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

Active substancePericiazinePericiazine

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Neuleptil®

solution inwards

Sanofi-Aventis France France

Neuleptil®

capsules inwards

Sanofi-Aventis France France

Periciazine

capsules inwards

R-PHARM, CJSC Russia

Dosage form: & nbspcapsules

Composition:

1 capsule contains:

active substance: pericyazine - 10,00 mg;

Excipients: calcium hydrophosphate dihydrate - 137.00 mg, magnesium stearate - 3.00 mg.

Capsule shell: titanium dioxide (E 171) - 3%, gelatin - up to 100%.

Black ink: shellac, ethanol, isopropanol, butanol, propylene glycol, water, ammonia aqueous, potassium hydroxide, dye iron oxide black (E 172) - traces.

Description:

Opaque hard gelatinous capsules No. 4, consisting of a shell and caps of white color.

Content of capsules: powder yellow color.

Body and capsule capsules have marking "PERI 10 mg & quot ;.

ATX: & nbsp

N.05.A.C.01 Periciazine

Pharmacodynamics:

Pericyiazine is a neuroleptic from the group of piperidine derivatives of phenothiazine, antidophaminergic activity of which causes the development of therapeutic antipsychotic (without stimulating component), as well as antiemetic and hypothermic effects of the drug. However, the development of its side effects (extrapyramidal syndrome, motor disorders and hyperprolactinemia) is also associated with antidopaminergic activity.

The antidopaminergic activity of pericyazine is moderately pronounced, due to which it has a moderate antipsychotic effect with moderate manifestation of extrapyramidal disorders. Due to the blocking effect of pericyazine on adrenergic receptors of the reticular formation of the brainstem and central histamine receptors, the drug has a distinct sedative effect, which can also be a desirable clinical effect, especially in spite of irritable and angry types of affect, and a decrease in aggressiveness is not accompanied by a returnMr.the appearance of lethargy and inhibition. Compared with chlorpromazine pericyazine has a more pronounced antiserotonin, antiemetic and central sedative effect, but less pronounced antihistamine action.

Pericyzine reduces aggressiveness, excitability, disinhibition, due to which it is effective in behavior disorders. Because of the normalizing influence on behavior pericyazine was called the "behavior corrector."

The blockade of peripheral H1-histamine receptors causes the antiallergic effect of the drug.Blockade of peripheral adrenergic structures is manifested by its hypotensive effect. In addition, the drug has cholinolytic activity.

Pharmacokinetics:

After oral administration pericyazine is well absorbed, however, like other phenothiazine derivatives, it undergoes intensive pre-systemic metabolism in the intestine and / or liver, so after its intake, the concentration of unchanged pericyazine in the plasma is lower than for the / m administration and varies widely.

After ingestion of 20 mg periciazine (2 capsules), the maximum plasma concentration is reached within 2 hours and is 150 ng / ml (410 nmol / l).

The connection with plasma proteins is 90%. Periciazine intensively penetrates into the tissues, as it easily passes through the histohematological barriers, including through the blood-brain barrier.

Most of the pericyazine is metabolized in the liver by hydroxylation and conjugation. The metabolites released from the bile can be reabsorbed in the intestine. The half-life period of pericyazine is 12-30 hours; the elimination of metabolites is even more prolonged.Conjugated metabolites are excreted in the urine, and the rest of the drug and its metabolites - with bile and calves.

In elderly patients, metabolism and excretion of phenothiazines slows down.

Indications:

Acute psychotic disorders.

- Chronic psychotic disorders, such as schizophrenia, chronic non-schizophrenic delusional disorders: paranoid delusional disorders, chronic hallucinatory psychoses (for the treatment and prevention of relapses).

- Anxiety, psychomotor agitation, aggressive or dangerous impulsive behavior (as an additional drug for short-term treatment of these conditions).

Contraindications:

- Hypersensitivity to pericyazin and / or other ingredients of the drug.

- Closed-angle glaucoma.

- Retention of urine against the background of diseases of the prostate gland.

- Agranulocytosis in the anamnesis.

- Porphyria in the anamnesis.

- Concomitant therapy with dopaminergic agonists: levodopa, amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, pyribenidyl, pramipexole, quinagolide, ropinirole, with the exception of their use in patients with Parkinson's disease (see "Interactions with Other Drugs").

- Vascular insufficiency (collapse).

- Acute poisoning with substances depressing the central nervous system or coma.

- Heart failure.

- Pheochromocytoma.

- Myasthenia gravis is severe pseudo-paralytic (Erba-Goldflem disease).

- Children's age (for this dosage form)

Carefully:

- in patients with predisposing factors for the development of ventricular arrhythmias (patients with cardiovascular disease, congenital elongated interval QT, bradycardia, hypokalemia, hypomagnesemia, fasting and / or abusing alcohol, receiving concomitant therapy with drugs capable of lengthening the interval QT and / or cause a pronounced bradycardia of less than 55 beats per minute, slow intracardiac conduction, or alter the electrolyte composition of the blood), since phenothiazine antipsychotics in very rare cases may cause lengthening of the interval QT (this effect depends on the dose) and increase the risk of developing severe ventricular arrhythmias, including bi-directional ventricular pirouette tachycardia that can be life-threatening (sudden death);

- in patients with renal and / or hepatic insufficiency (risk of cumulation of the drug);

- in elderly patients (there is an increased predisposition to the development of postural hypotension, excessive hypotensive and sedative effects, the development of extrapyramidal disorders, hyperthermia in hot and hypothermia in cold weather, constipation, paralytic intestinal obstruction and urinary retention in diseases of the prostate, there is a risk of accumulation of the drug due to a decrease in the function of the liver and kidneys);

- in patients with cardiovascular diseases (due to the danger for them of possible hypotensive and quinidine-like effects, the ability of the drug to cause tachycardia);

- in elderly patients with dementia and patients with risk factors for stroke (elderly patients with dementia had a triple increase in the incidence of stroke);

- in patients with risk factors for thromboembolism (see "Side effects", "Special instructions").

- in patients with epilepsy who do not receive adequate anticonvulsant therapy (neuroleptics from the phenothiazine group reduce the threshold of convulsive readiness);

- in patients with Parkinson's disease;

- in patients with hyperthyroidism (increased risk of agranulocytosis with pericyazine in combination with drugs for the treatment of hyperthyroidism);

- Patients with changes in the pattern of blood (increased risk of developing leukopenia or agranulocytosis);

- in patients with breast cancer (the possibility of progression disease due to increased prolactin levels in the blood).

Pregnancy and lactation:

It is desirable to maintain the mental health of the mother during pregnancy in order to prevent decompensation. If medication is needed to maintain mental balance, then it must begin and continue at effective doses throughout the entire pregnancy. Experimental studies in animals did not reveal the teratogenic effect of pericyazine. Studies of the teratogenic effect of pericyazine in humans have not been conducted, there is no evidence of the effect of pericyazine during pregnancy on the development of the fetal brain, but the analysis of pregnancies that occurred against the background of pericyazine showed no specific teratogenic effects.Thus, the risk of teratogenic action of the drug, if it exists, is insignificant.

The appointment of pericyazine in pregnancy is possible, but each time it is necessary to compare the benefits for the mother with the risk for the fetus. It is advisable to limit the duration of the drug during pregnancy.

In rare cases, the following disorders were reported in neonates whose mothers received long-term treatment with large doses of pericyazine:

- tachycardia, hyperexcitability, bloating, delayed meconium withdrawal associated with atropine-like action of the drug, which can be potentiated if it is combined with corrective antiparkinsonian drugs that depress cholinergic transmission in the central nervous system;

- extrapyramidal disorders (muscle hypertonus, tremor);

- sedation.

If possible, at the end of pregnancy, it is desirable to reduce doses of pericyazine and antiparkinsonian drugs that correct it, capable of potentiating the atropine-like effect of neuroleptics. The neonates should monitor the state of the nervous system and the function of the gastrointestinal tract.

Lactation

Due to the lack of data on the penetration of the drug into breast milk, it is not recommended to breast-feed while taking the drug.

Dosing and Administration:

Neuleptil®, capsules 10 mg is intended for ingestion by adult patients. Children should use Neuleptil® 4%, solution for oral administration (see section "Contraindications").

The dosage regimen varies considerably depending on the indications and the patient's condition. Doses of the drug must be selected individually. If the patient's condition allows, then treatment should start with low doses, which then can gradually increase. Always use the lowest effective dose.

The daily dose should be divided into 2 or 3 doses and most of the dose should always be taken in the evening.

In adults, the daily dose can range from 30 mg to 100 mg.

The maximum daily dose is 200 mg.

Treatment of acute and chronic psychotic disorders

The initial daily dose is 70 mg (divided into 2-3 doses). The daily dose may be increased by 20 mg per week until the optimal effect is achieved (on average, up to 100 mg per day).

In exceptional cases, the daily dose may increase to 200 mg.

Correction of behavioral disorders The initial daily dose is 10-30 mg.

Treatment of elderly patients

Doses are reduced by 2-4 times.

Side effects:

Neuleptil® is usually well tolerated, however, in some cases, the undesirable reactions listed below may occur, the occurrence of which may, depending or not depend on the amount of the dose taken, and in the latter case be a consequence of the increased individual sensitivity of the patient.

From the central nervous system

Sedation or drowsiness, more pronounced at the beginning of the treatment and usually passing in a few days.

- Apathy, anxiety, mood changes.

- In some cases, paradoxical effects are possible: insomnia, agitation, sleep inversion, increased aggressiveness and increased psychotic symptoms.

- Extrapyramidal disorders (often occurring when using the drug in high doses):

- acute dystonia or dyskinesia (spasmodic torticollis, oculogic crises, trismus, etc.), usually occurring within 4 days after starting treatment or increasing the dose;

- Parkinsonism, which often develops in elderly patients and / or afterlong-term treatment (within weeks or months) and is partially eliminated when anticholinergic antiparkinsonics are prescribed and is manifested by the appearance of one or more of the following symptoms: tremor (very often is the only manifestation of the pairskinsonizm), rigidity, akinesia in combination with or without muscle hypertension;

- late dystonia or dyskinesia, usually (but not always) arising from long-term treatment and / or use of the drug in high doses, and capable of arising even after discontinuation of treatment (anticholinergic antiparkinsonics have no effect and may cause impairment if they occur);

- akathisia, usually observed after taking high initial doses.

- Inhibition of respiration (possibly in patients with predisposing factors to the development of respiratory depression, for example, in patients receiving other drugs that can depress respiration, in senile patients, etc.).

From the side of the autonomic nervous system

- Anticholinergic effects (dry mouth, paresis of accommodation, urinary retention, constipation, paralytic intestinal obstruction).

From the side of the cardiovascular system

- Lowering blood pressure, usually postural hypotension (usually occurs in the elderly and patients with reduced circulating blood volume, especially at the beginning of the treatment and when using a high initial dose).

- Arrhythmias, including atrial arrhythmias, atrioventricular block, ventricular tachycardia, including potentially fatal ventricular tachycardia type "pirouette" more probable when using high doses (see sections "Contraindications", subsection "Precautions"; ". Interaction with other drugs means ";" Special instructions ").

- ECG changes, usually minor: lengthening the interval QT, segment depression ST, appearance of a prong U and changes in the tooth T.

- In the application of neuroleptics observed cases of thromboembolic events, including pulmonary embolism (sometimes fatal) and cases of deep vein thrombosis (see. Section "Special instructions").

Endocrine and metabolic disorders (more frequent in use drug in high doses)

- Hyperprolactinemia, which can lead to amenorrhea, galactorrhea, gynecomastia, impotence, frigidity.

- Weight gain.

- Infringements of thermoregulation.

- Hyperglycemia, a decrease in glucose tolerance.

Skin and allergic reactions

- Allergic skin reactions, skin rash.

- Bronchospasm, laryngeal edema, angioedema, hyperthermia and other allergic reactions.

- Photosensitivity (more often when using the drug in high doses).

- Contact skin sensitization (see section "Special instructions").

Hematologic disorders

- Leukopenia (observed in 30% of patients receiving high doses of antipsychotics).

- It is extremely rare: agranulocytosis, the development of which does not depend on the dose, and which can occur either immediately or after two or three months of leukopenia.

Ophthalmic disorders

- Brownish deposits in the anterior chamber of the eye, pigmentation of the cornea and lens due to accumulation of the drug, usually not affecting the eyesight (especially when using high doses of phenothiazine derivatives for a long time).

From the liver and biliary tract

Very rarely: cholestatic jaundice and liver damage, predominantly cholestatic or mixed, requiring discontinuation of the drug.

Other

- Malignant neuroleptic syndrome, a potentially fatal syndrome that can occur with all neuroleptics and manifests itself as hyperthermia, muscle stiffness, autonomic disorders (pallor, tachycardia, unstable blood pressure, increased sweating, shortness of breath) and impaired consciousness up to coma. The emergence of a malignant neuroleptic syndrome requires the immediate cessation of treatment with neuroleptics. Although this effect of periciazine and other neuroleptics is associated with idiosyncrasy, there are predisposing factors for its occurrence, such as dehydration or organic lesions of the brain.

Positive serological test for the presence of antinuclear antibodies, without clinical manifestations of lupus erythematosis.

- Very rarely: priapism.

- Nasal congestion.

- Very rarely: the development of withdrawal syndrome with a sharp discontinuation of treatment with high doses of pericyazine, manifested by nausea, vomiting, insomnia and the possibility of exacerbation of the underlying disease or development of extrapyramidal disorders.

Among patients taking antipsychotics phenothiazine series, there were isolated cases of sudden death, possibly caused by cardiac causes (see Fig.sections "Contraindications", subsection "With caution"; "Special instructions"), as well as unexplained cases of sudden death.

Overdose:

Symptoms

Symptoms of an overdose of phenothiazines include CNS depression, progressing from drowsiness to coma with areflexia. In patients with initial manifestations of intoxication or intoxication of moderate severity, anxiety, confusion, agitation, an excited or derilyotic condition may be observed. Other manifestations of an overdose include lowering blood pressure, tachycardia, ventricular arrhythmias, ECG changes, collapse, hypothermia, pupil constriction, tremor, muscle twitching, spasm or muscle rigidity, convulsions, dystonic movements, muscle hypotension, difficulty swallowing, respiratory depression, apnea, cyanosis. Also, the appearance of polyuria leading to dehydration, and severe extrapyramidal dyskinesias.

Treatment

Treatment should be symptomatic and conducted in a specialized department where it is possible to monitor the functions of the respiration and cardiovascular system and continue it until the overdose phenomena are completely eliminated.

If after taking the drug it took less than 6 hours, then you should wash the stomach or aspirate its contents. The use of emetics is contraindicated because of the risk of aspiration of vomit due to inhibition and / or extrapyramidal disorders. It is possible to use activated carbon. There is no specific antidote.

Treatment should be aimed at maintaining vital body functions.

With a decrease in blood pressure, the patient must be moved to a horizontal position with raised legs. Infusion intravenous fluid injection was shown. If the administration of fluid is insufficient to eliminate hypotension, it is possible to administer norepinephrine, dopamine or phenylephrine. The introduction of epinephrine is contraindicated.

With hypothermia, one can wait for its independent resolution, except for cases when the temperature of the body withMr.It goes to a level at which the development of cardiac arrhythmias is possible (that is, up to 29.4 ° C).

Ventricular or supraventricular tachyarrhythmias usually respond to restoring normal body temperature and eliminating hemodynamic and metabolic disorders.With the preservation of life-threatening rhythm disturbances, antiarrhythmics may be required. Avoid the use of lidocaine and, if possible, long-acting antiarrhythmic drugs.

With CNS and respiratory depression, the patient may need to be transferred to artificial lung ventilation and antibiotic therapy to prevent pulmonary infections.

Severe dystonic reactions usually respond to intramuscular or intravenous administration of procyclidine (5-10 mg) or orfenadrine (20-40 mg). Seizures can be cured by intravenous diazepam.

Intramuscularly with extrapyramidal disorders anticholinergic antiparkinsonian agents are used.

Interaction:

Contraindicated combinations

- With dopaminergic agonists (levodopa, amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lysuride, pergolide, piribedil,

pramipexole, quinagolide, ropinirole) in patients without Parkinson's disease - mutual antagonism between dopaminergic agonists and pericyazine. Do not treat treatment with neuroleptic-induced extrapyramidal disorders usingdopaminergic agonists (reduction or loss of neuroleptic activity) - in this case, the use of anticholinergic antiparkinsonian agents is more evident.

Not recommended combinations

- With dopaminergic agonists (levodopa, amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole) in patients with Parkinson's disease - mutual antagonism between dopaminergic agonists and pericyazine. Dopaminergic agonists can exacerbate psychotic disorders. If patients with Parkinson's disease who are receiving dopaminergic agonists require treatment with an antipsychotic, then they should be abolished by gradually lowering the doses (sudden withdrawal of dopaminergic agonists may increase the risk of developing a neuroleptic malignant syndrome). When using periciazine together with the drug levodopa should use the lowest effective dose of both drugs.

With alcohol - potentiation of the sedative effect caused by pericyazin.

- With amphetamine, clonidine, guanetidine - the effect of these drugs decreases with simultaneous admission with neuroleptics.

- With sultopride, an increased risk of ventricular arrhythmias, in particular ventricular fibrillation.

Combinations of medicines that require the use of care

With drugs that can increase the interval QT (antiarrhythmics IA and III class, moxifloxacin, erythromycin, methadone, mefloquine, sertindole, tricyclic antidepressants, lithium salts and cisapride and others) - an increased risk of arrhythmias (see "Contraindications", "With caution").

With thiazide diuretics, the risk of arrhythmias increases, due to the possibility of developing electrolyte disorders (hypokalemia, hypomagnesemia).

With antihypertensive drugs, especially alpha-adrenoblockers - an increase in hypotensive action and the risk of development of orthostatic hypotension (additive effect). For clonidine and guanetidine, see "Interaction with other drugs", sub-section "Not recommended combinations of drugs."

- With other drugs that have a depressant effect on CNS: derivatives of morphine (analgesics, antitussives), barbiturates, benzodiazepines, nonbenzodiazepine anxiolytics, hypnotics, antipsychotics, antidepressants with sedative effect (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), histamine blockers Hi-receptors with sedative effect, antihypertensive agents of central action, baclofen, thalidomide, pizotifen - the danger of additional inhibitory effects on the central nervous system, respiratory depression.

- With tricyclic antidepressants, MAO inhibitors, and maprotilin increase the risk of developing a malignant neuroleptic syndrome, possibly increasing and prolonging the duration of sedative and anticholinergic effects.

- With atropine and other anticholinergics, as well as drugs with anticholinergic action (imipramine antidepressants, anticholinergic antiparkinsonian drugs, disopyramide) - the possibility of cumulation of undesirable effects associated with anticholinergic action, such as urinary retention, constipation,dry mouth, heat stroke, etc., as well as reducing the antipsychotic effect of neuroleptics.

- With beta-blockers, the risk of developing hypotension, especially orthostatic (additive effect), and the risk of developing irreversible retinopathy, arrhythmias and tardive dyskinesia.

- With hepatotoxic drugs - increased risk of hepatotoxic effects.

- With lithium salts - reduced absorption in the gastrointestinal tract, increased rate of excretion Li +, increased severity of extrapyramidal disorders; early signs of intoxication Li + (nausea and vomiting) may be masked by the antiemetic effect of phenothiazines.

- With alpha and beta adrenostimulators (epinephrine, ephedrine) - reducing their effects, perhaps a paradoxical reduction in blood pressure.

- With antithyroid drugs - an increased risk of agranulocytosis.

- With apomorphine - a decrease in the emetic action of alomorfin, an increase in its inhibitory effect on the central nervous system.

- With hypoglycemic drugs - when combined with neuroleptics, hypoglycemic action may decrease, which may require increasing their doses.

Combinations of medicines, in the application of which there is interaction, which should be taken into account

- With antacids (salts, oxides and hydroxides of magnesium, aluminum and calcium) - a decrease in the absorption of periciazin in the gastrointestinal tract. If possible, the interval between taking antacids and pericyazine should be at least two hours.

- With bromocriptine, an increase in the plasma concentration of prolactin when taking pericyazine interferes with the effects of bromocriptine.

- With the means to reduce appetite (with the exception of fenfluramine) - reducing their effect.

Special instructions:

When taking pericyazine, it is recommended that the composition peripheral blood, especially in the event of fever or adherence infection (the possibility of developing leukopenia and agranulocytosis). In case of significant changes in peripheral blood (leukocytosis, granulocytopenia), treatment with pericyazine should be discontinued.

Malignant neuroleptic syndrome - in the case of an unexplained increase in body temperature, treatment with pericyazine should be discontinued,since it can be a manifestation of malignant neuroleptic syndrome, early manifestations of which can also be the emergence of vegetative disorders (such as excessive sweating, pulse instability and blood pressure).

During the treatment, alcohol and alcohol-containing drugs should not be taken, since in this case, the potentiation of the sedative effect leads to a decrease in the response, which can be dangerous for persons driving vehicles and mechanisms (see the section on "Interactions with other drugs").

Due to the ability of the drug to reduce the threshold of convulsive readiness, when taking pericyazin by patients with epilepsy, they should be followed by a thorough clinical and, if possible, electroencephalographic observation.

Except in special cases, pericyazine should not be used in patients with Parkinson's disease (see "Contraindications", subsection "With caution").

Neuroleptics of the group of phenothiazine derivatives can dose-dependently lengthen the interval QT, which, as is known, can increase the risk of developing severe ventricular rhythm disturbances, including a life-threatening bidirectional ventricular tachycardia such as pirouette.The risk of their occurrence increases with the presence of bradycardia, hypokalemia and with lengthening of the interval QT (congenital or acquired under the influence of drugs that increase the duration of the interval QT). Before prescribing therapy with neuroleptics, if the patient's condition allows, it is necessary to exclude the presence of factors predisposing to the development of these severe arrhythmias (bradycardia less than 55 beats per minute, hypokalemia, hypomagnesemia, retardation of intraventricular conduction and congenital elongated interval QT or an elongated interval QT when using other drugs that extend the interval QT) (see the sections "Contraindications", subsection "With caution" "Side effect"). Control over these risk factors should be carried out during treatment with the drug.

In the case of abdominal and abdominal distention accompanied by pericyazin, a necessary examination should be made to exclude intestinal obstruction, since the development of this side effect requires the necessary urgent measures.

Particularly careful monitoring of the condition of patients and adherence to special care is required when prescribing pericyazine and other neuroleptics to elderly patients,patients with cardiovascular diseases, patients with hepatic and renal insufficiency, elderly patients with dementia and patients with risk factors for stroke (see "Contraindications", section "With caution").

In randomized clinical trials, compared with some atypical antipsychotics with placebo performed in elderly patients with dementia, there was a triple increase in the risk of developing cerebrovascular events. The mechanism of this risk is not known. It can not be ruled out that this risk increases with other neuroleptics or in other patient populations, so pericyazine should be used with caution in patients with risk factors for stroke.

In elderly patients with psychoses associated with dementia, in the treatment of antipsychotic drugs, there was an increased risk of death. An analysis of 17 placebo-controlled trials (mean longer than 10 weeks) showed that the majority of patients who received atypical antipsychotics had a 1.6-1.7 times greater risk of death than patients receiving placebo.Although the causes of death in clinical studies with atypical antipsychotics varied, most of the causes of death were either cardiovascular (eg, heart failure, sudden death), or infectious (eg, pneumonia) by nature. Observational studies have confirmed that, similar to treatment with atypical antipsychotics, treatment with conventional antipsychotics can also increase mortality. The extent to which an increase in mortality may be due to an antipsychotic drug, rather than to certain features of patients, is not clear.

With the use of antipsychotic drugs, there have been cases of venous thromboembolism, sometimes fatal. therefore pericyazine should be used with caution in patients with risk factors for thromboembolism, see "Side effect."

In connection with the possibility of developing a withdrawal syndrome with a sharp discontinuation of treatment with high doses of pericyazine (see the section "Adverse effects"), the withdrawal of the drug when used in high doses should be carried out gradually.

In connection with the possibility of developing photosensitization, patients receiving pericyazine, it should be recommended to avoid being exposed to direct sunlight.

Due to the fact that in persons who often treat phenothiazines, in very rare cases, the development of contact sensitization of the skin to phenothiazines is possible, direct contact of the drug with the skin should be avoided.

In pediatric practice, it is advisable to use Neuleptil® 4%, a solution for oral administration.

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

It is necessary to inform patients, especially those who are drivers of vehicles or persons working with other mechanisms, about the possibility of drowsiness and reaction in connection with taking the drug, especially at the beginning of treatment, since the disturbance of psychomotor reactions can be potentially dangerous when driving vehicles and work with mechanisms.

Form release / dosage:

Capsules 10 mg.

For 10 capsules in a blister of PVC / aluminum foil. For 5 blisters together with instructions for use in a cardboard box.

Packaging:(10) - blisters (5) - packs of cardboard

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

List B.

Shelf life:

3 of the year.

At expiration date the drug can not be used.

Terms of leave from pharmacies:On prescription

Registration number:П N014803 / 01

Date of registration:09.04.2008

The owner of the registration certificate:Sanofi-Aventis FranceSanofi-Aventis France France

Manufacturer: & nbsp

Famar Health Care Services Madrid Spain

Representation: & nbspSanofi Aventis GroupSanofi Aventis Group

Information update date: & nbsp29.08.2015

Illustrated instructions

Instructions

Neuleptil® (Neuleptil®)