Instructions Eglonil tablets 200 mg blister No. 12
Composition
active ingredient: sulpiride;
1 tablet contains sulpiride 200 mg;
Excipients: potato starch, lactose monohydrate, methylcellulose, colloidal silicon dioxide, talc, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: white or ivory-colored, round tablets, with a score line on one side and engraving on the other.
Pharmacotherapeutic group
Antipsychotics. ATX code N05A L01.
Pharmacological properties
Pharmacodynamics. Sulpiride acts on dopaminergic neurotransmission in the brain as a dopamine mimetic, thereby exerting an activating effect. In higher doses, sulpiride also reduces productive symptoms.
Pharmacokinetics.
After oral administration of one 200 mg tablet, peak plasma concentrations of sulpiride (0.73 mg/l) are reached after 3-6 hours.
The bioavailability of oral dosage forms is 25-35% with wide individual fluctuations; sulpiride has a linear pharmacokinetic profile after administration in doses from 50 to 300 mg.
Sulpiride is rapidly distributed in body tissues: the apparent volume of distribution at steady state is 0.94 l/kg. Plasma protein binding is 40%.
Sulpiride is found in small amounts in breast milk and can cross the placental barrier.
Sulpiride is practically not metabolized in the human body.
Sulpiride is excreted mainly by the kidneys by glomerular filtration. Its renal clearance is 126 ml/min. The plasma half-life is 7 hours.
Indication
Acute mental disorders. Chronic mental disorders (schizophrenia, chronic disorders of a non-schizophrenic nature: paranoid states, chronic hallucinatory psychosis).
Contraindication
Hypersensitivity to sulpiride or any of the excipients of the drug.
Prolactin-dependent tumors (e.g. prolactin-secreting pituitary adenoma (prolactinoma) and breast cancer).
Known or suspected diagnosis of pheochromocytoma.
Acute porphyria.
Combinations with non-antiparkinsonian dopamine agonists (cabergoline, rotigotine and quinagolide), combinations with levodopa
or antiparkinsonian drugs (including ropinorole), combinations with mecitalopram, citalopram and escitalopram (see section "Interaction with other medicinal products and other types of interactions").
Interaction with other medicinal products and other types of interactions
Sedatives.
It should be remembered that many drugs can have additive CNS depressant effects and lead to decreased mental performance. These drugs include morphine derivatives (analgesics, cough suppressants and substitution therapy), neuroleptics, barbiturates, benzodiazepines, non-benzodiazepine anxiolytics (such as meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative H1-antihistamines, centrally acting antihypertensives, baclofen and thalidomide.
Drugs that may cause the development of paroxysmal ventricular tachycardia (torsades de pointes)
This serious cardiac arrhythmia can be caused by a number of drugs, with or without antiarrhythmic activity. Precipitating factors include hypokalemia (see "Potassium-sparing drugs") and bradycardia (see "Bradycardia-inducing drugs") or the presence of congenital or acquired QT prolongation.
Such agents include, in particular, antiarrhythmic drugs of classes Ia and III and some neuroleptics.
Dolasetron, erythromycin, spiramycin, and vincamine only enter into this interaction in dosage forms for intravenous administration.
The concomitant administration of two "torsadogenic" (those that cause torsades de pointes) drugs is generally contraindicated. However, methadone and certain other substances are exceptions:
Antiparasitic drugs (halofantrine, lumefantrine, pentamidine) should not be combined with other drugs that can cause torsades de pointes;
Neuroleptics that can induce torsades de pointes are also not recommended, but are not contraindicated for use in combination with other drugs that can induce torsades de pointes.
Contraindicated combinations.
(see section "Contraindications").
Citalopram, escitalopram.
Increased risk of developing ventricular arrhythmias, especially polymorphic ventricular tachycardia.
Dopamine receptor agonists not for the treatment of Parkinson's disease (cabergoline, quinagolide, rotigotine)
There is mutual antagonism between dopamine agonists and neuroleptics.
Levodopa and antiparkinsonian drugs (including ropinorole)
Dopamine agonists may cause or exacerbate psychiatric disorders. If neuroleptics are required in patients with Parkinson's disease treated with dopamine agonists, the dose of dopamine agonists should be gradually reduced (abrupt withdrawal puts the patient at risk of neuroleptic malignant syndrome), as concomitant use is contraindicated.
Mechitazine.
Increased risk of developing ventricular arrhythmias, especially polymorphic ventricular tachycardia.
Undesirable combinations.
(see section "Features of use").
With antiparasitic drugs that can cause the development of paroxysmal ventricular tachycardia (torsades de pointes) (halofantrine, lumefantrine, pentamidine)
Increased risk of ventricular arrhythmias, particularly torsades de pointes. Azole antifungal treatment should be discontinued if possible.
If concomitant treatment cannot be avoided, the QT interval should be checked before starting treatment and ECG should be monitored during treatment.
With antiparkinsonian dopamine agonists (amantadine, apomorphine, bromocriptine, entacapone, lisuride, pergolide, piribedil, pramipexole, ropinorole, rasagiline, selegiline)
There is mutual antagonism between dopamine agonists and neuroleptics.
Dopamine agonists may cause or exacerbate psychiatric disorders. If neuroleptics are required in patients with Parkinson's disease treated with dopamine agonists, the dose of dopamine agonists should be gradually reduced (abrupt withdrawal puts the patient at risk of neuroleptic malignant syndrome).
With other drugs that may induce torsades de pointes (class Ia (quinidine, hydroquinidine, disopyramide) and class III (amiodarone, dronedarone, sotalol, dofetilide, ibutilide) antiarrhythmic drugs and other drugs such as bepridil, cisapride, diphemanil, dolasetron, intravenous erythromycin, levofloxacin, mizolastine, prucalopride, intravenous vincamine, moxifloxacin, intravenous spiramycin and toramifen)
High risk of ventricular arrhythmias, particularly torsades de pointes.
With other neuroleptics that may cause the development of torsades de pointes (amisulpride, chlorpromazine, cyamemazine, droperidol, flupentixol, fluphenazine, haloperidol, levomepromazine, pimozide, pipotiazide, sertindole, sultopride, tiapride, veralipride, zuclopenthixol)
High risk of ventricular arrhythmias, in particular paroxysmal ventricular tachycardia of the "pirouette" type (torsades de pointes).
With alcohol
Potentiation of the sedative effects of neuroleptics.
Patients should avoid drinking alcoholic beverages or using medications that contain alcohol.
With methadone
Increased risk of ventricular arrhythmias, in particular torsades de pointes.
Combinations requiring caution
Azithromycin
Increased risk of ventricular arrhythmias, especially polymorphic ventricular tachycardia. ECG and clinical monitoring are necessary during concomitant use.
With beta-blockers used for heart failure (bisoprolol, carvedilol, metoprolol, nebivolol)
Increased risk of ventricular arrhythmias, including torsades de pointes. Clinical and ECG monitoring is required.
Drugs that cause bradycardia (such as class Ia antiarrhythmics, beta-blockers, some class III antiarrhythmics, some calcium channel blockers (diltiazem, verapamil, clonidine, guanfacine), digitalis glycosides, pilocarpine, anticholinesterase agents)
Increased risk of ventricular arrhythmias, including torsades de pointes. Clinical and ECG monitoring is required.
Clarithromycin
Increased risk of ventricular arrhythmias, especially polymorphic ventricular tachycardia. ECG and clinical monitoring are necessary during concomitant use.
Potassium-sparing drugs (potassium-sparing diuretics, alone or in combination, stimulant laxatives, glucocorticoids, tetracosactide, and amphotericin B for intravenous use)
Increased risk of ventricular arrhythmias, in particular torsades de pointes.
Before administration, correction of existing hypokalemia should be performed and clinical monitoring and control of electrolytes and ECG should be performed.
Lithium preparations
Risk of neuropsychiatric signs suggestive of neuroleptic malignant syndrome or lithium poisoning.
It is necessary to regularly monitor the clinical picture and laboratory test results, especially at the beginning of concomitant use.
The use of lithium increases the risk of extrapyramidal adverse reactions.
Roxithromycin
Increased risk of ventricular arrhythmias, especially polymorphic ventricular tachycardia. ECG and clinical monitoring are necessary during concomitant use.
With sucralfate
Reduced absorption of sulpiride in the gastrointestinal tract.
With topical gastrointestinal agents, antacids, and activated charcoal
Reduced absorption of sulpiride in the gastrointestinal tract.
There should be a certain time interval (more than 2 hours, if possible) between the administration of these agents and sulpiride.
Combinations to consider
Other sedatives
More pronounced inhibition of central nervous system function. Due to impaired ability to concentrate, driving vehicles and working with other mechanisms may be dangerous.
Antihypertensives
Increased risk of arterial hypotension, especially orthostatic.
With beta-blockers (except esmolol, sotalol, and beta-blockers used in heart failure)
Vasodilator effect and risk of hypotension, particularly postural (additive effect).
With nitrates, nitrites and related drugs
Increased risk of hypotension, particularly postural.
Sulpiride may reduce the effectiveness of ropinorole.
Application features
In patients with diabetes mellitus or with risk factors for developing diabetes mellitus, adequate blood glucose control should be performed at the beginning of sulpiride therapy.
Except in special cases, this medicine should not be prescribed to patients with Parkinson's disease.
For patients with renal insufficiency, reduced dosage and increased monitoring are recommended; in case of severe renal insufficiency, intermittent courses of treatment are advisable.
During treatment with sulpiride, closer monitoring is necessary for:
patients with epilepsy, as sulpiride may lower the seizure threshold; there have been reports of seizures in patients treated with sulpiride (see section "Adverse reactions"), elderly patients who are more susceptible to the development of postural hypotension, sedation and extrapyramidal effects of the drug.
In patients with aggressive behavior or agitation with impulsivity, sulpiride should be administered together with sedatives.
Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including Eglonil®. Unexplained infections or fever may be signs of leukopenia (see section 4.8): in such cases, a blood test should be performed immediately.
Potentially fatal neuroleptic malignant syndrome. In the event of an increase in body temperature of unknown etiology, treatment should be discontinued immediately, as this may be one of the symptoms of a malignant syndrome that can develop while taking neuroleptics (pallor, hyperthermia, autonomic disorders, impaired consciousness, muscle rigidity).
Signs of autonomic nervous system dysfunction, such as increased sweating and changes in blood pressure, may develop before the onset of hyperthermia and should therefore be considered as early warning symptoms.
Although this effect of neuroleptics may be idiosyncratic in nature, risk factors such as dehydration and organic brain damage may be present.
QT prolongation: Sulpiride may cause dose-dependent prolongation of the QT interval. This effect, which is known to increase the risk of serious ventricular arrhythmias, including torsades de pointes, is more likely to occur in patients with bradycardia, hypokalemia, and congenital or acquired QT prolongation (when sulpiride is taken concomitantly with a drug that prolongs the QT interval).
QT interval) (see section "Adverse reactions").
Therefore, before administering the drug and if the clinical situation allows, patients should be checked for risk factors that may contribute to the development of this type of arrhythmia: bradycardia less than 55 beats per minute, hypokalemia, congenital prolongation of the QT interval, treatment with a drug that can cause severe bradycardia (less than 55 beats per minute),
hypokalemia, slowing of intracardiac conduction or prolongation of the QT interval (see sections "Contraindications" and "Interaction with other medicinal products and other types of interactions").
Except in urgent cases, it is recommended that an ECG be performed during the initial assessment of patients who are to receive treatment with a neuroleptic drug.
Stroke
In randomized, placebo-controlled clinical trials, an increased risk of stroke was observed in elderly patients with dementia treated with some atypical antipsychotics compared with those treated with placebo. The mechanism of this increased risk is unknown. An increased risk cannot be excluded with other antipsychotic agents or in other patient populations. This drug should be prescribed with caution to patients with risk factors for stroke.
Elderly patients with dementia
An analysis of data from 17 placebo-controlled trials (with a median duration of 10 weeks) conducted in patients taking atypical antipsychotics in general showed that the risk of death was increased 1.6- to 1.7-fold among patients taking these drugs compared with placebo.
After a median treatment period of 10 weeks, the risk of death was 4.5% in the treated group compared with 2.6% in the placebo group.
Although the causes of death during clinical trials with atypical antipsychotics varied, the majority of deaths were due to either cardiovascular (such as heart failure, sudden death) or infectious diseases (such as pneumonia).
Epidemiological studies suggest that treatment with standard antipsychotics may increase mortality in the same way as with atypical antipsychotics.
The respective role of antipsychotic drug and patient characteristics in increasing mortality rates in epidemiological studies remains uncertain.
Venous thromboembolism.
Venous thromboembolism (VTE), sometimes fatal, has been reported with antipsychotic drugs. Since patients taking antipsychotics often have acquired risk factors for VTE, all potential risk factors for VTE should be identified and preventive measures taken before and during treatment with Eglonil® (see section 4.8).
It is not recommended to take this medicine simultaneously with alcohol, levodopa, dopamine receptor agonists, antiparasitic drugs that can cause torsades de pointes, methadone, other neuroleptics and drugs that can cause torsades de pointes (see section "Adverse reactions").
When using the drug even at low doses, the risk of developing tardive dyskinesia should be considered, particularly among elderly patients.
Eglonil® has an anticholinergic effect, so it should be used with caution in patients with glaucoma, intestinal obstruction, congenital gastrointestinal stenosis, urinary retention, and a history of prostatic hyperplasia.
Eglonil® should be used with caution in patients with a tendency to hypertension, especially in elderly patients, due to the risk of hypertensive crisis.
This medicinal product contains lactose and is therefore not recommended for patients with galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption syndrome (a rare hereditary disease).
Use during pregnancy or breastfeeding
Pregnancy. In animals, a decrease in fertility was observed, which is associated with the pharmacological properties of the drug (prolactin-mediated effect). The results of animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development and/or postnatal development. Very limited data on effects on pregnancy are available in humans. In almost all cases of fetal or neonatal malformations reported in the context of sulpiride use during pregnancy, alternative explanations are considered to be more likely. Therefore, due to limited experience with sulpiride use during pregnancy, its use is not recommended. Neonates whose mothers have received antipsychotics during the third trimester of pregnancy are at risk of adverse effects, including extrapyramidal symptoms and/or withdrawal symptoms, of varying severity and duration, after birth. The following adverse reactions have been reported: agitation, hypertonia, hypotension, tremor, drowsiness, respiratory distress and feeding problems. Therefore, neonates should be closely monitored.
Breastfeeding period. Since sulpiride is found in breast milk, breastfeeding during treatment is not recommended.
Ability to influence reaction speed when driving vehicles or other mechanisms
Patients, especially those who drive or operate machinery, should be warned that taking this medicinal product may cause drowsiness (see section "Adverse reactions"). Driving and operating machinery is contraindicated during treatment with this medicinal product.
Method of administration and doses
For oral use.
The minimum effective dose should always be prescribed. If the patient's clinical condition permits, treatment should be initiated at a low dose, followed by gradual dose titration.
In this dosage form, the drug is intended only for adult patients.
The daily dose is 200-1000 mg.
Children.
The drug in this dosage form is intended for adults only.
Overdose
Sulpiride is partially removed by hemodialysis. There is no specific antidote for sulpiride.
Treatment should be symptomatic, resuscitation with careful monitoring of cardiac activity and respiratory function (risk of QT prolongation and ventricular arrhythmias), which should be continued until the patient recovers completely. In case of severe extrapyramidal syndrome, anticholinergic drugs should be administered.
Adverse reactions
Adverse drug reactions observed during clinical trials are listed below by system organ class in order of decreasing frequency.
Nervous disorders.
Early dyskinesia (spastic torticollis, oculogyric crises, trismus), which decreases with the use of anticholinergic antiparkinsonian drugs.
Extrapyramidal symptoms and related disorders:
parkinsonism and related symptoms: tremor, hypertonia, hypokinesia, hypersalivation;
akinetic symptoms, with or without hypertonicity, which are partially reduced by the use of anticholinergic antiparkinsonian agents;
hyperkinetic-hypertonic, excitable motor activity;
akathisia.
Tardive dyskinesia, characterized by involuntary rhythmic movements, particularly of the tongue and/or face, which can occur with long-term treatment with all neuroleptics; in this case, anticholinergic antiparkinsonian drugs are ineffective and may worsen clinical manifestations.
Sedative effect or drowsiness.
There were reports of insomnia and confusion.
Convulsions (see section "Special warnings and precautions for use").
Potentially fatal neuroleptic malignant syndrome (see section "Special warnings and precautions for use").
General violations.
Weight gain.
Immune system disorders.
Anaphylactic reactions, shortness of breath and anaphylactic shock.
Endocrine disorders.
Transient hyperprolactinemia, which resolves after discontinuation of treatment and which may lead to amenorrhea, galactorrhea, gynecomastia, impotence, frigidity, breast enlargement and breast pain.
Cardiological disorders.
QT prolongation, ventricular arrhythmias, including torsades de pointes
and ventricular tachycardia, which can lead to ventricular fibrillation or cardiac arrest, sudden death (see section "Special warnings and precautions for use").
Vascular disorders.
Orthostatic hypotension, increased blood pressure.
Cases of venous thromboembolism, including sometimes fatal cases of pulmonary embolism and deep vein thrombosis, have been reported with antipsychotic drugs; the frequency of occurrence is unknown.
From the blood and lymphatic system.
Leukopenia, neutropenia, agranulocytosis - frequency unknown.
On the part of the hepatobiliary system.
Increased liver enzyme activity.
Pathology of the skin and subcutaneous tissue.
Maculopapular rash, urticaria.
General disorders.
Hypersensitivity reactions.
Conditions during pregnancy, in the postpartum and perinatal periods.
Withdrawal syndrome in newborns – the frequency of occurrence is unknown.
Expiration date
3 years.
Storage conditions
Keep out of the reach of children. Store at a temperature not exceeding 30 °C.
Packaging. No. 12 (12x1); No. 60 (12x5): 12 tablets in a blister, 1 or 5 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Sanofi Winthrop Industries.
Location of the manufacturer and its business address
6, Boulevard de l'Europe, 21800 Quetigny, France.
