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Prestarium 10 mg No. 30 tablet.

Instructions for medical use of the drug PrestariumÒ 5 mg PrestariumÒ 10 mg Trade name PrestariumÒ 5 mg PrestariumÒ 10 mg International nonproprietary name Perindopril Dosage form Film-coated tablets 5 mg or 10 mg Composition One tablet contains the active substance - perindopril arginine 5 mg or 10 mg, respectively (equivalent to the content of perindopril 3.395 mg or 6.790 mg), excipients: lactose monohydrate, magnesium stearate, maltodextrin, colloidal silicon dioxide anhydrous, sodium starch glycolate (type A) shell: glycerin, hypromellose, copper chlorophyllin (E141ii), macrogol 6000, magnesium stearate, titanium dioxide (E171). Description PrestariumÒ 5 mg: elongated, light green film-coated tablets, marked “ ” on one side and scored on both sides. PrestariumÒ 10 mg: round tablets, with a biconvex surface, green film-coated tablets, marked “ ” on one side and “ ” on the other side. Pharmacotherapeutic group Drugs affecting the renin-angiotensin system. Angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors. Perindopril ATC code C09AA04 Pharmacological properties Pharmacokinetics Absorption After oral administration, perindopril is rapidly absorbed from the gastrointestinal tract (GIT). Cmax is reached after 1 hour. The bioavailability of the drug is 65-70%. Distribution and metabolism During metabolism, perindopril is biotransformed to form an active metabolite - perindoprilate (about 27%) and 5 inactive compounds. Cmax of perindoprilate in plasma is achieved between 3 and 5 hours after taking Prestarium. The binding of perindoprilate to plasma proteins (mainly ACE) is 20% and depends on the concentration of the drug. Vd of free perindoprilate is close to 0.2 l/kg. The drug does not accumulate in the body. Repeated administration does not lead to accumulation and T1/2 corresponds to the period of its activity. When taking the drug with food, the metabolism of perindopril slows down. The elimination T1/2 of perindopril is 1 hour. Perindoprilat is excreted from the body through the kidneys; T1/2 of its free fraction is about 17 hours, which allows it to reach a steady state in 4 days. Pharmacokinetics in special clinical situations: In elderly patients, as well as in patients with renal and heart failure, the elimination of perindoprilate is slowed down. In patients with cirrhosis, the hepatic clearance of the parent molecule perindopril is slowed by half. However, the amount of perindoprilate formed does not decrease, so no dose adjustment is required. Pharmacodynamics Perindopril is an angiotensin-converting enzyme (ACE) inhibitor. ACE catalyzes the conversion of angiotensin I to angiotensin II, which has vasoconstrictor properties. In addition, ACE stimulates the secretion of aldosterone and accelerates the breakdown of the vasodilator compound bradykinin to an inactive heptapeptide. The mechanism of the antihypertensive effect of perindoprilat is associated with inhibition of ACE activity, which leads to a decrease in the rate of conversion of angiotensin I to angiotensin II. As a result of a decrease in the concentration of angiotensin II, there is a secondary increase in plasma renin activity (due to the elimination of negative feedback during the release of renin) and a direct decrease in aldosterone secretion. In addition, perindoprilat affects the kinin-kallikrein system, preventing the breakdown of bradykinin. It is a prodrug from which the active metabolite perindoprilat is formed in the body. Hypertension Prestarium is effective for mild, moderate and severe arterial hypertension. The drug reduces systolic and diastolic blood pressure both in the supine and standing positions. Thanks to its vasodilating effect, the drug reduces total peripheral vascular resistance (TPVR) and reduces pathologically elevated blood pressure (BP), thereby improving the rheological properties of the blood without affecting the heart rate. The drug, as a rule, increases renal blood flow, while the level of glomerular filtration does not change. After oral administration in an average single dose, the maximum hypotensive effect is achieved after 4-6 hours and persists for 24 hours. If the patient responds adequately to the drug, blood pressure normalizes within 1 month and remains stable without the development of tachyphylaxis. Interruption of treatment is not accompanied by withdrawal syndrome. With long-term use, Prestarium helps restore the elasticity of large arterial vessels, corrects histomorphological changes in resistant arteries and causes regression of left ventricular hypertrophy of the heart. Chronic heart failure Prestarium® normalizes heart function, reducing preload and afterload. When using the drug, a decrease in filling pressure of the left and right ventricles and a decrease in peripheral vascular resistance were noted. When Prestarium is used for the treatment of heart failure in recommended doses, no significant changes in blood pressure are observed after the first dose of the drug and after long-term use. Indications for use: arterial hypertension, chronic heart failure, coronary heart disease: reduction in the frequency of cardiac events in patients with a history of myocardial infarction and/or condition after revascularization. Method of administration and dosage The drug is recommended to be taken in the morning, 1 time per day, before meals. In the treatment of arterial hypertension, Prestarium can be used as monotherapy or in combination with antihypertensive drugs of other groups. The recommended initial dose is 5 mg once a day (in the morning), if necessary, the dose can be gradually increased to 2 tablets (10 mg) per day. If there is significant activation of the renin-angiotensin-aldosterone system (particularly in patients with renovascular hypertension, electrolyte disturbances and/or reduced circulating blood volume (BCV), cardiac decompensation or severe hypertension), a sharp drop may occur after taking the initial dose blood pressure. Treatment of such patients is recommended to begin with a dose of 2.5 mg under strict supervision. After 1 month of therapy, the dose can be increased to 10 mg once a day. Treatment of elderly patients with arterial hypertension should begin with a dosage of 2.5 mg, gradually increasing it: up to 5 mg one month after the start of treatment, then up to 10 mg, depending on the functional state of the kidneys (see table below). When treating chronic heart failure, the recommended dose is half a tablet (2.5 mg) per day. The use of the drug with non-potassium sparing diuretics and/or digoxin and/or beta-blockers should be initiated under close medical supervision, the recommended initial dose is 2.5 mg in the morning. If well tolerated, the dose is gradually increased by 2.5 mg to reach a dose of 5 mg once a day, maintaining an interval of at least 2 weeks. The basis for such correction should be the clinical response of each individual patient. When treating coronary heart disease, the drug should be started with a dose of 5 mg once a day for 2 weeks, then increased to 10 mg once a day, depending on the condition of the kidneys and provided that the dose of 5 mg is well tolerated. In elderly patients, therapy should begin with a dose of 2.5 mg 1 time per day for 1 week, then for 1 week - 5 mg 1 time per day, then increase the daily dose to 10 mg depending on renal function ( see table below). The dose is increased only if the lower previous dose is well tolerated. Dose adjustment for renal impairment Creatinine clearance (ClCr), ml/min Recommended dose of ClCr≥ 60 5 mg per day 30 2.5 mg per day 15 2.5 mg per day every other day Patients on hemodialysis* ClCr<30 2 .5 mg per day of dialysis * Dialysis clearance of perindoprilate is 70 ml/min. Patients on hemodialysis should take the drug after the dialysis session. No dose adjustment is required for liver dysfunction. Side effects The frequency of adverse reactions that may occur during therapy is given in the following gradation: very often (>1/10); often (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10,000, <1/1000); very rare (<1/10,000); frequency not established (frequency cannot be calculated from available data). Often cough (often described as dry or irritating), shortness of breath - headache, asthenia, dizziness, convulsions, paresthesia, taste disturbances, visual disturbances, tinnitus, vertigo, - arterial hypotension - nausea, vomiting, abdominal pain, dysgeusia, diarrhea or constipation, dyspepsia - rash, pruritus Uncommon - eosinophilia - hyponatremia - hyperkalemia, transient increase in serum urea and creatinine - hypoglycemia, - drowsiness, - syncope, malaise, chest pain - tachycardia, palpitations - vasculitis , peripheral edema, increased body temperature - eczema, photosensitivity - arthralgia, myalgia - accidental injuries due to a fall Rarely - bronchospasm - dry mouth, increased activity of liver enzymes and serum bilirubin levels - renal failure, impotence - angioedema of the face, limbs, lips , mucous membranes, tongue, larynx, glottis and/or larynx, urticaria - increased sweating - mood and sleep disturbances Very rare - arrhythmia, angina pectoris, myocardial infarction and stroke (possibly caused by severe hypotension in high-risk patients) - eosinophilic pneumonia , rhinitis - pancreatitis, cytolytic or cholestatic hepatitis - erythema (various types) - decreased hemoglobin and hematocrit, thrombocytopenia, leukopenia/neutropenia, agranulocytosis or pancytopenia, hemolytic anemia (in patients with congenital deficiency of the enzyme glucose-6-phosphate dehydrogenase (G-6PDH) )). - confusion - acute renal failure Contraindications - hypersensitivity to perindopril and other components of the drug or any other ACE inhibitor - angioedema (hereditary or idiopathic) due to previous therapy with ACE inhibitors in history - pregnancy and lactation - combined use with Aliskiren in patients, suffering from diabetes mellitus or renal failure (GFR <60 ml/min/1.73 m²) - children and adolescents under 18 years of age (efficacy and safety have not been established). Drug interactions ACE inhibitors reduce potassium loss caused by diuretics. Potassium-sparing diuretics (eg, spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may cause significant increases in serum potassium levels. Potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes should be used with caution and frequent monitoring of serum potassium is necessary. In patients taking diuretic drugs, especially in patients with decreased blood volume and/or electrolyte disturbances, a marked decrease in blood pressure may be observed after initiation of ACE inhibitor therapy. Discontinuation of the diuretic, replenishment of blood volume or correction of electrolyte balance before starting treatment, as well as the administration of low initial doses of perindopril and their gradual increase reduce the risk of hypotension. When taking lithium and ACE inhibitors in combination, there have been cases of reversible increases in serum lithium concentrations and the development of lithium toxicity. Concomitant use of thiazide diuretics may increase the existing risk of toxicity and increase the toxicity of lithium. The combined use of perindopril and lithium preparations is not recommended, but if necessary, lithium levels in the blood serum should be carefully monitored. Nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid at a dose of ≥3 g/day, reduce the hypotensive effect of ACE inhibitors. In addition, it has been noted that NSAIDs and ACE inhibitors have an additive effect on increasing plasma potassium levels, leading to a deterioration in renal function. This effect is reversible, but in rare cases, acute renal failure may develop, especially in patients with impaired renal function, for example, in elderly patients or in cases of dehydration. The combined use of antihypertensive and vasodilator drugs can lead to an increase in the hypotensive effect of perindopril. Concomitant use of nitroglycerin and other nitrates or vasodilators may lead to a further decrease in blood pressure. Co-administration of ACE inhibitors and antidiabetic drugs (insulins, oral hypoglycemic drugs) can lead to increased hypoglycemic effect, especially in the first weeks of therapy and in patients with impaired renal function. Perindopril can be prescribed simultaneously with acetylsalicylic acid, thrombolytic drugs, β-blockers and/or nitrates. The combined use of tricyclic antidepressants, antipsychotic drugs and antipsychotics with ACE inhibitors can lead to a further decrease in blood pressure. Sympathomimetic agents may reduce the hypotensive effect of ACE inhibitors. When combined with perindopril and gold preparations (sodium aurothiomalate injection), some patients experienced reactions (including facial flushing, nausea, vomiting and hypotension). Special instructions Aortic and mitral stenosis/hypertrophic cardiomyopathy Prestarium, like other ACE inhibitors, should be prescribed with extreme caution to patients with mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy. Coronary heart disease If an episode of unstable angina occurs during the first month of perindopril therapy, a careful assessment of the therapeutic benefit-risk ratio should be performed before continuing treatment. Hypotension ACE inhibitors may cause a decrease in blood pressure. Hypotension with clinical manifestations rarely develops in hypertensive patients without concomitant diseases, but more often occurs in patients with reduced blood volume (taking diuretics, on a diet with limited salt intake, patients on dialysis, patients suffering from diarrhea or vomiting) or in patients with severe renin -dependent hypertension. Symptomatic hypotension has been reported in patients with severe symptomatic heart failure, with or without concomitant renal failure. It is most likely to occur in patients with more severe heart failure, as a result of taking high doses of loop diuretics, hyponatremia or impaired renal function. Patients at increased risk for symptomatic hypotension should be closely monitored during initiation of therapy and during dose adjustment. A similar approach should also be followed when treating patients suffering from ischemia or cerebrovascular disease, in whom acute hypotension can lead to myocardial infarction or stroke. In some patients with congestive heart failure with normal or low blood pressure, taking Prestarium® may lead to an additional decrease in systemic blood pressure. This is an expected effect and usually does not require discontinuation of treatment. In some cases, with the onset of severe clinical manifestations of hypotension, it may be necessary to reduce the dose or discontinue the drug. Renal failure In case of impaired renal function (creatinine clearance < 60 ml/min), the initial dose should be adjusted according to the patient's creatinine clearance and then according to the patient's response to treatment. For these patients, regular monitoring of potassium and creatinine levels is common practice. Hypotension that occurs early in ACE inhibitor therapy in patients with symptomatic heart failure may lead to further deterioration of renal function. There are reports of acute renal failure occurring in this situation, which is usually reversible. Reversible increases in serum urea and creatinine levels have been reported in some patients with bilateral renal artery stenosis or solitary renal artery stenosis (especially those with renal failure) taking ACE inhibitors. In some patients with hypertension without visible renal vascular impairment, an increase in the concentration of urea in the blood and creatinine in the serum was observed, usually it was minor and transient, especially with the combined use of Prestarium and a diuretic. This is most likely in patients who already have impaired renal function. In this case, it may be necessary to reduce the dosage and/or stop taking the diuretic and/or Prestarium. Hemodialysis in patients receiving AKF inhibitors, during hemodialysis using high -flow membranes (for example, AN69®), anaphylactoid reactions were noted. Therefore, it is advisable to use a membrane of a different type or use a hypotensive agent of another pharmacotherapeutic group. Increased sensitivity/ anaphylactic swelling of the Angioneurotic edema of the face, limbs, lips, mucous membranes, tongue, voice gap and/ or larynx in patients undergoing AEF inhibitors, including the preserium, were rare. These reactions can occur at any time during therapy. In such cases, the reception of the Preminum should be immediately terminated and appropriate monitoring until the symptoms completely disappear. Usually, in cases where the edema affected only his face and lips, it took place without any treatment, although antihistamine drugs helped alleviate the symptoms. With the edema of the tongue, the voice gap or larynx, in which the obstruction of the respiratory tract is likely, the appropriate measures should be immediately taken. Emergency assistance may include the purpose of adrenaline and/or maintaining the patency of the respiratory tract. The patient should be under close medical supervision until symptoms disappear completely and completely. An increased risk of the onset of angioedema when taking the AKF inhibitor exists for patients who have undergone angioedema, not associated with the receipt of AKF inhibitors. There are rare reports of angioedema, affecting the gastrointestinal tract, in patients taking AKF inhibitors. These patients complained about abdominal pain (accompanied or not vomiting and nausea); In some cases, the Angiootects of the face did not precede this, and the level of C-1 esterase was normal. Diagnostics of the angiooteite was carried out using the procedures that included computed tomography of the abdomen, or during an ultrasound examination, or during a surgical operation; The symptoms took place after the termination of the reception of the AKF inhibitor. In patients taking AKF inhibitor, with complaints of abdominal pain, angioteum affecting the gastrointestinal tract should be included in the differential diagnosis. Anaphylactoid reactions during the procedures of low -density lipoprotein procedures (LDL) and during desensitization in rare cases in patients receiving LDSP anti -sulfate absorption, when prescribing AKF inhibitors, cases of development of anaphylactoid reactions were noted. It was possible to avoid these reactions by temporary cancellation of the AKF inhibitor every time before the apel. Anaphylactoid reaction occurred in some patients who received AKF inhibitors during desensitizing therapy (for example, hymenoperic poison). In some patients, these reactions were able to avoid by temporary abolition of the AKF inhibitor, but they again occurred in case of careless administration of the drug. Violation of the liver function, patients receiving AKF inhibitors who develop jaundice or the level of liver enzymes develops noticeably should stop taking the AKF inhibitor and undergo a thorough medical examination. Neutropenia/agranulocytosis/thrombocytopenia/anemia in patients with normal liver function and the absence of other complicating factors, neutropenia rarely occurs. Perindopril should be used with extreme caution in patients with systemic connective tissue diseases, while taking immunosuppressive drugs, allopurinol or procainamide and when used together, especially in patients with underlying renal impairment. Some patients developed severe infectious diseases, in some cases resistant to intensive antibiotic therapy. When prescribing perindopril to such patients, it is recommended to periodically monitor the number of leukocytes in the blood. Patients should report any signs of infectious diseases (eg, sore throat, fever) to their doctor. The race of angioedemic edema in the treatment of AKF inhibitors is more often occurs in patients of a non -graid race than in patients of other races. Like other AKF inhibitors, the hypotensive efficiency of perindopril in patients of a non -graid race can be lower than in patients of other races. Perhaps the reason for this is that hypertension in such patients very often occurs against a background of low renin content. Cough during treatment with ACE inhibitors in the patient may occur dry unproductive cough, which stops after the cancellation of the drug. Surgical intervention/General anesthesia. The use of AKF inhibitors in patients undergoing surgical intervention using general anesthesia can lead to a pronounced decrease in blood pressure, especially when using general anesthesia that have an antihypertensive effect. It is recommended to stop taking long -acting AKF inhibitors, including perindopril, 12 hours before surgery. Hyperkalemia hyperkalemia can develop during treatment with AKF inhibitors, including and perindopril. Hyperkalemia risk factors are renal failure, impaired renal function, elderly *over 70 years), diabetes mellitus, some concomitant conditions (dehydration, acute decompensation of chronic heart failure, metabolic acidosis), simultaneous intake of potassium -saving diuretics (such as spironolactone, eplerenon, triamateren , amyloride), as well as potassium and potassium -containing food substitutes, as well as the use of other products that help increase the content of potassium ions in blood plasma (for example, heparin) (especially in patients with reduced renal function). Hyperkalemia can lead to serious, sometimes fatal, heart rhythm disturbances. If you need a combined technique of the above funds, treatment should be carried out with caution, amid regular control of potassium ions in blood serum. Potassium -saving diuretics and potassium preparations are usually the joint use of perindopril and potassium -saving diuretics, as well as potassium preparations and potassium -containing food substitutes, is not recommended. The double blockade of the renin-angiotensin-aldosterone system in susceptible patients, especially with combined administration of drugs affecting this system, there were cases of hypotension, syncopes, strokes, hypercalemia and changes in renal function (including acute renal failure). In this regard, the dual blockade of the renin-angiotensin-aldosterone system by combined receiving an angiotensin-I-transforming enzyme and a receptor of angiotensin II or aliskirene receptors is not recommended. Patients with diabetes for patients with diabetes taking oral antidiabetic drugs or insulin, during the first month of treatment with AKF inhibitors, careful monitoring should be performed. Excipients with planned surgical intervention with anesthesia should stop treatment with the presetarium 1 day before surgery. The drug contains lactose, so it should not be used for congenital galactosemia, glucose-galactose malabsorption syndrome, as well as with lactase deficiency. The use of the effectiveness and safety of the use of the drug in children and adolescents in pediatrics is not established, and therefore the prescription of the drug to these categories of patients is not recommended. Pregnancy and lactation, if the pregnancy is planned or the fact of pregnancy has been confirmed, you should switch to an alternative type of treatment as soon as possible. The use of the drug in the II - III trimesters of pregnancy and during lactation is contraindicated. Features of the effect of the drug on the ability to drive a car and potentially dangerous mechanisms in some patients in response to a decrease in blood pressure can develop various individual reactions, especially at the beginning of therapy or when other hypotensive drugs are added to the therapy. Caution should be observed when driving vehicles and working with potentially dangerous mechanisms in connection with the possible development of dizziness. Overdose symptoms: acute hypotension, bradycardia, dizziness, anxiety, coughing, electrolyte disorders, renal failure, shock, tachycardia, rhythm disturbance, hyperpine (lung hyperventilation). Treatment: intravenous administration of sodium chloride solution of 9 mg/ml (0.9%), giving horizontal position, intravenous administration of solutions to replenish the fluid deficiency, angiotensin II and/or catecholamines, atropine. The patient should be under close attention, preferably in the intensive care unit. The content of electrolytes and creatinine in the patient serum should be constantly monitored. If necessary, pacemanism (to eliminate bradycardia). Hemodialysis (the use of polyacrylonitril high -flow membranes should be avoided). The production form and packaging of 30 tablets are placed in a polypropylene container. 1 container (for a dosage of 5 mg and 10 mg) or 3 containers (for a dosage of 10 mg) along with instructions for medical use in the state and Russian languages are placed in a cardboard box. Storage conditions are stored in a tightly cooled container at a temperature of not higher than 30 ° C. Keep out of the reach of children! Shelf life 3 years Do not use after the expiration date indicated on the package. Conditions of the vacation from pharmacies according to the recipe manufacturer Les Laboratoires Servier Industrie (Le Laboratory Servier Industri), France or Servier (Ireland) Industries Ltd (Servia (Ireland) Industry LTD), Ireland Owner Laboratoires Servier registration certificate Boratoire Servier), France address organizations receiving in the territory of the Republic of Kazakhstan claims from consumers for products: Representative Office in the Republic of Kazakhstan 050020, Almaty, Prospect of Dostyk 310 g, business center, 3rd floor of tel., 386 76 63, 386 76 64, 386 76 70, 386 76 71 fax e -mail