Esribel 50mg 28 tablets

Esribel 50 mg Qualitative and quantitative composition Each film-coated tablet contains Sertraline hydrochloride equivalent to 50 mg of Sertraline. Pharmaceutical form Film-coated tablets Oval, biconvex, white film-coated tablets with a score on one side. Pharmacological properties Pharmacodynamic properties Pharmacotherapeutic group: Selective serotonin reuptake inhibitors (SSRIs). Mechanism of action Sertraline is a potent and selective inhibitor of serotonin (5-hydroxytryptamine (5-HT)) reuptake in vitro, leading to enhanced 5-HT effects in animals. It has only a very weak effect on norepinephrine and dopamine reuptake in neurons. Clinical efficacy and safety Major depressive disorder A study was conducted with ambulatory patients with depression who responded to sertraline treatment at doses of 50-200 mg per day at the end of an initial 8-week open-label phase. Post-traumatic stress disorder (PTSD) Combined data from 3 studies of post-traumatic stress disorder in the general population showed a lower response rate in men than in women. Pediatric population No data are available in children under 6 years of age. Pharmacokinetic properties Absorption After oral administration of 50-200 mg once daily for 14 days, the maximum concentration of sertraline in human plasma was observed approximately 4.5-8.4 hours after administration. Food intake does not significantly affect the bioavailability of sertraline in tablet form. Distribution Approximately 98% of the drug in circulation is bound to plasma proteins. Biotransformation Sertraline undergoes extensive first-pass metabolism in the liver. Elimination The mean elimination half-life of sertraline is approximately 26 hours (range 22-36 hours). Linearity/non-linearity In the dose range of 50-200 mg, the pharmacokinetics of sertraline are dose-proportional. Therapeutic indications Sertraline is indicated for the treatment of: Major depressive episodes. Prevention of relapse of major depressive episodes. Panic disorder with or without agoraphobia. Obsessive-compulsive disorder (OCD) in adults and children aged 6-17 years. Social anxiety disorder. Post-traumatic stress disorder. Dosage and administration Dosage Initial dose Depression and obsessive-compulsive disorder Treatment with sertraline should be initiated at a dose of 50 mg/day. Panic disorder, post-traumatic stress disorder, and social anxiety disorder Treatment should be initiated at a dose of 25 mg/day. One week after starting the drug, the dose should be increased to 50 mg once daily. This dosing regimen reduces the incidence of early, unexpected adverse effects characteristic of panic disorder. Dose titration Depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, and post-traumatic stress disorder For patients for whom a dose of 50 mg is ineffective, dose increases may be necessary. Dose adjustments should be made in increments of 50 mg at intervals of at least one week, up to a maximum dose of 200 mg per day. Given the 24-hour half-life of sertraline, dose adjustments should not be made more frequently than once a week. Initial therapeutic effect may be observed within 7 days. However, longer periods are usually required for therapeutic response, especially in obsessive-compulsive disorder. Maintenance therapy During long-term therapy, the maintenance dose of the drug should be the minimum effective dose, adjusted according to the therapeutic effect. Depression For the prevention of relapse of major depressive episodes, long-term administration of the drug may also be indicated. In most cases, the recommended dose for preventing relapse of major depressive episodes is the same as the dose prescribed for the current episode. Treatment of patients with depression should be sufficiently long-term, at least 6 months, to ensure the absence of disease symptoms. Panic disorder and obsessive-compulsive disorder For panic disorder and obsessive-compulsive disorder, the results of long-term treatment should be regularly assessed, as the efficacy of the drug for preventing relapse of similar disorders has not been established. Elderly patients Dose should be selected with caution in elderly patients due to the increased risk of developing hyponatremia. Patients with hepatic impairment Sertraline should be used with caution in patients with liver disease. In patients with hepatic impairment, a lower dose or increased interval between doses may be used. Sertraline should not be used in patients with severe hepatic impairment due to lack of clinical data. Patients with renal impairment Dose adjustment is not required in patients with renal impairment. Pediatric population Children and adolescents with obsessive-compulsive disorder Age 13-17 years: Initial dose 50 mg once daily. Age 6-12 years: Initial dose 25 mg once daily. One week after starting the drug, the dose may be increased to 50 mg once daily. If necessary, if the treatment effect is less than expected, the dose may be further increased by 50 mg per day over several weeks. The maximum daily dose is 200 mg. However, when increasing the dose by 50 mg, body weight, which is usually lower in children than in adult patients, should be considered. Dose adjustment should not be made at intervals of less than one week. The efficacy of the drug for the treatment of major depressive disorder in children has not been established. No data are available for children under 6 years of age. Method of administration Sertraline should be taken once daily, in the morning or evening. Sertraline tablets can be taken independently of food intake. Withdrawal symptoms Avoid abrupt discontinuation of therapy when discontinuing sertraline treatment. If sertraline therapy needs to be discontinued, the dose should be gradually reduced over at least 1-2 weeks to minimize the risk of withdrawal reactions. If severe withdrawal syndrome occurs during dose reduction or after discontinuation of treatment, the possibility of resuming therapy at the same dose should be considered. The physician can then restart dose reduction, but at longer intervals. Contraindications Hypersensitivity to the active substance or any of the excipients. Concomitant use with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of developing serotonin syndrome with symptoms such as agitation, tremor, and hyperthermia. Sertraline should not be administered within at least 14 days of discontinuation of treatment with irreversible monoamine oxidase inhibitors. Sertraline therapy should be discontinued at least 7 days before starting treatment with irreversible monoamine oxidase inhibitors. Concomitant use with pimozide is contraindicated. Special warnings and precautions for use Serotonin syndrome or neuroleptic malignant syndrome Cases of potentially life-threatening syndromes, such as serotonin syndrome or neuroleptic malignant syndrome, have been reported with the use of selective serotonin reuptake inhibitors (SSRIs), including sertraline. The risk of developing serotonin syndrome or neuroleptic malignant syndrome during SSRI treatment is increased when co-administered with other serotonergic drugs (including other serotonergic antidepressants, amphetamines, and triptans), drugs that inhibit serotonin metabolism (including MAOIs, e.g., methylene blue), antipsychotic drugs and other dopamine antagonists, as well as opioids. Patients should be monitored for signs and symptoms of serotonin syndrome or neuroleptic malignant syndrome. Transition from SSRIs, antidepressants, or antiobsessive drugs Controlled experience regarding the optimal timing for switching from SSRIs, antidepressants, or antiobsessive drugs to sertraline is limited. Caution and careful medical evaluation are required when switching medications, especially long-acting drugs such as fluoxetine. Other serotonergic agents, such as tryptophan, fenfluramine, and 5-HT agonists Caution should be exercised when prescribing sertraline with other drugs that enhance serotonergic neurotransmission, such as amphetamines, tryptophan, fenfluramine, 5-HT receptor agonists, or the herbal product St. John's Wort (Hypericum perforatum), and if possible, such combinations should be avoided, considering the risk of potential pharmacodynamic interactions. QTc interval prolongation/Torsade de Pointes (TdP) Cases of QTc interval prolongation and Torsade de Pointes (TdP) have been reported during post-marketing use of sertraline. Most cases occurred in patients with other risk factors for QTc interval prolongation/TdP. The effect on QTc interval prolongation has been confirmed in a detailed study of QTc interval in healthy volunteers, which showed a statistically significant positive dose-response relationship. Therefore, sertraline should be used with caution in patients with risk factors for QTc interval prolongation, such as cardiovascular disease, hypokalemia or hypomagnesemia, a family history of QTc interval prolongation, bradycardia, and concomitant use of QTc-prolonging drugs. Activation of hypomania or mania In a small proportion of patients taking marketed antidepressants and antiobsessive drugs, including sertraline, manic/hypomanic symptoms have been reported. Therefore, sertraline should be used with caution in patients with a history of mania/hypomania. Patients should be closely monitored during treatment. If the patient transitions to a manic phase of the illness, sertraline treatment should be discontinued. Schizophrenia Psychotic symptoms may be exacerbated in patients with schizophrenia. Seizures Seizures may occur during sertraline treatment: patients with unstable epilepsy should avoid sertraline, and patients with controlled epilepsy should be carefully monitored. If seizures occur, sertraline therapy should be discontinued. Suicide/suicidal thoughts/suicide attempt or worsening of clinical condition The risk of suicidal thoughts, self-harm, and suicide (suicidal behavior and ideation) increases in depression. This risk persists until long-term remission is achieved. Improvement may be observed several weeks or more after the start of therapy, so patients should be closely monitored until improvement occurs. Clinical experience suggests that the risk of suicide may increase in the early stages of recovery. In other mental disorders for which sertraline is prescribed, the risk of suicidal behavior and ideation may also be increased. In addition, these conditions may be accompanied by major depressive disorder. Therefore, the same precautions should be taken when treating other mental disorders as when treating major depressive disorder. In patients with a history of suicidal behavior and ideation, as well as significant suicidal thoughts, the risk of suicidal thoughts and suicide attempts increases during treatment. Such patients should be closely monitored during therapy. A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients under 25 years of age with mental disorders showed an increased risk of suicidal behavior with antidepressants compared to placebo. During drug therapy, especially in the initial stages and when changing drug doses, patients, especially those in risk groups, should be closely monitored. Patients (and their caregivers) should be warned of any signs of clinical worsening, suicidal behavior and thoughts, as well as any changes in behavior, and should seek medical advice immediately if these symptoms occur. Sexual dysfunction Selective serotonin reuptake inhibitors (SSRIs) can cause symptoms of sexual dysfunction. There have been reports of prolonged sexual dysfunction, with symptoms persisting even after discontinuation of SSRI treatment. Pediatric population Sertraline is not recommended for the treatment of children and adolescents under 18 years of age, except for patients aged 6-17 years with obsessive-compulsive disorder. Suicidal behavior and ideation (suicide attempts or suicidal thoughts) and hostility (primarily aggression, oppositional behavior, and anger) were more frequent in children and adolescents treated with antidepressants compared to the placebo group. If a decision is made to use the drug based on the patient's clinical condition, the patient's condition should be closely monitored for the emergence of suicidal symptoms. In addition, for long-term safety in children and adolescents, including the effect of the drug on growth, sexual maturation, and mental and behavioral development, clinical data are limited. In the post-marketing period, several cases of growth retardation and delayed sexual maturation have been reported. Clinical significance and causal relationship have not been established. Physicians should monitor the condition of pediatric patients in terms of growth and development norms during long-term treatment. Pathological bleeding/bruising Cases of pathological bleeding associated with SSRIs, including bruising (subcutaneous bruising and purpura), and other hemorrhagic events such as gastrointestinal bleeding and vaginal bleeding (in women), including fatal bleeding, have been reported. The risk of postpartum hemorrhage may increase with the use of SSRIs/SNRIs. Caution is recommended when using SSRIs, especially when co-administered with drugs that affect platelet function (e.g., anticoagulants, atypical antipsychotics, and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid, and non-steroidal anti-inflammatory drugs (NSAIDs)), as well as in patients with a history of hemorrhagic disorders. Hyponatremia Hyponatremia may develop as a result of treatment with SSRIs or SNRIs, including sertraline. In most cases, hyponatremia appears to be a consequence of the syndrome of inappropriate secretion of antidiuretic hormone. Decreased serum sodium levels <110 mmol/L have been reported. Elderly patients may have an increased risk of developing hyponatremia when taking SSRIs or SNRIs. The risk is also increased in the presence of diuretic use or dehydration for other reasons (see Use in elderly patients). Patients with symptomatic hyponatremia should consider discontinuing sertraline therapy and receive appropriate medical care. Signs and symptoms of hyponatremia include headache, impaired concentration, memory impairment, confusion, weakness, and balance disorders, which may lead to falls. More severe or acute signs and symptoms include hallucinations, loss of consciousness, seizures, coma, respiratory arrest, and death. Withdrawal symptoms Withdrawal symptoms often occur when discontinuing sertraline treatment, especially with abrupt discontinuation. The risk of withdrawal symptoms depends on several factors, including duration of therapy and dosage, as well as the rate of dose reduction. The most frequently reported reactions are dizziness, sensory disturbances (including paresthesia), sleep disturbances (including insomnia and vivid dreams), anxious agitation or anxiety, nausea and/or vomiting, tremor, and headache. These symptoms are usually mild to moderate in severity; however, in some cases, they can be severe. These symptoms typically develop within a few days of discontinuing treatment, but there are very rare cases of such symptoms developing in patients who have accidentally missed a dose. These symptoms usually resolve within 2 weeks without treatment, but in some cases may persist for longer (2-3 months or more). Therefore, when discontinuing therapy, gradual dose reduction of sertraline over several weeks or months, depending on the patient's condition, is recommended. Akathisia/psychomotor restlessness In some cases, the use of sertraline has been associated with the development of akathisia, characterized by an unpleasant or severe feeling of restlessness and a need to move, with an inability to remain still. These symptoms are most common in the first weeks of treatment. Increasing the dose of the drug in the presence of these symptoms may worsen the patient's condition. Hepatic impairment Sertraline is extensively metabolized in the liver. Pharmacokinetic studies of multiple doses in patients with stable cirrhosis of mild severity showed a prolonged half-life and approximately a threefold increase in AUC and Cmax values compared to healthy patients. No significant difference in plasma protein binding was observed between these two groups. Sertraline should be used with caution in patients with liver disease. In patients with hepatic impairment, the dose or frequency of administration of the drug should be reduced. Sertraline is not recommended for use in patients with severe hepatic impairment. Renal impairment Sertraline is extensively metabolized, and unchanged drug excretion in urine is an additional route of elimination. In studies conducted in patients with mild to moderate renal impairment (creatinine clearance 30-60 mL/min) or moderate to severe renal impairment (creatinine clearance 10-29 mL/min), pharmacokinetic parameters (AUC 0-24 or C max ) after multiple doses did not differ significantly from control parameters. Dose adjustment of sertraline is not required regardless of the degree of renal impairment. Use in elderly patients Over 700 elderly patients (>65 years) participated in clinical studies. The nature and frequency of adverse reactions in elderly patients were similar to those observed in younger patients. However, the use of SSRIs or SNRIs, including sertraline, has been associated with cases of clinically significant hyponatremia in elderly patients, who may be at higher risk of developing this side effect. Diabetes In patients with diabetes, SSRIs can disrupt glycemic control. Dose adjustment of insulin and/or oral hypoglycemic agents may be necessary. Electroconvulsive therapy Clinical studies evaluating the risks and potential benefits of combining ECT and sertraline treatment have not been conducted. Grapefruit juice Concomitant use of sertraline with grapefruit juice is not recommended. Effects on urine screening tests False-positive results for benzodiazepines in urine screening immunoassays have been reported in patients taking sertraline. This is due to the low specificity of screening tests. False-positive results may occur for several days after discontinuation of sertraline therapy. Additional tests, such as gas chromatography/mass spectrometry, can differentiate sertraline from benzodiazepines. Angle-closure glaucoma Selective serotonin reuptake inhibitors, including sertraline, can affect pupil size, causing mydriasis. In this case, angle-closure glaucoma may occur, leading to increased intraocular pressure and the development of angle-closure glaucoma, especially in predisposed patients. Therefore, sertraline should be used with caution in patients with angle-closure glaucoma or a history of glaucoma. Information on excipients Lactose Esribel contains lactose monohydrate. Patients with rare hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product. This medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is practically "sodium-free". Interactions with other medicinal products and other forms of interaction Contraindicated Monoamine oxidase inhibitors Irreversible monoamine oxidase inhibitors (e.g., selegiline) Sertraline should not be used concomitantly with irreversible monoamine oxidase inhibitors, such as selegiline. Sertraline should not be administered within at least 14 days of discontinuation of treatment with irreversible monoamine oxidase inhibitors. Sertraline therapy should be discontinued at least 7 days before starting treatment with irreversible monoamine oxidase inhibitors. Reversible, selective monoamine oxidase inhibitors (moclobemide) Due to the risk of serotonin syndrome, sertraline should not be administered concomitantly with reversible selective monoamine oxidase inhibitors, such as moclobemide. A washout period of less than 14 days may be observed after treatment with a reversible MAOI before starting sertraline treatment. Discontinuation of sertraline therapy is recommended at least 7 days before starting treatment with a reversible monoamine oxidase inhibitor. Reversible, non-selective monoamine oxidase inhibitors (linezolid) The antibiotic linezolid is a weak reversible, non-selective MAO inhibitor and should not be administered during sertraline therapy. Severe adverse reactions have been reported in some patients who have recently completed MAOI therapy (e.g., methylene blue) and started sertraline, or who have recently discontinued sertraline and started MAOI therapy. These reactions included tremor, myoclonus, increased sweating, nausea, vomiting, flushing, dizziness, and hyperthermia with signs of neuroleptic malignant syndrome, seizures, and death. Pimozide In a study, a single dose of low-dose pimozide (2 mg) resulted in an approximately 35% increase in pimozide levels. These increased levels were not associated with any ECG changes. Since the mechanism of this interaction is unknown and pimozide has a narrow therapeutic index, concomitant use of sertraline and pimozide is contraindicated. Concomitant use with sertraline is not recommended Central nervous system depressants and alcohol In healthy subjects, concomitant administration of sertraline 200 mg did not enhance the effects of alcohol, carbamazepine, haloperidol, or phenytoin on cognitive and psychomotor function; however, concomitant use of sertraline and alcohol is not recommended. Other serotonergic drugs Co-administration with fentanyl (used for general anesthesia or chronic pain management), other serotonergic drugs (including other serotonergic antidepressants, amphetamines, triptans), and other opioid agents is recommended with caution. Special precautions QTc-prolonging drugs The risk of QTc interval prolongation and/or ventricular arrhythmias (e.g., TdP) may increase with concomitant administration of other QTc-prolonging drugs (e.g., certain antipsychotics and antibiotics). Lithium In a placebo-controlled study in healthy volunteers, concomitant administration of sertraline and lithium did not significantly alter lithium pharmacokinetics but increased tremor compared to placebo, suggesting a possible pharmacodynamic interaction. Appropriate patient monitoring is recommended when sertraline and lithium are used concomitantly. Phenytoin Results from a placebo-controlled study in healthy volunteers indicate that long-term use of sertraline at a dose of 200 mg per day does not cause clinically significant inhibition of phenytoin metabolism. However, in some cases, phenytoin exposure has been high during sertraline treatment, so monitoring of phenytoin levels in plasma and dose adjustment of phenytoin are recommended when prescribing sertraline. Additionally, concomitant use of phenytoin may reduce sertraline levels in plasma. It is possible that other CYP3A4 inducers, such as phenobarbital, carbamazepine, St. John's Wort preparations, and rifampicin, may also reduce plasma levels of sertraline. Triptans Rare cases of weakness, hyperreflexia, impaired coordination, confusion, anxiety, and agitation have been reported after concomitant use of sertraline and sumatriptan during post-marketing use. Signs of serotonin syndrome may also occur with the use of other products in this class (triptans). Appropriate patient monitoring is recommended when sertraline and triptans are used concomitantly. Warfarin Concomitant administration of sertraline 200 mg daily with warfarin resulted in a small but statistically significant increase in prothrombin time, which in some rare cases may lead to INR disturbance. Therefore, careful monitoring of prothrombin time is recommended at the beginning and during withdrawal of sertraline therapy. Other drug interactions, digoxin, atenolol, cimetidine Concomitant administration with cimetidine was associated with a significant decrease in sertraline clearance. The clinical significance of these changes is unknown. Sertraline did not affect the beta-adrenergic blocking ability of atenolol. No interaction was observed between sertraline 200 mg daily and digoxin. Drugs affecting platelets If drugs affecting platelet function (e.g., NSAIDs, acetylsalicylic acid, and ticlopidine), as well as other drugs that increase the risk of bleeding, are prescribed concomitantly with SSRIs, including sertraline, the probability of bleeding may increase. Neuromuscular blockers SSRIs can reduce cholinesterase activity in plasma, leading to prolonged effects of neuromuscular transmission of drugs such as mivacurium or other neuromuscular blockers. Cytochrome P450 metabolizers Sertraline can inhibit the isoenzyme CYP 2D6 to a mild or moderate extent. It has been established that long-term administration of sertraline at a dose of 50 mg per day is associated with a moderate increase in plasma levels of desipramine (average 23-37%) (a marker of CYP2D6 isoenzyme activity). Clinically significant interactions may occur with CYP2D6 substrates with a narrow therapeutic index, such as class 1C antiarrhythmics, particularly propafenone and flecainide, tricyclic antidepressants, and typical antipsychotics, especially at high doses of sertraline. Sertraline does not have a clinically significant inhibitory effect on CYP 3A4, CYP 2C9, CYP 2C19, and CYP 1A2 isoenzymes. This has been confirmed by in vivo studies of interactions with substrates of CYP3A4 (endogenous cortisol, carbamazepine, terfenadine, alprazolam), CYP2C19 (diazepam), and CYP2C9 (tolbutamide, glibenclamide, and phenytoin). In vitro studies indicate that sertraline has a negligible or no inhibitory effect on CYP 1A2 activity. In individuals with slow metabolism mediated by CYP2C19, plasma concentrations of sertraline are approximately 50% higher than in individuals with active metabolism. The interaction of sertraline with strong inhibitors of CYP2C19, such as omeprazole, lansoprazole, pantoprazole, rabeprazole, fluoxetine, and fluvoxamine, cannot be ruled out. Fertility, pregnancy, and lactation Pregnancy No adequately controlled studies have been conducted in pregnant women. However, a significant amount of data has not revealed evidence of sertraline-induced birth defects. Some newborns whose mothers received sertraline during pregnancy exhibited symptoms similar to withdrawal reactions. This phenomenon has also been observed with other antidepressants in the SSRI class. Sertraline administration during pregnancy is not recommended unless the expected benefit to the mother outweighs the potential risk to the fetus. Observational study data have shown an increased risk of postpartum hemorrhage (twice as likely) following exposure to SSRIs/SNRIs within one month before delivery. Newborns whose mothers continued to take sertraline in late pregnancy, especially in the third trimester, should be monitored. Newborns whose mothers received sertraline in late pregnancy may exhibit the following symptoms: respiratory distress, cyanosis, apnea, seizures, unstable body temperature, feeding difficulties, vomiting, hypoglycemia, hypertonia, hypotonia, hyperreflexia, tremor, nervousness, irritability, lethargy, prolonged crying, drowsiness, and sleep disturbances. These symptoms may be related to the serotonergic effects of sertraline, as well as withdrawal syndrome. In most cases, the described complications develop immediately after birth or shortly thereafter (within 24 hours). Breastfeeding According to published literature, sertraline and its metabolite N-desmethylsertraline are excreted in breast milk in small amounts. Use of the drug in breastfeeding mothers is not recommended unless the physician deems the benefit to outweigh the risk. Fertility Data from animal studies indicate that sertraline does not affect fertility rates. In humans, some SSRIs have been shown to reversibly affect sperm quality. No effects of sertraline on human fertility have been reported to date. Effects on the ability to drive and operate machinery Clinical pharmacology studies have shown that sertraline does not affect psychomotor function. However, patients should be warned that psychotropic drugs can adversely affect mental or physical reactions required for potentially hazardous tasks, such as driving or operating machinery. Adverse reactions The most common adverse reaction is nausea. In the treatment of social anxiety disorder, sexual dysfunction in men (ejaculatory disorder) was observed in 14% of patients taking sertraline, compared to 0% in the placebo group. These adverse events are dose-dependent and often resolve spontaneously with continued treatment. In double-blind, placebo-controlled studies in patients with obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder, the most frequently reported adverse reaction profile was similar to that observed in clinical studies of patients with depression. Table 1 lists adverse reactions reported during post-marketing use (frequency unknown) and in placebo-controlled clinical trials (total number of participants - 2542 in the sertraline group and 2145 in the placebo group) in patients with depression, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. The intensity and frequency of some adverse drug reactions listed in Table 1 may decrease with continued therapy and generally do not require discontinuation of therapy. Table 1. Adverse reactions Frequency of adverse reactions reported in placebo-controlled clinical trials for depression, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. Pooled analysis and post-marketing experience. System and organ class Very common (>1/10) Common (>1/100 to <1/10) Uncommon (>1/1000 to <1/100) Rare (>1/10000 to <1/1000) Frequency unknown (frequency cannot be determined from available data) Infections and parasitic diseases Upper respiratory tract infections, pharyngitis, rhinitis Gastroenteritis, otitis media Diverticulitis § Benign, malignant and unspecified neoplasms (including cysts and polyps) Neoplasm Blood and lymphatic system disorders Lymphadenopathy, thrombocytopenia*, leukopenia* Immune system disorders Hypersensitivity*, seasonal allergy* Anaphylactoid reaction* Endocrine disorders Hypothyroidism* Hyperprolactinemia*, syndrome of inappropriate secretion of antidiuretic hormone* § Metabolic and nutritional disorders Decreased appetite, increased appetite* Hypercholesterolemia, diabetes mellitus*, hypoglycemia*, hyperglycemia* § , hyponatremia* § Psychiatric disorders Insomnia Anxiety*, depression*, agitation*, decreased libido*, nervousness, depersonalization, nightmares, bruxism* Suicidal thoughts/behavior, psychotic disorder*, pathological thinking, apathy, hallucinations*, aggression*, euphoric mood*, paranoia Conversion disorder* § , paroniria* § , drug dependence, lunatism, premature ejaculation Nervous system disorders Dizziness, headache*, somnolence Tremor, movement disorder (including extrapyramidal symptoms such as hyperkinesia, hypertonia, dystonia, teeth grinding or gait disturbance), paresthesia*, amnesia, hypesthesia*, involuntary muscle contractions*, syncope*, hyperkinesia*, migraine*, seizures*, postural dizziness, coma*, akathisia, dyskinesia, hyperesthesia, cerebral artery spasm (reversible cerebral vasoconstriction and Col-Fleming syndrome)* § , Hypertension*, impaired concentration, dysgeusia Impaired coordination, speech disorder Psychomotor restlessness* § , sensory disturbance, choreoathetosis § , also reported are signs and symptoms associated with serotonin syndrome* or neuroleptic malignant syndrome, which in some cases developed with concomitant use of serotonergic drugs: agitation, confusion, sweating, diarrhea, fever, hypertension, rigidity, and tachycardia § Eye disorders Visual impairment* Mydriasis* Scotoma, glaucoma, diplopia, photophobia, hyphema* § , anisocoria* § , visual disturbance § , lacrimal apparatus pain Maculopathy Ear and labyrinth disorders Tinnitus* Ear pain Cardiac disorders Palpitations* Tachycardia*, cardiac disorders Myocardial infarction* § , Torsade de Pointes* § , bradycardia, QTc interval prolongation* Vascular disorders Flushing* Pathological bleeding (e.g., gastrointestinal bleeding)*, hypertension*, hyperemia, hematuria* Peripheral ischemia Respiratory, thoracic and mediastinal disorders Yawning* Dyspnea, epistaxis*, bronchospasm* Hyperventilation, interstitial lung disease* § , pharyngeal spasm, dysphonia, stridor* § , hypoventilation, hiccups Gastrointestinal disorders Nausea, diarrhea, dry mouth Dyspepsia, constipation*, abdominal pain*, melena, dental disorders, esophagitis, aphthous stomatitis, pancreatitis* § , hematochezia, microscopic colitis* Vomiting*, flatulence Glossitis, hemorrhoids, increased salivation, dysphagia, belching, tongue pain Ulcers on the tongue, stomatitis Hepatobiliary disorders Hepatic function disorder, serious hepatic events (including hepatitis, jaundice, and hepatic failure) Skin and subcutaneous tissue disorders Hyperhidrosis, rash* Periorbital edema*, urticaria*, alopecia*, pruritus*, purpura*, dermatitis, dry skin, facial edema, cold sweat Rare reports of severe skin adverse reactions: e.g., Stevens-Johnson syndrome* and epidermal necrolysis* § , skin reaction* § , photosensitivity § , angioneurotic edema, hair texture disorder, change in skin odor, bullous dermatitis, vesicular rash Musculoskeletal and connective tissue disorders Back pain, arthralgia*, myalgia Osteoarthritis, muscle cramps, muscle spasm*, muscle weakness Rhabdomyolysis* § , bone damage Trismus* Renal and urinary disorders Pollakiuria, urinary disorder, urinary retention, urinary incontinence*, polyuria, nocturia Difficulty initiating urination*, oliguria Reproductive system and breast disorders Absence of ejaculation Irregular menstruation*, erectile dysfunction Sexual dysfunction, menorrhagia, vaginal bleeding, female sexual dysfunction Galactorrhea*, atrophic vulvovaginitis, genital discharge, balanoposthitis* § , gynecomastia*, priapism* Postpartum hemorrhage*† General disorders and administration site conditions Increased fatigue* Malaise*, chest pain*, asthenia*, pyrexia* Peripheral edema*, tremor, gait disturbance*, thirst Hernia, decreased drug tolerance Laboratory and instrumental findings Weight gain* Increased alanine aminotransferase*, increased aspartate aminotransferase*, weight loss* Increased blood cholesterol*, abnormal laboratory findings, abnormal findings in semen analysis, altered platelet function* § Trauma Trauma Intoxication and procedural complications Surgical and medical procedures Vasodilation * Adverse drug reactions identified during post-marketing period § Frequency of adverse reactions is presented using the upper limit of the 95% confidence interval using the "rule of 3". † This event was reported within the therapeutic class of SSRI/SNRI. Overdose Toxicity The safety profile of sertraline depends on the patient population and/or concomitant medications. Fatalities have been reported in cases of sertraline overdose, either alone or in combination with other drugs or alcohol. Therefore, intensive medical therapy is recommended in case of any overdose. Symptoms Symptoms of overdose include serotonin-induced side effects such as somnolence, gastrointestinal disturbances (e.g., nausea and vomiting), tachycardia, tremor, agitation, and dizziness. Rare cases of coma have been reported. QTc interval prolongation/Torsade de Pointes has been observed in sertraline overdose; therefore, ECG monitoring is recommended in case of any sertraline overdose. Treatment There is no specific antidote for sertraline. Maintaining a patent airway, and if necessary, adequate oxygenation and ventilation should be ensured. Administration of activated charcoal with a laxative may be more effective than gastric lavage, so its use should be considered in the treatment of overdose. Induction of vomiting is not recommended. Monitoring of cardiac function (e.g., ECG) and vital signs, as well as general symptomatic and supportive therapy, is recommended. Due to the wide volume of distribution of sertraline, forced diuresis, dialysis, hemoperfusion, and blood transfusion may be ineffective. Shelf life 2 years Dispensing category: Pharmaceutical product group II, dispensed with form №3 prescription Special precautions for storage Store below 25°C, in its original packaging. Keep out of reach of children. Packaging type and contents White transparent PVC/PE/PVDC-Al blister (14 film-coated tablets/1 blister/1 box) (28 film-coated tablets/2 blisters/1 box) See also: STIMULOTON - Stimuloton 50mg 30 tablets