Risperidone, 2 mg, film-coated tablets, 20 pcs.

Risperidone

Active substance:

Risperidone*

Pharmgroup:

Neuroleptics

Average price in pharmacies

Indications for use

• schizophrenia;
• manic episodes associated with severe/moderate bipolar disorder;
• persistent aggression in patients with dementia due to moderate/severe Alzheimer's disease, which is not amenable to non-pharmacological methods of correction in cases where there is a possibility of harm by the patient to himself/others (short therapy for up to 6 weeks);
• persistent aggression in the structure of conduct disorder in children over 5 years of age with mental retardation, which is diagnosed in accordance with DSM-IV, for which drug therapy is indicated due to the severity of aggression/other destructive behavior; pharmacological treatment should be part of a broader program that includes educational and psychosocial interventions; Risperidone can be prescribed by a specialist in child neurology, child and adolescent psychiatry, or a doctor who is familiar with the treatment of behavioral disorders in children and adolescents (short-term symptomatic therapy for up to 6 weeks);
• dementia (therapy for behavioral disorders) (solution).

Instructions:

Clinical and pharmacological group

02.001 (Antipsychotic drug (neuroleptic))

pharmachologic effect

Antipsychotic drug (neuroleptic), benzisoxazole derivative. It has a high affinity for serotonin 5-HT2 and dopamine D2 receptors. Binds to α1-adrenergic receptors and, with slightly lower affinity, to histamine H1 receptors and α2-adrenergic receptors. Has no affinity for cholinergic receptors. Although risperidone is a potent D2 antagonist (which is believed to be the main mechanism for improving the productive symptoms of schizophrenia), it causes less pronounced suppression of motor activity and induces catalepsy to a lesser extent than classical antipsychotics. Due to balanced antagonism to serotonin and dopamine receptors in the central nervous system, the likelihood of developing extrapyramidal side effects is reduced.

Risperidone may induce a dose-dependent increase in plasma prolactin concentrations.

Pharmacokinetics

After oral administration, risperidone is completely absorbed from the gastrointestinal tract, Cmax in plasma is reached within 1-2 hours. Food does not affect the absorption of risperidone.

Css of risperidone in the body in most patients is achieved within 1 day. Css of 9-hydroxyrisperidone is achieved within 4-5 days. Plasma concentrations of risperidone are dose proportional (over the therapeutic dose range).

Risperidone is rapidly distributed in the body, Vd is 1-2 l/kg. In plasma, risperidone binds to albumin and alpha1 glycoprotein. The binding of risperidone to plasma proteins is 88%, 9-hydroxyrisperidone - 77%.

Risperidone is metabolized in the liver with the participation of the CYP2D6 isoenzyme with the formation of 9-hydroxyrisperidone, which has a pharmacological effect similar to risperidone. The antipsychotic effect is due to the pharmacological activity of risperidone and 9-hydroxyrisperidone. Another route of metabolism for risperidone is N-dealkylation.

After oral administration in patients with psychosis, T1/2 of risperidone from plasma is 3 hours. T1/2 of 9-hydroxyrisperidone and the active antipsychotic fraction is 24 hours.

After 1 week of use, 70% is excreted in the urine, 14% in feces. In urine, the total content of risperidone and 9-hydroxyrisperidone is 35-45%. The rest is inactive metabolites.

In elderly patients and in patients with renal insufficiency, increased plasma concentrations and delayed elimination of risperidone were observed after a single oral dose.

Dosage

Individual. When taken orally, the initial dose for adults is 0.25-2 mg/day, on the 2nd day - 4 mg/day. Then the dose can either be kept at the same level or, if necessary, adjusted. Typically, the optimal therapeutic dose, depending on the indications, is in the range of 0.5-6 mg/day. In some cases, a slower dose escalation and lower initial and maintenance doses may be justified.

For schizophrenia, for elderly patients, as well as for concomitant liver and kidney diseases, an initial dose of 500 mcg 2 times a day is recommended. If necessary, the dose can be increased to 1-2 mg 2 times a day.

Maximum dose: When using risperidone at a dose of more than 10 mg/day, there is no increase in effectiveness compared to lower doses, but the risk of developing extrapyramidal symptoms increases. The safety of risperidone in doses greater than 16 mg/day has not been studied, so further excess of the dose is not allowed.

Drug interactions

With the simultaneous use of inducers of microsomal liver enzymes, a decrease in the concentration of risperidone in the blood plasma is possible.

When used simultaneously with phenothiazine derivatives, tricyclic antidepressants and beta-blockers, the concentration of risperidone in the blood plasma may increase.

When used simultaneously with carbamazepine, the concentration of risperidone in the blood plasma is significantly reduced.

When used concomitantly, risperidone reduces the effects of levodopa and other dopamine receptor agonists.

When used simultaneously with fluoxetine, an increase in the concentration of risperidone in the blood plasma is possible.

Use during pregnancy and lactation

Use during pregnancy is possible if the expected benefit of therapy for the mother outweighs the potential risk to the fetus. If use is necessary during lactation, breastfeeding should be discontinued.

Side effects

From the side of the central nervous system: often - insomnia, agitation, anxiety, headache; possible - drowsiness, fatigue, dizziness, impaired ability to concentrate, impaired vision; rarely - extrapyramidal symptoms (including tremor, rigidity, hypersalivation, bradykinesia, akathisia, acute dystonia). Patients with schizophrenia may experience tardive dyskinesia, NMS, thermoregulation disorders, and seizures.

From the digestive system: constipation, dyspeptic symptoms, nausea, vomiting, abdominal pain, increased activity of liver enzymes.

From the reproductive system: priapism, erectile dysfunction, ejaculation disorders, orgasm disorders.

From the cardiovascular system: rarely - orthostatic hypotension and reflex tachycardia, arterial hypertension.

From the endocrine system: galactorrhea, gynecomastia, menstrual irregularities, amenorrhea, weight gain.

From the hematopoietic system: a slight decrease in the number of neutrophils and/or platelets.

Allergic reactions: rhinitis, skin rash, angioedema.

Other: urinary incontinence.

Indications

Treatment of schizophrenia (including new-onset acute psychosis, acute attack of schizophrenia, chronic schizophrenia); psychotic states with pronounced productive (hallucinations, delusions, thought disorders, hostility, suspicion) and/or negative (blunted affect, emotional and social detachment, poverty of speech) symptoms; to reduce affective symptoms (depression, guilt, anxiety) in patients with schizophrenia; prevention of relapses (acute psychotic states) in chronic schizophrenia; treatment of behavioral disorders in patients with dementia with symptoms of aggressiveness (outbursts of anger, physical violence), mental disturbances (agitation, delusions) or psychotic symptoms; treatment of mania in bipolar disorders (as a mood stabilizer as an adjuvant therapy).

Contraindications

Hypersensitivity to risperidone.

special instructions

Use with caution in patients with diseases of the cardiovascular system (including heart failure, myocardial infarction, cardiac muscle conduction disorders), as well as in cases of dehydration, hypovolemia or cerebrovascular disorders. In this category of patients, the dose should be increased gradually.

The risk of developing orthostatic hypotension is especially increased in the initial period of dose selection. If hypotension occurs, dose reduction should be considered.

When using drugs that have the properties of dopamine receptor antagonists, the occurrence of tardive dyskinesia, characterized by involuntary rhythmic movements (mainly of the tongue and/or face), was noted. There are reports that the occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. Risperidone causes extrapyramidal symptoms to a lesser extent than classical antipsychotics. If symptoms of tardive dyskinesia occur, discontinuation of all antipsychotic medications should be considered.

If NMS develops, all antipsychotics, including risperidone, should be discontinued.

Risperidone should be used with caution in patients with Parkinson's disease, as it is theoretically possible that the disease may worsen.

Classical antipsychotics are known to lower the seizure threshold. Given this, risperidone is recommended to be used with caution in patients with epilepsy.

Risperidone should be used with caution in combination with other centrally acting drugs.

When discontinuing carbamazepine and other hepatic enzyme inducers, the dose of risperidone should be reconsidered and, if necessary, reduced.

During the treatment period, patients should be advised to refrain from overeating due to the possibility of weight gain.

There are no data on the safety of risperidone in children under 15 years of age.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, until individual sensitivity to risperidone is determined, patients should avoid driving vehicles and other activities that require high concentration and speed of psychomotor reactions.

Preparations containing RISPERIDONE

• RISPOLUX® (RISPOLUX®) tab., coated. film coating, 4 mg: 20, 50 or 60 pcs. • LEPTINORM tablets, film-coated 2 mg: 30 pcs. • SPERIDAN® tab., coated. film-coated, 4 mg: 20 pcs. • RISPOLUX® (RISPOLUX®) tab., coated. film coating, 1 mg: 20, 50, 60 or 100 pcs. • TORENDO® (TORENDO) tab., coated. film coating, 3 mg: 20, 30 or 60 pcs. • RISDONAL® tab., coated. coated, 3 mg: 20 pcs. • RISPEN tab. 4 mg: 20, 30 or 50 pcs. • RISPOLEPT® tab., coated. coated, 2 mg: 20 pcs. • RISDONAL® tab., coated. coated, 1 mg: 20 pcs. • RISPEN tab. 1 mg: 20, 30 or 50 pcs. • NEIPILEPT film-coated tablets 4 mg: 20 pcs. • RISPEN tab. 3 mg: 20, 30 or 50 pcs. • RISPOLEPT® tab., coated. coated, 4 mg: 20 pcs. • SPERIDAN® tab., coated. coated, 1 mg: 10, 20, 100, 200, 400 or 600 pcs. • TORENDO® (TORENDO) tab., coated. film coating, 2 mg: 20, 30 or 60 pcs. • RISDONAL® tab., coated. coated, 2 mg: 20 pcs. • RISPOLUX® (RISPOLUX®) tab., coated. film coating, 2 mg: 20, 50, 60 or 100 pcs. • NEIPILEPT film-coated tablets 2 mg: 20 pcs. • SPERIDAN® tab., coated. coated, 2 mg: 10, 20, 100, 200, 400 or 600 pcs. • SPERIDAN® tab., coated. coated, 4 mg: 20 pcs. • RISPAKSOLE 1 mg film-coated tablets: 20 or 60 pcs. • RILEPTID® tab., coated. coated, 3 mg: 10, 20 or 60 pcs. • RISPOLEPT® QUIСKLET tab. for resorption 1 mg: 28 or 56 pcs. • RISPAKSOLE tablets, film-coated 2 mg: 20 or 60 pcs. • LEPTINORM tablets, film-coated 4 mg: 30 pcs. • RILEPTID® tab., coated. coated, 4 mg: 20 pcs. • TORENDO® KU-TAB (TORENDO Q-TAB) tab. for resorption 500 mcg: 30 pcs. • RISDONAL® tab., coated. coated, 2 mg: 20 pcs. • RIDONEX® (RIDONEX) tab., coated. film-coated, 2 mg: 20 pcs. • RISPOLEPT CONSTA powder for preparation. susp. d/i/m administration prolonged. action 37.5 mg: vial. 1 PC. included with solvent (syringes) • SPERIDAN® tab., coated. coated, 2 mg: 20 or 100 pcs. • RISPOLEPT CONSTA powder for preparation. susp. d/i/m administration prolonged. actions 25 mg: vial. 1 PC. included with solvent (syringes) • RISPEN tab. 2 mg: 20, 30 or 50 pcs. • RISSET® tab., coated. film-coated, 1 mg: 20 or 60 pcs. • SPERIDAN® tab., coated. coated, 2 mg: 20 pcs. • SPERIDAN® tab., coated. coated, 1 mg: 20 pcs. 1 • RISPOLEPT® QUICKLET tab. for resorption 2 mg: 28 or 56 pcs. • SPERIDAN® tab., coated. coated, 4 mg: 10, 20, 100, 200, 400 or 600 pcs. • RISPOLEPT® tab., coated. coated, 2 mg: 20 or 60 pcs. • SIZODON-SUN (SIZODON-SUN) tab., cover. coated, 2 mg: 10, 20 or 30 pcs. • RIDONEX® (RIDONEX) tab., coated. film-coated, 1 mg: 20 pcs. • SIZODON-SUN (SIZODON-SUN) tab., cover. coated, 1 mg: 10, 20 or 30 pcs. • RILEPTID® tab., coated. coated, 1 mg: 10, 20 or 60 pcs. • TORENDO® (TORENDO) tab., coated. film coating, 4 mg: 20, 30 or 60 pcs. • RISSET® tab., coated. film-coated, 2 mg: 20 or 60 pcs. • RILEPTID® tab., coated. coated, 2 mg: 20 pcs. • TORENDO® KU-TAB (TORENDO Q-TAB) tab. for resorption 1 mg: 30 pcs. • SPERIDAN® tab., coated. coated, 1 mg: 20 pcs. • RISPOLEPT CONSTA powder for preparation. susp. d/i/m administration prolonged. actions 50 mg: vial. 1 PC. included with solvent (syringes) • RISPOLEPT® tab., coated. coated, 4 mg: 20 or 60 pcs. • RIDONEX® (RIDONEX) tab., coated. film-coated, 4 mg: 20 pcs. • SIZODON-SUN (SIZODON-SUN) tab., cover. coated, 4 mg: 10, 20 or 30 pcs. • RISPOLEPT® solution for oral administration 1 mg/1 ml: vial. 30 ml or 100 ml per set. with graduated pipette • RISPOLUX® (RISPOLUX®) tab., coated. film coating, 3 mg: 20, 50 or 60 pcs. • RISPOLEPT® tab., coated. coated, 3 mg: 20 or 60 pcs. • SIZODON-SUN (SIZODON-SUN) tab., cover. coated, 3 mg: 10, 20 or 30 pcs. • RISDONAL® tab., coated. coated, 1 mg: 20 pcs. • RISPOLEPT® tab., coated. coated, 1 mg: 20 or 60 pcs. • RISSET® tab., coated. film-coated, 4 mg: 20 or 60 pcs. • RISPAKSOLE tablets, film-coated 4 mg: 20 or 60 pcs. • RISSET® tab., coated. film-coated, 3 mg: 20 or 60 pcs. • TORENDO® (TORENDO) tab., coated. film coating, 1 mg: 20, 30 or 60 pcs. • TORENDO® KU-TAB (TORENDO Q-TAB) tab. for resorption 2 mg: 30 pcs. • RISDONAL® tab., coated. coated, 3 mg: 20 pcs.

Release form and composition

Dosage forms of Risperidone:

• film-coated tablets: capsule-shaped, biconvex, engraved “A” on one side, line and engraving on the other (depending on the dose); 0.5 mg – green, engraved on the second side “50”; 1 mg – white, engraved on the second side “51”; 2 mg – light orange, engraved on the second side “52”; 3 mg – yellow, engraved on the second side “53”; 4 mg – green, engraved on the second side “54”; 6 mg – white, engraved on the second side “55”; the shape of the tablets and the composition of the auxiliary components may vary from different manufacturers (5, 10, 15, 20 or 30 pieces in blister packs, 1–6, 10 packs in a cardboard pack; 10, 20, 30, 40 in polymer jars , 50, 60, 90 or 100 pcs., 1 can in a cardboard pack);
• solution for oral administration: colorless, transparent, has a slight characteristic odor (in bottles of 30 or 100 ml, in a cardboard box 1 bottle complete with a dosing syringe).

Composition of the core of 1 tablet:

• active ingredient: risperidone – 0.5, 1, 2, 3, 4, 6 mg;
• additional components (0.5/1/2/3/4/6 mg): lactose monohydrate – 59.5/59/118/177/236/234 mg; microcrystalline cellulose – 38.75/38.75/77.5/116.25/155/155 mg; colloidal silicon dioxide – 0.5/0.5/1/1.5/2/2 mg; Magnesium stearate – 0.75/0.75/1.5/2.25/3/3 mg.

Composition of the shell of 1 tablet:

• 0.5/4 mg: Opadry green 03B51373 (hypromellose-6cP – 62.5%; titanium dioxide – 26.4%; macrogol – 6.25%; quinoline yellow dye – 4%; indigo carmine – 0.85%) – 3.58/14.29 mg;
• 1/6 mg: Opadry white Y-1-7000 (hypromellose-5cP – 62.5%; titanium dioxide – 31.25%; macrogol – 6.25%) – 3.57/14.29 mg;
• 2 mg: Opadry orange 03B53576 (hypromellose-6cP – 62.5%; titanium dioxide – 29.704%; macrogol – 6.25%; red iron oxide dye – 0.35%; yellow iron oxide dye – 1.154%; iron oxide dye black – 0.042%) – 7.14 mg;
• 3 mg: Opadry yellow 03B52852 (hypromellose-6cP - 62.5%; titanium dioxide - 28.75%; macrogol - 6.25%; quinoline yellow dye - 2.5%) - 10.71 mg.

Composition of 1 ml solution:

• active ingredient: risperidone – 1 mg;
• additional components: sodium benzoate – 2.36 mg; tartaric acid – 7.5 mg; sodium hydroxide – up to pH 3 + 0.2; water – up to 1 ml.

Contraindications

Absolute:

• glucose-galactose malabsorption syndrome, lactase deficiency, galactosemia (tablets);
• age up to 5 years (therapy of persistent aggression in behavior disorder in children with mental retardation);
• age up to 10 years (therapy of manic episodes in the structure of bipolar disorder) (solution);
• age up to 13 years (therapy for schizophrenia) (solution);
• age up to 18 years (therapy of schizophrenia and manic episodes in the structure of bipolar disorder) (tablets);
• lactation period;
• individual intolerance to the components included in the drug.

Relative (Risperidone is prescribed with caution and under medical supervision):

• chronic heart failure, previous myocardial infarction, cardiac muscle conduction disorders and other diseases of the cardiovascular system;
• hypovolemia and dehydration;
• Parkinson's disease;
• cerebrovascular accidents;
• seizures and epilepsy, including a family history;
• severe liver/renal failure;
• medication overuse/dependence;
• cases of acute drug overdose;
• Reye's syndrome;
• conditions that predispose to the appearance of torsades de pointes (electrolyte imbalance, bradycardia, combination therapy with drugs that prolong the QT interval);
• combination therapy with furosemide;
• thrombophlebitis (tablets);
• presence of risk factors for the development of venous thromboembolism (solution);
• hyperglycemia;
• intestinal obstruction;
• brain tumor;
• diffuse Lewy body disease (solution);
• combination with other centrally acting drugs (solution);
• pregnancy;
• old age (when treating manic episodes in the structure of bipolar disorder) (tablets);
• elderly people with dementia.

Use during pregnancy and lactation

• pregnancy: therapy requires caution, since special studies have not been conducted; before prescribing the drug, the benefit-risk ratio must be assessed; when using Risperidone in the third trimester of pregnancy, there is a possibility of extrapyramidal disorders/withdrawal syndrome in newborns [possible symptoms include tremor, agitation, respiratory distress syndrome, muscle tone/nutrition disorders (are reversible, but require long-term therapy)];
• lactation period: the drug is not prescribed.

Drug interactions

Possible interactions:

• drugs that increase the QT interval, including tricyclic and tetracyclic antidepressants (amitriptyline, maprotiline), antiarrhythmics (amiodarone, quinidine, procainamide, disopyramide, propafenone, sotalol), some antihistamines, other antipsychotics, some antimalarials (mefloquine, quinine), drugs that can cause electrolyte imbalance (hypokalemia, hypomagnesemia), bradycardia, drugs that inhibit the hepatic metabolism of risperidone: the combination requires caution;
• centrally acting substances/medicines, especially alcohol, opiates, antihistamines, benzodiazepines: increased likelihood of sedation; the combination requires caution;
• levodopa and dopamine receptor agonists: decreased effectiveness; if their combined use is necessary, especially in the terminal stage of Parkinson's disease, the administration of the minimum effective doses of each drug is indicated;
• drugs with antihypertensive effects: development of clinically significant hypotension;
• paliperidone: increased concentration of the active antipsychotic fraction; the combination is not recommended;
• potent inhibitors of the CYP2D6 isoenzyme, including paroxetine, quinidine: increased plasma concentrations of risperidone; adjustment of its dose may be required, especially at the beginning/when canceling this combination;
• inhibitors of the CYP3A4 and/or P-gp isoenzyme, including itraconazole, ketoconazole: a significant increase in the plasma concentration of the active antipsychotic fraction of risperidone; adjustment of its dose may be required, especially at the beginning/when canceling this combination;
• inducers of the isoenzyme CYP3A4 and/or P-gp, including rifampicin, carbamazepine, phenytoin, phenobarbital: decreased plasma concentration of the active antipsychotic fraction of risperidone; adjustment of its dose may be required, especially at the beginning/when canceling this combination; it is necessary to take into account that the effect of inducers of the CYP3A4 isoenzyme manifests itself gradually, and therefore it may take up to 14 days to achieve the maximum effect after starting administration; accordingly, the same period may be required when canceling the inducer of the CYP3A4 isoenzyme until the effect disappears;
• phenothiazines, some beta-blockers: an increase in plasma concentrations of risperidone, but not the active antipsychotic fraction;
• protease inhibitors and ritonavir: increased concentrations of the active antipsychotic fraction of risperidone;
• verapamil: increased plasma concentrations of risperidone and the active antipsychotic fraction;
• H2 receptor antagonists, including ranitidine, cimetidine: increased bioavailability of risperidone, the effect on the concentration of the active antipsychotic fraction is insignificant;
• fluoxetine, paroxetine: an increase in the concentration of risperidone in plasma, the effect on the concentration of the active antipsychotic fraction is insignificant;
• tricyclic antidepressants: increased plasma concentrations of risperidone;
• sertraline, fluvoxamine (in a daily dose of more than 100 mg): an increase in the plasma concentration of the active antipsychotic fraction of risperidone;
• Furosemide: combination in elderly patients with dementia requires caution.

Overdose

Main symptoms: decreased blood pressure, drowsiness, depression of consciousness, tachycardia, sedation, extrapyramidal symptoms, rarely - convulsions and prolongation of the QT interval. With the simultaneous use of increased doses of Risperidone and paroxetine, the development of bidirectional ventricular tachycardia (pirouette type) was observed.

In cases of overdose, the possibility of overdose from multiple medications should be considered.

In order to ensure adequate oxygen supply and ventilation, it is necessary to achieve and maintain an open airway. Gastric lavage and activated charcoal along with a laxative are also indicated for an hour after an overdose. ECG monitoring should be started immediately to identify possible arrhythmias. It should be carried out until the symptoms of intoxication completely disappear.

There is no specific antidote for risperidone. In case of overdose, appropriate symptomatic therapy should be carried out, the action of which is aimed at maintaining the vital functions of the body. Collapse and decreased blood pressure are treated with adrenergic agonists and/or intravenous fluid infusions. In cases of development of acute extrapyramidal symptoms, m-anticholinergic blockers (in particular, trihexyphenidyl) are administered. Constant medical monitoring is carried out until the symptoms of overdose disappear.

Side effects

Most often (> 5%) the following adverse reactions occur while taking Risperidone: upper respiratory tract infections, parkinsonism, anxiety, insomnia, headache. Dose-dependent disorders include akathisia and parkinsonism.

Possible adverse reactions (> 10% - very common; > 1% and < 10% - often; > 0.1% and < 1% - uncommon; > 0.01% and < 0.1% - rare; < 0. 01% – very rarely; with uncertain frequency – if it is impossible to assess the frequency of occurrence of the disorder):

• lymphatic system/hematological disorders: uncommon - anemia, neutropenia, decreased white blood cell count, thrombocytopenia, decreased hemoglobin level, decreased eosinophil count and hematocrit; rarely – agranulocytosis, granulocytopenia;
• cardiovascular system: often – arterial hypertension, tachycardia; uncommon – prolongation of the QT interval on the ECG, atrioventricular block, palpitations, left/right bundle branch block, atrial fibrillation, cardiac conduction disturbances, ECG abnormalities, hypotension, bradycardia, hot flashes, orthostatic hypotension; rarely - sinus bradycardia/arrhythmia, pulmonary embolism, deep vein thrombosis;
• organ of vision: often – blurred vision, conjunctivitis; uncommon – blurred vision, increased lacrimation, conjunctival hyperemia, periorbital edema, eye discharge, dry eyes, photophobia; rarely - involuntary rotation of the eyeballs, decreased visual acuity, impaired eye movement, intraoperative floppy iris syndrome, crust formation on the edge of the eyelid, retinal artery occlusion, glaucoma;
• nervous system: very often – parkinsonism, drowsiness, headache, sedation; often – dyskinesia, dystonia, akathisia, tremor, dizziness, lethargy; uncommon – imbalance, loss of consciousness, lack of response to stimuli, fainting, decreased level of consciousness, impaired consciousness, hypersomnia, transient ischemic attack, dysarthria, stroke, impaired attention, postural dizziness, tardive dyskinesia, taste disorder, psychomotor agitation, taste perversion , cerebral ischemia, convulsions, hypoesthesia, paresthesia, impaired movement, coordination and speech; rarely - diabetic coma, cerebrovascular disorders, head tremor, neuroleptic malignant syndrome;
• kidneys/urinary tract: often – urinary incontinence, enuresis; uncommon – dysuria, urinary retention, pollakiuria;
• organ of hearing: uncommon – tinnitus, ear pain, vertigo;
• digestive system: often - dry mouth, vomiting, diarrhea, dyspepsia, abdominal discomfort, constipation, nausea, abdominal pain, toothache, hypersalivation; uncommon – gastroenteritis, fecaloma, dysphagia, gastritis, flatulence, fecal incontinence; rarely - swelling of the lips, pancreatitis, swelling of the tongue, intestinal obstruction, cheilitis; very rarely - ileus;
• respiratory system: often – cough, nasal congestion, pain in the pharynx/larynx, shortness of breath, nosebleeds; infrequently - aspiration pneumonia, wheezing, moist rales, pulmonary congestion, respiratory failure and airway obstruction, dysphonia; rarely – sleep apnea syndrome, hyperventilation;
• skin: often – erythema, skin rash; uncommon – discoloration, dryness and lesions of the skin, urticaria, disruption of the integrity of the skin, acne, itching, acne, hyperkeratosis, seborrheic dermatitis, alopecia; rarely – dandruff, drug rash; very rarely - Quincke's edema;
• endocrine system: often - increased prolactin levels; rarely – glucosuria, impaired production of antidiuretic hormone;
• musculoskeletal system: often – pain in the limbs, back and buttocks, muscle spasms, musculoskeletal pain, arthralgia; uncommon – muscle pain in the chest, increased creatine phosphokinase levels, neck pain, joint stiffness, muscle weakness, joint swelling, poor posture, myalgia; rarely - rhabdomyolysis;
• infections: often - ear infections, pneumonia, bronchitis, influenza, upper respiratory and urinary tract infections, sinusitis; uncommon – otitis media, tonsillitis, viral infections, inflammation of subcutaneous fat, eye infections, localized infections, respiratory tract infections, acarodermatitis, cystitis, onychomycosis; rarely - chronic otitis media, lower respiratory tract infections, subcutaneous abscess;
• metabolism and nutrition: often - increased/decreased appetite, weight gain; uncommon – weight loss, anorexia, polydipsia, diabetes mellitus, increased cholesterol concentrations, hyperglycemia; rarely – hypoglycemia, water intoxication, increased concentrations of triglycerides and insulin; very rarely - diabetic ketoacidosis;
• liver/biliary tract: uncommon – increased liver enzymes, increased levels of gamma-glutamyltransferase and transaminases; rarely – jaundice;
• psyche: very often – insomnia; often - sleep disturbances, anxiety, depression, agitation, anxiety; infrequently - lethargy, nightmares, mania, confusion, nervousness, decreased libido; rarely – flattening of affect, anorgasmia;
• immune system: uncommon – hypersensitivity reactions; rarely – anaphylactic reaction, drug hypersensitivity;
• reproductive system/breast: uncommon - amenorrhea, gynecomastia, galactorrhea, sexual/erectile dysfunction, ejaculation disorders, menstrual disorder, discomfort in the breast area, pain in the breast area, vaginal discharge; rarely - discharge from the mammary glands, delayed menstruation, priapism, engorgement/enlargement of the mammary glands;
• general disorders: often - asthenia, edema, fatigue, pyrexia, chest pain, generalized/peripheral edema, pain; infrequently - feeling unwell, swelling of the face, discomfort in the chest, gait disturbance, slowness, discomfort, malaise, chills, flu-like condition, increased body temperature, thirst; rarely - induration, cold extremities, withdrawal syndrome, decreased body temperature, hypothermia;
• others: often – falling; rarely – withdrawal syndrome in newborns (if the woman took the drug during pregnancy).

Side effects that were observed with greater frequency in pediatric patients during clinical trials than in other patient groups: cough, abdominal pain, drowsiness/sedation, vomiting, fatigue, increased appetite, headache, fever, diarrhea, tremor, enuresis, upper respiratory tract infections, nasal congestion, dizziness.