Instructions for use Escitalopram-Teva film-coated tablets 10 mg blister No. 28
Composition
active ingredient: escitalopram;
1 tablet contains escitalopram 5 mg, 10 mg, 15 mg, 20 mg;
excipients: core: microcrystalline cellulose, colloidal anhydrous silicon dioxide, croscarmellose sodium, stearic acid, magnesium stearate;
shell: hypromellose, titanium dioxide (E 171), macrogol 400.
Dosage form
Film-coated tablets.
Main physicochemical properties:
Escitalopram-Teva, 5 mg: white, standard convex, film-coated tablets, embossed with "93" on one side of the tablet and "7414" on the other side of the tablet, without visible cracks or chips.
Escitalopram-Teva, 10 mg: white, standard convex, film-coated tablets with a breakline on one side and embossed with "9" to the left and "3" to the right of the breakline. The other side is embossed with "7462", without visible cracks or chips. The tablet can be divided into two equal parts along the score line.
Escitalopram-Teva, 15 mg: white, standard convex, film-coated tablets with a breakline on one side, embossed with "S" to the left and "C" to the right of the breakline. The other side is embossed with "15", without visible cracks or chips.
The score is not intended to break the tablet into two equal doses, but to make swallowing easier.
Escitalopram-Teva, 20 mg: white, standard convex, film-coated tablets with a breakline on one side, embossed with "9" to the left and "3" to the right of the breakline. The other side is embossed with "7463", without visible cracks or chips. The tablet can be divided into two equal parts along the score line.
Pharmacotherapeutic group
Antidepressants. Selective serotonin reuptake inhibitors. ATX code N06A B10.
Pharmacological properties
Pharmacodynamics.
Escitalopram is an antidepressant, a selective serotonin (5-HT) reuptake inhibitor with high affinity for the primary binding site. It also binds to the allosteric site of the serotonin transporter with 1000-fold lower affinity.
Escitalopram has a very weak ability to bind to a number of receptors, including 5-HT1A, 5-HT2, dopamine D1 and D2 receptors, α1-, α2-, β-adrenergic receptors, histamine H1, muscarinic cholinergic, 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. The mean time to reach maximum concentration (mean Tmax) is about 4 hours. The absolute bioavailability of escitalopram is expected to be 80%.
The apparent volume of distribution (Vd, β/F) after oral administration is 12 to
26 l/kg. The binding of escitalopram and its main metabolites to blood plasma proteins is less than 80%.
Escitalopram is metabolized in the liver to the demethylated and didemethylated metabolites. Both are biologically active. Nitrogen can also be oxidized to the N-oxide metabolite. Both metabolites and the parent compound are partially excreted as glucuronides. After multiple administration, the average concentration of the demethylated and didemethyl metabolites is usually 28-31% and < 5% of the concentration of escitalopram, respectively. The biotransformation of escitalopram to the demethylated metabolite occurs mainly with the help of cytochrome CYP2C19. Some participation of the enzymes CYP3A4 and CYP2D6 is also possible.
The elimination half-life (t½β) after multiple administration is about 30 hours. The plasma clearance after oral administration is 0.6 l/min. The main metabolites of escitalopram have a longer half-life. Escitalopram and its main metabolites are believed to be eliminated via the liver (metabolic pathway) and the kidneys. The majority is excreted as metabolites in the urine.
The kinetics of escitalopram are linear. Steady-state concentrations are reached in 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.
Elderly patients (over 65 years of age)
Escitalopram is eliminated more slowly in elderly patients than in younger patients. The amount of substance in the systemic circulation, calculated using the pharmacokinetic parameter "area under the curve" (AUC), is 50% higher in elderly patients than in young healthy volunteers.
Liver failure
In patients with moderate or mild hepatic impairment (Child-Pugh A and B), the half-life of escitalopram was almost doubled and exposure was 60% higher than in subjects with normal hepatic function.
Decreased kidney function
In patients with reduced renal function (CLcr 10-53 ml/min), an increase in the half-life of racemic citalopram and a slight increase in exposure were observed. Plasma concentrations of metabolites have not been studied, but an increase can be assumed.
With insufficient activity of the CYP2C19 isoenzyme, double the concentration of the drug in the blood plasma was observed compared to that in patients with normal metabolism of escitalopram.
No significant changes in exposure were observed in CYP2D6 isoenzyme deficiency.
Indication
Ø major depressive episodes;
Ø panic disorders with/without agoraphobia;
Ø social anxiety disorders (social phobia);
Ø generalized anxiety disorders;
Ø obsessive-compulsive disorders.
Contraindication
Hypersensitivity to the active substance or to any other component of the drug. Concomitant treatment with non-selective irreversible monoamine oxidase inhibitors (MAO), due to the risk of developing serotonin syndrome, which is manifested by agitation, tremor, hyperthermia.
Combination treatment with escitalopram and reversible MAO inhibitors type A (e.g. moclobemide) or reversible non-selective MAO inhibitors (linezolid), due to the risk of developing serotonin syndrome.
If the patient is known to have QT prolongation or congenital long QT syndrome, use with drugs that prolong the QT interval is contraindicated.
Concomitant treatment with pimozide.
Interaction with other medicinal products and other types of interactions
Pharmacodynamic interactions
Contraindicated combinations.
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, in particular halofantrine), certain antihistamines (astemizole, mizolastine) is contraindicated.
Non-selective irreversible MAOIs
Serious reactions have been reported in patients receiving SSRIs in combination with non-selective irreversible monoamine oxidase inhibitors (MAOIs) and in patients who have recently stopped taking SSRIs and switched to similar MAOIs. Serotonin syndrome has occasionally occurred in patients. The combination of escitalopram with non-selective irreversible MAOIs is contraindicated. Escitalopram treatment should not be started until 14 days after the last use of an irreversible MAOI. In turn, MAOI treatment should not be started until 7 days after the end of escitalopram treatment.
The combination of pimozide and racemic citalopram resulted in a prolongation of the QT interval by approximately 10 msec. Due to the interaction of escitalopram with low doses of pimozide and increased side effects of the latter, the simultaneous use of these drugs is contraindicated.
The antibiotic linezolid is not recommended for use in patients receiving escitalopram. If such a combination is necessary, treatment should be initiated at the lowest recommended dose with close clinical monitoring.
Concomitant use of escitalopram with a reversible selective MAO inhibitor of type A (moclobemide) is not recommended due to the risk of serotonin syndrome. If such a combination is necessary, treatment should be initiated at the lowest recommended dose with careful clinical monitoring. Treatment with escitalopram should not be started earlier than 1 day after discontinuation of the reversible MAO inhibitor moclobemide.
Due to the risk of serotonin syndrome, caution is advised when escitalopram is co-administered with selegiline (an irreversible MAO type B inhibitor). Selegiline doses up to 100 mg/kg/day are safe for concomitant use with racemic citalopram.
10 mg/day.
Combinations that require caution.
Serotonergic medications.
Concomitant use with serotonergic medicinal products (e.g. sumatriptan, other triptans, tramadol, oxitriptan and tryptophan) may lead to serotonin syndrome.
Drugs that lower the seizure threshold.
SSRIs may lower the seizure threshold. Caution is advised when escitalopram is co-administered with other drugs that may lower this threshold [e.g. antidepressants (tricyclines, SSRIs), neuroleptics (phenothiazines, thioxanthenes and butyrophenones), mefloquine, bupropion and tramadol].
Lithium, tryptophan.
Since cases of enhanced serotonergic effects have been reported when SSRIs are used in combination with lithium or tryptophan, caution is recommended when escitalopram is co-administered with these drugs. Regular monitoring of lithium and tryptophan levels is mandatory.
Hypericum.
Concomitant use of escitalopram and herbal preparations containing St. John's wort (Hypericum perforatum) may increase the frequency of adverse reactions. Therefore, escitalopram and St. John's wort preparations should not be prescribed simultaneously.
Anticoagulants and drugs that affect blood clotting.
Caution is required when treating patients who are concomitantly taking anticoagulants, medicinal products that affect platelet function, in particular non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, dipyridamole, ticlopidine or other agents (e.g. atypical antipsychotics, phenothiazines, tricyclic depressants) that may increase the risk of bleeding.
Escitalopram-Teva does not show any pharmacodynamic or pharmacokinetic interaction with ethanol, but, as with other psychotropic drugs, concomitant administration of escitalopram with drugs containing ethanol is not recommended.
Drugs causing hypokalemia/hypomagnesemia
Caution is required with concomitant use of drugs that cause hypokalemia/hypomagnesemia, as this increases the risk of malignant arrhythmias.
Effect of other drugs on the pharmacokinetics of escitalopram.
The metabolism of escitalopram is mainly mediated by CYP2C19, but CYP3A4 and CYP2D6 are also involved, 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).
Concomitant use of escitalopram and omeprazole 30 mg once daily (CYP2C19 inhibitor) causes a moderate increase (approximately 50%) in escitalopram plasma concentrations.
Concomitant use of escitalopram and cimetidine 400 mg twice daily (a moderate general enzyme inhibitor) causes a moderate increase (approximately 70%) in plasma escitalopram concentrations.
Therefore, caution should be exercised when escitalopram is co-administered with CYP2C19 inhibitors (e.g. omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine. When co-administered with the above-mentioned drugs, side effects may require a reduction in the dose of escitalopram.
Effect of escitalopram on the pharmacokinetics of other drugs.
Escitalopram is an inhibitor of the CYP2D6 isoenzyme. Caution is required when prescribing escitalopram simultaneously with drugs metabolized by this isoenzyme, as well as with drugs with a narrow therapeutic index, such as flecainide, propafenone, metoprolol (used in heart failure), or with drugs that act on the CNS and are mainly metabolized by CYP2D6, such as the antidepressants desipramine, clomipramine and nortriptyline; the antipsychotics risperidone, thioridazine or haloperidol. In these cases, dose adjustment may be required.
Concomitant use with desipramine (the main metabolite of imipramine) or metoprolol results in a two-fold increase in plasma levels of these two CYP2D6 substrates. Escitalopram causes weak inhibition of CYP2C19. Therefore, caution is recommended when co-prescribing drugs metabolized by CYP2C19.
Application features
The following special warnings and precautions apply to the entire therapeutic class of selective serotonin reuptake inhibitors (SSRIs).
Paradoxical anxiety.
Some patients with panic disorder may experience increased anxiety when starting antidepressant treatment. This paradoxical reaction usually disappears within the first two weeks of treatment. A low initial dose is recommended to reduce the likelihood of anxiogenic effects.
Convulsive attacks.
Escitalopram should be discontinued if the patient develops a seizure for the first time or if the 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 patient develops a manic state, the SSRI should be discontinued.
Diabetes.
In patients with diabetes mellitus, treatment with SSRIs may affect 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 an increased risk of suicide, suicidal thoughts and self-harm (suicidality). This risk persists until sustained remission is achieved. As improvement may not occur within the first few weeks or more of treatment, patients treated with antidepressants should be closely monitored. It is known that the risk of suicide may be increased in the early stages of recovery.
Other psychiatric disorders for which Escitalopram is used may also be associated with an increased risk of suicidal behaviour. In addition, these conditions may accompany major depressive disorder. Similar caution should be exercised when treating other psychiatric disorders because of the possibility of concomitant development of major depressive disorder.
Because of the high risk of suicidal thoughts and actions during treatment, patients with a history of suicidal thoughts or behavior, or with a significant level of suicidal ideation prior to initiation of treatment, should be closely monitored. Drug therapy should be accompanied by close monitoring of patients, particularly those at increased risk, particularly at the beginning of treatment and after dose changes. Patients (and caregivers of patients) should be warned about the need to monitor for the appearance of such actions and to seek emergency medical help if appropriate symptoms occur.
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.
Isolated cases of hyponatremia, probably caused by inappropriate antidiuretic hormone secretion (SIADH), have been reported with SSRIs, which usually resolved after discontinuation of therapy. Particular caution is required when treating patients at risk (elderly age, presence of liver cirrhosis or concomitant use of drugs with hyponatremic properties).
Hemorrhages.
Skin hemorrhages, 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 (NSAIDs), ticlopidine, and dipyridamole), and in patients with bleeding tendencies.
Electroconvulsive therapy (ECT).
Clinical experience with the concomitant use of SSRIs and ECT is limited, therefore caution is recommended.
Reversible, selective MAO type A inhibitors.
Combining escitalopram and MAO inhibitors type A is contraindicated due to the risk of serotonin syndrome.
Serotonin syndrome.
Caution is required when escitalopram is used concomitantly with serotonergic agents such as sumatriptan or other triptans, tramadol and tryptophan.
Isolated cases of serotonin syndrome have been reported in patients receiving concomitant SSRIs and serotonergic medicinal products. Symptoms such as agitation, tremor, myoclonus and hyperthermia may be the initial signs of this condition. In such cases, escitalopram should be discontinued immediately and symptomatic treatment initiated.
Hypericum.
Concomitant use of SSRIs and herbal preparations containing St. John's wort (Hypericum perforatum) may increase the frequency of adverse reactions.
Coronary heart disease.
Due to limited clinical experience, caution is required when treating patients with coronary heart disease.
Withdrawal symptoms.
Withdrawal symptoms are common when treatment is stopped (especially suddenly). In clinical trials, adverse events related to discontinuation of treatment were observed in approximately 25% of patients in the escitalopram group and 15% of patients in the placebo group.
The risk of withdrawal symptoms depends on several factors, including the duration and dose of therapy and the gradualness of dose reduction. 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 have been reported as 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, it is recommended to gradually discontinue escitalopram by reducing the dose over a period of several weeks or months, depending on the patient's condition.
QT prolongation
Escitalopram has been shown to cause dose-dependent prolongation of the QT interval. Cases of QT prolongation, including torsades de pointes, have been reported in the post-marketing setting, predominantly in female patients with hypokalaemia or pre-existing QT prolongation or other cardiac disease.
It is recommended to use the drug with caution in patients with significant bradycardia or in patients with a recent acute myocardial infarction or uncompensated heart failure.
Electrolyte disorders such as hypokalemia and hypomagnesemia increase the risk of malignant arrhythmias and should be corrected before starting treatment with escitalopram.
In patients with stable cardiac disease, an ECG should be reviewed before initiating treatment.
If signs of cardiac arrhythmia occur during treatment with escitalopram, treatment should be discontinued and an ECG performed.
During treatment with Escitalopram-Teva, you should not drink alcoholic beverages.
Angle-closure glaucoma
SSRIs, including escitalopram, may affect pupil size, resulting in mydriasis. In turn, pupil dilation may lead to narrowing of the angle of the eye and, as a result, increase intraocular pressure and provoke 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
Data on the use of escitalopram during pregnancy are limited. Escitalopram is contraindicated in pregnant women unless the need for the drug has been clearly demonstrated after careful consideration of the risks and benefits. Careful observation of newborns whose mothers have taken escitalopram during pregnancy, especially in the third trimester, is recommended.
The use of the drug during pregnancy should not be stopped suddenly.
The following disorders have been reported in newborns whose mothers took SSRIs/NSAIDs in late pregnancy: respiratory distress syndrome, cyanosis, apnea, seizures, temperature instability, difficulty sucking, vomiting, hypoglycemia, hypertension, hypotension, hyperreflexia, tremor, nervous excitement, irritability, drowsiness, constant crying, lethargy, and difficulty falling asleep. These disorders may be a manifestation of serotonergic effects or withdrawal syndrome. In most cases, complications began immediately or shortly (< 24 hours) after delivery.
It has been reported that the use of SSRIs during pregnancy may increase the risk of persistent pulmonary hypertension in the newborn.
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 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
Although Escitalopram has minor or moderate influence on the ability to drive, as with other psychotropic drugs, patients should be warned about the potential risk of adverse effects on the ability to drive and use machines.
Method of administration and doses
The safe use of doses above 20 mg has not been demonstrated.
Escitalopram-Teva is administered orally once a day, regardless of meals.
Major depressive episode.
Usually prescribed 10 mg/day. Depending on the individual patient's response, the dose can be increased to a maximum of 20 mg/day. The antidepressant effect usually develops 2-4 weeks after the start of treatment. After the symptoms of depression disappear, treatment should be continued for at least 6 months to consolidate the achieved effect.
Panic disorders with/without agoraphobia.
The recommended dose is 5 mg/day for the first week of treatment, which is then increased to 10 mg/day. Depending on the individual patient's response, the dose can be further increased to a maximum of 20 mg/day.
The maximum therapeutic effect is achieved after approximately 3 sessions. Therapy lasts for several months.
Social anxiety disorders.
Usually, a dose of 10 mg is prescribed once a day. Symptom relief usually occurs within 2-4 weeks. 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, the minimum recommended duration of treatment is 12 weeks to consolidate the achieved effect. To prevent relapses, the drug can be prescribed for
6 months depending on individual patient response. Therapeutic benefit of treatment should be reviewed regularly.
Social anxiety disorder has a well-defined diagnostic terminology for a specific disorder, which should not be confused with hypertrophied shyness. Pharmacotherapy is indicated only for the disorder, which significantly affects the professional and social activity of the person. The effectiveness of such treatment compared with cognitive behavioral therapy has not been studied. Pharmacotherapy should be part of an overall therapeutic strategy.
Generalized anxiety disorders.
The recommended initial dose is 10 mg once a day. Depending on the individual patient's response, the dose can be further increased to a maximum of 20 mg per day. It is recommended to continue treatment for 3 months. Long-term administration of the drug (6 months) at a dose of 20 mg per day is allowed to prevent relapses. The therapeutic benefit of treatment should be regularly checked.
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 (over 65 years of age).
The initial dose is 5 mg/day. Depending on the individual patient's response, the dose may be increased to 10 mg once daily. The lowest effective dose is prescribed.
The effectiveness of Escitalopram Teva in social anxiety disorder in elderly patients has not been studied.
Kidney dysfunction.
No dose adjustment is required in patients with moderate to mild renal impairment. Caution should be exercised in patients with severe renal impairment (CLCR less than 30 mL/min).
For patients with moderate and mild hepatic impairment, the recommended initial dose in the first two weeks is 5 mg/day. Depending on the individual patient response, the dose may be increased to 10 mg/day. In severe hepatic impairment, caution and careful dose titration are required.
Reduced activity of the CYP2C19 isoenzyme.
For patients with known low CYP2C19 activity, the recommended starting dose of Escitalopram Teva is 5 mg/day for the first two weeks. Depending on the individual patient response, the dose may be increased to
10 mg/day.
Withdrawal symptoms after stopping treatment.
Abrupt discontinuation of this medicine should be avoided. The dose of escitalopram should be reduced gradually over 1-2 weeks to avoid possible withdrawal symptoms. If withdrawal symptoms occur during the gradual dose reduction, the dose can be resumed at the previously prescribed dose. Your doctor may then continue to reduce the dose, but more gradually.
Children
Antidepressants are contraindicated in children. Suicidal behavior (suicide attempt and suicidal ideation) and hostility (predominantly aggression, oppositional behavior, and anger) were observed more frequently in children and adolescents treated with antidepressants than in those treated with placebo. If a decision to prescribe is made for clinical reasons, the patient should be closely monitored for suicidal symptoms.
In addition, there are no data on the continued safety of children and adolescents with regard to growth, puberty, and cognitive and behavioral development.
Overdose
Data on overdose with escitalopram are limited. In most cases, symptoms were absent or mild. Fatalities have been reported rarely with overdose with escitalopram. In most of these cases, concomitant overdose with other drugs was noted. Escitalopram doses of 400-800 mg did not cause severe symptoms.
Symptoms: Signs of escitalopram overdose generally involved the central nervous system (ranging from dizziness, tremor and agitation to rare cases of serotonin syndrome, convulsions and coma), the gastrointestinal system (vomiting, nausea), the cardiovascular system (hypotension, tachycardia, QT prolongation, arrhythmia), and electrolyte and fluid balance (hypokalaemia, hyponatraemia).
Treatment. There is no specific antidote. Maintain and ensure a patent airway, adequate oxygenation and respiratory function. Gastric lavage, which should be performed as soon as possible after oral administration, and administration of activated charcoal. Continuous monitoring of cardiovascular function and vital signs is recommended, in conjunction with general symptomatic supportive measures.
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 metabolic disorders, e.g., hepatic insufficiency.
Adverse reactions
Adverse reactions most often occur in the first and second weeks of treatment and subsequently become less intense, and their frequency decreases with continued treatment.
From the side of the circulatory and lymphatic system: thrombocytopenia.
Immune system disorders: anaphylactic reactions.
On the part of the endocrine system: impaired secretion of antidiuretic hormone.
Nutritional and metabolic disorders: decreased or increased appetite, weight gain, weight loss, hyponatremia, anorexia2.
Psychiatric: anxiety, fear, restlessness, dysphoria, abnormal dreams, decreased libido in men and women, anorgasmia in women, teeth grinding during sleep, bruxism, agitation, nervousness, panic attacks, confusion, aggression, depersonalization, hallucinations, mania, suicidal thoughts, suicidal behavior1.
Nervous system: headache, insomnia, drowsiness, dizziness, paresthesia, tremor, taste disturbance, sleep disturbance, syncope, serotonin syndrome, dyskinesia, movement disorders, convulsions, psychomotor restlessness/akathisia2.
From the organs of vision: mydriasis, blurred vision.
On the part of the organs of hearing: ringing in the ears.
Cardiovascular system: tachycardia, bradycardia, ventricular arrhythmia, including torsade de pointes, prolongation of the QT interval on the electrocardiogram, orthostatic hypotension.
Respiratory disorders: sinusitis, yawning, nosebleeds.
Gastrointestinal: nausea, diarrhea, constipation, vomiting, dry mouth, gastrointestinal bleeding (including rectal).
Hepatobiliary disorders: hepatitis, changes in liver function tests.
Skin and subcutaneous tissue disorders: increased sweating, skin rash, alopecia, urticaria, itching, bruising, swelling.
Musculoskeletal disorders: arthralgia, myalgia.
Renal and urinary disorders: urinary retention.
From the reproductive system and mammary glands: galactorrhea, men: ejaculation disorders, priapism, impotence; women: metrorrhagia, menorrhagia.
1 Cases of suicidal thinking or behavior have been observed both during escitalopram therapy and immediately after treatment discontinuation.
2These adverse reactions have been reported for the SSRI therapeutic class as a whole.
During the post-marketing period, cases of QT prolongation, including torsades de pointes, have been reported, predominantly in female patients with hypokalemia or pre-existing QT prolongation or other cardiac disease.
Class-specific effects of SSRIs: Epidemiological studies, mainly in patients aged 50 years and over, have shown an increased risk of bone fractures in patients receiving SSRIs and tricyclic antidepressants. The mechanism of this effect is unknown.
Withdrawal symptoms when use is stopped suddenly.
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 have been reported as 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, it is recommended to gradually discontinue escitalopram by reducing the dose over a period of several weeks or months, depending on the patient's condition.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 30 °C in the original packaging to protect from light and moisture and out of the reach of children.
Packaging
Escitalopram-Teva, 5 mg: 28 tablets in a blister, 1 blister in a cardboard box.
Escitalopram-Teva, 10 mg, 15 mg, 20 mg: 14 tablets in a blister, 2 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Teva Operations Poland LLC.
Location of the manufacturer and address of its place of business
80 Mogilska Street, 31-546 Krakow, Poland
