Enalozid Mono tablets are used for the following indications:
Treatment of arterial hypertension. Treatment of clinically significant heart failure. Prevention of clinically significant heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction ≤ 35%).
Composition
Active ingredient: enalapril;
1 tablet contains enalapril maleate in terms of 100% dry matter 5 mg or 10 mg;
Excipients: sodium bicarbonate, lactose monohydrate, corn starch, pregelatinized starch, magnesium stearate.
Contraindication
Hypersensitivity to enalapril, to any of the excipients or to any other ACE inhibitor. History of angioedema associated with the use of ACE inhibitors. Hereditary or idiopathic angioedema. Enalapril should not be used with drugs containing aliskiren, in patients with diabetes mellitus or with impaired renal function (GFR <60 ml/min/1.73 m2). Pregnant women or women planning to become pregnant. Enalapril should not be taken within 36 hours of switching from/to sacubitril/valsartan, a drug containing a neprilysin inhibitor.
Method of application
Food intake does not affect the absorption of Enalozid® Mono tablets. If the drug is prescribed in a dose of less than 5 mg, it is possible to divide the tablet.
The dosage should be selected individually, according to each patient's condition and blood pressure response.
Application features
Pregnant women
The drug should not be used by pregnant women or women planning to become pregnant.
Children
Apply to children over 6 years old.
Enalozid® Mono is not recommended for newborns and children with glomerular filtration rate <30 ml/min/1.73 m2 due to lack of data.
Drivers
When driving or operating other machinery, the possible development of dizziness or fatigue should be taken into account.
Overdose
There are limited data on overdose of the drug. The main signs of overdose, according to the available data, are pronounced arterial hypotension, which begins approximately 6 hours after taking the drug and coincides with the blockade of the renin-angiotensin system, and stupor. Symptoms associated with overdose with ACE inhibitors may include circulatory shock, electrolyte imbalance, renal failure, hyperventilation of the lungs, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough. Plasma levels of enalaprilat exceeding 100 and 200 times the maximum levels achieved with therapeutic doses have been reported after taking 300 mg and 440 mg of enalapril, respectively.
For the treatment of overdose, intravenous infusions of isotonic solution are recommended. If hypotension occurs, the patient should be placed in a horizontal position. The need for angiotensin II infusion and / or intravenous administration of catecholamines may be considered. If the drug has been taken recently, measures to eliminate enalapril maleate (such as artificial vomiting, gastric lavage, administration of absorbents and sodium sulfate) are recommended. Enalaprilat can be removed from the systemic circulation by hemodialysis. In bradycardia resistant to therapeutic agents, pacemaker therapy is indicated. Vital signs, electrolyte concentrations and serum creatinine levels should be monitored continuously.
When using Enalozide® Mono, in most cases, side effects were minor, temporary, and did not require discontinuation of therapy.
Blood and lymphatic system disorders: anemia (including aplastic and hemolytic), neutropenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, agranulocytosis, bone marrow suppression, pancytopenia, lymphadenopathy, autoimmune diseases. Endocrine system disorders: syndrome of inappropriate antidiuretic hormone secretion. Metabolism and nutrition disorders: hypoglycemia. Nervous system disorders: depression, headache, confusion, drowsiness, insomnia, nervousness, paresthesia, vertigo, sleep disorders, abnormal dreams. Visual system disorders: blurred vision. Cardiovascular: dizziness, hypotension (including orthostatic hypotension), syncope, chest pain, arrhythmia, angina, tachycardia, palpitations, myocardial infarction or stroke, possibly due to excessive pressure reduction in high-risk patients, Raynaud's phenomenon. Respiratory: cough, shortness of breath, rhinorrhea, sore throat and hoarseness, bronchospasm / asthma, pulmonary infiltrates, rhinitis, allergic alveolitis / eosinophilic pneumonia. Gastrointestinal: nausea, diarrhea, abdominal pain, taste perversion, intestinal obstruction, pancreatitis, vomiting, dyspepsia, constipation, anorexia, gastric irritation, dry mouth, peptic ulcers, stomatitis / aphthous ulcers, glossitis, angioedema of the intestine. Hepatobiliary system: hepatic failure, hepatitis hepatocellular or cholestatic; hepatitis (including necrosis); cholestasis (including jaundice). Skin and subcutaneous tissue disorders: rash, hypersensitivity/angioedema of the face, extremities, lips, tongue, glottis and/or larynx, increased sweating, itching, urticaria, alopecia, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma. A complex symptom complex has been reported, including some or all of the following: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, positive antinuclear antibody test, increased erythrocyte sedimentation rate (ESR), eosinophilia, and leukocytosis. Rash, photosensitivity, and other skin reactions may also occur as adverse reactions. Urinary system: renal dysfunction, renal failure, proteinuria, oliguria. Reproductive system: impotence, gynecomastia. General disorders: asthenia, fatigue, muscle cramps, hot flashes, tinnitus, malaise, fever.
Interaction
Alcohol enhances the hypotensive effect of ACE inhibitors.
Sympathomimetics may reduce the antihypertensive effects of ACE inhibitors.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 2 years.
