Active substanceOlanzapineOlanzapine
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, contains:

    Tablets 2.5 mg

    active substance: olanzapine 2.5 mg;

    Excipients: tablet core: crospovidone 2,000 mg, microcrystalline cellulose (type 102) 11,500 mg, microcrystalline cellulose (type 200) 26,500 mg, lupus, 58,250 mg [lactose monohydrate 93%, povidone 3.5%, crospovidone 3.5%], magnesium stearate 1.250 mg;

    tablet shell: Opadrai II white 3,000 mg (polyvinyl alcohol 45.52%, titanium dioxide 32.00%, talc 20.00%, lecithin soybean 2.00%, gum xanthan 0.48%).

    Tablets 5 mg

    active substance: olanzapine 5 mg;

    Excipients: tablet core: crospovidone 4,000 mg, cellulose microcrystalline (type 102) 23,000 mg, microcrystalline cellulose (type 200) 53,000 mg, ludosepress 116,500 mg [lactose monohydrate 93%, povidone 3.5%, crospovidone 3.5%], magnesium stearate 2,500 mg;

    tablet shell: Opadrai II white 6,000 mg (polyvinyl alcohol 45.52%, titanium dioxide 32.00%, talc 20.00%, lecithin soybean 2.00%, gum xanthan 0.48%).

    Tablets 7.5 mg

    active substance: olanzapine 7.5 mg;

    Excipients: tablet core: crospovidone 6,000 mg, microcrystalline cellulose (type 102) 34,500 mg, microcrystalline cellulose (type 200) 79,500 mg, ludose 174,750 mg [lactose monohydrate 93%, povidone 3.5%, crospovidone 3.5%], magnesium stearate 3,750 mg;

    tablet shell: Opadrai II white 9,000 mg (polyvinyl alcohol 45.52%, titanium dioxide 32.00%, talc 20.00%, lecithin soybean 2.00%, gum xanthan 0.48%).

    Tablets 10 mg

    active substance: olanzapine 10 mg;

    Excipients: tablet core: crospovidone 8,000 mg, microcrystalline cellulose (type 102) 46.0 mg, microcrystalline cellulose (type 200) 106,000 mg, ludistress 233,000 mg [lactose monohydrate 93%, povidone 3.5%, crospovidone 3.5%], magnesium stearate 5,000 mg;

    tablet shell: Opadrai II white 12.0 mg (polyvinyl alcohol 45.52%, titanium dioxide 32.00%, talc 20.00%, lecithin soybean 2.00%, gum xanthan 0.48%).

    Tablets 15 mg

    active substance: olanzapine 15 mg;

    Excipients: tablet core: crospovidone 6,000 mg, cellulose microcrystalline (type 102) 34,500 mg, microcrystalline cellulose (type 200) 72,000 mg, ludose 174,750 mg [lactose monohydrate 93%, povidone 3.5%, crospovidone 3.5%], magnesium stearate 3,750 mg;

    tablet shell: Opadrai II white 9.0 mg (polyvinyl alcohol 45.52%, titanium dioxide 32.00%, talc 20.00%, lecithin soybean 2.00%, gum xanthan 0.48%).

    Tablets 20 mg

    active substance: olanzapine 20 mg;

    Excipients: tablet core: crospovidone 8,000 mg, microcrystalline cellulose (type 102) 46.0 mg, microcrystalline cellulose (type 200) 96,000 mg, ludistress 233,000 mg [lactose monohydrate 93%, povidone 3.5%, crospovidone 3.5%], magnesium stearate 5,000 mg;

    tablet shell: Opaprai II white 12.00 mg (polyvinyl alcohol 45.52%, titanium dioxide 32.00%, talc 20.00%, lecithin soybean 2.00%, gum xanthan 0.48%).

    Description:

    Dosage of 2.5 mg. White, round, biconcave, pills covered with a film sheath, engraved N 23 on one side.

    Dosage of 5 mg. White, round, biconcave, pills covered with a film sheath, engraved N 24 on one side.

    The dosage is 7.5 mg. White, round, biconcave, tablets covered with a film sheath, engraved N 25 on one side.

    Dosage of 10 mg. White, round, biconcave, pills covered with a film sheath, engraved N 26 on one side.

    Dosage of 15 mg. White, oblong, biconcave, film-coated tablets, engraved N 27 on one side.

    Dosage of 20 mg. White, oblong, biconcave, film-coated tablets, engraved N 28 on one side.

    Pharmacotherapeutic group:antipsychotic agent (antipsychotic)
    ATX: & nbsp

    N.05.A.H.03   Olanzapine

    Pharmacodynamics:

    Olanzapine is an antipsychotic agent (neuroleptic) with a broad pharmacological spectrum of action. Antipsychotic action due to blockade of dopamine D2-receptor mesolimbic and mesocortical system; sedative effect - adrenoreceptor blockade of the brainstem formation; antiemetic effect - blockade of dopamine D2receptors of the trigger zone of the vomiting center; hypothermic action - blockade of dopamine receptors of the hypothalamus. In addition, it affects muscarinic, adrenergic, H1-gastamine and some subclasses of serotonin receptors.

    Olanzapine significantly reduces productive (delusions, hallucinations) and negative symptoms (hostility, suspicion, emotional and social autism) psychosis. Rarely causes extrapyramidal disorders.

    Pharmacokinetics:

    Absorption of olanzapine is high, does not depend on food intake; time required for reaching the maximum concentration of the drug in the blood plasma (TSmax) after oral administration - 5-8 hours.

    When taken in the dose range of 1-20 mg, the concentration in the plasma changes linearly, in proportion to the dose. At a plasma concentration of 7-1000 ng / ml, the association with proteins is 93%, mainly with albumin and alpha1-acid glycoprotein. Penetrates through gistogematicheskie barriers, incl. blood-brain barrier (BBB).

    Metabolised in the liver by conjugation and oxidation, active metabolites are not formed, the main pharmacological activity of the drug is due to olanzapine. The main circulating metabolite is glucuronide, does not penetrate the BBB. Isozymes CYP1A2 and CYP2D6 cytochrome P450 are involved in the formation of N-desmethyl and 2-hydroxymethyl metabolites of olanzapine.

    Smoking, sex and age affect half-life (T1/2) and plasma clearance. Non-smoking (ground clearance -18.6 l / h, T1/2 - 38,6 h), smoking (clearance - 21,1 l / h; T1/2- 30.4 hours), women (ground clearance - 18.9 l / h, T1/2- 36.7 hours), men (ground clearance - 27.3 l / h, T1/2 - 32.3 hours). In patients over 65 years of age, T1/2 is 51.8 h and the plasma clearance is 17.5 l / h; in patients younger than 65 years - 33.8 hours and plasma clearance - 18.2, l / h. Plasma clearance is lower in patients with hepatic insufficiency, women and non-smokers compared to the corresponding groups of patients. It is excreted mainly by kidneys (60%) in the form of metabolites.

    Indications:

    Schizophrenia in adults (exacerbation, sustained and prolonged anti-relapse therapy), psychotic disorders in schizophrenia with productive (including delirium, hallucinations, automatisms) and / or negative (emotional flattening, decreased social activity, impoverishment of speech), symptomatology and concomitant affective disorders.

    Bipolar affective disorder in adults (monotherapy or in combination with lithium preparations or valproic acid): acute manic or mixed episodes with / without psychotic manifestations and with / without rapid phase change.

    Prevention of mania recurrence in bipolar disorder (with the effectiveness of the drug in the treatment of the manic phase).

    Contraindications:

    Hypersensitivity to the active substance and other components of the drug, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, period of breastfeeding, age to 18 years (efficacy and safety not established).

    Carefully:

    Renal failure, liver failure, benign prostatic hyperplasia, closed angle glaucoma, paralytic intestinal obstruction, epilepsy, history of convulsive syndrome, leukopenia and / or neutropenia of various genesis, myelosuppression of various genesis, incl. myeloproliferative diseases, hypereosinophilic syndrome, cardiovascular and cerebrovascular diseases, or other conditions predisposing to arterial hypotension,congenital increase in the QT interval on the ECG (increase in the QT interval corrected on the ECG) or in the presence of conditions potentially capable of inducing an increase in the QT interval (eg simultaneous use of QT prolonging drugs, chronic heart failure, hypokalemia, hypomagnesemia), elderly age, as well as the simultaneous intake of drugs of central action, phenylketonuria, immobilization, pregnancy.

    Pregnancy and lactation:

    Due to the limited experience of using the drug in pregnant women, Parnasan® should Apply in pregnancy only if the expected benefit justifies the potential risk to the fetus. Women should be informed of the need to inform the doctor about the pregnancy or planned pregnancy with Parnasan®. There are isolated reports of tremors, arterial hypertension, lethargy and drowsiness in children born to mothers who took olanzapine in the third trimester of pregnancy.

    In studies, it was found that Parnasan ® penetrates into breast milk. The average dose (mg / kg) received by the child when the mother's equilibrium concentration reached equilibrium was 1.8% of the dose of Parnasan® to the mother (mg / kg).It is recommended that breastfeeding be given against Parnasan® therapy.

    Dosing and Administration:

    Inside, regardless of food intake, wash down with water.

    With schizophrenia in adults, the recommended initial dose is 10 mg / day.

    In the episode of mania associated with bipolar disorders in adults -15 mg / day (1 time) as monotherapy or 10 mg / day (1 time) in combination with lithium or valproic acid (maintenance therapy at the same dose).

    Prevention of mania recurrence in bipolar disorder: the recommended initial dose of the drug in a state of remission of 10 mg / day. For patients who have already received Parnasan® for the treatment of manic episodes, maintenance therapy is administered in the same doses. In the case of a new manic, mixed or depressive episode, if necessary, increase the dose of the drug with additional treatment of mood disorders, in accordance with clinical indications.

    The daily dose of the drug in the treatment of schizophrenia, a manic episode or the prevention of recurrence of bipolar disorder may be 5-20 mg / day, depending on the clinical condition of the patient.An increase in the dose above the recommended initial dose is only possible after an adequate repeated clinical assessment of the patient's condition and is usually performed with an interval of at least 24 hours.

    Special patient groups

    In elderly patients, a reduction in the initial dose (up to 5 mg / day) is usually not recommended, but it is possible in patients older than 65 years with risk factors (see section "Special instructions").

    Patients with liver and / or kidney disease are recommended to reduce the initial dose to 5 mg / day. For moderate hepatic insufficiency (cirrhosis, class A or B on the Child-Pugh scale), the initial dose is 5 mg / day, a further dose increase with caution is possible.

    Women do not need a correction of the dosing regimen compared to men.

    In non-smoking patients, dose adjustments compared to smokers (see "Interactions with other drugs") are not required.

    If the patient has more than one factor that can influence the absorption of the drug (female, elderly, non-smokers), it may be necessary to reduce the initial dose of the drug. If necessary, further increase in dose with caution.

    Side effects:

    The incidence of side effects noted with the administration of Parnasan® is given in accordance with the WHO classification: very often (> 1/10), often (> 1/100 and <1/10), infrequently (> 1/1000 and <1 / 100), rarely (> 1/10000 and <1/1000), very rarely (<1/10000), including individual messages.

    From the nervous system: very often - drowsiness; often - dizziness, akathisia, parkinsonism, asthenia, dyskinesia; rarely - convulsive syndrome (more often in the background of convulsive syndrome in anamnesis); very rarely - malignant neuroleptic syndrome (see section "Special instructions"), dystonia (including oculogic crisis) and tardive dyskinesia. With the abrupt withdrawal of Parnasan ®, very seldom have symptoms such as increased sweating, insomnia, tremors, anxiety, nausea, or vomiting.

    From the side of the cardiovascular system: often - arterial hypotension (including orthostatic); infrequently - a bradycardia with a collapse or without; very rarely - an increase in the QTc interval on the ECG (see section "Special instructions"), ventricular tachycardia / fibrillation and sudden death (see section "Special instructions"), very rarely - thromboembolism (including pulmonary artery embolism and deep vein thrombosis).

    From the digestive system: often - transient anticholinergic effects, including constipation and dryness of the oral mucosa; rarely - hepatitis; very rarely - pancreatitis.

    From the side of metabolism: very often - weight gain; often - increased appetite, hypertriglyceridemia; very rarely - hyperglycemia and / or decompensation of diabetes mellitus, sometimes manifested by ketoacidosis or coma, including death; hypercholesterolemia, hypothermia.

    From the digestive system: frequent - transient, asymptomatic increase in the activity of "liver" transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (ACT)), especially at the beginning of therapy (see section "Special instructions"), rarely - hepatitis (including hepatocellular, cholestatic or mixed lesions liver).

    On the part of the organs of hematopoiesis: often - eosinophilia; rarely - leukopenia; very rarely - thrombocytopenia, neutropenia.

    From the side of the musculoskeletal system: very rarely - rhabdomyolysis.

    From the genitourinary system: very rarely - urinary retention, priapism.

    From the skin: rarely - skin rash; infrequently - photosensitization reactions; very rarely - alopecia.

    Allergic reactions: rarely - skin rash; very rarely - anaphylactoid reactions, angioedema, skin itching or urticaria.

    Other: often - asthenia, peripheral edema; very rarely - withdrawal syndrome.

    Laboratory indicators: very often hyperprolactinemia, but clinical manifestations (eg, gynecomastia, galactorrhea and breast enlargement) are rare.

    In most patients, prolactin levels spontaneously normalized without withdrawal therapy. Rarely - transient, asymptomatic increase in ALT activity, ACT.

    Infrequently, an increase in the activity of creatine phosphokinase (CKF); very rarely - increase activity of alkaline phosphatase (APF) and total bilirubin. In isolated cases, an increase in plasma glucose of more than 200 mg / dl (suspected diabetes mellitus), 160-200 mg / dL (suspected hyperglycemia) in patients with baseline glucose concentrations of less than 140 mg / dl. There have been cases of elevation of triglycerides (by 20 mg / dl from the initial), cholesterol (by 0.4 mg / dl from the initial), asymptomatic eosinophilia (single cases).

    In elderly patients with dementia, a higher frequency deaths and cerebrovascular disorders (stroke, transient ischemic attacks).

    Very frequent in this category of patients were violations of gait and fall. Also often observed pneumonia, fever, lethargy, erythema, visual hallucinations and urinary incontinence.

    Among patients with medicinal (against the background of taking dopamine agonists) with psychoses on the background of Parkinson's disease often worsened parkinsonian symptoms and the development of hallucinations. There are data on the development of neutropenia (4.1%) against a combination therapy with valproic acid in patients with bipolar, mania. Simultaneous treatment with valproate or lithium increases the frequency (10%) of tremor, dryness of the oral mucosa, increased appetite or weight gain. Violations of speech (from 1 to 10%) were also recorded.

    Overdose:

    Symptoms: very frequent (over 10%) with an overdose of the drug are Parnasan®: tachycardia, agitation / aggression, dysarthria, various extrapyramidal symptoms, decreased level of consciousness from the retardation to coma; less than 2% of cases occur: delirium, convulsions, coma,malignant neuroleptic syndrome, oppression, respiratory depression, aspiration, hypertension or arterial hypotension, arrhythmias; in very rare cases, cardiopulmonary insufficiency.

    The minimum dose of Parnasan® in acute overdose with fatal outcome - 450 mg, the maximum dose was registered in case of an overdose with a favorable outcome (survival) -1500 mg.

    Treatment: there is no specific antidote. It is not recommended to provoke vomiting. It is necessary to carry out: gastric lavage, reception of activated charcoal (reduces the bioavailability of olanzapine by 60%), symptomatic treatment under the control of vital functions, including treatment of arterial hypotension and collapse, maintenance of respiratory function. It is not recommended to use epinephrine, dopamine or other sympathomimetics with beta-adrenergic activity, the latter can aggravate arterial hypotension. To identify possible arrhythmias, cardiovascular control is necessary. The patient should be under continuous medical supervision until complete recovery.

    Interaction:

    Potential drug interactions affecting olanzapine metabolism: olanzapine is metabolized by the isoenzyme CYP1A2, therefore inhibitors or inducers of cytochrome P450 isoenzymes exhibiting specific activity against CYP1A2 may influence the pharmacokinetic parameters of olanzapine.

    Inductors CYP1A2: The clearance of olanzapine may be increased in smokers or with simultaneous administration of carbamazepine, which leads to a decrease in the concentration of olanzapine in the blood plasma. Clinical observation is recommended. some cases require an increase in the dose of the drug.

    Inhibitors of CYP1A2: fluvoxamine, a specific inhibitor of CYP1A2 - significantly reduces the clearance of olanzapine. The average increase in the maximum concentration (Cmax) of olanzapine after taking fluvoxamine in non-smokers was 54%, and for men who smoke, 77%. The average increase in the area under the concentration-time curve (AUC) of olanzapine in these categories of patients was 52% and 108%, respectively. In patients receiving fluvoxamine or any other inhibitor of the CYP1A2 isoenzyme (eg, ciprofloxacin), therapy with olanzapine is recommended to begin with smaller doses.A decrease in the dose of olanzapine may also be required if the inhibitors of the isoenzyme CYP1A2 are added to the therapy.

    Drug interactions affecting / not affecting the bioavailability of olanzapine: Activated carbon reduces the absorption of olanzapine when ingested by 50-60%, so it should be taken at least 2 hours before or after taking olanzapine.

    Fluoxetine - inhibitor of the isoenzyme CYP1A2 (60 mg once or 60 mg daily for 8 days) increases CmOh olanzapine by 16% and reduces clearance by 16%, which has no clinical significance (no correction of olanzapine dose is required).

    Single dose magnesium or aluminum containing antacids or cimetidine do not affect the pharmacokinetics of olanzapine.

    Potential ability of olanzapine to influence other drugs

    Olanzapine may reduce the effects of direct and indirect dopamine agonists.

    In conditions in vitro olanzapine does not suppress the basic isoenzymes of CYP450 (eg, 1A2, 2D6, 2C9, 2C19, 4A4). In vivo There was no inhibition of metabolism of the following active substances: tricyclic antidepressants (CYP2D6), warfarin (CYP2C9), theophylline (CUR1A2) and diazepam(СУРЗА4и2С19).

    No interaction was detected when used simultaneously with lithium or biperidene.

    Olanzapine slightly suppresses the formation of valproyric glucuronide acid (the main pathway of metabolism). Valproic acid slightly affects the metabolism of olanzapine. Clinically significant pharmacokinetic interaction between olanzapine and valproic acid is unlikely. Therapeutic monitoring of the content of valproic acid in the blood plasma showed that, when applied simultaneously with olanzapine, no changes in valproic acid doses are required (see the "Side effect" section).

    Care should be taken when using other central-action drugs at the same time. Despite the fact that a single dose of alcohol (45 mg / 70 kg) has no effect pharmacokinetic, alcohol together with olanzapine may be accompanied by increased sedative action on the central nervous system.

    Special instructions:

    There are very rare reports of the development of hyperglycemia and / or decompensation of diabetes, sometimes accompanied by the development of ketoacidosis or diabetic coma, including there are several reports of fatal cases.There is no causal relationship between antipsychotic agents and these conditions. In some cases, there was a previous decompensation of weight gain, which could become a predisposing factor. Patients with diabetes mellitus or with risk factors for the development of this disease are recommended regular clinical monitoring and control of the concentration of glucose in the blood.

    When the lipid concentration changes, correction of therapy is required.

    With a sharp discontinuation of admission of Parnasan® is very rare (less than 0.01%), the following symptoms may develop: sweating, insomnia, tremor, anxiety, nausea, or vomiting. With the withdrawal of the drug, a gradual dose reduction is recommended.

    Anticholinergic activity. Since the clinical experience of using Parnasan® in patients with concomitant diseases is limited, the drug should be used with caution in patients with benign prostatic hyperplasia, paralytic intestinal obstruction, and closed-angle glaucoma.

    The experience of using Parnasan® in patients with psychoses in Parkinson's disease, induced dopaminomimetic. Parnasan is not recommended for the treatment of psychosis in Parkinson's disease caused by dopaminomimetic treatment.

    The symptoms of parkinsonism and hallucinations increase. In this case, Parnasan® on the effectiveness of psychosis treatment did not exceed the placebo. Parnasan® is not indicated for the treatment of psychoses and / or behavioral disorders in dementia due to increased mortality and increased risk of cerebrovascular disorders (stroke, transient ischemic attacks). These patients had previous risk factors (cerebrovascular disorders (history), transient ischemic attack, hypertension, smoking), as well as concomitant diseases and / or drug administration associated with cerebrovascular disorders. The increase in mortality does not depend on the dose of Parnasan® or the duration of therapy. Risk factors predisposing to increased mortality include: age over 65 years, dysphagia, sedation, malnutrition and dehydration, lung diseases (eg pneumonia, including aspiration), simultaneous reception of benzodiazepines.However, the increased mortality in the Parnasan® group compared to placebo did not depend on these risk factors.

    With antipsychotic therapy, an improvement in the clinical state of the patient occurs in period from several days to several weeks. During this period, the patient needs careful monitoring

    Violation of the function of the liver. At the beginning of therapy, an asymptomatic increase in the activity of "liver" transaminases (ALT and ACT) is possible. In patients with initially elevated ACT and / or ALT activity, with hepatic insufficiency and conditions potentially limiting the functionality of the liver, as well as those taking hepatotoxic drugs, caution should be exercised when using Parnasan®. When the activity of ALT and / or ACT is increased against the background of drug therapy, it is recommended to observe the patient and, possibly, reduce the dose of the drug. When diagnosing hepatitis (including hepatocellular, cholestatic or mixed), Parnasan® should be discontinued.

    Hematologic disorders. The drug should be used with caution in patients with leukopenia and / or neutropenia of any genesis,myelosuppression of drug origin, as well as against radiation or chemotherapy, as a result of concomitant diseases, in patients with hyperesonophilic conditions or myeloproliferative diseases. Neutropenia has often been observed with simultaneous administration of Parnasan® and valproic acid (see "Side effect")

    Malignant neuroleptic syndrome (CNS). ZNS potentially life-threatening condition associated with antipsychotic drugs (neuroleptics), including Parnasan®. Clinical manifestations of ZNS: fever, rigidity of muscles, impaired consciousness, vegetative disorders (unstable pulse or lability of arterial pressure, tachycardia, increased sweating, arrhythmias). Additional symptoms of CNS: increased activity of creatinine phosphokinase (CK), myoglobinuria (against rhabdomyolysis) and acute renal failure. With the development of symptoms of the ZNS, as well as an increase in body temperature for no apparent reason, it is necessary to cancel all neuroleptics, including Parnasan®.

    Convulsive syndrome. The drug Parnasan® should be used with caution in patients with a history of seizures or the presence of factors,reducing the threshold of convulsive readiness. Against the background of taking Parnasan®, cramps were rarely recorded.

    Late dyskinesia. Therapy with Parnasan® was accompanied by a significantly lower incidence of late dyskinesia compared with haloperidol. The risk of developing tardive dyskinesia increases with increasing duration of therapy. If there are signs of this condition, the patient taking the Parnasan® drug should cancel the drug or reduce its dose. Symptoms of tardive dyskinesia may increase or manifest after the drug is discontinued.

    General activity in relation to the central nervous system. Care should be taken when using other means of central action and alcohol.

    Cerebrovascular adverse events, including stroke in elderly patients with dementia. In elderly patients, postural arterial hypotension is infrequent. Patients over 65 years of age are recommended to periodically monitor blood pressure. Parnasan® should be administered with caution to patients with an established extended QTc interval, especially elderly patients, with congenital QT syndrome, chronic heart failure,hypertrophy of the myocardium, hypokalemia and hypomagnesemia.

    When taking Parnasan ®, very rarely (less than 0.01%) cases of development venous thromboembolism. The causal relationship between Parnasan® therapy and vein thrombosis has not been established. Since patients with schizophrenia often have acquired risk factors for venous thrombosis, all possible other factors (eg, immobilization) should be identified and preventive measures taken.

    In conditions in vitro olanzapine exhibits antagonism against dopamine and, like other neuroleptics, can theoretically suppress the action of levodopa and dopamine agonists.

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

    Because Parnasan® can cause drowsiness and dizziness, patients Care should be taken when working with mechanisms that require increased concentration of attention, including when driving vehicles.

    Form release / dosage:

    Tablets, film-coated, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg.

    Packaging:

    For 10 tablets in a blister of ORA / Al / PVC-foil and aluminum foil.

    For 3 blisters in a cardboard box together with instructions for use.

    Storage conditions:Store at a temperature not exceeding 30 ° C.
    Keep out of the reach of children.
    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000609
    Date of registration:21.09.2011
    The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
    Information update date: & nbsp16.08.2015
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