active substance: one coated tablet contains sertraline hydrochloride in an amount equivalent to 50 mg sertraline;
auxiliary substances: calcium hydrophosphate dihydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch, magnesium stearate, Opadry white (hypromellose, titanium dioxide (E 171), polyethylene glycol, Polysorbate 80), Opadry transparent (hydroxypropyl methylcellulose, polyethylene glycol).
Pharmacological group. Antidepressants. Selective serotonin reuptake inhibitors. ATC code N06A B06.
Sertraline is indicated for the treatment of the following disorders:
Major depressive episodes. Prevent the recurrence of the big depressive episodes.
Panic disorder with or without agoraphobia.
Obsessive-compulsive disorder (OCD) in adults and children 6-17 years of age.
Social anxiety disorder.
Post-traumatic stress disorder (PTSD).
Hypersensitivity to the active substance or to any of the auxiliary substances.
Do not use sertraline with MAO inhibitors (MAOIS) irreversible actions related to the risk of serotonin syndrome with the manifestations of such symptoms as agitation, tremor and hyperthermia. Sertraline therapy should not be started for at least 14 days after the termination of MAO inhibitor treatment with irreversible action. The use of sertraline should be discontinued at least 7 days before therapy MAO inhibitor irreversible actions. Do not use sertraline and pimozide simultaneously (see also Section "Interaction with other medicinal products and other forms of interaction").
Method of application and doses
Sertraline take 1 time per day (morning or evening).
Tablets of sertraline can be taken with or without food.
beginning of treatment
Depression and OCD
Treatment with sertraline should be started at a dose of 50 mg/day.
Panic disorders, PTSD and social anxiety disorder
Treatment should be initiated with a dose of 25 mg/day. After 1 week the dose should be increased to 50 mg 1 time a day. It has been shown that such a dosing regimen reduces the frequency of development at the initial stage of treatment side effects characteristic of panic disorder.
Depression, OCD, panic disorders, social anxiety disorder and PTSD
In patients who do not respond to a dose of 50 mg, the effect can be achieved by increasing the dose. Dose adjustment should start no earlier than 1 week of treatment, increasing gradually to 50 mg at intervals of duration at least one week. The maximum dose should not exceed 200 mg/day. Dose correction should be carried out no more often than once a week, given the half-life of sertraline, which is 24 hours.
The first manifestations of the therapeutic effect can be observed within 7 days of treatment. However, to achieve a therapeutic response usually requires a long period of time, especially in patients with OCD.
Dosage for long-term therapy should be kept at a low effective level, followed by adjustment depending on the therapeutic response.
Long-term therapy can be used to prevent the recurrence of large depressive episodes (RES). In most cases, the recommended dose for the prevention of resurgence of RES is the same as the dose used during the treatment of this depressive episode. Patients with depression should receive therapy for a sufficient time, for at least 6 months, to make sure that there are no symptoms.
Panic disorder and OCD
With long-term therapy in patients with panic disorder and OCD should be regular evaluation of the therapy, since these disorders was noted to have efficacy in preventing relapse.
the use of children
Children with obsessive-compulsive disorder
Children 13-17 years: the initial dose is 50 mg once a day.
Children 6-12 years: the initial dose is 25 mg once a day. After 1 week the dose may be increased to 50 mg 1 time a day.
If necessary, in the absence of the desired effect on the background of taking the drug at a dose of 50 mg/day, it may be further increased with an increase in the dose of 50 mg per day at a time for several weeks. The maximum dose is up to 200 mg/day.
However, when increasing the dose of 50 mg in Pediatrics should take into account the overall low body weight of children compared to adults. Do not change the dose more often than once a week.
The effectiveness of the drug in children with large depressive disorder has not been demonstrated.
Data on the use of the drug in children under 6 years are not available (see. "Features of application").
Use in elderly patients
Elderly patients the drug should be used with caution, since these patients may have an increased risk of developing hyponatremia (see Section "Peculiarities of use").
Application in hepatic insufficiency
Care should be taken when using sertraline in patients with liver disease. In violation of liver function, it is necessary to reduce the dose or frequency of taking the drug. Sertraline should not be used in patients with severe hepatic insufficiency, since clinical data on the use of the drug in such patients are not available (see section "features of application").
Use in renal failure
In the human kidney correction dose is not required (see Section "Peculiarities of use").
Withdrawal symptoms that occur when discontinuing treatment with sertraline
Avoid sudden discontinuation of the drug. When discontinuing treatment with sertraline to reduce the risk of developing reactions of the syndrome, the dose should be gradually reduced over at least 1-2 weeks (see Section "peculiarities of use" and "Adverse reactions"). If, after discontinuation of the drug or discontinuation of its use, there are unbearable symptoms, it may be considered to restore the use of the drug in a previously prescribed dose. In the future, the doctor may continue to reduce the dose, but more gradually.
Most often there is such a side effect as nausea. In the treatment of social anxiety disorder sertraline in 14% of men noted sexual dysfunction (ejaculation) compared with 0% of patients receiving placebo. These side effects are dose-dependent and often disappear on their own when continuing therapy.
The profile of side effects, often observed during the double-blind, placebo-controlled studies involving patients with OCD, panic disorder, PTSD and social anxiety disorders, was similar to that in patients with depression, who participated in clinical trials.
Below shows adverse reactions that were observed during post-marketing surveillance (frequency of their development is unknown) and during the placebo-controlled clinical studies (which in total took part 2542 of patients treated with sertraline and 2145 patients treated with placebo) with patients with depression, OCD, panic disorder, PTSD and social anxiety disorders.
Some of the adverse reactions listed below may decrease in intensity and frequency subject to long-term treatment and do not lead to cessation of therapy.
The following incidence of adverse reactions that have been observed during placebo-controlled clinical studies in patients with depression, OCD, panic disorder, PTSD and social anxiety disorders. The data of clinical trials and post-registration supervision are combined (the frequency is unknown).
Infections and infestation. Often, pharyngitis; rarely, infections of the upper respiratory tract, rhinitis rarely diverticulitis, gastroenteritis, otitis media.
Tumors benign and malignant (including cysts and polyps). Rarely neoplasms (one case of neoplasm in one patient receiving sertraline was reported, compared to the absence of such cases in a group of patients receiving placebo).
On the part of the blood system and lymphatic system. Rarely lymphadenopathy; unknown: leukopenia, thrombocytopenia.
From the immune system. Rarely hypersensitivity; rarely, anaphylactoid reactions; not known: allergic.
On the part of the endocrine system. Infrequently the hypothyroidism is unknown: hyperprolactinemia, syndrome of inappropriate secretion of ADH.
Metabolic and alimentary disorders. Common: loss of appetite, gain of appetite *; rare: diabetes mellitus, hypercholesterolaemia, hypoglycaemia not known: hyponatremia, hyperglycemia.
Mental disorder. Very common: insomnia (19%); frequent: depression, depersonalization, nightmares, anxiety * arousal *, nervousness, decreased libido *, bruxism; rare hallucinations * aggression * euphoric *, apathy, thinking abnormal; rare conversion disorder, drug dependence, psychotic disorder *, paranoia, suicidal thinking/suicidal behaviour (only for patients with OCD, short-term use, in studies with a duration of 1-12 weeks, was registered the occurrence of suicidal ideation and suicidal behavior during treatment with sertraline or shortly after cessation of therapy (see section "Peculiarities of application")), somnambulism, premature ejaculation; unknown: paroniria.
From the nervous system. Very often, dizziness (11%), somnolence (13%), headache (21%) *; frequent: paraesthesia *, tremor, hypertonia, dysgeusia, impaired attention, rarely convulsion *, muscle contractions involuntary *, coordination of movements, hyperkinesis, amnesia, hypesthesia, speech disorder, dizziness postural, syncope, migraine *; rarely coma * choreoathetosis, dyskinesia, hyperesthesia, sensory disturbance; unknown: movement disorders (including extrapyramidal symptoms including hyperkinesis, hypertonicity, spasms of the jaw or gait disturbance). There were also signs and symptoms of serotonin syndrome or neuroleptic malignant syndrome, in some cases associated with concomitant ingestion of serotonergic agents, namely: agitation, confusion, sweating, diarrhoea, fever, hypertension, rigidity and tachycardia. Akathisia and psychomotor agitation (see Section "Peculiarities of use"). A spasm of cerebral vessels (including syndrome fleeting or cerebral vasoconstriction syndrome Call-Fleming).
From the side of organs of vision. Often visual disturbances; rarely, mydriasis; rare: glaucoma, violation of tearing, scotoma, diplopia, photophobia, hyphema; unknown: blurred vision, pupils of different sizes.
On the part of hearing and vestibular apparatus. Often ringing in the ears *; infrequent: ear pain.
Cardiac disorders: palpitations Often *; rarely, tachycardia rare: myocardial infarction, bradycardia, violation of cardiac activity.
Vascular disorders. Often tides *; infrequently: arterial hypertension * hyperemia rarely peripheral ischemia, hematuria unknown: pathological hemorrhagic phenomena (such as, gastrointestinal bleeding).
From the respiratory system, chest and mediastinum. Often yawn *; infrequently bronchospasm*, shortness of breath, nasal bleeding; rarely laryngospasm, hyperventilation, hypoventilation, stridor, dysphonia, hiccups; unknown: interstitial lung disease.
The gastro-intestinal tract. Very often diarrhea (18%), nausea (24%), dry mouth (14%); often: abdominal pain*, vomiting * constipation *, dyspepsia, flatulence; infrequently esophagitis, dysphagia, hemorrhoids, hypersalivation, changes in the tongue, burp; rarely ground, hematochesia, stomatitis, ulcers in the tongue, diseases of the teeth, glossitis, mouth ulcers; unknown: unknown pancreatitis.
From the digestive system. Rare: abnormal liver function unknown: hepatic failure, may rarely lead to fatal, fulminant hepatitis, necrotizing hepatitis, cholestatic jaundice.
From the skin and subcutaneous tissue. Often rash * rash; rarely, periorbital oedema *, face oedema *, purpura *, alopecia *, cold sweat, dry skin, urticaria * itching rare dermatitis, bullous dermatitis, vezikulezny lesions, pathological changes in the hair texture, unusual odor of the skin; unknown: there have been rare cases of serious adverse reactions in the skin such as Stevens-Johnson syndrome and toxic epidermal necrolysis), angioedema, photosensitivity, skin reactions.
From the side of musculoskeletal system and connective tissue. Frequent: arthralgia, myalgia uncommon osteoarthritis, muscular weakness, back pain, muscle twitching, rare lesions of the bones; not known: muscle spasms.
From the kidneys and urinary system. Not often nicturia, urinary retention *, polyuria, pollakiuria,impaired urination, urinary incontinence*; rarely oliguria, obstructed urination.
On the part of the reproductive system and mammary glands **. Very often: ejaculation disorders (14%); often: erectile dysfunction infrequently vaginal bleeding, sexual dysfunction, sexual dysfunction in women, irregular menstrual cycle; rarely menorrhagia, atrophic vulvovaginitis, balanoposthitis, discharge from the genital organs, priapism *, galactorrhea *; unknown: gynecomastia.
Common violations. Very often, fatigue (10%) *; frequent: chest pain *, malaise *; rarely peripheral edema, chills, pyrexia *, asthenia *, thirst hernia, rarely, reduced tolerability, gait disturbance.
Research. Uncommon: increase of a level alaninaminotransferase * increased AST * weight loss * weight gain *; rare: impaired sperm quality; increase the level of cholesterol in the blood; unknown: abnormal results of clinical laboratory tests, the altered function of platelets.
Injuries and poisoning. Rarely trauma.
Surgical interventions and medical procedures. Rarely vasodilation.
If the side effect was observed in patients with depression, OCD, panic disorder, PTSD and social anxiety disorder, the terms used to characterize the side effects, reclassified by time, which were applied to patients with depression.
* These adverse reactions were also recorded during post-marketing surveillance
** The frequency of these adverse reactions was determined for the number of patients in a particular group by sex: sertraline (1118 males, 1424 females), placebo (926 males, 1219 females).
Withdrawal syndromes observed at the termination of therapy with sertraline
Discontinuation of sertraline therapy (especially in the case of abrupt discontinuation of therapy) usually leads to the development of withdrawal symptoms. Side effects such as dizziness, sensory disturbances (including paresthesia), sleep disorders (including insomnia and vivid dreams), anxiety, nausea and/or vomiting, tremor and headache were most commonly reported. Typically, these side effects were mild to moderate and occurred on their own; however, in some patients they may be severe and/or prolonged. In this regard, in cases where there is no longer a need for therapy with sertraline, it is recommended to gradually cancel the drug by gradually reducing the dose (see Sections "Method of application and dose" and "Features of application").
Use in elderly patients
The use of selective serotonin reuptake inhibitors (sioss) or noradrenaline reuptake and serotonin reuptake inhibitors (ISPS), including sertraline, has been associated with clinically significant cases of hyponatremia in elderly patients who may have an increased risk of developing this side effect (see "application Features ").
the use of children
In more than 600 children receiving sertraline, the overall profile of adverse reactions was generally similar to that observed in studies involving adult patients. In the course of clinical controlled trials have been reported following adverse reactions (number of patients taking sertraline, was 281):
Very often (?1/10): headache (22%), insomnia (21%), diarrhea (11%) and nausea (15%). Often (?1/100 to <1/10): chest pain, mania, pyrexia, vomiting, lack of appetite, affective lability, aggression, excitement, nervousness, attention disorder, dizziness, hyperkinesia, migraine, drowsiness , tremor, visual impairment, dry mouth, dyspepsia, nightmares, fatigue, urinary incontinence, rash, acne, nasal bleeding, flatulence. Infrequently (?1/1,000 to <1/100): prolonged QT interval on ECG, suicide attempts, convulsions, extrapyramidal disorder, paraesthesia, depression, hallucination, purpura, hyperventilation, anaemia, abnormal liver function, increased levels of alanine aminotransferase, cystitis , herpes simplex, otitis media, outer ear, Earache, eye pain, mydriasis, malaise, haematuria, rash pustular, rhinitis, injury, weight loss, muscle twitching, unusual dreams, apathy, albuminuria, pollakiuria, polyuria, breast pain, menstrual disorders, alopecia, dermatitis, skin lesions, unusual skin odor, urticaria, bruxism, flushing. Frequency not known: enuresis.
Effects characteristic of this class of medicines
As a result of epidemiological studies, mainly conducted in patients aged 50 years and over, was discovered an increased risk of bone fractures in patients receiving SSRIs and tricyclic antidepressants. The mechanism that increases this risk is unknown.
The message of suspected adverse reactions
Reporting suspected adverse reactions during the post-registration period is an important activity. This allows you to continue monitoring the benefit/risk ratio when using the drug. Doctors are requested to report any suspected adverse reactions.
Sertraline has a range of safety, depends on the population of patients and/or the concomitant use of drugs. It was reported fatal cases of overdose with sertraline as the individual application (no concomitant medications) or in combination with other drugs and/or alcohol. In this regard, each case of overdose requires intensive therapy.
Symptoms of overdose include serotonin-mediated side effects such as drowsiness, gastrointestinal disorders (including nausea and vomiting), tachycardia, tremor, arousal and dizziness. Less frequently reported cases of coma.
Specific antidotes sertraline does not exist. Respiratory tract patency and adequate oxygenation and ventilation must be ensured and maintained. Intake of activated charcoal, which can be used together with a laxative, can be no less effective for gastric lavage and should be taken into account in the case of overdose therapy. Vomiting is not recommended. Recommended monitoring of cardiac activity and other major vital signs along with symptomatic and supportive therapy. Given the large volume of distribution of sertraline, measures such as forced diuresis, dialysis, hemoperfusion, or substitution blood transfusion are unlikely to be useful.
Overdose of sertraline can lead to prolongation OF Qt interval, so it is recommended to carry out ECG monitoring in all cases of overdose of the drug.
Use during pregnancy or breast-feeding.
There are no well-controlled studies of the drug in pregnant women. However, a significant amount of data does not show evidence of occurrence congenital malformations of the fetus due to the use of sertraline. In animal studies, the effect on reproductive function was revealed, probably due to the toxic effect of the drug on the mother's body caused by the pharmacodynamic action of the drug and/or the direct pharmacodynamic effect of the drug on the fetus.
It has been reported that the use of sertraline during pregnancy causes in some newborns (mothers who have taken sertraline), symptoms similar to withdrawal reactions. This phenomenon was also observed when using other SSRI antidepressants. Sertraline is not recommended during pregnancy, except in cases when the clinical condition of the woman such that the expected benefit of the drug outweighs the potential risk.
Women of childbearing age should use appropriate contraceptives when taking sertraline.
You should observe the newborn, if the mother continues the use of sertraline in late pregnancy, especially in the third trimester. After the use of sertraline in the later stages of pregnancy in infants can cause the following symptoms: respiratory distress, cyanosis, apnea, seizures, temperature instability, difficulty feeding, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, syndrome of increased neuro-reflex excitability , irritability, listlessness/lethargy, constant crying, somnolence and difficulty falling asleep. These symptoms may be due to other serotoninergic effects or withdrawal symptoms. In most cases, these complications develop immediately after delivery or in the near future (within less than 24 hours).
According to epidemiological studies, it is expected that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of development of a syndrome of persistent pulmonary hypertension of the newborn. The risk against the background of taking the drug is observed with a frequency of about 5 cases per 1000 pregnancies. In the General population there are 1-2 cases of persistent pulmonary hypertension syndrome in newborns per 1000 pregnancies.
Published data on the levels of sertraline in breast milk indicate that sertraline and its metabolite N-desmethylsertraline are excreted in breast milk in small amounts. In total, the serum concentrations of infants showed a slight drug concentration or drug concentration, inaccessible to determine, except for one case, when the serum concentration of the infant was about 50% of the concentration of the drug in the mother's serum (but without any noticeable effect on the health of "I this baby). To date, no side effects of the drug on the health of children who were breastfed by women who used sertraline have been reported, but this risk can not be ruled out. The use of the drug during lactation is not recommended, except when, in the opinion of the physician, the benefits of the drug outweigh the potential risks.
Sertraline should not be used for the treatment of children, except children with obsessive-compulsive disorder of 6 years (see section "dosage and Administration").
Features of the application.
Symptoms such as anxiety, excitement, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsiveness, psychomotor anxiety, hypomania and mania were observed in adults and children treated with antidepressants. These symptoms may precede the appearance of suicide. It is necessary to consider the possibility of changing the therapeutic regimen or discontinuation of the drug if the manifestations of depression steadily deteriorate, there is a suicide or symptoms of worsening suicide. If it is decided to discontinue treatment, the drug should be abolished gradually as quickly as possible, but it should be remembered that a sharp cessation of treatment may be accompanied by withdrawal syndrome. Before starting treatment, it is necessary to examine the patient to determine the risk of bipolar disorder. To do this, carefully going psychiatric history, including family history of suicide, bipolar disorders and depression. Zoloft is not intended for the treatment of bipolar depression.
Serotonin syndrome (SS) or neuroleptic malignant syndrome (NMS)
When using SSRIs, including treatment with sertraline, reported on the development of syndromes that can be life-threatening, such as SS or NMS. The risk of SS or CNS with the use of SSRIs increases with concomitant use of other serotonergic drugs (including other serotonergic antidepressants, triptan and fentanyl) with the means, which disrupt the metabolism of serotonin (including MAO, for example, methylene blue), antipsychotic drugs and other dopamine antagonists and opiates . Serotonin syndrome may include mental status changes (e.g., agitation, hallucinations, coma), disorders of the autonomic nervous system (tachycardia, fluctuations in blood pressure, hyperthermia), neuromuscular disorders (hyperreflexia, loss of coordination) and/or violations on the part of the digestive system (nausea, vomiting, diarrhea). Some manifestations of serotonin syndrome, including hyperthermia, muscle rigidity, changes in the autonomic nervous system and changes in mental state similar manifestations of malignant neuroleptic syndrome. Patients should be monitored for signs and symptoms of SS or CNS (see Section "Contraindications").
The switching from SSRIs, antidepressants or drugs antiobsessive
There are limited data of controlled studies on the optimal timing of switching from SSRIs, antidepressants or antiobsessional drugs to sertraline. You should be careful with such changes in treatment, especially when switching to sertraline from long-acting drugs such as fluoxetine.
Other serotonergic tools, such as tryptophan, fenfluramine and 5-HT agonists
The simultaneous use of sertraline and other tools that enhance serotonergic neurotransmission, in particular tryptophan, fenfluramine, fentanyl, 5-HT agonists, or the herbal preparations containing St. John's wort ( Hypericum perforatum ) should be undertaken with caution and such combined therapy should (if possible ) be avoided (due to possible pharmacodynamic interactions).
Strengthening hypomania or mania
Increased symptoms of mania/hypomania were reported in a small percentage of patients who were registered with antidepressants and anti-oxidants, including sertraline. Therefore, sertraline should be used with caution in patients with history of mania/hypomania. It is necessary to carefully monitor the doctor. If there are signs of a manic phase use of sertraline should be discontinued.
While taking the drug in patients with schizophrenia may increase psychotic symptoms.
In the treatment of sertraline, convulsions may occur: sertraline should not be prescribed to patients with unstable epilepsy; in patients with controlled epilepsy, the use of sertraline requires careful monitoring. Patients who have seizures, the drug should be canceled.
Suicide/suicidal thoughts/suicide attempts or clinical signs of deterioration
Patients with depression have an increased tendency to the emergence of suicidal thoughts, self-injury and suicide attempts (suicidal actions and manifestations). This risk exists immediately prior to the time of achieving a significant remission. Since improvements in the condition of patients may occur during the first few weeks or a longer period of therapy, patients should be monitored before the onset of this improvement. In General, clinical experience suggests that in the early stages of recovery, the risk of suicide may increase.
Other mental disorders for which sertraline is prescribed can also be associated with the risk of developing suicidal actions and manifestations. In addition, these diseases can be associated with a large depressive disorder. Thus, similar measures concerning the treatment of patients with a large depressive disorder are necessary in the treatment of patients with other mental disorders.
It is known that for patients with suicidal actions and manifestations in the anamnesis or patients who have a significant degree of suicidal thinking before the start of therapy, there is a greater risk of suicidal thoughts or suicidal attempts during treatment, in this regard, they should be carefully monitored against the backdrop of taking the drug. A meta-analysis of the data obtained as a result of the placebo-controlled clinical studies of antidepressants in adult patients with psychiatric disorders showed an increased risk of manifestations of suicidal behavior with antidepressant use in patients younger than 25 years compared with that in the application of placebo.
Against the background of this drug, careful supervision of patients with a high risk of developing suicide is shown, especially at the beginning of therapy and after any changes in the dosage of the drug. Patients (and those who care for them) need to warn about the need to monitor any signs of clinical deterioration, the occurrence of suicidal behavior or suicidal thoughts, as well as any unusual changes in behavior, and immediately seek medical help if you experience these symptoms.
the use of children
Sertraline should not be used for the treatment of children and adolescents, except in patients with obsessive-compulsive disorder aged 6-17 years. During clinical trials in children treated with antidepressants compared to placebo patients, were more frequently observed suicidal behavior (suicide attempts and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger). If, on the basis of clinical need, a decision is made in favor of use of this drug requires close monitoring to identify signs of suicidal symptoms. In addition, only a limited amount of clinical evidence is available on the safety of prolonged use in children and adolescents, including effects on their growth, puberty, and cognitive and behavioural development. In post-marketing period there has been reports of several cases of delayed growth and puberty. Clinical significance and causation have not yet been clarified. In long-term therapy of children's patients, doctors should monitor for deviations from the norms in the process of growth and development of the body.
Cases of pathological hemorrhagic phenomena, including skin hemorrhagic phenomena (ecchymosis and purpura), and other hemorrhagic phenomena, such as gastrointestinal or gynecological bleeding, including bleeding with a fatal outcome, were reported in the application of sihs. It is recommended to apply caution in SSRI patients, especially with simultaneous use with drugs known to affect platelet function (e.g. anticoagulants, atypical antipsychotics and phenothiazine funds, most tricyclic antidepressants, acetylsalicylic acid and nonsteroidal anti-inflammatory drugs (NSAIDs)), as in patients with hemorrhagic disorders in anamnesis (see section "Interaction with other medicinal products and other forms of interaction").
As a result of therapy or ISSNS SSRIs, including sertraline, may develop hyponatremia. In many cases, hyponatremia is the result of inadequate ADH secretion syndrome. It was reported on the levels of sodium in blood serum lower than 110 mmol/l in patients of advanced age may exist a greater risk of developing hyponatremia during the use of SSRIs and ISSNS. Also, the risk of this complication may be increased in patients taking diuretics or in patients with hypovolemia of any other origin (see section "application in elderly patients"). In patients with symptomatic hyponatremia should be considered for discontinuation of therapy with sertraline and introduce appropriate medical intervention. Signs and symptoms of hyponatremia include headache, problems with concentration, memory impairment, confusion, weakness and loss of physical balance, which can lead to falls. Signs and symptoms associated with more severe and/or acute EP