Name:
Enap-HL 20 tablets 20 mg 12.5 mg in a blister. in pack. No. 10х2
Description:
Round, flat tablets of white color, with slanted edges and a notch on one side. The notch is not intended for dividing the tablet into parts. The main active ingredient Enalapril + hydrochlorothiazide Release form tablets Dosage 20 mg 12.5 mg Such an effect is rarely observed in patients with uncomplicated hypertension and is most likely in violation of water and electrolyte metabolism (for example, hypovolemia, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia), as a result of previous diuretic therapy, hyposodium diet, dialysis, diarrhea or vomiting. In such patients, periodic determination of serum electrolytes should be carried out. With extreme caution, the drug should be used in patients with coronary artery disease or cerebrovascular disease, since a sharp decrease in blood pressure can lead to myocardial infarction or stroke. If arterial hypotension develops, the patient should be placed in the supine position and, if necessary, an intravenous infusion of saline should be administered. Transient arterial hypotension is not a contraindication for further treatment. After normalization of blood pressure and replenishment of BCC, therapy with the drug can be continued in smaller doses (it is also possible with only one active substance). Dual blockade of the RAAS The simultaneous use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalemia, impaired renal function (including acute renal failure). Due to the dual blockade of the RAAS, the combined use of ACE inhibitors, angiotensin II receptor blockers, or aliskiren is not recommended. The appointment of therapy for dual blockade of the RAAS, due to its absolute necessity, should occur only under the supervision of a specialist and subject to frequent close monitoring of renal function, electrolytes and blood pressure. Co-administration of ACE inhibitors and angiotensin II blockers is not recommended in patients with diabetic nephropathy. Aortic Stenosis/Hypertrophic Cardiomyopathy As with all vasodilators, ACE inhibitors should be used with extreme caution in patients with left ventricular outflow tract obstruction. Changes in the content of potassium In the combined treatment of enalapril and potassium-sparing and diuretics, the possibility of hyperkalemia cannot be ruled out. Impaired renal function Thiazide diuretics may not be effective enough in patients with renal insufficiency and are ineffective at CC 30 ml / min or less (ie, with moderate to severe renal insufficiency). Fixed combinations of enalapril and hydrochlorothiazide should not be prescribed to patients with renal insufficiency (CC ? 80 ml / min) until the dose of the individual active components corresponding to the doses in the combined preparation is determined by selection. Some patients with arterial hypertension without obvious signs of kidney disease, taking enalapril together with diuretics, may develop a slight transient increase in the concentration of urea and serum creatinine. If this occurs during therapy with a combination of enalapril and hydrochlorothiazide, then treatment should be discontinued. In the future, it is possible to resume therapy in smaller doses or to prescribe the components of the drug separately. In some patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney, an increase in the concentration of urea and serum creatinine levels, reversible after discontinuation of therapy, was observed with the use of ACE inhibitors. Patients on hemodialysis If hemodialysis is required, the patient should initially be switched to a different drug class appropriate for the particular case, or membranes alternative to high-flux membranes (eg, AN 69) should be used. Anaphylactic reactions during LDL apheresis Patients receiving ACE inhibitors may experience life-threatening anaphylactoid and allergic reactions during LDL apheresis with dextran sulfate in rare cases. These reactions can be avoided by temporarily stopping treatment with ACE inhibitors before each apheresis. Impaired liver function Thiazide diuretics should be used with caution in patients with impaired liver function or progressive liver disease, because. minor changes in water and electrolyte balance can lead to hepatic coma. Surgery/Anesthesia In patients undergoing major surgery or during anesthesia with drugs that cause arterial hypotension, enalapril may block the formation of angiotensin II secondary to compensatory renin release. Arterial hypotension associated with this mechanism can be corrected by increasing the BCC. Metabolic and endocrine effects Therapy with thiazide diuretics may lead to impaired glucose tolerance. This may require dose adjustment of antidiabetic agents, including insulin. Thiazide diuretics may decrease urinary calcium excretion and cause slight and transient increases in serum calcium levels. Severe hypercalcemia may be a sign of latent hyperparathyroidism. Thiazide diuretics should be discontinued pending tests to assess parathyroid function. An increase in cholesterol and triglyceride levels may also be associated with thiazide diuretic therapy, however, with the use of low doses of diuretics (12.5 mg), this effect is minimal or absent. In some patients, thiazide diuretic therapy may lead to hyperuricemia and/or exacerbation of gout. However, enalapril may increase the amount of uric acid in the urine and thus weaken the hyperuricemic effect of hydrochlorothiazide. Hypersensitivity/angioneurotic edema During treatment with ACE inhibitors, including enalapril maleate, angioedema of the face, extremities, lips, tongue, pharynx and/or larynx may develop in rare cases at any stage of treatment. In such cases, you should immediately stop taking enalapril and monitor the patient’s condition until the symptoms resolve completely. Angioedema of the face and lips usually does not require treatment, however, antihistamines may be used to relieve symptoms. With angioedema of the tongue, pharynx or larynx, which can cause airway obstruction, it is necessary to immediately prescribe epinephrine (0.3-0.5 ml s / c solution of epinephrine in a combination of 1: 1000) and ensure free airway patency. Patients with a history of angioedema unrelated to treatment with ACE inhibitors have an increased risk of developing angioedema while receiving ACE inhibitors. Black patients taking ACE inhibitors are more likely to develop angioedema compared to patients of other racial origins. In patients receiving thiazide diuretics, hypersensitivity reactions may occur regardless of a history of allergy or asthma. Exacerbation or worsening of the severity of systemic lupus erythematosus has also been reported in patients treated with thiazides. Anaphylactoid reactions during desensitization Rarely, life-threatening anaphylactoid (allergic-type) reactions may occur in patients taking ACE inhibitors during desensitization against wasp or bee venom. These reactions can be avoided by temporarily stopping treatment with ACE inhibitors before each desensitization. Cough During treatment with ACE inhibitors, a persistent, dry, non-productive cough may occur, which stops after treatment is discontinued. This should be included in the differential diagnosis. Excipients Enap®-NL 20 contains lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency and malabsorption of glucose-galactose should not take this drug. Influence on the ability to drive vehicles and control mechanisms There are no data to suggest that the combination of enalapril and hydrochlorothiazide affects the ability to drive vehicles or work with mechanisms. When performing such work, it should be taken into account that in some cases, patients may experience dizziness and decreased performance. Pharmacological action ACE inhibitors in combination with diuretics. ATX code: C09BA02. Pharmacodynamics Enap-NL 20 is a drug designed to lower blood pressure (BP). The drug contains active substances – enalapril and hydrochlorothiazide. Enalapril belongs to the group of angiotensin-converting enzyme inhibitors (ACE inhibitors). When it is used, the blood vessels dilate, which leads to a decrease in blood pressure and an increase in the flow of blood and oxygen to the heart muscle and other organs. Hydrochlorothiazide belongs to a group of drugs that increase urine output (diuretics) and thereby lower blood pressure. The combination of enalapril and hydrochlorothiazide is more effective in lowering blood pressure than the individual components. Indications for use Arterial hypertension of mild to moderate severity (patients who are indicated for combination therapy). Dosage and administration The drug should be taken according to the doctor’s recommendations. If you have any questions, it is recommended to consult your doctor. Dosing This drug is prescribed to you personally. It should not be passed on to others. The recommended dose is one tablet per day. If necessary, the doctor can increase the dose to two tablets per day. If you are taking diuretics (water pills), you should consult your doctor before taking them. It is recommended to stop taking diuretics 2-3 days before taking Enap-NL 20. Method of administration Tablets should be taken whole, regardless of food intake, with water. The drug should be taken regularly, preferably in the morning, at the same time of day. If a dose is missed, the next dose should be taken as usual. Do not double the dose to make up for a missed dose. After discontinuation of treatment, an increase in blood pressure and, accordingly, an increase in the risk of complications associated with arterial hypertension, especially from the heart, brain and kidneys, is possible. Use during pregnancy and lactation Pregnancy If you are pregnant or think you are pregnant or plan to become pregnant, please consult your doctor before taking the drug. As a rule, the doctor will recommend that you stop taking Enap-NL 20 before or immediately after pregnancy and prescribe another drug. Enap-NL 20 is not recommended during the first 3 months of pregnancy. Enap-NL 20 is contraindicated in the later stages of pregnancy, because. it can cause serious harm to your child. Lactation Tell your doctor if you are breastfeeding. Enap-NL 20 is not recommended during lactation. Precautions Before taking the drug, you should consult your doctor. Caution should be exercised in patients: with low blood pressure and impaired water and electrolyte balance; being treated for impaired kidney or liver function, diabetes mellitus, connective tissue disease (systemic lupus erythematosus), gout; being treated by hemodialysis; with a recent kidney transplant; with obstruction of the outflow tract of the left ventricle or other heart diseases; with hypersensitivity to sulfonamides; during vomiting or diarrhea, or who have recently had heavy vomiting or diarrhea; with high levels of uric acid in the blood; with intolerance to some sugars; if you have had skin cancer or have an unexpected skin lesion during treatment. The use of hydrochlorothiazide, especially long-term use of high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). If you are taking hydrochlorothiazide, you must protect your skin from exposure to sunlight and ultraviolet rays. taking diuretics (diuretics), lithium preparations (for the treatment of mental illness), as well as the following drugs for the treatment of high blood pressure: “angiotensin II receptor blockers (also known as sartans – valsartan, telmisartan, irbesartan), especially in the presence of associated with diabetes mellitus kidney disease, “aliskiren. If necessary, your doctor will monitor your kidney function, blood pressure, and electrolytes (eg potassium) at regular intervals. Also pay attention to the information from the section “Contraindications”. Before surgery or anesthesia, you should inform your doctor (or dentist) that you are taking Enap-NL 20. If you are planning the following procedures, you should inform your doctor that you are taking Enap-NL 20: hemodialysis, apheresis, desensitization directed against wasp or bee venom, examination of the parathyroid glands. If angina pectoris worsens, you should consult a doctor. Tell your doctor if you are (or think you are) pregnant. Enap-NL 20 is not recommended for early pregnancy. Enap-NL 20 is contraindicated in the second and third trimesters of pregnancy, because. it can cause serious harm to your child. Use in children and adolescents The drug is not recommended for children, because. its efficacy and tolerability in this population have not been determined. Special information about some of the ingredients of the drug Enap-NL 20 contains lactose. Patients with intolerance to some sugars should consult a doctor before taking the drug. Reception with food, drinks or alcohol As a rule, Enap-NL 20 tablets are taken with water. You can take the drug with or without food, with a small amount of liquid. During treatment, you should not drink alcoholic beverages, because. it can cause dizziness, especially when standing up. If dizziness occurs, alcohol intake should be stopped immediately. Interactions with other drugs Tell your doctor if you are taking or have recently taken any medicines. Particular attention should be paid if you are taking: drugs to lower blood pressure; potassium supplements, potassium-containing salt substitutes, or potassium-sparing diuretics (eg, spironolactone, amiodarone); painkillers or anti-inflammatory drugs (non-steroidal anti-inflammatory drugs such as ibuprofen, diclofenac); antidepressants (eg, lithium preparations, tricyclic antidepressants, antipsychotics); diuretics (diuretics); cholesterol-lowering drugs (such as cholestyramine or colestipol); cytostatics; medicines to treat rheumatism, arthritis, allergies, asthma, or corticosteroids; medicines for the treatment of cardiac arrhythmia (procainamide, amiodarone or sotalol); medicines for the treatment of heart failure (foxglove preparations); medicines used to treat coughs and colds (sympathomimetics), norepinephrine or epinephrine used in case of low blood pressure, shock, heart failure, asthma or allergies; it is possible to reduce the hypotensive effect of Enap-NL 20; drugs for the treatment of diabetes, such as insulin; an excessive decrease in blood sugar levels is possible in the case of joint use; muscle relaxants (eg, tubocurarine for anesthesia); injectable gold preparations for the treatment of arthritis (sodium aurothiomalate); mammalian target inhibitors of rapamycin (eg, temsirolimus, sirolimus, everolimus); with concomitant treatment, the risk of angioedema increases. You may need to change the dose of the drug and / or take other precautions: in the case of the use of angiotensin II receptor blockers or aliskiren. Contraindications The drug should not be taken by patients: with hypersensitivity to enalapril maleate, hydrochlorothiazide, any of the excipients or sulfonamides; who have previously experienced allergic reactions during therapy with ACE inhibitors, accompanied by itching, rash, difficulty breathing, hoarseness, swelling of the hands, face, lips, neck or eyelids; with hereditary or idiopathic angioedema; with severe renal or hepatic impairment; with stenosis (narrowing) of the renal arteries; with anuria (urinary retention); in the second and third trimesters of pregnancy; the simultaneous use of Enap-NL 20 and aliskiren-containing drugs is contraindicated in patients with diabetes mellitus or renal insufficiency (GFR < 60 ml / min / 1.73 m2). Composition Each tablet contains Active substances: enalapril maleate, 20 mg and hydrochlorothiazide, 12.5 mg. Excipients: sodium bicarbonate, lactose monohydrate, corn starch, pregelatinized starch, talc, magnesium stearate. Overdose The most common symptoms of overdose are nausea, palpitations, dizziness and loss of consciousness, which is the result of an excessive decrease in blood pressure (hypotension). In case of overdose (simultaneous intake of a large number of pills), you should immediately consult a doctor. Side effects Like all medicines, Enap-NL 20 can cause side reactions in isolated cases. In case of itching, difficulty breathing, hoarseness, skin rash or swelling of the hands, lips, neck, face, eyelids, you should stop taking the drug and consult a doctor immediately. You should immediately contact your doctor if you feel very dizzy, for example when standing up (usually at the beginning of treatment or when the dose is increased). Classification of the incidence of side effects according to the World Health Organization: very common (? 1/10), frequent (? 1/100 to < 1/10), infrequent (? 1/1,000 to < 1/100), rare (? 1 /10,000 to < 1/1,000), very rare (< 1/10,000), unknown (cannot be estimated from the available data). Very common: blurred vision; dizziness; cough; nausea; asthenia (weakness). Frequent: hypokalemia, increased cholesterol, increased triglycerides, hyperuricemia; headache, depression, loss of consciousness (syncope), change in taste sensations; decrease in blood pressure when standing up and weakness, rhythm disturbances, tachycardia, chest pain; dyspnea; diarrhea, abdominal pain; rash; muscle spasms; chest pain, fatigue; hyperkalemia, increased serum creatinine. Uncommon: anemia, flushing, palpitations, acute cardiac or cerebrovascular complications, possibly due to excessive hypotension in high-risk patients; noise in ears; nasal discharge (rhinorrhea), sore throat and hoarseness, asthma; intestinal obstruction, pancreatitis, vomiting, indigestion (dyspepsia), flatulence, constipation, loss of appetite (anorexia), stomach irritation, dry mouth, peptic ulcer; impaired renal function, renal failure, proteinuria; itching, increased sweating, alopecia; joint pain (arthralgia); hypoglycemia, hypomagnesemia, gout; impotence; malaise, fever; confusion, decreased libido, insomnia, drowsiness, nervousness, dizziness, tingling of the arms and legs (paresthesia); increase in the level of urea in the blood serum, hyponatremia. Rare: neutropenia, decreased hemoglobin and hematocrit, thrombocytopenia, agranulocytosis, leukopenia, bone marrow depression, lymphadenopathy, autoimmune disease, pancytopenia; hyperglycemia; pathological dreams, sleep disturbances, decreased motor activity; Raynaud's phenomenon; infiltrates in the lungs, rhinitis, eosinophilic pneumonia (signs: cough, high body temperature, difficulty breathing); stomatitis / aphthous ulceration, glossitis; liver failure or hepatitis, possibly with jaundice, cholecystitis (particularly in patients with cholelithiasis); erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, purpura, cutaneous lupus erythematosus, erythroderma, pemphigus; oliguria, interstitial nephritis; gynecomastia; increased activity of "liver" enzymes and bilirubin. Very rare: intestinal angioedema (signs include abdominal pain, nausea); hypercalcemia. Frequency unknown: skin and lip cancer (non-melanoma skin cancer); syndrome of inappropriate secretion of antidiuretic hormone. The literature describes a symptom complex that includes all or only some of these signs: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, positive antinuclear antibodies (ANA), increased erythrocyte sedimentation rate (ESR), eosinophilia, and leukocytosis. If you experience any of the side effects listed or not listed in this package insert, you should contact your doctor. Storage conditionsStore at a temperature not exceeding 25 °C. Store in original packaging to protect from moisture. Keep out of the reach of children. Buy Enap-NL 20 tablets 20mg/12.5mg No. 10x2 Price for Enap-NL 20 tablets 20mg/12.5mg No. 10x2
INN | ENALAPRIL + HYDROCHLOROTHIAZIDE |
---|---|
The code | 23 415 |
Barcode | 3 838 989 523 121 |
Dosage | 20mg/12.5mg |
Active substance | Enalapril, hydrochlorothiazide |
Manufacturer | KRKA, d.d., Slovenia, Slovenia |
Trademark | KRKA |
trade line | Enap |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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