Instructions Escitalopram Asino film-coated tablets 10 mg blister No. 60
Composition
active ingredient: escitalopram;
1 tablet contains escitalopram oxalate (12.775 mg or 25.55 mg) equivalent to escitalopram 10 mg or 20 mg;
excipients: microcrystalline cellulose, croscarmellose sodium, hydroxypropylmethylcellulose (hypromellose), colloidal anhydrous silicon dioxide, talc, magnesium stearate;
Opadry II White shell: polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol (macrogol), talc.
Dosage form
Film-coated tablets.
Main physicochemical properties:
10 mg tablets: round tablets with a biconvex surface, film-coated in white, with a score;
20 mg tablets: round tablets with a biconvex surface, coated with a white film coating.
Pharmacotherapeutic group
Antidepressants. Selective serotonin reuptake inhibitors (SSRIs). ATC code N06A B10.
Pharmacological properties
Pharmacodynamics. Escitalopram is an antidepressant, a selective serotonin reuptake inhibitor, which determines the clinical and pharmacological effects of the drug. It has high affinity for the main binding element and the adjacent allosteric element 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-, M-cholinoreceptors, benzodiazepine and opiate receptors.
Inhibition of 5-HT serotonin reuptake is only a possible mechanism of action that may explain the pharmacological and clinical effects of escitalopram.
Pharmacokinetics. Absorption is almost complete and independent of food intake. Maximum plasma concentration is reached 4 hours after administration. The bioavailability of escitalopram is approximately 80%. The apparent volume of distribution (Vd, β/F) after oral administration is from 12 to 26 l/kg.
The binding of escitalopram and its main metabolites to blood proteins is less than 80%.
In the liver, metabolites are formed that are demethylated and didemethylated and are pharmacologically active. Nitrogen can also be oxidized to the N-oxide metabolite.
Both metabolites and the parent compound are partially excreted in the form of glucuronides.
After multiple administration, the average concentration of demethyl and didemethyl metabolites is usually 28-31% and < 5% of the concentration of escitalopram, respectively. Biotransformation of escitalopram to the demethyl metabolite occurs mainly with the help of cytochrome CYP2C19. Minor participation in the process isoenzymes CYP3A4 and CYP2D6 isoenzymes is possible. The half-life (T1/2) of the drug is approximately 30 hours. Clearance (Cloral) when taken orally is approximately 0.6 l / min. The main metabolites have a longer half-life. Escitalopram and its main metabolites are excreted by the liver (metabolic pathway) and the kidneys. Most of the dose is excreted in the form of metabolites with urine. The kinetics of escitalopram are linear. Equilibrium concentration is reached after approximately 1 week. The average steady-state concentration of 50 nmol/l (range 20 to 125 nmol/l) is achieved with a daily dose of 10 mg.
In elderly patients (65 years and older), escitalopram is eliminated more slowly than in young patients. Systemic exposure (AUC) in elderly subjects is 50% higher than in young healthy volunteers.
In patients with mild to moderate hepatic impairment (Child-Pugh classes A and B), the half-life was twice as long and exposure was 60% higher than in subjects with normal hepatic function.
In patients with reduced renal function (CLcr 10-53 ml/min) a longer half-life and slightly higher exposure were observed with racemic citalopram. 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.
Clinical characteristics.
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 any of the other ingredients of the drug; concomitant treatment with non-selective, irreversible monoamine oxidase inhibitors (MAOIs), as there is a risk of developing serotonin syndrome, manifested by agitation, tremor, hyperthermia. QT prolongation or congenital long QT syndrome. Concomitant use with drugs that prolong the QT interval and pimozide.
Interaction with other medicinal products and other types of interactions
Pharmacodynamic interactions.
Non-selective irreversible MAO inhibitors. Serious reactions have been reported in patients taking SSRIs in combination with a non-selective irreversible MAOI and in patients who have recently stopped taking an SSRI 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 initiated 14 days after discontinuation of the irreversible MAOI. Treatment with non-selective irreversible MAOIs should be initiated no earlier than 7 days after discontinuation of escitalopram.
Pimozide: Due to the interaction of escitalopram with low doses of pimozide and increased side effects of the latter, concomitant use is contraindicated.
QT prolongation. Pharmacokinetic and pharmacodynamic studies of escitalopram in combination with other drugs that prolong the QT interval have not been conducted. A synergistic 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, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarials, including halofantrine), certain antihistamines (astemizole, mizolastine), is contraindicated.
Combinations that require caution.
Reversible selective MAOI type A (moclobemide). Due to the risk of serotonin syndrome, the combination of escitalopram with a MAOI type A such as moclobemide is contraindicated. If the need for this combination is proven, the minimum recommended doses should be used initially with close clinical monitoring.
The antibiotic linezolid is not recommended for use in patients taking escitalopram. If the combination is absolutely necessary, treatment should be initiated at the lowest recommended dose with close clinical monitoring.
Selegiline: Combination with selegiline (an irreversible MAOI type B) requires caution due to the risk of serotonin syndrome. There is experience of safe combination of selegiline at a dose of up to 10 mg per day with racemic citalopram.
Serotonergic drugs: Concomitant use with serotonergic drugs (e.g. tramadol, sumatriptan and other triptans) may lead to the development of serotonin syndrome.
Agents that lower the seizure threshold. SSRIs may lower the seizure threshold. Caution is advised with concomitant use of agents that lower the seizure threshold, such as 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, caution is recommended when these drugs are prescribed simultaneously.
St. John's wort. 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 oral anticoagulants may be altered by concomitant use with escitalopram. Patients taking oral anticoagulants should have their blood coagulation status monitored closely before and after use of escitalopram.
Concomitant use of nonsteroidal anti-inflammatory drugs may increase the tendency to bleed.
Alcohol: Escitalopram does not interact pharmacodynamically or pharmacokinetically with alcohol. However, as with other psychotropic drugs, the combination with alcohol is undesirable.
Pharmacokinetic interactions.
Effect of other agents on the pharmacokinetics of escitalopram.
The metabolism of escitalopram is mainly mediated by CYP2C19. CYP3A4 and CYP2D6 enzymes may also be involved in the metabolism, although to a lesser extent. The CYP2D6 isoenzyme is believed to be a partial catalyst for the metabolism of the main metabolite S-DCT (demethylated escitalopram).
Co-administration of escitalopram and omeprazole 30 mg once daily (CYP2C19 inhibitor) leads to a moderate (approximately 50%) increase in escitalopram plasma concentrations.
Co-administration of escitalopram and cimetidine 400 mg twice daily (a moderate general enzyme inhibitor) increases the plasma concentration of escitalopram by approximately 70%.
Therefore, caution should be exercised when escitalopram is co-administered with CYP2C19 inhibitors (e.g. omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine. A dose reduction of escitalopram may be required when co-administered with the above-mentioned drugs.
Effect of escitalopram on the pharmacokinetics of other drugs. Escitalopram is an inhibitor of the CYP2D6 enzyme.
Combination with desipramine or metoprolol resulted in a twofold increase in plasma levels of these two agents.
Caution is recommended when used concomitantly with drugs metabolized by CYP2C19.
Application features
The following application features apply to the therapeutic group of selective serotonin reuptake inhibitors (SSRIs).
Paradoxical anxiety. Some patients with panic disorder may experience increased anxiety when starting treatment with SSRIs. This paradoxical reaction usually resolves within two weeks of treatment. To reduce the likelihood of anxiogenic effects, low initial doses are recommended.
Seizures. The drug 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, SSRIs should be discontinued.
Diabetes mellitus: In patients with diabetes mellitus, treatment with SSRIs may alter glycemic control (hypoglycemia or hyperglycemia). Dosage adjustments of insulin and/or oral hypoglycemic agents may be required.
Suicide, suicidal ideation 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 be achieved within the first few weeks of treatment or longer, patients should be closely monitored until their condition improves. 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 behaviour prior to initiation of treatment are at greatest risk of suicidal thoughts or suicide attempts and require close monitoring during treatment. A meta-analysis of studies with escitalopram found an increased risk of suicidal behaviour in patients aged <25 years who received antidepressants compared with those who received placebo. Close monitoring of patients at high risk is particularly necessary at the start of treatment and when changing the dose.
Patients and caregivers should be warned about the need to monitor for any worsening of condition, suicidal behavior or thoughts, and unusual changes in behavior, and to seek medical advice immediately if these symptoms develop.
Akathisia. The use of SSRIs/SNRIs has been associated with the development of akathisia, a condition characterised 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 worsen the condition of patients who develop these symptoms.
Hyponatremia. Hyponatremia, possibly related to impaired antidiuretic hormone (ADH) secretion, occurs rarely with SSRIs and usually resolves after discontinuation of therapy. SSRIs should be prescribed with caution in patients at risk (elderly, with cirrhosis of the liver, or concomitant treatment with drugs that cause hyponatremia).
Bleeding. When taking SSRIs, skin bleeding (ecchymosis and purpura) may develop. SSRIs should be used with caution in patients taking anticoagulants and drugs that affect platelet function (e.g. atypical antipsychotics, phenothiazines, tricyclic antidepressants, acetylsalicylic acid and nonsteroidal anti-inflammatory drugs, dipyridamole and ticlopidine), as well as in patients with a tendency to bleeding.
ECT (electroconvulsive therapy): Clinical experience with the concomitant use of SSRIs and ECT is limited, so caution is recommended.
Reversible selective MAO type A inhibitors. Combining escitalopram and MAO type A inhibitors is contraindicated due to the risk of serotonin syndrome.
Serotonin syndrome: Caution is recommended when escitalopram is used concomitantly with drugs that have serotonergic effects, such as sumatriptan or other triptans, tramadol and tryptophan.
In patients taking SSRIs concomitantly with serotonergic drugs, serotonin syndrome may develop in isolated cases. Its development may be indicated by a combination of symptoms such as agitation, tremor, myoclonus, hyperthermia. If this situation occurs, SSRIs and serotonergic drugs should be urgently discontinued and symptomatic treatment should be prescribed.
Withdrawal symptoms. Withdrawal symptoms are common when treatment is discontinued, especially if it is abrupt. In studies, it is known that adverse reactions occurred in approximately 25% of patients taking escitalopram and in 15% of patients taking 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, but may be more severe in some patients. They usually occur within the first few days after stopping treatment, but there have been very rare reports of similar symptoms in patients who have accidentally missed a dose. Withdrawal symptoms usually resolve within 2 weeks, but may last longer in some patients (2-3 months or more). Therefore, it is recommended to gradually discontinue escitalopram treatment by reducing the dose over a period of several weeks or months, depending on the patient's condition.
Coronary heart disease: Due to limited clinical experience, caution is recommended when using the drug in patients with coronary heart disease.
QT prolongation: Escitalopram has been shown to cause dose-dependent prolongation of the QT interval. Cases of QT prolongation and ventricular arrhythmias, including torsade de pointes, have been reported, predominantly in female patients with hypokalaemia or pre-existing QT prolongation or other cardiac disease.
Caution is recommended in patients with marked 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.
In patients with stable cardiac disease, an ECG should be reviewed before treatment is initiated. If signs of cardiac arrhythmia occur during treatment with escitalopram, therapy should be discontinued and an ECG should be performed.
Angle-closure glaucoma: SSRIs, including escitalopram, may affect pupil size.
This mydriatic effect has the potential to narrow the angle of the eye, which in turn may lead to increased intraocular pressure and the development of angle-closure glaucoma, especially in predisposed patients. Therefore, escitalopram should be used with caution in patients with angle-closure glaucoma or a history of glaucoma.
Use during pregnancy or breastfeeding
Clinical data on the use of escitalopram in pregnant women are limited.
Escitalopram® Asino is contraindicated in pregnant women, except in cases where, after careful consideration of all the disadvantages and benefits, the need for the drug has been clearly proven. Careful examination of newborns whose mothers took Escitalopram® Asino during pregnancy, especially in the third trimester, is recommended. Abrupt discontinuation of the drug during pregnancy should be avoided.
Neonates whose mothers took SSRIs/SNRIs in late pregnancy may experience the following symptoms: respiratory distress, cyanosis, apnea, seizures, temperature fluctuations, feeding difficulties, vomiting, hypoglycemia, hypertension or hypotension, hyperreflexia, tremor, agitation, irritability, apathy, constant crying, drowsiness, and difficulty sleeping. These symptoms may be due to serotonergic effects or may be signs of withdrawal. In most cases, the symptoms of complications occur immediately or shortly (< 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). In the general population, the incidence is 1 to 2 cases per 1000 pregnancies.
Since escitalopram passes into breast milk, breastfeeding is not recommended during treatment.
Fertility. Some SSRIs may affect sperm quality. Reports of some SSRIs have shown that the effects on sperm quality in humans are reversible. Effects on human fertility have not been observed to date.
Ability to influence reaction speed when driving vehicles or other mechanisms
Escitalopram does not generally affect intellectual function or psychomotor reactions, but it should be borne in mind that any psychoactive drug may impair the skills or 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.
Escitalopram is administered orally to adults once a day, regardless of meals.
Major depressive episode.
The antidepressant effect usually occurs after 2-4 weeks. After the symptoms disappear, treatment should be continued for 6 months in order to consolidate the effect.
Panic disorders with or without agoraphobia.
An initial dose of 5 mg per day is recommended during the first week, after which the dose can be increased to 10 mg per day. The dose can be further increased 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 disorders (social phobia).
Usually, 10 mg is prescribed once a day. Relief of symptoms usually occurs after 2-4 weeks of treatment. Depending on the individual patient's response, the dose can be further reduced to 5 mg/day or increased to a maximum of 20 mg/day.
Since social anxiety disorder is a chronic disease, it is recommended to continue treatment for 12 weeks to consolidate the achieved effect.
Long-term treatment for 6 months is prescribed to prevent relapse, taking into account individual manifestations of the disease; the effectiveness of treatment is regularly assessed.
Social anxiety disorder has a well-defined diagnostic terminology for a specific condition and should not be confused with hypertrophic shyness. Pharmacotherapy is indicated only for disorders that significantly affect the person's professional and social activities. The value of such treatment compared to cognitive behavioral therapy has not been studied. Pharmacotherapy should be part of an overall therapeutic strategy.
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 per day.
It is recommended to continue treatment for 3 months to consolidate the effect. Long-term treatment for 6 months is prescribed to prevent relapse, taking into account individual manifestations of the disease; the effectiveness of treatment is regularly assessed.
Obsessive-compulsive disorder (OCD).
Usually, 10 mg is prescribed once a day. Depending on individual sensitivity, the dose can be increased to 20 mg per day. OCD is a chronic disease, treatment should last for a sufficient period to ensure complete disappearance of symptoms, which may be several months or even more.
Elderly patients (aged 65 and over).
The initial dose is 5 mg per day. Depending on the individual patient's response, the daily dose may be increased to 10 mg per day.
Kidney failure.
In the presence of mild to moderate renal insufficiency, there is no need for dose adjustment. The drug should be used with caution in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Decreased liver function.
In patients with moderate and mild hepatic impairment, the recommended starting dose during the first two weeks of treatment is 5 mg per day. Depending on the individual patient response, the dose may be increased to 10 mg per day. In severe hepatic impairment, caution and careful dose titration are required.
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.
Discontinuation of treatment.
Abrupt discontinuation of treatment should be avoided. When discontinuing treatment with Escitalopram® Asino, the dose should be reduced gradually over 1-2 weeks to avoid possible withdrawal symptoms. If adverse reactions occur after dose reduction or discontinuation of treatment, the previously prescribed dose can be resumed. In the future, the doctor may continue to reduce the dose, but more gradually.
Children
Antidepressants should not be prescribed for the treatment of children. Suicidal behavior (suicidal attempts and suicidal thoughts) and hostility (predominantly aggression, oppositional behavior, and anger) are more common in children and adolescents,
taking antidepressants compared to those taking placebo. If a clinical decision is made to prescribe antidepressants, the patient should be closely monitored for suicidal thoughts. In addition, there are no data on the continued safety of children and adolescents with regard to growth, puberty, cognitive and behavioral development.
Overdose
Toxicity. Data on overdose with escitalopram are limited. Most cases have been caused by concomitant overdose with other drugs. In most cases, mild or asymptomatic symptoms of overdose have been observed. Reports of fatal outcomes of escitalopram overdose are exceptional, most of them involving concomitant overdose with other drugs. Doses in the range of 400-800 mg of escitalopram have not caused any severe symptoms.
Escitalopram overdose is manifested mainly by symptoms from the central nervous system (ranging from dizziness, tremor and agitation to rare cases of serotonin syndrome, seizures and coma), the gastrointestinal system (nausea/vomiting), the cardiovascular system (arterial hypotension, tachycardia, QT prolongation, arrhythmia) and electrolyte imbalance (hypokalemia, hyponatremia).
Treatment. There is no specific antidote. Maintain a patent airway, adequate oxygenation, and support respiratory function. Gastric lavage and administer activated charcoal. Gastric lavage should be performed as soon as possible after oral administration. Continuous monitoring of cardiac and vital signs is required, along with symptomatic supportive treatment.
In case of overdose, ECG monitoring is recommended in patients with congestive heart failure/bradyarrhythmia, in patients taking concomitant medications that prolong the QT interval, or in patients with altered metabolism, such as hepatic insufficiency.
Adverse reactions
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 common to all SSRIs and escitalopram, observed in placebo-controlled studies and in clinical practice, are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or frequency unknown (cannot be estimated from the available data).
From the side of the blood and lymphatic system: frequency unknown - thrombocytopenia.
On the part of the immune system: rare - anaphylactic reactions.
On the part of the endocrine system: unknown - impaired secretion of antidiuretic hormone.
Metabolism and metabolism: frequent - decreased or increased appetite, weight gain; infrequent - decreased body weight; frequency unknown - hyponatremia, anorexia2.
Psychiatric: common: anxiety, restlessness, abnormal dreams, decreased libido in men and women, anorgasmia in women; uncommon: teeth grinding, agitation, nervousness, panic attacks, confusion; rare: aggression, depersonalization, hallucinations; frequency unknown: mania, suicidal thoughts, suicidal behavior1.
Nervous system disorders: very common - headache; common - insomnia, drowsiness, dizziness, paresthesia, tremor; uncommon - taste disturbance, sleep disturbance, syncope; rare - serotonin syndrome; frequency unknown - dyskinesia, movement disorders, convulsions, psychomotor restlessness/akathisia2.
On the part of the organs of vision: infrequent - pupil dilation, blurred vision.
On the part of the organs of hearing: infrequent - ringing in the ears.
Cardiovascular system: infrequent - tachycardia; rare - bradycardia; frequency unknown - prolongation of the QT interval on the electrocardiogram, ventricular arrhythmia, including torsade de pointes; frequency unknown - orthostatic hypotension.
Respiratory disorders: common - sinusitis, yawning; uncommon - epistaxis.
Gastrointestinal: very common - nausea; common - diarrhea, constipation, vomiting, dry mouth; uncommon - gastrointestinal bleeding (including rectal).
Hepatobiliary disorders: frequency unknown - hepatitis, changes in liver function tests.
Skin and subcutaneous tissue disorders: frequent - increased sweating; infrequent - rash, alopecia, urticaria, itching; frequency unknown - bruising, swelling.
Musculoskeletal disorders: common – arthralgia, myalgia.
Renal and urinary disorders: frequency unknown - urinary retention.
From the reproductive system and mammary glands: frequent - in men: ejaculation disorders, impotence; infrequent - in women: metrorrhagia, menorrhagia; frequency unknown - galactorrhea, in men - priapism.
General disorders: common - fatigue, pyrexia; uncommon - edema.
1 Cases of suicidal ideation and behavior have been reported during escitalopram treatment or shortly after its discontinuation.
2 Such cases are known for the entire class of SSRIs.
Cases of QT prolongation and ventricular arrhythmias, including torsade de pointes, have been reported, occurring predominantly in female patients with hypokalemia or pre-existing QT prolongation or other cardiac disease.
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.
Expiration date
1 year 6 months.
Storage conditions
Store out of the reach of children, in the original packaging, at a temperature not exceeding 25 °C.
Packaging
10 tablets in a blister; 1, 3 or 6 blisters in a cardboard pack.
Vacation category
According to the recipe.
Producer
Pharma Start LLC, Ukraine.
Location of the manufacturer and its business address
Ukraine, 03124, Kyiv, I. Lepse Blvd., 8.
In case of side effects and questions regarding the safety of the drug, please contact the Pharmacovigilance Department of Pharma Start LLC at the address: 8 Ivana Lepse Blvd., Kyiv, 03124,
phone/fax: +38 044 281 2333.
