Risperidone - instructions for use, doses, side effects, contraindications

Composition:1 tablet, film-coated, contains
Active substance: risperidone - 2 mg
Excipients (core): lactose monohydrate (milk sugar) 155.0 mg, microcrystalline cellulose 30.0 mg, povidone (polyvinylpyrrolidone) 7.0 mg, magnesium stearate 2.0 mg, sodium carboxymethyl starch 4.0 mg.
Auxiliary substances (shell): Opaprai II 85F48105 White - 6.0 mg, incl. polyvinyl alcohol - 2,814 mg, macrogol 3350 - 1,416 mg, talc - 1,044 mg, titanium dioxide - 0,726 mg.
1 tablet, film-coated, contains
Active substance: risperidone - 4 mg
Excipients (core): lactose monohydrate (sugar milk) - 153.0 mg, microcrystalline cellulose - 30.0 mg, povidone (polyvinylpyrrolidone) - 7.0 mg, magnesium stearate 2.0 mg, sodium carboxymethyl starch 4.0 mg.
Auxiliary substances (shell): Opadrai II 85F240012 Pink - 6.0 mg, incl. polyvinyl alcohol 2,400 mg, macrogol 3350-1.463 mg, iron dye red oxide 0.024 mg, iron oxide yellow oxide 0.013 mg, talc 0.888 mg, titanium dioxide 1.212 mg.

Description:Dosage 2 mg: round biconvex tablets, with a risk on the one hand, covered with a film coat of white or almost white.
Dosage 4 mg: round biconvex tablets, with a risk on the one hand, covered with a filmy coat of pink or pale pink.

Pharmacotherapeutic group:antipsychotic agent (antipsychotic).

ATX: & nbsp

N.05.A.X Other antipsychotics

N.05.A.X.08 Risperidone

Pharmacodynamics:

Risperidone is a selective monoaminergic antagonist, has a high affinity for serotonergic 5-HT₂ and dopaminergic D₂receptors. Risperidone is also associated with α₁-adrenergic receptors and, somewhat weaker with H₁- histaminergic and α₂-adrenergic receptors. Risperidone does not have tropism for cholinergic receptors. Antipsychotic action due to blockade D₂dopaminergic receptors of the mesolimbic and mesocortical systems. Risperidone reduces the productive symptoms of schizophrenia (delirium, hallucinations), aggressiveness, automatism. A balanced central antagonism to serotonin and dopamine can reduce the propensity to extrapyramidal side effects and extend the therapeutic effect of the drug to cover the negative and affective symptoms of schizophrenia.

Pharmacokinetics:

Risperidone after oral administration is completely absorbed, reaching the maximum concentrations in the plasma after 1-2 hours. Food does not affect the absorption of the drug, so risperidone can be administered regardless of food intake. Risperidone quickly distributed in the body. The volume of distribution is 1-2 l / kg. In the plasma risperidone binds to albumin and α₁glycoprotein. Risperidone 88% bound by plasma proteins, 9-hydroxy-risperidone - by 77%.The equilibrium concentration of risperidone in the body in most patients is reached within 1 day. The equilibrium concentration of the metabolite of 9-hydroxyrisperidone is reached after 4-5 days. The concentrations of risperidone in plasma are proportional to the dose of the drug (within therapeutic doses). Risperidone metabolized (isoenzyme CYP2D6) cytochrome enzyme P-450 CYP2D6 up to 9-hydroxy-risperidone, which has a pharmacological action similar to risperidone. Risperidone and 9-hydroxy-risperidone constitute an active antipsychotic fraction. Another way of metabolizing risperidone is N- dealkylation. After oral administration in patients with psychosis, the half-life (T1/2) risperidone about 3 hours. T_1/2 9-hydroxy-risperidone and the active antipsychotic fraction are 24 hours. After a week of taking the drug, 70% of the dose is excreted by the kidneys (35-45% of them in the form of a pharmacologically active fraction), and 14% by the intestine.

Pharmacokinetics in special groups

When the renal function of medium and severe degree is violated, the excretion of the active antipsychotic fraction is reduced by 60%. In liver failure, plasma concentrations of risperidone were normal, but the value of the free fraction of risperidone in blood plasma increased by approximately 35%.

Studies of single doses used in the elderly revealed high plasma concentrations of the active antipsychotic fraction, delayed excretion and decrease in clearance of the active fraction by 30%

The pharmacokinetics of risperidone, 9-hydroxy-risperidone, the active antipsychotic fraction in children was similar to the pharmacokinetics in adults.

Population pharmacological analysis has not revealed a clear effect of sex, race, smoking on the pharmacokinetics of risperidone and its active antipsychotic fraction.

Indications:

Treatment of schizophrenia.

Treatment of manic episodes associated with bipolar disorder of moderate to severe severity.

Contraindications:- Individual hypersensitivity to risperidone or other components of the drug;

- renal or hepatic insufficiency (for these dosages);

- lactose intolerance, lactase deficiency or glucose-galactose malabsorption;

- the period of breastfeeding,

- Children under 18 years of age (efficacy and safety not established).

Carefully:

Should be used with the following conditions:

- Elderly age in patients with dementia;
- diseases of the cardiovascular system (chronic heart failure, suffered myocardial infarction, conduction disorders of the heart muscle);
- dehydration and hypovolemia;
- disorders of cerebral circulation;
- Parkinson's disease;
- convulsions and epilepsy (including in the anamnesis);
- drug abuse or drug dependence (see recommendations for dosing);
- conditions predisposing to the development of tachycardia such as "pirouette" (bradycardia, electrolyte imbalance, concomitant medication prolonging the interval QT);
- brain tumor;
- intestinal obstruction;
- Reye's syndrome (risperidone can mask symptoms);
- application in combination with furosemide;
- thrombophlebitis;
- hyperglycemia;
- pregnancy.

Pregnancy and lactation:

The safety of risperidone in pregnant women has not been studied. In animals risperidone did not have a direct toxic effect on the reproductive system, but caused some indirect effects, mediated by the effect on the central nervous system and the concentration of prolactin. None of the studies risperidone did not possess a teratogenic effect. Risperidone can be used during pregnancy only if the positive effect for the mother justifies the possible risk to the fetus / child. In this case, careful monitoring of the state of newborns is necessary. With the use of antipsychotics (including risperidone) in the last trimester of pregnancy, the development of extrapyramidal symptoms and / or withdrawal syndrome in newborns was associated. There have been reports of agitation, hypertension, hypotension, tremor, drowsiness, breathing disorder, and eating disorders in newborns exposed to antipsychotics during intrauterine development in the last trimester of pregnancy. These symptoms varied in severity and were usually reversible, but in some cases required prolonged therapy.

Because the risperidone and 9-hydroxy-risperidone penetrate into breast milk, to women who use the drug Risperidone, do not breast-feed.

Dosing and Administration:

Inside, regardless of food intake.

A. Schizophrenia

Adults. Risperidone can appointed once or twice a day.

The initial dose of risperidone is 2 mg per day.On the second day, the dose should be increased to 4 mg per day. From this moment, the dose can either be kept at the same level, or individually adjusted if necessary, Usually the optimal dose is 4-6 mg per day. In some cases, a slower dose increase and lower initial and maintenance doses may be justified.

Doses above 10 mg per day did not show a higher efficacy compared with smaller doses and may cause extrapyramidal symptoms. Due to the fact that safety of doses above 16 mg per day has not been studied, doses above this level can not be used.

For the treatment with risperidone, benzodiazepines can be added if an additional sedative effect is required.

Information on use for the treatment of schizophrenia in children under 18 years of age is absent.

Elderly patients. The recommended initial dose of 0.5 mg per reception twice a day. The dose can be individually increased by 0.5 mg twice a day to 1-2 mg twice a day.

B. Manic episodes associated with bipolar disorder of moderate to severe severity

The recommended initial dose of the drug is 2 mg per day at a time. If necessary, this dose can be increased at least 24 hours per 1 mg per day. For most patients, the optimal dose is 1-6 mg per day.Doses over 6 mg per day in patients with this pathology have not been studied. Like any symptomatic treatment, the constant use of the drug requires regular monitoring and justification.

Elderly patients. The recommended initial dose of 0.5 mg per reception twice a day. Dosage can individually be increased by 0.5 mg twice a day to 1-2 mg twice a day. Since the experience of use in elderly patients is limited, the drug should be used with caution.

Children. Use in children with bipolar disorder under 18 years is not recommended due to insufficient data on efficacy and safety.

Transition from other antipsychotics. If necessary, gradual discontinuation of previous treatment and simultaneous initiation of risperidone therapy is recommended. If it is clinically justified. However, if necessary, when transferring patients from treatment with depot forms of antipsychotics, it is recommended that starting therapy with risperidone should be started instead of the next planned injection.

Side effects:

Side effects of risperidone in therapeutic doses are given with a frequency distribution and system-organ classes.The frequency of side effects was classified as follows: very often (≥1 / 10 cases), often (≥1 / 100, <1/10 cases), sometimes (≥1 / 1000, <1/100 cases), rarely (≥1 / 10 000, <1/1000 cases), very rarely (<1/10 000 cases).

Infections:

very often - in elderly patients with dementia - urinary tract infections;

often - nasopharyngitis, upper respiratory tract infections, sinusitis, urinary tract infections, in elderly patients with dementia - pneumonia, phlegmon; infrequently - ear infections, viral infections, pharyngitis, tonsillitis, bronchitis, eye infections, localized infections, cystitis, onychomycosis, acrodermatitis, bronchopneumonia, respiratory infections, tracheobronchitis.

Hematologic disorders and disorders of the lymphatic system:

often - anemia;

infrequently - granulocytopenia, neutropenia;

very rarely - thrombocytopenia, agranulocytosis.

From the immune system:

infrequently - hypersensitivity;

very rarely - anaphylactic shock.

From the endocrine system:

infrequently hyperprolactinemia, diabetic coma;

very rarely - a violation of the secretion of antidiuretic hormone.

Metabolic and nutritional disorders:

often - in elderly patients with dementia - decreased appetite;

infrequently - polydipsia, anorexia;

rarely - diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication.

Mental disorders:

very often insomnia;

often - anxiety, nervousness, in elderly patients with dementia - confusion;

infrequent - excitation, flattening of affect, sleep disturbance, weakening of libido, anorgasmia;

very rarely - mania.

From the nervous system:

very often - parkinsonism (including extrapyramidal disorders, cogwheel syndrome, akinesia, bradykinesia, hypokinesia, muscle rigidity); often - akathisia (including anxiety), drowsiness, dizziness, sedation, tremor, dystonia (including muscle spasms, involuntary muscle contractions, muscle contractions, involuntary eyeball movements, tongue paralysis), lethargy, postural dizziness, dyskinesia (including muscle twitching, chorea and choreoathetosis), fainting, in elderly patients with dementia - depressed condition;

infrequent - lack of response to stimuli, impaired coordination, loss of consciousness, speech impairment, hypoesthesia, impaired movement, tardive dyskinesia, cerebral ischemia, cerebrovascular disorders, malignant neuroleptic syndrome, rhythmic nodding.

Ophthalmic disorders:

often - visual acuity, in elderly patients with dementia - conjunctivitis;

infrequent conjunctival hyperemia, visual impairment, involuntary eyeball rotations, eyelid edema, periorbital edema, crust formation at the edges of the eyelids, dry eyes, increased lacrimation, photophobia, increased intraocular pressure.

From the side of the ear and the labyrinth:

often - pain in the ear;

infrequently, noise in the ears.

From the cardiovascular system:

often - tachycardia, orthostatic hypotension, lowering of arterial pressure, in elderly patients with dementia - transient ischemic attack, myocardial infarction, stroke;

infrequently - sinus bradycardia, sinus tachycardia, palpitations, atrioventricular blockade of the 1st degree, blockage of the right and left legs of the bundle of the Guiss, atrioventricular blockade, "hot flashes" of blood;

very rarely - atrial fibrillation.

Respiratory, thoracic disorders and disorders of the mediastinum:

often - nasal congestion, shortness of breath, epistaxis, sinus congestion, in elderly patients with dementia - cough, rhinorrhea;

infrequently - wheezing, aspiration pneumonia, dysphonia, productive cough, blockage of the respiratory tract, wet wheezing, respiratory failure, edema of the nose, hyperventilation;

very rarely - sleep apnea syndrome.

From the gastrointestinal tract:

often - nausea, constipation, indigestion, vomiting, diarrhea, drooling, dry mouth, stomach discomfort, abdominal pain, elderly patients with dementia - dysphagia, fecaloma;

infrequently - encopresis, gastritis, edema of lips, cheilitis, aptialism, dysgeusia;

very rarely - intestinal obstruction, pancreatitis.

Hepatobiliary disorders:

very rarely - jaundice.

From the skin and subcutaneous tissues:

often - rashes, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, in elderly patients with dementia - erythema;

infrequently - a violation of skin pigmentation, erythematous rashes, papular rashes, generalized rash, maculopapular rash; very rarely - Quincke's edema, alopecia.

From the osteomuscular system and connective tissue:

often - pain in the back, arthralgia, pain in the extremities, in elderly patients with dementia - gait disturbance, swelling of the joints;

infrequently - muscular pain in the chest, stiffness in the joints, muscle weakness, rhabdomyolysis.

From the side of the kidneys and urinary tract:

often - urinary incontinence;

infrequently - pain when urinating;

very rarely - urinary retention.

On the part of the reproductive system and mammary glands:

often - absence of ejaculation;

infrequent - menstruation, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory disturbance, breast enlargement, sexual dysfunction, retrograde ejaculation;

very rarely - priapism.

Influence on the course of pregnancy, postpartum and perinatal conditions:

very rarely - withdrawal syndrome in newborns.

Common violations:

often - fatigue, asthenia, fever, pain in the chest, in elderly patients with dementia - peripheral edema;

infrequent - thirst, flu-like condition, swelling, poor health, swelling of the face, general edema, chills, cold extremities, withdrawal syndrome; very rarely - hypothermia.

Violation of laboratory and instrumental indicators:

often - an increase in the activity of creatine phosphokinase, an increase in heart rate, in elderly patients with dementia - an increase in body temperature;

infrequently, an increase in alanine aminotransferase activity, an ECG disorder, an increase in the number of eosinophils in the blood, an increase in activity of aspartate aminotransferase,increased blood glucose concentration, decreased hemoglobin concentration, decreased hematocrit, decreased blood pressure, increased transaminase activity, increased blood cholesterol levels, increased triglyceride levels in the blood;

very rarely - interval lengthening QT on the ECG.

Overdose:

Symptoms represent already known pharmacological effects of the drug in a strengthened form: drowsiness, oppression of consciousness, sedation, tachycardia, arterial hypotension, extrapyramidal symptoms. Up to 360 mg of the drug was reported. The data obtained suggest a wide range of drug safety. In rare cases, an overdose marked lengthening interval QT. Bi-directional ventricular tachycardia was noted with concurrent administration of an increased dose of risperidone and paroxetine. In the case of acute overdose with combined therapy, the possibility of involving several drugs should be analyzed.

Treatment: it is necessary to achieve and maintain free airway to ensure adequate oxygen supply and ventilation, gastric lavage (after intubation if the patient is unconscious) and the appointment of activated carbon along with a laxative.Immediately begin monitoring the ECG to identify possible arrhythmias.

Specific antidote does not exist, appropriate symptomatic therapy should be conducted. Arterial hypotension and vascular collapse should be eliminated by intravenous fluid infusions and / or sympathomimetic drugs. In the case of development of acute extrapyramidal symptoms, anticholinergic drugs should be prescribed. Constant medical supervision and ECG monitoring should be continued until the disappearance of symptoms of intoxication.

Interaction:

In applying risperidone as the use of other antipsychotics caution is recommended while the use of drugs that prolong the interval QT, in particular: with antiarrhythmic drugs of the class Ia, antiarrhythmic agents of class III, tricyclic antidepressants, some antihistamines, other antipsychotic drugs, antimalarial drugs, and drugs that cause electrolyte imbalance that cause bradycardia, as well as drugs inhibiting risperidone metabolism in the liver.Given that risperidone has an effect primarily on the central nervous system, it should be used with caution in combination with other drugs of central action and with alcohol. Risperidone reduces the effectiveness of levodopa and other dopamine agonists. Clozapine reduces the clearance of risperidone.

When carbamazepine was used, a decrease in the concentration of the active antipsychotic fraction of risperidone in plasma was noted. Similar effects can be observed with the use of other inducers of hepatic enzymes. Phenothiazines, tricyclic antidepressants and some β-adrenoblockers can increase the concentration of risperidone in plasma, but this does not affect the concentration of the active antipsychotic fraction. Similar reactions are noted for rifampicin, phenytoin, phenobarbital. With the appointment or withdrawal of carbamazepine or other stimulants of the hepatic enzymes of the system CYP ZA4 and P-glycoprotein need to adjust the dose of risperidone. Fluoxetine and paroxetine, inhibitors of hepatic enzymes, increase the concentration of risperidone in plasma, but to a lesser extent the concentration of the active antipsychotic fraction.When the appointment and after the abolition of fluoxetine or paroxetine should adjust the dose of the drug Risperidone.

With the use of risperidone, along with other drugs that bind highly to plasma proteins, there is no clinically significant displacement of any drug from the plasma protein fraction. Verapamil increases the plasma concentration of risperidone.

Galantamine and donepezil did not demonstrate a clinically significant effect on the pharmacokinetics of risperidone and its active antipsychotic fraction. Amitriptyline does not affect the pharmacokinetics of risperidone and its active antipsychotic fraction. Cimetidine and ranitidine increase the bioavailability of risperidone, but have a minimal effect on the concentration of the active antipsychotic fraction. Risperidone does not have a clinically significant effect on the pharmacokinetics of lithium, valproic acid, digoxin, topiramate.

Hypotensive drugs increase the severity of lowering blood pressure in the background of risperidone.

Inhibitor CYP AP4 erythromycin does not affect the pharmacokinetics of risperidone and its active antipsychotic fraction. The simultaneous use of paliperidone with risperidone is not recommended, since paliperidone is an active metabolite of risperidone and a combination of these two drugs can exert an excessive additive effect of the active antipsychotic fraction.

See the "Special Advice" section on the increased mortality of elderly patients with dementia in the combined use of furosemide and oral forms of risperidone.

Special instructions:

Transition from therapy with other antipsychotic drugs. In schizophrenia, at the beginning of risperidone treatment, it is recommended that the previous therapy be gradually phased out if clinically justified. In this case, if patients are transferred from the therapy of depot forms of antipsychotics, then risperidone therapy should be started instead of the next scheduled injection. Periodically, the need to continue current therapy with antiparkinsonian drugs should be evaluated.

Use in elderly patients with dementia.

In elderly patients with dementia in the treatment of atypical antipsychotics, there is an increased mortality compared with placebo in studies of atypical antipsychotics, including risperidone. When using risperidone for a given population, the incidence of fatalities was 4.0% for patients taking risperidone, compared with 3.1% for placebo. The average age of the deceased patients is 86 years (range 67-100 years).

For elderly patients with dementia who take oral forms of risperidone, there was an increased mortality in patients taking furosemide and risperidone (7.3%, mean age 89 years, range 75-97 years) compared with the group taking only risperidone (4.1%, average age 84 years, range 75-96) and a group that only took furosemide (3.1%, the average age is 80 years, the range is 67-90 years). There are no pathophysiological mechanisms that explain this observation. Nevertheless, special care should be taken when prescribing the drug in such cases. There was no increase in mortality in patients taking other diuretics simultaneously with risperidone. Regardless of treatment, dehydration is a common risk factor for mortality and should be carefully monitored in elderly patients with dementia.

In elderly patients with dementia, there was an increase in cerebrovascular accidents, including deaths in patients (mean age 85 years,range 73-97 years) with risperidone compared with placebo.

Side effects from the cerebrovascular system

In placebo-controlled trials, elderly patients with dementia experienced an increase in the number of side effects from the cerebrovascular system (acute and transient cerebral circulatory disorders), including deaths in patients (mean age 85 years, range 73-79) with risperidone compared with placebo.

In connection with αthe blocking action of risperidone may cause orthostatic hypotension, especially during the initial dose selection. If hypotension occurs, consider lowering the dose. In patients with diseases of the cardiovascular system, as well as during dehydration, hypovolemia or cerebrovascular disorders, the dose should be increased gradually, according to the recommendations (see "Method of administration and dose"). There are reports that the occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. Risperidone rarely causes the appearance of extrapyramidal symptoms than classical neuroleptics.If signs and symptoms of tardive dyskinesia occur, you should consider withdrawing all antipsychotics.

In the case of neuroleptic malignant syndrome, characterized by hyperthermia, muscle rigidity, instability of autonomic functions, impaired consciousness and increased levels of creatine phosphokinase, all antipsychotic drugs must be discontinued including risperidone. With the withdrawal of carbamazepine and other inducers of hepatic enzymes, the dose of risperidone should be reduced. Patients should be advised to refrain from overeating due to the possibility of weight gain.

Risperidone should be used with caution in patients with risk factors for strokes. The risk of developing is significantly higher in patients with mixed or vascular depressive depression than in patients with dementia due to Alzheimer's disease. Therefore, patients with dementia of a different type (not due to Alzheimer's disease) should not be prescribed risperidone. It is necessary to assess the risks and therapeutic benefits of using risperidone in elderly patients with dementia, taking into account the prognostic risk factors for stroke in each patient.Patients and their surroundings should be warned about the urgent need to report symptoms and signs of potential cerebrovascular unwanted reactions, in particular about sudden weakness or numbness in the face, upper or lower extremities, speech or vision impairment. In this case, it is urgently necessary to consider all therapies, including the abolition of the drug.

In connection with α-adrenoblocking action of risperidone may cause orthostatic hypotension, especially during the initial dose selection. Clinically significant reduction in blood pressure is observed with the simultaneous use of risperidone with antihypertensive drugs. In patients with diseases of the cardiovascular system, as well as in dehydration, hypovolemia or cerebrovascular disorders. The dose should be increased gradually, according to the recommendations. When there is an arterial hypertension should consider reducing the dose.

Drugs with the properties of dopamine receptor antagonists can cause the emergence of tardive dyskinesia, characterized by rhythmic spontaneous movements, mainly of the tongue and face.When symptoms of late dyskinesia are considered, the question of the abolition of all antipsychotic drugs.

With the use of antipsychotic drugs, cases of malignant neuroleptic syndrome, characterized by hyperthermia, muscle rigidity, vegetative disorders, changes in the state of consciousness and increased levels of creatine phosphokinase were reported. Additionally, myoglobinuria (rhabdomyolysis) and acute renal failure may also occur. In the case of malignant neuroleptic syndrome, all antipsychotics should be discontinued, including risperidone. The use of antipsychotics, including risperidone patients with Parkinson's disease or dementia with Lewy bodies should be treated with caution, since increased risk of malignant neuroleptic syndrome and increased sensitivity to antipsychotic drugs (including blunting of pain sensitivity, confusion, postural instability with frequent falls and extrapyramidal symptoms).

In the treatment with risperidone there is hyperglycemia, diabetes mellitus or exacerbation of already existing diabetes mellitus. The relationship between the use of atypical antipsychotics and the development of adverse reactions associated with hyperglycemia is not fully established. In all patients, it is necessary to conduct clinical monitoring for the presence of symptoms of hyperglycemia and diabetes mellitus. In the treatment with risperidone, a significant increase in body weight was observed. It is necessary to monitor the body weight of patients with risperidone. Patients should be advised to refrain from overeating due to a possible increase in body weight. Studies of tissue cultures have shown that prolactin is able to stimulate the division of tumor cells of the female breast. Although clinical and epidemiological studies have not revealed a direct link with the use of antipsychotics, caution should be exercised in the treatment of patients with appropriate medical history. Risperidone should be used with caution in patients with hyperprolactinemia or in which prolactin-dependent tumors are not excluded.

As with other antipsychotics, caution should be exercised in prescribing risperidone to patients with a history of cardiac arrhythmias. Patients with congenital lengthening of the interval QT, bradycardia, or electrolyte balance disorders (hypokalemia, hypomagnesemia), since such treatment may increase the risk of arrhythmias. It is necessary to use caution risperidone on the background of therapy with drugs that extend the interval QT. Caution should be exercised when using risperidone in patients with epileptic seizures in the anamnesis or other disorders that lead to a reduction in the threshold of convulsive readiness. As a result, α-adrenoblocking action of risperidone treatment with the drug may lead to the occurrence of priapism.

With the use of antipsychotic agents, a violation of thermoregulation is associated. Caution should be exercised in appointing risperidone to patients who may be exposed to conditions that increase internal body temperature (physical activity), high temperatures, concomitant medication with anticholinergic activity, and a state of dehydration.

Antipsychotic drugs, including risperidone, promote the development of thromboembolic complications in patients with a predisposition to the formation of thrombi. Before starting risperidone therapy, it is necessary to identify all possible risk factors for venous thromboembolism and to take appropriate measures to prevent possible complications.

When treating risperidone, regular examinations are needed to identify extrapyramidal symptoms and other motor disorders.

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

During the treatment period it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Film coated tablets 2 mg, 4 mg.

Packaging:

For 10, 20 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

By 10, 20, 30, 40, 50 or 100 tablets in cans of polymeric for medicines. One jar or 1, 2, 3, 4, 5 or 10 contour mesh packages together with the instruction for use are placed in a cardboard package (bundle).

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002262

Date of registration:01.10.2013

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp13.10.2015

Illustrated instructions

Instructions

Risperidone (Risperidone)