Eglonase tablets 5mg, No. 28

Schizophrenia (exacerbation, maintenance and long-term anti-relapse therapy).

Bipolar disorder (monotherapy or in combination with Li + or valproic acid): acute manic or mixed episodes with / without psychotic manifestations and with / without rapid phase changes.

Recurrence of bipolar disorder and prevention of recurrence of bipolar disorder (if the drug is effective in treating the manic phase).

Inside, regardless of food intake, once - 5-20 mg / day. For schizophrenia in adults, the recommended starting dose is 10 mg / day. In acute mania associated with bipolar disorders in adults - 15 mg / day (1 time) as monotherapy or 10 mg / day (1 time) in combination with Li + or valproic acid (maintenance therapy at the same dose).

Prevention of recurrence of bipolar disorder: The recommended starting dose is 10 mg per day. Patients who have previously received olanzapine for the treatment of a manic episode should continue with the same dose to prevent relapse. If there is a new manic, mixed or depressive episode, olanzapine should be continued (if necessary, adjusting the dose); in the presence of clinical indications, additional drugs should be prescribed to eliminate mood disorders.

In the treatment of schizophrenia, a manic episode, as well as for the prevention of recurrence of bipolar disorder, the daily dose can subsequently be adjusted in the range from 5 to 20 mg, taking into account the clinical condition of the individual patient. Dose adjustments beyond the recommended starting dose are recommended only after careful clinical analysis, and should generally occur at intervals of at least 24 hours.

Before you stop taking olanzapine, you should gradually reduce the dose. The maximum daily dose of olanzapine is 20 mg.

Elderly Patients
A lower starting dose (5 mg per day) is not necessary for all patients, but is possible for patients 65 years of age and older if clinically indicated.

Impaired renal and / or liver function
For such patients, it may be necessary to reduce the initial dose (up to 5 mg per day). With moderate hepatic impairment (cirrhosis, Child-Pugh class A or B), an initial dose of 5 mg should be prescribed and increased with caution.

Gender
Women should be prescribed the drug in the same doses as men.

Smokers
Smokers should be prescribed the drug in the same doses as non-smokers. In the presence of more than one factor that can cause a slowdown in metabolism (female, elderly, nonsmoking patients), the need to reduce the initial dose to 5 mg / day should be considered. If necessary, the dose may be increased further with caution.

Active ingredient: 5mg olanzapine

Hypersensitivity to the active substance or any of the components of the drug. Angle-closure glaucoma. Psychoses and / or behavioral disorders associated with dementia. Lactation period. Children's age (up to 18 years of age due to insufficient clinical data). Lactose intolerance, lactase deficiency or glucose-galactose malabsorption (the drug contains lactose).

Carefully
Hepatic failure, renal failure, prostatic hyperplasia, epilepsy, a history of convulsive syndrome, myelosuppression (including leukopenia, neutropenia). myeloproliferative diseases, hypereosinophilic syndrome, paralytic intestinal obstruction, pregnancy, cardiovascular and cerebrovascular diseases or other conditions predisposing to arterial hypotension, congenital increase in the QT interval on the electrocardiogram (ECG) (increase in the corrected QT interval (QTc), or on the ECG) conditions potentially capable of causing an increase in the QT interval (for example, the simultaneous administration of drugs that prolong the QT interval, congestive heart failure, hypokalemia, hypomagnesemia), old age, as well as the simultaneous administration of other centrally acting drugs;immobilization.

Trade name: EGOLANZAЃ

International non-proprietary name:

Olanzapine

Dosage form:

film-coated tablets

Composition:

Active substance:

5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg olanzapine (in the form of 7.03 mg, 10.55 mg, 14.06 mg, 21.09 mg and 28.12 mg olanzapine dihydrochloride trihydrate, respectively, in each film-coated tablet).

Excipients:

core: microcrystalline cellulose (40.99 / 61.48 / 81.97 / 122.96 / 163.94 mg), lactose monohydrate (40.98 / 61.47 / 81.97 / 122.95 / 163.94 mg ), hyprolosis (hydroxynropyl cellulose) (5.0 / 7.5 / 10.0 / 15.0 / 20.0 mg), crospovidone (5.0 / 7.5 / 10.0 / 15.0 / 20.0 mg), magnesium stearate (1.0 / 1.5 / 2.0 / 3.0 / 4.0 mg).

Sheath: hypromellose (1.4 / 1.9 / 2.4 / 3.1 / 3.8 mg), quinoline yellow dye (0.014 / 0.019 / 0.023 / 0.031 / 0.038 mg), opadry Y-1-7000 white ( 2.79 / 3.78 / 4.68 / 6.27 / 7.66 mg): hypromellose (62.5%), titanium dioxide (31.25%), macrogol 400 (6.25% mg).

Description:
Tablets 5 mg: Oblong biconvex film-coated tablets, yellow, odorless or almost odorless, with a score on one side and engraving E 402 on the other side of the tablet.

Tablets 7.5 mg: Round biconvex film-coated tablets, yellow, odorless or almost odorless, engraved with E 403 on one side of the tablet.

Tablets 10 mg: Round biconvex film-coated tablets, yellow, odorless or almost odorless, engraved with E 404 on one side of the tablet.

Tablets 15 mg: Round biconvex film-coated tablets, yellow, odorless or almost odorless, engraved with E 405 on one side of the tablet.

Tablets 20 mg: Round biconvex film-coated tablets, yellow, odorless or almost odorless, engraved with E 406 on one side of the tablet.

Pharmacotherapeutic group:

antipsychotic agent (neuroleptic) ATX code: N05A H03

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics
Olanzapine is an antipsychotic agent (neuroleptic) with a wide pharmacological spectrum of influence on a number of receptor systems. It has an affinity for serotonin (5-HT2A / C, 5HTZ, 5HT6), dopamine (D1, D2, D3, D4, D5), muscarinic (M1-5), adrenergic (alpha1) and histamine (H1) receptors.

Revealed antagonism to serotonin (5HT), dopamine and cholinergic receptors. It has a more pronounced affinity and activity for serotonin 5HT2 receptors in comparison with dopamine D2 receptors.

Selectively reduces the excitability of mesolimbic (A10) dopaminergic neurons, has an insignificant effect on striatal (A9) nerve pathways involved in the regulation of motor functions. Reduces the conditioned defense reflex in lower doses than doses causing catalepsy. Enhances the anti-anxiety effect during the 'anxiolytic' test. Reliably reduces productive (including delusions, hallucinations) and negative symptoms.

Pharmacokinetics
Olanzapine is well absorbed after oral administration. Cmax after oral administration is achieved after 5-8 hours. Food does not affect the absorption of the drug. When taken in the dose range of 1-20 mg, the plasma concentration changes linearly, in proportion to the dose.

At a plasma concentration of 7-1000 ng / ml, the connection with proteins is 93%; mainly with albumin and alpha1-acid glycoprotein.

It is metabolized in the liver by conjugation and oxidation. The main circulating metabolite, 10-N-glucuronide, does not cross the blood-brain barrier (BBB). The isoenzymes CYP1A2 and CYP2D6 of cytochrome P450 are involved in the formation of N-desmethyl and 2-hydroxymethyl metabolites of olanzapine.

The main pharmacological activity of the drug is due to olanzapine, the activity of its metabolites is less pronounced.

It is excreted by the kidneys - 57% (mainly in the form of metabolites).

In healthy volunteers after oral administration, the half-life T1 / 2 of olanzapine is 33 hours (21-54 hours), and the mean plasma clearance is 26 l / h (12-47 l / h).

The half-life of olanzapine can vary depending on age and gender, as well as smoking status: non-smokers (clearance - 18.6 l / h, T1 / 2 - 38.6 h), smokers (clearance - 27.7 l / h, T1 / 2 - 30.4 h), women (clearance - 18.9 l / h, T1 / 2 - 36.7 h), men (clearance - 27.3 l / h, T1 / 2 - 32.3 h ), patients 65 years of age and older (clearance - 17.5 l / h, T1 / 2 - 51.8 h), patients under 65 (clearance - 18.2 l / h, T1 / 2 - 33.8 h) ...

The degree of changes in T1 / 2 and plasma clearance under the influence of each of these factors is significantly inferior to the degree of individual differences in these indicators. There were no significant differences between the mean values ??of T1 / 2 and plasma clearance of olanzapine in patients with severe renal impairment and in those with normal renal function.

Indications for use
Schizophrenia (exacerbation, maintenance and long-term anti-relapse therapy).

Bipolar disorder (monotherapy or in combination with Li + or valproic acid): acute manic or mixed episodes with / without psychotic manifestations and with / without rapid phase changes.

Recurrence of bipolar disorder and prevention of recurrence of bipolar disorder (if the drug is effective in treating the manic phase).

Contraindications
Hypersensitivity to the active substance or any of the components of the drug. Angle-closure glaucoma. Psychoses and / or behavioral disorders associated with dementia. Lactation period. Children's age (up to 18 years of age due to insufficient clinical data). Lactose intolerance, lactase deficiency or glucose-galactose malabsorption (the drug contains lactose).

Carefully
Hepatic failure, renal failure, prostatic hyperplasia, epilepsy, a history of convulsive syndrome, myelosuppression (including leukopenia, neutropenia). myeloproliferative diseases, hypereosinophilic syndrome, paralytic intestinal obstruction, pregnancy, cardiovascular and cerebrovascular diseases or other conditions predisposing to arterial hypotension, congenital increase in the QT interval on the electrocardiogram (ECG) (increase in the corrected QT interval (QTc), or on the ECG) conditions potentially capable of causing an increase in the QT interval (for example, the simultaneous administration of drugs that prolong the QT interval, congestive heart failure, hypokalemia, hypomagnesemia), old age, as well as the simultaneous administration of other centrally acting drugs;immobilization.

Pregnancy and lactation There have been no
strictly controlled clinical studies of the safety of olanzapine during pregnancy. Application is possible only in cases where the expected benefit of therapy to the mother significantly outweighs the potential risk to the fetus.

Olanzapine may be excreted in breast milk. Breastfeeding is not recommended during therapy with EGOLANZA.

Dosing and Administration
Inside, regardless of food intake, once - 5-20 mg / day. For schizophrenia in adults, the recommended starting dose is 10 mg / day. In acute mania associated with bipolar disorders in adults - 15 mg / day (1 time) as monotherapy or 10 mg / day (1 time) in combination with Li + or valproic acid (maintenance therapy at the same dose).

Prevention of recurrence of bipolar disorder: The recommended starting dose is 10 mg per day. Patients who have previously received olanzapine for the treatment of a manic episode should continue with the same dose to prevent relapse. If there is a new manic, mixed or depressive episode, olanzapine should be continued (if necessary, adjusting the dose); in the presence of clinical indications, additional drugs should be prescribed to eliminate mood disorders.

In the treatment of schizophrenia, a manic episode, as well as for the prevention of recurrence of bipolar disorder, the daily dose can subsequently be adjusted in the range from 5 to 20 mg, taking into account the clinical condition of the individual patient. Dose adjustments beyond the recommended starting dose are recommended only after careful clinical analysis, and should generally occur at intervals of at least 24 hours.

Before you stop taking olanzapine, you should gradually reduce the dose. The maximum daily dose of olanzapine is 20 mg.

Elderly Patients
A lower starting dose (5 mg per day) is not necessary for all patients, but is possible for patients 65 years of age and older if clinically indicated.

Impaired renal and / or liver function
For such patients, it may be necessary to reduce the initial dose (up to 5 mg per day). With moderate hepatic impairment (cirrhosis, Child-Pugh class A or B), an initial dose of 5 mg should be prescribed and increased with caution.

Gender
Women should be prescribed the drug in the same doses as men.

Smokers
Smokers should be prescribed the drug in the same doses as non-smokers. In the presence of more than one factor that can cause a slowdown in metabolism (female, elderly, nonsmoking patients), the need to reduce the initial dose to 5 mg / day should be considered. If necessary, the dose may be increased further with caution.

Side effect
The frequency of side effects noted when taking the drug is given in accordance with the WHO classification: very often (> 1/10), often (> 1/100 and 1/1000 and 1/10000 and From the nervous system: very often - drowsiness; often - dizziness, akathisia, parkinsonism, asthenia, dyskinesia; rarely - convulsive syndrome (more often against the background of a history of convulsive syndrome); very rarely - dystonia (including oculogyric crisis) and tardive dyskinesia. Very rarely, neuroleptic malignant syndrome (NMS) can develop. Clinical manifestations of ZNS are fever, muscle stiffness, changes in mental state, instability of autonomic functions (inconsistent levels of heart rate and blood pressure, tachycardia, sweating, cardiac arrhythmia).Additional signs may include elevated creatine phosphokinase levels, myoglobinuria (rhabdomyolysis), and acute renal failure. If the patient develops symptoms and signs of NNS or the appearance of unexplained fever without additional clinical manifestations of NNS, all antipsychotics, including olanzapine, should be discontinued.

With abrupt withdrawal of the drug, symptoms such as increased sweating, insomnia, tremors, anxiety, nausea or vomiting are very rare.

From the side of the cardiovascular system: often - arterial hypotension (including orthostatic); infrequently - bradycardia with or without collapse; very rarely - an increase in the QTc interval on the ECG, ventricular tachycardia / fibrillation and sudden death, very rarely - thromboembolism (including pulmonary embolism and deep vein thrombosis).

From the digestive system: often - transient anticholinergic effects, including constipation and dryness of the oral mucosa; rarely - hepatitis; very rarely - pancreatitis.

From the side of metabolism: very often - an increase in body weight; often - increased appetite, hypertriglyceridemia; very rarely - hyperglycemia and / or decompensation of diabetes mellitus, sometimes manifested by ketoacidosis or coma, including death; hypercholesterolemia, hypothermia.

From the digestive system: often - a transient, asymptomatic increase in the activity of 'hepatic' transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (ACT), especially at the beginning of therapy; rarely - hepatitis (including hepatocellular, cholestatic or mixed liver damage).

From the side of the hematopoietic organs: often - eosinophilia; rarely - leukopenia; very rarely - thrombocytopenia, neutropenia.

From the side of the musculoskeletal system: very rarely - rhabdomyolysis.

From the genitourinary system: very rarely - urinary retention, priapism.

On the part of the skin: rarely - skin rash, infrequently - photosensitivity reactions; very rarely - alopecia.

Allergic reactions: rarely - skin rash; very rarely - anaphylactoid reactions, angioedema, pruritus or urticaria.

Others: often - asthenia, peripheral edema; very rarely - withdrawal syndrome.

Laboratory indicators: very often - hyperprolactinemia, but clinical manifestations (for example, gynecomastia, galactorrhea and enlargement of the mammary glands) are rare. In most patients, prolactin levels spontaneously normalize without discontinuation of therapy. Rarely - a transient, asymptomatic increase in the activity of ALT, ACT. Infrequently - increased activity of creatine phosphokinase (CPK); very rarely - an increase in the activity of alkaline phosphatase (ALP) and total bilirubin. In isolated cases, there was an increase in the concentration of glucose in the blood plasma, triglycerides, cholesterol, asymptomatic eosinophilia.

In elderly patients with dementia, a high frequency of deaths and cerebrovascular disorders (stroke, transient ischemic attacks) has been recorded in studies. Gait disorders and falls were very common in this category of patients. Pneumonia, fever, lethargy, erythema, ocular gatlucation, and urinary incontinence were also common.

Among patients with drug (while taking dopamine agonists) psychoses against the background of Parkinson's disease, deterioration of parkinsonian symptoms and the development of hallucinations were often recorded.

There is evidence of the development of neutropenia (4.1%) against the background of combination therapy with valproic acid in patients with bipolar mania. Simultaneous therapy with valproic acid or lithium increases the frequency (more than 10%) of tremor, dryness of the oral mucosa, increased appetite or weight gain. Speech disorders were also recorded (from 1 to 10%).

Overdose
Symptoms: tachycardia, agitation / aggressiveness, articulation disorder, extrapyramidal disturbances, depression of consciousness of varying severity (from sedation to coma), delirium, convulsions, neuroleptic malignant syndrome, respiratory depression, aspiration, increase or decrease in blood pressure, arrhythmias, cardiac arrest and breathing.

The minimum dose for an acute overdose with a lethal outcome was 450 mg, the maximum dose with a favorable outcome (survival) was 1500 mg.

Treatment: gastric lavage, the appointment of activated charcoal, symptomatic treatment, maintenance of respiratory function.

You should not use sympathomimetics (including norepinephrine, dopamine), which are beta-adrenergic receptor agonists (stimulation of these receptors can aggravate the decrease in blood pressure). Careful medical supervision and monitoring should continue until the patient recovers.

Interaction with other medicinal products
Inducers or inhibitors of the isoenzyme CYP1A2 can alter the metabolism of olanzapine. Inducers of the isoenzyme CYP1A2: the clearance of olanzapine increases in smoking patients and with the simultaneous use of carbamazepine, which leads to a decrease in the concentration of olanzapine in the blood plasma. An increase in the dose of the drug may be required. CYP1A2 isoenzyme inhibitors: fluvoxamine significantly inhibits olanzapine metabolism. Reducing the clearance of olanzapine increases the Cmax of olanzapine in nonsmoking women by 54% and 77% in smoking men, AUC by 52% and 108%, respectively, therefore, in patients taking fluvoxamine or any other inhibitor of the CYP1A2 isoenzyme (for example, ciprofloxacin) should be considered the possibility of using a lower starting dose of olanzapine.

Activated charcoal reduces the bioavailability of olanzapine by 50-60% and should be taken at least 2 hours before or 2 hours after olanzapine.

Fluoxetine (a CYP2D6 inhibitor), as well as a single dose of antacids (aluminum or magnesium) or cimetidine, did not significantly affect the pharmacokinetics of olanzapine.

Ethanol did not affect the pharmacokinetics of olanzapine in the equilibrium state, however, taking ethanol together with olanzapine may be accompanied by an increase in the pharmacological effects of olanzapine (sedative action).

Olanzanin slightly inhibits the formation of valproic acid glucuronide (the main metabolic pathway). Valproic acid has little effect on olanzapine metabolism. A clinically significant pharmacokinetic interaction between olanzapine and valproic acid is unlikely.

Ќеобходима осторожность при применении оланзапина с препаратами, удлин¤ющими интервал QTc (амитриптилином, хлорпромазином. дроперидолом, тиоридазином, пимозидом, хинидином, прокаинамидом, соталолом, эфедрином, адреналином, тербуталином, эритромицином, триметопримом/сульфаметоксазолом, кетоконазолом, флуконазолом и др.), нарушающими электролитный баланс или тормоз¤щими метаболизм оланзапина в печени.

ќдновременное применение оланзапина и антипаркинсонических препаратов у пациентов с болезнью ѕаркинсона и деменцией не рекомендуетс¤.

ќланзапин про¤вл¤ет антагонизм в отношении дофамина и, теоретически, может подавл¤ть действие леводопы и агонистов дофамина.

ќланзапин не подавл¤ет основные изоферменты CYP450 in vitro (например, 1ј2, 2D6, 2—9, 2—19, «ј4), клинически значимое взаимодействие маловеро¤тно. Ќе обнаружено подавлени¤ метаболизма следующих активных веществ: трициклических антидепрессантов (представл¤ющих в основном путь CYP2D6), варфарина (CYP2C9), теофиллина (CYP1A2) или диазепама (CYP3A4 и 2—19).

Ќе вы¤влено взаимодействи¤ при одновременном применении с литием или бипериденом.

ќсобые указани¤
¬о врем¤ приема антипсихотических препаратов улучшение клинического состо¤ни¤ пациентов может произойти в течение нескольких дней или недель. Ќа прот¤жении этого периода пациенты нуждаютс¤ в тщательном наблюдении.

ѕсихоз и/или нарушени¤ поведени¤, св¤занные с деменцией
ќланзапин не разрешен к применению дл¤ лечени¤ психоза и/или нарушений поведени¤, св¤занных с деменцией, и этот препарат не рекомендуетс¤ примен¤ть у таких пациентов из-за повышенной смертности и риска нарушени¤ мозгового кровообращени¤. ѕри приеме оланзапина у пожилых пациентов с психозом на фоне деменции отмечались цереброваскул¤рные нарушени¤ (инсульт, транзиторна¤ ишемическа¤ атака), включа¤ летальные исходы. ?анные пациенты имели предшествующие факторы риска (цереброваскул¤рные нарушени¤ (в анамнезе), транзиторные ишемические атаки, артериальную гипертензию, курение), а также сопутствующие заболевани¤ и/или прием Ћ—, по времени св¤занные с церебро-васкул¤рными нарушени¤ми.

ѕрименение оланзапина не рекомендуетс¤ дл¤ лечени¤ психозов, св¤занных с приемом агонистов дофамина, у пациентов с болезнью ѕаркинсона.

«локачественный нейролептический синдром («Ќ—)
ѕри лечении нейролептиками (в т.ч. оланзапином) может развитьс¤ злокачественный нейролептический синдром.  линическими про¤влени¤ми «Ќ— ¤вл¤ютс¤ повышение температуры, ригидность мышц, изменение психического состо¤ни¤, нестабильность вегетативных функций (непосто¤нные уровни частоты сердечных сокращений и артериального давлени¤, тахикарди¤, потливость, сердечна¤ аритми¤). ?ополнительными признаками могут быть повышение уровней креатинфосфокиназы, миоглобинури¤ (рабдомиолиз) и остра¤ почечна¤ недостаточность. ѕри развитии у пациента симптомов и признаков «Ќ— или по¤влении необъ¤снимой лихорадки без дополнительных клинических про¤влений «Ќ— следует отменить все антипсихотические средства, в том числе оланзапин.

vипергликеми¤ и сахарный диабет
ќтмечаетс¤ более высока¤ распространенность сахарного диабета у пациентов с шизофренией. ќчень редко отмечались случаи гипергликемии, развити¤ сахарного диабета или обострени¤ ранее существовавшего сахарного диабета, кетоацидоза и диабетической комы. Ќе установлена причинна¤ взаимосв¤зь между антипсихотическими Ћ— и этими состо¤ни¤ми. –екомендуетс¤ клинический мониторинг пациентов с сахарным диабетом или с факторами риска его развити¤.

»зменени¤ уровн¤ липидов
ѕри изменении уровней липидов на фоне приема оланзапина следует назначать соответствующее лечение, особенно у пациентов с дислипидемией или факторами риска развити¤ нарушений жирового обмена.

јнтихолинергическа¤ активность
Ќесмотр¤ на то, что оланзапин in vitro имеет антихолинергическую активность, вследствие ограниченности клинического опыта применени¤ оланзапина у пациентов с сопутствующими заболевани¤ми, рекомендуетс¤ осторожность при назначении этого препарата пациентам с гипертрофией предстательной железы, паралитической кишечной непроходимостью и другими аналогичными состо¤ни¤ми.

‘ункци¤ печени
ќсоба¤ осторожность необходима при повышении активности печеночных трансаминаз, јЋ“ и/или ACT у пациентов с печеночной недостаточностью или получающих лечение потенциально гепатотоксичными Ћ—. “ребуетс¤ наблюдение за пациентом и, при необходимости, снижение дозы. ѕри вы¤влении гепатита (в том числе гепатоцеллюл¤рного, холестатического или смешанного поражени¤ печени) прием оланзапина следует прекратить.

Ќейтропени¤
ќланзапин следует примен¤ть с осторожностью у пациентов со снижением числа лейкоцитов в том числе нейтрофилов; с признаками угнетени¤ или токсического нарушени¤ функции костного мозга под воздействием Ћ— (в анамнезе); с угнетением функции костного мозга, обусловленного сопутствующим заболеванием, радио- или химиотерапией (в анамнезе); с гиперэозинофилией или миелопролиферативным заболеванием. Ќейтропени¤ часто наблюдаетс¤ при сочетанном применении оланзапина и вальпроата. ѕрименение оланзапина у больных с клозапинзависимой нейтроиенией или агранулоцитозом (в анамнезе) не сопровождалось рецидивами указанных нарушений.

ѕрекращение приема препарата
ѕри резком прекращении приема оланзапина в очень редких случа¤х (»нтервал ќ“
 ак и в случае применени¤ других антипсихотических препаратов, во врем¤ курса лечени¤ оланзапином следует соблюдать осторожность, если этот препарат назначаетс¤ одновременно с препаратами, удлин¤ющими интервал QTc, особенно у пожилых пациентов, пациентов с синдромом врожденного удлинени¤ QT, застойной сердечной недостаточностью, гипертрофией сердца, гипокалиемией, гипомагнезиемией или удлинением QT в семейном анамнезе.

—ледует избегать одновременного применени¤ других нейролептиков или лекарственных средств, также удлин¤ющих интервал QT или вызывающих гипокалиемию.

“ромбоэмболи¤
—овпадение во времени приема оланзапина и тромбоэмболии вен зарегистрировано в редких случа¤х (менее 0,01%). ѕричинна¤ св¤зь симптомов тромбоэмболии вен и приемом оланзапина не установлена. ќднако поскольку больные шизофренией часто имеют приобретенные факторы риска тромбоэмболии вен, следует вы¤вл¤ть все возможные факторы риска тромбоэмболии вен, например, неподвижность пациентов, и принимать профилактические меры.

—удорожные припадки
ќланзапин следует примен¤ть с осторожностью у пациентов, имеющих в анамнезе судорожные припадки или подвергающихс¤ воздействию факторов, снижающих порог судорожной готовности. —удорожные припадки у пациентов, получающих оланзапин, наблюдаютс¤ редко. ¬ большинстве этих случаев зарегистрированы судорожные припадки в анамнезе или факторы риска судорожных припадков.

ѕоздн¤¤ дискинези¤
ѕри развитии признаков поздней дискинезии рекомендуетс¤ снижение дозы или отмена оланзапина. —имптомы поздней дискинезии могут нарастать или манифестировать после отмены препарата.

ќртпостатическа¤ гипотензи¤
¬ клинических испытани¤х оланзапина ортостатическа¤ гипотензи¤ нечасто наблюдалась у пожилых пациентов.  ак и в случае приема других антипсихотических препаратов, рекомендуетс¤ периодически измер¤ть ј? пациентам старше 65 лет.

ѕрименение в педиатрии
ќланзапин не рекомендуетс¤ примен¤ть при лечении детей и подростков. »сследовани¤, проведенные у пациентов в возрасте 13-17 лет, вы¤вили различные нежелательные реакции, в том числе увеличение массы тела, изменение параметров метаболизма и повышение уровн¤ пролактина. ?олгосрочные исходы этих ¤влений не были изучены и остаютс¤ неизвестными.

Ћактоза
Ётот препарат содержит лактозу, поэтому его не следует назначать пациентам с редкими наследственными нарушени¤ми толерантности к галактозе, наследственным дефицитом лактазы саами или глюкозо-галактозна¤ мальабсорбции. —ледует соблюдать осторожность при применении оланзапина в сочетании с другими препаратами центрального действи¤ и этанолом.

¬ли¤ние на управление транспортными средствами и механизмами
¬ период лечени¤ необходимо соблюдать осторожность при управлении транспортными средствами и зан¤ти¤х потенциально опасными видами де¤тельности, требующими повышенной концентрации внимани¤ и быстроты психомоторных реакций.

‘орма выпуска
“аблетки покрытые пленочной оболочкой 5 мг, 7,5 мг, 10 мг, 15 мг и 20 мг. ѕо 7 таблеток в блистере из комбинированной пленки Ђcoldї (полиамид/алюминиева¤ фольга/ѕ¬’)//алюминиевой фольги. 4 или 8 блистеров вместе с инструкцией по применению упакованы в картонную пачку.

—рок хранени¤
5 лет. Ќе примен¤ть после истечени¤ срока указанного на упаковке.

”слови¤ хранени¤
’ранить при температуре не выше 25 ?—. ’ранить препарат в недоступном дл¤ детей месте!

Terms of dispensing from pharmacies
Prescription