Hartil, pills 5mg 28pcs

Composition

1 tablet contains: ramipril 5 mg. Auxiliary substances: sodium bicarbonate, lactose monohydrate, pregelatinized starch 1500, sodium croscarmellose, sodium stearyl fumarate.

Pharmacological action

Hartil is an antihypertensive drug, an ACE inhibitor. As a result of ACE inhibition (regardless of plasma renin activity), a hypotensive effect develops (in the patient’s lying and standing positions) without a compensatory increase in heart rate. ACE inhibition increases plasma renin activity, reduces angiotensin II and aldosterone levels. Ramipril acts on ACE that circulates in the blood and is located in tissues, including in the vascular wall. Reduces OPSS (afterload), pressure in the pulmonary capillaries (preload); increases cardiac output and increases exercise tolerance. With prolonged use, ramipril promotes the reverse development of myocardial hypertrophy in patients with arterial hypertension. Ramipril reduces the incidence of arrhythmia during myocardial reperfusion; improves blood supply to the ischemic myocardium. Ramipril inhibits the breakdown of bradykinin and stimulates the formation of nitric oxide (NO) in the endothelium. The antihypertensive effect begins 1-2 hours after oral use, the maximum effect develops within 3-6 hours and persists for 24 hours. With daily use, the antihypertensive effect increases within 3-4 weeks and persists with long-term treatment (1-2 years). Antihypertensive efficacy does not depend on the patient’s gender, age, or body weight. In patients with acute myocardial infarction, ramipril restricts the spread of necrosis, improves the prognosis of life; reduces mortality in the early and long-term period of myocardial infarction, the frequency of recurrent heart attacks; reduces the severity of manifestations of heart failure, slows its progression. With prolonged use (at least 6 months) reduces the degree of pulmonary hypertension in patients with congenital and acquired heart defects. Ramipril reduces portal vein pressure in patients with portal hypertension; inhibits microalbuminuria (in the initial stages) and deterioration of renal function in patients with severe diabetic nephropathy. In nondiabetic nephropathy, accompanied by proteinuria (more than 3 g / day) and renal failure, it slows down further deterioration of renal function, reduces proteinuria, reduces the risk of increased creatinine levels or the development of end-stage renal failure.

Indications

-Arterial hypertension. – Chronic heart failure. – Chronic heart failure after acute myocardial infarction in patients with stable hemodynamics. – Diabetic nephropathy and chronic diffuse kidney diseases (non-diabetic nephropathy). – To reduce the risk of myocardial infarction, stroke, or coronary death in high-risk cardiovascular patients with CHD, including patients who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, and coronary artery bypass grafting.

Contraindications

-Angioedema in the anamnesis, including associated with previous therapy with ACE inhibitors. – Hemodynamically significant bilateral renal artery stenosis or stenosis of the artery of a single kidney. – Hypotension or unstable hemodynamics. – Pregnancy. – Lactation period (breastfeeding). – Primary hyperaldosteronism. – Renal failure (CC – Hypersensitivity to ramipril or any other component of the drug. Use with caution when:  – Hemodynamically significant aortic or mitral stenosis (risk of excessive lowering of blood pressure with subsequent renal dysfunction). – Severe primary malignant arterial hypertension. – Severe lesions of the coronary and cerebral arteries (the risk of reduced blood flow with an excessive decrease in blood pressure). – Unstable angina pectoris. – Severe ventricular arrhythmias. – End-stage CHF. – Decompensated pulmonary heart. – For diseases that require the use of corticosteroids and immunosuppressants (lack of clinical experience) – including systemic connective tissue diseases. – Severe renal and / or hepatic insufficiency. – Hyperkalemia. – Hyponatremia (including on the background of taking diuretics and a diet with limited sodium intake). – Initial or pronounced manifestations of fluid and electrolyte deficiencies; conditions accompanied by a decrease in BCC (including diarrhea, vomiting), diabetes mellitus. – Inhibition of bone marrow hematopoiesis. – Condition after a kidney transplant. – In elderly patients. – In children and adolescents under 18 years of age (efficacy and safety have not been established). There is only limited experience with ramipril in dialysis patients.

Side effects

From the cardiovascular system: reduced blood pressure, orthostatic hypotension, tachycardia; rarely-arrhythmia, increased blood supply disorders caused by narrowing of blood vessels. With an excessive decrease in blood pressure, mainly in patients with CHD and clinically significant narrowing of the cerebral vessels, myocardial ischemia (angina pectoris or myocardial infarction) and cerebral ischemia (possibly with dynamic cerebrovascular accident or stroke) may develop.

From the genitourinary system: development or worsening of renal failure, increased existing proteinuria, decreased urine volume (at the beginning of taking the drug).

From the central nervous system: dizziness, headache, weakness, drowsiness, paresthesia, nervous excitability, anxiety, tremor, muscle spasm, mood disorders; when used in high doses — insomnia, anxiety, depression, confusion, fainting.

From the sensory organs: vestibular disorders, disorders of taste (for example, metallic taste), smell, hearing and vision, tinnitus.

From the digestive system: nausea, vomiting, diarrhea or constipation, epigastric pain, dry mouth, thirst, decreased appetite, stomatitis, hypersensitivity or inflammation of the cheek mucosa, pancreatitis; rarely-hepatitis, cholestatic jaundice, impaired liver function with the development of acute liver failure.

From the respiratory system: “dry” cough, bronchospasm (in patients with increased cough reflex), shortness of breath, rhinorrhea, rhinitis, sinusitis, bronchitis.

Allergic reactions: skin rash, pruritus, urticaria, conjunctivitis, photosensitization; rarely — angioedema of the face, limbs, lips, tongue, pharynx or larynx, exfoliative dermatitis, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), pemphigus (pemphigus), serositis, onycholysis, vasculitis, myositis, myalgia, arthralgia, arthritis, eosinophilia.

From the hematopoietic organs: anemia, decreased hemoglobin and hematocrit concentrations, thrombocytopenia, leukocytopenia, neutropenia, agranulocytosis, pancytopenia, hemolytic anemia; possibly a decrease in the number of red blood cells, bone marrow depression.

Interaction

Concomitant use of Hartil with allopurinol, corticosteroids, procainamide, cytostatics and other substances that cause blood changes increases the risk of disorders of the hematopoietic system. When Hartil is co-administered with hypoglycemic drugs (insulin or sulfonylureas), an excessive decrease in blood sugar levels may occur. This phenomenon may be related to the fact that ACE inhibitors can increase the sensitivity of tissues to insulin. When used concomitantly with other antihypertensive agents (including diuretics) or other drugs that have a hypotensive effect (for example, nitrates, tricyclic antidepressants and anesthetics): it is possible to increase the antihypertensive effect. Concomitant use of potassium salts, potassium-sparing diuretics, and heparin with ramipril is not recommended due to the risk of hyperkalemia. When used concomitantly with lithium preparations, an increase in the concentration of lithium in the blood serum is observed, which leads to an increased risk of cardio – and nephrotoxicity. NSAIDs and sodium salts reduce the effectiveness of ACE inhibitors.

How to take, course of use and dosage

Tablets should be taken orally, swallowing them whole, without chewing, with a large amount of liquid (about 1 cup). Tablets can be taken regardless of the meal time. The dose is set individually, taking into account the therapeutic effect and tolerability. In patients with arterial hypertension, the recommended initial dose is 2.5 mg 1 time/day. (1 2.5 mg tablet daily). Depending on the therapeutic effect, the dose can be increased by doubling the daily dose every 2-3 weeks. The standard maintenance dose is 2.5-5 mg / day. (1 tablet 2.5 mg or 1 tablet 5 mg). The maximum daily dose should not exceed 10 mg. In patients with chronic heart failure, the recommended starting dose is 1.25 mg once a day. (daily 1 tablet of Hartil 1.25 mg). Depending on the therapeutic effect, the dose can be increased by doubling the daily dose every 2-3 weeks. If you need to take more than 2.5 mg of the drug, this dose can be taken immediately or divided into 2 doses. The maximum daily dose should not exceed 10 mg. For treatment after myocardial infarction, it is recommended to start taking the drug 2-9 days after acute myocardial infarction. The recommended initial dose, depending on the patient’s condition and the time elapsed after acute myocardial infarction, is 2.5 mg 2 times/day. (2 tablets of 1.25 mg or 1 tablet of 2.5 mg 2 times / day.Depending on the therapeutic effect, the initial dose can be doubled to 5 mg (2 tablets of 2.5 mg or 1 tablet of 5 mg) 2 times / day. The maximum daily dose should not exceed 10 mg. If the drug is intolerant, the dose should be reduced. For nondiabetic or diabetic nephropathy, the recommended starting dose is 1.25 mg (1 tablet of 1.25 mg) 1 time / day. daily. Depending on the therapeutic effect, the dose can be increased by doubling the daily dose every 2-3 weeks. If you need to take more than 2.5 mg of the drug, this dose can be taken immediately or divided into 2 doses. The recommended maximum daily dose is 5 mg. For the prevention of myocardial infarction, stroke or death from cardiovascular disorders, the recommended initial dose is 2.5 mg 1 time / day. Depending on the tolerability of the drug, after 1 week of use, the dose should be doubled compared to the initial one. This dose should be doubled again after 3 weeks of use. The recommended maintenance dose is 10 mg once a day. Use in elderly patients taking diuretics and / or with heart failure, as well as with impaired liver or kidney function: the dose should be determined by individual selection, depending on the patient’s response to treatment. Patients with renal insufficiency need to adjust the dosage regimen. With moderate renal impairment (creatinine clearance from 20 to 50 ml / min per 1.73 m2 of body surface), the initial dose is usually 1.25 mg 1 time / day. (1 tablet 1.25 mg / day). The maximum daily dose should not exceed 5 mg. If creatinine clearance is not measured, it can be calculated from serum creatinine using the Cockcroft formula. For men: Creatinine clearance (ml / min) = (140 – age) x body weight (kg) / 72 x serum creatinine (mg / dl). For women: the calculation result should be multiplied by 0.85. With impaired liver function, a reduced or increased effect of the drug Hartil can equally often be observed, so careful medical supervision is required in the early stages of treatment of this category of patients. The maximum daily dose in such cases should not exceed 2.5 mg. Use in patients receiving diuretic therapy: Due to the risk of a significant decrease in blood pressure, consideration should be given to temporarily discontinuing or at least reducing the dose of diuretics at least 2-3 days (or longer, depending on the duration of action of diuretics) before starting Hartil. For patients who have previously received diuretics, the initial dose is usually 1.25 mg.

Overdose

Symptoms: marked decrease in blood pressure, bradycardia, shock, impaired water-electrolyte balance, acute renal failure. Treatment: in case of mild overdose-gastric lavage, use of adsorbents and sodium sulfate (preferably within 30 minutes after use). In acute overdose: control and support of vital functions in the ICU; with a decrease in blood pressure – the introduction of catecholamines and angiotensin II. The patient should be placed on his back with an elevated position of the legs, enter additional amounts of fluid and sodium. It is not known whether forced diuresis, hemofiltration, and urinary pH correction accelerate the elimination of ramipril. This should be taken into account when considering the possibility of hemodialysis and hemofiltration.

Special instructions

Regular medical monitoring is required during treatment with Hartil. After taking the first dose, as well as when increasing the dose of diuretics and/or Hartil, patients should be under medical supervision for 8 hours to avoid the development of an uncontrolled hypotensive reaction; repeated blood pressure measurement is recommended. If possible, you should correct dehydration, hypovolemia, and a decrease in the number of red blood cells before taking the drug. If these disorders are severe, ramipril should not be started or continued until measures are taken to prevent an excessive drop in blood pressure and impaired renal function. Careful monitoring is required in patients with renal vascular damage (for example, clinically insignificant renal artery stenosis or hemodynamically significant artery stenosis of a single kidney), impaired renal function, with a pronounced decrease in blood pressure, mainly in patients with heart failure, as well as after kidney transplantation. Impaired renal function can be detected by elevated serum urea and creatinine levels, especially if the patient is taking diuretics. Due to a decrease in angiotensin II synthesis and aldosterone secretion in the blood serum, sodium levels may decrease and potassium levels may increase. Hyperkalemia is more common in patients with impaired renal function (for example, diabetic nephropathy) or when taken concomitantly with potassium-sparing diuretics. In case of an excessive decrease in blood pressure, the patient should be laid down, raise his legs; fluid use and other measures may also be required. Blood changes are more likely in patients with impaired renal function and concomitant connective tissue diseases (for example, SLE and scleroderma), as well as in the case of other drugs that affect the hematopoietic and immune systems. Serum sodium levels should also be regularly monitored in patients taking diuretics at the same time as Hartil. You should also check your white blood cell count regularly to avoid developing leukopenia. Monitoring should be more frequent at the beginning of therapy and in patients belonging to any risk group. Experience with ramipril in patients with severe renal insufficiency (CKD) There have been reports of life-threatening anaphylactoid reactions, sometimes leading to shock, in patients on hemodialysis using membranes with high hydraulic permeability (for example, polyacrylonitrile) with simultaneous use of ACE inhibitors. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate uptake. When desensitizing therapy is performed to reduce an allergic reaction to insect bites (for example, bees and wasps), a severe, life-threatening anaphylactoid reaction (drop in blood pressure, respiratory disorders, vomiting, skin reactions) may occur while taking ACE inhibitors. Therefore, ACE inhibitors should not be given to patients receiving desensitizing therapy. In cases of lactase deficiency, galactosemia, or glucose / lactose malabsorption syndrome, it should be noted that each tablet of Hartil 10 mg contains 193.2 mg of lactose. Use in pediatrics: experience of using ramipril in children with severe renal insufficiency (CKD) affecting the ability to drive vehicles and manage mechanisms:at the beginning of treatment, a decrease in blood pressure may affect the ability to concentrate. In this case, patients are advised to refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions. In the future, the degree of restriction is determined for each patient individually.

Storage conditions

The drug should be stored at a temperature below 25°C.

Shelf life

2 years

Active ingredient

Ramipril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Heart failure, Kidney damage, Prevention of heart attacks and strokes, Hypertension