Opipramol инструкция по применению 50

Противорвотный препарат центрального действия, блокирующий серотониновые рецепторы

Фармако-терапевтическая группа

Противорвотное средство-серотониновых рецепторов антагонист

Состав

Активное вещество — опипрамола
дигидрохлорид. Драже.

Показания к применению

Депрессии различного генеза, неврозы, психопатии, сопровождающиеся страхом, напряжением, беспокойством, расстройствами сна, снижением способности к
концентрации, вегетативными нарушениями. Психосоматические и функциональные синдромы

Противопоказания к применению

Повышенная чувствительность к препарату.

Возможные побочные эффекты

ВНИМАНИЕ! Если вы подозреваете, что при приеме препарата ваше самочувствие ухудшилось, появились какие-то побочные эффекты, нужно сразу же обратиться очно к врачу, назначившему препарат!

Редко в начале лечения — утомляемость,
сухость во рту, запоры, потливость, головокружение, нарушения аккомодации, расстройства мочеиспускания, кожные аллергические реакции. Очень редко — нарушения функции
печени, гипербилирубинемия, агранулоцитоз.

Дозировка, как принимать Опипрамол

Взрослым назначают по 1 драже 2-3 раза
в сутки или 1 драже в полдень и 2 драже вечером. Максимальная суточная доза для стационарных больных составляет 5
драже (0.25 г). Детям старше 6 лет назначают по 1-2 драже в
сутки. Средняя продолжительность курса лечения — 1 месяц.

Дополнительные указания при приеме Опипрамол

С осторожностью назначают опипрамол
при беременности, глаукоме, нарушении оттока мочи, вызванном заболеваниями предстательной железы и другими
причинами. Применять препарат можно не ранее, чем через 2
нед. после прекращения приема ингибиторов МАО. В течение
лечения следует периодически осуществлять контроль за картиной периферической крови.

Не рекомендуется заниматься
видами деятельности, требующими повышенного внимания и
скорости реакций.

Производители. Инсидон (Insidon) CIBA-GEIGY, Швейцария; Прамолан (Pramolan) POLFA, Польша.

Недостаточная доза или прерывание лечения, особенно при инсулинзависимом сахарном диабете (1 типа) может привести к гипергликемии и диабетическому кетоацидозу.
Опыта клинического применения у детей младше 6 лет нет. НовоРапид следует использовать у детей вместо обычного инсулина короткого действия только в тех случаях, если быстрое начало действия может оказать лучший эффект — например, если ребенку трудно соблюдать необходимый интервал между инъекциями и приемом пищи.
Сопутствующие заболевания, в частности, инфекции, обычно увеличивают, а поражения почек или печени — уменьшают потребность в инсулине. Перевод больного на новый тип или торговую марку инсулина нужно осуществлять под строгим медицинским контролем.

При использовании препарата НовоРапид Пенфилл может потребоваться большее число инъекций в сутки или изменение дозы, по сравнению с таковыми при использовании обычных препаратов инсулина. Если возникнет потребность в коррекции дозы, это может произойти уже при первом введении или в первые несколько недель или месяцев после перевода.

После компенсации углеводного обмена у больных могут измениться типичные для них симптомы-предвестники гипогликемии, о чем их следует проинформировать. Пропуск приема пищи или незапланированная физическая нагрузка могут привести к гипогликемии. С особой осторожностью применять во время работы водителям транспортных средств и людям, профессия которых связана с повышенной концентрацией внимания, т.к. может развиться гипогликемия, особенно у пациентов со слабо выраженными или отсутствующими симптомами предвестниками гипогликемии или ее частыми эпизодами. В таких случаях следует серьезно подумать о том, желательно ли пациенту водить автомобиль. Картридж Пенфилл предназначен исключительно для индивидуального пользования. После инъекции в течение минимум 6 с игла должна оставаться под кожей для полного введения дозы.

Передозировка

Симптомы: выраженное снижение АД, тахикардия, чрезмерная периферическая вазодилатация.

Лечение: промывание желудка, назначение активированного угля, поддержание функции сердечно-сосудистой системы, мониторинг показателей работы сердца и легких, возвышенное положение конечностей, контроль ОЦК и диуреза. Для восстановления тонуса сосудов — применение сосудосуживающих препаратов (при отсутствии противопоказаний к их применению); для устранения последствий блокады кальциевых каналов — в/в введение глюконата кальция. Гемодиализ не эффективен.

Как хранить препарат

Список Б. Хранят в сухом, защищенном от света и недоступном для детей месте, при температуре не выше 25°С. Срок годности — 2 года. Не использовать по истечении срока годности.

Условия отпуска

Препарат отпускается по рецепту.

Информация для врачей о препарате Опипрамол

Фармакодинамика

Транквилизатор. Устраняет
состояние напряжения, тревоги, страха, обладает регулирующим влиянием при вегетативных дисфункциях и функциональных нарушениях сна. Оказывает седативный эффект,
который предшествует повышению настроения. Не вызывает
развития зависимости.

Фармакокинетика

После приема внутрь ондансетрон хорошо всасывается из ЖКТ. Подвергается эффекту «первого прохождения» через печень. Связывание с белками высокое (70-76%). Биотрансформируется в печени, главным образом путем гидроксилирования. Средний T1/2 у взрослых пациентов около 4 ч. При нарушении функции печени отмечается увеличение T1/2.

Взаимодействие с другими веществами

Требуется осторожность при совместном применении: с индукторами цитохрома CYP2D6 и CYP3A — барбитураты, карбамазепин, каризопродол, глютетимид, гризеофульвин, динитроген оксид, папаверин, фенилбутазон, фенитоин (вероятно, и др. гидантоины), рифампицин, толбутамид; с ингибиторами ферментов CYP2D6 и CYP3A — аллопуринол, макролидные антибиотики, антидепрессанты (ингибиторы МАО), хлорамфеникол, циметидин, эстрогенсодержащие пероральные контрацептивы, дилтиазем, дисульфирам, вальпроевая кислота и ее соли, эритромицин, флуконазол, фторхинолоны,изониазид, кетоконазол, ловастатин, метронидазол, омепразол, пропранолол, хинидин, хинин, верапамил.

Ондансетрон в концентрации 16-160 мкг/мл фармацевтически совместим и может вводиться через Y-образный инжектор в/в капельно совместно со следующими ЛС: циспластин (в концентрации до 0.48 мг/мл) в течение 1-8 ч; 5-фторурацил (в концентрации до 0.8 мг/мл со скоростью 20 мл/ч — более высокие концентрации могут вызвать преципитациюондансетрона); карбоплатин (в концентрации 0.18-9.9 мг/мл в течение 10-60 мин); этопозид (в концентрации 0.14-0.25 мг/мл в течение 30-60 мин);цефтазидим (в дозе 0.25-2 г, в виде в/в болюсной инъекции в течение 5 мин); циклофосфамид (в дозе от 0.1-1 г, в виде в/в болюсной инъекции в течение 5 мин); доксорубицин (в дозе 10-100 мг, в виде в/в болюсной инъекции в течение 5 мин); дексаметазон: возможно в/в введение 20 мг дексаметазонанатрия фосфата медленно, в течение 2-5 мин. ЛС можно вводить через одну капельницу, при этом в растворе концентрации дексаметазона натрия фосфата могут составлять от 32 до 2500 мкг/мл, ондансетрона — от 8 до 100 мкг/мл.

Смотрите также:

• Октреотид, 111 In — лиофилизат, инструкция лекарства
• Окумед® — капли, инструкция лекарства
• Орликсен 120 — капсулы, инструкция лекарства
• Ортосифона тычиночного — капсулы, инструкция лекарства

From Wikipedia, the free encyclopedia

Opipramol

Clinical data
Trade names	Insidon, Pramolan, others
Other names	G-33040; RP-8307[1]
AHFS/Drugs.com	International Drug Names
Routes of administration	Oral
ATC code	N06AA05 (WHO)
Legal status
Legal status	BR: Class C1 (Other controlled substances)[2] In general: ℞ (Prescription only)
Pharmacokinetic data
Bioavailability	94%[3]
Protein binding	91%[3]
Metabolism	CYP2D6-mediated[3]
Elimination half-life	6–11 hours[3]
Excretion	Urine (70%), feces (10%)[3]
Identifiers
IUPAC name 4-[3-(5H-dibenz[b,f]azepin- 5-yl)propyl]-1-piperazinethanol
CAS Number	315-72-0  909-39-7 (dihydrochloride)
PubChem CID	9417
ChemSpider	9046
UNII	D23ZXO613C
KEGG	D08297
ChEMBL	ChEMBL370753
CompTox Dashboard (EPA)	DTXSID3023394
ECHA InfoCard	100.005.687
Chemical and physical data
Formula	C23H29N3O
Molar mass	363.505 g·mol−1
3D model (JSmol)	Interactive image
SMILES OCCN1CCN(CC1)CCCN4c2ccccc2\C=C/c3ccccc34
InChI InChI=1S/C23H29N3O/c27-19-18-25-16-14-24(15-17-25)12-5-13-26-22-8-3-1-6-20(22)10-11-21-7-2-4-9-23(21)26/h1-4,6-11,27H,5,12-19H2  Key:YNZFUWZUGRBMHL-UHFFFAOYSA-N
(what is this?)  (verify)

Opipramol, sold under the brand name Insidon among others, is an anxiolytic and tricyclic antidepressant that is used throughout Europe.^{[1][4][5][6][7]} Despite chemically being a tricyclic dibenzazepine (iminostilbene) derivative similar to imipramine, opipramol is not a monoamine reuptake inhibitor like most other tricyclic antidepressants, and instead, uniquely among antidepressants, acts primarily as a SIGMAR1 agonist.^[7] It was developed by Schindler and Blattner in 1961.^[8]

Medical uses[edit]

Opipramol is typically used in the treatment of generalized anxiety disorder (GAD) and somatoform disorders.^[3][6] Preliminary studies suggest that opipramol shows potential clinical significance in the treatment of severe sleep bruxism.^[9]

Contraindications[edit]

• In patients with hypersensitivity to opipramol or another component of the formulation
• Acute alcohol, sedative, analgesic, and antidepressant intoxications
• Acute urinary retention
• Acute delirium
• Untreated narrow-angle glaucoma
• Benign prostatic hyperplasia with residual urinary retention
• Paralytic ileus
• Pre-existing higher-grade atrioventricular blockages or diffuse supraventricular or ventricular stimulus conduction disturbances
• Combination with monoamine oxidase inhibitor (MAOI)

Pregnancy and lactation[edit]

Experimental animal studies did not indicate injurious effects of opipramol on the embryonic development or fertility. Opipramol should only be prescribed during pregnancy, particularly in the first trimester, for compelling indication.
It should not be used during lactation and breastfeeding, since it passes into breast milk in small quantities.

Side effects[edit]

Frequently (≥1% to <10%) reported adverse reactions with opipramol, especially at the beginning of the treatment, include fatigue, dry mouth, blocked nose, hypotension, and orthostatic dysregulation.

Adverse reactions reported occasionally (≥0.1% to <1%) include dizziness, stupor, micturition disturbances, vigilance, accommodation disturbances, tremor, weight gain,^[10] thirst, allergic skin reactions (rash, urticaria), abnormal ejaculation, erectile impotence, constipation, transient increases in liver enzymes, tachycardia, and palpitations.^{[11][12][13][3]}

Rarely (≥0.01% to <0.1%) reported adverse reactions include excitation, headache, paresthesia especially in elderly patients, restlessness, sweating, sleep disturbances, edema, galactorrhea, urine blockage, nausea and vomiting, fever,^[14] collapse conditions, stimulation conducting disturbances, intensification of present heart insufficiency, blood profile changes particularly leukopenia, confusion, delirium, stomach complaints, taste disturbance, and paralytic ileus especially with sudden discontinuation of a longer-term high-dose therapy.^[3]

Very rarely (<0.01%) reported adverse reactions include seizures, motor disorders (akathisia, dyskinesia, ataxia), polyneuropathy, glaucoma, anxiety, hair loss, agranulocytosis, severe liver dysfunction after long-term treatment, jaundice, and chronic liver damage.^[13][3][15]

It could also cause headache.

Overdose[edit]

Symptoms of intoxication from overdose include drowsiness, insomnia, stupor, agitation, coma, transient confusion, increased anxiety, ataxia, convulsions, oliguria, anuria, tachycardia or bradycardia, arrhythmia, AV block, hypotension, shock, respiratory depression, and, rarely, cardiac arrest.

Since no antidote for tricyclic antidepressant overdose is known, its treatment remains largely supportive. Removal of the drug should be facilitated by vomiting or gastric lavage. Cardiovascular function should be monitored continuously for at least 48 hours. Arrhythmias should be treated on a case-by-case basis with an appropriate pacemaker and correction of metabolic irregularities, particularly electrolyte imbalances. Respiratory failure should be managed by intubation and artificial respiration. Convulsions should be managed with anticonvulsants (typically diazepam), while monitoring for any worsening in CNS depression. Hypotension can be treated by assuming the corresponding recovery position, by increasing plasma volume with saline infusions, or by pressors, such as adrenaline or dobutamine.

Interactions[edit]

Opipramol can be co-prescribed with other psychiatric drugs, such as antidepressants, anxiolytics and antipsychotics, in which case it can interact with them. Most problematic interactions are generally additive or synergistic, such that, when drugs are combined, their effects intensify, which usually manifests as an increase in side effects, but can also be dangerous, depending on the drugs involved.

While opipramol is not a monoamine reuptake inhibitor, any irreversible MAOIs should still be discontinued at least 14 days before treatment. Opipramol can compete with other TCAs, beta blockers, antiarrhythmics (of class 1c) and other drugs for microsomal enzymes, which can lead to slower metabolism and higher plasma concentrations of these drugs. Co-administration of antipsychotics (e.g., haloperidol, risperidone) can increase the plasma concentration of opipramol. Barbiturates and anticonvulsants, on the other hand, can reduce the plasma concentration of opipramol and thereby weaken its therapeutic effect.^[3]

Pharmacology[edit]

Pharmacodynamics[edit]

Opipramol^[16]

Site	Ki (nM)	Species	Ref
σ1	0.2–50	Rodent	[17][18][19]
σ2	110	ND	[20]
SERTTooltip Serotonin transporter	≥2,200	Rat/?	[21][22][23]
NETTooltip Norepinephrine transporter	≥700	Rat/?	[21][22][23]
DATTooltip Dopamine transporter	≥3,000	Rat/?	[21][22][23]
5-HT1A	>10,000	?	[23]
5-HT2A	120	?	[23]
5-HT2C	ND	ND	ND
α1	200	?	[23]
α2	6,100	?	[23]
D1	900	Rat	[19]
D2	120–300	Rat	[23][19]
H1	6.03	Human	[24]
H2	4,470	Human	[24]
H3	61,700	Human	[24]
H4	>100,000	Human	[24]
mAChTooltip Muscarinic acetylcholine receptor	3,300	?	[23]
NMDA/PCP	>30,000	Rat	[19]
Values are Ki (nM). The smaller the value, the more strongly the drug binds to the site.

Opipramol acts as a high affinity sigma receptor agonist, primarily of the σ₁ subtype, but also of the σ₂ subtype with lower affinity.^[6][3] In one study of σ₁ receptor ligands that also included haloperidol, pentazocine, (+)-3-PPP, ditolylguanidine, dextromethorphan, SKF-10,047 ((±)-alazocine), ifenprodil, progesterone, and others, opipramol showed the highest affinity (K_i = 0.2–0.3) for the guinea pig σ₁ receptor of all the tested ligands except haloperidol, which it was approximately equipotent with.^[17] The sigma receptor agonism of opipramol is thought to be responsible for its therapeutic benefits against anxiety and depression.^[7][3]

Unlike other TCAs, opipramol does not inhibit the reuptake of serotonin or norepinephrine.^[3] However, it does act as a high affinity antagonist of the histamine H₁ receptor^[24] and is a low to moderate affinity antagonist of the dopamine D₂, serotonin 5-HT₂, and α₁-adrenergic receptors.^[3][23] H₁ receptor antagonism accounts for its antihistamine effects and associated sedative side effects.^[6][3] In contrast to other TCAs, opipramol has very low affinity for the muscarinic acetylcholine receptors and virtually no anticholinergic effects.^[23][25]

Sigma receptors are a set of proteins located in the endoplasmic reticulum.^[3] σ₁ receptors play key role in potentiating intracellular calcium mobilization thereby acting as sensor or modulator of calcium signaling.^[3] Occupancy of σ₁ receptors by agonists causes translocation of the receptor from endoplasmic reticulum to peripheral areas (membranes) where the σ₁ receptors cause neurotransmitter release.^[3] Opipramol is said to have a biphasic action, with prompt initial improvement of tension, anxiety, and insomnia followed by improved mood later.^[3] Hence, it is an anxiolytic with an antidepressant component.^[3] After sub-chronic treatment with opipramol, σ₂ receptors are significantly downregulated but σ₁ receptors are not.^[3]

Pharmacokinetics[edit]

Opipramol is rapidly and completely absorbed by the gastrointestinal tract.^[3] The bioavailability of opipramol amounts to 94%.^[3] After single oral administration of 50 mg, the peak plasma concentration of the drug is reached after 3.3 hours and amounts to 15.6 ng/mL.^[3] After single oral administration of 100 mg the maximum plasma concentration is reached after 3 hours and amounts to 33.2 ng/mL.^[3] Therapeutic concentrations of opipramol range from 140 to 550 nmol/L.^[26] The plasma protein binding amounts to approximately 91% and the volume of distribution is approximately 10 L/kg.^[3] Opipramol is partially metabolized in the liver to deshydroxyethylopipramol.^[3] Metabolism occurs through the CYP2D6 isoenzyme.^[3] Its terminal half-life in plasma is 6–11 hours.^[3] About 70% is eliminated in urine with 10% unaltered.^[3] The remaining portion is eliminated through feces.^[3]

History[edit]

Opipramol was developed by Geigy.^[27] It first appeared in the literature in 1952 and was patented in 1961.^[27] The drug was first introduced for use in medicine in 1961.^[27] Opipramol was one of the first TCAs to be introduced, with imipramine marketed in the 1950s and amitriptyline marketed in 1961.^[27]

Society and culture[edit]

Generic names[edit]

Opipramol is the English, German, French, and Spanish generic name of the drug and its INNTooltip International Nonproprietary Name, BANTooltip British Approved Name, and DCFTooltip Dénomination Commune Française, while opipramol hydrochloride is its USANTooltip United States Adopted Name, BANMTooltip British Approved Name, and JANTooltip Japanese Accepted Name.^{[1][4][28][5]} Its generic name in Italian and its DCITTooltip Denominazione Comune Italiana is opipramolo and in Latin is opipramolum.^[4][5]

Brand names[edit]

Opipramol is marketed under the brand names Deprenil, Dinsidon, Ensidon, Insidon, Insomin, Inzeton, Nisidana, Opipram, Opramol, Oprimol, Pramolan, and Sympramol among others.^[1][4][5]

References[edit]

Content

• What is it and what is it used for?
• Text package leaflet Opipramol-neuraxpharm 50 mg (film-coated tablets)
• What do you need to consider before use?
• Do not take Opipramol-neuraxpharm 50 mg:
• Take special care with Opipramol-Neuraxpharm 50 mg:
• Text package leaflet Opipramol-neuraxpharm 50 mg (film-coated tablets)
• Taking Opipramol-Neuraxpharm 50 mg with other medicines:
• Text package leaflet Opipramol-neuraxpharm 50 mg (film-coated tablets)
• Taking Opipramol-Neuraxpharm 50 mg together with
• Pregnancy and breast feeding period:
• Driving and using machines:
• Important information about some of the ingredients of Opipramol- neuraxpharm 50 mg:
• How is it used?
• Unless otherwise prescribed by your doctor, the usual dose is:
• Text package leaflet Opipramol-neuraxpharm 50 mg (film-coated tablets)
• Type of application:
• Duration of application:
• If you take more Opipramol-Neuraxpharm 50 mg than you should:
• If you forget to take Opipramol-Neuraxpharm 50 mg:
• Text package leaflet Opipramol-neuraxpharm 50 mg (film-coated tablets)
• If you stop taking Opipramol-Neuraxpharm 50 mg:
• What are the possible side effects?
• Text package leaflet Opipramol-neuraxpharm 50 mg (film-coated tablets)
• How should it be stored?
• Store drug out of reach of children!

ATC code N06AA05

Active ingredient	Addictive drug	Psychotropic
Opipramol	no	no

Date of approval	27.03.2003
Pharmacological group	Antidepressants

What is it and what is it used for?

Opipramol-neuraxpharm 50 mg is a medicine used to treat anxiety, agitation and tension (sedatives / anxiolytics).

Application areas:

Opipramol-Neuraxpharm 50 mg is used to treat:

• generalized anxiety disorder,
• somatoform disorders.

Text package leaflet Opipramol-neuraxpharm 50 mg (film-coated tablets)

What do you need to consider before use?

Do not take Opipramol-neuraxpharm 50 mg:

• if you are allergic (hypersensitive) to opipramol, tricyclic antidepressants (certain active substances that are related to opipramol) or any of the other ingredients of Opipramol-neuraxpharm 50 mg,
• when combined with MAO inhibitors,
• in acute alcohol, sleeping pills, analgesic and psychotropic drug poisoning,
• in acute delirium (states of confusion and excitement with hallucinations and sometimes severe physical disorders),
• with acute urinary behavior,
• in prostatic hyperplasia (enlarged prostate) with residual urine,
• with paralytic ileus (intestinal obstruction),
• with untreated narrow-angle glaucoma (glaucoma),
• in the case of certain damage to the heart (pre-existing high-grade AV blockages or diffuse supraventricular or ventricular conduction disorders).

Take special care with Opipramol-Neuraxpharm 50 mg:

The following describes when you should only take Opipramol-neuraxpharm 50 mg under certain conditions and only with special caution. Please ask your doctor about this. This also applies if this information applied to you in the past.

Opipramol-neuraxpharm 50 mg should only be used with special caution in:

• Liver and kidney diseases,
• increased tendency to convulsions (including epilepsy),
• Prostatic hyperplasia (enlarged prostate) without residual urine formation,
• Disorder of blood formation,
• cerebrovascular insufficiency (circulatory disorders in the brain),
• Previous damage to the heart, especially conduction disorders.
  Patients with pre-existing first-degree AV block or other conduction disorders should only be treated with opipramol under close ECG monitoring, patients with pre-existing higher-grade AV blocks or diffuse supraventricular or ventricular conduction disorders should not be treated with opipramol.

Since changes in the blood count (neutropenia, agranulocytosis) can rarely occur during treatment with medicinal products that have a similar effect to opipramol, the blood count should also be checked during treatment with Opipramol-neuraxpharm 50 mg, especially if fever, flu-like infections and strep throat occur.

If allergic skin reactions occur, a doctor should be consulted immediately.

Text package leaflet Opipramol-neuraxpharm 50 mg (film-coated tablets)

In the case of long-term treatment, it is advisable to have the liver values ​​checked.

Children:

Opipramol-neuraxpharm 50 mg should not be used in children under 6 years of age. For children from 6 years of age, special dosage guidelines apply (see under “3.

How to take Opipramol-neuraxpharm 50 mg? «).

Taking Opipramol-Neuraxpharm 50 mg with other medicines:

Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.

Therapy with Opipramol-neuraxpharm 50 mg does not exclude additional treatment with neuroleptics (drugs for the treatment of certain mental disorders), hypnotics and tranquilizers (certain sleeping pills or sedatives, e.g. barbiturates, benzodiazepines). It should be noted that some preparation-specific effects, especially central depressant effects, can become more pronounced with combined treatment. The same applies to sedation after systemic anesthetics (certain narcotics).

The effect especially of strong anticholinergics, such as. B. Antiparkinson drugs and certain neuroleptics (phenothiazines), can be strengthened.

Simultaneous treatment with serotonin reuptake inhibitors and Opipramol-neuraxpharm 50 mg can lead to additive effects on the serotonergic system. Fluoxetine and fluvoxamine (medicines used to treat depressive disorders) can lead to an increase in plasma concentrations of tricyclic psychotropic drugs and, in connection with this, to an increase in side effects. If necessary, the dose of Opipramol-neuraxpharm 50 mg should be reduced.

Opipramol-neuraxpharm 50 mg must not be used together with certain preparations for the treatment of depressive disorders (MAO inhibitors).MAO inhibitors should be discontinued by the doctor at least 14 days before treatment with Opipramol-neuraxpharm 50 mg. The same applies to Opipramol-neuraxpharm 50 mg if MAO inhibitors are then taken.

The simultaneous use of β-blockers (e.g. propranolol), class Ic antiarrhythmics, as well as drugs from the group of tricyclic antidepressants, which are related to opipramol, and preparations that influence a specific breakdown system of the liver (microsomal enzyme system with monooxygenases) , can change the plasma concentrations of these medicines and opipramol. Barbiturates and drugs against epileptic seizures (anticonvulsants) can lower the plasma concentration of opipramol and thus weaken the therapeutic effect. Concomitant use of neuroleptics (e.g. haloperidol, risperidone) can increase the plasma concentration of opipramol. If necessary, appropriate dose adjustments should be made by the doctor.

Text package leaflet Opipramol-neuraxpharm 50 mg (film-coated tablets)

Taking Opipramol-Neuraxpharm 50 mg together with

Food and drinks:

Avoid drinking alcoholic beverages as the combination of Opipramol-Neuraxpharm 50 mg with alcohol can cause drowsiness.

Pregnancy and breast feeding period:

Pregnancy:

Opipramol-neuraxpharm 50 mg should only be used during pregnancy, especially in the first three months, after the attending physician has carefully weighed the risks and benefits.

Breastfeeding:

Opipramol-neuraxpharm 50 mg should not be used during breastfeeding, as the active ingredient is excreted in breast milk in small amounts. If treatment is required during the breastfeeding period, breastfeeding should be discontinued.

Ask your doctor or pharmacist for advice before taking / using any medicine.

Driving and using machines:

The ability to actively drive or use machines can be impaired by individually occurring reactions. This applies to a greater extent at the start of treatment and when changing preparations, as well as in conjunction with other centrally acting drugs (pain relievers, sleeping pills, psychotropic drugs). You may then no longer be able to react quickly and purposefully enough to unexpected and sudden events. In this case, do not drive a car or any other vehicle! Do not operate power tools and machines! Do not work without a safe grip! Be especially aware that alcohol will make your ability to drive even worse!

Important information about some of the ingredients of Opipramol- neuraxpharm 50 mg:

This medicine contains lactose. Therefore, please only take Opipramol-neuraxpharm 50 mg after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

How is it used?

Always take Opipramol-Neuraxpharm 50 mg exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is:

Adults usually receive 4 film-coated tablets Opipramol-neuraxpharm 50 mg (equivalent to 200 mg opipramol dihydrochloride) daily. The daily dose is reduced to three

Text package leaflet Opipramol-neuraxpharm 50 mg (film-coated tablets)

Distributed single doses, with a larger part being taken in the evening (1 film-coated tablet in the morning, 1 film-coated tablet at noon, 2 film-coated tablets in the evening).

The dose can be reduced to 1 film-coated tablet (corresponding to 50 mg), preferably in the evening, or increased to a maximum of 6 film-coated tablets (300 mg) daily, depending on effectiveness and tolerability, after consultation with the attending physician.

Experience with opipramol in pediatrics is limited. For children from 6 years of age there are reports on the administration of 50-100 mg opipramol dihydrochloride (corresponding to 1-2 film-coated tablets Opipramol-neuraxpharm 50 mg) daily.

Type of application:

It is taken with or without food, whole with sufficient liquid.

Duration of application:

The practicing doctor will decide about the length of the treatments.

Since the effect of Opipramol-neuraxpharm 50 mg does not appear suddenly and the overall change takes place gradually, the drug should be taken regularly for at least 2 weeks.

An average treatment duration of 1 to 2 months is advisable.

Please talk to your doctor or pharmacist if you have the impression that the effect of Opipramol-neuraxpharm 50 mg is too strong or too weak.

If you take more Opipramol-Neuraxpharm 50 mg than you should:

If you take too large amounts of Opipramol, the following symptoms of poisoning can occur within a few hours: drowsiness, insomnia, drowsiness, restlessness, coma, stupor, temporary states of confusion, increased anxiety, coordination disorders (ataxia), cramps, urination disorders (oliguria, Anuria), cardiovascular disorders (tachycardia, bradycardia, arrhythmia, AV block, hypotension), shock, respiratory depression, rarely cardiac arrest.

If you accidentally take more than the prescribed dose, please inform a doctor. Depending on the dose taken or the symptoms that arise, the doctor will decide how to proceed. In the case of children, a doctor must be consulted in any case — even if the ingestion is low. Please note that even with a small overdose, the ability to react is impaired more in any case than with normal dosage.

If you forget to take Opipramol-Neuraxpharm 50 mg:

Next time do not take a larger amount of Opipramol-neuraxpharm 50 mg, but continue the treatment with the prescribed dose.

Text package leaflet Opipramol-neuraxpharm 50 mg (film-coated tablets)

If you stop taking Opipramol-Neuraxpharm 50 mg:

In any case, talk to your doctor before you — e. B. due to the occurrence of side effects — interrupt treatment with Opipramol-neuraxpharm 50 mg or end it prematurely.

If the treatment is to be stopped, the dose should be reduced slowly.

If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.

What are the possible side effects?

Like all medicines, Opipramol-Neuraxpharm can cause side effects, although not everybody gets them.

The frequency of side effects is based on the following categories:

Very often:	more than 1 patient in 10
Frequently:	1 to 10 patients in 100
Occasionally:	This affects 1 to 10 users in 1,000
Rarely:	This affects 1 to 10 users in 10,000
Very rare:	less than 1 patient in 10,000
Not known:	Frequency cannot be estimated from the available data

Nervous system, vegetative system, psyche:

Often, tiredness, a dry mouth and a blocked nose can occur, especially at the start of treatment. Occasionally, dizziness, light-headedness and micturition disorders (urination disorders), accommodation disorders (blurred vision), tremors (shaking), weight gain and feeling thirsty occur. Excitement, headaches, paresthesias (sensory disturbances) occur rarely, confusion and delirium especially in older patients and, above all, restlessness, sweating and sleep disorders when a long-term, high-dose therapy is suddenly discontinued. Very rarely there are epileptic seizures, disorders of the movement sequence (dyskinesia, ataxia), inability to sit quietly (akathisia), diseases of peripheral nerve cells (polyneuropathy), glaucoma (glaucoma attack) and anxiety states.

Skin and appendages:

Occasionally, allergic skin reactions (exanthema, urticaria), rarely water retention in the tissue (edema) and very rarely hair loss occur.

Endocrine system:

Occasionally there are sexual dysfunction (ejaculation disorders, erectile dysfunction) and rarely milk flow (galactorrhea).

Text package leaflet Opipramol-neuraxpharm 50 mg (film-coated tablets)

Genitourinary system:

A urinary obstruction occurs rarely.

Gastrointestinal system:

Occasionally constipation (constipation) occurs, in rare cases there are stomach problems, taste disturbances, intestinal obstruction as a result of intestinal paralysis (paralytic ileus) and, especially when suddenly discontinuing long-term, high-dose therapy, nausea and vomiting.

Liver and biliary system:

Transient increases in liver enzyme activities have occasionally been observed, very rarely severe liver dysfunction and, after long-term treatment, jaundice and chronic liver damage.

Cardiovascular system:

Frequently, especially at the start of treatment, hypotension (low blood pressure) and orthostatic dysregulation (drop in blood pressure when standing) occur. Occasionally, you experience a faster heartbeat and palpitations. Rarely, there are states of collapse, conduction disorders of the heart and exacerbation of an existing cardiac output weakness (heart failure).

Blood system:

Changes in the blood count, in particular a decrease in white blood cells (leukopenia), have been reported rarely, and very rarely the loss of white blood cells (agranulocytosis).

Please inform your doctor or pharmacist if any of the listed side effects gets serious, or if you notice any side effects not listed in this leaflet.

How should it be stored?

Store drug out of reach of children!

Do not use the medicine after the expiry date which is stated on the carton and blister packs after «Use by:». That

The expiry date refers to the last day of the month.

Storage conditions:

Do not store above 30 ° C!