Hartil, tablets 5 mg 28 pcs

Hartil is an antihypertensive drug, an ACE inhibitor. As a result of suppression of ACE activity (regardless of plasma renin activity), a hypotensive effect is developed (in the prone and standing position) without a compensatory increase in HR. Suppression of ACE activity increases plasma renin activity and decreases angiotensin II and aldosterone levels. Ramipril acts on ACE circulating in blood and in tissues, including the vascular wall. It decreases OPPS (post-load), pulmonary capillary pressure (preload), increases cardiac output and increases exercise tolerance.

Indications

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

Pharmacological effect

Hartil is an antihypertensive drug, an ACE inhibitor. As a result of suppression of ACE activity (regardless of plasma renin activity), a hypotensive effect develops (with the patient lying and standing) without a compensatory increase in heart rate. Suppression of ACE activity increases plasma renin activity and reduces the levels of angiotensin II and aldosterone. Ramipril acts on ACE, circulating in the blood and located in tissues, incl. in the vascular wall. Reduces peripheral vascular resistance (afterload), pressure in the pulmonary capillaries (preload); increases cardiac output and increases exercise tolerance.

Special instructions

During treatment with Hartil, regular medical monitoring is required. After taking the first dose, as well as when increasing the dose of the diuretic and/or Hartil, patients should be under medical supervision for 8 hours to avoid the development of an uncontrolled hypotensive reaction; Repeated blood pressure measurements are recommended. If possible, dehydration, hypovolemia, and a decrease in the number of red blood cells should be corrected before starting the drug. If these disorders are severe, ramipril should not be started or continued until measures are taken to prevent an excessive fall in blood pressure and renal dysfunction.

Active ingredient

Ramipril

Composition

1 tablet contains:

Contraindications

– History of angioedema, incl. associated with previous therapy with ACE inhibitors.
– Hemodynamically significant bilateral renal artery stenosis or stenosis of the artery of a single kidney.
– Arterial hypotension or unstable hemodynamics.
– Pregnancy.
– Lactation period (breastfeeding).
– Primary hyperaldosteronism.
– Renal failure (KR – Hypersensitivity to ramipril or any other component of the drug.
Use with caution when:
– Hemodynamically significant aortic or mitral stenosis (risk of excessive reduction in blood pressure with subsequent impaired renal function).
– Severe primary malignant arterial hypertension.
– Severe lesions of the coronary and cerebral arteries (danger of decreased blood flow with an excessive decrease in blood pressure).
– Unstable angina.
– Severe ventricular arrhythmias.
– Terminal stage of CHF.
– Decompensated cor pulmonale.
– For diseases requiring the use of corticosteroids and immunosuppressants (lack of clinical experience) – incl. for systemic connective tissue diseases.
– Severe renal and/or liver failure.
– Hyperkalemia.
– Hyponatremia (including while taking diuretics and a diet with limited sodium intake).
– Initial or severe manifestations of fluid and electrolyte deficiency; conditions accompanied by a decrease in blood volume (including diarrhea, vomiting), diabetes mellitus.
– Inhibition of bone marrow hematopoiesis.
– Condition after 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 the use of ramipril in patients on dialysis.

Side Effects

From the cardiovascular system: decreased blood pressure, orthostatic hypotension, tachycardia; rarely – arrhythmia, increased disturbances in the blood supply to organs caused by narrowing of blood vessels. With an excessive decrease in blood pressure, mainly in patients with coronary artery disease and clinically significant narrowing of 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 side of the central nervous system: dizziness, headache, weakness, drowsiness, paresthesia, nervous excitability, anxiety, tremor, muscle spasms, mood disorders; when used in high doses – insomnia, anxiety, depression, confusion, fainting.

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

From the digestive system: nausea, vomiting, diarrhea or constipation, pain in the epigastric region, dry mouth, thirst, decreased appetite, stomatitis, hypersensitivity or inflammation of the buccal 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 an increased cough reflex), shortness of breath, rhinorrhea, rhinitis, sinusitis, bronchitis.

Allergic reactions: skin rash, itching, urticaria, conjunctivitis, photosensitivity; rarely – angioedema of the face, extremities, lips, tongue, pharynx or larynx, exfoliative dermatitis, exudative 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 concentration of hemoglobin and hematocrit, thrombocytopenia, leukocytopenia, neutropenia, agranulocytosis, pancytopenia, hemolytic anemia; Possible decrease in the number of red blood cells, bone marrow depression.

Interaction

When Hartil is used simultaneously with allopurinol, corticosteroids, procainamide, cytostatics and other substances that cause changes in the blood, the risk of disorders of the hematopoietic system increases.

Overdose

Symptoms: marked decrease in blood pressure, bradycardia, shock, water and electrolyte imbalance, acute renal failure.

Storage conditions

The drug should be stored at temperatures below 25°C.

Shelf life

2 years

Manufacturer

EGIS, Hungary