Enarenal tablets 5mg №10×2

Description of goods Enarenal tablets: instructions for use Release form: tablets INN: Enalapril FTG: APF blocker Prices in pharmacies in Minsk 1.55 – 6.16 rubles. Where to buy Instructions Composition Pharmacotherapeutic group Indications for use Contraindications Method of administration and doses Overdose Storage conditions Dispensing conditions Packing Instructions Brief description of Enarenal 5 mg: tablets are white, oblong, biconvex, with dividing risks on both sides. Tablets can be divided in half. Enarenal 10 mg and 20 mg: tablets are white, round, flat, with bevelled edges. Composition One tablet contains the active ingredient: 5 mg, 10 mg or 20 mg of enalapril maleate. excipients: lactose monohydrate, modified corn starch, sodium croscarmellose, sodium bicarbonate, magnesium stearate. Pharmacotherapeutic group Means that affect the renin-angiotensin system. ACE inhibitors. Pharmacological properties Enarenal contains the active substance – enalapril maleate, which is an angiotensin-converting enzyme (ACE) inhibitor, i.e. a drug that lowers blood pressure and facilitates the work of the heart. Indications for use Enarenal is used: in the treatment of arterial hypertension; in the treatment of heart failure with clinical manifestations; for the prevention of clinically significant heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction ≤ 35%). Contraindications Do not use the drug Enarenal if the patient has hypersensitivity to enalapril or any other ingredients of this drug (listed in the “Composition” section) or to another drug from the group of angiotensin-converting enzyme inhibitors; if the patient has ever had angioedema after the use of ACE inhibitors; if the patient or any of the relatives has ever had angioedema for any reason (hereditary or idiopathic angioedema); if the patient suffers from diabetes mellitus or impaired renal function, and at the same time takes an antihypertensive drug containing aliskiren; after 3 months of pregnancy. (Enarenal should be avoided in early pregnancy – see section “Use during pregnancy and lactation”). Precautions for use Before using the drug Enarenal, you should consult your doctor in case of: The appearance of dizziness, a feeling of emptiness in the head, especially after the start of treatment or when the dose is increased, or if dizziness is caused by a transition to an upright position from a sitting or lying position. The presence of heart failure (insufficient contractile function of the heart), when a drop in blood pressure is possible. The risk is higher in patients with severe heart failure who use high doses of loop diuretics, in patients with low blood sodium levels or reduced renal function. The presence of heart disease caused by ischemia or disease of the cerebral arteries. The treatment of this group of patients requires special care, since a pronounced drop in blood pressure can lead to the development of myocardial infarction or cerebral stroke. The use of a low-salt diet, the presence in the recent past of intense vomiting or diarrhea, taking diuretics. The presence of diseases such as: aortic valve stenosis (narrowing of the aortic mouth), hypertrophic cardiomyopathy or narrowing of the outflow tract from the left ventricle. Kidney diseases, conditions after kidney transplantation or during dialysis (the use of high-permeability dialysis membranes simultaneously with enalapril can cause severe allergic reactions), high blood pressure due to renal artery stenosis (renovascular hypertension). Liver dysfunction. The presence of collagen diseases, the use of immunosuppressive drugs (used to treat autoimmune diseases such as rheumatoid arthritis or a condition after transplantation), allopurinol (used to treat gout) or procainamide (used to treat cardiac arrhythmia). In such patients, the doctor may order more frequent blood tests and monitoring of white blood cells. If patients develop symptoms of infection (high body temperature, chills), the attending physician should be informed immediately. A history of angioedema (symptoms such as pruritus, hives, wheezing, or swelling of the hands, throat, lips, or eyelids) while taking other medications. Taking hypoglycemic drugs or insulin; during the first month of treatment with enalapril, blood glucose levels should be carefully monitored. Taking potassium-sparing diuretics, potassium replacement therapy, table salt substitutes containing potassium, and other substances that can increase the concentration of potassium in the blood. Taking medicines containing lithium salts (used in the treatment of certain types of mental illness). Taking any of the following drugs to treat high blood pressure: an angiotensin II receptor blocker (ARB) (these drugs are also known as “sartans” – for example, valsartan, telmisartan, irbesartan), especially if you have kidney complications related to with diabetes; aliskiren. Your doctor should check your kidney function, blood pressure, and electrolytes (such as potassium) in your blood on a regular basis. See also the information in the “Contraindications” section. You should immediately contact your doctor if the following symptoms occur during the treatment period: Jaundice (jaundice of the skin and sclera of the eyes). Dry cough lasting for a long time. You should inform the doctor about taking Enarenal if the following procedures are planned: LDL apheresis, a method for removing cholesterol from the blood. Desensitization, which reduces sensitivity to bee or wasp venom. Any surgery or injection of an anesthetic drug. In case of pregnancy (or suspected pregnancy), you should consult a doctor. Enarenal is not recommended to be taken in early pregnancy and should not be taken during pregnancy for more than 3 months, since in this period it may pose a threat to the child (see section “Use during pregnancy and lactation”). At the start of treatment, the doctor will frequently monitor blood pressure to make sure the dose is appropriate for the patient. In addition, in some patients, the doctor may order a blood test to determine the level of potassium and creatinine or liver enzymes. Children and adolescents Enalapril is used in children and adolescents exclusively in the treatment of arterial hypertension. The dose of the drug is set by the doctor individually, depending on the patient’s condition and blood pressure values. Enarenal contains lactose If the patient has previously been diagnosed with intolerance to some sugars, he should consult a doctor before taking the drug. Use during pregnancy and lactation Before using any drug, you should consult your doctor or pharmacist. Treatment with ACE inhibitors should not be initiated during pregnancy. Patients planning pregnancy should be switched to an alternative antihypertensive treatment with an established safety profile during pregnancy, unless further treatment with an ACE inhibitor is considered necessary. If pregnancy is confirmed, treatment with ACE inhibitors should be discontinued and alternative treatment instituted if necessary. It is not recommended to use enalapril during breastfeeding. Influence on the ability to drive vehicles and maintain mechanisms Individual reaction to the drug may be different. However, some side effects observed after taking enalapril, such as dizziness or fatigue, may affect the ability to drive vehicles and use machines in some patients. Interaction with other medicinal products and other forms of interaction Tell the doctor or pharmacist about all drugs that the patient is taking or has taken recently, as well as those that the patient plans to take. Some medicines should not be used at the same time. In some cases, the doctor may recommend changing the dosage of drugs if they are used simultaneously with other drugs. It is especially important if enalapril is used concomitantly: Potassium-sparing diuretics such as spironolactone, triamterene or amiloride, potassium preparations or kitchen salt substitutes containing potassium. Enalapril can increase the level of potassium in the blood, leading to hyperkalemia. Mild hyperkalemia causes few or no symptoms and is usually diagnosed based on a blood test or ECG. Diuretics such as furosemide, other antihypertensive drugs, nitroglycerin or other nitrates, and other drugs that dilate blood vessels. Their combined use with enalapril can cause arterial hypotension. Lithium preparations used in the treatment of certain mental illnesses. Enarenal should not be taken with lithium salts. Tricyclic antidepressants such as amitriptyline (used to treat depression), antipsychotics such as phenothiazine derivatives (depresses increased arousal), narcotics such as morphine (used to treat moderate to severe pain), and anesthetics. Taking such drugs with Enarenal may enhance the hypotensive effect. Non-steroidal anti-inflammatory drugs (NSAIDs), such as diflunisal or diclofenac (drugs that reduce pain and inflammation). These drugs inhibit the hypotensive effect of enalapril and increase the level of potassium in the blood. Gold salts (used in the treatment of arthritis). Mammalian target inhibitors of rapamycin (for example: temsirolimus, a drug used to treat certain cancers; sirolimus or everolimus, drugs that prevent rejection of transplanted organs). Their combined use with enalapril increases the risk of angioedema. Sympathomimetics such as ephedrine, norepinephrine and epinephrine used in the treatment of arterial hypotension, shock, circulatory failure, bronchial asthma or allergies. Taking these drugs with enalapril can lead to retention of high blood pressure. Drugs used in diabetes mellitus (for example: insulin, glibenclamide or metformin). With simultaneous use with enalapril, an increase in blood glucose levels is possible. Your doctor may need to change your dose and/or take other precautions if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also Contraindications and Precautions for use). Simultaneous intake of alcohol and the drug Enarenal may increase the hypotensive effect and dizziness, a feeling of emptiness in the head or fainting may occur. Alcoholic beverages should be kept to a minimum. Dosage and Administration The drug should always be used in accordance with the doctor’s recommendations. If you have any questions or concerns, please contact your doctor or pharmacist. The dose of the drug is set by the doctor individually, depending on the patient’s condition and the effect of the drug on blood pressure. You should not independently modify the dose of the drug or stop treatment. Enarenal tablets can be taken with or without food. The following doses are generally recommended: Adults Hypertension The initial dose is 5 mg to 20 mg, depending on the severity of hypertension and the condition of the patient. The drug is taken once a day. For mild hypertension, the recommended dose is 5 to 10 mg. In patients with increased activity of the renin-angiotensin-aldosterone system (eg, renovascular hypertension, excessive loss of salt and (or) water, chronic heart failure in the stage of decompensation or severe arterial hypertension), after taking the initial dose, a pronounced decrease in blood pressure may occur. In such patients, the recommended starting dose is 5 mg or less, and treatment should be initiated under medical supervision. In patients taking high doses of diuretics, special care must be taken at the beginning of treatment with Enarenal, since after taking the first dose of the drug, arterial hypotension may occur as a result of a decrease in blood volume. In these patients, administration of the drug at an initial dose of 5 mg or less is recommended. If possible, the diuretic should be discontinued 2-3 days before the start of treatment with Enarenal. Kidney function and potassium levels in the blood should be monitored. The usual maintenance dose is 20 mg per day. The maximum maintenance dose is 40 mg per day. Heart failure / asymptomatic left ventricular dysfunction For the treatment of clinically significant heart failure, Enarenal is used in combination with diuretics, and, if necessary, with digitalis glycosides or β-blockers. The initial dose of Enarenal in patients with symptomatic heart failure or asymptomatic left ventricular dysfunction is 2.5 mg and should be used under close medical supervision to determine the effect on blood pressure at the beginning of the drug. If at the beginning of treatment with Enarenal heart failure, there is no symptomatic hypotension or its effective treatment has been carried out, the dose of enalapril should be gradually increased to the usual maintenance dose of 20 mg, which is taken once or twice, depending on the patient’s tolerance to the drug. It is recommended that doses be modified no earlier than 2 to 4 weeks apart. The maximum dose is 40 mg per day, in 2 divided doses. Use in patients with renal insufficiency In patients with renal insufficiency, the dosage is selected depending on the creatinine clearance. Kidney function is reflected in the level of creatinine (a metabolic product) in the urine and a blood test. In the case of dialyzed patients, the dose of the drug will change every day, which will be informed by the attending physician. Use in elderly patients The dose of the drug is selected by the attending physician, depending on the degree of impaired renal function of the patient. Use in children and adolescents There are limited clinical data on the use of enalapril in children with hypertension. If the child is able to swallow the tablet, the dose will be adjusted according to the child’s body weight and blood pressure. The recommended starting dose for children weighing 20 kg to < 50 kg is 2.5 mg, and for patients weighing ≥ 50 kg, 5 mg. Enarenal is taken once a day. If necessary, you can increase the applied dose to a maximum of 20 mg per day for children weighing 20 kg to < 50 kg and up to 40 mg for children weighing ≥ 50 kg. Enarenal is not recommended for use in newborns and children with impaired renal function. If you miss a dose of Enarenal If you forget to take a dose of the drug, you should take it as soon as possible. However, if the time is approaching to take the next dose of the drug, you should not take the missed dose. Do not take a double dose of the drug. Stopping the drug Enarenal Do not stop taking the drug without consulting your doctor. In case of any further doubts related to the use of the drug, you should consult your doctor or pharmacist. Overdose In case of taking a dose of the drug greater than the recommended one, you should immediately consult a doctor who will take the appropriate treatment. The most common symptoms of an overdose of the drug are a drop in blood pressure and a state of almost complete loss of consciousness. Other symptoms of overdose: dizziness, feeling of emptiness in the head due to a drop in blood pressure, increased heart rate, tachycardia, bradycardia, anxiety, cough, kidney failure and rapid breathing. Side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. You should immediately stop taking Enarenal and consult a doctor if dizziness, a feeling of emptiness in the head appear, especially after the start of treatment or when the dose is increased, or if dizziness is caused by a transition to an upright position from a sitting or lying position. You should immediately stop taking Enarenal and consult a doctor if you experience itching, choking or wheezing, or swelling of the hands, lips, larynx, face or eyes. The following is a list of side effects that were observed in patients taking enalapril, with the frequency of occurrence presented: very often (in more than 1 in 10 patients; often (in less than 1 in 10 patients); infrequently (in less than 1 in 100 patients ) rare (in less than 1 in 1000 patients) very rare (in less than 1 in 10,000 patients) frequency unknown (frequency cannot be established from the available data) Blood and lymphatic system disorders: Uncommon: anemia . Rare: blood disorders related to blood cells or constituents usually found on a blood test (symptoms such as fatigue, weakness, choking, inability to exercise, fatigue, persistent or recurring colds, increased bleeding time, bruising of unknown origin) , swollen lymph nodes, autoimmune diseases (diseases when the body's immune system acts on its own cells as foreign and produces antibodies to them). Endocrine system disorders: Frequency unknown: Syndrome of inappropriate secretion of antidiuretic hormone, which is accompanied by headache, weakness, nausea, vomiting, confusion and convulsions. Metabolic and nutritional disorders: Uncommon: Decreased blood glucose levels. Nervous system disorders: Often: headaches, depression. Infrequently: disorientation, drowsiness, insomnia, nervousness, paresthesia, dizziness. Rarely: unusual dreams, sleep disturbances. On the part of the organ of vision: Very often: blurred vision. Cardiovascular disorders: Very common: dizziness. Often: arterial hypotension (including orthostatic hypotension associated with a change in body position to a vertical position), fainting, chest pain, heart rhythm disturbances, a feeling of pressure in the chest (angina pectoris), rapid heartbeat. Uncommon: hypotension, palpitations, myocardial infarction or cerebrovascular stroke (probably due to excessive hypotension in high-risk patients). Rare: Raynaud's syndrome (a condition where small arterial vessels in the fingers or toes narrow, causing pale, blue, or red patches of skin). Respiratory, thoracic and mediastinal disorders: Very common: cough. Often: feeling of suffocation. Uncommon: nasal discharge, sore throat and hoarseness, bronchospasm or bronchial asthma. Rarely: fluid in the lungs, inflammation of the nasal mucosa, pneumonia. Gastrointestinal disorders: Very common: nausea. Often: diarrhea, abdominal pain, taste disturbances. Uncommon: Feeling of bloating or crampy pain in the abdomen (may be caused by intestinal obstruction), severe abdominal pain (pancreatitis), vomiting, dyspepsia, constipation, lack of appetite, stomach irritation, dry mouth, stomach ulcers (symptoms are: acute stabbing pain and hunger, especially on an empty stomach). Rare: inflammation and (or) ulceration (aphthae) of the oral mucosa, glossitis. Very rare: angioedema of the intestine. Liver and biliary tract disorders: Rare: liver failure, hepatitis, decreased or delayed bile secretion (symptoms are yellowness of the skin of the sclera. Skin and subcutaneous tissue disorders: Often: rash, hypersensitivity reactions / angioedema: swelling of the face, extremities, lips, tongue, glottis and (or) larynx Uncommon: increased sweating, itching, urticaria, hair loss Rare: hypersensitivity reactions (skin itching, sudden reddening of the face, skin blisters, desquamation of the skin) A complex of side effects has also been described , which may include some or all of the following: fever, phlebitis, muscle pain, myositis and arthritis, blood abnormalities found on examination, rash, photosensitivity, and other skin symptoms. ways: Infrequently: impaired renal function or renal failure (a symptom may be pain in the lumbar and decrease in urine volume), the presence of protein in the urine. Rarely: oliguria (significant decrease in urine volume). Genital and breast disorders: Uncommon: impotence. Rarely: breast enlargement in men. General disorders and disorders at the injection site: Very often: weakness. Often: feeling tired. Infrequently: muscle spasms, flushing of the face, tinnitus, feeling unwell, fever. Influence on the results of laboratory and instrumental studies: Often: an increase in the level of potassium, an increase in the concentration of creatinine. Uncommon: increased urea levels, increased sodium levels. Rarely: increased activity of liver enzymes, increased concentration of bilirubin. In case of aggravation of any side effect or the appearance of side effects not mentioned in the instructions, you should contact your doctor or pharmacist. Storage conditions Keep out of the reach of children. Store in a place protected from moisture and light at a temperature not exceeding 25°C. Medicines must not be flushed down the drain or thrown into the wastebasket. It is necessary to ask the pharmacist what to do with unused medicines. This is important for environmental protection. Shelf life Shelf life: 3 years Do not use the medicinal product after the expiration date indicated on the package. Expiration date means the last day of the specified month. Holiday conditions It is dispensed by prescription. Packing Enarenal is packed in Al/OPA/Al/PVC foil blisters of 20 tablets (2 blisters of 10 tablets), which are placed together with instructions for use in a cardboard box. application for Enarenal tablets 5mg №10x2