Plizil N tablets p / o 20mg, No. 30

• Depressive disorder;

• obsessive compulsive disorder (OCD);

• panic disorder, including agoraphobia;

• social anxiety disorder / social phobia;

• generalized anxiety disorder;

• post-traumatic stress disorder.

Inside, 1 time per day, in the morning, with meals. The tablet is swallowed whole with water. The dose is selected individually during the first two to three weeks after the start of therapy and is subsequently adjusted if necessary.
Depressive disorder - 20 mg once a day. If necessary, the dose is gradually increased by 10 mg / day, up to a maximum of 50 mg / day, depending on the patient's response, the maximum daily dose should not exceed 50 mg. After 2-3 weeks after starting treatment, the efficacy and need for dose adjustment of paroxetine should be assessed.
To relieve depressive syndromes and prevent relapses, it is necessary to observe an adequate duration of supportive and supportive therapy, which can last for several months or more.
For obsessive-compulsive disorders, the initial therapeutic dose is 20 mg / day, followed by a weekly increase of 10 mg. The recommended average therapeutic dose is 40 mg / day, if necessary, the dose can be increased to 60 mg / day. The duration of maintenance therapy is from 6 months or more.
For panic disorders, the initial dose is 10 mg / day (to reduce the possible risk of exacerbation of panic symptoms), followed by a weekly increase of 10 mg. The average therapeutic dose is 40 mg / day. The maximum dose is 50 mg / day.
A low starting dose is recommended to minimize the possible increase in panic disorder symptoms that may occur at the start of treatment with any antidepressant medication. It is recommended to observe adequate terms of therapy (from 3 months or more).
Social anxiety disorders / social phobia : the initial dose is 20 mg per day; if there is no effect for at least two weeks, the dose may be increased to a maximum of 50 mg per day. The dose should be increased by 10 mg at intervals of at least a week in accordance with the clinical effect. The duration of maintenance therapy is from 3 months or more.
Generalized Anxiety Disorders:the initial and recommended dose is 20 mg per day. If there is no effect for at least 2 weeks, the dose may be increased to a maximum of 50 mg / day. The dose should be increased by 10 mg / day at intervals of at least a week in accordance with the clinical effect. The duration of maintenance therapy is from 2 months or more.
Post-traumatic stress disorder : For most patients, the starting and therapeutic doses are 20 mg per day. In some cases, it is recommended to increase the dose of paroxetine to a maximum of 50 mg per day. The dose should be increased by 10 mg every week according to the clinical response. The duration of maintenance therapy is from 3 months or more.
For renal and / or hepatic insufficiency, the recommended dose is 20 mg per day.
For elderly patients, the initial dose is 10 mg, the daily dose should not exceed 40 mg.
Cancellation of the drug Plizil . In order to prevent the development of the 'withdrawal' syndrome, the discontinuation of the drug Plizil is carried out gradually and the following withdrawal scheme can be recommended: a decrease in the daily dose by 10 mg per week; after reaching a dose of 20 mg per day, patients continue to take this dose for 1 week, and only after that the drug is completely canceled.
If withdrawal symptoms develop during, dose reduction or after drug withdrawal, it is advisable to resume taking the previously prescribed dose. Subsequently, the doctor may continue to reduce the dose, but at a slower rate ..
The use of paroxetine in children is contraindicated because the safety and effectiveness of paroxetine for this age group have not been established.

1 tablet contains:
Active substance: substance paroxetine mesylate 25.83 mg, in terms of paroxetine 20.00 mg;

Excipients : anhydrous calcium hydrogen phosphate 317.75 mg, sodium carboxymethyl starch 5.95 mg, magnesium stearate 7.00 mg;

Film shell: lactose monohydrate 3.81 mg, hypromellose 2.97 mg, titanium dioxide (E171) 2.60 mg, macrogol 4000 1.06 mg, iron oxide yellow (E172) 0.16 mg, iron oxide red (E172) 0.002 mg.

Hypersensitivity to paroxetine and other components of the drug; simultaneous use with irreversible MAO inhibitors (MAOIs) and within 14 days after their cancellation, reversible MAO inhibitors and within 24 hours after their cancellation, thioridazine, pimozide; pregnancy; breastfeeding period; children under 18 years of age (efficacy and safety have not been established); lactose intolerance; lactase deficiency; glucose-galactose malabsorption.

Carefully

Liver failure; renal failure; angle-closure glaucoma; hyperplasia of the prostate; mania; heart pathology; epilepsy, with unstable epilepsy, avoid taking the drug; convulsive conditions; the use of electrical impulse therapy; taking medications and the presence of diseases that increase the risk of bleeding; the presence of risk factors for increased bleeding; elderly age.

Trade name of the drug:

Plizil

International non-proprietary name:

paroxetine

Dosage form:

film-coated tablets

Composition:

1 tablet contains:
Active substance: substance paroxetine mesylate 25.83 mg, in terms of paroxetine 20.00 mg;

Excipients : anhydrous calcium hydrogen phosphate 317.75 mg, sodium carboxymethyl starch 5.95 mg, magnesium stearate 7.00 mg;

Film shell: lactose monohydrate 3.81 mg, hypromellose 2.97 mg, titanium dioxide (E171) 2.60 mg, macrogol 4000 1.06 mg, iron oxide yellow (E172) 0.16 mg, iron oxide red (E172) 0.002 mg.

Pharmacotherapeutic group:

antidepressant

Pharmacological properties

Pharmacodynamics

Paroxetine is a potent and selective inhibitor of the uptake of 5-hydroxytryptamine (5-HT, serotonin) by neurons in the brain, which determines its antidepressant effect and effectiveness in the treatment of obsessive-compulsive (OCD) and panic disorder.
Paroxetine has a low affinity for muscarinic cholinergic receptors and has only weak anticholinergic properties. Possessing a selective effect, unlike tricyclic antidepressants, paroxetine showed low affinity for ? -1, ? -2, ?-adrenergic receptors, as well as for dopamine (D2), 5-HT1-, 5-HT2-serotonin and H1-histamine receptors ... Paroxetine does not inhibit the central nervous system, does not violate psychomotor functions and does not potentiate the depressing effect of ethanol on them.
Like other selective serotonin reuptake inhibitors, paroxetine causes symptoms of 5-HT receptor overstimulation when administered to animals that have previously received monoamine oxidase inhibitors (MAOs) or tryptophan. According to a study of behavior and EEG changes, paroxetine exhibits weak activating properties when used in doses exceeding those required to inhibit serotonin reuptake. By its nature, its activating properties are not 'amphetamine-like'.
In healthy volunteers, it does not cause significant changes in blood pressure, heart rate, or ECG.
In contrast to antidepressants, which inhibit the uptake of norepinephrine, paroxetine suppresses the antihypertensive effects of guanethidine much weaker.

Pharmacokinetics
Paroxetine is well absorbed after oral administration and is metabolized by the first passage through the liver.
Since the metabolism of paroxetine includes the stage of the first passage through the liver, its amount determined in the systemic circulation is less than that which is absorbed from the gastrointestinal tract. With an increase in the dose of paroxetine or with repeated dosing, when the load on the body increases, there is a partial absorption of the effect of the first passage through the liver and a decrease in the plasma clearance of paroxetine. As a result, it is possible to increase the concentration of paroxetine in plasma and fluctuations in pharmacokinetic parameters, which can only be observed in those. patients who, when taking low doses, reach a low plasma concentration of the drug.
Paroxetine is extensively distributed in tissues, and pharmacokinetic calculations show that only 1% of it is present in plasma, and at therapeutic concentrations 95% is associated with plasma proteins. Equilibrium concentration is reached by 7-14 days after the start of treatment, and the pharmacokinetics does not change during long-term treatment. The clinical effects of paroxetine (side effects and efficacy) do not correlate with its plasma concentration.
The main metabolites of paroxetine are polar and conjugated products of oxidation and methylation, which are rapidly excreted from the body, have weak pharmacological activity and do not affect its therapeutic effect. With the metabolism of paroxetine, the selective uptake of serotonin due to its action is not disturbed.
Urinary excretion of unchanged paroxetine is usually less than 2% of the dose, with metabolites accounting for about 64% of the dose. The intestine excretes about 36% of the dose, probably in bile, and unchanged paroxetine is less than 1% of the dose.
Thus, paroxetine is excreted primarily as metabolites.
The excretion of paroxetine metabolites from the body is biphasic, first as a result of the metabolism of the first passage through the liver, and then it is controlled by systemic elimination. The half-life is usually around 16-24 hours.
Pharmacokinetics in special clinical situations
In patients with severely impaired renal function (CC less than 30 ml / min) and in patients with impaired liver function, the plasma concentration of paroxetine is increased.
In elderly patients, when using paroxetine at a dose of 20, 30.40 mg per day, the minimum plasma concentration increased by 70-80%, which should be taken into account when selecting the initial dose.

Indications for use

• Depressive disorder;

• obsessive compulsive disorder (OCD);

• panic disorder, including agoraphobia;

• social anxiety disorder / social phobia;

• generalized anxiety disorder;

• post-traumatic stress disorder.

Contraindications

Hypersensitivity to paroxetine and other components of the drug; simultaneous use with irreversible MAO inhibitors (MAOIs) and within 14 days after their cancellation, reversible MAO inhibitors and within 24 hours after their cancellation, thioridazine, pimozide; pregnancy; breastfeeding period; children under 18 years of age (efficacy and safety have not been established); lactose intolerance; lactase deficiency; glucose-galactose malabsorption.

Carefully

Liver failure; renal failure; angle-closure glaucoma; hyperplasia of the prostate; mania; heart pathology; epilepsy, with unstable epilepsy, avoid taking the drug; convulsive conditions; the use of electrical impulse therapy; taking medications and the presence of diseases that increase the risk of bleeding; the presence of risk factors for increased bleeding; elderly age.

Application during pregnancy and during breastfeeding

Fertility . Paroxetine, like other selective serotonin reuptake inhibitors. can affect the quality of the semen. This effect is reversible after discontinuation of the drug.
Pregnancy . There was no teratogenic or selective embryotoxic activity. When taking the drug in the first trimester of pregnancy, the risk of congenital anomalies, in particular of the cardiovascular system, increases. When used in late pregnancy, the risk of developing persistent pulmonary hypertension in newborns increases.
Paroxetine is contraindicated for use during pregnancy and during difficult feeding.

Method of administration and dosage

Inside, 1 time per day, in the morning, with meals. The tablet is swallowed whole with water. The dose is selected individually during the first two to three weeks after the start of therapy and is subsequently adjusted if necessary.
Depressive disorder - 20 mg once a day. If necessary, the dose is gradually increased by 10 mg / day, up to a maximum of 50 mg / day, depending on the patient's response, the maximum daily dose should not exceed 50 mg. After 2-3 weeks after starting treatment, the efficacy and need for dose adjustment of paroxetine should be assessed.
To relieve depressive syndromes and prevent relapses, it is necessary to observe an adequate duration of supportive and supportive therapy, which can last for several months or more.
For obsessive-compulsive disorders, the initial therapeutic dose is 20 mg / day, followed by a weekly increase of 10 mg. The recommended average therapeutic dose is 40 mg / day, if necessary, the dose can be increased to 60 mg / day. The duration of maintenance therapy is from 6 months or more.
For panic disorders, the initial dose is 10 mg / day (to reduce the possible risk of exacerbation of panic symptoms), followed by a weekly increase of 10 mg. The average therapeutic dose is 40 mg / day. The maximum dose is 50 mg / day.
A low starting dose is recommended to minimize the possible increase in panic disorder symptoms that may occur at the start of treatment with any antidepressant medication. It is recommended to observe adequate terms of therapy (from 3 months or more).
Social anxiety disorders / social phobia : the initial dose is 20 mg per day; if there is no effect for at least two weeks, the dose may be increased to a maximum of 50 mg per day. The dose should be increased by 10 mg at intervals of at least a week in accordance with the clinical effect. The duration of maintenance therapy is from 3 months or more.
Generalized Anxiety Disorders:the initial and recommended dose is 20 mg per day. If there is no effect for at least 2 weeks, the dose may be increased to a maximum of 50 mg / day. The dose should be increased by 10 mg / day at intervals of at least a week in accordance with the clinical effect. The duration of maintenance therapy is from 2 months or more.
Post-traumatic stress disorder : For most patients, the starting and therapeutic doses are 20 mg per day. In some cases, it is recommended to increase the dose of paroxetine to a maximum of 50 mg per day. The dose should be increased by 10 mg every week according to the clinical response. The duration of maintenance therapy is from 3 months or more.
For renal and / or hepatic insufficiency, the recommended dose is 20 mg per day.
For elderly patients, the initial dose is 10 mg, the daily dose should not exceed 40 mg.
Cancellation of the drug Plizil . In order to prevent the development of the 'withdrawal' syndrome, the discontinuation of the drug Plizil is carried out gradually and the following withdrawal scheme can be recommended: a decrease in the daily dose by 10 mg per week; after reaching a dose of 20 mg per day, patients continue to take this dose for 1 week, and only after that the drug is completely canceled.
If withdrawal symptoms develop during, dose reduction or after drug withdrawal, it is advisable to resume taking the previously prescribed dose. Subsequently, the doctor may continue to reduce the dose, but at a slower rate ..
The use of paroxetine in children is contraindicated because the safety and effectiveness of paroxetine for this age group have not been established.

Side effect

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - at least 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely (including isolated cases) - less than 0.01%.
From the side of the blood and lymphatic system : infrequently - abnormal bleeding, mainly bleeding into the skin and mucous membranes (most often bruising); very rarely, thrombocytopenia.
From the nervous system: often - drowsiness, tremors, paresthesias, insomnia, dizziness, abnormal dreams (including nightmares); infrequently - confusion of consciousness, hallucinations, extrapyramidal symptoms; rarely - mania, anxiety, depersonalization, panic attacks, restless legs syndrome, seizures, akathisia; very rarely - serotonin syndrome (agitation, confusion, diaphoresis, hallucinations, hyperreflexia, myoclonus, tachycardia, tremor, increased sweating, chills); the frequency is unknown - suicidal thoughts, suicidal behavior (during therapy with paroxetine or early after stopping treatment).
In patients with movement disorders or taking antipsychotics - extrapyramidal disorders with oromandibular dystonia. Some symptoms (drowsiness, insomnia, agitation, confusion, hallucinations, mania) may be due to an underlying medical condition.
From the side of the organ of vision : often - blurred vision; infrequently - mydriasis; very rarely - closed-angle glaucoma.
On the part of the organ of hearing: the frequency is unknown - tinnitus.
From the side of the cardiovascular system : infrequently - a transient increase or decrease in blood pressure (usually in patients with arterial hypertension and anxiety), sinus tachycardia, orthostatic hypotension; very rarely - peripheral edema.
From the digestive system: very often - nausea, loss of appetite; often - dry mouth, vomiting, constipation, diarrhea; rarely - increased activity of 'hepatic' transaminases; very rarely - gastrointestinal bleeding, hepatitis (sometimes with jaundice), liver failure (with the development of side effects from the liver, the question of the advisability of stopping therapy should be decided in cases where there is a prolonged increase in the indicators of functional tests).
From the urinary system: rarely - urinary retention, urinary incontinence.
From the genitourinary system : very often - sexual dysfunction; rarely priapism.
From the endocrine system: rarely - hypoprolactinemia / galactorrhea and hyponatremia (mainly in elderly patients), which is sometimes caused by a syndrome of insufficient secretion of antidiuretic hormone.
From the side of the musculoskeletal system : rarely - arthralgia, myalgia.
Allergic reactions : very rarely - angioedema, urticaria; rarely, skin rash; photosensitivity reactions.
Others : very often - asthenia, cholesterolemia, decreased appetite, increased sweating, yawning, weight gain; very rarely - peripheral edema.
Paroxetine withdrawal syndrome : often - dizziness, sensory disturbances, sleep disturbances, anxiety, headache; infrequently - agitation, nausea, tremors, confusion, sweating, diarrhea.

Overdose

Symptoms : nausea, vomiting, tremors, dry mouth, mydriasis, blurred vision, nystagmus, fever, changes in blood pressure, headache, involuntary muscle contractions, agitation, anxiety, sinus tachycardia, sweating, drowsiness, bradycardia, junctional rhythm.
In very rare cases, when taken simultaneously with other psychotropic drugs and / or alcohol, changes in the electrocardiogram, coma, and death were noted.
Treatment : gastric lavage, activated carbon. If necessary, symptomatic therapy. There is no specific antidote.

Interaction with other medicinal products

The use of paroxetine with MAOIs, including linezolid, an antibiotic that transforms into a nonselective reversible MAOI, is contraindicated due to the high risk of developing serotonin syndrome.
Careful clinical monitoring of patients' condition is required while using paroxetine with serotonergic drugs, including L-tryptophan, tryptans, tramadol, other drugs of the group of selective serotonin reuptake inhibitors (SSRIs), lithium and herbal preparations containing St. John's wort, i.e. to. serotonin syndrome may develop.
It is required to monitor the patient's condition while using paroxetine with fentanyl, used for general anesthesia or for the treatment of chronic pain.
With the simultaneous use of paroxetine with pimozide in a low dose (2 mg once), an increase in the concentration of pimozide was recorded, which is explained by the property of paroxetine to inhibit the isoenzyme CYP2D6. Due to the narrow therapeutic index of pimozide and its known ability to prolong the QT interval, the concomitant use of pimozide and paroxetine is contraindicated.
The metabolism and pharmacokinetics of paroxetine may change under the influence of induction or inhibition of liver microsomal enzymes that are involved in its metabolism. When using paroxetine simultaneously with inhibitors of enzymes involved in the metabolism of drugs, the appropriateness of using a dose of paroxetine that is in the lower part of the therapeutic dose range should be assessed. The initial dose of paroxetine does not need to be adjusted if it is used simultaneously with a drug that is a known inducer of enzymes involved in the metabolism of drugs (for example, carbamazepine, rifampicin, phenobarbital, phenytoin). Any subsequent dose adjustment of parokeetine should be determined by its clinical effects (tolerance and efficacy).
The simultaneous use of fosamprenavir / ritonavir with paroxetine led to a significant decrease in the concentration of parokeetine in the blood plasma. Any subsequent dose adjustment of parokeetine should be determined by its clinical effects (tolerance and efficacy).
Daily intake of parokeetine significantly increases plasma concentrations of procyclidine.
If anticholinergic effects occur, the dose of procyclidine should be reduced. The simultaneous use of parokeetin with anticonvulsants, including carbamazepine, phenytoin, sodium valproate, does not affect their pharmacokinetics and pharmacodynamics in patients with epilepsy.
Clinical studies have shown that the absorption and pharmacokinetics of parokeetin do not depend or practically do not depend (that is, the existing dependence does not require changing the dose) from food intake, antacids, digoxin, propranolol, alcohol. Like other antidepressants, including other SSRI drugs, paroxetine inhibits the CYP2D6 isoenzyme, which belongs to the cytochrome P450 system. Inhibition of the isoenzyme CYP2D6 can lead to an increase in plasma concentrations of concurrently used drugs that are metabolized by this isoenzyme. These drugs include tricyclic antidepressants (including amitriptyline, nortriptyline, imipramine and desipramine), phenothiazine antipsychotics (including perphenazine and thioridazine), risperidone, atomoxetine,some type 1c antiarrhythmic drugs (including propafenone and flecainide) and metoprolol.
The simultaneous use of parokeetin with tamoxifen can lead to a decrease in the concentration of the active metabolite of tamoxifen in the blood plasma due to inhibition of the isoenzyme CYP2D6, and, as a consequence, reduce the effectiveness of tamoxifen. A study of the in vivo interaction with the simultaneous use, under equilibrium conditions, of parokeetine and terfenadine, which is a substrate of the CYP3A4 enzyme, showed that paroxetine does not affect the pharmacokinetics of terfenadine.
In a similar in vivo interaction study, no effect of parokeetine on the pharmacokinetics of alprazolam was found, and vice versa. The combination of parokeetine with terfenadine, alprazolam and other drugs that are substrates of the CYP3A4 isoenzyme does not cause undesirable reactions.
It is recommended to be careful in patients taking SSRIs concurrently with anticoagulant drugs (including warfarin), drugs that are known to affect the functional state of platelets and increase the risk of bleeding (including clozapine) , phenothiazines, tricyclic antidepressants, nonsteroidal anti-inflammatory drugs (including acetylsalicylic acid, other inhibitors of cyclooxygenase-2).

special instructions

¬о врем¤ лечени¤ препаратом ѕлизил необходимо удел¤ть особое внимание пациентам, имеющим в анамнезе суицидальное поведение или суицидальные мысли, пациентам в возрасте до 25 лет, а также пациентам, имеющим суицидальные мысли до начала лечени¤. ѕациентов и обслуживающий персонал следует предупредить о необходимости следить за ухудшением их состо¤ни¤ и/или по¤влением суицидальных мыслей/суицидального поведени¤ или мыслей о причинении себе вреда во врем¤ всего курса лечени¤, особенно в начале лечени¤ и во врем¤ изменени¤ дозы препарата ѕлизил (увеличение и снижение). ¬ случае возникновени¤, этих симптомов необходимо немедленно обратитьс¤ за медицинской помощью.
Ќеобходимо помнить, что такие симптомы как ажитаци¤, акатизи¤ или мани¤ могут быть св¤заны с основным заболеванием или ¤вл¤тьс¤ последствием-примен¤емой терапии. ¬еро¤тность возникновени¤ акатизии наиболее высока в первые несколько недель лечени¤.
ѕри возникновении симптомов клинического ухудшени¤ (включа¤ новые симптомы) и/или суицидальных мыслей/поведени¤, особенно при внезапном их по¤влении, нарастании т¤жести про¤влений, или в том случае, если они не ¤вл¤лись частью предшествующего симптомокомплекса у данного пациента, необходимо пересмотреть режим терапии вплоть до отмены препарата ѕлизил.
¬ редких случа¤х на фоне лечени¤ пароксетином может возникнуть серотониновый синдром или симптоматика, подобна¤ злокачественному нейролептическому синдрому, особенно если пароксетин примен¤ют одновременно с другими серотонинергическими препаратами и/или нейролептиками. Ёти синдромы представл¤ют потенциальную угрозу жизни и поэтому лечение пароксетином необходимо прекратить в случае их возникновени¤ (они характеризуютс¤ следующими симптомами: гипертерми¤, мышечна¤ ригидность, миоклонус, вегетативные расстройства с возможными быстрыми изменени¤ми показателей жизненно важных функций, изменени¤ психического статуса, включающие спутанность сознани¤, раздражимость, крайне выраженную ажитацию, прогрессирующую до делири¤ и комы) и начать поддерживающую симптоматическую терапию. ѕароксетин не следует примен¤ть одновременно с предшественниками серотонина (такими как L-триптофан, окситриптан) в св¤зи с риском развити¤ серотонинергического синдрома.
Ѕольшой депрессивный эпизод может быть начальным про¤влением бипол¤рного расстройства. Ћечение такого эпизода одним только антидепрессантом может увеличить веро¤тность ускоренного развити¤ смешанного/маниакального эпизода , у пациентов, подверженных риску возникновени¤ бипол¤рного расстройства. ѕеред началом лечени¤ антидепрессантом необходимо провести тщательный скрининг дл¤, оценки риска возникновени¤ у данного пациента бипол¤рного расстройства; такой скрининг должен включать сбор детального психиатрического анамнеза, включа¤ данные о наличии в семье случаев суицида, бипол¤рного расстройства и депрессии.
ѕрепарат ѕлизил следует примен¤ть с осторожностью у пациентов, имеющих в анамнезе манию.
Ћечение препаратом ѕлизил следует начинать осторожно, не ранее чем через 2 недели после прекращени¤ терапии ингибиторами ћјќ; дозу препарата ѕлизил нужно повышать постепенно до достижени¤ оптимального терапевтического эффекта. –екомендуетс¤ соблюдать осторожность при лечении препаратом ѕлизил пациентов с нарушением функции почек и пациентов с нарушени¤ми функции печени.
 ак и другие антидепрессанты, препарат ѕлизил следует примен¤ть с осторожностью у пациентов с эпилепсией. „астота судорожных припадков у пациентов, принимающих пароксетин, составл¤ет менее 0,1%. ¬ случае возникновени¤ судорожного припадка лечение препаратом ѕлизил необходимо прекратить.
»меетс¤ ограниченный опыт одновременного применени¤ парокеетина и электросудорожной терапии.
ѕрепарат ѕлизил (как и другие селективные ингибиторы обратного захвата серотонина) может вызвать мидриаз. ѕрепарат ѕлизил необходимо примен¤ть с осторожностью у пациентов с закрытоугольной глаукомой.
ѕри лечении препаратом ѕлизил гипонатриеми¤ возникает редко и преимущественно у пожилых пациентов и нивелируетс¤ после его отмены.
—ообщалось о кровоизли¤ни¤х в кожу и слизистые оболочки (включа¤ желудочно-кишечные кровотечени¤) у пациентов, принимающих пароксетин, поэтому препарат ѕлизил следует примен¤ть с осторожностью у пациентов, которые одновременно получают препараты, повышающие риск кровотечений, у пациентов с известной склонностью к кровотечени¤м и у пациентов с заболевани¤ми, предрасполагающими к кровотечени¤м.
ѕри лечении пациентов с заболевани¤ми сердца следует соблюдать меры предосторожности, контролиру¤ функциональное состо¤ние сердечно-сосудистой системы.
 ак и при отмене многих психотропных лекарственных препаратов, прекращение лечени¤ пароксетином (особенно резкое) может вызывать такие симптомы, как головокружение, сенсорные- нарушени¤1 (включа¤, парестезию и ощущение разр¤да электрического тока), нарушени¤ сна (включа¤ ¤ркие сны), ажитаци¤ или тревога, тошнота, головна¤ боль, тремор, спутанность, сознани¤, диаре¤ и потливость. ” большинства пациентов эти симптомы ¤вл¤ютс¤ легкими или умеренно выраженными и проход¤т самопроизвольно. ќбычно симптомы отмены возникают в первые несколько дней после отмены, препарата, однако в редких случа¤х отмечены после случайного пропуска одной дозы.  ак правило, эти симптомы проход¤т самосто¤тельно в течение двух недель, но у некоторых пациентов сохран¤ютс¤ до 2-3 мес. и более. –екомендуетс¤ постепенно снижать , дозу парокеетина (на прот¤жении нескольких недель или мес¤цев перед его полной отменой в- зависимости от состо¤ни¤ пациента). ¬озникновение симптомов отмены не означает, что препарат ѕлизил вызывает зависимость.
¬ы¤влена св¤зь переломов костей с приемом антидепрессантов,, включа¤, —»ќ«—.
¬озможность переломов костей следует учитывать при применении препарата ѕлизил.
ѕри лечении или профилактике рака груди препаратом тамоксифен следует учитывать, что эффективность тамоксифена уменьшаетс¤ при одновременном применении с пароксетином, в большей степени риск возрастает при одновременном применении в течение длительного времени.

¬ли¤ние на способность управл¤ть транспортными средствами и механизмами

“ерапи¤ препаратом ѕлизил не вызывает когнитивных нарушений и психомоторной заторможенности. “ем не менее, как и при лечении любыми психотропными препаратами, при применении препарата ѕлизил пациентам следует соблюдать осторожность при выполнении действий, требующих повышенной концентрации внимани¤ и быстроты психомоторных реакций.

Release form

Film-coated tablets, 20 mg.
10 tablets per PVC / PE / PVDC / aluminum foil blister.
3 blisters with instructions for use in a cardboard box.

Storage conditions

Store at a temperature not exceeding 30 ? C.
Keep out of the reach of children.

Shelf life

3 years. Do not use after the expiration date.

Vacation conditions

On prescription.