Essobel
Ukraine
Table of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ESSOBEL®
Composition:
Active substance: escitalopram;
One tablet contains escitalopram oxalate equivalent to escitalopram 10 mg or 20 mg;
Excipients: copovidone, lactose monohydrate, maize starch, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, Sepifilm LP 770 coating: hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide (E 171).
Pharmaceutical form. Film-coated tablets.
Main physicochemical properties:
10 mg tablets: white, oval, film-coated tablets with a break line on one side and engraved «10» on the other;
20 mg tablets: white, oval, film-coated tablets with a break line on one side and engraved «20» on the other.
Pharmacotherapeutic group.
Antidepressants. Selective serotonin reuptake inhibitors.
ATC code N06AB10.
Pharmacological properties.
Pharmacodynamics.
Escitalopram**®** is an antidepressant, selective serotonin reuptake inhibitor (SSRI), which determines the clinical and pharmacological effects of the drug. It has high affinity for the primary binding site and the adjacent allosteric site of the serotonin transporter, and has no or very weak binding affinity for 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 opioid receptors.
Escitalopram is the S-enantiomer of racemic citalopram and possesses its own therapeutic activity. It has been demonstrated that the R-enantiomer is not inert, but counteracts the serotonergic properties and corresponding pharmacological effects of the S-enantiomer.
Pharmacokinetics.
Absorption is nearly complete and is independent of food intake. Maximum plasma concentration is reached within 4 hours after administration. The bioavailability of escitalopram is approximately 80%.
Protein binding of escitalopram and its main metabolites is less than 80%.
Metabolism occurs in the liver, producing demethylated and didemethylated metabolites. Both are pharmacologically active. The biotransformation of escitalopram into the demethylated metabolite is mediated by the cytochrome CYP2C19. A minor contribution of the isoenzymes CYP3A4 and CYP2D6 to this process is possible. The elimination half-life of the drug is approximately 30 hours. Creatinine clearance after oral administration is approximately 0.6 L/min. The main metabolites have a longer elimination half-life. Escitalopram and its main metabolites are eliminated via the liver (metabolic pathway) and kidneys. The majority of the dose is excreted in the urine as metabolites. The pharmacokinetics of escitalopram are linear. Steady-state concentration is reached after approximately 1 week. In elderly patients (aged 65 years and older), escitalopram is eliminated more slowly than in younger patients.
In patients with mild to moderate hepatic impairment (Child–Pugh classes A and B), the elimination half-life was twice as long, and drug exposure was 60% higher compared to individuals with normal liver function.
In patients with reduced renal function, administration of racemic citalopram resulted in a prolonged elimination half-life and slightly increased drug exposure. Plasma concentrations of metabolites have not been studied but may be elevated.
Patients with poor metabolic function of CYP2C19 had twice the plasma concentration of escitalopram compared to patients with normal CYP2C19 function. No significant changes in exposure were observed with reduced CYP2D6 function.
Clinical characteristics.
Indications.
Treatment of major depressive episodes, panic disorders with or without agoraphobia, social anxiety disorders (social phobia), generalized anxiety disorders, obsessive-compulsive disorders.
Contraindications.
- Hypersensitivity to escitalopram or to any other component of the medicinal product;
- Concomitant use of non-selective irreversible monoamine oxidase inhibitors (MAOIs), due to the risk of developing serotonin syndrome, which manifests as agitation, tremor, hyperthermia;
- Combination with reversible MAO-A inhibitors (e.g., moclobemide) or with the reversible non-selective MAO inhibitor linezolid, due to the risk of serotonin syndrome;
- QT interval prolongation or congenital long QT syndrome;
- Concomitant use of medicinal products that prolong the QT interval;
- Concomitant treatment with pimozide.
Interaction with other medicinal products and other forms of interaction.
Pharmacodynamic interactions
Contraindicated combinations
Non-selective irreversible MAOIs
Serious reactions have been reported in patients taking selective serotonin reuptake inhibitors (SSRIs) in combination with non-selective irreversible MAOIs, and in patients who have recently discontinued SSRIs and started MAOI therapy. In some cases, serotonin syndrome developed. The combination of escitalopram with non-selective irreversible MAOIs is contraindicated. Escitalopram therapy should be initiated no earlier than 14 days after discontinuation of irreversible MAOIs. Treatment with non-selective irreversible MAOIs should not be initiated earlier than 7 days after stopping escitalopram.
Pimozide
Combination of pimozide with racemic citalopram resulted in a mean QTc prolongation of approximately 10 msec. Due to the interaction between escitalopram and low doses of pimozide, and the potentiation of pimozide's adverse effects, concomitant use of these medicinal products is contraindicated.
Reversible selective MAO-A inhibitor (moclobemide)
Due to the risk of serotonin syndrome, combination of escitalopram with the MAO-A inhibitor moclobemide is not recommended. If combination is necessary, treatment should be initiated with the lowest recommended doses and careful clinical monitoring is required.
Escitalopram treatment may be initiated no earlier than 1 day after discontinuation of the reversible MAOI moclobemide.
Antibiotic linezolid is not recommended for patients taking escitalopram. If such a combination is absolutely necessary, treatment should be initiated with the lowest recommended dose and mandatory careful clinical monitoring is required.
QT interval prolongation
Pharmacokinetic and pharmacodynamic studies of escitalopram in combination with other medicinal products that increase the QT interval have not been conducted. A cumulative effect of escitalopram and these medicinal products cannot be excluded. Therefore, concomitant use of escitalopram with medicinal products that prolong the QT interval, such as class IA and III antiarrhythmics, neuroleptics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial agents, including halofantrine), certain antihistamines (astemizole, mizolastine), is contraindicated.
Selegiline
Combination with selegiline (an irreversible type-B MAOI) requires caution due to the risk of serotonin syndrome.
Combinations requiring caution
Serotonergic medicinal products
Concomitant use with serotonergic agents (e.g., tramadol, sumatriptan, and other triptans) may lead to serotonin syndrome.
Medicinal products that lower the seizure threshold
SSRIs may lower the seizure threshold. Caution is recommended when using concomitantly with medicinal products that may lower the seizure threshold (e.g., antidepressants (tricyclics, SSRIs), neuroleptics (phenothiazines, thioxanthenes, butyrophenones), mephenoxalone, bupropion, and tramadol).
Lithium, tryptophan
Cases of enhanced effects have been reported with concomitant use of SSRIs and lithium or tryptophan. Therefore, these medicinal products should be used concomitantly with caution.
Hypericum perforatum (St. John's wort)
Concomitant use of SSRIs and herbal preparations containing Hypericum perforatum may lead to an increased frequency of adverse reactions.
Anticoagulants
The effects of anticoagulants may be altered when used concomitantly with escitalopram. If patients are taking oral anticoagulants, careful monitoring of the blood coagulation system before and after escitalopram administration is necessary.
Concomitant use of non-steroidal anti-inflammatory drugs may enhance the tendency to bleeding.
Alcohol
Escitalopram does not exhibit pharmacodynamic or pharmacokinetic interaction with alcohol. However, combination with alcohol is not recommended.
Medicinal products causing hypokalemia/hypomagnesemia
Caution is required when using concomitantly medicinal products that cause hypokalemia/hypomagnesemia, as this may increase the risk of developing malignant arrhythmias.
Pharmacokinetic interactions
Effect of other agents on escitalopram pharmacokinetics
The metabolism of escitalopram is primarily mediated by CYP2C19.
Concomitant administration of escitalopram and omeprazole (a CYP2C19 inhibitor) leads to a moderate (approximately 50%) increase in escitalopram plasma concentration.
Concomitant administration of escitalopram and cimetidine (a moderately potent basic enzyme inhibitor) leads to a moderate (approximately 70%) increase in escitalopram plasma concentration.
Therefore, when escitalopram is used concomitantly with CYP2C19 inhibitors (e.g., omeprazole, esomeprazole, fluconazole, fluvoxamine, lansoprazole, ticlopidine) or with cimetidine, dose reduction may be necessary depending on monitoring of adverse reactions (see section "Special precautions for use").
Effect of escitalopram on the pharmacokinetics of other agents
Escitalopram is an inhibitor of the CYP2D6 enzyme. Caution is recommended when using escitalopram concomitantly with medicinal products that are primarily metabolized by this enzyme and have a narrow therapeutic index, such as flecainide, propafenone, and metoprolol (in heart failure), or with certain central nervous system (CNS) agents primarily metabolized by CYP2D6, such as the antidepressants desipramine, clomipramine, and nortriptyline, and the antipsychotics risperidone, thioridazine, and haloperidol. Dose adjustment may be required.
Combination with desipramine or metoprolol resulted in a doubling of plasma levels of these two agents.
Caution is recommended when using concomitantly with medicinal products metabolized by CYP2C19.
Special precautions for use.
The following special precautions apply to the therapeutic class of SSRIs.
Paradoxical anxiety
Some patients with panic disorders may experience increased anxiety at the beginning of treatment with antidepressants. This paradoxical reaction usually resolves within two weeks of treatment. A low initial dose is recommended to reduce the likelihood of an anxiogenic effect.
Seizures
Discontinue escitalopram if a patient develops a first seizure or experiences increased seizure frequency (in patients with a confirmed diagnosis of 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 develops, SSRIs should be discontinued.
Diabetes mellitus
In patients with diabetes mellitus, treatment with SSRIs may alter glycaemic control. The dose of insulin and/or oral hypoglycaemic agents may require adjustment.
Suicide, suicidal thoughts, or clinical worsening
Depression is associated with a risk of suicidal thoughts, self-harm, and suicide. This risk persists until sustained remission is achieved. Since improvement may not occur during 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 increase in the early stages of recovery.
Other conditions for which escitalopram is prescribed may also be associated with a risk of suicidal behaviour. Moreover, these 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 starting treatment are at the highest risk of suicidal thoughts or attempts and require close monitoring during treatment. A meta-analysis of clinical trials revealed an increased risk of suicidal behaviour among patients under the age of 25 who were taking antidepressants compared to those receiving placebo. Close monitoring of high-risk patients is particularly necessary at the beginning of treatment and when the dose is changed.
Patients and their caregivers should be warned to monitor for any worsening of symptoms, suicidal behaviour or thoughts, or unusual changes in behaviour, and to seek immediate medical consultation if these symptoms develop.
Akathisia
The use of SSRIs or serotonin-norepinephrine reuptake inhibitors (SNRIs) may be associated with the development of akathisia—a condition characterized by an unpleasant, distressing sense of restlessness and an urge 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 symptoms in patients who develop such reactions.
Hyponatraemia
Hyponatraemia, possibly related to impaired secretion of antidiuretic hormone, is rare during SSRI treatment and usually resolves after discontinuation of therapy. SSRIs should be prescribed with caution in patients at risk (elderly patients, patients with liver cirrhosis, or those receiving concomitant medications that may cause hyponatraemia).
Bleeding
Skin bleeding, ecchymoses, and purpura may occur during SSRI treatment. SSRIs should be used with caution in patients receiving concomitant anticoagulants, medications affecting platelet function (e.g., atypical antipsychotics, phenothiazines, tricyclic antidepressants, acetylsalicylic acid, and non-steroidal anti-inflammatory drugs (NSAIDs), dipyridamole, and ticlopidine), and in patients with a predisposition to bleeding.
The use of SSRIs/SNRIs may increase the risk of postpartum haemorrhage (see sections "Use during pregnancy or breastfeeding" and "Side effects").
Electroconvulsive therapy (ECT)
Clinical experience with the concomitant use of SSRIs and ECT is limited; therefore, caution is recommended.
Reversible, selective MAO-A inhibitors
Combining escitalopram with MAO-A inhibitors is not recommended due to the risk of serotonin syndrome.
Serotonin syndrome
Caution is advised when escitalopram is used concomitantly with serotonergic agents such as sumatriptan or other triptans, tramadol, and tryptophan.
Cases of serotonin syndrome have been reported in isolated cases in patients taking SSRIs concomitantly with serotonergic drugs. Escitalopram should be used with caution when administered together with medications having serotonergic activity. A 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 agent should be discontinued immediately, and symptomatic treatment should be initiated.
St. John’s wort
Concomitant use of SSRIs and herbal preparations containing St. John’s wort may lead to an increased frequency of adverse reactions.
Withdrawal symptoms
Withdrawal symptoms upon discontinuation of treatment, especially abrupt discontinuation, are common. In clinical trials, adverse reactions during treatment discontinuation occurred in approximately 25% of patients treated with escitalopram and in 15% of patients receiving placebo.
The risk of withdrawal symptoms may depend on several factors, including duration and dose of treatment, and the rate of dose reduction. Dizziness, sensory disturbances (including paraesthesia, electric shock sensations), sleep disturbances (including insomnia and vivid dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances are the most commonly reported reactions. These symptoms are usually mild to moderate in severity and resolve within 2 weeks, although they may persist longer (2–3 months or more) in some patients. Therefore, it is recommended that escitalopram treatment be gradually discontinued by tapering the dose over several weeks or months, depending on the patient's condition.
Ischaemic heart disease
Due to limited clinical experience, caution is recommended when using the drug in patients with ischaemic heart disease.
QT interval prolongation
Escitalopram has been shown to cause dose-dependent QT interval prolongation. Cases of QT interval prolongation and ventricular arrhythmias, including torsade de pointes, have been reported, primarily in female patients with hypokalaemia or pre-existing QT prolongation, or other cardiac conditions.
The drug should be used with caution in patients with marked bradycardia or in those with recent acute myocardial infarction or uncompensated heart failure. Electrolyte imbalances, such as hypokalaemia and hypomagnesaemia, increase the risk of malignant arrhythmias and should be corrected before initiating escitalopram treatment.
In patients with stable cardiac disease, an ECG should be reviewed before starting treatment. If signs of cardiac arrhythmia occur during escitalopram treatment, therapy should be discontinued and an ECG should be performed.
Closed-angle glaucoma
SSRIs, including escitalopram, may affect pupil size.
This mydriatic effect may potentially narrow the anterior chamber angle of the eye, which in turn may lead to increased intraocular pressure and the development of closed-angle glaucoma, particularly in predisposed patients. Therefore, escitalopram should be used with caution in patients with closed-angle glaucoma or a history of glaucoma.
Sexual dysfunction
Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see section "Side effects"). Reports have been received of persistent sexual dysfunction, with symptoms lasting for a prolonged period despite discontinuation of SSRIs/SNRIs.
Esbelle**®** contains lactose. Patients with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medication.
Use during pregnancy or breastfeeding
Clinical data on the use of escitalopram in pregnant women are limited.
Escitalopram is contraindicated during pregnancy except in cases where, after careful evaluation of risks and benefits, the necessity of treatment has been clearly established. Newborns of mothers who took escitalopram during pregnancy, especially in the third trimester, should be carefully examined.
Newborns of mothers who took SSRIs/SNRIs in late pregnancy may develop symptoms such as respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulties, vomiting, hypoglycaemia, hypertension, hypotension, hyperreflexia, tremor, nervous excitation, irritability, apathy, persistent crying, somnolence, and sleep disturbances. These symptoms may arise either due to excessive serotonergic activity or as withdrawal symptoms. In most cases, such complications occur immediately or shortly (within 24 hours) after delivery.
Epidemiological data indicate that the use of SSRIs during pregnancy may increase the risk of persistent pulmonary hypertension in newborns (up to 5 cases per 1000 pregnancies, according to observational studies). In the general population, the incidence is 1 to 2 cases per 1000 pregnancies. Observational data also suggest an increased risk (less than 2-fold) of postpartum haemorrhage following the use of SSRIs/SNRIs within one month before delivery (see sections "Special precautions for use" and "Side effects").
Since escitalopram passes into breast milk, breastfeeding is not recommended during treatment.
Fertility
Animal studies have shown that some SSRIs may affect sperm quality. Reports on human use of certain SSRIs have indicated that the effect on sperm quality is reversible. No effect on human fertility has been observed to date.
Ability to drive and use machines
Although escitalopram does not affect intellectual or psychomotor performance, any psychoactive drug may impair skills or the ability for rational thinking. Patients should be warned about the potential risk of impaired ability to drive or operate machinery.
Method of Administration and Dosage
Esobel® is administered orally once daily to adults, independent of food intake.
The safety of doses exceeding 20 mg per day has not been established.
Major Depressive Episode
The usual dose is 10 mg once daily. Depending on individual patient sensitivity, the daily dose may be increased to 20 mg.
Antidepressant effect typically occurs within 2–4 weeks. After symptom remission, treatment should usually be continued for 6 months to consolidate the therapeutic effect.
Panic Disorders with/without Agoraphobia
A starting dose of 5 mg per day is recommended during the first week, after which the dose may be increased to 10 mg per day. The dose may be further increased up to 20 mg per day depending on individual patient sensitivity.
Maximum therapeutic effect in panic disorder treatment is achieved within 3 months. The duration of treatment lasts several months and depends on disease severity.
Social Anxiety Disorders (Social Phobia)
The usual dose is 10 mg once daily. Depending on individual patient sensitivity, the dose may be increased to 20 mg per day.
Symptom improvement usually occurs within 2–4 weeks of treatment. Treatment should be continued for 3 months. Long-term treatment for 6 months is recommended to prevent relapse, taking into account individual disease manifestations; treatment efficacy should be regularly assessed.
Generalized Anxiety Disorders
The usual dose is 10 mg once daily. Depending on individual patient sensitivity, the dose may be increased up to a maximum of 20 mg per day.
Treatment should be continued for 3 months. Long-term treatment for 6 months is indicated to prevent relapse, considering individual disease manifestations; treatment efficacy should be regularly evaluated.
Obsessive-Compulsive Disorders (OCD)
The usual dose is 10 mg once daily. Depending on individual patient sensitivity, the dose may be increased up to 20 mg per day. OCD is a chronic condition; treatment should continue for a sufficient duration to ensure complete symptom remission, which may take several months or longer.
Elderly Patients (aged 65 years and older)
The initial dose should be half the usual recommended dose. The recommended daily dose for elderly patients is 5 mg. Depending on individual sensitivity and severity of depression, the daily dose may be increased up to a maximum of 10 mg per day.
Renal Impairment
No dosage adjustments are required in patients with mild to moderate renal impairment. Esobel® should be used with caution in patients with severe renal impairment (creatinine clearance < 30 mL/min).
Hepatic Impairment
The recommended initial dose during the first two weeks of treatment is 5 mg per day. Depending on individual patient response, the dose may be increased to 10 mg per day.
Reduced Activity of Cytochrome Isoenzyme CYP2C19
For patients with low CYP2C19 isoenzyme activity, the recommended initial dose during the first two weeks of treatment is 5 mg per day. Depending on individual patient response, the dose may be increased to 10 mg per day.
Discontinuation of Treatment
When discontinuing Esobel® therapy, the dose should be gradually reduced over 1–2 weeks to avoid withdrawal reactions.
Children
Antidepressants are contraindicated for use in children. Suicidal behavior (suicidal attempts and suicidal thoughts) and hostility (mainly aggression, oppositional behavior, and anger) have been observed more frequently in children and adolescents receiving antidepressants compared to those receiving placebo in clinical trials. If, based on clinical judgment, a decision to prescribe is made, careful monitoring for the emergence of suicidal symptoms is required.
Overdose.
Toxicity. Clinical data on escitalopram overdose are limited. Many cases involve concomitant overdose with other medicinal products. In most cases, mild symptoms or asymptomatic overdose have been reported. Reports of fatal outcomes following escitalopram overdose are rare and mostly involve concomitant overdose with other drugs. Doses of escitalopram ranging from 400–800 mg have not caused severe symptoms.
Symptoms. Signs of escitalopram overdose are primarily related to the CNS (from dizziness, tremor, and agitation to rare cases of serotonin syndrome, seizures, and coma), gastrointestinal system (nausea, vomiting), cardiovascular system (hypotension, tachycardia, QT interval prolongation, arrhythmia), and fluid/electrolyte imbalance (hypokalemia, hyponatremia).
Treatment. There is no specific antidote. Maintain adequate respiratory function and ensure proper oxygenation. Gastric lavage and activated charcoal may be used. Continuous monitoring of cardiac and vital functions is recommended, along with symptomatic and supportive treatment.
Adverse Reactions
Adverse reactions most commonly occur during the first or second week of treatment, and their frequency and intensity usually gradually decrease with continued treatment.
Blood system: thrombocytopenia.
Immune system: anaphylactic reactions.
Endocrine system: disturbance in antidiuretic hormone secretion.
Metabolism and nutrition: decreased or increased appetite, weight gain, weight loss, hyponatremia, anorexia2.
Psychiatric disorders: anxiety, restlessness, abnormal dreams, decreased libido in both men and women, anorgasmia in women, bruxism, agitation, nervousness, panic attacks, confusion, aggression, depersonalization, hallucinations, mania, suicidal behaviour1, suicidal ideation.
Nervous system: insomnia, somnolence, dizziness, paraesthesia, tremor, taste disturbance, sleep disorders, loss of consciousness, serotonin syndrome, dyskinesia, movement disorders, seizures, psychomotor restlessness/akathisia2, headache.
Eye disorders: mydriasis, blurred vision.
Ear and labyrinth disorders: tinnitus.
Cardiac disorders: tachycardia, bradycardia, QT interval prolongation on electrocardiogram, orthostatic hypotension, ventricular arrhythmia (including torsade de pointes).
Respiratory system: sinusitis, yawning, epistaxis.
Gastrointestinal disorders: nausea, diarrhoea, constipation, vomiting, dry mouth, gastrointestinal haemorrhage (including rectal).
Hepatobiliary disorders: hepatitis, changes in liver function tests.
Skin and subcutaneous tissue disorders: increased sweating, rash, alopecia, urticaria, pruritus, bruising, angioneurotic edema.
Musculoskeletal and connective tissue disorders: arthralgia, myalgia.
Renal and urinary disorders: urinary retention.
Reproductive system: Men: ejaculation disorders, impotence, priapism; Women: metrorrhagia, menorrhagia, galactorrhea, postpartum haemorrhage3.
General disorders: fatigue, pyrexia, oedema.
1 Cases of suicidal ideation and behaviour have been reported during treatment with escitalopram or shortly after discontinuation.
2 Such cases are known for the entire SSRI class.
3 This adverse reaction has been reported for the therapeutic class of SSRIs/SNRIs in general (see sections "Special Warnings and Precautions for Use", "Use During Pregnancy or Breastfeeding").
Cases of QT interval prolongation and ventricular arrhythmia, including torsade de pointes, have been reported during post-marketing use, primarily in female patients with hypokalemia or pre-existing QT interval prolongation, or existing heart disease. In one study in healthy volunteers, the mean change from baseline in QTc interval (using Fridericia's formula) was 4.3 ms with 10 mg daily and 10.7 ms with 30 mg daily.
Epidemiological studies, primarily in patients aged 50 years and older, have shown an increased risk of bone fractures associated with the use of SSRIs and tricyclic antidepressants. The mechanism behind this phenomenon is unknown.
Withdrawal symptoms
Discontinuation of SSRIs (especially abrupt discontinuation) 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, excessive sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances are the most commonly reported reactions. These symptoms are usually mild to moderate and transient, but may be severe and/or prolonged in some patients. Therefore, it is recommended that treatment with escitalopram be gradually discontinued by dose tapering.
Shelf life: 3 years.
Storage conditions
Store at temperatures not exceeding 25°C in the original packaging.
Keep out of reach and sight of children.
Packaging
14 tablets in a blister pack, 2 blisters in a cardboard box.
Prescription status: Prescription only.
Manufacturer:
NOBEL ILAC SANAYI VE TICARET A.S.
Manufacturer's address:
Sankaklar Quarter, Eskisehir Yolu Akcakoca Highway No: 299, 81100 Duzce, Turkey.