Sanzipam - instructions for use, dose, side effects, contraindications

Excipients: lactose 47.65 mg / 85.88 mg / 181.76 mg, microcrystalline cellulose 5.00 mg / 10.00 mg / 20.00 mg, corn starch 10.00 mg / 20.00 mg / 40, 00 mg, copovidone 1.50 mg / 3.00 mg / 6.00 mg, talc 1.50 mg / 3.00 mg / 6.00 mg, magnesium stearate 0.75 mg / 1.50 mg / 3.00 mg, silicon dioxide colloid - 0.40 mg / 0.75 mg / 1.50 mg, croscarmellose sodium - 2.70 mg / 5.00 mg / 10.00 mg, iron coloration yellow oxide (E172) - 0.10 mg / 0.10 mg / 0.20 mg;

composition of the shell: hypromellose-2910 1.25 mg / 2.50 mg / 5.00 mg, macrogol-6000 0.25 mg / 0.50 mg / 1.00 mg, titanium dioxide (E171) 0.10 mg / 0 , 25 mg / 0.50 mg, iron oxide, yellow oxide (E172) 0.20 mg / 0.20 mg / 0.20 mg, talc 0.40 mg / 0.75 mg / 0.50 mg.

Description:Round biconvex tablets covered with a film membrane, yellow, with a risk on one side.

Pharmacotherapeutic group:antidepressant

ATX: & nbsp

N.06.A.B.10 Escitalopram

Pharmacodynamics:

Antidepressant, selective serotonin reuptake inhibitor (SSRI). Inhibition of serotonin reuptake leads to an increase in the concentration of this neurotransmitter in the synaptic cleft, enhances and prolongs its effect on receptors of the postsynaptic membrane.

Escitalopram does not have at all or has a very weak ability to bind to a number of receptors, including: serotonin 5-HT_1A-, 5-HT₂-receptors, dopamine D₁- and D₂-receptors, α₁-, α₂-, β-adrenergic receptors, histamine H₁receptors, muscarinic cholinergic receptors, benzodiazepine and opioid receptors.

Pharmacokinetics:

Suction

Absorption is not dependent on food intake. Bioavailability of escitalopram is about 80%. The mean time to reach the maximum concentration in the blood plasma (T_mOh) is about 4 hours.

Distribution

The binding of escitalopram and its major metabolites with blood plasma proteins is below 80%. Apparent volume of distribution (V_{d, β}/ F) after oral administration is from 12 to 26 l / kg.

Metabolism

Escitalopram is metabolized in the liver to demethylated and demodetylated metabolites, which are pharmacologically active. The main substance and its metabolites are partially derived in the form of glucuronides.

After repeated use, the average concentration of demethyl- and didemethyl metabolites is usually 28-31% and less than 5%, respectively, of the concentration of escitalopram. Biotransformation of escitalopram to the demethylated metabolite occurs mainly with the participation of the isoenzyme CYP2C19. Some participation of isoenzymes is possible CYP3A4 and CYP2D6.

Excretion

The half-life (T_1/2) is about 30 hours. Clearance for oral administration (Cl_{oga |}) is about 0.6 l / min. The main metabolites of escitalopram T_1/2more prolonged. Escitalopram and its main metabolites are excreted by the liver (the metabolic pathway) and the kidneys. Most of it is excreted in the form of metabolites with urine.

The kinetics of escitalopram are linear.

The equilibrium concentration (C_ss) is reached after about 1 week. Average C_ss 50 nmol / l (20 to 125 nmol / l) is achieved with a daily dose of 10 mg.

Pharmacokinetics in special clinical cases

In elderly patients (over 65 years)

In the elderly (over 65) escitalopram is slower than in younger patients. The amount of the substance in the systemic circulation, calculated using the pharmacokinetic indicator "area under the concentration-time curve" (AUC) in the elderly is 50% greater than in young healthy volunteers (see section "Method of administration and dose").

Decreased liver function

In patients with mild to moderate liver cirrhosis (classes A and B on the Child-Pugh scale), the half-life of escitalopram is approximately twice as long, a AUC approximately 60% higher than in patients with normal liver function (see section "Method of administration and dose").

Decreased kidney function

In patients with reduced renal function (creatinine clearance (CL_cr 10-53 ml / min)) there is an elongation of the half-life and a slight increase AUC, in comparison with racemic citalopram.The concentration of metabolites in the blood plasma was not determined, but it is also likely to increase (see the section "Dosing and Administration").

Patients with low isoenzyme activity CYP2C19

In individuals with low isoenzyme activity CYP2C19 the concentration of escitalopram is 2 times higher than in cases with high activity of this isoenzyme.

Significant changes in drug concentration in cases with low isoenzyme activity CYP2D6 was not found.

Indications:

- Depressive disorders of any severity;

- panic disorders (including with agoraphobia);

- social anxiety disorder (social phobia);

- generalized anxiety disorder.

Contraindications:

Hypersensitivity to the active ingredient or any other component of the drug, lactase deficiency, lactose intolerance, glucose-galactose malabsorption, childhood and adolescence (up to 18 years), simultaneous treatment with nonselective irreversible monoamine oxidase inhibitors (MAOI) in connection with the risk of developing serotonin syndrome, , tremor, hyperthermia.

Combination treatment with escitalopram and reverse MAOI type A (eg, moclobemide) or inverse non-selective MAOI (linezolid) is also contraindicated in connection with the risk of developing serotonin syndrome.

If you know about the patient's lengthening interval QT or congenital syndrome of long QT, the drug is contraindicated to be used together with drugs that extend the interval QT.

Simultaneous treatment with pimozide.

Carefully:

- Presence of drug dependence (including in the anamnesis);

- marked renal failure (creatinine clearance (CC) below 30 ml / min);

- manic disorders;

- convulsive disorders;

- pharmacologically uncontrolled epilepsy;

- pronounced suicidal behavior;

- diabetes;

- cirrhosis of the liver;

- propensity to bleed;

- simultaneous reception with serotonergic drugs; drugs that reduce the threshold of convulsive readiness; lithium, tryptophans, drugs containing St. John's wort; oral anticoagulants and drugs that affect blood clotting; drugs that cause hyponatraemia; ethanol; drugs metabolized with the participation of isoenzyme CYP2C19;

- electroconvulsive therapy;

- elderly age.

Pregnancy and lactation:

Pregnancy

To date, there are limited data on the use of escitalopram during pregnancy.

Studies in animals have shown reproductive toxicity. For this reason, the drug should not be given to pregnant women, except in cases of emergency and only after a thorough analysis of the risk / benefit ratio.

It is necessary to observe the development of the fetus in pregnant women who continue to receive escitalopram in later terms of pregnancy, especially in the third trimester. Avoid sudden discontinuation of the drug during pregnancy.

In newborns whose mothers took SSRIs / SSRIs late in pregnancy, the following symptoms may occur: respiratory failure, cyanosis, apnea, convulsions, temperature jumps, feeding difficulties, vomiting, hypoglycemia, hypertension, hypotension, hyperreflexia, tremor, reflex excitability, irritability, lethargy, constant crying, drowsiness and bad sleep. These symptoms may be a manifestation of serotonergic effects or a symptom of "withdrawal."In most cases, such complications occur immediately or within a short time (<24 hours) after delivery.

Epidemiological data have shown that the use of SSRIs during pregnancy, especially late in pregnancy, may increase the risk of developing persistent pulmonary hypertension in newbornsPPHN). There were approximately 5 cases per 1000 pregnancies. In the general population, there were 1 to 2 cases PPHN for 1000 pregnancies.

Lactation

Escitalopram penetrates into breast milk. Escitalopram should not be given to nursing mothers. During the period of breastfeeding, the drug should be immediately discontinued.

Dosing and Administration:

Inside, regardless of food intake.

Depressive disorders: 10 mg once a day. Depending on the individual reaction of the patient, the dose may be increased to a maximum of 20 mg / day. The antidepressant effect usually develops in 2-4 weeks after the start of treatment. After the disappearance of the symptoms of depression, it is necessary to continue therapy to fix the effect for 6 months.

Panic disorders (including with agoraphobia): 5 mg / day during the first week of treatment, then 10-20 mg / day. The maximum daily dose is 20 mg. The maximum therapeutic effect is achieved approximately 3 months after the start of treatment. Duration of treatment is several months.

When social anxiety disorder (social phobia) prescribe 10 mg 1 time / day. Symptom weakening usually develops 2-4 weeks after the start of treatment. Depending on the individual reaction of the patient, the dose can subsequently be reduced to 5 mg / day or increased to a maximum of 20 mg / day.

Because social anxiety disorder is a disease with chronic course, the minimum recommended duration of a therapeutic course is 12 weeks. To prevent recurrence of the disease, the drug can be administered for 6 months or longer, depending on the individual reaction of the patient.

When generalized anxiety disorder the recommended initial dose is 10 mg 1 time / day. Depending on the individual reaction of the patient, the dose can be increased to a maximum of 20 mg / day. Long-term administration of the drug (6 months and longer) is possible at a dose of 20 mg / day.

In elderly patients (over 65 years of age) it is recommended to use half of the usually recommended dose (ie, only 5 mg / day) and a lower maximum dose (10 mg / day).

When renal failure light and moderate severity of dose correction is not required.

Patients with severe renal insufficiency (CC <30 mL / min) the drug should be administered with minimal doses, gradually increasing them taking into account portability and effectiveness.

When mild to moderate hepatic impairment the recommended initial dose for the first 2 weeks of treatment is 5 mg / day. Depending on the individual response to treatment, the dose may be increased to 10 mg / day.

With reduced isoenzyme activity CYP2C19 the recommended initial dose for the first 2 weeks of treatment is 5 mg / day. Depending on the individual response to treatment, the dose may be increased to 10 mg / day.

At the end of treatment, the dose should gradually decrease within 1-2 weeks in order to avoid the occurrence of a "withdrawal syndrome".

Side effects:

Side effects occur most often in the first or second week of treatment, then usually become less intense and occur less frequently with continued therapy.

The following side effects associated with the administration of escitalopram are distributed according to the frequency of occurrence in accordance with the following gradation: very often (≥ 1/10), often (from ≥ 1/100 to <1/10), infrequently (from ≥ 1/1000 up to <1/100), rarely (from ≥ 1/10000 to <1/1000), very rarely (<1/10000), or unknown (the frequency of occurrence can not be estimated from the available data).

From the blood and lymphatic system: unknown - thrombocytopenia.

From the immune system: rarely anaphylactic reactions.

From the endocrine system: unknown - a violation of secretion antidiuretic hormone (ADH).

Metabolic disorders and eating disorders: often - decreased or increased appetite, weight gain; infrequently - weight loss; unknown hyponatremia, anorexia.

From the side of the psyche: often - anxiety, anxiety, unusual dreams, decreased libido, anorgasmia (in women); infrequently - bruxism, agitation, nervousness, panic attacks, confusion; rarely - aggression, hallucinations, depersonalization; unknown - mania, suicidal thoughts, suicidal behavior. Cases of the appearance of suicidal thoughts and behavior were noted when taking escitalopram and immediately after the abolition of therapy.

From the nervous system: very often - headache, often - insomnia, drowsiness, dizziness, paresthesia, tremor; infrequently - disorders of taste sensations, sleep disturbance, syncopal conditions; rarely - serotonin syndrome; unknown - dyskinesia, motor disorders, convulsive disorders, psychomotor agitation / akathisia.

From the side of the organ of vision: infrequently - mydriasis (dilated pupil), visual impairment.

From the side of the hearing organ and labyrinthine disorders: infrequently - tinnitus (ringing in the ears).

From the cardiovascular system: infrequently - tachycardia, rarely - bradycardia; unknown - interval lengthening QT on an electrocardiogram, ventricular arrhythmia, including arrhythmia torsade de pointes, orthostatic hypotension.

From the respiratory system, chest and mediastinum: often sinusitis, yawning; infrequently - epistaxis.

From the gastrointestinal tract: very often - nausea; often - diarrhea, constipation, vomiting, dry mouth; infrequently - gastrointestinal bleeding (including rectal bleeding).

From the liver and bile ducts: unknown - hepatitis, impaired liver function.

From the skin and subcutaneous tissue: often - increased sweating; infrequently - a rash, alopecia, hives, itching; unknown - ecchymosis, angioedema.

From the side of the musculoskeletal and connective tissue: often - arthralgia, myalgia.

From the side of the kidneys and urinary tract: unknown - urinary retention.

On the part of the reproductive system and mammary glands: often - impotence, violation of ejaculation; infrequently metrorrhagia (uterine bleeding), menorrhagia; unknown - galactorrhea, priapism.

From the side of the body as a whole and violations in the place of administration: often - weakness, hyperthermia; rarely - swelling.

There were cases of prolongation of the QT interval and ventricular arrhythmia (including arrhythmia torsade de pointes), predominantly in female patients with hypokalemia or the previously existing QT interval elongation or other cardiac diseases.

Epidemiological studies involving patients aged 50 years and older showed the existence of an increased risk of bone fractures in patients taking SSRIs and tricyclic antidepressants. The mechanism of this risk is not established. In addition, after long-term use of drugs groupSSRI / SSRIs (selective inhibitors of norepinephrine and serotonin reuptake) a sharp discontinuation of the drug may lead to a symptom of "withdrawal". The most often can occur such undesirable reactions as dizziness, upset sensitivity (including paresthesia and sensation of passing current), sleep disorders (including insomnia and intense dreams), agitation or anxiety, nausea and / or vomiting, tremor, confusion, increased separation, headache, diarrhea, palpitation, emotional instability, irritability, visual disturbances. Usually, these effects are mild or moderate and quickly pass, however, in some patients they may manifest themselves in a more acute form and / or longer. It is recommended to gradually phase out the drug by reducing its dose.

Overdose:

Symptoms: dizziness, tremor, agitation, increased sweating, drowsiness, suppression of consciousness of varying severity, convulsions, sinus tachycardia, ECG changes (ST segment and T wave changes, QRS complex expansion, QT interval prolongation), arrhythmia,ventricular arrhythmia, cyanosis, respiratory depression, vomiting, rhabdomyolysis, metabolic acidosis, hypokalemia, rarely acute renal failure.

Treatment: there is no specific antidote. Treatment is symptomatic and supportive - gastric lavage, adequate oxygenation. Monitoring the function of the cardiovascular and respiratory systems.

Interaction:

Pharmacodynamic interaction

Prohibited combinations

Non-selective irreversible inhibitors of monoamine oxidase

Serious reactions have been reported in patients taking SSRIs in combination with nonselective irreversible MAOIs, and in patients who have recently stopped taking SSRIs and switched to therapy similar to MAOI. Rarely, patients developed serotonin syndrome.

Simultaneous use of escitalopram with nonselective irreversible MAOI is contraindicated. Treatment with escitalopram can begin no earlier than 14 days after the last application of irreversible MAOI. In turn, treatment MAOI can be started only 7 days after the end of treatment with escitalopram.

Reversible selective MAO inhibitor A (moclobemide)

Simultaneous use of escitalopram with MAOI (moclobemide) is not recommended because of the risk of serotonin syndrome. If such a combination is extremely necessary, treatment is started at the minimum recommended dose with mandatory careful clinical monitoring.

Reversible non-selective MAO inhibitor (linezolid)

Antibiotic linezolid It is not recommended to appoint patients receiving escitalopram therapy. If such a combination is extremely necessary, treatment is started at the minimum recommended dose with mandatory careful clinical monitoring.

Irreversible selective inhibitor MAO B (selegiline)

Because of the risk of serotonin syndrome, caution is needed when taking escitalopram simultaneously with selegiline (irreversible IM AO B). For the simultaneous use with racemic citalopram, safe doses of selegiline are up to 10 mg / day.

Interval lengthening QT

Pharmacokinetic and pharmacodynamic studies of escitalopram in combination with other drugs that extend the interval QT, not conducted. It is impossible to exclude the general effect of escitalopram and these drugs.Therefore, simultaneous use of escitalopram with drugs that extend the interval QT, such as antiarrhythmic drugs of class IA and III, antipsychotics (phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (for example, sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarials, in particular halofantrine), certain antihistamines (astemizole, misolastine), is contraindicated.

A combination of medications that require caution:

Serotonergic drugs

Simultaneous use of escitalopram with serotonergic drugs (eg, tramadol, sumatriptan and other triptans) may lead to the development of serotonin syndrome.

Drugs that reduce the threshold of convulsive readiness

Escitalopram can reduce the threshold of convulsive alertness. Caution is needed when concomitantly administering escitalopram and other drugs that reduce the threshold of convulsive readiness (tricyclic antidepressants, SSRIs, neuroleptics: phenothiazines, thioxanthenes and butyrophenones, mefloquine, bupropion and tramadol).

Lithium, tryptophan

Since there have been recorded cases of increased serotonergic effects in the use of SSRIs in combination with lithium or tryptophan, caution should be exercised when concomitant administration of escitalopram with these preparations.

St. John's wort perforated (Hypericum perforatum)

Simultaneous use of escitalopram and preparations containing St. John's Wort (Hypericum perforatum), may lead to an increase in the number of side effects.

Anticoagulants and other drugs that affect blood clotting

Violation of blood clotting can occur with the simultaneous use of escitalopram with oral anticoagulants and other drugs that affect blood clotting (for example, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs, ticlopidine and dipyridamole). In such cases, monitoring of indicators is necessary blood coagulation. Simultaneous reception with non-steroidal anti-inflammatory drugs can lead to an increase in the number of bleedings.

Alcohol (ethanol)

With simultaneous reception of alcohol escitalopram does not enter the pharmacodynamic or pharmacokinetic interaction.

However, as with other psychotropic drugs, simultaneous use of escitalopram and alcohol is not recommended.

Drugs that cause hypokalemia / hypomagnesemia

With the simultaneous administration of escitalopram with drugs that cause hypokalemia / hypomagnesemia, the risk of malignant arrhythmias increases.

Pharmacokinetic interactions

The effect of other drugs on the pharmacokinetics of escitalopram

Escitalopram is metabolized, mainly, with the participation of isoenzymes CYP2C19, CYP3A4 and CYP2D6.

Simultaneous use of escitalopram and omeprazole 30 mg once a day caused a moderate increase (approximately 50%) in the concentration of escitalopram in blood plasma. Simultaneous use of escitalopram and cimetidine 400 mg 2 times a day causes a moderate increase (about 70%) in the concentration of escitalopram in the blood plasma.

It is necessary to appoint with caution escitalopram concomitantly with omeprazole, esomeprolol, fluvoxamine, lansoprazole, ticlopidine).

Based on the clinical evaluation of the occurrence of side effects with simultaneous use with the above drugs may require a reduction in the dose of escitalopram.

The effect of escitalopram on the pharmacokinetics of other drugs

Escitalopram is an inhibitor of the isoenzyme CYP2D6. Caution should be exercised in the simultaneous administration of escitalopram and drugs metabolized with this isoenzyme and having a small therapeutic index, for example, flecainide, propafenone and metoprolol (in cases of heart failure) or drugs that are mainly metabolized by isoenzyme CYP2D6 and acting on the CNS, for example, antidepressants of desipramine, clomipramine, nortriptyline or antipsychotic agents risperidone, thioridazine, haloperidol.

In these cases, dose adjustment may be required, as it increases concentration of escitalopram in blood plasma. Simultaneous administration of escitalopram and desipramine or metoprolol leads to a twofold increase in the concentration of the last two drugs, which should be taken into account when choosing doses.

Escitalopram may slightly inhibit the isoenzyme CYP2C19. Therefore, caution should be exercised while using escitalopram and drugs metabolized with the participation of this isoenzyme.

Special instructions:

Escitalopram should not be given to people under 25 due to an increased risk of suicidal behavior (suicide attempts and suicidal ideation), hostility (with a predominance of aggressive behavior, a tendency to confrontation and irritability).

If the clinical situation still requires the appointment of such treatment, the patient should be carefully monitored for the timely detection of suicidal symptoms.

Paradoxical anxiety

In some patients with panic disorders, anxiety may occur at the onset of antidepressant treatment.

Such a paradoxical reaction usually disappears within 2 weeks after the initiation of therapy. To reduce the likelihood of anxiogenic effect, it is recommended to start therapy with a minimum recommended therapeutic dose.

Convulsive Pregnancy

The use of escitalopram should be discontinued if the patient develops a seizure for the first time or attacks become more frequent (in patients with established diagnosis of epilepsy). SSRIs should be avoided in patients with unstable epilepsy, and patients with controlled epilepsy must be closely monitored.

Mania

SSRIs should be used with caution in patients with a history of mania / hypomania. When a patient has a manic condition, the SSRI should be canceled.

Suicide / suicidal thoughts or clinical worsening of depressive conditions

Depression is associated with an increased risk of suicide, suicidal thoughts and self-harm (suicidal actions). This risk persists until a stable remission is achieved. As the condition improves within 2-4 weeks of treatment, patients should be carefully monitored during the first weeks of therapy. It is known that the risk of suicide may increase in the early stages of recovery.

Other mental disorders in which escitalopram, may also be associated with an increased risk of suicidal actions.In addition, these conditions can be accompanied by a large depressive disorder. Such precautions are necessary adhere to and in the treatment of other mental disorders due to the possibility of simultaneous development of a major depressive disorder.

Also, drug therapy should be accompanied by careful monitoring of patients after a dose change. Patients (and those who care for them) need to be warned about the need to monitor the manifestation of suicidal actions and seek emergency help if symptoms occur.

Serotonin syndrome

Caution should be exercised when co-administration of escitalopram and serotonergic drugs, such as sumatriptan, other substances of the triptane group, tramadol and tryptophan. However, the development of serotonin syndrome in patients receiving both serotonergic drugs and SSRIs was extremely rare.

The development of this syndrome may indicate such signs as agitation, tremor, myoclonus and hyperthermia. In this case, simultaneous reception of SSRIs and serotonergic drugs should be stopped immediately and symptomatic therapy should be started.

Akathisia and psychomotor agitation

When SSRIs were used, there were cases of development of akathisia characterized by a constant or recurring feeling of internal motor anxiety and manifested in the inability of the patient to stay in one position for a long time or to remain without movement for a long time. In most cases, these symptoms develop within a few weeks after the initiation of therapy. The increase in dose in this case is undesirable.

Diabetes

In patients with diabetes mellitus, the treatment of SSRIs can alter the glucose level in the blood. Therefore, it may be necessary to adjust the dosages of insulin and / or oral hypoglycemic drugs.

Hyponatremia

When SSRIs were used, there were cases of development of hyponatremia, which is possibly associated with a violation of the secretion of antidiuretic hormone (ADH). For this reason, SSRIs should be used with caution in appointing persons at risk of developing hyponatremia: elderly, with cirrhosis of the liver, and taking drugs that can cause hyponatraemia.

Hemorrhages

When SSRIs were used, cases of development of skin hemorrhages were observed: ecchymosis and purpura.It is necessary to use SSRIs with caution in patients with a tendency to bleeding, as well as taking oral anticoagulants and drugs that affect blood clotting (for example, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs, ticlopidine and dipyridamole).

ECT (electroconvulsive therapy)

Because clinical experience The simultaneous use of SSRIs and ECTs is limited, in such cases care should be taken.

St. John's wort perforated (Hypericum perforatum)

Simultaneous administration of escitalopram and preparations containing St. John's Wort (Hypericum perforatum), may lead to an increase in the number of side effects.

Symptoms of "cancellation"

When discontinuing treatment (especially sudden), symptoms of "cancellation" usually arise. During clinical trials, side effects associated with discontinuation of treatment were noted in approximately 25% of patients in the escitalopram group and in 15% of the placebo group.

The risk of withdrawal symptoms depends on several factors, in particular the duration of therapy, the dose, and the gradual reduction of the dose.

Dizziness, sensory disturbances (including paresthesia and sensation of electric shock), sleep disorders (including insomnia and vivid dreams), agitation or anxiety, nausea and / or vomiting, tremors, confusion, increased sweating, headache, diarrhea, tachycardia, emotional instability, irritability and visual impairment were noted as the most frequent reactions. Typically, these symptoms are mild or moderate in severity and transient, but some patients may be severe and / or prolonged. Thus, it is recommended that the use of escitalopram be gradually phased out by lowering the dose for several weeks or several months, depending on the patient's condition.

Coronary heart disease

Due to the limited clinical experience, caution is needed in the treatment of patients with coronary heart disease.

Interval lengthening QT

Determined that escitalopram causes dose-dependent lengthening of the interval QT. During the postmarketing period, cases of lengthening of the interval QT, in particular ventricular arrhythmia, predominantly in female patients with hypokalemia or pre-existing lengthening of the interval QT or other heart diseases.

It is recommended to be used with caution in patients with significant bradycardia or with recent acute myocardial infarction or uncompensated heart failure.

Electrolyte disorders, such as hypokalemia and hypomagnesemia, increase the risk of malignant arrhythmias, and they should be corrected before starting treatment with escitalopram.

In the treatment of patients with stable heart disease, ECG should be revised before treatment begins.

If there are signs of cardiac arrhythmia during treatment with escitalopram, stop treatment and make an ECG.

Closed-angle glaucoma

SSRIs, including escitalopram, can cause a dilated pupil (mydriasis). This mydriatic effect is able to narrow the angle of the eye, which increases intraocular pressure and angle-closure glaucoma, especially in patients who have previously had these diseases. For this reason escitalopram should be used with caution in patients with a closed-angle glaucoma or glaucoma in the anamnesis.

Effect on the ability to drive transp. cf. and fur:

Although escitalopram does not affect psychomotor activity, during the period of treatment it is not recommended to drive or operate machinery.

Form release / dosage:

Tablets, film-coated, 5 mg, 10 mg, 20 mg.

Packaging:

10 tablets per blister, made of PVC and aluminum foil.

For 1, 2, 3 or 5 blisters together with the instructions for use are placed in a cardboard box.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001534

Date of registration:24.02.2012

Date of cancellation:2017-02-24

The owner of the registration certificate:San Pharmaceutical Industries Co., Ltd.San Pharmaceutical Industries Co., Ltd. India

Manufacturer: & nbsp

Sun Pharmaceutical Industries, Ltd. India

Representation: & nbspSAN PHARMACEUTICAL INDUSTRIES LTD. SAN PHARMACEUTICAL INDUSTRIES LTD. India

Information update date: & nbsp04.10.2015

Illustrated instructions

Instructions

Sanctipam (SUNCIPAM)