Recita-5

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT RECITA-5 (RECITA-5), RECITA-10 (RECITA-10), RECITA-20 (RECITA-20)

Composition:

Active substance: escitalopram;

1 tablet contains escitalopram oxalate equivalent to escitalopram 5 mg, 10 mg, or 20 mg;

Excipients: microcrystalline cellulose, sodium croscarmellose, talc, colloidal anhydrous silicon dioxide, magnesium stearate;

coating: hypromellose, titanium dioxide (E 171), talc, macrogol (PEG-400), purified water.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties:

5 mg tablets: white or almost white film-coated tablets, round, biconvex, with "C5" engraved on one side and plain on the other;

10 mg tablets: white or almost white film-coated tablets, oval, biconvex, with "C4" engraved on one side and a division line on the other;

20 mg tablets: white or almost white film-coated tablets, oval, biconvex, with "C3" engraved on one side and a division line on the other.

Pharmacotherapeutic group.

Antidepressants. Selective serotonin reuptake inhibitors (SSRIs).

ATC code N06AB10.

Pharmacological Properties.

Pharmacodynamics.

Escitalopram is an antidepressant and selective serotonin reuptake inhibitor (SSRI), responsible for 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 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 almost complete and is not affected by food intake. Maximum plasma concentration (Cmax) 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 (t1/2) of the drug is approximately 30 hours. Oral clearance (Cloral) is approximately 0.6 L/min. The main metabolites have a longer t1/2. 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 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), t1/2 was twice as long and exposure was 60% higher compared to individuals with normal liver function.

In patients with reduced renal function, administration of racemic citalopram was associated with a prolonged t1/2 and slightly increased exposure. Plasma concentrations of metabolites have not been studied but may be elevated.

Patients with poor CYP2C19 metabolic function had twice the plasma concentration of escitalopram compared to patients with normal CYP2C19 function. No significant changes in exposure were observed in patients 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 of the excipients of the medicinal product;
• Concomitant use of non-selective irreversible monoamine oxidase inhibitors (MAOIs), due to the risk of serotonin syndrome, which manifests as agitation, tremor, hyperthermia;
• Combination with reversible MAO-A inhibitors (e.g., moclobemide) or 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 MAO inhibitors

Serious reactions have been reported in patients taking SSRIs in combination with non-selective irreversible MAO inhibitors, as well as in patients who recently discontinued SSRIs and started MAO inhibitors. In some cases, serotonin syndrome developed.

The combination of escitalopram with non-selective irreversible MAO inhibitors is contraindicated. Escitalopram treatment should be initiated no earlier than 14 days after discontinuation of an irreversible MAOI. Treatment with non-selective irreversible MAO inhibitors should not be started earlier than 7 days after stopping escitalopram.

Pimozide

Combination of pimozide and racemic citalopram resulted in an average QTc prolongation of approximately 10 msec. Due to the interaction between escitalopram and low doses of pimozide and the potentiation of the latter’s adverse effects, concomitant use of these drugs is contraindicated.

Combinations requiring caution

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 at the lowest recommended doses with careful clinical monitoring.

Escitalopram treatment may be started no earlier than 1 day after discontinuation of the reversible MAOI, moclobemide.

Antibiotic linezolid is not recommended for administration to patients taking escitalopram. If such combination is absolutely necessary, treatment should be initiated at the minimum recommended dose with mandatory close clinical monitoring.

QT interval prolongation

Pharmacokinetic and pharmacodynamic studies of escitalopram in combination with other medicinal products that prolong 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, antimalarials including halofantrine), certain antihistamines (astemizole, mizolastine), is contraindicated.

Selegiline

Combination with selegiline (an irreversible MAO-B inhibitor) requires caution due to the risk of serotonin syndrome.

Serotonergic medicinal products

Concomitant use of serotonergic medicinal products (e.g., tramadol, sumatriptan, and other triptans) may lead to serotonin syndrome.

Medicinal products that lower seizure threshold

SSRIs may lower the seizure threshold. Caution is recommended when co-administering medicinal products that may reduce the seizure threshold (e.g., antidepressants (tricyclics, SSRIs), neuroleptics (phenothiazines, thioxanthenes, butyrophenones), mefloquine, bupropion, and tramadol).

Lithium, tryptophan

Cases of enhanced effects have been reported with concomitant use of SSRIs and lithium or tryptophan. Therefore, caution is recommended when co-administering these agents.

St. John’s wort

Concomitant use of SSRIs and herbal preparations containing St. John’s wort may increase the frequency 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 coagulation system before and after escitalopram administration is required.

Concomitant use of nonsteroidal 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 co-administering medicinal products that cause hypokalemia/hypomagnesemia, as this may increase the risk of developing malignant arrhythmias.

Pharmacokinetic interactions

Effect of other medicinal products on escitalopram pharmacokinetics

Escitalopram metabolism is primarily mediated by CYP2C19.

Concomitant administration of escitalopram and omeprazole (a CYP2C19 inhibitor) results in a moderate (approximately 50%) increase in escitalopram plasma concentration.

Concomitant administration of escitalopram and cimetidine (a moderately potent basic enzyme inhibitor) results in a moderate (approximately 70%) increase in escitalopram plasma concentration.

In general, caution should be exercised when co-administering escitalopram with CYP2C19 inhibitors (e.g., omeprazole, esomeprazole, fluconazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine. Depending on the monitoring of adverse reactions during co-administration, dose reduction may be necessary (see section "Special precautions for use").

Effect of escitalopram on the pharmacokinetics of other medicinal products

Escitalopram is an inhibitor of the CYP2D6 enzyme. Caution is recommended when co-administering escitalopram 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-acting drugs primarily metabolized by CYP2D6, such as antidepressants (desipramine, clomipramine, nortriptyline) and antipsychotics (risperidone, thioridazine, haloperidol). Dose adjustment may be required.

Combination with desipramine or metoprolol resulted in a doubling of plasma levels of these two drugs.

Caution is recommended when co-administering escitalopram with medicinal products metabolized by CYP2C19.

Special precautions for use.

The special precautions listed below 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

Escitalopram should be discontinued if a patient develops a first seizure or increased seizure frequency (in patients with established epilepsy). SSRIs should be avoided in patients with unstable epilepsy, and close monitoring is required in patients with controlled epilepsy.

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.

Suicidality, 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 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 the start of 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 25 years of age taking antidepressants compared to those taking placebo. Close monitoring of high-risk patients is particularly necessary at the beginning of treatment and when the dose is changed.

Patients and caregivers should be advised to monitor for any worsening of symptoms, suicidal behaviour or thoughts, or unusual changes in behaviour, and to seek immediate medical advice if such symptoms occur.

Akathisia

The use of SSRIs and serotonin-norepinephrine reuptake inhibitors (SNRIs) has been 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, has been reported rarely in patients taking SSRIs and usually resolves after discontinuation of therapy. SSRIs should be used with caution in patients at risk (elderly patients, patients with hepatic cirrhosis, or those receiving concomitant medications that may cause hyponatraemia).

Bleeding

Skin haemorrhages, ecchymoses, and purpura may occur during SSRI treatment. SSRIs may also increase the risk of postpartum haemorrhage (see sections "Use during pregnancy or breastfeeding" and "Adverse reactions"). SSRIs should be used with caution in patients receiving concomitant anticoagulants, drugs affecting platelet function (e.g., atypical antipsychotics, phenothiazines, tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs, dipyridamole, and ticlopidine), and in patients with a predisposition to bleeding.

Electroconvulsive therapy (ECT)

Clinical experience with the concomitant use of SSRIs and ECT is limited; therefore, caution is recommended.

Reversible, selective monoamine oxidase A inhibitors (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 using escitalopram concomitantly with serotonergic agents such as sumatriptan or other triptans, tramadol, and tryptophan.

Cases of serotonin syndrome have been reported in patients taking SSRIs concomitantly with serotonergic drugs. Escitalopram should be used with caution when combined with serotonergic medications. The combination of symptoms such as agitation, tremor, myoclonus, 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 increase the frequency of adverse reactions.

Discontinuation symptoms

Discontinuation symptoms upon cessation of treatment, especially abrupt discontinuation, are common. In clinical trials, adverse reactions during discontinuation occurred in approximately 25% of patients treated with escitalopram and in 15% of patients receiving placebo.

The risk of discontinuation 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, 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 be more prolonged (2–3 months or longer) in some patients. Therefore, it is recommended to gradually discontinue escitalopram treatment by tapering the dose over several weeks or months, depending on the patient's condition.

Sexual dysfunction

SSRIs/SNRIs may cause symptoms of sexual dysfunction (see section "Adverse reactions"). There have been reports of persistent sexual dysfunction, with symptoms persisting for a prolonged period despite discontinuation of SSRIs/SNRIs.

Ischaemic heart disease

Due to limited clinical experience, caution is recommended when using escitalopram 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.

Caution is recommended when using escitalopram in patients with marked bradycardia or those with recent acute myocardial infarction or uncompensated heart failure. Electrolyte imbalances such as hypokalaemia and hypomagnesaemia increase the risk of developing 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 develop during escitalopram treatment, therapy should be discontinued and an ECG should be performed.

Closed-angle glaucoma

SSRIs, including escitalopram, may affect pupil size, leading to mydriasis.

This mydriatic effect may potentially narrow the anterior chamber angle of the eye, thereby increasing intraocular pressure and triggering 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.

This medicinal product contains sodium croscarmellose – 1.30 mg per 5 mg tablet; 2.60 mg per 10 mg tablet; 5.20 mg per 20 mg tablet. Caution is advised when administering to patients on a sodium-restricted diet.

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 a careful evaluation of risks and benefits has clearly demonstrated the necessity of treatment.

Newborns whose mothers have taken escitalopram during pregnancy, particularly in the third trimester, should be carefully monitored.

Observational data indicate an increased risk (less than 2-fold) of postpartum haemorrhage following escitalopram use within one month of delivery (see sections "Special precautions for use" and "Adverse reactions").

Newborns whose mothers have taken 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 irritability, lethargy, 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 have shown that the use of SSRIs during pregnancy may increase the risk of persistent pulmonary hypertension in newborns (up to 5 cases per 1000 pregnancies, based on observational data). In the general population, the incidence is 1 to 2 cases per 1000 pregnancies.

Since escitalopram is excreted in breast milk, breastfeeding is not recommended during treatment.

Fertility

Animal studies have shown that some SSRIs may affect sperm quality. Reports on the use of certain SSRIs in humans suggest 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 cognitive or psychomotor functions, any psychoactive drug may impair skills or the ability to make prudent judgements. Patients should be warned about the potential risk of impaired ability to drive or operate machinery.

Dosage and Administration

The safety of doses exceeding 20 mg per day has not been established.

Recita is administered orally once daily to adults, independent of food intake.

Major Depressive Episode

The usual dose is 10 mg once daily. Depending on individual patient sensitivity, the daily dose may be increased up to the maximum of 20 mg.

Antidepressant effect usually occurs within 2–4 weeks. After symptom remission, treatment should be continued for at least 6 months to consolidate the therapeutic effect.

Panic Disorders, with or without Agoraphobia

An initial dose of 5 mg (administered in corresponding dosage form) once daily is recommended during the first week before increasing the dose to 10 mg daily. The dose may be further increased up to the maximum of 20 mg daily, depending on individual patient sensitivity.

Maximum therapeutic effect in treating panic disorders is achieved within 3 months. The duration of treatment is several months and depends on the severity of the condition.

Social Anxiety Disorders (Social Phobia)

The usual dose is 10 mg once daily. Depending on individual patient sensitivity, the daily dose may be increased up to the maximum of 20 mg daily.

Symptom improvement usually occurs within 2–4 weeks of treatment. Treatment should be continued for 3 months to consolidate the effect. Long-term treatment for 6 months has been shown to prevent relapse and may be prescribed individually; benefits of continued treatment should be regularly evaluated.

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 daily.

Treatment should be continued for 3 months to consolidate the effect. Long-term treatment for 6 months has been shown to prevent relapse and may be prescribed individually; benefits of continued treatment 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 daily. 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 (administered in corresponding dosage form). Depending on individual sensitivity and severity of depression, the daily dose may be increased up to the maximum of 10 mg daily.

Renal Impairment

No dosage adjustments are required in mild to moderate renal impairment. Recita 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 daily. Depending on individual patient response, the dose may be increased to 10 mg daily.

Reduced CYP2C19 Isoenzyme Activity

For patients with poor CYP2C19 isoenzyme activity, the recommended initial dose during the first two weeks of treatment is 5 mg daily. Depending on individual patient response, the dose may be increased to 10 mg daily.

Discontinuation of Treatment

When discontinuing treatment with Recita, the dose should be gradually reduced over 1–2 weeks to avoid potential withdrawal symptoms.

Children

Antidepressants are contraindicated for use in children. In clinical trials, suicidal behavior (suicide attempts and suicidal thoughts) and hostility (predominantly aggression, oppositional behavior, and anger) were observed more frequently in children receiving antidepressants compared to those receiving placebo. If a decision to prescribe is made based on clinical judgment, careful monitoring for emergence of suicidal symptoms is necessary.

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 were reported. Fatal outcomes following escitalopram overdose are rare and mostly involve concomitant overdose with other medications. Doses of escitalopram ranging from 400 to 800 mg have not caused severe symptoms.

Symptoms. Signs of escitalopram overdose primarily involve the central nervous system (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, arrhythmias), and fluid/electrolyte imbalances (hypokalemia, hyponatremia).

Treatment. There is no specific antidote. Maintain adequate respiratory function and ensure proper oxygenation. Gastric lavage and activated charcoal may be considered. 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 therapy.

Blood and lymphatic system disorders: thrombocytopenia.

Immune system disorders: anaphylactic reactions.

Endocrine system disorders: syndrome of inappropriate antidiuretic hormone secretion.

Metabolism and nutrition disorders: decreased or increased appetite, weight gain, weight loss, hyponatremia, anorexia.

Psychiatric disorders: anxiety, restlessness, abnormal dreams, decreased libido in men and women, anorgasmia in women, bruxism, agitation, nervousness, panic attacks, confusion, aggression, depersonalization, hallucinations, mania, suicidal behaviour¹.

Nervous system disorders: insomnia, somnolence, dizziness, paraesthesia, tremor, taste disturbance, sleep disorders, syncope, serotonin syndrome, dyskinesia, movement disorders, seizures, psychomotor agitation/akathisia², headache.

Eye disorders: mydriasis, blurred vision.

Ear and labyrinth disorders: tinnitus.

Cardiac disorders: tachycardia, bradycardia, QT interval prolongation on ECG, orthostatic hypotension, ventricular arrhythmia (including torsade de pointes).

Respiratory system disorders: 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, angioedema.

Musculoskeletal and connective tissue disorders: arthralgia, myalgia.

Renal and urinary disorders: urinary retention.

Reproductive system and breast disorders: males – ejaculation disorders, impotence, priapism; females – metrorrhagia, menorrhagia; galactorrhoea, postpartum haemorrhage (frequency unknown)³.

General disorders: fatigue, pyrexia, oedema.

Notes:

¹ Cases of suicidal thoughts and behaviour have been reported during treatment with escitalopram or shortly after discontinuation.

² Such cases are known for all medicinal products within the entire SSRI class.

³ This reaction has been reported for the therapeutic class of SSRIs/SNRIs (see sections "Special precautions for use" and "Use during pregnancy or breastfeeding").

Cases of QT interval prolongation and ventricular arrhythmia, including torsade de pointes, have been reported during escitalopram 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 (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 of this phenomenon is unknown.

Withdrawal symptoms

Discontinuation of SSRIs (especially abrupt discontinuation) typically 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 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 to gradually discontinue escitalopram treatment by dose tapering.

Shelf life. 3 years.

Storage conditions.

Store in a light-protected place at a temperature not exceeding 25°C. Keep out of the reach of children.

Packaging.

14 tablets in a blister pack. 2 blisters in a cardboard carton.

Prescription status.

Prescription only.

Manufacturer.

Ipca Laboratories Limited.

Manufacturer's address and place of business.

Plot No. 255/1, Village – Atal, U.T. Dadra and Nagar Haveli, 396230 Silvassa, India.