Paroxetin Actavis

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Overview of Paroxetin Actavis

Defining Paroxetin Actavis: Identity and Pharmacological Class

Property Description
Active ingredient Paroxetine
Form Film-coated tablets
Pharmacological class Selective Serotonin Reuptake Inhibitor (SSRI)
Common use Mood stabilization and anxiety relief
Origin Synthetic phenylpiperidine derivative

Paroxetin Actavis is a prescription-only medicine whose fundamental identity is defined by its active ingredient, Paroxetine. Paroxetine is classified as a potent antidepressant belonging to the drug class known as Selective Serotonin Reuptake Inhibitors (SSRIs). Chemically, the active compound is a synthetic phenylpiperidine derivative. This classification places the medicine within a group of psychotropic drugs whose primary action is highly targeted toward a specific neurotransmitter system. Pharmacological data indicate Paroxetine's strong and highly selective affinity for the serotonin reuptake transporter. This selectivity indicates the medicine is designed to increase serotonin availability in the brain.

Composition, Form, and General Therapeutic Role

The medicinal product Paroxetin Actavis is supplied as film-coated tablets designed for oral administration, typically utilizing the hydrochloride salt of Paroxetine as its sole active ingredient. This specific formulation is characteristic of the Actavis brand’s generic presentation of the widely used SSRI. This controlled, solid dosage form ensures a consistent quantity of the single active substance is reliably delivered for systemic absorption. The medicine's general therapeutic role is centered on contributing to the stabilization of mood and helping to relieve general emotional and psychological distress. This effect is achieved through the potentiation of serotonergic activity, which is the core physiological action that underpins the drug’s usefulness by modulating the brain’s neurochemical environment. The use of Paroxetine in promoting emotional regulation is established in mental health contexts. Therefore, the drug has a pronounced effect on regulating mood and reducing anxiety symptoms.

Regulatory References

  1. NIH: Paroxetine - Mechanism of Action
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What side effects are possible with Paroxetin Actavis?

Possible Side Effects and Safety Information

Paroxetin Actavis's safety profile is defined by officially documented adverse reactions classified by frequency and the body systems affected, based on regulatory standards. The medicine is associated with effects across several System-Organ Classes, including psychiatric, nervous system, and gastrointestinal disorders. The most frequently occurring reactions, classified as Very Common, include nausea and forms of sexual dysfunction, such as abnormal ejaculation. Common reactions often involve the nervous system (e.g., somnolence, dizziness, tremor) and general complaints like asthenia (weakness) and increased sweating.

Specific regulatory warnings highlight the risk of certain Serious Adverse Reactions. These include the documented potential for an increased risk of Suicidal thoughts and behavior, particularly in younger adults during the initial months of treatment or following dose changes. Other documented serious concerns are the risk of Serotonin Syndrome, severe Bleeding events, Seizures, and Angle-Closure Glaucoma.

Official labeling includes Population-Specific Safety Notes. The use of Paroxetine is restricted or contraindicated in the pediatric population (under 18) due to the documented elevated risk of hostility and suicidal ideation. Furthermore, reduced initial dosing is required for older adults and individuals with severe renal or hepatic impairment due to documented changes in drug plasma concentrations. The official safety profile also notes the potential for a Discontinuation Syndrome upon cessation, which necessitates a gradual reduction in dosage.

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Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information

The official regulatory profile for Paroxetin Actavis overdose details specific manifestations and mandated emergency actions. While a wide margin of safety is generally evident from available data, overdose can present with significant effects.

Documented Overdose Presentations and Scope

  • Clinical Manifestations: Regulatory sources list central nervous system effects such as somnolence, tremor, agitation, confusion, and mydriasis (dilated pupils). Other documented signs include nausea, vomiting, tachycardia, and blood pressure changes.
  • Severe Outcomes: The official labeling documents potentially life-threatening complications including Serotonin Syndrome, seizures (convulsions), coma, and severe ECG abnormalities (ventricular dysrhythmias).
  • Population Notes: An increased risk of hyponatremia (low serum sodium) has been reported in the elderly population in the context of Paroxetine.

Required Emergency Actions

  • Immediate Medical Help: Regulatory guidance requires patients and caregivers to seek immediate medical attention upon suspected overdose or if severe symptoms occur, such as seizures, trouble breathing, or inability to be awakened. Immediate contact with emergency services or a Poison Help line is mandated in such cases.
  • Management Notes: No specific antidote is known for Paroxetine overdose; therefore, management is based on general supportive and symptomatic measures. This includes ensuring an adequate airway and required hospital monitoring, particularly for cardiac rhythm and vital signs.

Regulatory documents define this profile to ensure recognition of severe signs and to trigger the immediate emergency response required for the management of these documented risks.

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Therapeutic Uses of Paroxetin Actavis

Paroxetin Actavis is generally used across conditions characterized by periods of heightened symptoms, and is relevant in situations involving recurrent or fluctuating manifestations. Its use is established within specific therapeutic domains. The medicine is applied in contexts marked by increased discomfort or tension and offers symptomatic relief that helps patients cope more steadily with symptom fluctuations.

This medication is relevant for easing symptoms related to heightened physiological activity, symptoms that interfere with daily functioning, and symptoms associated with acute or episodic changes. The therapeutic role includes providing support that helps ease the overall symptom burden and assists with maintaining functional stability.


Easing Symptom Burdens and Enhancing Stability

This domain is applicable within clinical settings that involve acute or disruptive symptom patterns, focusing on symptom clusters that may become intense or disruptive. The medicine is often used when symptoms intensify and supportive relief is needed, contributing to easing the overall symptom load. It is applied across domains where additional symptomatic support is needed, particularly for symptoms that interfere with daily comfort.


It supports the patient during difficult episodes by easing distress.


Quick Fact: Support for Functional Stability

Paroxetin Actavis may assist with maintaining functional stability when symptoms create noticeable physiological strain or interfere with routine activities.

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Eligibility and Restrictions for Use

Population Eligibility and Contraindications

Paroxetin Actavis (Paroxetine) is officially labeled for use only in adults (patients 18 years of age and older). Eligibility is strictly defined by regulatory documents, which outline populations permitted, restricted, or absolutely prohibited from using the medicine.

Category Regulatory Status
Pediatric Use (Under 18) Not Recommended. Efficacy has not been adequately established, and official data noted an increased risk of suicidal behavior and hostility in this age group.
Geriatric Use (65+) Restricted. Use is permitted but requires caution, and a lower initial dose is mandated due to higher plasma concentrations in this population.

Absolute Contraindications (Must Not Use)

Use of Paroxetin Actavis is absolutely prohibited under the following conditions, regardless of the patient's health status:

  • Monoamine Oxidase Inhibitors (MAOIs): Concurrent use, or use within 14 days of stopping an MAOI, is contraindicated due to the risk of Serotonin Syndrome.
  • Specific Medicines: Use with Pimozide or Thioridazine is contraindicated.
  • Allergy: Patients with documented hypersensitivity to paroxetine or any component of the tablet.

Conditional Use (Requires Caution)

Eligibility is restricted for patients with certain medical conditions, requiring close monitoring or dose adjustment as stated in the label:

  • Severe Renal or Hepatic Impairment: Use requires caution, and a lower initial dose is required due to increased drug levels.
  • Pregnancy/Lactation: Use is restricted during pregnancy, particularly the first trimester, due to a labeled increased risk of cardiovascular malformations; caution is advised during breastfeeding.
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What should I know about interactions with other medicines?

Paroxetin Actavis (paroxetine) can interact with various medications and supplements, potentially altering the drug's effectiveness or increasing the risk of adverse effects, including the life-threatening Serotonin Syndrome. It is essential to inform your doctor or pharmacist about all other medicines, herbal products, and supplements you are taking.

Contraindicated Combinations

Interaction Type Examples of Medicine/Product Potential Risk Important Note
MAO Inhibitors Phenelzine, Isocarboxazid, Moclobemide, Linezolid, Methylene blue Severe or fatal Serotonin Syndrome Must wait at least 14 days after stopping an MAOI before starting Paroxetin Actavis, and vice versa.
Antipsychotics Thioridazine, Pimozide Risk of serious heart problems (QT prolongation, Torsades de Pointes) Combination is strictly avoided.
Serotonin Precursors Tryptophan Increased risk of Serotonin Syndrome Avoid co-administration.

Combinations Requiring Caution or Dose Adjustment

Co-administering Paroxetin Actavis with other medicines that increase serotonin levels (e.g., other SSRIs, SNRIs, Triptans for migraine, Tramadol, Fentanyl, St. John's wort) can raise the risk of Serotonin Syndrome. Careful monitoring and dose adjustments may be necessary.

Paroxetin Actavis can also increase the risk of bleeding when taken with blood thinners (e.g., Warfarin, Rivaroxaban) or NSAIDs (e.g., Ibuprofen, Naproxen, Aspirin). Increased monitoring for signs of bleeding or bruising is recommended.

As Paroxetin Actavis is a strong inhibitor of the enzyme CYP2D6, it can increase the concentration of other drugs metabolized by this pathway, such as certain antiarrhythmics (e.g., Flecainide, Propafenone) and other antidepressants. Additionally, concurrent use with Tamoxifen may reduce the efficacy of Tamoxifen, requiring a consultation with your healthcare provider about alternative treatment options.

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Mechanism of Action

The action of Paroxetin Actavis (paroxetine) is focused on modifying chemical signaling in the brain and adjusting the body's drug breakdown pathways. The mechanism is characterized by a time-dependent shift in neurochemical balance.

Selective Serotonin Reuptake Inhibition

This domain covers the drug's primary molecular target: the Serotonin Transporter ( SERT). Paroxetine selectively blocks this transporter, immediately preventing the reabsorption of the neurotransmitter serotonin ( 5-HT) back into the nerve cell. This action increases the concentration of 5-HT in the synaptic space, leading to enhanced signaling across the serotonergic pathway, a fundamental step in the molecule’s function.

Gradual Neurochemical Adaptation

This mechanistic domain encompasses the long-term physiological consequence of sustained SERT inhibition. The chronic elevation of synaptic 5-HT levels triggers a neuroadaptive process where specific 5-HT receptors become down-regulated and less responsive over several weeks. This slow, homeostatic adjustment results in the stabilization and functional rebalancing of activity within central neural circuits, which defines the drug’s characteristic time-dependent action.

Modulation of Metabolic Pathways

This addresses the drug's secondary interaction with the liver enzyme Cytochrome P450 2D6 ( CYP2D6). Paroxetine inhibits this enzyme, which slows the metabolic breakdown of the drug itself and other compounds processed by CYP2D6. This action influences the drug's overall exposure in the body and dictates its pharmacokinetic behavior.

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Dosage and Administration Information

How to Use Paroxetin Actavis: Official Administration Guidelines

The usage protocol for Paroxetin Actavis is based on established protocols, focusing on the standardized method of administration, dose adjustments, and required schedules. As a film-coated tablet, the medicine is for oral administration and should be taken once daily, typically in the morning, to establish a consistent schedule. The tablets must be swallowed whole and should not be chewed or crushed to ensure the proper release of the active substance. Administration is generally advised to be with food.

Official Dosing and Adjustment Rules

The approved regimens specify a slow titration process. The usual starting dose is 10 mg or 20 mg per day, depending on the specific context of use. Dosage changes, if needed, are performed gradually with increments of no more than 10 mg per day. A minimum interval of one week must separate any dose adjustment. The maximum daily dose ranges from 40 mg to 60 mg, as specified for this formulation.

Treatment consists of an acute phase followed by a maintenance phase, which for some conditions, requires continuation for at least six months. Discontinuation of Paroxetin Actavis must always be gradual through a structured dose reduction process (tapering), rather than abrupt cessation.

Population-Specific Use

Standard guidelines include specific modifications for certain populations. Older adults typically begin with a lower initial dose and observe a restricted maximum daily dose, often limited to 40 mg. Similarly, patients with severe hepatic or renal impairment require a lower initial dose and a maximum dosage at the lower end of the total range. The use of Paroxetine in the pediatric population is generally not approved for certain conditions within standard clinical frameworks.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Paroxetin Actavis

Paroxetin Actavis (paroxetine) was evaluated in research to evaluate the relationship between the medicine and observed symptom patterns of several conditions. The evidence base is centered on data from Randomized Controlled Trials (RCTs), which are the standard study design for establishing clinical evaluation findings. Research was studied for both immediate symptom changes and the durability of measured outcomes.


Evidence for Use in Major Depressive Disorder (MDD)

The core clinical evaluation for Major Depressive Disorder (MDD) used multiple short-term, placebo-controlled trials, typically lasting between six and eight weeks. These research studies examined how patient symptoms evolved during periods of increased symptom activity, using standardized scales to track changes in depression severity. After the initial assessment, researchers also conducted long-term RCTs that tracked adult patients for up to one year to monitor the rate of symptom recurrence, or relapse.

Studies reported measurements of symptom change over the short-term observation period. Follow-up research reports how symptoms evolved in the observed populations, and the analysis of longer-term studies contributes to the broader evidence landscape regarding symptom evolution over defined time intervals. What remains uncertain is the evidence in populations outside the primary adult study group.


Evidence for Use in Anxiety and Related Disorders

Paroxetin Actavis was evaluated in a range of research exploring its use for Obsessive Compulsive Disorder (OCD), Panic Disorder (PD), Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Post-Traumatic Stress Disorder (PTSD). Studies for these conditions typically used placebo-controlled trials with an acute observation phase lasting between 10 and 12 weeks.

In these trials, research examined condition-specific outcomes related to systemic or functional imbalance, such as the frequency of panic attacks or the severity of intrusive thoughts. The studies report how symptoms evolved in the observed populations, and findings indicate patterns of short-term change during the acute study phase.


Evidence Gaps and Areas of Uncertainty

A review of the research base highlights several areas where data are still emerging or where certainty remains low. Follow-up durations were limited to approximately one year in the main continuation studies, meaning long-term effects are not fully established beyond this period. Research concerning pediatric populations was conducted; however, efficacy evidence was not adequately demonstrated in these younger groups, leading to specific regulatory considerations regarding that age group. Limited data are available for patients with complex medical conditions or certain psychiatric comorbidities.

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Frequently Asked Questions (FAQ)

Common questions about Paroxetin Actavis (FAQ)

Q: How long does it usually take to notice any effect from Paroxetin Actavis?

A: Clinical literature suggests that symptom changes may take several weeks to occur. This time-dependent process is due to the gradual neurochemical adaptation required for the medicine to fully function. Response to the medicine is often assessed after approximately six weeks of regular use, although the drug typically achieves a steady concentration in the body within one to two weeks.

Q: What are the most commonly reported side effects when starting Paroxetin Actavis?

A: Official product information, derived from clinical trials, lists certain adverse reactions that may be observed when beginning treatment. These commonly reported effects include nausea, somnolence (drowsiness), dizziness, and tremor. Insomnia and forms of sexual dysfunction are also frequently noted in the clinical data.

Q: Is it possible for Paroxetin Actavis to cause increased feelings of nervousness or agitation initially?

A: Yes, official regulatory documents note that agitation is a reported side effect of this medicine. Monitoring for behavioral changes, including agitation, is often advised, particularly during the initial few months of therapy or when dosage adjustments are made.

Q: How quickly does the risk of withdrawal symptoms begin if a dose is missed?

A: Paroxetine is associated with the risk of a discontinuation syndrome, which is a collection of withdrawal-like symptoms that can occur upon cessation. The official label warns that abrupt discontinuation can lead to these symptoms, indicating that the risk is connected to the interruption of the regular dosing schedule and requires careful, gradual dose reduction.

Q: Can taking Paroxetin Actavis make existing symptoms temporarily worse?

A: Official guidance advises monitoring for signs of clinical worsening of the condition, especially during the initial few months of therapy or following any dosage changes. This monitoring is advised because some individuals may experience temporary intensification of symptoms or behavioral changes during the early stages of using the medicine.

Q: Can Paroxetin Actavis cause weight gain, and if so, how common is it?

A: Weight gain is listed as a reported adverse reaction in the official product information. Additionally, changes in appetite, specifically decreased appetite, are also commonly observed reactions noted in clinical trials.

Q: Is it safe to drink alcohol while taking Paroxetin Actavis?

A: Official regulatory guidance advises that alcohol consumption should generally be avoided while taking this medicine. Official warnings advise that alcohol may increase the risk of certain central nervous system side effects.

Q: Can Paroxetin Actavis affect my ability to drive or operate machinery?

A: Yes, official warnings indicate that the medicine can cause reactions such as dizziness, somnolence (drowsiness), confusion, and blurred vision. If these effects are present, they may impair the ability to safely drive or operate machinery.

Q: Is there a risk of dependency or addiction with Paroxetin Actavis?

A: The medicine is not classified as a controlled substance. However, abruptly stopping the medicine may lead to a discontinuation syndrome, which is a set of temporary, withdrawal-like symptoms. For this reason, official instructions mandate a gradual dose reduction, or tapering, when stopping use.

Q: What is the process for stopping Paroxetin Actavis after taking it for a long time?

A: The official regulatory protocol mandates that treatment cessation must always be gradual to reduce the risk of discontinuation symptoms. The process involves a structured dose reduction, or tapering, over a period of time. The total duration of use is a decision made by a healthcare provider.

Q: What foods or beverages should I avoid when taking Paroxetin Actavis?

A: Official instructions specify that alcohol should be avoided, and, in the context of interactions, avoiding certain herbal products such as St. John's Wort is advised. The tablets are generally advised to be taken with food, but no specific foods are usually restricted.

Q: How does Paroxetin Actavis compare to the original branded version of paroxetine?

A: Paroxetin Actavis is a generic medicine containing the same active ingredient, paroxetine, as the original branded product. Generic medicines must meet regulatory standards for bioequivalence, confirming that they contain the identical active ingredient and are absorbed into the bloodstream at a similar rate and extent as the original branded product.

Q: Can men experience sexual side effects from taking Paroxetin Actavis?

A: Sexual side effects are commonly noted in the official adverse event data. Clinical trial information specifically lists adverse reactions such as abnormal ejaculation, decreased libido, and impotence among men.

Q: Are there any long-term health risks associated with taking Paroxetin Actavis for years?

A: The official research base notes that the duration of follow-up in the main clinical continuation studies was generally limited to about one year. While certain long-term risks are documented in the label (e.g., bone fracture risk), the overall evidence for effects extending beyond this period is not fully established in the primary clinical trials.

Q: Why is it sometimes recommended to take Paroxetin Actavis in the morning?

A: Administration instructions state that the medicine should be taken once daily, typically in the morning, to establish a consistent dosing schedule. This timing may also be suggested to manage the potential for side effects such as insomnia (trouble sleeping).

Q: How often do people taking Paroxetin Actavis need to have blood tests?

A: Official warnings note a documented risk of hyponatremia (low sodium levels in the blood), particularly in older adults. While routine blood tests for all patients are not universally mandated in the label, monitoring to check serum sodium concentration may be recommended by a healthcare provider for vulnerable patients.

Q: Is Paroxetin Actavis used to treat symptoms of Obsessive-Compulsive Disorder (OCD)?

A: Yes, official regulatory documents list the treatment of Obsessive-Compulsive Disorder (OCD) as an approved indication for this medicine in adults.

Q: What information is available regarding the use of Paroxetin Actavis in children or adolescents?

A: Official regulatory documents specify that the medicine is not approved for use in children and adolescents under 18 for most conditions. This decision is based on regulatory data from clinical trials that noted an increased risk of suicidal thinking and behavior, as well as hostility, in this age group.

Q: Can Paroxetin Actavis cause problems with sleep, such as insomnia or vivid dreams?

A: Yes, insomnia (difficulty sleeping) is listed as a commonly reported side effect in the clinical data. Vivid dreams and other sleep disturbances have also been noted in clinical reports, particularly as a symptom of the discontinuation syndrome.

Q: Is the dose of Paroxetin Actavis based on a person's weight?

A: Official dosing guidelines are not determined by body weight. Dosage is primarily guided by the specific condition being treated, the patient's age (as lower initial doses are required for older adults), and the presence of severe hepatic or renal impairment.

Q: Are there generic versions of Paroxetin Actavis, and are they the same?

A: Paroxetine is the active ingredient in this medicine. The regulatory system allows for multiple generic versions of paroxetine, including the Actavis brand. These products must contain the identical active ingredient and meet federal standards for bioequivalence to ensure they function comparably to the original branded medicine.

Q: What should I look out for as a potential sign that Paroxetin Actavis is not working?

A: The official label requires that patients be monitored for signs of clinical worsening of their condition. A lack of improvement or a return of existing symptoms after starting the medicine is a finding that should be discussed with a healthcare provider for further assessment.

Q: Can Paroxetin Actavis cause changes in appetite?

A: Yes, clinical data lists decreased appetite as a commonly reported adverse reaction. This may be related to changes in weight, which are also noted as reported side effects.

Q: Can Paroxetin Actavis make me feel emotionally 'numb' or flat?

A: Related effects, such as emotional blunting or apathy (a lack of emotion), have been noted as adverse effects in clinical literature and patient information summaries.

Q: Are there specific times of day that Paroxetin Actavis should be avoided?

A: The official instructions specify taking the medicine once daily, typically in the morning, to maintain a consistent dosing schedule. Taking the dose late in the day may be discouraged due to the potential for side effects such as insomnia.

Q: Does Paroxetin Actavis cause hair loss?

A: Official summaries of adverse events list alopecia (hair loss) as a reported side effect of the medicine, though it is not generally categorized as a very common or common reaction.

Q: Can Paroxetin Actavis be used for Premenstrual Dysphoric Disorder (PMDD)?

A: Official regulatory documents list the treatment of Premenstrual Dysphoric Disorder (PMDD) as an approved indication for the controlled-release formulation of the medicine.

Q: Does Paroxetin Actavis interact with supplements like melatonin or multivitamins?

A: Official data advises caution regarding co-administration with melatonin, as this combination may increase the risk of side effects such as dizziness, drowsiness, and confusion. Multivitamins are generally not noted in regulatory documents as a restrictive interaction.

Q: Is Paroxetin Actavis considered a treatment that must be taken permanently?

A: Treatment protocols involve an acute phase followed by a maintenance phase. For some conditions, the maintenance phase is typically recommended to continue for at least six months. The total duration of use is a decision made by a healthcare provider.

Q: Is it true that Paroxetin Actavis can cause jaw clenching or teeth grinding?

A: Clinical reports and literature have noted an association between SSRI medicines, including paroxetine, and the occurrence or worsening of bruxism (teeth grinding) and jaw clenching as an adverse reaction.

Q: Does Paroxetin Actavis cause constipation or diarrhea?

A: Yes, both constipation and diarrhea are listed among the reported adverse reactions in the clinical data reviewed by regulatory bodies.

Q: Is Paroxetin Actavis considered a 'new' or 'old' generation of antidepressant?

A: Paroxetin Actavis belongs to the drug class known as Selective Serotonin Reuptake Inhibitors (SSRIs). SSRIs are generally classified as the first generation of modern antidepressants, having been introduced in the late 1980s and early 1990s.

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How should Paroxetin Actavis be stored and disposed of?

Storage and Disposal Requirements for Paroxetin Actavis

Official regulatory documents define strict conditions for storing and disposing of Paroxetin Actavis (Paroxetine) to ensure product stability and safety.

Storage Component Requirement (as stated in labeling)
Temperature Store at Controlled Room Temperature (20 C to 25 C), or below 30 C depending on the formulation.
Protection Keep in the original container, protected from light and moisture.
Child Safety Keep out of the sight and reach of children at all times.
Disposal Dispose of unused product in accordance with local requirements, utilizing authorized drug take-back programs where available.

Disposal must be managed safely, and the product must not be released into the environment or flushed into the sanitary sewer system.

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

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