ENAHEXAL. 20 mg. 30 tablets
ENAHEXAL. 20 mg. 30 tablets
What is the active ingredient ?
1 tablet contains 20 mg enalapril maleate
What else Enahexal tablets contain 20 mg?
Sodium hydrogen carbonate, lactose monohydrate, maize starch , talc , ferric oxide (red) , magnesium stearate (Ph.Eur.)
Tip for diabetics :
1 tablet contains 0.01 carbohydrate units .
Formulation and packaging :
Original packages containing 30 tablets
What Enahexal tablets 20 mg?
Enahexal tablets ACE inhibitors - angiotensin converting enzyme inhibitors.
What is it used Enahexal tablets 20 mg?
- High blood pressure (hypertension)
- Heart failure ( in combination with a 'water - diuretic drugs ) and particularly in cases of severe heart failure ( in combination with digitalis )
- Dysfunction of the left ventricle without obvious symptoms (eg difficulty breathing load ) ( asymptomatic left ventricular dysfunction)
When should you take 20 mg tablets Enahexal
- In hypersensitivity to enalapril maleate to other ACE inhibitors or any of the other ingredients of the product.
- With a tendency to swelling of tissues ( angioedema inherited angioedema or another as a result of previous treatment with ACE inhibitors
- In a narrowing of the renal arteries
- After renal transplantation
- In a narrowing of the aortic or mitral valve or difficulty swelling of the left ventricle ( hypertrophic cardiomyopathy )
- In primary liver disease or liver failure
- During pregnancy (pre- should be excluded pregnancy and to take appropriate measures against pregnancy during treatment ) and during karmenePri dialysis renal patients and concomitant Enahexal ® high - flux membranes " as . AN 69 " there is a risk of hypersensitivity reactions to shock. This combination should be avoided by the use of other drugs ( other than ACE) inhibitors to treat high blood pressure or heart failure, or by use of other membranes dializa.Pri patients with elevated cholesterol receiving ACE inhibitors may arise threatening hypersensitivity reactions . If necessary study of low-density lipoproteins , Enahexal must be replaced temporarily with another medicine used for high blood pressure or heart nedostatachnost.Pri patients exhibiting hypersensitivity to insect venom ( bees, wasps ) and in patients who are desensitisation therapy , concomitant administration of Enahexal can lead to severe hypersensitivity reactions associated with low blood pressure , impaired breathing , vomiting and / or allergic skin reactions. Therefore Enahexal treatment should be discontinued prior to desensitization therapy.
In which case you can use Enahexal ® tablets 20 mg only after consulting a doctor ?
Enahexal can be used only after careful evaluation of the risk / benefit tracking down clinical and chemical laboratory parameters at regular intervals at :
- Severe renal impairment (creatinine clearance below 30 ml / min)
- Dialysis patients
- Increased excretion of urinary protein (greater than 1 g / day )
- Severe electrolyte disturbances
- Impaired immune response or existing collagen diseases (eg lupus erythematosus, scleroderma )
- Concomitant treatment with drugs that suppress the immune system (eg corticosteroids , cytotoxic agents, anti-metabolites ) , allopurinol, procainamide or lithium ( see also Precautions )
What precautions you should consider ?
Low blood pressure (hypotension ) Enahexal ® may cause significant decrease in blood pressure, especially after the first administration of the product. Drop in blood pressure pressure occurs more often in patients with disorders of fluid and electrolyte balance (eg water pills therapy in cases of low-salt diet , vomiting , diarrhea, or after dialysis) . These are mainly patients with severe heart failure, with or without renal impairment . In these patients, therapy Enahexal ® should be started under very close monitoring by a doctor .
Special care is also required in patients with reduced blood flow to the heart muscle ( coronary artery disease ) or narrowing of brain arteries. In these cases it may be a myocardial infarction or ischemic attack as a result of a sharp drop in blood pressure. Therapy should be started at low doses and dose can be increased after careful monitoring of renal function and potassium level . At the start of therapy if possible should be temporarily stopped existing drainage therapy.
Renal hypertension / renal artery stenosis (see Contraindications ) in patients with hypertension associated with diseases of the renal vessels when taking Enahexal ® increased risk of a sharp drop in blood pressure and kidney failure. Decrease in renal function is accompanied by slight changes in serum creatinine , even in patients with unilateral renal artery stenosis . Treatment should be initiated under close medical supervision in a hospital with a low dose and increase the dose carefully . Undergoing treatment with water pills should be gradually discontinued and renal function should be accurately tracked during the first weeks of therapy.
Renal failure / dialysis
Enahexal ® should be carefully dosed in patients with impaired renal function (renal failure) , as may be necessary to reduce the dose (see Dosage and Administration ) . In patients with severe renal insufficiency (creatinine clearance below 30 ml / min) and dialysis patients (see Dosage and method of administration ) the product can be applied only after a very critical assessment of the benefit / risk ratio and direct monitoring of renal function before and during terapiyata.Osobeno in patients with severe heart failure , or kidney disease (including renal artery stenosis ) is communicated renal failure associated with ACE inhibitor therapy . In some patients free of any obvious renal disease concomitant water pills have been measured elevated levels of urea and creatinine in the blood. This may require reducing the dose of ACE inhibitor and / or discontinuation of water pills .
Coadministration of Enahexal ® and high - flux membranes in dialysis suggests a risk of reactions svrahn # vegv4ytelnost to shock. The first symptoms of severe hypersensitivity reactions are swelling of the face , flushing , low blood pressure and difficulty breathing . Symptoms appear a few minutes after the start of hemodialysis. Tazikombinatsiya should be avoided by the application of membranes for dialysis or use another product to treat high blood pressure or heart failure.
Electrolyte disturbances / Hyperkalemia
During treatment with Enahexal ® may be a higher level of potassium, especially in kidney and / or heart failure . Administration of potassium -sparing water pills or potassium products such as accompanying therapy is not recommended as it can lead to a significant increase in the level of potassium in the serum. If necessary concomitant therapy with the above mentioned products , potassium levels should be regularly prosledyavani.V cases of severe disturbance of electrolyte balance (especially potassium and sodium ) Enahexal ® should be used only after careful evaluation of the risk / benefit and immediately regularly monitoring the levels of electrolytes in serum.
Patients with primary aldosteronism not react to drugs that lower blood pressure , whose effect is based on inhibition of the renin -angiotensin system. Therefore it is not recommended to use Enahexal
Separation of protein in the urine ( proteinuria)
In rare cases it may be proteinuria in patients with pre-existing renal impairment or after administration of relatively high doses of Enahexal. In cases of clinically significant proteinuria (more than 1 g / day ) Enahexal can be applied only after very accurate assessment of the risk / benefit of regular clinical and laboratory parametri.Otok tissue / angioneurotic edema (see "Contraindications" ) in patients treated with ACE inhibitors, including Enahexal ® were observed swelling of the face , extremities, lips, tongue , glottis and / or larynx . They can occur at any time during treatment. In these cases, treatment with enalapril maleate should be discontinued immediately and the patient should be monitored . Swelling confined to the face and lips, usually disappear upon discontinuation of therapy. Antihistamines have proved their advantages in the removal of these symptoms. In patients with a history of angioedema is an increased risk of developing one, and after taking ACE inhibitori.Pri black patients were more often reported cases of angioedema while receiving an ACE inhibitori.Angioedem involving the tongue , glottis and / or larynx may be life-threatening . In this case you should take urgent treatment with 0,3-0,5 mg epinephrine, administered subcutaneously or 0,1 mg epinephrine, administered intravenously slowly with ECG and blood pressure. Patients should be treated in a hospital setting to be observed for at least 12-24 h, to ensure complete removal of siptomite before discharge of the patient.
Changes in blood count (neutropenia , agranulocytosis ) in patients with hypertension treated with ACE inhibitors, rarely decrease the number of white blood cells ( neutropenia or agranulocytosis) - mainly in patients in whom treatment of hypertension uncomplicated . With impaired renal function changes occur more frequently, especially if there is both a disease of the vascular and connective tissue disorders ( such as systemic lupus erythematosus or scleroderma ) or if both conducted therapy suppresses the immune system. Blood counts should be monitored in these patients at regular intervals. Neutropenia and agranulocytosis are reversible after discontinuation of treatment with an ACE inhibitor. If symptoms such as fever , swollen lymph nodes and / or sore throat in the course of therapy should be - consult a doctor and blood count monitored .
Other products that interfere with the effect of 20 mg tablets Enahexal or may be affected by the product?
- Medicines that lower blood pressure, strengthen the effect of Enahexal, especially water pills
- Products for pain and inflammation ( eg, aspirin , indomethacin ) decreased effects of Enahexal
- Potassium- sparing water pills (such as spironolactone, amiloride , triamterene ) , and other drugs cause elevated concentration of serum potassium (eg heparin)
- Lithium: Increased serum concentration of lithium - requires regular monitoring
- Hypnotics, narcotics , anesthetics cause increased drop in blood pressure ( the doctor conducting anesthesia should be informed therapy Enahexal)
- Allopurinol, drugs that suppress the protective effects ( cytotoxic agents, immunosuppressive agents , systemic corticosteroids , procainamide ) cause reduction in the number of leukocytes in the blood
- Medicines that lower blood sugar ( sulphonylureas / biguanides ) or insulin administered with Enahexal enhance the effect of lowering blood glucose
What foods and spices you should avoid ?
- Sodium chloride ( common salt ) reduces the effect of lowering blood pressure and enhances the symptoms associated with heart failure
- Alcohol : enhanced effects of alcohol
What should I take into account children and adults with use of Enahexal tablets 20 mg?
Children should not be treated with Enahexal ® tablets 20 m, as there is insufficient data on its impact. Elderly patients may respond better to ACE inhibitors than younger patients . Treatment of elderly patients should be performed carefully. Patients over 65 years recommended daily dose of 2,5 mg enalapril maleate and monitoring of renal function at the initiation of therapy.
What special precautions should be taken during pregnancy and lactation ?
During pregnancy and breastfeeding should not use ACE inhibitors as Enahexal ®. Women of childbearing age before starting therapy Enahexal ® should be excluded pregnancy. During treatment , women should use an appropriate method to prevent pregnancy . If a woman becomes pregnant during treatment , it is necessary to consult a doctor and switched to another therapy less risk to the fetus. Taking Enahexal may cause fetal harm and lead to death , especially during the last 6 months of bremennostta.Enahexal ® passes into breast milk. There are insufficient data to receive the products during breastfeeding , which means that it should be used during this period.
What you must consider when driving or operating machinery ?
Enahexal treatment requires regular medical supervision. Since patients respond individually to therapy reactivity can be influenced so that distortions occur in the ability to drive , operate machinery or in an unstable position ( eg climbing stairs ) . This occurs early in treatment , increasing the dose or change the drug as well as alcohol use during therapy .
Dose , route and duration of administration :
Suggested dosage unless your doctor has prescribed Enahexal ® tablets 20 mg tablets in different dosing regimens . Please follow these instructions for use . Otherwise, it will not work pravilno.V beginning of therapy may occur a decrease in blood pressure , especially in patients suffering from electrolyte depletion and / or fluids ( eg, dialysis patients , drainage therapy in case of vomiting / diarrhea ) , heart failure , severe or renal hypertension . In the electrolyte and / or fluid violations must be corrected before initiating therapy or therapy with the existing water pills to reduce or possibly prekasnata.Pri these patients, therapy should be initiated with the lowest single dose of 2,5 mg enalapril maleate . The condition of these patients should be monitored for at least 8 hours after administration of the first dose , also when increasing the dose of enalapril maleate and / or drainage means , in order to avoid the occurrence of uncontrolled drop in blood pressure . Patients in serious condition (malignant hypertension or patients suffering from severe heart failure should be admitted to hospital to determine treatment Enahexal ® tablets 20 mg
How much and how often you can take Enahexal tablets 20 mg?
The usual starting dose is half a tablet of 20 mg Enahexal morning. If not achieved normalization of blood pressure after administration of this dose , the dose may be increased to one tablet Enahexal ® 10 mg ( 10 mg enalapril maleate) per day. The dose should be increased at intervals of not less than 3 sedmitsi.Po rule maintenance dose is 1 tablet Enahexal ® 10 mg ( 10 mg enalapril maleate ) per day. Maximum dose is 2 x 2 tablets Enahexal 10 mg ( 2 x 20 mg enalapril maleate ) dnevno.Sardechna failure / dysfunction of the left ventricle starting dose is 2,5 mg enalapril maleate morning. Your doctor may increase the dose only gradually depending on individual patient tolerance to lechenieto.Po rule maintenance dose is 1/2-1 tablet Enahexal ® 10 mg daily (5-10 mg enalapril maleate ) . The maximum dose of 2 tablets of Enahexal ® 10 mg per day ( 20 mg enalapril maleate ) must not be exceeded.
Dosage in patients with moderate renal impairment (creatinine clearance 30-60 mi / min) and elderly (over 65 years) starting dose is 2,5 mg enalapril maleate morning. As a rule, maintenance dose is 1/2-1 tablet Enahexal 10 mg (5-10 mg enalapril maleate ) per day. The maximum dose of 2 tablets of Enahexal ® 10 mg per day ( 20 mg enalapril maleate ) must not be exceeded.
Dosage in patients with severe renal impairment (creatinine clearance below 30 ml / min) and dialysis patients starting dose is 2,5 mg enalapril maleate morning. Dialysis patients should not take this dose after dializa.Po rule maintenance dose is half a tablet of Epagny ! . 10 mg ( 5 mg of enalapril maleate ) daily. The maximum dose of 1 tablet Enahexal ® 10 mg ( 10 mg enalapril maleate ) daily should not be exceeded.
When and how you can take Enahexal tablets 20 mg?
You can take Enahexal tablets 10 mg without food. As a rule, the required daily dose taken in the morning , but it is possible to be in 2 divided doses - morning and evening. Please take the tablets with a sufficient amount of fluid (eg a glass of water). Guide for use: To facilitate individual titration , Enahexal 10 mg tablets are scored . To split the tablet put it on a sound basis scored higher. The tablet is divided under slight pressure with the thumb .
How long can you take Enahexal tablets 20 mg
The duration of application of the product is determined by the attending physician .
What should I do if Enahexal tablets 20 mg were taken in very large quantities ( intentional or unintentional overdose ) ?
Depending on the extent of possible overdose symptoms: weakness, dizziness , sweating, blurred vision , drowsiness, unconsciousness , vomiting , convulsions, renal failure. In case of overdose you need medical attention !
What should you do if you take more than the prescribed dose of 20 mg tablets Enahexal or you forget to take the product ?
You should not take double or multiple dose. Continue to take tablets 20 mg Enahexal as prescribed.
What you should know if you have discontinued or have it terminated prematurely ?
In patients suffering from high blood pressure can be monitored re- raising . In patients with myocardial failure may occur recurrence of symptoms.
What side effects can cause the application of Enahexal ® tablets 20 mg?
Rarely can arise drop in blood pressure with symptoms such as dizziness, weakness , visual disturbances, loss of consciousness. This is especially true for the beginning of therapy for patients with electrolyte and / or fluid ( eg pre-treatment with water pills ), heart failure , severe renal hypertension and also increasing the dose of Enahexal ® tablets 10 mg and / or drainage sredstva.Pri intake of reported instances of adverse reactions associated with a decrease in blood pressure : increased heart rate , palpitations , arrhythmias , tightness of chest pain , myocardial infarction, transient symptomatic hypoperfusion (decreased blood supply ) brain stroke.
Rarely may arise or be strengthened violations in renal function , in some cases even acute renal failure. Rarely was observed increased excretion of protein in the urine with both deterioration of renal function.
Occasionally dry cough , sore throat , hoarseness and bronchitis. Can rarely be established disordered breathing , inflammation of the sinuses , rhinitis, individual cases of bronchospasm / asthma , pulmonary infiltrates (accumulation of substances in the lung tissue ), inflammatory changes in the lining of the mouth, tongue and dry B ustata.V some cases the application of ACE inhibitors has resulted in swelling of the tissue changes in laryngeal , throat and / or tongue .
Gastrointestinal tract / liver
Rarely observed nausea , pain in the upper abdomen , indigestion , vomiting, diarrhea , constipation and lack of appetite. Rarely, treatment with ACE inhibitors has been associated with a syndrome that begins with jaundice due to decreased biliary secretion to liver necrosis ( sometimes fatal ) . The reasons are not izyasneni.Opisani were isolated cases of liver function abnormalities , inflammation of the liver , liver failure , inflammation of the pancreas and volvulus with ACE - inhibitor therapy .
Rarely allergic skin reactions : rash, urticaria, pruritus and angioedema of the lips, face and / or limbs . In individual cases have been described severe skin reactions such as pemphigus , erythema multiforme , exfoliative dermatitis syndrome, Stevens-Johnson, and toxic epidermal nekroliza.Kozhnite changes may be accompanied by fever, muscle and joint pain , inflammation, vascular inflammation the mucous membranes, and changes in laboratory parameters (excess of eosinophils , excessive leukocytes in the blood , etc. . ) in some cases , changes were observed in the skin, like psoriasis , sensitivity to light , flushing , sweating, alopecia, nail fragility and enhance vascular spasms disease Raynaud.
Rarely headaches and fatigue , sleepiness , depression, sleep disturbances , impotence, numbness and coldness of the limbs , impaired balance , muscle cramps , nervousness , abnormal behavior , tinnitus , blurred vision and changes or temporary loss of taste .
Laboratory parameters (blood, urine )
Rarely observed decrease in hemoglobin concentration , hematocrit , the number of leukocytes and platelets. In renal dysfunction , diseases of the connective tissue or concomitant therapy with allopurinol , procainamide or drugs that suppress the immune system , it may cause a significant decrease in the number of blood cells ( anemia , decreased platelet count , decrease of neutrophil increase in eosinophils , etc.). in individual cases, to the effect on all types of blood cells. In the presence of glucose-6- phosphate dehydrogenase deficiency may occur damage to erythrocytes ( hemolysis / hemolytic anemia ) manifested eg . a dark -colored urine , and / or jaundice . In this case there is no proven link with the ACE - inhibitor.Pri patients with impaired renal function may increase serum concentrations of urea, creatinine , potassium and decrease sodium concentrations in blood serum. In patients with diabetes may increase the concentration of potassium in the serum. It is possible that increased excretion of protein with urinata.Vazmozhni isolated cases of elevated bilirubin and elevated levels of liver enzymes.
The aforementioned laboratory parameters should be monitored before and regularly during treatment with Enahexal ® tablets 10 mg.Ako notice any side effects not listed in this leaflet, please tell your doctor or farmatsevt.Kakvi measures must be taken in connection with the side effects ? with swelling of tissues caused by Enahexal ® affecting the larynx , pharynx, and / or tongue should be administered once 0,3-0,5 mg epinephrine subcutaneously or 0.1 mg epinephrine (please follow the instructions dilution !) slowly intravenously at ECG and blood pressure. Then apply corticoids . It is recommended that intravenous administration of antihistamines and H2 antagonisti.Ako jaundice occurs or a significant increase in liver enzymes , treatment with Enahexal ® should be discontinued and patients should consult with lekar.V case of severe skin reactions require immediate medical advice and if necessary , discontinuation of Enahexal.
Storage Instructions :
The shelf-life of the drug is printed on opakovkata.Da not use after the expiry date stated on the package .
How should I store Enahexal tablets 20 mg
Enahexal should be stored at temperatures below 25 ° C. Keep out of reach of children : If you have additional questions , please ask your doctor or pharmacist.