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Stoppress 8mg TB No. 30

Trade name Stoppress® International nonproprietary name Perindopril Dosage form Tablets 4 mg and 8 mg Composition One tablet contains the active substance: perindopril with tert-butylamine 4 mg or 8 mg excipients: mannitol, crospovidone, magnesium stearate, butyl methacrylate copolymer main, colloidal silicon dioxide

anhydrous Pharmacodynamics Perindopril is an inhibitor of the enzyme that converts angiotensin I to angiotensin II (angiotensin-converting enzyme, ACE). The converting enzyme, or kinase, is an exopeptidase that converts angiotensin I into the vasoconstrictor angiotensin II and also causes the breakdown of the vasodilator bradykinin to form an inactive heptapeptide. ACE inhibition leads to a decrease in plasma angiotensin II levels, which entails an increase in plasma renin activity (by inhibiting the negative feedback of renin release) and a decrease in aldosterone secretion. Because ACE inactivates bradykinin, ACE inhibition also leads to increased activity of the circulating and local kallikrein-kinin systems (and thereby activation of the prostaglandin system). It is possible that this mechanism contributes to the blood pressure-lowering effect of ACE inhibitors and partly explains certain side effects (eg, cough). The effect of perindopril is due to its active metabolite perindoprilate. Other metabolites have not shown the ability to inhibit ACE activity in vitro. Hypertension Perindopril is active in all degrees of hypertension: mild, moderate and severe; a decrease in systolic and diastolic blood pressure was noted. Perindopril reduces peripheral vascular resistance, leading to a decrease in blood pressure. As a consequence, there is an increase in peripheral blood flow without affecting the heart rate. Typically, renal blood flow increases, while glomerular filtration rate (GFR) usually does not change. The maximum hypotensive effect occurs between 4 and 6 hours after a single dose of the drug and persists for at least 24 hours: the minimum effects are 87-100% of the maximum effects. The decrease in blood pressure occurs quickly. In patients who respond to treatment, blood pressure normalizes within a month and is maintained without the development of tachyphylaxis. Perindopril reduces left ventricular hypertrophy. Perindopril demonstrates vasodilating properties. It improves the elasticity of arteries and reduces the media-lumen ratio of small arteries. Adjuvant treatment with thiazide diuretics provides a synergistic effect of an additive type. The combination of an ACE inhibitor and a thiazide diuretic reduces the risk of diuretic-induced hypokalemia. Heart failure Stoppress® reduces heart function by reducing pre- and afterload. Studies in patients with heart failure have shown: - decreased filling pressure of the left and right ventricles - decreased total peripheral vascular resistance - increased cardiac output and cardiac index Indications for use - arterial hypertension - chronic heart failure - coronary heart disease: reduced risk of cardiovascular complications in patients with a history of myocardial infarction and/or condition after revascularization Method of administration and dosage It is recommended to take Stopress® once a day in the morning, before meals. The dose should be selected individually, taking into account the patient's profile and the dynamics of blood pressure levels. Arterial hypertension Stopress® can be used as monotherapy or in combination with antihypertensive drugs of other classes. The recommended starting dose is 4 mg once daily in the morning. In patients with severe activation of the renin-angiotensin-aldosterone system (especially with renovascular hypertension, decreased circulating blood volume, cardiac decompensation, or severe hypertension), a sharp drop in blood pressure may occur after taking the initial dose of the drug. For such patients, an initial dose of 2 mg is recommended; treatment should begin under the supervision of a physician. After one month of treatment, the dose can be increased to 8 mg once daily. After initiation of treatment with perindopril, clinically significant hypotension may develop, the likelihood of which is higher in patients with concomitant treatment with diuretics. Such patients are advised to take the drug with caution due to a possible decrease in circulating blood volume and/or electrolyte deficiency. If possible, diuretics should be discontinued 2-3 days before starting treatment with perindopril. In patients with hypertension who cannot be discontinued from diuretics, treatment with perindopril should be initiated at a dose of 2 mg. Kidney function and blood potassium levels should be monitored. Subsequent doses of perindopril should be adjusted according to blood pressure response. If necessary, treatment with diuretics can be resumed. In elderly patients, treatment should begin with a dose of 2 mg, which after a month can be increased to 4 mg, and then, if necessary, to 8 mg, depending on renal function (see table below). Chronic heart failure Stopress® is often combined with the prescription of diuretics that do not save potassium, and/or digoxin and/or beta blockers; in such cases, the drug should be taken under close medical supervision at the recommended starting dose of 2 mg in the morning. If well tolerated, after at least 2 weeks, this dose can be increased by 2 mg - 4 mg once a day. Dose selection should be based on the clinical response of the individual patient. In severe heart failure and in other high-risk patients (patients with impaired renal function and a tendency to electrolyte disturbances, with concomitant use of diuretics and/or vasodilators), treatment should be initiated under close medical supervision. Before initiating Stoppress® treatment in patients at high risk of developing clinically significant hypotension (i.e., patients with electrolyte loss with or without hyponatremia, hypovolemia, or patients with concomitant active diuretic therapy), these conditions should be corrected, if possible. Blood pressure, renal function and serum potassium levels should be monitored before and during treatment with perindopril. Coronary heart disease Stoppress® should be prescribed at a dose of 4 mg once a day for two weeks, then increase the dose to 8 mg once a day (depending on renal function and provided that the 4 mg dose is well tolerated). Before increasing the dose to 8 mg once daily, depending on renal function, elderly patients should be given 2 mg once daily for one week, then 4 mg once daily for the next week (see Table 1 "Dose adjustment for renal impairment"). The dose should be increased only if the previous lower dose was well tolerated. Dose Adjustment in Patients with Renal Impairment As presented in Table 1 below, the dose in patients with renal impairment should be based on creatinine clearance: Table 1: Dose Adjustment in Patients with Renal Impairment

Creatinine clearance (ml/min)	Recommended dose
ClCR ≥ 60	4 mg per day
30 < ClCR < 60	2 mg per day
15 < ClCR < 30	2 mg every other day
Patients on hemodialysis*, ClCR < 15	2 mg on the day of dialysis

* The clearance of perindoprilate during dialysis is 70 ml/min. Hemodialysis patients should receive this dose after the hemodialysis session. Dose adjustment in patients with impaired liver function No dose adjustment is required in patients with impaired liver function. Side effects Often (≥1/100, <1/10) - muscle cramps - rash, itching - nausea, vomiting, abdominal pain, change in taste, dyspepsia, diarrhea, constipation - cough, shortness of breath - arterial hypotension - headache, dizziness , ringing in the ears, blurred vision, paresthesia - asthenia Uncommon (≥1/1000, <1/100) - angioedema of the face, extremities, lips, mucous membranes, tongue, vocal folds and/or larynx, urticaria - photosensitivity reactions, pemphigoid , hyperhidrosis - drowsiness, fainting - dry mouth - bronchospasm - palpitation, tachycardia - chest pain, poor health, peripheral edema, fever - vasculitis - increased activity of liver enzymes and serum bilirubin levels - increased urea concentration in the blood, increased concentration creatinine in the blood - mood or sleep disturbances - renal failure - impotence - increased sweating - hypoglycemia, hyponatremia, hyperkalemia - arthralgia, myalgia - accidental injuries due to a fall Very rare (<1/10000) - confusion - arrhythmia, angina, myocardial infarction, stroke - eosinophilic pneumonia, rhinitis - pancreatitis, cytolytic or cholestatic hepatitis - erythema multiforme - acute renal failure - decreased hemoglobin and hematocrit, thrombocytopenia, leukopenia/neutropenia, agranulocytosis or pancytopenia, hemolytic anemia (in patients with congenital deficiency of the glucose-6-enzyme phosphate dehydrogenase (G-6PDG)) Contraindications - hypersensitivity to perindopril or auxiliary components of the drug, as well as to other ACE inhibitors - history of angioedema associated with taking ACE inhibitors - hereditary or idiopathic angioedema - pregnancy and lactation - childhood and adolescence up to 18 years of age Pharmacodynamics Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (angiotensin-converting enzyme, ACE). The converting enzyme, or kinase, is an exopeptidase that converts angiotensin I into the vasoconstrictor angiotensin II and also causes the breakdown of the vasodilator bradykinin to form an inactive heptapeptide. ACE inhibition leads to a decrease in plasma angiotensin II levels, which entails an increase in plasma renin activity (by inhibiting the negative feedback of renin release) and a decrease in aldosterone secretion. Because ACE inactivates bradykinin, ACE inhibition also leads to increased activity of the circulating and local kallikrein-kinin systems (and thereby activation of the prostaglandin system). It is possible that this mechanism contributes to the blood pressure-lowering effect of ACE inhibitors and partly explains certain side effects (eg, cough). The effect of perindopril is due to its active metabolite perindoprilate. Other metabolites have not shown the ability to inhibit ACE activity in vitro. Hypertension Perindopril is active in all degrees of hypertension: mild, moderate and severe; a decrease in systolic and diastolic blood pressure was noted. Perindopril reduces peripheral vascular resistance, leading to a decrease in blood pressure. As a consequence, there is an increase in peripheral blood flow without affecting the heart rate. Typically, renal blood flow increases, while glomerular filtration rate (GFR) usually does not change. The maximum hypotensive effect occurs between 4 and 6 hours after a single dose of the drug and persists for at least 24 hours: the minimum effects are 87-100% of the maximum effects. The decrease in blood pressure occurs quickly. In patients who respond to treatment, blood pressure normalizes within a month and is maintained without the development of tachyphylaxis. Perindopril reduces left ventricular hypertrophy. Perindopril demonstrates vasodilating properties. It improves the elasticity of arteries and reduces the media-lumen ratio of small arteries. Adjuvant treatment with thiazide diuretics provides a synergistic effect of an additive type. The combination of an ACE inhibitor and a thiazide diuretic reduces the risk of diuretic-induced hypokalemia. Heart failure Stoppress® reduces heart function by reducing pre- and afterload. Studies in patients with heart failure have shown: - decreased filling pressure of the left and right ventricles - decreased total peripheral vascular resistance - increased cardiac output and cardiac index Indications for use - arterial hypertension - chronic heart failure - coronary heart disease: reduced risk of cardiovascular complications in patients with a history of myocardial infarction and/or condition after revascularization Method of administration and dosage It is recommended to take Stopress® once a day in the morning, before meals. The dose should be selected individually, taking into account the patient's profile and the dynamics of blood pressure levels. Arterial hypertension Stopress® can be used as monotherapy or in combination with antihypertensive drugs of other classes. The recommended starting dose is 4 mg once daily in the morning. In patients with severe activation of the renin-angiotensin-aldosterone system (especially with renovascular hypertension, decreased circulating blood volume, cardiac decompensation, or severe hypertension), a sharp drop in blood pressure may occur after taking the initial dose of the drug. For such patients, an initial dose of 2 mg is recommended; treatment should begin under the supervision of a physician. After one month of treatment, the dose can be increased to 8 mg once daily. After initiation of treatment with perindopril, clinically significant hypotension may develop, the likelihood of which is higher in patients with concomitant treatment with diuretics. Such patients are advised to take the drug with caution due to a possible decrease in circulating blood volume and/or electrolyte deficiency. If possible, diuretics should be discontinued 2-3 days before starting treatment with perindopril. In patients with hypertension who cannot be discontinued from diuretics, treatment with perindopril should be initiated at a dose of 2 mg. Kidney function and blood potassium levels should be monitored. Subsequent doses of perindopril should be adjusted according to blood pressure response. If necessary, treatment with diuretics can be resumed. In elderly patients, treatment should begin with a dose of 2 mg, which after a month can be increased to 4 mg, and then, if necessary, to 8 mg, depending on renal function (see table below). Chronic heart failure Stopress® is often combined with the prescription of diuretics that do not save potassium and/or digoxin and/or beta blockers; in such cases, the drug should be taken under close medical supervision at the recommended starting dose of 2 mg in the morning. If well tolerated, after at least 2 weeks, this dose can be increased by 2 mg - 4 mg once a day. Dose selection should be based on the clinical response of the individual patient. In severe heart failure and in other high-risk patients (patients with impaired renal function and a tendency to electrolyte disturbances, with concomitant use of diuretics and/or vasodilators), treatment should be initiated under close medical supervision. Before initiating Stoppress® treatment in patients at high risk of developing clinically significant hypotension (i.e., patients with electrolyte loss with or without hyponatremia, hypovolemia, or patients with concomitant active diuretic therapy), these conditions should be corrected, if possible. Blood pressure, renal function and serum potassium levels should be monitored before and during treatment with perindopril. Coronary heart disease Stoppress® should be prescribed at a dose of 4 mg once a day for two weeks, then increase the dose to 8 mg once a day (depending on renal function and provided that the 4 mg dose is well tolerated). Before increasing the dose to 8 mg once daily, depending on renal function, older patients should be given 2 mg once daily for one week, then 4 mg once daily for the next week (see Table 1 "Dose adjustment for renal impairment"). The dose should be increased only if the previous lower dose was well tolerated. Dose Adjustment in Patients with Renal Impairment As presented in Table 1 below, the dose in patients with renal impairment should be based on creatinine clearance: Table 1: Dose Adjustment in Patients with Renal Impairment

Creatinine clearance (ml/min)	Recommended dose
ClCR ≥ 60	4 mg per day
30 < ClCR < 60	2 mg per day
15 < ClCR < 30	2 mg every other day
Patients on hemodialysis*, ClCR < 15	2 mg on the day of dialysis