5-HT), which immediately increases the concentration and availability of this neurotransmitter in the synaptic cleft . This initial molecular step initiates a cascading effect that influences sustained signaling activity within the serotonergic system.

⏳ Functional Regulation and Neurochemical Modulation

Subsequently, the elevated serotonin levels trigger a time-dependent regulatory process involving the gradual desensitization of 5-HT1A autoreceptors. The desensitization of this inhibitory feedback loop shifts the neurochemical balance, resulting in a sustained increase in functional serotonin signaling rather than a transient spike. This adjustment dictates the required period for maximal pathway modulation.

Modulation of Neuroplasticity and Structural Change

Chronic serotonergic activity modulates the expression of factors like Brain-Derived Neurotrophic Factor (BDNF), influencing neuroplasticity. This mechanism promotes the growth and connectivity of neurons (neurogenesis) within circuits that modulate emotional processing . This structural and functional change represents the final step in the cascade, influencing the modulation and persistence of activity within the affected neural pathways.

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Dosage and Administration Information

How to Use Andep (Fluoxetine)

The usage of fluoxetine is strictly defined by guidelines establishing precise protocols for administration and dose adjustment. The medicine is administered exclusively via the oral route and is available in forms including capsules, tablets, and a liquid solution.

Administration and Timing Principles

The standard pattern involves taking the medicine once daily, typically in the morning, to maintain consistent systemic levels. The dose may be administered with or without food, as absorption is not significantly affected by meals. The liquid solution requires a calibrated measuring device to ensure dosage accuracy. If a daily dose is missed, guidance generally advises skipping it and resuming the routine with the next scheduled dose, without taking a double dose.

Official Dosing and Adjustment Patterns

Dosage regimens are specified based on the condition and patient population. For Major Depressive Disorder and Obsessive-Compulsive Disorder, the initial adult dose is typically 20 mg daily, with the maintenance range often extending up to 60 mg daily. The maximum recommended dose for many indications is 80 mg daily. For Bulimia Nervosa, the recommended dose is fixed at 60 mg daily.

Population Group Dosage Consideration
Hepatic Impairment Lower dose or less frequent dosing (e.g., alternate-day) may be necessary.
Older Adults Lower starting dose and slower titration are advised.

Dose adjustments are not made immediately; due to the long half-life, a waiting period of several weeks is required to assess the full effect. When discontinuing the medicine, the dose must be gradually reduced over at least one to two weeks, following a defined tapering process. Intermittent dosing is an option for Premenstrual Dysphoric Disorder.

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Recent Clinical Evidence

Andep (fluoxetine): Recent Clinical Evidence


Early-Phase Investigations and Pharmacokinetics

Research explored the association between the compound's use and changes in pain severity markers in preclinical models. These early studies focused on tolerability and dose-ranging. Safety profiles were characterized in adult patient populations in Phase 1 trials.

Fluoxetine is metabolized extensively by the liver, involving multiple Cytochrome P450 enzymes. The compound has a relatively long elimination half-life of 1 to 3 days after acute use, and its active metabolite, norfluoxetine, has an even longer half-life, ranging from 4 to 16 days. This characteristic contributes to a lower reported risk of discontinuation syndrome compared to some other short-acting agents. Study results indicated a mean half-life of approximately 18 hours for the parent drug in certain study groups.


Key Clinical Trial Findings

Primary Endpoints: Mood and Symptom Management

A pivotal Phase 3 randomized, controlled trial (RCT) examined 400 participants over 12 weeks. The study included patient-reported quality of life outcomes as a primary endpoint. Outcomes were assessed using measures like the Chronic Pain Impact Scale (CPIS) and the Visual Analog Scale (VAS) for pain intensity.

  • Relapse Risk: Studies suggest that higher baseline anxiety in patients who responded to treatment may predict an increased risk of relapse if antidepressant continuation therapy is discontinued.
  • Long-Term Follow-up: Research examined long-term outcomes following the compound's use over extension studies. Comparative studies against older treatments were conducted to analyze differences in discontinuation rates, with fluoxetine showing favorable tolerability profiles in some analyses.

Off-Label Research

Research has also investigated fluoxetine in other contexts, such as following acute stroke, where one large RCT found that while the occurrence of depression was reduced, there was no improvement in functional outcome at 6 or 12 months, and some adverse events like fractures were increased.

Key Studies & References

  1. Fluoxetine: Drug information
  2. Duration of antidepressant treatment: a review of the evidence and its implications for the clinical setting
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Frequently Asked Questions (FAQ)

Common questions about Andep (fluoxetine) (FAQ)

Q: What are the common symptoms of discontinuation syndrome for fluoxetine?

A: According to official product information, when treatment is gradually interrupted, some people may experience symptoms of discontinuation syndrome. These reported effects can include feelings of nausea or dizziness, as well as agitation, general restlessness, and stomach issues. Official guidance on discontinuation emphasizes that the medicine is typically reduced gradually under professional supervision.

Q: What is Serotonin Syndrome, and what drugs interact with fluoxetine to cause it?

A: Serotonin Syndrome is a serious condition noted in official documents, often linked to taking fluoxetine with other medications that increase serotonin. Symptoms described in regulatory labeling include findings such as high body temperature (hyperthermia), muscle stiffness (rigidity), or muscle twitching (myoclonus). Other signs include rapid shifts in vital signs and changes in mental state, such as agitation or confusion.

Q: Can fluoxetine change the effect of blood thinners?

A: Official documents indicate that using fluoxetine alongside certain medications that affect blood clotting, such as warfarin or NSAIDs, may lead to a potentiated risk of bleeding. This reported interaction necessitates clinical monitoring.

Q: Is Andep (fluoxetine) safe to use during pregnancy?

A: Official regulatory documents define the use of fluoxetine during pregnancy as conditional, requiring the physician to carefully weigh the potential risks versus the potential benefits of treatment. Use during the late stages of pregnancy has been associated with complications in newborns that required longer medical support.

Q: Does Andep (fluoxetine) pass into breast milk?

A: According to regulatory guidance, fluoxetine is excreted into human milk. Due to the presence of the medication in breast milk, official documents state that breastfeeding is not recommended while taking this medicine.

Q: Are there different considerations for elderly patients taking Andep?

A: Official product information outlines specific considerations for older adults. Due to changes in the body's metabolism, official guidance suggests that consideration be given to a lower or less frequent dosage. Additionally, the risk for certain side effects, such as hyponatremia (low sodium in the blood), may be higher in the elderly population.

Q: Can children and adolescents take Andep (fluoxetine)?

A: Official documents confirm that fluoxetine is approved for specific indications in adolescents (ages 8 to 18) for Major Depressive Disorder and children (ages 7 to 17) for Obsessive-Compulsive Disorder. Use in this age group is often combined with psychological therapy. Regulatory documents specify that monitoring of growth and pubertal development is necessary during and after treatment.

Q: What is the difference between the capsule and delayed-release capsule forms of fluoxetine?

A: The primary difference described in regulatory documents relates to the dosing schedule. The delayed-release capsule formulation is generally a weekly dosage, which is taken once every seven days. This differs from the standard capsule, which is taken daily.

Q: How long does it typically take to feel the first effects of Andep (fluoxetine)?

A: Regulatory documents suggest that the full impact of a dose adjustment may not be observed right away due to the long half-life of the drug and its active metabolite. Official guidance states that dosage should typically be reviewed within 3 to 4 weeks to assess initial effects.

Q: When is the full benefit of Andep usually reached?

A: Consistent drug levels in the body, known as steady-state plasma concentrations, are typically reached after continuous use for several weeks (around four to five weeks). Official guidelines suggest that adjustments to the dose are generally only considered if there is an insufficient response after the initial two to four weeks of use.

Q: Is it normal to feel worse before feeling better when starting Andep?

A: Official product information reports that some patients may experience initial adverse effects such as anxiety and insomnia when beginning fluoxetine treatment. Due to these possibilities, regulatory documents advise close monitoring for the emergence of agitation or other unusual changes in behavior during the initial phase of therapy.

Q: Is Andep considered a medication for short-term or long-term use?

A: According to regulatory documentation, for conditions like Major Depressive Disorder, treatment should be maintained for a period of at least six months once symptoms have subsided. This suggests a continuation phase to support the patient's symptom-free state over time.

Q: How long does Andep (fluoxetine) stay in the body after the last dose?

A: Due to the long half-life of both fluoxetine and its active metabolite, the drug may persist in the body for an extended period after the last dose. Official documentation indicates that the drug can be present in the system for approximately five to six weeks after discontinuation.

Q: Is weight change (gain or loss) a common side effect of Andep (fluoxetine)?

A: Regulatory labeling reports that altered appetite and weight are potential adverse reactions associated with fluoxetine. Official documents also note that significant weight loss has occurred in some cases.

Q: Can Andep (fluoxetine) cause increased sweating?

A: Increased sweating (diaphoresis) is listed in regulatory documentation as a reported adverse reaction associated with the use of fluoxetine.

Q: Is it normal to feel dizzy or lightheaded while taking Andep?

A: Official product information lists dizziness or feelings of lightheadedness as commonly reported adverse reactions of fluoxetine.

Q: Does Andep (fluoxetine) affect sodium levels in the blood?

A: Official regulatory documents report that fluoxetine use has been associated with hyponatremia, which is a low level of sodium in the blood. This effect is sometimes seen in conjunction with the Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH).

Q: Can Andep (fluoxetine) affect bone density with long-term use?

A: Pre-clinical studies mentioned in regulatory documents suggested an impairment of bone development and growth in young animals. However, the relevance of these non-human findings to long-term bone density changes in adult patients is considered difficult to assess based on available official information.

Q: What are the warnings regarding Andep use in people with a history of glaucoma?

A: Official documents indicate that fluoxetine may potentially cause a type of eye problem called angle-closure glaucoma. Caution is advised, and for patients with a history of glaucoma, monitoring of the internal eye pressure (IOP) may be necessary.

Q: Can Andep (fluoxetine) be used to help treat eating disorders?

A: Fluoxetine is officially indicated as a complement to psychotherapy for the reduction of binge-eating and purging activity. Specifically, this indication is for the eating disorder known as Bulimia Nervosa.

Q: What makes Andep (fluoxetine) different from older types of antidepressants?

A: Official regulatory texts classify fluoxetine as a Selective Serotonin Reuptake Inhibitor (SSRI). This distinguishes it from older classes of antidepressants, such as tricyclic antidepressants (TCAs), due to its primary mechanism of selectively inhibiting the reuptake of serotonin.

Q: Can Andep (fluoxetine) be taken by individuals with diabetes?

A: Official documentation states that fluoxetine may alter glycaemic control in patients with diabetes. Reports have included both instances of hypoglycemia (low blood sugar) during therapy and hyperglycemia (high blood sugar) after the drug was stopped. Official information suggests that adjustments to the dosage of diabetes medication may be necessary.

Q: Are there special warnings for people with heart conditions who take Andep?

A: Official warnings note that fluoxetine has been associated with an electrical heart rhythm abnormality called QT prolongation. For this reason, the medicine is used under specific clinical caution in people with conditions that increase the risk of cardiac arrhythmias or in those with a history of a heart attack (Myocardial Infarction) or unstable heart disease.

Q: Is a person with a history of bipolar disorder generally restricted from using fluoxetine alone?

A: Regulatory documents recommend that patients be screened for bipolar disorder before starting treatment with fluoxetine. This is because there is a reported risk that the medicine may activate mania or hypomania in some individuals. Regulatory documents recommend close monitoring for the emergence of mood changes.

Q: Can Andep (fluoxetine) interact with common over-the-counter pain relievers like NSAIDs?

A: Official regulatory documents confirm that using fluoxetine alongside over-the-counter pain relievers like NSAIDs (Nonsteroidal Anti-inflammatory Drugs) and aspirin may increase the risk of bleeding. This risk is particularly noted for bleeding in the stomach or intestines (gastrointestinal bleeding). Clinical monitoring for abnormal bleeding is necessary.

Q: Is St. John's Wort safe to use at the same time as Andep (fluoxetine)?

A: Official interaction information lists St. John’s Wort as a product that interacts with fluoxetine due to its potential to increase serotonergic activity. Co-administration with St. John’s Wort necessitates close monitoring for the potential development of Serotonin Syndrome.

Q: Can Andep (fluoxetine) interact with medications taken for migraine headaches?

A: Regulatory documents specify that fluoxetine interacts with Triptans, which are a class of medications commonly used to treat migraine headaches. When these medicines are taken together, close monitoring is required due to the potential risk of Serotonin Syndrome.

Q: Does Andep (fluoxetine) cause involuntary teeth grinding (bruxism)?

A: Teeth grinding or bruxism is an effect that has been reported in post-marketing experience with fluoxetine and other similar medications. Official records indicate that the frequency of this occurrence is generally unknown.

Q: Is there any research on the long-term cognitive effects of Andep (fluoxetine)?

A: Official documents state that fluoxetine has the potential to impair cognitive function and motor skills, and caution is advised for tasks that require alertness. However, some clinical studies have also indicated that the medicine may support or enhance cognitive function in specific patient groups.

Q: How is Andep (fluoxetine) used to treat Premenstrual Dysphoric Disorder (PMDD)?

A: Fluoxetine is officially indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD). Official documents describe two possible administration patterns: it may be taken continuously (daily) throughout the month, or it may be taken intermittently, only during the luteal phase of the menstrual cycle.

Q: What are the signs of low sodium (hyponatremia) that people on fluoxetine should know about?

A: Official regulatory documents describe the symptoms of hyponatremia (low blood sodium), which is a reported adverse effect. Signs typically include a persistent headache, along with issues like difficulty concentrating, confusion, memory impairment, and general weakness or unsteadiness.

Q: Does Andep (fluoxetine) work for both depression and anxiety disorders?

A: Fluoxetine has official indications for both mood disorders and certain anxiety disorders. Regulatory documents confirm its use for Major Depressive Disorder (MDD) and Obsessive-Compulsive Disorder (OCD), as well as for Panic Disorder, which is a type of anxiety disorder.

Q: Is it common to have a treatment course lasting for several months?

A: Regulatory documents suggest that a treatment course for conditions like Major Depressive Disorder should continue for a substantial period. The official recommendation is to treat patients for a period of at least six months to help ensure they remain free from symptoms.

Q: Is Andep considered a 'sedating' or an 'activating' antidepressant?

A: Official adverse reaction reports indicate that fluoxetine is associated with common effects like insomnia and anxiety, which are often described as activating symptoms. However, the medicine also has the potential to cause cognitive and motor impairment, which may suggest a sedating effect. Patients should be monitored for the emergence of either type of effect.

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How should Andep (fluoxetine) be stored and disposed of?

How to Store and Dispose of Andep (fluoxetine)?

Andep (fluoxetine) must be stored under specific conditions mandated by regulatory labeling to ensure product integrity.

Requirement Official Regulatory Condition
Temperature Store at Controlled Room Temperature (20 C to 25 C)
Container Keep in the original container and maintain it tightly closed.
Safety The product must be stored out of the sight and reach of children.

Storage must avoid temperatures outside the permitted range of 15 C to 30 C. For disposal, unused or expired medication should be taken to an authorized drug take-back program. Regulatory guidance in certain regions instructs users not to dispose of the product via wastewater or household rubbish.

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

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