Ena-denk 10mg 30 tablets

Form

tableti

Dosage mg

10

Pack

30

Composition Active substance: 1 tablet contains 10 mg enalapril maleate. Excipients: sodium bicarbonate, lactose monohydrate, magnesium stearate, corn starch, talc, iron (III) oxide (E 172). Pharmacological properties Pharmacological group: Angiotensin-converting enzyme inhibitor. En-Denk 10 (enalapril maleate) is the salt of enalapril maleate, a derivative of two amino acids (L-alanine and L-proline). Angiotensin-converting enzyme (ACE) is a peptidyl peptidase that converts angiotensin I to the vasoactive substance, angiotensin II. After absorption, enalapril maleate is hydrolyzed to enalaprilat, which inhibits angiotensin-converting enzyme. Inhibition of ACE leads to a decrease in plasma angiotensin II levels. This leads to an increase in plasma renin activity (due to the removal of negative feedback on renin secretion) and a decrease in aldosterone secretion. ACE is identical to kininase II. Consequently, enalapril may suppress the degradation of bradykinin (a potential vasodepressor peptide). However, it is not yet known what role this mechanism plays in the therapeutic effect of enalapril maleate. Although the hypoglycemic effect of enalapril maleate is mainly due to the suppression of the renin-angiotensin-aldosterone system, the hypotensive effect of enalapril maleate is also observed in hypertension when plasma renin concentration is reduced. In hypertension, enalapril maleate intake lowers blood pressure in various positions (both lying and standing) and does not cause significant acceleration of heart rate. Symptomatic orthostatic hypotension is rare. In some patients, several weeks of treatment may be necessary to achieve optimal blood pressure. Sudden discontinuation of enalapril maleate intake may cause a rapid increase in blood pressure. Effective suppression of ACE activity is usually achieved 2-4 hours after a single oral dose of enalapril maleate. The hypotensive effect is usually seen within 1 hour, and blood pressure is maximally reduced 4-6 hours after oral administration. The duration of effect is dose-dependent. However, with the recommended dose, hypotensive and hemodynamic effects are observed for at least 24 hours. Pharmacokinetics Oral enalapril maleate is rapidly absorbed. Peak plasma concentration is observed within 1 hour. Based on the concentration excreted in urine, 60% of the enalapril maleate contained in the tablet is absorbed by the body. The presence of food in the gastrointestinal tract does not affect the absorption of oral enalapril maleate. After absorption, oral enalapril maleate is rapidly and significantly hydrolyzed to enalaprilat (a potent inhibitor of angiotensin-converting enzyme). Peak plasma concentration of enalaprilat is observed approximately 4 hours after taking the enalapril maleate tablet. After multiple doses, the accumulated elimination half-life of enalaprilat is 11 hours. In patients with normal renal function, steady-state enalaprilat concentration is achieved approximately 4 days after the start of treatment. In case of therapeutic dose overdose, more than 60% of enalaprilat is not bound to plasma proteins. With the exception of conversion to enalaprilat, enalapril maleate does not undergo significant metabolism. Enalapril is mainly excreted by the kidneys. The main substances excreted in urine are enalaprilat, accounting for 40% of the administered dose, and unchanged enalapril maleate (approximately 20%). Renal impairment: Excretion of enalapril maleate and enalaprilat is reduced in patients with impaired renal function. After taking 5 mg once daily, in patients with mild to moderate renal insufficiency (creatinine clearance 40-60 ml/min), the AUC of steady-state enalaprilat is approximately 4 times higher compared to patients with normal renal function. In severe renal insufficiency (creatinine clearance ≤30 ml/min), AUC increases approximately 8-fold. In renal insufficiency of this degree, the half-life of enalapril maleate is prolonged after multiple doses, and the time to reach steady-state concentration increases (see section "Dosage"). Enalapril can be removed from circulation by hemodialysis. Dialysis clearance is 62 ml/min. Children and adolescents: Pharmacological studies were conducted in 40 hypertensive adults and children (from 2 months to 16 years of age) using multiple doses, who received 0.07 – 0.14 mg/kg of enalapril maleate daily. The final results of this study showed that the pharmacokinetics of enalapril do not differ significantly between adults and children. Data indicate that AUC (dose standardized to body weight) increases with age; however, an increase in AUC is not observed when these data are standardized according to body surface area. The accumulated elimination half-life of enalapril in steady state is 14 hours. Indications En-Denk 10 is an ACE inhibitor, an antihypertensive drug that also reduces the load on the heart. En-Denk 10 is used in the following cases: - Treatment of high blood pressure (hypertension), - Treatment of heart failure – used in addition to diuretics, and in severe heart failure, in addition to digitalis. Dosage and administration En-Denk 10 should always be taken as prescribed by a doctor. If in doubt about taking the medication, consult your doctor or pharmacist. En-Denk 10 must be taken for the duration prescribed by your doctor. Depending on your health status and the severity of the disease, your doctor will select the initial dose of the medication and gradually increase it depending on how your blood pressure responds to treatment. Dosage: Unless otherwise indicated, the following doses should be taken: Hypertension: Initial dose: The initial dose varies and ranges from 5 mg to a maximum of 20 mg of enalapril maleate per day, depending on the patient's health status and the severity of the disease. Moderate hypertension: The recommended initial dose is 1 tablet of 5 mg enalapril maleate per day (equivalent to 10 mg enalapril maleate) per day. Patients with a highly activated blood pressure regulatory system, such as those with renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension: The initial dose is 5 mg enalapril maleate or less per day. A sharp drop in blood pressure is expected after the initial dose; therefore, the patient should be under medical supervision during this period. Patients previously treated with high doses of diuretics: The initial dose is 5 mg enalapril maleate or less per day. If the patient has been treated with high doses of diuretics before treatment, this may lead to volume depletion. In such cases, starting enalapril maleate treatment may lead to a decrease in blood pressure. If possible, discontinue diuretic therapy 2-3 days before starting En-Denk 10 treatment. Renal function and serum potassium levels should also be monitored. Maintenance dose: The maintenance dose is 2 tablets of En-Denk 10 per day (equivalent to 20 mg enalapril maleate). The maximum daily dose of 40 mg enalapril maleate should not be exceeded. Heart failure (symptomatic heart failure)/left ventricular dysfunction (asymptomatic left ventricular dysfunction): Initial dose: For the treatment of heart failure, En-Denk 10 is usually used in combination with diuretics, digitalis, or beta-blockers. The initial dose is 2.5 mg enalapril maleate per day. At the beginning of treatment, the patient should be under medical supervision to monitor blood pressure response. Maintenance dose: A decrease in blood pressure is expected in patients with heart failure after starting En-Denk 10 treatment. If blood pressure is effectively regulated, the dose should be gradually increased over 2-4 weeks until the maintenance dose reaches 2 tablets of En-Denk 10 per day (equivalent to 20 mg enalapril maleate). This dose can be taken as a single dose or divided into two doses. The maximum daily dose of 40 mg enalapril maleate divided into 2 doses should not be exceeded. Special caution is required when taking the first dose or increasing the dose. If drowsiness or dizziness occurs, consult your doctor. Blood pressure and renal function should be checked before and after En-Denk 10 treatment, as cases of hypotension and (less commonly) acute renal failure have been reported. If the patient is receiving diuretic therapy, the dose should be reduced before starting En-Denk 10 treatment. If hypotension occurs at the start of En-Denk 10 treatment, it does not mean that a similar episode will recur during En-Denk 10 treatment, and therefore treatment does not need to be discontinued. Serum potassium levels and renal function should also be checked. Dosage in renal impairment: Generally, the intervals between doses of En-Denk 10 should be prolonged and/or the dose should be reduced. The doctor will decide on the appropriate treatment strategy for the patient. For moderate renal impairment, taking 5-10 mg enalapril maleate per day is recommended. For severe renal impairment, 2.5 mg enalapril maleate per day is recommended. For patients on dialysis, 2.5 mg enalapril maleate per day is recommended on dialysis days. On other days, the dosage should be adjusted according to blood pressure. Dosage in the elderly: The dose should be adjusted according to the patient's renal function. Dosage in children: In children who can swallow tablets, the dose should be adjusted according to the patient's health status and blood pressure. For pediatric patients with hypertension weighing 20-50 kg, the recommended initial dose is 2.5 mg enalapril maleate per day. If the child weighs more than 50 kg, 5 mg enalapril maleate per day is prescribed. The doctor will adjust the dose according to the child's condition. In children weighing 20-50 kg, no more than 20 mg enalapril maleate per day should be prescribed, and in children weighing more than 50 kg, no more than 40 mg enalapril maleate per day should be taken. En-Denk 10 is not recommended for newborns and children with kidney disease. Duration of administration: The tablet should be swallowed with sufficient fluid (e.g., 1 glass of water). The tablet should not be taken with food. The daily dose is usually taken once in the morning, but if necessary, it can be divided into two doses, morning and evening. The doctor will determine the duration of treatment. En-Denk 10 treatment is usually long-term. If the patient thinks that En-Denk 10 is too weak or too strong, they should consult their doctor. Side effects Like other medications, En-Denk 10 can cause side effects. The side effects of En-Denk 10 or ACE inhibitors are listed below. The following classification is usually used to assess side effects: Very common: More than 1 in 10 cases Common: Less than 1/10, but more than 1/100 Uncommon: Less than 1/100, but more than 1/1000 Rare: Less than 1/1000, but more than 1/10000 Very rare: 1/10000 or less, including individual cases Blood and lymphatic system: Uncommon: Anemia due to red blood cell destruction (hemolytic anemia), anemia due to impaired bone marrow hematopoiesis (aplastic anemia). Rare: Decrease in the number of certain blood cells (neutropenia, thrombocytopenia, pancytopenia) and severe decrease in white blood cells, increasing the risk of infection and general symptoms (agranulocytosis), decrease in laboratory parameters (hemoglobin and hematocrit), decrease in bone marrow function (bone marrow depression), lymph node swelling, autoimmune diseases. Metabolism: Uncommon: Decrease in blood glucose levels (hypoglycemia). Eye: Very common: Blurred vision. Nervous system: Common: Headache, depression. Uncommon: Confusion, drowsiness, insomnia, neurosis, paresthesia (e.g., tingling, numbness), dizziness. Rare: Sleep disturbances, nightmares. Cardiovascular system: Very common: Dizziness. Common: Sharp decrease in blood pressure, including hypotension upon standing (orthostatic hypotension), brief loss of consciousness (syncope), heart attack and stroke, which can occur due to severe hypotension in high-risk patients (patients with impaired cerebral and/or coronary circulation), chest pain, arrhythmia, chest tightness (angina), rapid heart rate (tachycardia). Uncommon: Severe hypotension upon standing (orthostatic hypotension), palpitations. Rare: Circulatory disorders in the hands and feet due to vasospasm (Raynaud's phenomenon). Respiratory system: Very common: Cough. Common: Difficulty breathing (dyspnea). Uncommon: Runny nose (rhinorrhea), sore throat and hoarseness, narrowing of the bronchi (bronchospasm) and asthma. Rare: Lung tissue changes (pulmonary infiltration), cold, allergic inflammation of the lungs (allergic alveolitis / eosinophilic pneumonia). Gastrointestinal tract: Very common: Nausea. Common: Diarrhea, abdominal pain, taste disturbance. Uncommon: Intestinal obstruction, pancreatitis, vomiting, dyspepsia, constipation, loss of appetite, stomach irritation, dry mouth, stomach ulcer (peptic ulcer). Rare: Infection and ulcer of the oral mucosa (stomatitis/aphthous ulcers), inflammation of the tongue mucosa (glossitis). Very rare: Swelling of intestinal tissue (intestinal angioedema). Liver and gallbladder: Rare: Liver failure, liver inflammation (hepatitis - hepatocellular or cholestatic, including liver necrosis), jaundice. Skin and subcutaneous tissue: Common: Rash, allergy/tissue swelling (angioedema); facial, limb, lip, tongue, uvula and/or larynx angioedema has also been observed. Uncommon: Increased sweating, itching, rash, alopecia. Rare: Severe skin reactions (erythema multiforme), Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma). A symptom complex has also been observed, which may include some or all of the following reactions: fever, inflammation of serous tissues (serositis), inflammation of blood vessels (vasculitis), muscle and joint pain and/or inflammation (myalgia/myositis, arthralgia/arthritis), changes in some laboratory parameters (positive ANA, increased ESR, eosinophilia and leukocytosis). Rash, photosensitivity, or other skin reactions may also occur. Kidneys and lower urinary tract: Uncommon: Kidney dysfunction, renal failure, increased protein in urine (proteinuria). Rare: Decreased urine output (oliguria). Reproductive system and breast: Uncommon: Impotence. Rare: Breast enlargement (gynecomastia) may occur in men. General: Very common: Fatigue. Common: Redness. Uncommon: Muscle cramps, flushing, tinnitus, weakness, fever. Laboratory parameters: Common: Increased serum potassium and creatinine. Uncommon: Increased blood urea, decreased serum sodium levels. Rare: Increased liver parameters (liver enzymes, serum bilirubin). Precautions: In case of severe skin reactions, the patient should contact their doctor, and if necessary, treatment with En-Denk 10 should be discontinued. In case of swelling of the larynx, uvula and/or tongue (angioedema), seek immediate medical attention. In case of jaundice or significant increase in liver parameters, treatment should be discontinued and the patient should be under medical supervision. In case of fever, swollen lymph nodes and/or sore throat, consult your doctor and have the white blood cell count checked. If the patient notices any of the above side effects, they should consult their doctor. They will assess the severity of the condition and take appropriate measures if necessary. If any side effect occurs that is not described above, inform your doctor or pharmacist. Contraindications En-Denk 10 is not used: - If the patient is hypersensitive (allergic) to the active substance – enalapril maleate or any other ACE inhibitor, or to any of the excipients in En-Denk 10, - If the patient has a history of angioedema caused by an angiotensin-converting enzyme inhibitor, - If the patient has been diagnosed with hereditary angioedema or has angioedema of unknown etiology (hereditary or idiopathic edema), - During the last 6 months of pregnancy. En-Denk 10 should be used with particular caution in the following cases: If the patient has any of the following conditions, they should inform their doctor before starting treatment. They will determine the necessary precautions. - If the patient is at risk of severe hypotension associated with salt and fluid imbalance, caused by diuretic use, dietary salt restriction, or vomiting or diarrhea. - If the patient has aortic valve stenosis or if there is obstruction of blood flow from the left ventricle. - If the patient has heart disease that impedes blood flow (ischemia). - If the patient has cerebrovascular disease. - If the patient has impaired renal function (creatinine clearance less than 80 ml/min). - If the patient has renal artery stenosis (bilateral or unilateral). - If the patient has recently undergone kidney transplantation. - If the patient has elevated liver enzymes or develops jaundice. - If the patient has a reduced white blood cell count (leukopenia) or a severe reduction in certain white blood cells, increasing the risk of infection and severe general symptoms (agranulocytosis). - If the patient has connective tissue diseases with vascular involvement (collagen diseases). - If the patient is being treated with immunosuppressants. - If the patient is also being treated with allopurinol (gout medication), procainamide (antiarrhythmic medication), or lithium (medication for certain types of depression). - If hypersensitivity reaction or angioedema develops during En-Denk 10 treatment. - If the patient has diabetes mellitus. - If the patient has developed a persistent dry cough. - If the patient is at risk of increased serum potassium. - If the hypotensive effect is not sufficiently pronounced due to the patient's ethnic group (especially in black patients). If the patient requires hymenoptera desensitization (e.g., to bee or wasp stings), En-Denk 10 should be temporarily replaced with another medication from the same class of drugs. Otherwise, life-threatening allergic reactions may occur (e.g., hypotension, difficulty breathing, vomiting, allergic skin reactions). These reactions can also occur after insect bites (e.g., after bee or wasp stings). The use of En-Denk 10 in a patient undergoing dialysis with certain dialysis membranes (high-flux membranes) or in those treated for high blood lipid levels (low-density lipoprotein apheresis with dextran sulfate absorption) may cause allergic reactions or even life-threatening shock. If emergency dialysis, hemofiltration, or LDL apheresis is necessary, the medication should be changed (ACE inhibitors are no longer prescribed) or a different dialysis membrane should be used before treatment. The treating physician should be aware that the patient is taking En-Denk 10 or requires dialysis so that this can be taken into account during the course of treatment. Before surgery or anesthesia, the treating physician (dentist) should be aware that the patient is taking En-Denk 10, as a sharp drop in blood pressure is expected during anesthesia. Seek immediate medical attention if the patient notices the following symptoms: - Swelling of the face, limbs, lips, mucous membranes, tongue and/or larynx, difficulty breathing, - Jaundice of the skin and mucous membranes, - Fever, swollen lymph nodes and/or sore throat. In such cases, treatment with En-Denk 10 should be discontinued and the doctor should take appropriate measures. During treatment with this medication, the patient should be under medical supervision. Therefore, the patient should have blood tests and other examinations as directed by the doctor. Children: Limited information is available on the use of enalapril molecule in hypertensive children. No data are available on the use of the drug for other therapeutic purposes. Its safety and efficacy have only been studied in hypertensive children over 6 years of age. Therefore, apart from hypertension, the use of En-Denk 10 in children for other indications is not recommended. En-Denk 10 is not recommended for newborns and children with kidney disease. Pregnancy and lactation En-Denk 10 is not used during the first 3 months of pregnancy. If the patient is pregnant