Thorendo Ku-tab, 2mg, 30pcs

Composition

1 tablet dispersed in the oral cavity,0.5 mg/1 mg / 2 mg contains:

Active ingredient:

Risperidone 0.50 mg / 1.00 mg/2.00 mg

Excipients: mannitol, butylmethacrylate, dimethylaminoethylmethacrylate and methyl methacrylate copolymer [1: 2: 1], povidone 25, cellulose microcrystalline, hyprolose viscosimetry, aspartame, crospovidone, dye iron axecrazy (E 172), flavor mint 1,2 menthol flavor, calcium silicate, magnesium stearate

mint Flavor 1: corn maltodextrin, acacia gum, sorbitol, field mint oil, levomenthol.

2 Menthol flavor: corn maltodextrin, flavoring components.

Pharmacological action

antipsychotic agent (neuroleptic)

Clinical Pharmacology

Pharmacodynamics

Risperidone is a selective monoaminergic antagonist with high affinity for serotonin 5-HT2 and dopamine D2receptors. Risperidone also binds to alpha_-1-adrenergic receptors and to a lesser extent to_H1-histamine and alpha_-2-adrenergic receptors.

It has a weak affinity for 5-HT1A-,5-HT1C-,5-_HT1D-serotonergic, _D1-dopaminergic receptors and haloperidol-sensitive binding sites of sigma receptors, and insignificant affinity for 5-HT1B-and 5-HT3-receptors. It does not have the ability to interact with m-cholinergic and beta_-1-, beta_-2-adrenergic receptors.

Risperidone reduces the productive symptoms of schizophrenia, causes less suppression of motor activity, and induces catalepsy to a lesser extent than classical neuroleptics. Balanced central antagonism to serotonin and dopamine reduces the likelihood of developing extrapyramidal disorders and expands the therapeutic effect of the drug to cover the negative and affective symptoms of schizophrenia.

Pharmacokinetics

Suction

Risperidone is completely absorbed after oral use, reaching maximum plasma concentrations in 1-2 hours. The absolute bioavailability of risperidone after oral use is 70%. The relative bioavailability after oral use of risperidone in tablet form is 94% when compared with risperidone in solution form. Food intake does not affect the absorption of the drug, so risperidone can be used regardless of the time of meal. The equilibrium concentration of risperidone in the body in most patients is reached within 1 day. The equilibrium concentration of 9-hydroxyrisperidone is reached within 4-5 days.

Distribution

Risperidone is rapidly distributed in the body. The volume of distribution is 1-2 l/kg. In blood plasma, risperidone binds to albumin and alpha_-1-acid glycoprotein. Risperidone is 90% bound by plasma proteins, and 9-hydroxyrisperidone is 77% bound.

Metabolism and elimination

Risperidone is metabolized in the liver with the participation of the CYP2D6 isoenzyme. The main metabolite is 9-hydroxyrisperidone, which has similar pharmacological activity to risperidone. Risperidone and 9-hydroxyrisperidone constitute the active antipsychotic fraction. The CYP2D6 isoenzyme is susceptible to genetic polymorphism. In patients with intensive metabolism of the CYP2D6 isoenzyme, risperidone is rapidly converted to 9-hydroxyrisperidone, while in patients with weak metabolism of the CYP2D6 isoenzyme, this process is much slower. Although the concentration of risperidone is lower in patients with intensive metabolism and the concentration of 9-hydroxyrisperidone is higher than in patients with weak metabolism, the pharmacokinetics of the active antipsychotic fraction after taking one or more doses are similar in the two groups of patients.

Another route of risperidone metabolism is N-dealkylation. In vitro studies on human liver microsomes have shown that risperidone in clinically significant concentrations does not significantly inhibit the metabolism of drugs biotransforming under the action of cytochrome P450 isoenzymes, including CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4 and CYP3A5. One week after starting risperidone,70% of the dose is excreted by the kidneys (with the elimination of risperidone and 9-hydroxyrisperidone by the kidneys being 35-45% of the dose taken, the remainder being inactive metabolites) and 14% through the intestine. After oral use in patients with psychosis, the half-life (T_1/2) of risperidone is about 3 hours, the T_1/2 of 9-hydroxyrisperidone and the active antipsychotic fraction is 24 hours.

Linearity

The concentration of risperidone in blood plasma is directly proportional to the dose taken in the therapeutic dose range.

Pharmacokinetics in selected groups of patients

Elderly patients, patients with impaired liver and kidney function

After a single dose of risperidone in elderly patients, the concentration of the active antipsychotic fraction in blood plasma increased by an average of 43%, T_1/2-by 38%, and clearance – decreased by 30%.

In patients with renal insufficiency, an increase in plasma concentration and a decrease in the clearance of the active antipsychotic fraction by an average of 60% were observed. In patients with hepatic insufficiency, the plasma concentrations of risperidone did not change, but the average concentration of the free fraction of risperidone increased by 35%.

Children

The pharmacokinetics of risperidone,9-hydroxyrisperidone, and the active antipsychotic fraction in children are comparable to those in adult patients.

Gender, race, smoking

Population pharmacokinetic analysis revealed no obvious effect of gender, race, or smoking on the pharmacokinetics of neticurisperidone and the active antipsychotic fraction.

Indications

• Treatment of schizophrenia in adults and children over 13 years of age.
• Treatment of moderate to severe bipolar disorder-related manic episodes in adults and children over 10 years of age.
• Short-term (up to 6 weeks) treatment of persistent aggression in patients with moderate to severe Alzheimer’s dementia, which is not amenable to non-pharmacological methods of correction, and if there is a risk of harm to the patient to himself or others.

• Short-term (up to 6 weeks) symptomatic treatment of persistent aggression in the structure of a behavior disorder in children aged 5 years and older with mental retardation diagnosed in accordance with the DSM-IV criteria, in which drug treatment is required due to the severity of aggression or other destructive behavior. Pharmacotherapy should be part of a comprehensive treatment program, including psychological and educational interventions. Risperidone should be prescribed by a specialist in child neurology and child psychiatry or a doctor who is well-versed in the treatment of behavioral disorders in children and adolescents.

Use during pregnancy and lactation

Pregnancy

No controlled studies have been conducted on the use of risperidone in pregnant women. In animal studies, risperidone did not have a teratogenic effect, but other types of toxic effects on the reproductive system were observed. The potential risk of using risperidone in humans is not known.

When using antipsychotic drugs (including risperidone) during the third trimester of pregnancy, the newborn developed reversible extrapyramidal symptoms and / or withdrawal syndrome, which varied in severity and duration. Cases of agitation, hypertension, hypotension, tremor, drowsiness, respiratory distress, and eating disorders have been reported. Therefore, newborns should be carefully monitored.

The use of Torendo ® Cu-tab® during pregnancy is only possible if the expected benefit to the mother exceeds the potential risk to the fetus. If it is necessary to stop therapy during pregnancy, the drug should be discontinued gradually.

Breast-feeding period

In animal studies, risperidone and 9-hydroxyrisperidone were excreted in breast milk. Risperidone and 9-hydroxyrisperidone have also been shown to pass into human breast milk in small amounts. There are no data on the development of side effects in infants during breastfeeding. Therefore, the question of breastfeeding should be decided taking into account the possible risk to the child.

Fertility

Like other drugs that are antagonists_{of dopamine D2}receptors, risperidone increases the concentration of prolactin in the blood plasma. Hyperprolactinemia can inhibit the secretion of hypothalamic gonadotropin-releasing hormone, which leads to a decrease in the secretion of pituitary gonadotropin. This, in turn, can cause suppression of reproductive function due to impaired steroidogenesis in the gonads in male and female patients. No significant effects were observed in preclinical studies.

Contraindications

·             Hypersensitivity to risperidone or any other components of the drug.

* Phenylketonuria.

* Congenital fructose intolerance.

Side effects

The most frequently observed adverse reactions (incidence ≥ 5%) were insomnia, anxiety, headache, upper respiratory tract infections, and parkinsonism.

Dose-dependent adverse reactions include parkinsonism and akathisia.

Side effects of risperidone reported in clinical studies of risperidone in oral dosage forms and in the long-acting injectable form, as well as those obtained during post-marketing surveillance, are given with a distribution by frequency and organ systems. The frequency of side effects was classified as follows: very common (≥ 1/10 of cases), common (≥ 1/100 to < 1/10 of cases), uncommon (≥1/1000 to < 1/100 of cases), rare (≥1/10000 to < 1/1000 of cases), very rare ( In each frequency group, side effects are presented in decreasing order of importance.

Infectious and parasitic diseases:

frequent: pneumonia, influenza, bronchitis, infections of the upper respiratory tract, urinary tract infection, sinusitis, ear infection;

infrequent: viral infection, tonsillitis, inflammation of the subcutaneous fat, otitis media, eye infection, localized infection, acarodermatitis, respiratory tract infections, cystitis, onychomycosis;

rare: infections of the lower respiratory tract, chronic otitis media, infection, subcutaneous abscess.

Disorders of the blood and lymphatic system:

infrequently: neutropenia, decreased white blood cell count, anemia, thrombocytopenia, decreased hematocrit, decreased eosinophil count, decreased hemoglobin;

rarely: granulocytopenia, agranulocytosis.

Immune system disorders:

infrequently: hypersensitivity reactions to the components of the drug;

rarely: drug hypersensitivity, anaphylactic reaction.

Endocrine systemdisorders:

common: increased levels of prolactin 1;

rarely: impaired production of antidiuretic hormone, glucosuria.

Metabolic and nutritional disorders:

common: weight gain, increased appetite, decreased appetite;

uncommon: weight loss, diabetes mellitus 3, anorexia, polydipsia, hyperglycemia, increased plasma cholesterol;

rare: hypoglycemia, water intoxication, increased insulin, increased plasma triglyceride concentrations;

very rare: diabetic ketoacidosis.

Mental disorders:

very common: insomnia;

common: restlessness, agitation, sleep disturbances, anxiety, depression;

uncommon: confusion, mania, decreased libido, lethargy, nervousness, nightmares;

rare: anorgasmia, flattening of affect.

Nervous system disorders:

very common: Parkinsonism 2, headache, drowsiness, sedation;

common: 2 akathisia, dizziness 2,2 tremor, dystonia 2, lethargy, dyskinesia 2;

infrequent: lack of response to stimuli, loss of consciousness, depressed level of consciousness, fainting, disturbance of consciousness, stroke, transient ischemic attack, dysarthria, impaired attention, hypersomnia, postural dizziness, balance disorder, tardive dyskinesia, slurring of speech, loss of coordination, hypesthesia, impairment of taste, taste perversion, seizures, cerebral ischemia, impaired movements, agitation, paresthesia;

rare: neuroleptic malignant syndrome (NMS), diabetic coma, cerebrovascular disorders, tremor of the head;

the frequency is unknown: stammering.

Violations on the part of the organ of vision:

frequent: blurred vision, conjunctivitis;

rare: conjunctival hyperemia, blurred vision, discharge from the eyes, periorbital edema, dry eye, increased lacrimation, photophobia;

rare: decreased visual acuity, impaired eye movements, involuntary rotation of the eyeballs, the formation of crusts on the edge of the eyelid, glaucoma, intraoperative syndrome “flabby” iris (ISDR), occlusion of the retinal artery.

Hearing disorders and labyrinth disorders:

infrequently: vertigo, ear pain, tinnitus.

Cardiac disorders:

common: tachycardia;

Infrequent: atrioventricular block, right or left bundle branch block, atrial fibrillation, palpitation sensation, cardiac conduction disorders, ECG QT prolongation, bradycardia, ECG abnormalities;

rare: sinus arrhythmia, sinus bradycardia;

frequency unknown: grade I atrioventricular block.

Vascular disorders:

common: arterial hypertension;

uncommon: hypotension, orthostatic hypotension, hot flashes;

rare: pulmonary embolism, deep vein thrombosis.

Respiratory, thoracic, and mediastinaldisorders:

common:shortness of breath, nosebleeds, cough, nasal congestion, pain in the larynx and pharynx;

infrequently: wheezing, aspiration pneumonia, congestion in the lungs, respiratory disorders, wet wheezing, airway obstruction, dysphonia;

rarely:sleep apnea syndrome, hyperventilation.

Digestive system disorders:

common: vomiting, diarrhea, constipation, nausea, abdominal pain, dyspepsia, dry oral mucosa, abdominal discomfort, hypersalivation, toothache;

uncommon: dysphagia, gastritis, fecal incontinence, fecaloma, gastroenteritis, flatulence;

rare:intestinal obstruction, pancreatitis, lip edema, tongue edema, cheilitis;

very rare:ileus.

Liver and biliary tract disorders:

infrequent: increased activity of transaminases, gamma-glutamyltransferase, “liver” enzymes (in particular, increased activity of alanine aminotransferase) in blood plasma;

rarely: jaundice.

Skin and subcutaneous tissue disorders:

common: skin rash, erythema;

uncommon: urticaria, skin damage, skin integrity disorders, pruritus, acne, acne, skin discoloration, alopecia, seborrheic dermatitis, dry skin, hyperkeratosis, eczema;

rare: drug rash, dandruff;

very rare: angioedema.

Musculoskeletal and connective tissuedisorders:

common: muscle spasms, musculoskeletal pain, arthralgia, back pain, limb pain, buttock pain;

Infrequent: increased plasma creatine phosphokinase activity, muscle weakness, myalgia, neck pain, joint swelling, poor posture, stiffness in the joints, muscle pain in the chest;

rarely: rhabdomyolysis.

Renal and urinary tractdisorders:

common:enuresis, urinary incontinence;

infrequently: urinary retention, dysuria, pollakiuria.

Pregnancy, postpartum and perinatal conditions:

rare: withdrawal syndrome in newborns.

Genital and breast disorders:

Infrequently: amenorrhea, sexual dysfunction, erectile dysfunction, ejaculatory disorders, galactorrhea, gynecomastia, menstrual disorders, vaginal discharge, breast pain, breast discomfort;

rarely: priapism, delayed menstruation, breast engorgement, breast enlargement, discharge from the mammary glands.

General disorders and disorders at the injection site:

frequent: edema, pyrexia, fatigue, peripheral edema, generalized edema, asthenia, pain in the chest, pain;

infrequent: face edema, gait disturbance, malaise, lethargy, flu-like condition, malaise, thirst, discomfort in the chest, chills, fever, malaise;

rarely:hypothermia, low body temperature, withdrawal syndrome, cold extremities, induration.

Injuries, intoxications, and manipulation complications:

common: falling;

infrequent:bolvo time of procedures.

1-hyperprolactinemia in some cases can lead to gynecomastia, menstrual disorders, amenorrhea and galactorrhea.

2– extrapyramidal disorders may occur as Parkinson’s disease (hypersalivation, musculoskeletal stiffness, parkinsonism, drooling, rigidity type “gears”, bradykinesia, hypokinesia, Mesopotamia face, muscle tension, akinesia, rigidity of the occipital muscles, muscle rigidity, Parkinsonian gait, violations glabellar reflex, Parkinsonian rest tremor), akathisia (akathisia, anxiety, hyperkinesis and the syndrome of “restless” legs), tremor, dyskinesia (dyskinesia, muscle twitching, choreoathetosis, atetoz and myoclonus), dystonia.

The term “dystonia” includes dystonia, muscle spasms, muscle hypertension, torticollis, involuntary muscle contractions, muscle contracture, blepharospasm, eyeball movements, tongue paralysis, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurototonus, tongue spasm, and trismus. Tremors include rest tremor and parkinsonian tremor. It should also be noted that there is a broader range of symptoms that do not always have an extrapyramidal origin. Insomnia includes a falling asleep disorder, an intrasomnic disorder. Seizures include a large convulsive seizure. Menstrual disorders include irregular periods and oligomenorrhea. Edema includes generalized edema, peripheral edema, and mild edema.

3-in placebo-controlled trials, diabetes mellitus was observed in 0.18% of patients taking risperidone, compared with 0.11% of patients in the placebo group. In all clinical trials, the overall incidence of diabetes mellitus in patients taking risperidone was 0.43%.

Undesirable effects when using paliperidone

Paliperidone is an active metabolite of risperidone, so the adverse reaction profiles of risperidone and paliperidone are interrelated. In addition to the above, the following adverse reactions have been reported with paliperidone, which may also occur with risperidone:

From the cardiovascular system: postural orthostatic tachycardia syndrome.

Class-effects

As with other antipsychotic medications, there were very rare cases of prolongation of the QT interval in the post-marketing follow-up period. Other class-effects from the cardiovascular system observed with antipsychotic drugs that prolong the QT interval: ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and polymorphic ventricular tachycardia of the “pirouette”type.

Venous thromboembolism

Cases of venous thromboembolism, including pulmonary embolism and cases of deep vein thrombosis, have been reported with antipsychotic medications (frequency unknown).

Weight gain

In placebo-controlled studies in patients with schizophrenia, an increase in body weight of at least 7% after 6-8 weeks was observed in 18% of patients taking risperidone and in 9% of patients taking placebo. In placebo-controlled clinical trials in patients with manic episodes, the number of cases of weight gain of 7% or more after 3 weeks of treatment was comparable in the risperidone group (2.5%) and in the placebo group (2.4%), and in the active control group it was slightly higher (3.5%).

In children with behavioral disorders in long-term clinical trials, body weight increased by an average of 7.3 kg after 12 months of therapy. The expected increase in body weight in children aged 5-12 years with normal development is 3-5 kg per year, from 12-16 years-3-5 kg per year for girls and about 5 kg per year for boys.

Special patient groups

Side effects that have been reported more frequently in elderly patients with dementia and in children than in adult patients are described below.

Elderly patients with dementia

Transient ischemic attacks and stroke were observed in clinical trials with a frequency of 1.4% and 1.5%, respectively, in elderly patients with dementia. In addition, the following side effects were reported in elderly patients with dementia with a frequency of ≥ 5% and with a frequency at least 2 times higher than in other patient populations: urinary tract infections, peripheral edema, lethargy and cough.

Children

The following adverse events were reported in children (5 to 17 years of age) with a frequency of ≥ 5% and with a frequency at least 2 times higher than in other patient populations in clinical studies: drowsiness/sedation, fatigue, headache, increased appetite, vomiting, upper respiratory tract infections, nasal congestion, abdominal pain, dizziness, cough, pyrexia, tremor, diarrhea, enuresis.

Interaction

Interactions related to drug pharmacodynamics

Drugs that prolong the QT interval

As with other antipsychotic medications, caution should be exercised when using Torendo® Cu-tab® concomitantly with drugs that prolong the QT interval, for example, with antiarrhythmic agents (quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol, etc. ), tricyclic antidepressants (amitriptyline, etc. ), tetracyclic antidepressants (maprotilin, etc. ), some antihistamines, other antipsychotic agents, certain antimalarial drugs (quinine, mefloquine, etc. ), drugs that cause electrolyte imbalance (hypokalemia, hypomagnesemia), bradycardia, or inhibit the hepatic metabolism of risperidone. This list is not exhaustive.

Central-acting drugs and alcohol

Torendo ® Cu-tab® should be used with caution in combination with other drugs and substances of central action, especially with alcohol, opiates, antihistamines and benzodiazepines due to the increased risk of sedation.

Levodopa and dopamine receptor agonists

Torendo ® Cu-tab® may reduce the effectiveness of levodopa and other dopamine receptor agonists. If this combination is necessary, especially in the end-stage of Parkinson’s disease, the lowest effective dose of each drug should be prescribed.

Antihypertensive drugs

When using risperidone simultaneously with antihypertensive drugs in the post-marketing period, clinically significant arterial hypotension was observed.

Paliperidone

Concomitant use of Torendo ® Cu-tab® and paliperidone is not recommended, as paliperidone is an active metabolite of risperidone. Concomitant use of a combination of risperidone and paliperidone may lead to an increase in the concentration of the active antipsychotic fraction.

Interactions related to drug pharmacokinetics

Food intake does not affect the absorption of risperidone.

Risperidone is mainly metabolized by the CYP2D6 isoenzyme and to a lesser extent by the CYP3A4 isoenzyme. Risperidone and its active metabolite 9-hydroxyrisperidone are substrates of P-glycoprotein (P-gp). Drugs that affect the activity of the CYP2D6 isoenzyme and drugs that significantly inhibit or induce the activity of the CYP3A4 and/or P-gp isoenzyme may affect the pharmacokinetics of the active antipsychotic fraction of risperidone.

Potent inhibitors of the CYP2D6 isoenzyme

Concomitant use of risperidone and potent inhibitors of the CYP2D6 isoenzyme may increase the plasma concentration of risperidone and, to a lesser extent, the active antipsychotic fraction. Higher doses of a potent inhibitor of the CYP2D6 isoenzyme may increase the concentration of the active antipsychotic fraction of risperidone (for example, paroxetine, see below). It is expected that other inhibitors of the CYP2D6 isoenzyme, such as quinidine, may have a similar effect on the concentration of risperidone in blood plasma. When initiating or discontinuing therapy with a combination of risperidone and paroxetine, quinidine, or another potent CYP2D6 inhibitor, especially at higher doses, the dose of Torendo® Cu-tab®should be adjusted.

Inhibitors of the CYP3A4 and/or P-gp isoenzyme

Concomitant use of Torendo ® Ku-tab® and potent inhibitors of the CYP3A4 and/or P-gp isoenzyme may significantly increase the concentration of the active antipsychotic fraction of risperidone in blood plasma. When initiating or discontinuing therapy with a combination of risperidone and itraconazole or another potent inhibitor of the CYP3A4 isoenzyme and/or P-gp, the dose of Torendo® Cu-tab®should be adjusted.

Inducers of the CYP3A4 and/or P-gp isoenzyme

Concomitant use of Torendo ® Ku-tab® with a potent inducer of the CYP3A4 isoenzyme and/or P-gp may reduce the concentration of the active antipsychotic fraction of risperidone in blood plasma. When initiating or discontinuing therapy with a combination of risperidone and carbamazepine or another potent inducer of the CYP3A4 isoenzyme and/or P-gp, the dose of Torendo® Cu-tab®should be adjusted. The effect of inducers of the CYP3A4 isoenzyme manifests itself over time, so it may take up to 2 weeks before the maximum effect is achieved after the start of use. Accordingly, when the CYP3A4 inducer is discontinued, it may take up to 2 weeks before the effect disappears.

Drugs that bind strongly to plasma proteins

When Torendo® Cu-tab® is co-administered with drugs that have a high binding to plasma proteins, there is no clinically significant displacement of the drug from the complex with plasma proteins.

When using concomitant treatment, you should refer to the instructions for use of the appropriate drug and, if necessary, adjust the doses of the drugs taken.

Psychostimulants

When psychostimulants (for example, methylphenidate) and risperidone are used simultaneously, changing the order of use of one or both drugs may lead to extrapyramidal symptoms (see the section “Special instructions”).

Children

Drug interaction studies were conducted only in adult patients. The relevance of the results of these studies in children is unknown.

Concomitant use of psychostimulants (e. g., methylphenidate) and Torendo ® Cu-tab® in children does not alter the pharmacokinetic parameters and efficacy of risperidone.

Effect of other drugs on the pharmacokinetics of cisperidone

Antibacterial drugs

Erythromycin, a moderate inhibitor of the CYP3A4 isoenzyme and P-gp, does not affect the pharmacokinetics of cisperidone and the active antipsychotic fraction.

Rifampicin, a potent inducer of the CYP3A4 isoenzyme and P-gp, causes a decrease in the concentration of the active antipsychotic fraction in blood plasma.

Anticholinesterase drugs

Donepezil and galantamine, which are substrates of the CYP2D6 and CYP3A4 isoenzymes, do not have a clinically significant effect on the pharmacokinetics of neticurisperidone and the active antipsychotic fraction.

Antiepileptic drugs

Carbamazepine, a potent inducer of the CYP3A4 and P-gp isoenzymes, reduces the concentration of the active antipsychotic fraction of risperidone in blood plasma. Similar effects were observed with the use of phenytoin and phenobarbital, which are also inducers of the CYP3A4 and P-gp isoenzymes.

Topiramate modestly reduces the bioavailability of risperidone, but not the active antipsychotic fraction. This interaction is not considered clinically significant.

Antifungal medications

Itraconazole, a potent inhibitor of the CYP3A4 isoenzyme and P-gp, at a dose of 200 mg/day increases the concentration of the active antipsychotic fraction in plasma by approximately 70% when using risperidone at a dose of 2 to 8 mg / day.

Ketoconazole, a potent inhibitor of the CYP3A4 isoenzyme and P-gp, at a dose of 200 mg/day increases the concentration of risperidone in blood plasma and reduces the concentration of 9-hydroxyrisperidone in blood plasma.

Neuroleptics

Phenothiazines can increase the concentration of risperidone in blood plasma, but not the active antipsychotic fraction.

Antiviral drugs

Protease inhibitors: no official research data available. Since ritonavir is a potent inhibitor of the CYP3A4 isoenzyme and a weak inhibitor of the CYP2D6 isoenzyme, ritonavir and protease inhibitors enhanced with ritonavir may lead to an increase in the concentration of the active antipsychotic fraction of risperidone.

Beta-blockers

Some beta-blockers may increase the plasma concentration of risperidone, but not the active antipsychotic fraction.

Calcium Channel Blockers

Verapamil, a moderate inhibitor of the CYP3A4 isoenzyme and P-gp, increases the concentration of risperidone and the active antipsychotic fraction in blood plasma.

Drugs for the treatment of diseases of the gastrointestinal tract

_H2-receptor antagonists cimetidine and ranitidine, which are weak inhibitors of the CYP2D6 and CYP3A4 isoenzymes, increase the bioavailability of risperidone, but have minimal effect on the concentration of the active antipsychotic fraction in blood plasma.

Serotonin reuptake inhibitors and tricyclic antidepressants

Fluoxetine, a potent inhibitor of the CYP2D6 isoenzyme, increases the concentration of risperidone in blood plasma, but to a lesser extent affects the concentration of the active antipsychotic fraction.

Paroxetine, a potent inhibitor of the CYP2D6 isoenzyme, increases the concentration of risperidone in blood plasma, but at doses up to 20 mg / day it has a lesser effect on the concentration of the active antipsychotic fraction. However, higher doses of paroxetine may increase the concentration of the active antipsychotic fraction of risperidone.

Tricyclic antidepressants may increase the concentration of risperidone in the blood plasma, but do not affect the concentration of the active antipsychotic fraction. Amitriptyline does not affect the pharmacokinetics of risperidone or the active antipsychotic fraction.

Sertraline is a weak inhibitor of the CYP2D6 isoenzyme, and fluvoxamine is a weak inhibitor of the CYP3A4 isoenzyme. At doses up to 100 mg/day, sertraline and fluvoxamine do not have a clinically significant effect on the concentration of the active antipsychotic fraction of risperidone. However, the use of sertraline or fluvoxamine in doses higher than 100 mg / day may lead to an increase in the concentration of the active antipsychotic fraction of risperidone.

Effect of risperidone on the pharmacokinetics of other drugs

Antiepileptic drugs

Risperidone has no clinically significant effect on the pharmacokinetics of valproic acid or topiramate.

Neuroleptics

Aripiprazole, a substrate of CYP2D6 and CYP3A4 isoenzymes: risperidone has no effect on the pharmacokinetics of aripiprazole and its active metabolite, dehydroaripiprazole.

Cardiac Glycosides

Risperidone has no clinically significant effect on the pharmacokinetics of digoxin. The use of therapeutic doses of digoxin in combination with risperidone at a dose of 0.25 mg 2 times a day did not lead to a change in exposure and did not require dosage adjustment.

Lithium preparations

Risperidone has no clinically significant effect on the pharmacokinetics of lithium preparations.

Concomitant use with furosemide

See. For information on increased mortality in elderly patients with dementia taking furosemide concomitantly, see the section “Special Instructions”.

How to take, course of use and dosage

Torendo ® Cu-tab® can be used as an alternative to Torendo®in patients who have difficulty swallowing the tablet.

Due to the fact that tablets are fragile, they should not be squeezed out through the foil of the package, as they may break. Do not take the tablet with wet hands, because the tablet may melt.

Remove the tablet as follows:

1. Take the blister, bend it along the tear line and tear it off.

2. Open the blister by gently pulling on the edge of the foil.

3. Gently shake the tablet into the palm of your hand.

4. Then it should be immediately placed on the tongue.

The tablet should be held in the mouth for a few seconds until it is fully dissolved (to facilitate swallowing), then you can wash it down with liquid. Do not mix the tablet in your mouth with food.

You can also put the pill in a full glass of water and drink it immediately.

Schizophrenia

Adults

Torendo®preparation Cu-tab® can be used 1 or 2 times a day.

Initial dose of Torendo®Cu-tab® is 2 mg per day. On the second day, the dose can be increased to 4 mg per day. From this point on, 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 increase in the dose and lower initial and maintenance doses may be justified.

Doses higher than 10 mg / day have not been shown to be more effective than lower doses and may cause extrapyramidal symptoms. Due to the fact that the safety of doses above 16 mg per day has not been studied, doses above this level are not recommended.

Elderly patients

The recommended starting dose is 0.5 mg taken 2 times a day. The dose can be individually increased by 0.5 mg 2 times a day to 1-2 mg 2 times a day.

Children over 13 years old

An initial dose of 0.5 mg once daily in the morning or evening is recommended. If necessary, the dosage can be increased after at least 24 hours by 0.5-1 mg per day to the recommended dose of 3 mg per day if well tolerated. Despite the efficacy demonstrated in the treatment of schizophrenia in adolescents at doses of 1-6 mg per day, no additional efficacy was observed at doses higher than 3 mg per day, and higher doses caused more side effects. The use of doses higher than 6 mg per day has not been studied.

Patients with persistent drowsiness are recommended to take half the daily dose 2 times a day.

Manic episodes associated with bipolar disorder, moderate to severe

Adults

The recommended starting dose of Torendo ® Cu-tab® is 2 mg once a day. If necessary, this dose can be increased by at least 1 mg per day after 24 hours. For most patients, the optimal dose is 1-6 mg per day. The use of doses higher than 6 mg per day in patients with manic episodes has not been studied. As with any other symptomatic therapy, the feasibility of continuing treatment with Torendo ® Cu-tab® should be regularly evaluated and confirmed.

Elderly patients

The recommended starting dose is 0.5 mg taken 2 times a day. The dose can be individually increased by 0.5 mg 2 times a day to 1-2 mg 2 times a day. The experience of use in elderly patients is limited, caution should be exercised.

Children over 10 years old

An initial dose of 0.5 mg once daily in the morning or evening is recommended. If necessary, the dosage can be increased after at least 24 hours by 0.5-1%^%mg per day to the recommended dose of 1-2.5 mg per day if well tolerated. Despite the efficacy demonstrated in the treatment of manic episodes associated with bipolar disorder in children at doses of 0.5-6 mg per day, no additional efficacy was observed at doses higher than 2.5 mg per day, and higher doses caused more side effects. The use of doses higher than 6 mg per day has not been studied.

Patients with persistent drowsiness are recommended to take half the daily dose 2 times a day.

Persistent aggression in patients with moderate to severe Alzheimer’s dementia

The recommended starting dose is 0.25 mg twice daily. If necessary, an individual increase in the dose of 0.25 mg 2 times a day with an interval of at least 1 day is possible. For most patients, the optimal dose is 0.5 mg 2 times a day. In some patients, however, the effective dose may be 1 mg twice daily. Torendo ® Ku-tab® should not be used for more than 6 weeks with persistent aggression in patients with Alzheimer’s dementia. During treatment with Torendo® Cu-tab®, a frequent and regular assessment of the patient’s condition is necessary to decide whether to continue therapy.

Persistent aggression in the structure of behavioral disorders in children from 5 years of age with mental retardation

Children from 5 to 18 years old

For patients with a body weight of 50 kg or more, an initial dose of Torendo® Cu-tab®0.5 mg once a day is recommended. If necessary, this dose can be increased by 0.5 mg once a day after at least 24 hours. For most patients, the optimal dose is 1 mg once a day. However, for some patients,0.5 mg per day is preferable, while some require an increase in the dose to 1.5 mg per day.

For patients with a body weight of less than 50 kg, an initial dose of 0.25 mg once a day is recommended. If necessary, this dose can be increased by 0.25 mg once a day after at least 24 hours. For most patients, the optimal dose is 0.5 mg once a day. However, for some patients,0.25 mg per day is preferable, while some require an increase in the dose to 0.75 mg per day.

As with any other symptomatic therapy, the feasibility of continuing treatment with Torendo ® Cu-tab® should be regularly evaluated and confirmed.

Use in children under 5 years of age is not recommended due to lack of data.

Special patient groups

Impaired kidney and liver function

In patients with impaired renal function, the ability to remove the active antipsychotic fraction is reduced compared to other groups of patients. In patients with impaired liver function, an increased concentration of the free fraction of risperidone in the blood plasma is observed.

The initial and maintenance dose should be reduced by 2 times according to the indications, and the dose increase in patients with impaired liver and kidney function should be carried out more slowly.

Torendo ® Cu-tab® should be used with caution in this category of patients.

Method of application

Inside, regardless of the meal time.

At the beginning of the dosage and when increasing the dose, as well as if it is necessary to take a dosage of risperidone 0.25 mg, adequate dosage forms of risperidone should be used with the possibility of dosing 0.25 mg.

Torendo ® Cu-tab® should be discontinued gradually. With abrupt discontinuation of high-dose antipsychotic medications, including risperidone, in very rare cases, the development of “withdrawal” syndrome (nausea, vomiting, increased sweating and insomnia), possible relapses of psychotic symptoms and the appearance of involuntary movements (such as akathisia, dystonia and dyskinesia) was observed.

Transition from therapy with other antipsychotic drugs

At the beginning of the use of Torendo® Cu-tab®, it is recommended to gradually cancel the previous therapy, if this is clinically justified. In the case of previous therapy with depo-forms of antipsychotic drugs, therapy with Torendo ® Cu-tab® is recommended to begin instead of the next scheduled injection. Periodically, the need to continue current therapy with Antiparkinsonian drugs should be evaluated.

Overdose

Symptoms: drowsiness, sedation, depression of consciousness, tachycardia, hypotension, extrapyramidal disorders, in rare cases prolongation of the QT interval and convulsions. Polymorphic ventricular tachycardia of the “pirouette” type has been described in overdose in patients taking risperidone and paroxetine concomitantly.

In the case of acute overdose, it is necessary to consider the possibility of overdose from taking several medications.

Treatment: provide free airway patency for adequate oxygenation and ventilation. Gastric lavage (after intubation, if the patient is unconscious), as well as the use of activated charcoal and laxatives should only be performed if risperidone was taken no more than 1 hour ago.

For timely diagnosis of a possible cardiac arrhythmia, it is necessary to start ECG monitoring as soon as possible. There is no specific antidote, and appropriate symptomatic therapy should be performed. Intravenous use of infusion solutions and/or sympathomimetic drugs is recommended for low blood pressure and vascular collapse. In case of acute extrapyramidal symptoms, anticholinergic agents should be prescribed. Careful medical monitoring and ECG monitoring are performed until the symptoms of intoxication completely disappear.

Description

Round, slightly biconvex tablets of light pink color with visible inclusions.

Special instructions

· cardiovascular Disease (congestive heart failure, myocardial infarction, conduction disorders cardiac muscle);

· hypotension (a correction of the dose);

· dehydration and hypovolemia;

· disorders of cerebral circulation;

· Parkinson’s disease;

· seizures (including in the anamnesis);

· severe renal and/or hepatic failure (see section “Method of use and dose”);

· abuse of drugs or drug dependence;

· state, predisposing to the development of tachycardia type “pirouette” (bradycardia, electrolyte imbalance, concomitant use of drugs, lengthening of the QT interval);

· metabolic disorders including hyperglycemia, dyslipidemia (need to control the weight of the patient);

· hyperprolactinemia;

· leukopenia, neutropenia, agranulocytosis;

· a brain tumor, intestinal obstruction, acute drug overdose, Reye’s syndrome (antiemetic effects of risperidone may mask the symptoms of these conditions);

· risk factors for thromboembolism venous vessels;

· diffuse disease Taurus Levi;

· use in elderly patients with cerebrovascular dementia;

· pregnancy;

· concomitant use with furosemide.

Schizophrenia

Children over 13 years old

An initial dose of 0.5 mg once daily in the morning or evening is recommended. If necessary, the dosage can be increased after at least 24 hours by 0.5-1 mg per day to the recommended dose of 3 mg per day if well tolerated. Despite the efficacy demonstrated in the treatment of schizophrenia in adolescents at doses of 1-6 mg per day, no additional efficacy was observed at doses higher than 3 mg per day, and higher doses caused more side effects. The use of doses higher than 6 mg per day has not been studied.

Patients with persistent drowsiness are recommended to take half the daily dose 2 times a day.

Manic episodes associated with bipolar disorder, moderate to severe

Children over 10 years old

An initial dose of 0.5 mg once daily in the morning or evening is recommended. If necessary, the dosage can be increased at least 24 hours later by 0.5-1 mg per day to the recommended dose of 1-2.5 mg per day if well tolerated. Despite the efficacy demonstrated in the treatment of manic episodes associated with bipolar disorder in children at doses of 0.5-6 mg per day, no additional efficacy was observed at doses higher than 2.5 mg per day, and higher doses caused more side effects. The use of doses higher than 6 mg per day has not been studied.

Patients with persistent drowsiness are recommended to take half the daily dose 2 times a day.

Persistent aggression in the structure of behavioral disorders in children from 5 years of age with mental retardation

Children from 5 to 18 years old

For patients with a body weight of 50 kg or more, an initial dose of Torendo® Cu-tab®0.5 mg once a day is recommended. If necessary, this dose can be increased by 0.5 mg once a day after at least 24 hours. For most patients, the optimal dose is 1 mg once a day. However, for some patients,0.5 mg per day is preferable, while some require an increase in the dose to 1.5 mg per day.

For patients with a body weight of less than 50 kg, an initial dose of 0.25 mg once a day is recommended. If necessary, this dose can be increased by 0.25 mg once a day after at least 24 hours. For most patients, the optimal dose is 0.5 mg once a day. However, for some patients,0.25 mg per day is preferable, while some require an increase in the dose to 0.75 mg per day.

As with any other symptomatic therapy, the feasibility of continuing treatment with Torendo ® Cu-tab® should be regularly evaluated and confirmed.

Use in children under 5 years of age is not recommended due to lack of data.

Elderly patients

The recommended starting dose is 0.5 mg taken 2 times a day. The dose can be individually increased by 0.5 mg 2 times a day to 1-2 mg 2 times a day. The experience of use in elderly patients is limited, caution should be exercised.

Impaired kidney and liver function

In patients with impaired renal function, the ability to remove the active antipsychotic fraction is reduced compared to other groups of patients. In patients with impaired liver function, an increased concentration of the free fraction of risperidone in the blood plasma is observed.

The initial and maintenance dose should be reduced by 2 times according to the indications, and the dose increase in patients with impaired liver and kidney function should be carried out more slowly.

Torendo ® Cu-tab® should be used with caution in this category of patients.

Use in elderly patients with dementia

Increased mortality in elderly patients with dementia

According to the results of a meta-analysis of clinical trials in elderly patients with dementia who used atypical antipsychotic drugs, an increase in mortality was found compared with the placebo group. Mortality in patients treated with risperidone or placebo was 4.0% and 3.1%, respectively. The average age of deceased patients was 86 years (range 67-100 years). According to two extensive observational studies, elderly patients with dementia who are treated with typical antipsychotic medications show a slight increase in the risk of death compared to those who do not receive treatment. Currently, insufficient data has been collected to accurately assess this risk. The reason for the increase in this risk is also unknown. Also, the extent to which the increase in mortality can be attributed to antipsychotic drugs, rather than to the characteristics of this group of patients, has not been determined.

Concomitant use with furosemide

When furosemide and risperidone were co-administered orally, elderly patients with dementia experienced increased mortality (7.3%, mean age 89 years, range 75-97 years). compared to the risperidone-only group (3.1%, mean age 84 years, range 70-96 years) and the furosemide-only group (4.1%, mean age 80 years, range 67-90 years). An increase in mortality when furosemide was administered concomitantly with risperidone was observed in 2 out of 4 clinical trials. Concomitant use of risperidone with other diuretics (mainly low-dose thiazide diuretics) was not associated with increased mortality.

No pathophysiological mechanisms have been established to explain this observation. However, special care should be taken when using the drug in such cases. The risk/benefit ratio should be carefully evaluated before use. There was no increase in mortality in patients taking other diuretics concomitantly with risperidone. Regardless of therapy, dehydration is a common risk factor for mortality and should be carefully monitored in elderly patients with dementia.

When using risperidone compared with placebo in elderly patients with dementia, there was an increase in side effects from the cerebrovascular system (acute and transient disorders of the cerebral circulation), including deaths (mean age 85 years, range 73-97 years). Therefore, risperidone should be used with caution in patients at risk of stroke.

Cerebrovascular adverse events

In placebo-controlled clinical trials, patients with dementia taking certain atypical antipsychotic medications experienced an approximately 3-fold increased risk of cerebrovascular side effects. Summary data from 6 placebo-controlled trials, which included mainly elderly patients with dementia (over 65 years of age), show that cerebrovascular side effects (serious and non-serious) occurred in 3.3% (33/1009) of patients taking risperidone, and in 1.2% (8/712) of patients taking placebo. The risk ratio was 2.96 (1.34; 7.50) with a 95% confidence interval. The mechanism of increased risk is unknown. An increased risk cannot be excluded with other antipsychotic medications or in other patient populations. Torendo ® Cu-tab® should be used with caution in patients with risk factors for stroke.

The risk of developing cerebrovascular adverse events in patients with mixed or vascular dementia was significantly higher than in patients with Alzheimer’s disease-related dementia. Therefore, risperidone should not be used in patients with any type of dementia other than Alzheimer’s dementia.

It is necessary to evaluate the risk/benefit ratio before using Torendo ® Cu-tab® in elderly patients with dementia, taking into account the risk factors for stroke in a particular patient. Patients and their caregivers should be informed immediately to inform the doctor about possible manifestations of cerebrovascular disorders (such as sudden weakness or immobility/numbness in the face, legs, hands, as well as speech difficulties and visual disturbances). The necessary medical measures should be taken immediately, including discontinuation of risperidone.

Torendo ® Ku-tab® can only be used for short-term therapy of persistent aggression in patients with moderate to severe Alzheimer’s dementia, as an adjunct to non-pharmacological correction methods, if they are ineffective or of limited effectiveness, and when there is a risk of harm to the patient to himself or others.

It is necessary to constantly assess the patient’s condition and the need to continue risperidone therapy.

Orthostatic hypotension

Due to the alpha-blocking effect of risperidone, orthostatic hypotension may develop in some patients, especially during the initial dose selection period. Cases of clinically significant arterial hypotension with concomitant use of risperidone with antihypertensive drugs in the post-marketing period are described. Torendo ® Cu-tab® should be used with caution in patients with cardiovascular diseases (for example, chronic heart failure, myocardial infarction, cardiac muscle conduction disorders, dehydration, hypovolemia or cerebrovascular diseases). Appropriate dose adjustment is also necessary. It is recommended to evaluate the possibility of reducing the dose in case of hypotension.

Leukopenia, neutropenia and agranulocytosis

Cases of leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotic medications, including risperidone. Agranulocytosis was very rare ( Patients with a clinically significant decrease in white blood cell count or a history of drug-induced leukopenia / neutropenia should be monitored in the first few months after starting therapy, and when the first signs of a clinically significant decrease in white blood cell count appear, in the absence of other causal factors, treatment should be discontinued.

Patients with clinically significant neutropenia should be closely monitored for fever or other symptoms of infection, and immediately begin treatment if such symptoms occur. Patients with severe neutropenia (absolute neutrophil count

Tardive dyskinesia/extrapyramidal symptoms

Dopamine receptor antagonist therapy can cause tardive dyskinesia, which is characterized by rhythmic involuntary movements, mainly of the tongue and / or facial muscles. The occurrence of extrapyramidal symptoms is a risk factor for tardive dyskinesia. If a patient experiences objective or subjective symptoms that indicate tardive dyskinesia, discontinuation of all antipsychotic medications, including Torendo® Cu-tab®, should be considered.

Caution should be exercised in patients taking concomitant psychostimulants (e. g., methylphenidate) and risperidone, due to the possibility of extrapyramidal symptoms. In these cases, gradual withdrawal of psychostimulants is recommended.

Neuroleptic malignant syndrome (NMS)

When treated with antipsychotic drugs, it is possible to develop NMS characterized by hyperthermia, muscle rigidity, instability of the autonomic nervous system function, depression of consciousness and increased activity of creatine phosphokinase in blood plasma, as well as myoglobinuria (rhabdomyolysis) and acute renal failure. If a patient experiences objective or subjective symptoms of NMS, all antipsychotic medications, including risperidone, should be discontinued immediately.

Parkinson’s disease and dementia with Lewy bodies

Antipsychotic medications, including Torendo Ku-tab, should be used with caution in patients with Parkinson’s disease or Lewy body dementia, as both groups of patients have an increased risk of developing NMS and increased sensitivity to antipsychotic medications (including blunted pain sensitivity, confusion, postural instability with frequent falls, and extrapyramidal symptoms). When taking risperidone, the course of Parkinson’s disease may worsen.

Hyperglycemia and diabetes mellitus

Cases of hyperglycemia, diabetes mellitus, and worsening of the course of diabetes mellitus are described. In some cases, there is an increase in body weight prior to therapy, which can be regarded as a predisposing factor. In very rare cases, ketoacidosis and rarely diabetic coma were observed. As with any antipsychotic medication, patients should be supervised by a doctor, and hyperglycemic symptoms (such as polydipsia, polyuria, polyphagia, and weakness) should be monitored. In patients with diabetes mellitus, blood glucose levels should be monitored regularly.

Weight gain

There is a significant increase in body weight. It is necessary to conduct regular monitoring of patients ‘ body weight.

Hyperprolactinemia

Based on the results of initro studies, it is suggested that the growth of breast cancer cells can be stimulated by prolactin. Despite the fact that clinical and epidemiological studies have not shown a clear association of hyperprolactinemia with antipsychotic medications, caution should be exercised when using risperidone in patients with a burdened anamnesis. Torendo ® Cu-tab® should be used with caution in patients with pre-existing hyperprolactinemia and in patients with possible prolactin-dependent tumors.

Prolongation of the QT interval

In very rare cases, prolongation of the QT interval in the post-marketing period was noted. As with other antipsychotics, caution should be exercised when using the drug Torendo® Q-tab® in patients with cardiovascular disease, QT prolongation, family history, bradycardia, impaired electrolyte balance (hypokalemia, hypomagnesemia), as this may increase the risk of arrhythmogenic actions or with simultaneous use with drugs that lengthen the QT interval.

Convulsions

Torendo ® Cu-tab® should be used with caution in patients with a history of seizures or in conditions with a decrease in the threshold of convulsive activity.

Priapism

Since risperidone has an alpha-adrenoblocking effect, priapism may develop when used.

Dysregulation of body temperature

When using antipsychotic drugs, such an undesirable effect as a violation of thermoregulation is described. Caution should be exercised when using Torendo ® Cu-tab® in patients who may be exposed to factors that cause an increase in body temperature, such as intense physical activity, dehydration, high ambient temperature, simultaneous use with drugs that have anticholinergic activity.

Antiemetic effect

In preclinical studies of the use of risperidone, an antiemetic effect was observed. This effect, when experienced in humans, can mask the signs and symptoms of overdose of certain medications or diseases such as intestinal obstruction, Reye’s syndrome, and brain tumors.

Impaired kidney and liver function

In patients with impaired renal function, the ability to remove the active antipsychotic fraction is lower than in adult patients with normal renal function. In patients with impaired liver function, the concentration of the free fraction of risperidone in the blood plasma increases.

Venous thromboembolism

When using antipsychotic drugs, cases of venous thromboembolism have been described. All possible risk factors for thromboembolic events should be identified before and during therapy with Torendo ® Cu-tab® and preventive measures should be taken.

Intraoperative flabby iris syndrome (ISDR)

ISDROT has been observed during cataract surgery in patients treated with drugs that are antagonistic to alpha_-1adrenergic receptors, including Torendo ® Cu-tab®. ISDR may increase the risk of visual complications during and after surgery. It is necessary to inform the ophthalmologist in advance about the use of drugs that have antagonism to alpha_-1-adrenergic receptors at the present time or in the past. The potential benefit of discontinuing therapy with alpha_-1-adrenergic antagonists prior to cataract surgery has not been established. It is necessary to assess the benefit / risk ratio of discontinuation of antipsychotic therapy.

Children and teenagers

Before using Torendo® Cu-tab® in children or adolescents with intellectual disability, a thorough assessment of their condition should be carried out for the presence of physical or social causes of aggressive behavior, such as pain or inadequate social requirements.

The sedative effect of risperidone should be carefully monitored in this population because of its possible effects on learning ability. Changing the time of taking risperidone may reduce the effect of sedation on the attention span of adolescents and children.

Risperidone use was associated with an increase in mean body mass and body mass index scores. Changes in height during long-term studies were within the expected age norms. The effect of long-term use of risperidone on sexual development and growth is not fully understood.

Due to the possible impact of prolonged hyperprolactinemia on growth and sexual development in children and adolescents, regular clinical assessment of hormonal status should be carried out, including measurement of height, body weight, monitoring of sexual development, menstrual cycle and other possible prolactin-dependent effects.

During risperidone therapy, a regular examination should be performed to detect extrapyramidal symptoms and other motor disorders.

Form of production

Tablets dispersed in the oral cavity,0.5 mg,1 mg,2 mg.

10 tablets in a blister of combined OPA/Al/PVC, PET/Al foil (OPA/Al/PVC, PET/Alpeeloffffoil).

3 blisters in a cardboard pack together with the instructions for use.

Storage conditions

At a temperature not exceeding 25 ° C, in the original packaging.

Keep out of reach of children.

Shelf

life is 3 years.

Do not use the drug after the expiration date.

Active ingredient

Risperidone

Conditions of release from pharmacies

By prescription

Dosage form

tablets for resorption

Purpose

For adults by doctor’s prescription, Children by doctor’s prescription, Children over 15 years of age

Indications

Schizophrenia, Manic-depressive psychosis, Alzheimer’s disease, Mental disorders