Enanorm - instructions for use, dose, side effects, contraindications

Similar drugsTo uncover

Dosage form: & nbsp

pills

Composition:

One tablet contains:

active substances: nitrendipine 20 mg, enalapril maleate 10 mg;

Excipients: sodium bicarbonate 5.00 mg, microcrystalline cellulose 20.00 mg, starch corn 20.00 mg, sodium lauryl sulfate 8.00 mg, povidone K-25 6.00 mg, magnesium stearate 1.20 mg, lactose monohydrate 63.58 mg .

Description:Oblong, biconvex tablets of yellow color, embossed on one side of the "E / N".

Pharmacotherapeutic group:Antihypertensive drug combined (blocker of "slow" calcium channels + inhibitor of angiotensin-converting enzyme

ATX: & nbsp

Nitrendipine and enalapril

Pharmacodynamics:

Enanorm is a combination of two antihypertensive drugs with a complementary mechanism for lowering blood pressure (BP): enalapril - angiotensin-converting enzyme (ACE) and nitrendipine - blocker of "slow" calcium channels (BCCC).

ENALAPRIL

Enalapril is a prodrug, as a result of its hydrolysis, an active metabolite is formed - enalaprilate, which inhibits ACE. The mechanism of its action is associated with a decrease in the formation of angiotensin I angiotensin II, decrease in content which leads to a direct decrease in the release of aldosterone.This reduces the overall peripheral vascular resistance (OPSS), systolic and diastolic blood pressure, postload and preload on the myocardium.

Enalapril extends the arteries more than the veins, with a reflex increase in heart rate (heart rate) is not noted.

The antihypertensive effect is more pronounced with high renin activity of blood plasma than with normal or reduced its activity. Decrease in blood pressure within the therapeutic limits does not affect cerebral circulation: the blood flow in the vessels of the brain is maintained at a sufficient level and against a background of reduced blood pressure. Strengthens coronary and renal blood flow.

With long-term use, hypertrophy of the left ventricle of the myocardium and myocytes of the walls of arteries of the resistive type decreases, progression of heart failure is prevented and the development of dilatation of the left ventricle slows down.

Enalapril improves the blood supply of the ischemic myocardium.

Time of onset of antihypertensive effect when administered orally - 1 hour, reaches a maximum after 4-6 hours and persists for 24 hours.

NITRENDIPIN

Nitrendipine - BCCC from the group of dihydropyridine derivatives, has an antihypertensive effect. Reduces the current of calcium ions in the smooth muscle cells of the coronary and peripheral arteries. Causes some increase in the excretion of sodium and water. Reduces afterload and myocardial oxygen demand, does not inhibit the conduction of the heart muscle.

Reduces the number of functioning channels, without affecting the time of their activation, inactivation and recovery. Separates the processes of excitation and contraction in the myocardium, mediated by tropomyosin and troponin, and in smooth muscle vessels, mediated by calmodulin. In therapeutic doses normalizes transmembrane current of calcium ions, disturbed in a number of pathological conditions, especially in hypertension.

The results of the clinical study of the Enanorm drug in patients with arterial hypertension who did not achieve satisfactory control of BP with monotherapy with enalapril 10 mg or nitrendipine at a dose of 20 mg showed that the Enanorm product had a more pronounced effect on the reduction of both diastolic and systolic blood pressure and the severity of the therapeutic response to ongoing therapy.

Pharmacokinetics:

ENALAPRIL

After oral intake absorbed from the gastrointestinal tract by 60%. Eating does not affect the absorption of enalapril.

The association of enalapril with plasma proteins is 50-60%. Enalapril fast metabolized in the liver with the formation of an active metabolite - enalaprilata. Bioavailability of enalapril - 40%.

The maximum concentration of enalapril in blood plasma is reached after 1 hour, enalaprilata - 3-4 hours. Enalaprilat easily passes through the histohematological barriers, excluding the blood-brain barrier, a small amount penetrates the placenta and into the breast milk.

The half-life (T₁_/₂) enalaprilata about 11 hours. enalapril mainly kidneys - 60% (20% - in the form of enalapril and 40% - in the form of enalaprilata), through the intestine - 33% (6% - in the form of enalapril and 27% - in the form of enalaprilata).

It is removed during hemodialysis (rate 62 ml / min) and peritoneal dialysis.

NITRENDIPIN

Quickly absorbed from the gastrointestinal tract by 88%. Bioavailability is 20-30% because of the pronounced effect of "primary transmission" through the liver. Relationship with plasma proteins (albumin) - 96-98%. Hemodialysis is ineffective. The time to reach the maximum concentration in the blood plasma is 1-3 hours after application.The volume of distribution in the equilibrium state is 5-9 l / kg, therefore hemodialysis and plasmapheresis are ineffective.

Metabolised in the liver, mainly by oxidation. Metabolites are pharmacologically inactive. Nitrendipine is excreted mainly through kidney: in the form of metabolites, about 77% of the dose taken is taken out, less than 0.1% of the accepted dose is excreted unchanged. The rest of nitrendipine is excreted through the intestine.

T₁_/₂Nitrendipine after oral administration is 8-12 hours. Neither nitrendipine nor its metabolites in the body cumulate. In elderly patients increases T₁_/₂, with cirrhosis of the liver - the area under the curve "concentration - time" (AUC) and the maximum concentration in the blood plasma increases.

In patients with impaired renal function, dose adjustment is not required.

The study of the interaction of enalapril and nitrendipine in healthy volunteers did not reveal changes in the pharmacokinetics of nitrendipine. As for enalaprilat, its bioavailability increases somewhat with simultaneous use with nitrendipine, but this does not seem to be of clinical significance. Bioavailability of nitrendipine with the use of a combined preparation is higher than when applied two drugs separately.

Indications:Essential hypertension (patients who are shown combined therapy).

Contraindications:

- Hypersensitivity to enalapril, nitrendipine or any Auxiliary substance of the preparation and other dihydropyridine derivatives;

- the presence of a history of angioedema, associated with the treatment of inhibitors ACE;

- hereditary or idiopathic angioedema;

- pregnancy, lactation period;

- shock, collapse;

- acute heart failure;

- various pathological syndromes (chronic heart failure in stage decompensation, requiring inotropic therapy) and conditions if unstable hemodynamics are present during their course (eg, cardiovascular shock, acute heart failure, acute coronary syndrome, acute stroke period);

- bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney;

- hemodynamically significant stenosis of the aortic or mitral valve and hypertrophic obstructive cardiomyopathy;

- severe renal dysfunction (creatinine clearance (CK) less than 10 ml / min) and hemodialysis;

severe hepatic impairment;

- intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption (the preparation contains lactose);

- age under 18 years (effectiveness and safety not established);

- severe arterial hypotension (systolic blood pressure less than 90 mm Hg);

- under conditions of unstable hemodynamics: acute myocardial infarction (in the first 4 weeks after myocardial infarction), chronic cardiac insufficiency III-IV functional class according to NYHA classification:

Carefully:

Aortic stenosis, cerebrovascular diseases (including cerebral insufficiency blood circulation), coronary heart disease, coronary insufficiency, severe autoimmune systemic diseases of connective tissue (including systemic lupus erythematosus, scleroderma), oppression of bone marrow hematopoiesis, diabetes mellitus, hyperkalemia, post-kidney transplant state, renal failure, mild or moderate disorders liver function, diet with restriction of table salt, conditions accompanied by a decrease in the volume of circulating blood (bcc) (including diarrhea, vomiting), elderly age.

Pregnancy and lactation:

Pregnancy

The use of ACE inhibitors in the first trimester of pregnancy is not recommended. Epidemiological data on the risk of teratogenic effects of ACE inhibitors in the first trimester of pregnancy are not convincing; However, this risk can not be ruled out. If continued use of ACE inhibitors during pregnancy is not considered absolutely necessary, then when planning pregnancy, patients should be transferred to alternative therapy, the safety of which is established during pregnancy. It is known that the use of ACE inhibitors in the second and third trimester of pregnancy has a toxic effect on the fetus (renal dysfunction, low blood pressure, ossification of the skull) and newborns (renal dysfunction, arterial hypotension, hyperkalemia). If ACE inhibitors have been used in the second or third trimesters of pregnancy, ultrasound is recommended to evaluate the function of the kidneys and the condition of the bones of the skull. It should also be carefully monitored for newborns to detect arterial hypotension, if the mother took ACE inhibitors.

Breastfeeding period

A few pharmacokinetic data indicate a very low concentration of enalapril in breast milk. Although these concentrations appear to be clinically insignificant, it is not recommended to use the drug in breast-feeding premature infants, and also in the first few weeks after birth because of the theoretically possible risk of cardiovascular and neonatal kidney effects and lack of sufficient clinical data . In older infants, the possibility of taking the drug by nursing women may be considered, if such treatment is necessary for the mother, and if a child is monitored to detect any adverse events.

Dosing and Administration:

Inside, not more than 1 tablet per day, tablets should be swallowed whole, do not break and do not chew, squeezed with enough water.

It is recommended to select the dose of the components by adjusting the dose individually.

Patients with impaired hepatic function

The drug Enanorm is contraindicated in patients with severe impairment of liver function (see section "Contraindications").In patients with mild or moderate impairment of liver function, monotherapy with either enalapril or nitrendipine is not contraindicated, but due to the fact that there is no experience of using Enanorm in such patients, the drug should be administered with caution.

Patients with impaired renal function

The drug Enanorm is contraindicated in patients with severe renal dysfunction (creatinine clearance less than 10 ml / min) and patients on hemodialysis. In patients with moderate renal failure (QC greater than 30 ml / min, serum creatinine ≤ 3 mg / ml) there is no need for dose adjustment, at the same time it is necessary to evaluate the kidney function.

Children and teens

The drug Enanorm should not be used in children and adolescents under 18 years due to lack of application data.

Side effects:

Classification of undesirable adverse reactions (NDP) by frequency of development: ooften (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); very rarely (1/10000, including individual messages); frequency is unknown (can not be estimated from available data).

The adverse reactions observed with Enanorm are similar to those for each of the components of the drug alone.

Oncardiovascular disruption:

Often: "tides" of blood to the skin of the face, peripheral edema.

Infrequently: tachycardia, dizziness, marked decrease in blood pressure.

Rarely: violation of peripheral circulation, dyspnea.

Disturbances from the nervous system:

Often; headache.

Rarely: asthenia, hypothermia, drowsiness, paresthesia, tremor, convulsions.

Disturbances from the respiratory system:

Often: cough.

Rarely: pharyngitis, tracheitis, dyspnea.

Disorders from the digestive system:

Infrequently: nausea, dyspepsia.

Rarely: flatulence.

Disturbances from the skin and subcutaneous tissues:

Infrequently: erythematous rash.

Disorders from the kidneys and urinary tract:

Rarely: hematuria.

Disturbances from musculoskeletal and connective tissue:

Rarely: muscle spasm.

Laboratory and instrumental data:

Rarely: increased activity of "liver" transaminases, hypokalemia.

The following adverse adverse reactions were noted when taking medications, containing similar components:

ENALAPRIL

Disorders from the cardiovascular system:

Infrequently: especially at the beginning of treatment and in patients with reduced BCC and / or salts, worsening of Raynaud's disease, heart failure, severe arterial hypertension, or renal hypertension, and also after increasing the dose of enalapril and / or using diuretics and / or standing: dizziness, weakness, and visual impairment.

Rarely: fainting

Rarely: in connection with the increase in antihypertensive effect, there was tachycardia, palpitations, atrial bradycardia, atrial fibrillation, chest pain, angina pectoris, myocardial infarction, transient cerebral blood flow disorder. Heart failure, embolism and pulmonary infarction, pulmonary edema.

Violations from hand kidney and urinary tract:

Infrequently: the appearance or intensification of renal dysfunction.

Rarely: acute renal failure.

Rarely: oliguria, proteinuria, in some cases with concomitant impairment of kidney function, pain in the ileum.

Violations from hand respiratory system:

Infrequently: dry cough, sore throat, hoarseness, bronchitis.

Rarely: shortness of breath, sinusitis, rhinitis.

Rarely: bronchospasm / attack of bronchial asthma, pulmonary infiltrates, stomatitis, glossitis, dry mouth, pneumonia, angioedema, affecting the pharynx, larynx and / or tongue and leading in some cases to death; more often in patients of the Negroid race.

Disorders from the digestive system:

Infrequently: nausea, pain in the upper abdomen, digestive disorders.

Rarely: vomiting, diarrhea, constipation, loss of appetite, change or transient loss of taste, anosmia.

Rarely: pancreatitis, intestinal obstruction, stomatitis, glossitis.

Disturbances from the liver and bile ducts:

Rarely: impaired liver function, hepatitis, liver failure, a syndrome that starts with cholestatic jaundice and progresses to liver necrosis, in some cases fatal.

Disorders from the endocrine system:

Rarely: gynecomastia.

Disturbances from the skin and subcutaneous tissues:

Infrequently: exanthema.

Rarely: urticaria, skin itching, angioedema, swelling of the lips, face and / or upper and lower extremities.

Rarely: severe skin reactions, for example, pemphigus, pemphigus, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome or toxic epidermal necrolysis; phenomena that resemble psoriasis, photosensitivity, "tides" of blood to the skin of the face, increased sweating, alopecia, onycholysis. Skin manifestations may be accompanied by fever, myalgia / myositis, arthralgia / arthritis, vasculitis, serositis, eosinophilia, leukocytosis, increased erythrocyte sedimentation rate and / or antinuclear antibody titers. If a severe skin reaction is suspected, the treatment is stopped.

Disturbances from the nervous system:

Infrequently: headache, weakness.

Rarely: dizziness, depression, sleep disorders, impotence, peripheral neuropathy with paresthesia, imbalance, muscle spasms, nervousness, confusion.

Hearing disorders:

Rarely: noise in ears.

Disturbances on the part of the organ of sight:

Rarely: blurred vision, dry eyes, increased lachrymation.

Laboratory and instrumental data:

Infrequently: reduction of hemoglobin, hematocrit, white blood cells or platelets.

Rarely: anemia, thrombocythemia, neutropenia, eosinophilia (in some cases - agranulocytosis or pancytopenia), especially in patients with impaired renal function, with systemic connective tissue diseases, patients receiving allopurinol, procainamide or immunosuppressants; increase in the concentration of urea, creatinine and potassium in the blood serum, decreased sodium in the blood serum, hyperkalemia (in patients with diabetes mellitus), increased albumin excretion, especially in patients with impaired renal function, severe heart failure, and renovascular hypertension.

Rarely: hemolysis / hemolytic anemia (also in combination with a deficiency of glucose-6-phosphate dehydrogenase), increased bilirubin concentration and increased activity of "hepatic" transaminases.

NITRENDIPIN

Immune system disorders:

Infrequently: influenza-like syndrome.

Disorders from the cardiovascular system:

Infrequently: arrhythmia, tachycardia, palpitations, peripheral edema, "tides" of blood to the skin of the face, increased symptoms of vasodilation.

Rarely: marked decrease in blood pressure, angina, chest pain.

Disorders from the gastrointestinal tract:

Infrequently: nausea, diarrhea.

Rarely: abdominal pain, constipation, indigestion, vomiting.

Rarely: gingival hyperplasia.

Disorders from the endocrine system:

Rarely: gynecomastia.

Violations of the blood and lymphatic system:

Rarely: leukopenia, agranulocytosis.

Disturbances from the nervous system:

Infrequently: headache, asthenia.

Rarely: nervousness, paresthesia, tremor, dizziness.

Violations from hand respiratory system:

Rarely: dyspnea.

Disturbances from the skin and subcutaneous tissues:

Rarely: itching, rash, hives.

Disturbances on the part of the organ of sight:

Rarely: visual impairment.

Disorders from the kidneys and urinary tract:

Rarely: increased frequency of urination, polyuria.

Laboratory and instrumental data:

Rarely: increased activity of "liver" enzymes.

If any of the side effects listed in the manual are aggravated, or any other side effects not indicated in the instructions were noticed, you should notify the doctor.

Overdose:

To date, cases of overdose of this combination are not registered. The most likely manifestation of an overdose - the drug Enanorm will be a marked decrease in blood pressure.

Treatment: there is no specific antidote. Gastric lavage, administration of adsorbents (if possible, in the first 30 minutes). It is necessary to control vital functions.

In the case of a pronounced decrease in blood pressure, the patient is transferred to a horizontal position with a low headboard.

In mild cases, gastric lavage and intake of saline sodium chloride are shown, in more severe cases, measures aimed at stabilizing blood pressure: intravenous administration of 0.9% sodium chloride solution; plasma-substituting solutions; if necessary - the introduction of angiotensin II, hemodialysis (the rate of excretion of enalaprilate - 62 ml / min).

Interaction:

Antihypertensive effect of the drug Enanorm can be strengthened with simultaneous use with other antihypertensive drugs, for example, diuretics, beta-adrenoblockers or alpha-adrenoblockers.

In addition, with the simultaneous use of individual components of the drug may exhibit the following interactions:

ENALAPRIL

Combinations that should be used with caution:

Potassium-sparing diuretics and potassium preparations

Angiotensin converting enzyme inhibitors (ACE inhibitors) reduce the diuretic-induced loss of potassium.

Potassium-sparing diuretics, potassium preparations and other drugs that can increase the potassium content in the blood serum (eg, heparin),can have an additive effect on the potassium content in the blood serum, especially in patients with impaired renal function. If the joint use of such drugs is necessary, for example, to eliminate hypokalemia, then caution should be exercised and the potassium content in the blood serum should be monitored frequently.

Lithium

The use of enalapril in combination with lithium is not recommended because of the risk of a significant increase in serum lithium concentration followed by the development of severe neurotoxicity. If the joint use of these drugs is necessary, then the concentration of lithium in the serum should be carefully monitored.

Nonsteroidal anti-inflammatory drugs

Non-steroidal anti-inflammatory drugs (NSAIDs) and ACE inhibitors additively increase the serum potassium content, which can lead to impaired renal function. In elderly patients and patients with reduced BCC, this combination can cause acute renal failure due to a direct effect on the rate of glomerular filtration. Moreover, NSAIDs can reduce the antihypertensive effect of ACE inhibitors.

Hypoglycemic agents for oral administration

Enalapril may increase the hypoglycemic effect of these drugs, so you should carefully monitor the concentration of glucose in the blood.

Baclofen

May enhance antihypertensive effect. If necessary, combined use should monitor blood pressure and adjust the dose.

Neuroleptics

The use of these drugs can cause orthostatic hypotension.

Antidepressants

Application together with tricyclic antidepressants can cause orthostatic hypotension.

Allopurinol, cytostatics, immunosuppressants, systemic corticosteroids (applied parenterally or orally), procainamide

Simultaneous use can cause leukopenia.

Combinations, which should be taken into accountь

Amifostine

The combination increases the antihypertensive effect.

NITRENDIPIN

Cimetidine and ranitidine

Cimetidine and, to a lesser extent, ranitidine, can increase the concentration of nitrendipine in blood plasma, but the clinical significance of this data is not known.

Digoxin

Enalapril was used together with digoxin without any signs of clinically significant adverse interaction.The simultaneous use of nitrendipine and digoxin can lead to an increase in the concentration of digoxin in the blood plasma. Therefore, the appearance of symptoms of an overdose of digoxin or, if necessary, monitor the concentration of digoxin in the blood plasma:

Muscle relaxants

The use of nitrendipine may increase the duration and severity of the effects of muscle relaxants, for example, pancuronium bromide.

Grapefruit juice suppresses oxidative metabolism, nitrendipine. Admission of the latter with grapefruit juice increases the concentration of nitrendipine in the blood plasma, which can enhance its antihypertensive effect.

Nitrendipine is metabolized by isoenzyme CYP3A4 cytochrome P450 in the intestinal mucosa and in the liver. Inductors of isoenzyme CYP3A4, for example, anticonvulsants (phenytoin, phenobarbital, carbamazepine) and rifampicin, can significantly reduce the bioavailability of nitrendipine.

Inhibitor inhibitors CYP3A4, for example, antifungal imidazoles (itraconazole and others) can increase the concentration of nitrendipine in the blood plasma.

Beta-blockers

Nitrendipine and beta-blockers act synergistically. This may be of particular importance for patients in whom an additional blockade of beta-adrenoceptors does not compensate for sympathetic vascular reactions and caution is recommended for such patients.

Special instructions:

Apply strictly according to the doctor's prescription.

Edema Quincke

With the use of ACE inhibitors, especially in the first weeks, and also in rare cases after prolonged use, angioedema may develop in the extremities, face, lips, mucous membranes, tongue, throat or pharynx. In such cases, treatment is immediately canceled.

With angioneurotic edema of the tongue, larynx or throat, a fatal outcome is possible; in these cases, emergency therapy with hospitalization of the patient should be carried out, the patient should be monitored for at least 12-24 hours, and it can be discharged from the hospital only after the symptoms have completely disappeared.

Neutropenia / agranulonitis

Enalapril should be used with extreme caution in patients with systemic connective tissue diseases, in patients receiving immunosuppressants, allopurinol or procainamide, or a combination thereof, especially if there is a kidney function disorder. When using the drug Enanorm in these patients it is recommended to control the leukocyte formula. During the treatment period, patients should be instructed to tell the doctor about any signs of infection. A drug Enanorm should be withdrawn if neutropenia is detected or suspected (neutrophil count less than 1000 / mm³).

Renal impairment

In patients with impaired renal function with the use of ACE inhibitors, monitoring of kidney function is necessary, especially in the first weeks of treatment. Care should be exercised in patients with the activated renin-angiotensin system.

For patients with moderate renal impairment (creatinine clearance is more than 30 ml / min, serum creatinine ≤3 mg / ml), dose adjustment is not required, but kidney function monitoring is necessary.

In some patients, a marked decrease in blood pressure at the start of treatment with ACE inhibitors may lead to a slight further deterioration in kidney function. In such circumstances, there were cases of acute renal failure, which was usually reversible.

There have been no trials of using Enanorm in patients who have recently undergone a kidney transplant.

Proteinuria

Rarely, proteinuria developed in patients with impaired renal function. In patients with clinically significant proteinuria (more than 1 g / day), Enanorm can only be used after a thorough assessment of the risk-benefit ratio and with regular monitoring of clinical and biochemical blood parameters.

Patients with impaired hepatic function

The experience of using Enanorm in patients with mild or moderate liver dysfunction is not present, so this drug should be used in such patients with caution if there is evidence for this.

Since individual cases of the syndrome starting with cholestatic jaundice and progressing to fatal liver necrosis are described, then when jaundice or a marked increase in the activity of "liver" transaminases, it is necessary to stop treatment and monitor patients.

Orthostatic hypotension

In some cases, the Enanorm drug may cause orthostatic hypotension, the risk of which is increased in patients with activated renin-angiotensin-aldosterone system.For example, with reduced blood volume or disturbance of the water-electrolyte balance of blood or salt deficiency due to the use of diuretics, consumption of low salt diet, hemodialysis, the presence of diarrhea or vomiting, as well as weakening left ventricular function and with renovascular hypertension. In such patients, the amount of blood or the concentration of salts must first be adjusted.

In patients with heart failure (with concomitant renal dysfunction or without it) symptomatic hypotension may develop. The risk of hypotension in these patients is increased with severe heart failure, with high doses of loop diuretics and with hyponatremia or renal dysfunction.

A transient hypotensive reaction is not a contraindication for continuing the use of the Enanorm drug, and usually does not present difficulties after restoring the volume of circulating blood and blood pressure.

Stenosis of the aortic valve

In patients with stenosis of the aortic valve, ACE inhibitors should be used with caution. With hemodynamically significant stenosis enalapril is contraindicated.

Primary hyperaldosteronism

The use of enalapril in patients with primary aldosteronism is not recommended.

Patients on hemodialysis

The use of the Enanorm product during dialysis through high-permeability membranes (from polyacrylonitrile, sodium methylallyl-sulfonate, for example - AN69) can lead to anaphylactic reactions, including facial swelling, "tides" of blood to the skin of the face, pronounced orthostatic hypotension and shortness of breath for several minutes after the onset of dialysis. Therefore, such combinations should be avoided.

Anaphylactoid reactions in the process of apheresis of LDL and desensitization to the hymenoptera

The use of ACE in the conduct of low-density lipoprotein apheresis (LDL) with dextran sulfate may be accompanied by life-threatening anaphylactoid reactions. The use of ACE inhibitors in carrying out specific immunotherapy (desensitization) to insect venoms (bees, wasps) may be accompanied by anaphylactoid reactions, which in some cases may threaten life. If it is necessary to have an apheresis of LDL or specific immunotherapy (desensitization) to insect venoms, the ACE should be temporarily replaced by other means of treating high blood pressure or heart failure.

Surgery / anesthesia

When carrying out major surgical operations or anesthesia with the use of drugs that cause orthostatic hypotension, enalapril leads to the blocking of the synthesis of angiotensin II, due to the compensatory release of renin. In such cases, if orthostatic hypotension develops (and it is assumed that the development of orthostatic hypotension occurs according to this mechanism), then it should be corrected by an increase in the volume of blood plasma.

Impact on fertility

In some cases of fertilization in vitro blockers of "slow" calcium channels, similar to nitrendipine, caused reversible biochemical changes in the heads of spermatozoa, which can lead to a disruption of sperm function. When repeated unsuccessful attempts at artificial insemination should be taken into account, among other factors, and the use of male blockers of "slow" calcium channels, such as nitrendipine.

Racial differences

Like other angiotensin-converting enzyme inhibitors, enalapril as a component of a fixed dose combination, is probably less effective in reducing blood pressure in representatives of the Negroid race than in patients of other races. Perhaps this is due to from a higher prevalence of low renin activity in representatives of the Negroid race with arterial hypertension.

Effect on the ability to drive transp. cf. and fur:When using Enanorm, care must be taken when driving vehicles and complex mechanisms.

Form release / dosage:Tablets, 20 mg + 10 mg.

Packaging:

For 10 tablets in a blister type aluminum / aluminum, the base of which is made of a 3-layer film of polyamide / aluminum / polyvinyl chloride (PVC). The base is closed with lacquered aluminum foil.

For 3, 6 or 10 blisters together with the instructions for use are placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-000880

Date of registration:18.10.2011

Expiration Date:18.10.2016

The owner of the registration certificate:Ferrer International, S.A.Ferrer International, S.A. Spain

Manufacturer: & nbsp

FERRER INTERNACIONAL, S.A. Spain

Representation: & nbspNycomed Distribution Ltd.Nycomed Distribution Ltd.

Information update date: & nbsp24.01.2017

Illustrated instructions

Instructions

Enanorm (Enanorm)