Paxil film coated pills 20mg N100
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Active ingredients
Paroxetine
Release form
Pills
Composition
Paroxetine hydrochloride hemihydrate 22.8 milligrams (equivalent to 20.0 milligrams of paroxetine) as excipients: calcium dihydrogen phosphate dihydrate, sodium carboxymethyl starch type A, magnesium stearic shell tablet - Opadry White YS - 1R - 7003 (macrogol 400, titanium dioxide, hypromellose, polysorbate 80).
Pharmacological effect
Paroxetine is a potent and selective inhibitor of the reuptake of 5-hydroxytryptamine (5-HT, serotonin). It is believed that its antidepressant activity and effectiveness in the treatment of obsessive-compulsive (OCD) and panic disorder is due to the specific inhibition of serotonin reuptake in brain neurons. In its chemical structure, paroxetine is different from tricyclic, tetracyclic and other known antidepressants. Paroxetine has a weak affinity for muscarinic cholinergic receptors, and animal studies have shown that it has only weak anticholinergic properties. In accordance with the selective effect of paroxetine, in vitro studies have shown that, unlike tricyclic antidepressants, it has a weak affinity for α1, α2, and β-adrenergic receptors, as well as for dopamine (D2), 5-HT1-like, 5HT2 - and histamine (H1) receptors. This lack of interaction with postsynaptic receptors in vitro is confirmed by the results of in vivo studies, which demonstrated the lack of the ability of paroxetine to inhibit the central nervous system and cause arterial hypotension. Pharmacodynamic effects: Paroxetine does not violate psychomotor functions and does not enhance the inhibitory effect of ethanol on the central nervous system. Like other selective serotonin reuptake inhibitors, paroxetine causes symptoms of excessive stimulation of 5-HT receptors when administered to animals that have previously received MAO inhibitors or tryptophan. Studies on behavior and EEG changes have demonstrated that paroxetine causes weak activating effects at doses higher than those required to inhibit serotonin reuptake. By nature, its activating properties are not amphetamine-like.Animal studies have shown that paroxetine does not affect the cardiovascular system. In healthy individuals, paroxetine does not cause clinically significant changes in blood pressure, heart rate and ECG. Studies have shown that, unlike antidepressants that inhibit the reuptake of norepinephrine, paroxetine has a much lower ability to inhibit the antihypertensive effects of guanethidine.
Pharmacokinetics
Absorption: After oral administration, paroxetine is well absorbed and metabolized during the first passage. Due to first-pass metabolism, less paroxetine is released into the systemic circulation than is absorbed from the gastrointestinal tract. As the amount of paroxetine in the body increases, with a single dose of large doses or with multiple doses of usual doses, the metabolic pathway of the first passage is partially saturated and the clearance of paroxetine from plasma decreases. This leads to a disproportionate increase in plasma concentrations of paroxetine. Therefore, its pharmacokinetic parameters are not stable, resulting in non-linear kinetics. It should be noted, however, that non-linearity is usually mild and is observed only in those patients who, while receiving low doses of the drug in plasma, achieve low levels of paroxetine. Stable plasma concentrations are achieved 7-14 days after the start of treatment with paroxetine. Its pharmacokinetic parameters most likely do not change during long-term therapy. Distribution: Paroxetine is widely distributed in tissues, and pharmacokinetic calculations show that only 1% of the total amount of paroxetine present in the body remains in plasma. At therapeutic concentrations, approximately 95% of paroxetine in plasma is associated with proteins. No correlation was found between plasma concentrations of paroxetine and its clinical effect (i.e., adverse reactions and efficacy). It is established that paroxetine in small amounts penetrates into the breast milk of women, as well as into embryos and fruits of laboratory animals. Metabolism: The main metabolites of paroxetine are polar and conjugated oxidation and methylation products, which are easily eliminated from the body.Given the relative lack of pharmacological activity of these metabolites, it can be argued that they do not affect the therapeutic effects of paroxetine. Metabolism does not impair the ability of paroxetine to selectively inhibit serotonin reuptake. Excretion: With urine in the form of unchanged paroxetine, less than 2% of the accepted dose is excreted, while the excretion of metabolites reaches 64% of the dose. About 36% of the dose is excreted in the feces, probably getting into it with bile; excretion of feces of unchanged paroxetine is less than 1% of the dose. Thus, paroxetine is eliminated almost entirely through metabolism. The excretion of metabolites is biphasic: first it is the result of first-pass metabolism, then it is controlled by the systemic elimination of paroxetine. T1 / 2 of paroxetine varies, but is usually about 1 day (16-24 hours).
Indications
Depression of all types, including reactive depression, severe endogenous depression, and depression accompanied by anxiety (the results of studies in which patients received the drug for 1 year show that it is effective in preventing recurrence of depression). Treatment (including supportive and prophylactic therapy) of obsessive-compulsive disorder (OCD) in adults, as well as in children and adolescents aged 7-17 years (it has been proven to preserve the effectiveness of the drug in treating OCD for at least 1 year and in the prevention of recurrence of OCD). Treatment (including supportive and prophylactic therapy) of panic disorder with and agoraphobia (the efficacy of the drug lasts for 1 year, preventing recurrence of panic disorder). Treatment (including supportive and prophylactic therapy) of social phobia in adults, as well as in children and adolescents aged 8-17 years (the effectiveness of the drug persists with long-term treatment of this disorder). Treatment (including supportive and prophylactic therapy) of generalized anxiety disorder (the efficacy of the drug remains with long-term treatment of this disorder, preventing the relapse of this disorder). Treatment of post-traumatic stress disorder.
Contraindications
Simultaneous administration of mao inhibitors and a period of 14 days after their withdrawal (mao inhibitors should not be prescribed for 14 days after treatment with paroxetine). Simultaneous administration of thioridazine. Hypersensitivity to paroxetine and other components of the drug.
Use during pregnancy and lactation
Fertility: According to animal studies, paroxetine can affect sperm quality. Data from human studies in vitro may indicate some influence on the quality characteristics of sperm, however, in reports on the use of certain preparations of the SSRI group (including paroxetine) in humans, the effect on the quality characteristics of sperm was shown to be reversible. To date, no effect on human fertility has been observed. Pregnancy: Animal studies have not detected teratogenic or selective embryotoxic activity in paroxetine. Epidemiological studies of pregnancy outcomes with antidepressants in the first trimester revealed an increase in the risk of congenital anomalies, in particular, the cardiovascular system (for example, ventricular and interatrial septal defects) associated with paroxetine. According to the available data, the occurrence of cardiovascular defects in the use of paroxetine during pregnancy is approximately 1/50, whereas the expected incidence of such defects in the general population is approximately 1/100 of newborns. When prescribing paroxetine, a doctor should consider the possibility of alternative treatment in pregnant women and women planning pregnancy, and paroxetine should be prescribed only if the potential benefit outweighs the potential risk. If it is decided to discontinue treatment with paroxetine during pregnancy, the doctor should follow the recommendations of the sections Dosage regimen and Special instructions. There are reports of preterm labor in women who received paroxetine or other drugs of the SSRI group during pregnancy, although the causal relationship between taking these drugs and preterm labor has not been established. It is necessary to carefully monitor the health status of those newborns whose mothers took paroxetine in late pregnancy, since there are reports of complications in newborns exposed to paroxetine or other products of the SSRI group in the third trimester of pregnancy. However, the causal relationship between these complications and this drug therapy has not been confirmed.The described clinical complications included: respiratory distress syndrome, cyanosis, apnea, convulsive seizures, instability of temperature, difficulties with feeding, vomiting, hypoglycemia, arterial hypertension, arterial hypotension, hyperreflexia, tremor, syndrome of increased neuro-reflex excitability, irritants, who have aphrodisclerosis, mild irritation, hypersensitivity, hyperreflexia, tremor crying and sleepiness. In some reports, symptoms have been described as neonatal manifestations of withdrawal syndrome. In most cases, the described complications occurred immediately after childbirth or soon after it (less than 24 hours). According to epidemiological studies, taking medications of the SSRI group (including paroxetine) during pregnancy, especially in the later periods, is associated with an increased risk of developing persistent pulmonary hypertension in the newborn. Increased risk is observed in children born to mothers who took drugs of the SSRI group at late stages of pregnancy, 4-5 times higher than that observed in the general population (1-2 per 1000 pregnancy cases). The results of animal studies showed the reproductive toxicity of the drug, but no direct adverse effect on pregnancy, embryo and fetus development, childbirth, or postnatal development was shown. Breastfeeding period: Minor amounts of paroxetine enter breast milk. In published studies in breastfed infants, the concentration of paroxetine was undetectable (less than 2 ng / ml) or very low (less than 4 ng / ml). In children, no signs of drug exposure have been identified. However, paroxetine should not be taken during breastfeeding, except when the benefits of therapy for the mother outweigh the potential risks to the baby.
Dosage and administration
Inside, in the morning - 20 mg. With insufficient effect, an increase in dose by 10 mg / day with an interval of at least 1 week is possible (the maximum dose is 50 mg / day). In elderly, malnourished patients, as well as in violation of kidney and liver function, the initial dose is 10 mg / day, the maximum is 40 mg / day.
Side effects
Drowsiness or insomnia, tremor, nervousness, increased central nervous system excitability, impaired concentration, emotional lability, amnesia, dizziness, accommodation paresis,pupil dilation, eye pain, noise and pain in the ears, increase or decrease in blood pressure, syncope, tachycardia or bradycardia, impaired cardiac conduction and peripheral circulation, cough, rhinitis, dipnea, tachypnea, nausea, decreased appetite, dyspepsia, increased activity of hepatic transaminases , stomatitis, arthralgia, arthritis, dysuria, polyuria, urinary incontinence, urinary retention, amenorrhea, dysmenorrhea, miscarriage, mastitis, impaired ejaculation, decreased libido and potency, peripheral edema, weight loss or increase, anemia, le Allergic reactions (itching, urticaria, chills). Seldom - thought disorder, akinesia, ataxia, seizures, hallucinations, hyperkinesia, manic or paranoid reactions, delirium, euphoria, grand mal seizures, aggressiveness, nystagmus, stupor, autism, decreased visual acuity, cataracts, conjunctivitis, glaucoma, exophthalmos, angina, myocardial infarction, cerebrovascular accident, cardiac arrhythmias, eosinophilia, leukocytosis, lymphocytosis, monocytosis, hematuria, nephrorolithiasis, renal dysfunction, dermatitis, erythema nodosum, depigmentation.
Overdose
Objective and subjective symptoms: available information about paroxetine overdose indicates its wide range of safety. With an overdose of paroxetine, in addition to the symptoms described in the Side Effects section, fever, changes in blood pressure, involuntary muscle contractions, anxiety and tachycardia are observed. The condition of patients usually returned to normal without serious consequences even with a single dose of up to 2000 mg. A number of reports described symptoms such as coma and ECG changes, deaths were very rare, usually in situations where patients took paroxetine with other psychotropic drugs or with alcohol. Treatment: paroxetine specific antidote does not exist. Treatment should consist of general measures applied in case of overdose of any antidepressants. Shown maintenance therapy and frequent monitoring of basic physiological parameters. Treatment of the patient should be carried out in accordance with the clinical picture or in accordance with the recommendations of the National Toxicological Center.
Interaction with other drugs
The use of paroxetine, as well as other drugs of the SSRI group, simultaneously with serotonergic drugs may cause effects associated with 5-HT receptors (serotonin syndrome). With the simultaneous use of serotonergic drugs (such as L-tryptophan, drugs from the group of triptans, tramadol, drugs: SSRI groups, fentanyl and St. John's wort) with paroxetine should be careful and conduct careful clinical monitoring. The simultaneous use of paroxetine with MAO inhibitors (including linezolid - an antibiotic that transforms into a non-selective MAO inhibitor, and methylthioninium chloride (methylene blue)) is contraindicated. Pimozide: In the study of the simultaneous use of paroxetine and pimozide in a single low dose (2 mg), an increase in the level of pimozide has been reported. This fact is explained by the known property of paroxetine to inhibit the CYP2D6 system. Due to the narrow therapeutic index of pimozide and its known ability to lengthen the QT interval, the simultaneous use of pimozide and paroxetine is contraindicated. Enzymes involved in drug metabolism: Paroxetine metabolism and pharmacokinetics may be altered by the induction or inhibition of enzymes that are involved in the metabolism of drugs. When paroxetine is used simultaneously with an inhibitor of enzymes involved in the metabolism of drugs, the use of paroxetine at a dose in the lower part of the range of therapeutic doses should be recommended. The initial dose of paroxetine does not need to be adjusted if it is used simultaneously with the drug, which is a known inducer of enzymes involved in the metabolism of drugs (for example, carbamazepine, rifampicin, phenobarbital, phenytoin). Any subsequent dose adjustment of paroxetine should be determined by its clinical effect (tolerability and effectiveness). Fosamprenavir and ritonavir: The simultaneous use of fosamprenavir / ritonavir with paroxetine resulted in a significant decrease in the concentration of paroxetine in the blood plasma. Plasamprenavir / ritonavir concentrations in plasma with simultaneous use with paroxetine were similar to control values from other studies, which indicates the absence of significant effect of paroxetine on fosamprenavir / ritonavir metabolism. There are no data on the effect of long-term combined use of paroxetine with fosamnenavir / ritonavir.Any subsequent dose adjustment of paroxetine should be determined by its clinical effect (tolerability and effectiveness). Procyclidine: Daily paroxetine significantly increases the concentration of procyclidine in the blood plasma. If anticholinergic effects occur, the dose of procyclidine should be reduced. Anticonvulsant drugs: The simultaneous use of paroxetine and anticonvulsant drugs (carbamazepine / phenytoin, sodium valproate) does not affect their pharmacokinetic and pharmacodynamic profiles in patients with epilepsy. Neuromuscular blockers: Preparations of the SSRI group can reduce the activity of plasma cholinesterase, which leads to an increase in the duration of the neuromuscular blocking action of mivakuria and suxamethonia. The ability of paroxetine to inhibit the CYP2D6 isoenzyme: Like other antidepressants, including other drugs of the SSRI group, paroxetine inhibits the hepatic isoenzyme CYP2D6, which belongs to the cytochrome P450 system. Inhibition of CYP2D6 isoenzyme can lead to an increase in plasma concentrations of simultaneously used drugs that are metabolized by this enzyme. Such drugs include some tricyclic antidepressants (for example, amitriptyline, nortriptyline, imipramine, and desipramine), neuroleptics of the phenothiazine series (perphenazine and thioridazine), risperidone, atomoxetine, some anti-arrhythmic drugs of the I C class (for example, prophenonone and I-C class), for example, I C class and lines, for the use of I C class and Figures and for the use of I-C class and for the use of I-C class and for the use of I-C class and line patterns and I’m using I-C class (for example, prophenazone) It is not recommended to use paroxetine in combination with metoprolol in heart failure, due to the narrow therapeutic index of metoprolol for this indication. Irreversible inhibition of the CYP2D6 system with paroxetine can lead to a decrease in plasma concentration of endoxifen and, as a result, reduce the effectiveness of tamoxifen. CYP3A4: Investigations of the interaction in vivo with simultaneous use of paroxetine and terfenadine in the equilibrium state, which is a substrate of the CYP3A4 isoenzyme, have shown that paroxetine does not affect the pharmacokinetics of terfenadine. In a similar in vivo interaction study, no effect of paroxetine on the pharmacokinetics of alprazolam was found, and vice versa.The simultaneous use of paroxetine with terfenadine, alprazolam and other drugs that serve as a substrate for the CYP3A4 isoenzyme can hardly cause harm to the patient. Clinical studies have shown that the absorption and pharmacokinetics of paroxetine are independent or practically independent (i.e., existing dependence does not require a dose change) from: food, antacids, digoxin, propranolol, alcohol - paroxetine does not increase the negative effect of alcohol on motor skills and mental functions; however, it is not recommended to take paroxetine and alcohol at the same time. Oral anticoagulants: Pharmacodynamic interactions between paroxetine and oral anticoagulants may occur. The combined use of paroxetine and oral anticoagulants may cause an increase in the activity of anticoagulants and the risk of bleeding. Therefore, paroxetine should be used with caution in the treatment of patients receiving oral anticoagulants. NSAIDs, acetylsalicylic acid and other antiplatelet drugs. Pharmacodynamic interactions between paroxetine and NSAIDs / acetylsalicylic acid may appear. Combined use of paroxetine and NSAIDs / acetylsalicylic acid may increase the risk of bleeding. Caution should be exercised in treating patients receiving drugs from the SNOSA group at the same time as oral anticoagulants, with drugs that affect platelet function or increase the risk of bleeding (for example, atypical antipsychotics such as clozapine, phenothiazines, most tricyclic antidepressants, acetylsalicylic acid, NPVPV, acetylsalicylic acid, NPVVP, acetylsalicylic acid, NIPVP, most tricyclic antidepressants, acetylsalicylic acid, NPVP, antivirals COX-2), as well as in the treatment of patients with indications of a history of bleeding disorders or conditions that may cause a predisposition to blood clotting. otecheniyam.
special instructions
Children and adolescents (under 18 years): Paxil should not be used in children and adolescents under 18 years of age. Treatment by antidepressants of children and adolescents suffering from major depressive disorder and other mental illnesses is associated with an increased risk of suicidal thoughts and suicidal behavior.In clinical studies, adverse events related to suicidal attempts and suicidal thoughts, hostility (mainly aggression, deviant behavior and anger) were more often observed in children and adolescents who received paroxetine than in patients of this age group who received placebo. There are currently no data on the long-term safety of paroxetine for children and adolescents, which would concern the effect of this drug on growth, maturation, cognitive and behavioral development. Clinical deterioration and suicidal risk in adults Young patients, especially those suffering from major depressive disorder, may be at an increased risk of suicidal behavior during paroxetine therapy. An analysis of placebo-controlled studies in adults suffering from mental illness suggests an increase in the frequency of suicidal behavior in young patients (aged 18–24 years) with paroxetine compared with the placebo group: 17/776 (2.19%) vs. 5 / 542 (0.92%), respectively, although this difference is not considered statistically significant. In patients of older age groups (from 25 to 64 years and over 65 years), an increase in the frequency of suicidal behavior was not observed. In adults of all age groups suffering from major depressive disorder, there was a statistically significant increase in cases of suicidal behavior during treatment with paroxetine compared with the placebo group (incidence of suicidal attempts: 11/3455 (0.32%) versus 1/1978 (0.05%), respectively. However most of these cases with paroxetine (8 out of 11) were reported in young patients between the ages of 18 and 30. The data obtained in a study in patients with major depressive disorder may indicate about an increase in the incidence of suicidal behavior in patients under 24 years of age who suffer from various mental disorders.In patients with depression, the worsening of symptoms of this disorder and / or the appearance of suicidal thoughts and suicidal behavior (suicidality) can be observed regardless of whether they receive antidepressants. persists until a pronounced remission is achieved.Improvement of the patient’s condition may be absent in the first weeks of treatment or more, and therefore the patient must be carefully monitored for timely detection of clinical exacerbation and suicidality, especially at the beginning of the course of treatment, as well as during periods of dose changes, whether they increase or decrease. Clinical experience with all antidepressants shows that the risk of suicide may increase in the early stages of recovery. Other mental disorders that paroxetine is used to treat may also be associated with an increased risk of suicidal behavior. In addition, these disorders can be comorbid conditions associated with major depressive disorder. Therefore, in the treatment of patients suffering from other mental disorders, the same precautions should be observed as in the treatment of major depressive disorder. Patients with a history of suicidal behavior or suicidal thoughts, young patients, as well as patients with strong suicidal thoughts before treatment, are at greatest risk of suicidal thoughts or attempts, and therefore they all need to pay special attention during treatment. Patients (and those who care for them) should be warned about the need to monitor the deterioration of their condition (including the development of new symptoms) and / or the appearance of suicidal behavior or thoughts about hurting themselves during the entire course of treatment, especially at the beginning of treatment or during time for changing the dose of the drug (increase and decrease). If these symptoms occur, you should immediately seek medical attention. It must be remembered that the occurrence of such symptoms as agitation, akathisia or mania can be associated both with the underlying disease and also be a consequence of the applied therapy. When symptoms of clinical deterioration (including the development of new symptoms) and / or suicidal thoughts / behavior occur, especially when they suddenly appear, the severity of manifestations increases, or if they are not part of the previous symptom complex in this patient, the treatment regimen should be reviewed up to before discontinuation of the drug.Akathisia: Occasionally, treatment with paroxetine or another drug from the SSRI group is accompanied by the appearance of akathisia, which is manifested by a feeling of internal anxiety and psychomotor agitation when the patient cannot sit or stand still; with akathisia, the patient usually experiences subjective discomfort. The likelihood of akathisia is highest in the first few weeks of treatment. Serotonin syndrome, neuroleptic malignant syndrome: In rare cases, with paroxetine treatment, serotonin syndrome or symptoms similar to the malignant neuroleptic syndrome may occur, especially if paroxetine is used in combination with other serotonergic drugs and / or neuroleptics. These syndromes represent a potential life-threatening condition, and therefore treatment with paroxetine should be stopped if they occur (they are characterized by groups of symptoms such as hyperthermia, muscle rigidity, myoclonus, autonomic disorders with possible rapid changes in vital signs, changes in mental status, including confusion, irritability, extremely severe agitation, progressing to delirium and coma), and initiate symptomatic supportive therapy. Paroxetine should not be administered in combination with serotonin precursors (such as L-tryptophan, oxytriptan) due to the risk of developing serotonin syndrome. Mania and bipolar disorder: A major depressive episode may be the initial manifestation of bipolar disorder. It is believed (although not proven by controlled clinical trials) that treating such an episode with an antidepressant alone can increase the likelihood of accelerated development of a mixed / manic episode in patients at risk for developing bipolar disorder. Before starting treatment with an antidepressant, thorough screening should be conducted to assess the risk of bipolar disorder in a given patient; Such screening should include a detailed psychiatric history, including evidence of suicide, bipolar disorder and depression in the family. Paroxetine is not registered to treat a depressive episode as part of bipolar disorder.Paroxetine should be used with caution in patients with a history of mania. Diabetes mellitus: In patients with diabetes mellitus, treatment with drugs of the SSRI group may affect the glycemic control parameters. Dosage adjustment of insulin and / or oral hypoglycemic drugs may be required. MAO inhibitors: Treatment with paroxetine should begin cautiously than 2 weeks after discontinuing therapy with irreversible MAO inhibitors or 24 hours after discontinuing treatment with reversible MAO inhibitors. The dose of paroxetine should be increased gradually until the optimum therapeutic effect is achieved. Impaired renal or hepatic function It is recommended to use caution when treating paroxetine in patients with severe impaired renal function and patients with impaired liver function. Epilepsy: Like other antidepressants, paroxetine should be used with caution in patients with epilepsy. Convulsive seizures: The frequency of convulsive seizures in patients taking paroxetine is less than 0.1%. In the event of a convulsive seizure, treatment with paroxetine should be stopped. Electroconvulsive therapy: There is only limited experience with the simultaneous use of paroxetine and electroconvulsive therapy. Glaucoma: Like other drugs of the SSRI group, paroxetine causes mydriasis, and it should be used with caution in patients with angle-closure glaucoma. Hyponatremia: When treating with paroxetine, hyponatremia occurs rarely and predominantly in elderly patients and is leveled after discontinuation of paroxetine. Bleeding: Hemorrhages in the skin and mucous membranes (including gastrointestinal and gynecological hemorrhages) have been reported in patients with paroxetine. Therefore, paroxetine should be used with caution in patients who simultaneously receive drugs that increase the risk of bleeding, in patients with a known tendency to bleeding and in patients with diseases that predispose to bleeding. Heart Disease: The usual precautions should be taken when treating patients with heart disease. Symptoms that may occur when discontinuing paroxetine treatment in adults: According to the results of clinical studies in adults, the incidence of adverse reactions at termination: treatment in patients taking paroxetine was 30%, while the incidence of adverse events in the placebo group was 20%.The occurrence of withdrawal symptoms does not mean that the drug is abused or addictive, as is the case with drugs and psychotropic substances. Such withdrawal symptoms as dizziness, sensory disturbances (including paresthesias, sensation of electric shock and tinnitus), sleep disturbances (including vivid dreams), agitation or anxiety, nausea, tremor, confusion, sweating, headaches and diarrhea are described. These symptoms are usually mild or moderate, but in some patients they can be severe. They usually occur in the first few days after discontinuation of the drug, but in very rare cases occur in patients who accidentally missed a dose. As a rule, these symptoms disappear spontaneously and disappear within 2 weeks, but in some patients they can last much longer (2-3 months or more). It is recommended to reduce the dose of paroxetine gradually, over several weeks or months before it is completely canceled, depending on the needs of the particular patient. Symptoms that may occur when discontinuing paroxetine treatment in children and adolescents: As a result of clinical studies in children and adolescents, the incidence of adverse reactions when discontinuing treatment in patients taking paroxetine was 32%, while the incidence of adverse reactions in the placebo group was 24%. After discontinuation of paroxetine, the following adverse reactions were recorded in at least 2% of patients and occurred at least 2 times more often than in the placebo group: emotional lability, including suicidal thoughts, suicidal