Active substanceEscitalopramEscitalopram
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  • Dosage form: & nbspfilm-coated tablets
    Composition:1 tablet, film-coated, contains:

    active substance: escitalopram oxalate 6.39 mg / 12.77 mg / 25.54 mg, equivalent to 5 mg / 10 mg / 20 mg escitalopram.

    Excipients: talc 5.04 mg / 7.0 mg / 14.0 mg, croscarmellose sodium 3.24 mg / 4.5 mg / 9.0 mg, microcrystalline cellulose ~ 72.94 mg / ~ 97.49 mg / ~ 195, 0 mg, silicon colloidal dioxide ~ 1.49 mg / ~ 1.99 mg / ~ 3.98 mg, magnesium stearate 0.9 mg / 1.25 mg / 2.5 mg;

    shell: hypromellose 5sP 1.58 mg / 2.19 mg / 3.51 mg, macrogol 400 0.146 mg / 0.20 mg / 0.325 mg, titanium dioxide (E 171) 0.526 mg / 0.73 mg / 1.17 mg.

    Description:

    5 mg: round, biconvex tablets coated with a film coating, white, marked "EK".

    10 mg: oval, biconvex tablets, film-coated, white with a risk and labeled "E" and "L"symmetrically around the risks.

    20 mg: oval, biconvex tablets, film-coated, white with a risk and labeling "E" and "N" symmetrically around the risks.
    Pharmacotherapeutic group:antidepressant
    ATX: & nbsp

    N.06.A.B.10   Escitalopram

    Pharmacodynamics:

    Escitalopram is an antidepressant, a selective serotonin reuptake inhibitor (SSRI) with a high affinity for the primary binding site. Escitalopram also binds to the allosteric binding site of the transporter protein, with a smaller affinity, a thousandfold. Allosteric modulation of the transporter protein enhances the binding of escitalopram in the primary, binding site, which leads to a more complete inhibition of serotonin reuptake.

    Escitalopram does not have at all or has a very weak ability to bind to a number of receptors, including: serotonin 5-HT1A, 5-HT2 receptors, dopamine D1 and D2 receptors, α1-, α2-, β-adrenergic receptors, histamine H1, muscarinic cholinergic, benzodiazepine and opiate receptors.

    Pharmacokinetics:

    Absorption is almost complete and does not depend on food intake. The mean time to reach the maximum concentration in the blood plasma (TmOh) is 4 hours after repeated use. Absolute bioavailability of escitalopram is about 80%.

    Apparent volume of distribution (Vd,β/F) after oral administration is from 12 to 26 l / kg. The binding of escitalopram and its major metabolites with blood plasma proteins is below 80%. Escitalopram is metabolized in the liver to demethylated and demodetylated metabolites. They are both pharmacologically active. Nitrogen can be oxidized to a metabolite Noxide. The basic substance and its metabolites are partially isolated in the form of glucuronides. After repeated use, the average concentration of demethyl- and didemetyl metabolites is usually 28-31% and less than 5%, respectively, of the concentration of escitalopram. Biotransformation of escitalopram to the demethylated metabolite occurs mainly through the use of an isoenzyme CYP2C19.Some participation of isoenzymes is possible CYP3A4 and CYP2D6. In persons with a weak isoenzyme activity CYP2C19 the concentration of escitalopram is twice as high as in cases with high activity of this isoenzyme. Significant changes in drug concentration in cases with a weak isoenzyme activity CYP2D6 was not found.

    The half-life (T1/2) after repeated use is about 30 hours. Oral clearance (Cloral) is about 0.6 l / min. The main metabolites of escitalopram have a longer half-life. Escitalopram and its major 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 is reached after about 1 week. An average equilibrium concentration of 50 nmol / L (20 to 125 nmol / L) is achieved at a daily dose of 10 mg.

    In the elderly (over 65) escitalopram is excreted more slowly than in younger patients. The amount of material in the systemic circulation, calculated using the pharmacokinetic indicator "area under the curve" (AUC) in the elderly is 50% more than in young healthy volunteers.

    Indications:

    - Depressive episodes of any severity;

    - panic disorder with / without agoraphobia;

    - social anxiety disorder (social phobia);

    generalized anxiety disorder;

    - obsessive-compulsive disorder.

    Contraindications:

    - Hypersensitivity to escitalopram and other components of the drug;

    - simultaneous reception of nonselective irreversible monoamine oxidase inhibitors (MAO);

    - simultaneous administration of pimozide;

    - children and adolescents (under 18 years of age) (efficacy and safety of use not confirmed).

    Carefully:

    Severe renal insufficiency (creatinine clearance (CK) below 30 ml / min), mania and hypomania, pharmacologically uncontrolled epilepsy, pronounced suicidal behavior, diabetes mellitus, cirrhosis, tendency to bleeding; simultaneous administration with an inhibitor of MAO A (moclobemide) and an MAO B inhibitor (selegiline); 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 coagulability; drugs that can cause hyponatraemia; drugs metabolized with the participation of isoenzyme CYP2C19; ethanol; electroconvulsive therapy; elderly age; pregnancy, the period of breastfeeding.

    Pregnancy and lactation:

    There are limited data on the use of escitalopram during pregnancy.

    Studies of escitalopram in animals have demonstrated reproductive toxicity. Escitalopram during pregnancy should be taken only in cases of emergency and after a thorough assessment of the benefit / risk ratio.

    If the use of escitalopram lasted late in pregnancy, especially in the third trimester, then a newborn should be monitored. In the event that escitalopram treatment was continued until delivery or was discontinued shortly before delivery, the development of withdrawal symptoms may develop in a newborn.

    In the case of the mother of SSRIs / SSRIs in late pregnancy, the following side effects may develop in the newborn; respiratory depression, cyanosis, apnea,convulsive disorders, temperature jumps, difficulty with feeding, vomiting, hypoglycemia, hypertension, muscle hypotension, hyperreflexia, tremor, increased nervous reflex excitability, irritability, lethargic sleep, constant crying, drowsiness, poor soy. These symptoms can occur due to the development of the syndrome of "withdrawal" or serotonergic action. In most cases, such complications occur within 24 hours of birth. Data from epidemiological studies suggest that the use of SSRIs during pregnancy, especially in later life, may increase the risk of developing persistent pulmonary hypertension in newborns (PPIIN). The observed risk was about 5 cases per 1000 pregnancies. In the general population there are 1-2 cases of PPHN per 1000 pregnancies.

    Expected that escitalopram will be excreted in breast milk, so during treatment with escitalopram, breast-feeding is not recommended.

    Animal studies have shown that some SSRIs can affect sperm quality. There are no data of studies of this aspect on animals for escitalopram.

    Reports on the use of certain SSRIs in humans have shown that the effect of these drugs on the quality of sperm is reversible. So far, the effects of escitalopram on fertility in humans have not been observed.

    Dosing and Administration:

    Cipralex is administered orally once a day, regardless of food intake.

    Depressive episodes

    Usually prescribe 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, at least for another 6 months, it is necessary to continue therapy to fix the effect.

    Panic disorder with or without agoraphobia

    During the first week of treatment, a dose of 5 mg / day is recommended, which is then increased to 10 mg / day. Depending on the individual patient's reaction dose can be increased to a maximum of 20 mg / day.

    The maximum therapeutic effect is achieved approximately 3 months after the start of treatment.

    The therapy lasts for several months.

    Social anxiety disorder (social phobia)

    Usually prescribe 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.

    Symptom weakening usually develops 2-4 weeks after the start of treatment.

    Since social anxiety disorder is a disease with chronic course, the minimum recommended duration of the therapeutic course is 3 months. To prevent relapses The drug may be given for 6 months or longer depending on the individual reaction of the patient. It is recommended to regularly evaluate the treatment.

    Generalized anxiety disorder

    Usually prescribe 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 minimum recommended duration of the therapeutic course is 3 months. To prevent recurrence of the disease, prolonged use of the drug (6 months and longer) is allowed. It is recommended to regularly evaluate the treatment.

    Obsessive-Compulsive Disorder

    Usually prescribe 10 mg once a day.Depending on the individual reaction of the patient, the dose can subsequently be increased to a maximum - 20 mg / day.

    Because obsessive-compulsive disorder is a disease with chronic course, treatment should be long enough to ensure complete relief from symptoms and last at least 6 months. To prevent relapse, treatment is recommended for at least 1 year.

    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).

    Children and adolescents (under 18 years of age)

    Cipralex should not be used in children and adolescents under the age of 18 (see section "Special instructions"). In addition, there is insufficient evidence of long-term safety studies in children and adolescents regarding growth, maturation, cognitive and behavioral development.

    Decreased kidney function

    With mild and moderate renal failure, dose adjustments are not required. Patients with severe renal insufficiency (QC below 30 ml / min) should be given Cipralex with caution.

    Decreased liver function

    The recommended initial dose for the first two weeks of treatment is 5 mg / day. Depending on the individual reaction of the patient, the dose may be increased to 10 mg / day.

    Reduced activity of the isoenzyme CYP2C19

    For patients with a weak activity of the isoenzyme CYP2C19, the recommended initial dose for the first two weeks of treatment is 5 mg / day. Depending on the individual reaction of the patient, the dose may be increased to 10 mg / day.

    Discontinuation of treatment

    When discontinuing treatment with Cipralex, the dose should be reduced gradually within 1-2 weeks to avoid the occurrence of the "withdrawal" syndrome.

    Side effects:

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

    The following side effects occur when taking drugs belonging to the class of SSRIs and noted when taking escitalopram. The information is presented on the basis of data from placebo-controlled clinical trials and spontaneous reports. The frequency is indicated as: very often (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1/100),rarely (from ≥1 / 10000 to <1/1000), very rarely (<1/10000), or unknown (the frequency of occurrence can not be estimated based on existing data).

    From the side of the blood and lymphatic system: unknown - thrombocytopenia.

    From the immune system: rarely anaphylactic reactions.

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

    Metabolic disorders and eating disorders: often - decreased appetite, 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, depersonalization; hallucinations; 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: often - insomnia, drowsiness, dizziness, paresthesia, tremor; infrequently - a violation of taste, sleep disturbance,syncopal states; rarely - serotonin syndrome; unknown - dyskinesia, motor disorders, convulsive disorders, psychomotor agitation / akathisia.

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

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

    From the side of the cardiovascular system: infrequently - tachycardia; rarely - bradycardia; unknown - prolongation of QT interval on electrocardiogram, orthostatic hypotension.

    On the part of the respiratory system, the organs of the thorax and the 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 tissues: often - increased sweating; infrequently - hives, alopecia, rash, 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.

    From the reproductive system and breast: 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.

    During the post-registration period cases of lengthening of the interval QT, mainly in patients with pre-existing heart disease. In double-blind, placebo-controlled studies of ECG in healthy volunteers, the change from baseline QTc (correction according to Friderichia's formula), was 4.3 msec at a dose of 10 mg / day and 10.7 msec at 30 mg / day.

    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.

    The abolition of SSRI / SSRIs (selective norepinephrine and serotonin reuptake inhibitors) (especially severe) often leads to withdrawal symptoms. Most often there is dizziness,sensitivity disorders (including paraesthesia and sensations of the current passage), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and / or vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual disturbances. As a rule, these effects are mild or moderate, and pass quickly, but they can manifest themselves in a more acute form and / or longer in some patients. It is recommended to gradually phase out the drug by reducing its dose.

    Overdose:

    Data on escitalopram overdose are limited, in many such cases there was an overdose of other drugs. In most cases, the symptoms of overdose do not manifest or manifest themselves poorly. Cases escitalopram overdose (without taking other drugs) deaths are rare in most cases there is also an overdose and other drugs.

    Symptoms

    In case of an overdose of escitalopram, symptoms mainly arise from the central nervous system (from dizziness,tremor and agitation up to rare cases of development of serotonin syndrome, convulsive disorders and coma), gastrointestinal tract (nausea / vomiting), cardiovascular system (hypotension, tachycardia, lengthening interval QT and arrhythmia) and electrolyte imbalance (hypokalemia, hyponatremia).

    Treatment

    There is no specific antidote. It is necessary to ensure normal airway patency, oxygenation and ventilation of the lungs. It is necessary to wash the stomach and appoint Activated carbon. Gastric lavage should be carried out as soon as possible after taking the drug. It is recommended to monitor the performance of the heart and other vital organs and conduct symptomatic and supportive therapy.

    Interaction:

    Pharmacodynamic interaction

    Non-selective irreversible MAO inhibitors

    There have been reports of serious adverse reactions with simultaneous / SSRIs and nonselective irreversible MAO inhibitors, as well as with the onset of taking MAO inducers with patients who had recently stopped taking SSRIs. In some cases, patients developed serotonin syndrome.

    Use, escitalopram simultaneously with nonselective irreversible MAO inhibitors is prohibited. The use of escitalopram can be started 14 days after the cancellation of the intake of irreversible MAO inhibitors. Before starting the intake of nonselective irreversible MAO inhibitors should be at least 7 days after the end of the escitalopram.

    Reversible selective MAO inhibitor A (moclobemide)

    Because of the risk of developing serotonin syndrome, it is not recommended to use escitalopram simultaneously with the MAO A inhibitor moclobemide. In the event that the reception of such a combination of drugs is clinically necessary, it is recommended to start with the lowest possible doses, as well as to conduct constant clinical monitoring of the patient's condition. The use of escitalopram can begin at least one day after the reversal of the reversible MAO A inhibitor of moclobemide.

    Irreversible inhibitor MAO B (selegiline)

    Because of the risk of developing serotonin syndrome, caution should be exercised when taking escitalopram simultaneously with an irreversible MAO inhibitor in selegiline.

    Serotonergic drugs

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

    Drugs that reduce the threshold of convulsive readiness SSRIs can reduce the threshold of convulsive alertness. Care should be taken when using other drugs that reduce the threshold of convulsive readiness (tricyclic antidepressants, SSRIs, antipsychotics (neuroleptics) - derivatives of phenothiazine, thioxanthene and butyrophenone, mefloquine, bupropion and tramadol) with escitalopram.

    Lithium, tryptophan

    Since there have been reported cases of increased effects with the simultaneous use of SSRIs and lithium or tryptophan, caution should be exercised when concomitantly using escitalopram with these drugs.

    St. John's wort perforated

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

    Anticoagulants and agents that affect blood coagulability

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

    Pharmacokinetic interaction

    The effect of other drugs on the pharmacokinetics of escitalopram

    Metabolism of escitalopram is mainly carried out with the participation of isoenzyme CYP2C19. To a lesser extent, isozymes may participate in the metabolism CYP3A4 and CYP2D6. Metabolism of the main metabolite - demethylated escitalopram - is apparently partially catalyzed by the isoenzyme CYP2D6.

    Simultaneous use of escitalopram and omeprazole (inhibitor of isoenzyme CYP2C19) leads to a moderate (approximately 50%) increase in the concentration of escitalopram in blood plasma.

    Simultaneous administration of escitalopram and cimetidine (inhibitor of isoenzymes CYP2D6, CYP3A4 and CYP1A2) leads to an increase (approximately 70%) of the concentration of escitalopram in the blood plasma.

    Thus, to apply the maximum possible doses of escitalopram simultaneously with inhibitors of isoenzyme CYP2C19 (e.g., omeprazole, fluoxetine, fluvoxamine, lansoprazole, ticlopidine) and cimetidine with caution. With simultaneous administration of escitalopram and the above drugs, a dose reduction of escitalopram may be required based on the clinical evaluation.

    The effect of escitalopram on the pharmacokinetics of other drugs

    Escitalopram is an inhibitor of the isoenzyme CYP2D6. Care should be taken when using escitalopram and drugs metabolized with this isoenzyme and having a small therapeutic index, for example, flecainide, propafenone and metoprolol (in cases of use in heart failure) or medical preparations, mainly metabolized by CYP2D6 and acting on the central nervous system, for example, antidepressants: desipramine, clomipramine, nortriptyline or antipsychotics: risperidone, thioridazine, haloperidol. In these cases, dose adjustment may be required.

    Simultaneous use of escitalopram and desipramine or metoprolol leads to a twofold increase in the concentration of the last two drugs.

    Escitalopram may slightly inhibit the isoenzyme CYP2C19. Therefore, caution should be exercised when concomitant use of escitalopram and drugs metabolized by isoenzyme CYP2C19.

    Special instructions:

    Antidepressants should not be given to children and adolescents under the age of 18 because of the increased risk of suicidal behavior (suicide attempts and suicidal ideation), hostility (with a predominance of aggressive behavior, a tendency to confrontation and irritation). If a decision is made on the basis of a clinical evaluation to initiate antidepressant therapy, the patient should be carefully monitored.

    When using drugs belonging to the therapeutic group of SSRIs, including escitalopram, the following should be considered.

    Some patients with panic disorder may experience anxiety at the onset of antidepressant treatment. A similar paradoxical reaction usually disappears during the first two weeks of treatment. To reduce the likelihood of an anxiogenic effect, it is recommended to use low initial doses.

    It should be canceled escitalopram in the case of primary development of convulsive seizures or in the case of an increase in their frequency (in patients with previously diagnosed epilepsy). SSRIs should not be used in patients with unstable epilepsy; with controlled seizures careful monitoring is necessary.

    Escitalopram should be used with caution in patients with a history of mania / hypomania. With the development of the manic state escitalopram should be canceled.

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

    Depression is associated with an increased risk of suicidal thoughts, self-injury and suicide (suicidal phenomena).This risk persists until a marked remission occurs. Since improvements may not be observed during the first few weeks of therapy or even a longer period of time, patients should be monitored continuously until their condition improves.

    General clinical practice shows that in the early stages of recovery may increase the risk of suicide.

    Other mental states for which treatment are prescribed escitalopram, may also be associated with an increased risk of suicidal events and events. In addition, these conditions can be a concomitant pathology in relation to a depressive episode. When treating patients with other psychiatric disorders, the same precautions should be followed, that in the treatment of patients with a depressive episode.

    Patients who have a history of suicidal behavior, or patients with a significant level of meditation on suicidal topics prior to initiation of treatment, are more likely to be at risk of suicidal thoughts or suicide attempts, so they should be closely monitored during treatment.A meta-analysis of placebo-controlled clinical trials of antidepressants with adult patients with mental disorders showed that when taking antidepressants in patients younger than 25, there is an increased risk of suicidal behavior compared with placebo. Drug treatment of these patients, and in particular of patients with a high risk of suicide, should be accompanied by careful monitoring, especially at an early stage of treatment and with dose changes.

    Patients (and caregivers) should be warned about the need to monitor any manifestations of clinical impairment, suicidal behavior or thoughts, and unusual behavioral changes, and seek medical advice immediately if these symptoms appear.

    SSRI / SSRI is associated with the development of akathisia characterized by the development of subjectively unpleasant or depressing anxiety and the need for constant movement, often in combination with the inability to sit or stand still. This is most often seen during the first few weeks of treatment. In patients with such symptoms, increasing the dose may lead to impairment.

    Hyponatremia, possibly associated with a violation of the secretion of antidiuretic hormone (ADH) on the background of taking SSRIs, appears rarely and usually disappears when therapy is withdrawn. Caution should be manifested in the appointment of escitalopram and other SSRIs to people at risk of developing hyponatremia: the elderly, the patient with cirrhosis of the liver and taking drugs that can cause hyponatraemia.

    When SSRIs were taken, cases of development of skin hemorrhages (ecchymosis and purpura) were noted. It is necessary to use caution escitalopram in patients taking oral anticoagulants and drugs that affect blood coagulability, as well as in patients with a tendency to bleeding.

    Since the clinical experience of simultaneous use of SSRIs and electroconvulsive therapy (ECT) is limited, caution should be exercised when concomitant use of escitalopram and ECT is used.

    Combine escitalopram and MAO A inhibitors are not recommended because of the risk of developing a serotonin syndrome.

    It is necessary to use caution escitalopram simultaneously with drugs that have a serotonergic effect, for example, sumatriptan or other triptans, tramadol and tryptophan. In patients receiving escitalopram and other SSRIs concomitantly with serotonergic drugs, in rare cases the serotonin syndrome developed. On its development may indicate a combination of such symptoms as agitation, tremor, myoclonus and hyperthermia. If this happens, immediately stop the simultaneous treatment of SSRIs and serotonergic drugs and begin symptomatic treatment.

    Alcohol

    Escitalopram does not enter with pharmacodynamic or pharmacokinetic interaction with alcohol. However, as with other psychotropic drugs, concomitant use of escitalopram and alcohol is not recommended.
    Effect on the ability to drive transp. cf. and fur:

    Despite the fact that Cipralex does not affect intellectual functions and psychomotor activity, it is not recommended to drive a car or mechanisms during treatment.

    Form release / dosage:

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

    Packaging:

    5 mg - 28 pieces;

    10 mg - 14 pcs., 28 pcs. And 56 pcs;

    20 mg - 28 pcs.

    For 14 tablets in a contour mesh package (blister) made of PVC / PE / PVDC and aluminum foil.
    1, 2 or 4 blisters with instructions for use in a cardboard box.
    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015653 / 01
    Date of registration:24.04.2009
    The owner of the registration certificate:H. Lundbeck A / SH. Lundbeck A / S Denmark
    Manufacturer: & nbsp
    Representation: & nbspLUNDBEK EXPORT A / C LUNDBEK EXPORT A / C Denmark
    Information update date: & nbsp04.10.2015
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