BERLIPRIL 20 PILLS 20MG

Adverse effects

Possible side effects with the use of the drug Berlipril® given below in descending frequency of occurrence: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10 000, <1/1000), very rarely (<1/10 000), including individual messages.

Hemic and lymphatic: infrequently - anemia (including aplastic and hemolytic); rarely - neutropenia, decreased serum hemoglobin and hematocrit, eosinophilia, thrombocytopenia, lymph node enlargement, pancytopenia, agranulocytosis, bone marrow hematopoiesis, autoimmune diseases.

Metabolism and nutrition: infrequently - hypoglycemia.

From the nervous system: often - headache, depression; infrequently - confusion, insomnia, irritability, paresthesia, vertigo, tinnitus; rarely - a change in the nature of dreams, sleep disorders.

Special senses: rarely blurred vision.

Since the cardiovascular system: very often dizziness; often - hypotension (including orthostatic hypotension), syncope, chest pain, cardiac arrhythmias, angina pectoris; infrequently, orthostatic hypotension, palpitations, myocardial infarction or cerebral stroke, possibly due to a sharp drop in blood pressure in high-risk patients; rarely Raynaud's syndrome.

On the part of the respiratory system: very often - unproductive dry cough; infrequently - rhinorrhea, sore throat and hoarseness, bronchospasm / bronchial asthma; rarely - shortness of breath, rhinitis, pulmonary infiltrates, allergic alveolitis / eosinophilic pneumonia.

From the digestive system: very often nausea; often - diarrhea, abdominal pain, change in taste perception; infrequently - intestinal obstruction, pancreatitis, lack of appetite, dryness of the oral mucosa, change in taste perception, peptic ulcer; rarely - stomatitis / aphthous ulcers, glossitis; very rarely - angioedema.

Liver and biliary tract: rarely - liver failure, hepatitis (hepatocellular or cholestatic), hepatic necrosis, cholestasis (including jaundice).

Skin and Subcutaneous Tissues: often - skin rash, urticaria, hypersensitivity reactions / angioedema of the face, extremities, lips, tongue, vocal folds and / or larynx; infrequently - increased sweating, pruritus, urticaria, alopecia; rarely, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma.

Symptom complex reportedwhich may be accompanied by some and / or all of the following side effects: fever, serositis, vasculitis, myalgia / myositis, arthralgia / arthritis, increased antinuclear antibody titer, increased erythrocyte sedimentation rate, eosinophilia and leukocytosis. Skin rashes, photosensitization, or other skin manifestations may occur.

From the kidneys and urinary tract: infrequently - renal failure, proteinuria, renal failure; rarely - oliguria.

From the genitals and mammary glands: infrequently - erectile dysfunction; rarely - gynecomastia.

Violations of a general nature: very often - asthenia; often - fatigue; infrequently - muscle cramps, flushing, tinnitus, fever.

Laboratory values: often - hyperkalemia, increased serum creatinine concentration; infrequently - increase in serum urea concentration, hyponatremia; rarely, increased liver enzyme activity, hyperbilirubinemia.

In rare cases, with the simultaneous use of ACE inhibitors (including enalapril) and / in the introduction of gold preparations (sodium aurothiomalate), a symptom complex is described, including facial flushing, nausea,vomiting and hypotension.

Contraindications

- the presence of a history of angioedema, in patients receiving ACE inhibitors;

- hereditary or idiopathic angioedema;

- lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

- pregnancy;

- breastfeeding period;

- age up to 18 years (efficiency and safety have not been established);

- increased sensitivity to enalapril and other ACE inhibitors or components of the drug.

WITH caution

Primary hyperaldosteronism, bilateral renal artery stenosis, single kidney artery stenosis, kidney transplantation, hyperkalemia, aortic stenosis, mitral stenosis (with impaired hemodynamics), idiopathic hypertrophic subaortic stenosis, systemic connective tissue diseases, coronary heart disease, cerebrovascular disease, diseases of the disease, cerebrovascular diseases, cerebral diseases, cerebrovascular diseases, diseases of the disease renal
failure (CK <80 mg / min), liver failure, in patients following a diet with restriction of table salt or being on hemodialysis, when used concurrently with immunosuppressants and saluretics, in patients over 65 years of age, with bone marrow hematopoietic depression; conditions accompanied by a decrease in the BCC, incl. diarrhea, vomiting.

Use during pregnancy and lactation

Use of the drug Berlipril® during pregnancy is contraindicated.Patients planning a pregnancy should be transferred to an alternative treatment with a confirmed safety profile for use in pregnant women. With the confirmation of pregnancy use of the drug Berlipril® should be discontinued immediately, and, if necessary, alternative therapy should be initiated. The use of ACE inhibitors in the second and third trimesters of pregnancy was accompanied by a negative effect on the fetus, including the development of arterial hypotension, renal failure, hyperkalemia and / or hypoplasia of the skull bones in the newborn. Perhaps the development of oligohydramnios, apparently due to a decrease in renal function of the fetus. This complication can lead to contracture of the limbs, deformation of the bones of the skull, including its facial part, and lung hypoplasia. When using the drug Berlipril® inform the patient about the potential risk to the fetus.

If you can not cancel the drug Berlipril® during pregnancy, careful observation of newborns whose mothers took burlipril® to identify a possible reduction in blood pressure, oliguria and hyperkalemia, control of the state of the renal function, as well as the bones of the skull of the newborn with the help of ultrasound.

Enalapril and enalaprilat are excreted in breast milk in trace amounts, but their safety has not been studied. If necessary, the use of the drug during lactation breastfeeding should be discontinued.

Enalapril can be removed from the blood circulation of a newborn with peritoneal dialysis; theoretically through exchange transfusions.

Application for violations of the liver

Caution should be given to Berlipril for liver failure.

Application for violations of kidney function

At chronic renal failure cumulation of the drug occurs with a decrease in filtration of less than 10 ml / min. At QC 80-30 ml / min Burlipril dose is usually 5-10 mg / day, with CC 30-10 ml / min - 2.5-5 mg / day, with QC <10 ml / min - 1.25-2.5 mg / day only on dialysis days.

Caution should be given to Berlipril for renal failure (proteinuria more than 1 g / day).

Use in children

Contraindications - children and adolescents up to 18 years.

Use in elderly patients

WITH caution burlipril should be prescribed to elderly patients (over 65 years).

special instructions

Care must be taken in patients with reduced BCC (including with simultaneous use with diuretics, in conditions of limiting salt intake, with hemodialysis, diarrhea, vomiting) in which a sudden and pronounced decrease in blood pressure may develop in response to the use of an ACE inhibitor . In patients with mild chronic heart failure, with or without chronic renal failure, symptomatic hypotension is usually not observed. The development of arterial hypotension is most likely in patients with a more severe degree of chronic heart failure due to the use of high doses of diuretics,hyponatremia or functional renal failure. In these patients, treatment should begin under the supervision of a physician until the optimal dose adjustment of the drug Berlipril® and / or diuretic. A similar tactic can be applied to patients with coronary artery disease and cerebrovascular diseases, in whom an excessive drop in blood pressure can lead to myocardial infarction or cerebral stroke. In case of development of severe arterial hypotension, the patient should be laid in a horizontal position and, if necessary, should be started in / in the infusion of saline.

Transient arterial hypotension is not a contraindication to continue treatment with enalapril after stabilization of blood pressure. In case of repeated pronounced decrease in blood pressure, reduce the dose or discontinue the drug. Before and during treatment with ACE inhibitors, dynamic control of blood pressure, some biochemical and electrolyte parameters of blood (hemoglobin concentration, potassium ions, sodium ions, creatinine, urea, liver enzymes in serum), and urine for the presence of protein is necessary.

Like all vasodilators, ACE inhibitors should be used with caution in patients with left ventricular hypertrophy and valvular obstruction and should refrain from using them in cases of cardiogenic shock and hemodynamically significant obstruction.

In cases of impaired renal function (CC <80 ml / min), careful monitoring of the concentration of potassium and serum creatinine is necessary. In patients with renal insufficiency, it may be necessary to reduce the dose and / or frequency of taking the drug.

In some patients with bilateral renal artery stenosis or arterial stenosis of a single kidney, an increase in serum urea and creatinine was observed. Changes were usually reversible and returned to normal after discontinuation of treatment.

In some patients in whom no kidney disease was detected before treatment, there was a slight and transient increase in serum urea and creatinine concentrations when enalapril was used simultaneously with diuretics. In such cases, a dose reduction and / or withdrawal of enalapril and / or diuretic may be required.

There is an increased risk of arterial hypotension and renal failure in patients with bilateral renal artery stenosis or arterial stenosis of a single kidney who are under treatment with ACE inhibitors. Only moderate changes in serum creatinine concentration can indicate a decrease in kidney function. In these patients, treatment should begin with small doses under close medical supervision, precise gradual selection of the individual dose and control of serum creatinine concentration.

Experience with the use of the drug Berlipril® in patients who have recently undergone kidney transplantation, is absent. Therefore, the treatment of such patients with this drug is not recommended.

Use of the drug Berlipril® in patients with hepatic insufficiency usually does not require dose adjustment.Rarely, the use of ACE inhibitors is associated with a syndrome that begins with the development of cholestatic jaundice until the development of fulminant necrosis of the liver. If jaundice symptoms appear or liver enzymes become more active in patients taking ACE inhibitors, the therapy should be discontinued and the examination should be carried out.

There are reports of the development of life-threatening Anaphylactic reactions in patients receiving ACE inhibitors during the procedure of desensitization with hymenoptera (heminopter). Such reactions can be avoided if prior to the onset of desensitization, temporarily stop taking the ACE inhibitor. The use of ACE inhibitors in patients receiving immunotherapy with bee venom should be avoided.

Neutropenia, agranulocytosis, thrombocytopenia, anemia can develop during therapy with ACE inhibitors. With normal kidney function and the absence of other complications, neutropenia rarely occurs.

ACE inhibitors are prescribed only in emergency cases when the patient has systemic connective tissue diseases, during immunosuppressive therapy, in cases of simultaneous use of Allopurinol or procainamide, as well as a combination of all these factors, especially against the background of existing renal failure.

Some of these patients developed severe infections, which in some cases did not respond to intensive antibiotic therapy.If enalapril is still used in these patients, periodic monitoring of the number of leukocytes in the blood formula is recommended, and patients should be instructed accordingly to immediately inform the doctor about any signs of infection.

It is reported about the occurrence of cough in the treatment of ACE inhibitors. Usually, the cough is unproductive and persistent after discontinuation of the drug. Cough due to treatment with ACE inhibitors should be considered in the differential diagnosis of cough.

Reports of angioedema (Quincke’s edema) of the face, extremities, lips, tongue, glottis and / or larynx have been recorded in patients who received ACE inhibitors, including Berlipril®at different periods of treatment. In such cases, treatment with Berlipril.® should be stopped immediately, proper medical supervision should be carried out until the relevant symptoms completely disappear. Even in cases where there is only difficulty in swallowing without difficulty in breathing, patients should be under medical supervision for a long time, since therapy with antihistamines and corticosteroids may not be sufficient. Angioedema of the larynx or tongue can be fatal. Swelling of the tongue, vocal folds or larynx can lead to airway obstruction, appropriate therapy, including sc injection of 0.1% adrenaline solution (0.3-0.5 ml) and / or measures to ensure the conductivity of the respiratory tract, should be carried out as soon as possible.

In patients of the Negroid race, the incidence of angioedema with the use of ACE inhibitors is higher than in other races. Like other ACE inhibitors, enalapril seems to be less effective in lowering blood pressure in patients of the Negroid race than in others, possibly because of the high prevalence of low renin levels in this population of patients with arterial hypertension.

During the period of treatment is not recommended to drink alcohol, because alcohol enhances the hypotensive effect of the drug.

In patients undergoing surgery or general anesthesia with the use of drugs that reduce blood pressure, enalapril can block the formation of angiotensin II under the influence of compensatory renin release. If it is assumed that arterial hypotension develops by this mechanism, it can be adjusted by increasing the BCC. Before surgical interventions (including dental procedures) it is necessary to warn the surgeon / anesthesiologist about the use of the drug Burlipril®.

In rare cases, life-threatening anaphylactoid reactions were observed in patients taking ACE inhibitors during apheresis of LDL with dextran sulfate. If LDL-apheresis is used, ACE inhibitors should be temporarily replaced with drugs for the treatment of arterial hypertension or heart failure from other groups.

In patients on dialysis using high-capacity membranes (for example, AN69®), against the background of the use of ACE inhibitors, anaphylactoid reactions were observed. Therefore, for these patients, it is recommended either to use dialysis membranes of another type, or to use antihypertensive drugs of another group.

In patients with diabetes mellitus, taking hypoglycemic agents for oral administration or insulin, it is necessary to carefully monitor the concentration of blood glucose during the first month of treatment with enalapril.

In some patients taking ACE inhibitors, including enalapril, an increase in the concentration of potassium ions in the serum. The risk of developing hyperkalemia includes patients suffering from renal insufficiency or diabetes mellitus, taking potassium-sparing diuretics or potassium-containing salt substitutes, other drugs that increase the concentration of potassium ions in the serum (for example, heparin). If the use of the above medicines during treatment with Berlipril® is necessary, it is recommended to regularly monitor the concentration of potassium ions in the serum. Like other ACE inhibitors, enalapril may be less effective in lowering blood pressure in the Negroid race than in other races, possibly due to the low renin level in patients with arterial hypertension in this population.

Sudden cessation of treatment with enalapril does not lead to the development of "withdrawal" syndrome (a sharp rise in blood pressure).

Influence on ability to drive motor transport and control mechanisms

Care must be taken when driving vehicles and practicing potentially hazardous activities that require increased concentration and psychomotor speed (dizziness is possible due to a sharp decrease in blood pressure, especially after taking the initial dose of enalapril in patients taking diuretics).

Overdose

Symptoms: approximately 6 hours after ingestion - marked reduction in blood pressure, up to the development of collapse, myocardial infarction, acute cerebrovascular accident or thromboembolic complications, impaired water and electrolyte balance, renal failure, increased breathing, tachycardia, palpitations, bradycardia, dizziness, anxiety, fear, muscle cramps, cough, stupor. Plasma concentration of enalaprilat is 100–200 times higher than after the application of therapeutic doses, was observed after oral administration of 300 mg and 440 mg of enalapril maleate, respectively.

Treatment: use of the drug should be discontinued immediately; therapeutic measures should be directed to the elimination of enalapril and enalaprilat and correction of arterial hypotension. The patient is transferred to a horizontal position with a low head.In mild cases, gastric lavage and administration of Activated carbon are shown, in more severe cases, intravenous infusion of saline, plasma substitutes, and, if necessary, administration of angiotensin II or catecholamines; hemodialysis (enalaprilat elimination rate - 62 ml / min). Patients with bradycardia resistant to therapy are shown to set a pacemaker.

Drug interaction

When applied simultaneously with NSAIDs, including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), possible reduction of the hypotensive effect of ACE inhibitors, including enalapril In some patients with impaired renal function, the simultaneous use of NSAIDs and ACE inhibitors can lead to a further deterioration in renal function. These changes are usually reversible.

Use of potassium-containing food additives, potassium-containing salt substitutes and / or use of potassium-saving diuretics, as well as Heparin can lead to a significant increase in the concentration of potassium ions in the serum, especially in patients with impaired renal function and / or diabetes mellitus. If necessary, simultaneous with enalapril use of the above drugs should be regularly monitored the concentration of potassium ions in the serum.

With the simultaneous use of the drug Berlipril® and thiazide diuretics hypokalemia caused by taking the latter, as a rule, decreases under the action of enalapril.

Previous therapy high doses of diuretics may lead to hypovolemia and risk of developing hypotension at the start of enalapril therapy. The excessive hypotensive effect of enalapril can be reduced either by abolishing the diuretic, or by increasing the BCC or by using table salt, as well as subject to the initiation of treatment with enalapril from a low dose. The simultaneous use of thiazide diuretics and ACE inhibitors can lead to hypovolemia and, thus, increase the risk of arterial hypotension.

Simultaneous use of the drug Berlipril® and lithium preparations not recommended due to the risk of lithium toxicity. If you need to use this combination requires careful monitoring of the concentration of lithium in the serum.

Simultaneous use with antipyretic and analgesic drugs may reduce the effectiveness of the drug.

Enalapril reduces the effects of drugs containing theophylline.

The hypotensive effect of enalapril is enhanced diuretics, as well as antihypertensive drugs of other groups, including beta-blockers, methyldopa, Nitroglycerin and other nitrates, slow Calcium channel blockers, hydralazine, prazosin, as well as some preparations for anesthesia, ethanol, tricyclic antidepressants, antipsychotics.

ACE inhibitors may enhance hematotoxicity immunosuppressants, allopurinol, cytostatics.

Drugs that cause the inhibition of bone marrow hematopoiesis, increase the risk of developing neutropenia and agranulocytosis.

ACE inhibitors increase bioavailability digoxinby increasing its concentration in the blood. In this regard, with the simultaneous appointment of ACE inhibitors and cardiac glycosides, the dose of the latter should be somewhat reduced in order to avoid the development of undesirable effects or the effect of relative overdose.

Neuroleptics may enhance the hypotensive effect of enalapril.

Sympathomimetics may weaken the hypotensive effect of enalapril.

Simultaneous use antacids, adsorbents can lead to a decrease in the bioavailability of ACE inhibitors by almost 50%, as well as slowing down and weakening their hypotensive action, therefore, the interval between taking the medications should be at least 2 h.

Enalapril can be used simultaneously with acetylsalicylic acid (in cardiological doses less than 300 mg / day), thrombolytic agents and beta-blockers.

Epidemiological studies have shown that the simultaneous use of ACE inhibitors and hypoglycemic agents (insulin, oral hypoglycemic agents) may further contribute to a decrease in blood glucose concentration, leading to the development of hypoglycemia. This phenomenon is most often observed during the first weeks of simultaneous use of the above drugs, as well as in patients with renal insufficiency. In patients with diabetes,receiving hypoglycemic agents for oral and / or insulin, requires regular monitoring of the concentration of blood glucose, especially careful - during the first month of simultaneous use with ACE inhibitors.

Terms and conditions of storage

The drug should be stored out of reach of children at a temperature not exceeding 25 ° C.