INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SOLEK® (SOLEX)

Composition:

Active substance: amisulpride;

One film-coated tablet contains 400 mg of amisulpride;

Excipients: lactose monohydrate; microcrystalline cellulose; methylcellulose 400 cP; sodium starch glycolate (type A); magnesium stearate;

Film-coating composition: acrylic copolymer (Eudragit® E 100), titanium dioxide (E 171), talc, macrogol 6000, magnesium stearate.

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: white or almost white, capsule-shaped, film-coated tablets with a dividing line on one side.

Pharmacotherapeutic group. Antipsychotic agents. ATC code N05AL05.

Pharmacological Properties

Pharmacodynamics

Its pharmacodynamic properties are characterized by selective and predominant affinity for D2 and D3 receptors of the limbic system, while lacking affinity for D1, D4, and D5 subtypes. Amisulpride has no affinity for serotonin receptors or other neuroreceptors, such as histamine H1, cholinergic, and adrenergic receptors. In addition, amisulpride does not bind to sigma sites.

In animal studies at high doses, amisulpride predominantly blocks dopaminergic neurons of the mesolimbic system compared to those of the striatal system.

At low doses, amisulpride primarily blocks presynaptic dopaminergic D2 and D3 receptors, which explains its effect on negative symptoms. This pharmacological profile accounts for the clinical efficacy of Solox® in both negative and positive symptoms of schizophrenia.

Pharmacokinetics

In humans, amisulpride exhibits two absorption peaks: the first occurs rapidly, within 1 hour after dose administration, and the second after 3–4 hours.

Corresponding plasma concentration levels after a 50 mg dose are 39 ± 3 and 54 ± 4 ng/mL.

The volume of distribution is 5.8 L/kg. Plasma protein binding is low (16%), making drug interactions related to protein binding unlikely. Absolute bioavailability is 48%.

Amisulpride is weakly metabolized: two inactive metabolites have been identified, accounting for approximately 4% of the administered dose.

Amisulpride does not accumulate in the body; after repeated dosing, its pharmacokinetics remain unchanged.

The elimination half-life after oral administration is approximately 12 hours.

Amisulpride is excreted in urine in unchanged form.

Renal clearance is approximately 20 L/h or 330 mL/min.

A carbohydrate-rich meal (containing 68% fluid) significantly reduces the AUC, Tmax, and Cmax of amisulpride, whereas fatty meals do not cause significant changes. The clinical significance of these changes during amisulpride treatment is unknown.

Hepatic impairment.

Since amisulpride is weakly metabolized, dose adjustment is not required in patients with hepatic impairment.

Renal impairment.

In patients with renal impairment, elimination half-life remains unchanged, while systemic clearance is reduced by 2.5–3 times.

AUC of amisulpride increases twofold in mild renal impairment and nearly tenfold in moderate renal impairment.

However, practical experience is limited, and data on doses exceeding 50 mg are lacking.

Amisulpride is very poorly dialyzed.

Elderly patients.

Available pharmacokinetic data in patients aged 65 years and older indicate that after a single 50 mg dose, Cmax, T1/2, and AUC increase by 10–30%. Data on repeated dosing are lacking.

Clinical characteristics.

Indications.

Treatment of schizophrenia.

Contraindications.

Hypersensitivity to the active substance or to any component of the medicinal product.
Serious episodes of arterial hypertension have been reported in patients with pheochromocytoma who were treated with antidopaminergic agents, including certain benzamides. It is advisable to avoid administration of this medicinal product in patients with diagnosed or suspected pheochromocytoma who are receiving antidopaminergic agents, including certain benzamides.
Known or suspected prolactin-dependent tumours, such as prolactin-secreting pituitary adenoma or breast cancer.
Combination with methysergide, citalopram, escitalopram, domperidone, hydroxyzine, non-anti-Parkinsonian dopaminergic agents (cabergoline, quinagolide). Use in combination with levodopa (see section "Interaction with other medicinal products and other forms of interaction").
Paediatric population under 15 years of age (due to lack of clinical data).
Combination with medicinal products that may cause torsades de pointes (see section "Interaction with other medicinal products and other forms of interaction").

Interaction with other medicinal products and other forms of interaction.

Sedatives. It should be borne in mind that many medicinal products or substances may cause additive central nervous system (CNS) depressant effects and contribute to reduced attention. These include morphine derivatives (analgesics, antitussives, and opioid substitution treatments), 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.

Medicinal products capable of inducing torsades de pointes. This serious arrhythmia may be triggered by a number of medicinal products, including antiarrhythmics and others. Contributing factors include hypokalaemia (see subsection "Medicinal products that reduce potassium levels"), bradycardia (see subsection "Medicinal products that slow heart rate"), or pre-existing congenital or acquired QT interval prolongation.

This particularly applies to class IA and III antiarrhythmics, as well as certain neuroleptics. This effect is also induced by other compounds not belonging to these classes.

For dolasetron, erythromycin, spiramycin, and vinpocetine, this interaction applies only to intravenous formulations.

Generally, the concomitant use of a medicinal product that may induce torsades de pointes with another agent having the same effect is contraindicated.

However, some of these agents are exceptions, as their use cannot always be avoided, and therefore their combination with medicinal products capable of inducing torsades de pointes is not recommended rather than strictly contraindicated. This applies to methadone, antiparasitic agents (halofantrine, lumefantrine, pentamidine), and neuroleptics.

However, citalopram, escitalopram, domperidone, and hydroxyzine are not among these exceptions, and therefore their concomitant use with any medicinal product capable of inducing torsades de pointes is contraindicated.

Contraindicated combinations (see section "Contraindications").

Dopamine agonists, except anti-Parkinsonian agonists (cabergoline, quinagolide, rotigotine). Mutual antagonism of effects between dopamine agonists and neuroleptics.
Citalopram, escitalopram, domperidone, hydroxyzine. Increased risk of ventricular arrhythmias, particularly torsades de pointes.
Methysergide. Increased risk of ventricular arrhythmias, particularly torsades de pointes.

Not recommended combinations (see section "Special precautions for use").

Antiparasitic agents capable of inducing torsades de pointes (chloroquine, halofantrine, lumefantrine, pentamidine). Increased risk of ventricular arrhythmias, particularly torsades de pointes. If possible, one of the two treatments should be discontinued. If this combination cannot be avoided, QT interval monitoring before treatment initiation and ECG monitoring are recommended.
Dopaminergic anti-Parkinson agents (amantadine, apomorphine, bromocriptine, entacapone, lisuride, pergolide, piribedil, pramipexole, rasagiline, ropinirole, rotigotine, selegiline, tolcapone). Mutual antagonism of effects between dopamine agonists and neuroleptics. Dopamine agonists may provoke or exacerbate psychotic disorders. When neuroleptic treatment is necessary in a patient with Parkinson's disease receiving dopamine agonists, the dose of dopamine agonists should be gradually reduced and eventually discontinued (abrupt withdrawal of dopaminergic agents may precipitate neuroleptic malignant syndrome).
Other medicinal products that may induce torsades de pointes: class IA antiarrhythmics (quinidine, hydroquinidine, disopyramide), class III antiarrhythmics (amiodarone, dronedarone, sotalol, dofetilide, ibutilide), and other agents such as arsenic compounds, bepridil, cisapride, difemethiazine, intravenous dolasetron, domperidone, intravenous erythromycin, levofloxacin, methysergide, mizolastine, prucalopride, intravenous vinpocetine, moxifloxacin, sparfloxacin, intravenous spiramycin, thioridazine, vandetanib, toremifene. Increased risk of ventricular arrhythmias, particularly torsades de pointes.
Other neuroleptics capable of inducing torsades de pointes (chlorpromazine, tiaramide, droperidol, flupentixol, fluphenazine, haloperidol, levomepromazine, pimozide, pipamperone, pipotiazine, sertindole, sulpiride, sultopride, tiapride, zuclopenthixol). Increased risk of ventricular arrhythmias, particularly torsades de pointes.
Alcohol consumption. Alcohol enhances the sedative effect of neuroleptics. Amisulpride may potentiate the CNS effects of alcohol. Reduced attention may render driving and operating machinery hazardous. Consumption of alcoholic beverages and use of medicinal products containing alcohol should be avoided.
Levodopa. Mutual antagonism of effects between levodopa and neuroleptics. Patients with Parkinson's disease should receive the minimum effective doses of each agent.
Methadone. Increased risk of ventricular arrhythmias, particularly torsades de pointes.
Sodium oxybate. Enhanced CNS depression. Reduced attention may pose risks during driving and operation of machinery.

Combinations requiring precautions.

Anagrelide. Increased risk of ventricular arrhythmia, particularly torsades de pointes. Clinical and electrocardiographic monitoring is required during concomitant use.
Azithromycin, clarithromycin, ciprofloxacin, levofloxacin, norfloxacin, roxithromycin. Increased risk of ventricular arrhythmias, particularly torsades de pointes. Clinical and ECG monitoring is required during concomitant use.
Beta-blockers in patients with heart failure (bisoprolol, carvedilol, metoprolol, nebivolol). Increased risk of ventricular arrhythmias, particularly torsades de pointes. In addition, vasodilatory effects and risk of arterial hypotension, especially orthostatic hypotension (additive effect), may occur. Clinical and ECG monitoring is required.
Medicinal products that slow heart rate (particularly class IA antiarrhythmics, beta-blockers, certain class III antiarrhythmics, certain calcium channel blockers, digitalis glycosides, pilocarpine, anticholinesterase agents). Increased risk of ventricular arrhythmias, particularly torsades de pointes. Clinical and ECG monitoring is required.
Medicinal products that reduce potassium levels (potassium-depleting diuretics, alone or in combination, stimulant laxatives, glucocorticoids, tetracosactide, intravenous amphotericin B). Increased risk of ventricular arrhythmias, particularly torsades de pointes. Any hypokalaemia should be corrected before initiating amisulpride treatment, and clinical status, electrolyte balance, and ECG should be monitored.
Lithium. Risk of neuropsychiatric signs suggestive of neuroleptic malignant syndrome or lithium toxicity. Regular clinical monitoring and laboratory tests, especially at the beginning of concomitant therapy, are indicated.
Ondansetron. Increased risk of ventricular arrhythmia, particularly torsades de pointes. Clinical and electrocardiographic monitoring is required during concomitant use.
Roxithromycin. Increased risk of ventricular arrhythmias, particularly torsades de pointes. Clinical and ECG monitoring is required during concomitant use.

Combinations to be considered.

Other sedative agents. Enhanced central nervous system depression. Impaired concentration may render driving and operating machinery hazardous.
Antihypertensive agents. Increased risk of arterial hypotension, particularly postural hypotension.
Nitrates and related substances. Increased risk of arterial hypotension, particularly postural hypotension.
Orlistat. Risk of reduced therapeutic effect when orlistat is used concomitantly.

Special precautions.

Special warnings.

Malignant neuroleptic syndrome.

As with other neuroleptics, malignant neuroleptic syndrome may develop, which can be fatal and is characterized by hyperthermia, muscle rigidity, dysfunction of the peripheral nervous system, altered consciousness, and elevated creatine kinase (CK) levels. If hyperthermia develops, especially when high doses are used, all antipsychotic drugs must be discontinued.

QT interval prolongation.

Solex® may cause dose-dependent prolongation of the QT interval on the electrocardiogram, increasing the risk of serious ventricular arrhythmias such as torsades de pointes.

The risk of serious ventricular arrhythmias increases in the presence of bradycardia, hypokalemia, or congenital or acquired prolonged QT interval (e.g., when combined with drugs that prolong the QT interval) (see section "Adverse reactions").

If the clinical situation allows, it is recommended to confirm the absence of factors that may predispose to this rhythm disturbance before initiating treatment, such as:

heart rate less than 55 beats/min;
electrolyte imbalance, particularly hypokalemia;
congenital prolonged QT interval;
concomitant use of drugs that may cause marked bradycardia (< 55 beats/min), hypokalemia, reduced cardiac conduction, or QT interval prolongation (see section "Contraindications").

Patients requiring long-term neuroleptic therapy should undergo ECG before starting treatment.

Stroke.

In randomized, placebo-controlled clinical trials involving elderly patients with dementia treated with certain atypical antipsychotics, an increased risk of stroke was observed compared to placebo.

The mechanism underlying this increased risk is unknown. The possibility of an increased risk associated with other antipsychotic agents and in other patient populations cannot be excluded. This medicinal product should be used with caution in patients with risk factors for stroke.

Elderly patients with dementia.

The risk of mortality increases in elderly patients with dementia-related psychosis who are treated with antipsychotic agents.

An analysis of 17 placebo-controlled clinical trials (mean duration 10 weeks), conducted in patients primarily receiving atypical antipsychotics, showed that the risk of death was 1.6–1.7 times higher in patients treated with these drugs compared to placebo.

After an average treatment duration of 10 weeks, the mortality risk was 4.5% in patients receiving treatment compared to 2.6% in the placebo group.

Although the causes of death in clinical trials with atypical antipsychotics were varied, most fatal cases were due to cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) causes.

Epidemiological studies indicate that traditional antipsychotics may also increase mortality, similar to atypical antipsychotics.

The relative contribution of antipsychotic drugs and individual patient characteristics to increased mortality in epidemiological studies remains unclear. Solex® is not licensed for the treatment of behavioral disorders associated with dementia.

Venous thromboembolism (VTE).

Cases of venous thromboembolism (VTE), sometimes fatal, have been reported during antipsychotic therapy. Since patients treated with antipsychotics often have acquired risk factors for VTE, potential VTE risk factors should be identified before initiating treatment with Solex® or during such treatment, and preventive measures should be taken (see section "Adverse reactions").

Hyperglycemia/metabolic syndrome.

Cases of hyperglycemia have been reported in patients treated with certain antipsychotic drugs, including amisulpride (see section "Adverse reactions").

Clinical and laboratory monitoring should be performed according to current guidelines in patients receiving Solex®. Particular attention should be paid to patients with diabetes mellitus or risk factors for diabetes.

Seizures.

Amisulpride may lower the seizure threshold. Therefore, patients with a history of seizures require careful monitoring during therapy with amisulpride.

Special patient groups.

Since amisulpride is eliminated via the kidneys, the dose should be reduced or alternative treatment considered in patients with renal impairment (see section "Dosage and administration"). Data are lacking in patients with severe renal impairment (see section "Dosage and administration").

As with other antipsychotics, amisulpride should be used with particular caution in elderly patients due to the potential risk of sedation and arterial hypotension. Dose reduction may also be required due to renal impairment.

As with other antidopaminergic agents, caution is advised when prescribing amisulpride to patients with Parkinson's disease, as it may worsen the condition. Amisulpride should be used only if neuroleptic treatment cannot be avoided.

Withdrawal syndrome.

Withdrawal symptoms have been described after abrupt discontinuation of high doses of antipsychotics, including nausea, vomiting, and insomnia. Rarely, such symptoms have been reported after sudden cessation of high-dose antipsychotic therapy. Psychotic symptoms may also recur. Involuntary movement disorders (such as akathisia, dystonia, and dyskinesia) have been reported during amisulpride treatment. Therefore, gradual discontinuation of amisulpride is recommended.

Concomitant use of this medicinal product with alcohol, dopaminergic antiparkinsonian agents, antiparasitic agents capable of provoking torsades de pointes, methadone, levodopa, other neuroleptics, or drugs that may provoke torsades de pointes is not recommended (see section "Interaction with other medicinal products and other forms of interaction").

Hyperprolactinemia.

Amisulpride may increase prolactin levels (see section "Adverse reactions"). Patients with hyperprolactinemia and/or potentially prolactin-dependent tumors should be closely monitored during treatment with amisulpride (see section "Contraindications").

Warnings related to excipients.

This medicinal product contains lactose. Patients with rare hereditary conditions such as galactose intolerance (galactosemia), lactase deficiency, or glucose-galactose malabsorption syndrome should not take this medicinal product.

Breast cancer.

Solex® may increase prolactin levels. Therefore, amisulpride should be prescribed with caution in patients with a personal or family history of breast cancer, and careful monitoring is required during therapy with this medicinal product.

Benign pituitary tumor.

Amisulpride may increase prolactin levels. Cases of benign pituitary tumors, such as prolactinoma, have been observed during amisulpride therapy (see section "Adverse reactions"). In cases of very high prolactin levels or clinical signs of pituitary tumor (such as visual field defects and headache), pituitary imaging should be performed. If a pituitary tumor is confirmed, treatment with amisulpride should be discontinued (see section "Contraindications").

Others.

Leukopenia, neutropenia, and agranulocytosis have been reported during treatment with antipsychotics, including Solex®. Fever or infection of unknown origin may indicate leukopenia (see section "Adverse reactions") and requires immediate hematological investigation.

Patients with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome should not take this medicinal product.

Severe hepatic toxicity has been reported with amisulpride. Patients should be advised to immediately inform their physician if symptoms such as asthenia, anorexia, nausea, vomiting, abdominal pain, or jaundice occur. Investigations, including clinical examination and biochemical assessment of liver function, should be performed immediately (see section "Adverse reactions").

Use during pregnancy or breastfeeding.

Pregnancy.

Animal studies have shown reproductive toxicity of amisulpride. Amisulpride crosses the placenta.

Clinical data on use during pregnancy are limited. Therefore, the safety of amisulpride during pregnancy has not been established. Use of amisulpride during pregnancy is not recommended, except when the benefits outweigh the potential risks.

If the drug is used during pregnancy, newborns may experience adverse effects of amisulpride. During the third trimester, there is a risk of adverse reactions such as extrapyramidal symptoms and/or withdrawal syndrome, which may vary in severity and duration after delivery. Reported adverse reactions include agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress syndrome, or feeding difficulties. Therefore, careful monitoring of newborns is required.

Fertility.

A decrease in fertility related to the pharmacological effects of the drug (prolactin-mediated effect) has been observed.

Breastfeeding.

Due to the lack of information on the passage of amisulpride into breast milk, breastfeeding is contraindicated.

Ability to affect reaction speed when driving or operating machinery.

Patients, especially those who drive or operate machinery, should be warned about the risk of somnolence and blurred vision associated with the use of this medicinal product (see section "Adverse reactions").

Dosage and Administration

If the daily dose does not exceed 400 mg, the drug should be taken once daily.

Doses exceeding 400 mg should be divided into two doses per day.

Acute psychotic episodes.

Treatment may be initiated with intramuscular administration for several days, at a maximum dose of 400 mg/day, followed by transition to oral therapy.

Doses from 400 mg/day to 800 mg/day are recommended to be administered orally. The maximum oral dose should not exceed 1200 mg/day. The safety of doses above 1200 mg/day has not been widely studied. Therefore, such doses should not be used.

Maintenance dose or dose adjustment should be individually determined according to the patient's response.

In all cases, maintenance therapy should be individually prescribed at the lowest effective dose.

Predominantly negative episodes.

Recommended doses range from 50 mg/day to 300 mg/day. Doses should be individually adjusted. The optimal dose is approximately 100 mg/day. It is recommended to use 100 mg or 200 mg tablets.

Elderly patients.

Amisulpride should be used with particular caution in this population due to the risk of arterial hypotension and sedation (see section "Contraindications"). Dose reduction may also be required in patients with renal impairment.

Renal impairment.

Since amisulpride is excreted by the kidneys, the daily dose should be halved in patients with creatinine clearance of 30–60 mL/min, and reduced to one-third in patients with creatinine clearance of 10–30 mL/min. Use of 100 mg or 200 mg tablets is recommended.

Due to insufficient data in patients with severe renal impairment (creatinine clearance < 10 mL/min), strict monitoring of these patients is recommended (see section "Contraindications").

Hepatic impairment.

Since the drug is weakly metabolized, dose reduction is not required.

Children.

The efficacy and safety of amisulpride in adolescents from puberty up to 18 years of age have not been established; data on the use of amisulpride in children with schizophrenia are limited. Therefore, the use of amisulpride in adolescents from puberty up to 18 years of age is not recommended. Amisulpride is contraindicated in children under 15 years of age due to the lack of clinical data.

Overdose.

Currently, there is limited data regarding acute amisulpride overdose. Reported symptoms are mainly due to the enhanced pharmacological activity, clinically manifesting as dizziness, sedation, coma, arterial hypotension, and extrapyramidal symptoms.

There have been reports of fatal outcomes with concomitant use of other psychotropic agents.

There is no specific antidote for amisulpride. In case of acute overdose, it is essential to determine whether other medicinal products have been co-ingested and to take appropriate measures:

careful monitoring of vital functions;
cardiac monitoring (risk of QT interval prolongation) until full recovery;
in case of severe extrapyramidal symptoms, anticholinergic agents should be administered;
since amisulpride is poorly dialyzable, the effectiveness of hemodialysis for elimination of this medicinal compound is limited.

Adverse Reactions

Adverse effects are classified by frequency according to the following scale: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10000, <1/1000), very rare (<1/10000), frequency not known (cannot be estimated from the available data).

Nervous system disorders

Very common: extrapyramidal symptoms may occur (tremor, rigidity, hypertonia, hypersalivation, akathisia, hypokinesia, dyskinesia). In most cases, these are mild in severity at maintenance doses and are partially reversible without discontinuation of amisulpride when anticholinergic antiparkinsonian agents are administered.

The incidence of extrapyramidal symptoms, which is dose-dependent, is very low in patients treated for predominantly negative symptoms at doses of 50–300 mg/day.

Common: somnolence; acute dystonia (spasmodic torticollis, oculogyric crisis, trismus) may occur. These are reversible without discontinuation of amisulpride upon administration of an anticholinergic antiparkinsonian agent.

Uncommon: tardive dyskinesia characterized by involuntary movements of the tongue and/or facial muscles has been reported, usually after long-term treatment.

Anticholinergic antiparkinsonian agents are ineffective or may even exacerbate symptoms.

Seizures.

Rare: neuroleptic malignant syndrome, a potentially fatal complication.

Frequency not known: restless legs syndrome.

Psychiatric disorders

Common: insomnia, anxiety, agitation, frigidity.

Uncommon: confusion.

Gastrointestinal disorders

Common: constipation, nausea, vomiting, dry mouth.

Endocrine disorders

Common: increased plasma prolactin levels, which is reversible upon discontinuation of the drug. This may lead to clinical symptoms such as galactorrhea, amenorrhea, gynecomastia, breast pain, and erectile dysfunction.

Rare: benign pituitary tumors such as prolactinoma (see sections "Contraindications" and "Special precautions").

Metabolism and nutrition disorders

Common: hyperglycemia (see section "Special precautions"), hypertriglyceridemia, and hypercholesterolemia.

Rare: hyponatremia, syndrome of inappropriate secretion of antidiuretic hormone (SIADH).

Investigations

Common: weight gain.

Uncommon: elevated liver enzymes, mainly transaminases, have been reported.

Immune system disorders

Uncommon: allergic reactions.

Cardiac disorders

Common: bradycardia.

Rare:

QT interval prolongation;
ventricular arrhythmias such as torsades de pointes and ventricular tachycardia, which may lead to ventricular fibrillation and cardiac arrest;
sudden death (see section "Special precautions").

Vascular disorders

Common: hypotension.

Uncommon: increased blood pressure.

Rare: cases of venous thromboembolism, including pulmonary embolism (sometimes fatal) and deep vein thrombosis, have been reported during treatment with antipsychotic agents (see section "Special precautions").

Blood and lymphatic system disorders

Uncommon: leukopenia, neutropenia.

Rare: agranulocytosis (see section "Special precautions").

Skin and subcutaneous tissue disorders

Rare: angioneurotic edema, urticaria.

Frequency not known: photosensitivity reaction.

Pregnancy, puerperium and perinatal conditions

Frequency not known: withdrawal syndrome in newborns (see section "Use in pregnancy or lactation").

Musculoskeletal and connective tissue disorders

Uncommon: osteopenia, osteoporosis.

Renal and urinary disorders

Uncommon: urinary retention.

Hepatobiliary disorders

Uncommon: hepatocellular injury.

Respiratory, thoracic and mediastinal disorders

Uncommon: nasal congestion, aspiration pneumonia (mainly in combination with other neuroleptics and CNS depressants).

Eye disorders

Common: blurred vision.

Reporting of adverse reactions

Reporting of suspected adverse reactions after registration of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions via the adverse reaction reporting system in Ukraine.

Shelf life. 36 months.

Storage conditions

Store in a dry, light-protected place in the original packaging at a temperature of 15–25 °C. Keep out of reach of children.

Packaging

No. 30 (10x3): 10 tablets in a blister; 3 blisters in a cardboard box.

Prescription status. Prescription only.

Manufacturer

Rivopharm SA.

Manufacturer's address and place of business

Centro Insema, 6928 Manno, Switzerland.