Instructions for Topex film-coated tablets 10 mg No. 30
Composition
active ingredient: escitalopram;
1 tablet contains 12.77 mg of escitalopram oxalate, equivalent to 10 mg of escitalopram,
or 25.54 mg of escitalopram oxalate, equivalent to 20 mg of escitalopram;
Excipients: microcrystalline cellulose; talc; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; hypromellose; titanium dioxide (E 171); polyethylene glycol 6000 (macrogol 6000).
Dosage form
Film-coated tablets.
Main physicochemical properties: round, biconvex tablets, white or almost white in color, film-coated.
Pharmacotherapeutic group
Psychostimulants. Antidepressants. Selective serotonin reuptake inhibitors (SSRIs). Escitalopram. ATC code N06A B10.
Pharmacological properties
Pharmacodynamics.
Escitalopram is an antidepressant, a selective serotonin reuptake inhibitor (SSRI), which determines the clinical and pharmacological effects of the drug. It has high affinity for the main binding site and the adjacent allosteric site of the serotonin transporter and has no or very weak ability to bind to a number of receptors, including serotonin 5-HT1A-, 5-HT2-receptors, dopamine D1- and D2-receptors, α1-, α2-, β-adrenergic receptors, histamine H1, muscarinic cholinergic, benzodiazepine and opiate receptors.
Escitalopram is the S-enantiomer of racemic citalopram with its own therapeutic activity. The R-enantiomer has been shown to be inert and to antagonize the serotonergic properties and corresponding pharmacological effects of the S-enantiomer.
Pharmacokinetics.
Absorption is almost complete and independent of food intake. Maximum plasma concentration is reached 4 hours after administration. Bioavailability of escitalopram is approximately 80%. Binding of escitalopram and its main metabolites to blood proteins is below 80%. Metabolism occurs in the liver to demethylated and didemethylated metabolites. Both of them are pharmacologically active. Biotransformation of escitalopram to the demethylated metabolite is mediated by cytochrome CYP2C19. Minor involvement of CYP3A4 and CYP2D6 isoenzymes is possible. The half-life (t½) of the drug is approximately 30 hours. Clearance (Cloral) when taken orally is approximately 0.6 l/min. The half-life of the main metabolites is longer. Escitalopram and its main metabolites are excreted via the liver (metabolic pathway) and the kidneys. Most of the dose is excreted as metabolites in the urine. The kinetics of escitalopram are linear. Steady-state concentrations are reached after approximately 1 week.
In patients over 65 years of age, escitalopram is eliminated more slowly than in younger patients.
In patients with mild to moderate hepatic impairment (Child-Pugh classes A and B), the half-life was 2-fold longer and exposure was 60% higher than in subjects with normal hepatic function.
In patients with reduced renal function, a longer half-life and slightly higher exposure were observed when racemic citalopram was administered. Plasma concentrations of metabolites have not been studied but may be increased.
Patients with poor CYP2C19 metaboliser function had twice the plasma concentrations of escitalopram as patients with normal CYP2C19 function. No significant changes in exposure were observed with reduced CYP2D6 function.
Indication
Treatment of major depressive episodes, panic disorders with or without agoraphobia, social anxiety disorders (social phobia), generalized anxiety disorders, obsessive-compulsive disorders.
Contraindication
Hypersensitivity to escitalopram or to other components of the drug;
concomitant treatment with non-selective irreversible monoamine oxidase inhibitors (MAOIs) or pimozide;
simultaneous treatment with reversible MAO-A inhibitors (e.g. moclobemide) or reversible non-selective MAO inhibitors (e.g. linezolid) due to the risk of serotonin syndrome (see section "Special warnings and precautions for use");
patients with known QT prolongation or congenital long QT syndrome;
simultaneous treatment with drugs that prolong the QT interval.
Interaction with other medicinal products and other types of interactions
Pharmacodynamic interactions
Contraindicated combinations
Non-selective, irreversible MAOIs
Serious reactions have been reported in patients taking SSRIs in combination with non-selective irreversible MAOIs and in patients who have recently stopped SSRIs and started taking an MAOI. In some cases, serotonin syndrome has developed. The combination of escitalopram with non-selective irreversible MAOIs is contraindicated. Escitalopram treatment should be started 14 days after discontinuation of the irreversible MAOI. Treatment with non-selective irreversible MAOIs should be started no earlier than 7 days after discontinuation of escitalopram.
Due to the risk of serotonin syndrome, the combination of escitalopram with the type A MAOI moclobemide is not recommended. If the need for this combination is proven, the minimum recommended doses should be prescribed initially with careful clinical monitoring.
Treatment with escitalopram can be started no earlier than 1 day after stopping the reversible MAOI moclobemide.
Reversible non-selective MAO inhibitor (linezolid)
The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients receiving escitalopram. If the combination proves necessary, it should be given at the lowest possible dose and under close clinical monitoring.
Irreversible selective MAO-B inhibitor (selegiline)
Combination with selegiline (an irreversible type B MAOI) requires caution due to the risk of serotonin syndrome. Selegiline at doses up to 10 mg/day has been safely administered concomitantly with racemic citalopram.
QT prolongation
Pharmacokinetic and pharmacodynamic studies of escitalopram in combination with other drugs that prolong the QT interval have not been performed. An additive effect of escitalopram and these drugs cannot be excluded. Therefore, the concomitant use of escitalopram with drugs that prolong the QT interval, such as class IA and III antiarrhythmics, neuroleptics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarials, especially halofantrine), certain antihistamines (e.g. astemizole, hydroxyzine, mizolastine) is contraindicated.
Combinations requiring caution
Serotonergic medications
Concomitant use with serotonergic agents (e.g. tramadol, sumatriptan and other triptans) may lead to serotonin syndrome.
Medications that lower the seizure threshold
SSRIs may lower the seizure threshold. Caution is advised with concomitant use of drugs that may lower the seizure threshold (e.g. antidepressants (tricyclics, SSRIs), neuroleptics (phenothiazines, thioxanthenes, butyrophenones), mefloquine, bupropion and tramadol).
Lithium, tryptophan
Since cases of enhanced effects have been reported with the combined use of SSRIs and lithium or tryptophan, it is recommended to prescribe these drugs concomitantly with caution.
Hypericum
Concomitant use of SSRIs and herbal remedies containing St. John's wort may lead to an increased incidence of adverse reactions.
Anticoagulants
The effects of anticoagulants may be altered by concomitant use with escitalopram. If patients are taking oral anticoagulants, careful monitoring of the blood coagulation system is necessary before and after the use of escitalopram.
Concomitant use of nonsteroidal anti-inflammatory drugs may increase the tendency to bleed.
Alcohol
Escitalopram does not interact with alcohol in a pharmacodynamic or pharmacokinetic manner. However, the combination with alcohol is undesirable.
Drugs causing hypokalemia/hypomagnesemia
Caution should be exercised when concomitantly using drugs that cause hypokalemia/hypomagnesemia, as these conditions increase the risk of malignant arrhythmias.
Pharmacokinetic interactions
Effect of other agents on the pharmacokinetics of escitalopram
The metabolism of escitalopram is mainly mediated by CYP2C19.
Co-administration of escitalopram and omeprazole (a CYP2C19 inhibitor) leads to a moderate (approximately 50%) increase in escitalopram plasma concentrations.
Concomitant administration of escitalopram and cimetidine (a moderately potent major enzyme inhibitor) results in a moderate (approximately 70%) increase in escitalopram plasma concentrations.
Therefore, when escitalopram is co-administered with CYP2C19 inhibitors (e.g. omeprazole, fluoxetine, fluconazole, fluvoxamine, lansoprazole, ticlopidine) and with cimetidine, caution should be exercised when prescribing the upper limit doses of escitalopram. A dose reduction of escitalopram may be necessary based on clinical judgment.
Effect of escitalopram on the pharmacokinetics of other drugs
Escitalopram is an inhibitor of the enzyme CYP2D6. Caution is recommended when escitalopram is co-administered with medicinal products that are metabolised primarily by this enzyme and have a narrow therapeutic index, such as flecainide, propafenone and metoprolol (in heart failure), or with certain central nervous system agents that are metabolised primarily by CYP2D6, such as antidepressants such as desipramine, clomipramine and nortriptyline, and antipsychotics such as risperidone, thioridazine and haloperidol. Dose adjustment may be necessary.
Combination with desipramine or metoprolol resulted in a doubling of plasma levels of these two agents.
In vitro studies have shown that escitalopram may cause weak inhibition of CYP2C19. Caution is recommended when co-administered with medicinal products metabolised by CYP2C19.
Application features
The following application features apply to the therapeutic class of SSRIs.
TOPEX should not be used in children. Suicide-related behavior (suicidal attempts and suicidal thoughts) and hostility (predominantly aggression, oppositional behavior, and anger) were more frequently observed in clinical trials among children treated with antidepressants compared to those treated with placebo. If a decision to treat is made based on clinical need, the patient should be closely monitored for suicidal symptoms. In addition, long-term safety data in the pediatric population regarding growth, maturation, cognitive and behavioral development are lacking.
Paradoxical anxiety
Some patients with panic disorder may experience increased anxiety when starting antidepressant treatment. This paradoxical reaction usually resolves within two weeks of treatment. A low initial dose is recommended to reduce the likelihood of anxiogenic effects.
Convulsive seizures
Escitalopram should be discontinued if the patient develops a seizure for the first time or if seizures become more frequent (in patients with established epilepsy). SSRIs should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be closely monitored.
Mania
SSRIs should be used with caution in patients with a history of mania/hypomania. If a manic state occurs, the SSRI should be discontinued.
Diabetes mellitus
In patients with diabetes mellitus, treatment with SSRIs may alter glycemic control. The dose of insulin and/or oral hypoglycemic agents may need to be adjusted.
Suicide, suicidal thoughts, or clinical worsening
Depression is associated with a risk of suicidal ideation, self-harm and suicide. This risk persists until sustained remission is achieved. As improvement may not occur within the first few weeks or more of treatment, patients should be closely monitored until improvement occurs. It is known that the risk of suicide may be increased in the early stages of recovery.
Other conditions for which escitalopram is used may also be associated with a risk of suicidal behaviour. In addition, such conditions may be comorbid with major depressive disorder. These warnings also apply to the treatment of patients with other psychiatric disorders.
Patients with a history of suicidal behavior prior to treatment are at greatest risk of suicidal thoughts or attempts and require close monitoring during treatment. A meta-analysis of studies has shown an increased risk of suicidal behavior in patients under 25 years of age who received antidepressants compared with those who received placebo. Close monitoring of high-risk patients is particularly important at the beginning of treatment and during dose changes.
Patients and caregivers should be warned to monitor for any worsening of condition, suicidal behavior or thoughts, and unusual changes in behavior and to seek immediate medical advice if these symptoms develop.
Akathisia
The use of SSRIs/SNRIs has been associated with the development of akathisia, a condition characterized by an unpleasant, debilitating feeling of restlessness and a need to move, often accompanied by an inability to sit or stand still. This condition is most likely to occur during the first few weeks of treatment. Increasing the dose may be harmful in patients who develop these symptoms.
Hyponatremia
Hyponatremia, possibly related to impaired antidiuretic hormone secretion, occurs rarely with SSRIs and usually resolves after discontinuation of therapy. SSRIs should be prescribed with caution in patients at risk (elderly age, presence of liver cirrhosis, or concomitant treatment with drugs that cause hyponatremia).
Hemorrhages
Skin bleeding, ecchymosis and purpura may occur with SSRIs. SSRIs should be used with caution in patients receiving concomitant anticoagulants, drugs that affect platelet function (e.g. atypical antipsychotics, phenothiazines, tricyclic antidepressants, acetylsalicylic acid and nonsteroidal anti-inflammatory drugs, dipyridamole and ticlopidine), and in patients with bleeding tendencies.
SSRIs/SNRIs may increase the risk of postpartum haemorrhage (see sections “Use during pregnancy or lactation”, “Adverse reactions”).
Electroconvulsive therapy (ECT)
Clinical experience with the concomitant use of SSRIs and ECT is limited, therefore caution is advised.
Serotonin syndrome
Caution is recommended when escitalopram is used concomitantly with serotonergic agents such as sumatriptan or other triptans, tramadol and tryptophan.
Serotonin syndrome has been reported in isolated cases in patients taking SSRIs concomitantly with serotonergic drugs. Caution should be exercised when escitalopram is used concomitantly with drugs that have serotonergic effects. The combination of symptoms such as agitation, tremor, myoclonus, and hyperthermia may indicate the development of this condition. In such cases, the SSRI and the serotonergic drug should be discontinued immediately and symptomatic treatment initiated.
Hypericum
Concomitant use of SSRIs and herbal remedies containing St. John's wort may lead to an increased incidence of adverse reactions.
Withdrawal symptoms are common when treatment is stopped, especially if it is stopped abruptly. In studies, adverse reactions on discontinuation of therapy occurred in approximately 25% of patients treated with escitalopram and 15% of patients treated with placebo.
The risk of withdrawal symptoms may depend on several factors, including duration and dose, and the rate of dose reduction. Dizziness, sensory disturbances (including paraesthesia, electric shock sensations), sleep disturbances (including insomnia, vivid dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, increased sweating, headache, diarrhoea, palpitations, emotional lability, irritability and visual disturbances are the most common reactions. These symptoms are usually mild to moderate in severity and resolve within 2 weeks, but may be more prolonged (2-3 months or longer) in some patients. Therefore, gradual discontinuation of escitalopram treatment by reducing the dose over a period of several weeks or months, depending on the patient's condition, is recommended.
Sexual dysfunction
SSRIs/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-term sexual dysfunction where symptoms persist despite discontinuation of SSRIs/SNRIs.
Coronary heart disease
Due to limited clinical experience, caution is recommended in patients with coronary artery disease.
QT prolongation
Escitalopram has been shown to cause dose-dependent prolongation of the QT interval. Cases of QT prolongation and ventricular arrhythmia have been reported in the post-marketing setting, predominantly in female patients, with hypokalaemia or pre-existing QT prolongation or other cardiac disease (see sections 4.3 and 4.5).
Caution should be exercised in patients with significant bradycardia or in patients with recent acute myocardial infarction or uncompensated heart failure. Electrolyte disturbances such as hypokalemia and hypomagnesemia increase the risk of malignant arrhythmias and should be corrected before initiating treatment with escitalopram.
If patients with stable heart disease are undergoing treatment, an ECG should be considered before starting treatment.
If signs of cardiac arrhythmia occur during treatment with escitalopram, treatment should be discontinued and an ECG performed.
Angle-closure glaucoma
SSRIs, including escitalopram, may affect pupil size, resulting in mydriasis. This mydriatic effect may lead to narrowing of the angle of the eye, which may lead to increased intraocular pressure and angle-closure glaucoma, especially in predisposed patients. Escitalopram should therefore be used with caution in patients with angle-closure glaucoma or a history of glaucoma.
Excipients
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.
Use during pregnancy or breastfeeding
Pregnancy
Clinical data on the use of escitalopram in pregnant women are limited.
Escitalopram is contraindicated in pregnant women, except in cases where the need for the drug has been clearly demonstrated after careful consideration of all the disadvantages and benefits. Careful examination of newborns whose mothers took escitalopram during pregnancy, especially in the third trimester, is recommended.
The following symptoms may occur in newborns whose mothers took SSRIs/SNRIs in the late stages of pregnancy: respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulties, vomiting, hypoglycemia, hypertension, hypotension, hyperreflexia, tremor, nervousness, irritability, apathy, constant crying, drowsiness and difficulty sleeping. Such complications may be a consequence of excessive serotonergic action or withdrawal symptoms. In most cases, such complications occur immediately or shortly (up to 24 hours) after delivery.
Epidemiological data have shown that the use of SSRIs during pregnancy may increase the risk of persistent pulmonary hypertension in the newborn (up to 5 cases per 1000 pregnancies, according to observational data). In the general population, the incidence is 1 to 2 cases per 1000 pregnancies.
Observational data indicate an increased risk (less than 2-fold) of postpartum hemorrhage after use of SSRIs/NSAIDs within the month before delivery.
Breast-feeding
Since escitalopram passes into breast milk, breastfeeding is not recommended during treatment.
Fertility
Animal data have shown that some SSRIs may affect sperm quality. Reports from some SSRIs in humans have shown that the effects on sperm quality are reversible. Effects on human fertility have not been observed to date.
Ability to influence reaction speed when driving vehicles or other mechanisms
Although escitalopram does not affect intellectual or psychomotor functioning, any psychoactive drug may impair skills or the ability to think rationally. Patients should be warned of the potential risk of impairment in driving or operating machinery.
Method of administration and doses
The safety of doses above 20 mg per day has not been established.
The drug TOPEX should be administered orally to adults once a day, regardless of meals.
Major depressive episode
Usually, 10 mg should be prescribed once a day. Depending on the individual sensitivity of the patient, the daily dose may be increased to a maximum of 20 mg.
The antidepressant effect usually occurs after 2–4 weeks. After the symptoms disappear, treatment should be continued for at least 6 months to consolidate the effect.
Panic disorder with or without agoraphobia
A starting dose of 5 mg per day is recommended for the first week before increasing to 10 mg per day. The dose may be increased further to a maximum of –
20 mg per day, depending on the individual sensitivity of the patient.
The maximum effect in the treatment of panic disorders is achieved after 3 months. The duration of treatment is several months and depends on the severity of the disease.
Social anxiety disorder (social phobia)
Usually, 10 mg should be prescribed once a day. Depending on the individual sensitivity of the patient, it is recommended to increase the daily dose to a maximum of 20 mg per day.
Symptom relief usually occurs after 2–4 weeks of treatment. It is recommended to continue treatment for 3 months to consolidate the effect. Continued treatment for 6 months has been shown to prevent relapse and can be individualized; the benefits of treatment should be regularly assessed.
Generalized anxiety disorders
The usual dose is 10 mg once daily. Depending on individual sensitivity, the dose may be increased to a maximum of 20 mg daily.
It is recommended to continue treatment for 3 months to consolidate the effect. Long-term treatment for 6 months has been shown to prevent relapse and can be prescribed individually; the benefits of treatment should be regularly assessed.
Obsessive-compulsive disorder (OCD)
Usually, 10 mg once daily should be prescribed. Depending on individual sensitivity, the dose can be increased to 20 mg daily. OCD is a chronic disease, the treatment of which should last for a sufficient period to ensure complete resolution of symptoms, which may be several months or even more.
Elderly patients (aged 65 years and over)
The initial dose should be half the usual recommended dose. The recommended daily dose for elderly patients is 5 mg (to be used in an appropriate dosage). Depending on individual sensitivity and severity of depression, the daily dose may be increased to a maximum of 10 mg per day.
Kidney failure
There are no restrictions in the presence of mild to moderate renal insufficiency. The drug should be used with caution in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Decreased liver function
The recommended starting dose for the first two weeks of treatment is 5 mg per day. Depending on the individual patient's response, the dose may be increased to 10 mg per day.
Reduced activity of the CYP2C19 isoenzyme
For patients with poor CYP2C19 activity, the recommended starting dose is 5 mg/day for the first two weeks of treatment. Depending on the individual patient response, the dose may be increased to 10 mg/day.
Treatment discontinuation
When discontinuing treatment with TOPEX, the dose should be gradually reduced over 1–2 weeks to avoid possible withdrawal symptoms.
Children.
TOPEX should not be used to treat children and adolescents under 18 years of age (see section "Special warnings and precautions for use").
Overdose
Toxicity
Clinical data on overdose with escitalopram are limited. Many cases have been caused by concomitant overdose with other medicinal products. In most cases, mild or asymptomatic symptoms have been reported. Fatal cases of overdose with escitalopram are rare, most of which involve concomitant overdose with other medicinal products. Escitalopram doses of 400–800 mg have not caused any severe symptoms.
Symptoms
Signs of escitalopram overdose: mainly symptoms from the central nervous system (from dizziness, tremor and agitation to rare cases of serotonin syndrome, seizures and coma), the gastrointestinal system (nausea, vomiting), the cardiovascular system (hypotension, tachycardia, QT prolongation, arrhythmia) and electrolyte/fluid imbalance (hypokalemia, hyponatremia).
Treatment
There is no specific antidote. Proper respiratory function should be maintained and adequate oxygenation should be ensured. Gastric lavage and activated charcoal may be used. Gastric lavage should be performed as soon as possible after oral ingestion. Monitoring of the cardiovascular system and vital signs is recommended in addition to general symptomatic supportive measures.
ECG monitoring is recommended in case of overdose in patients with congestive heart failure/bradyarrhythmia, in patients taking concomitant medications that prolong the QT interval, or in patients with altered metabolism, e.g., hepatic impairment.
Side effects
Adverse reactions are most often observed during the first or second week of treatment and usually their frequency and intensity gradually decrease with continued treatment.
Adverse reactions known for SSRIs and escitalopram, which have been observed in placebo-controlled studies and during clinical use, are listed below by system organ class and frequency. Frequency is defined as: very common (≥ 1/10), common (≥ 1/10), uncommon
(≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000) or frequency unknown (cannot be estimated from the available information).
Blood and lymphatic system disorders: frequency unknown - thrombocytopenia.
On the part of the immune system: rarely - anaphylactic reactions.
On the part of the endocrine system: frequency unknown - impaired secretion of antidiuretic hormone.
Metabolism and metabolism: often - decreased or increased appetite, weight gain; infrequently - decreased body weight; frequency unknown - hyponatremia, anorexia**.
On the part of the psyche: often - anxiety, restlessness, abnormal dreams, decreased libido in men and women, anorgasmia in women; infrequently - teeth grinding, agitation, nervousness, panic attacks, confusion; rarely - aggression, depersonalization, hallucinations; frequency unknown - mania, suicidal thoughts, suicidal behavior*.
Nervous system disorders: very common - headache; common - insomnia, drowsiness, dizziness, paresthesia, tremor; uncommon - taste disturbance, sleep disturbance, fainting; rare - serotonin syndrome; frequency unknown - dyskinesia, movement disorders, convulsions, psychomotor restlessness/akathisia**.
On the part of the eye: infrequently - pupil dilation, blurred vision.
On the part of the ear: infrequently - ringing in the ears.
Cardiac disorders: infrequently - tachycardia; rarely - bradycardia; frequency unknown - prolongation of the QT interval on the electrocardiogram, ventricular arrhythmia, including torsade de pointes.
Vascular disorders: frequency unknown - orthostatic hypotension.
From the respiratory system, thoracic and mediastinal organs: often - sinusitis, yawning; infrequently - epistaxis.
Gastrointestinal: very often - nausea; often - diarrhea, constipation, vomiting, dry mouth; infrequently - gastrointestinal bleeding (including rectal).
On the part of the hepatobiliary system: frequency unknown - hepatitis, changes in liver function tests.
Skin and subcutaneous tissue disorders: common: increased sweating; uncommon: rash, alopecia, urticaria, itching; frequency unknown: bruising, swelling.
Musculoskeletal and connective tissue disorders: often – arthralgia, myalgia.
Renal and urinary disorders: frequency unknown - urinary retention.
Reproductive system and breast disorders: common – men: ejaculation disorders, impotence; uncommon – women: metrorrhagia, menorrhagia; frequency unknown – galactorrhea, priapism (men), postpartum hemorrhage (women)***.
General disorders: often - fatigue, pyrexia; infrequently - edema.
*Cases of suicidal ideation and behavior have been reported during escitalopram treatment or shortly after its discontinuation.
**Such cases are known for the entire class of SSRIs.
***This event has been reported for the SSRI/SNRI therapeutic class.
QT prolongation
Cases of QT prolongation and ventricular arrhythmias, including torsade de pointes, have been reported with use predominantly in female patients, with hypokalemia or with pre-existing QT prolongation or other underlying cardiac disease. In one study in healthy volunteers, the mean change from baseline in QTc (Friedrich formula) was 4.3 ms at 10 mg/day and 10.7 ms at 30 mg/day.
Class effects
Epidemiological studies, mainly in patients aged 50 years and older, have shown an increased risk of bone fractures with the use of SSRIs and tricyclic antidepressants. The mechanism of this effect is unknown.
Withdrawal symptoms
Discontinuation of SSRI treatment (especially abrupt) usually leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia and electric shock sensations), sleep disturbances (including insomnia and vivid dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, increased sweating, headache, diarrhoea, palpitations, emotional lability, irritability and visual disturbances are the most common reactions. These symptoms are usually mild to moderate in severity and transient, but may be severe and/or prolonged in some patients. Therefore, gradual discontinuation of escitalopram treatment by dose reduction is recommended.
Reporting of suspected adverse reactions
It is important to report suspected adverse reactions after a medicinal product has been authorised. This allows for continuous monitoring of the benefit/risk balance of the medicinal product.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Keep out of reach of children.
Packaging
10 tablets in a blister, 3 blisters or 6 blisters in a cardboard pack.
Vacation category
According to the recipe.
Producer
LLC NVF "MICROCHEM"
Location of the manufacturer and address of its place of business.
Ukraine, 93400, Luhansk region, Severodonetsk city, Promyslova st., building 24-v.
