Active substanceFosinoprilFosinopril
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  • Dosage form: & nbspPills.
    Composition:

    For one tablet:

    Dosage of 5.0 mg

    Active substance: fosinopril sodium - 5.0 mg.

    Excipients: lactose 64.5 mg, microcrystalline cellulose 20.0 mg, croscarmellose sodium 5.0 mg, povidone-K25 2.5 mg, silicon dioxide colloid 1.0 mg, sodium stearyl fumarate 2.0 mg.

    Dosage of 10.0 mg

    Active substance: fosinopril sodium - 10.0 mg.

    Excipients: lactose 129.0 mg, microcrystalline cellulose 40.0 mg, croscarmellose sodium 10.0 mg, povidone-K25 5.0 mg, silicon dioxide colloidal - 2,0 mg, sodium stearyl fumarate 4.0 mg.

    Dosage of 20.0 mg

    Active substance: fosinopril sodium - 20.0 mg.

    Excipients: lactose - 119.0 mg, microcrystalline cellulose 40.0 mg, croscarmellose sodium 10.0 mg, povidone-K25 5.0 mg, silicon dioxide colloidal - 2,0 mg, sodium stearyl fumarate 4.0 mg.

    Description:

    Dosages of 5 and 10 mg: round, flat-cylindrical tablets of white or almost white color, with bevels on both sides and with a risk on one side.

    Dosage of 20 mg: round, flat-cylindrical tablets of white or almost white color, with bevels on both sides and with a cross-shaped risk on one side.

    Pharmacotherapeutic group:ACE inhibitor
    ATX: & nbsp

    C.09.A.A   ACE Inhibitors

    C.09.A.A.09   Fosinopril

    Pharmacodynamics:

    Fosinopril sodium chemically is the sodium salt of the ester of the pharmacologically active compound fosinoprilata. Getting into the body fosinopril undergoes enzymatic hydrolysis and is converted into fosinoprilat. Fosinoprilat, due to the presence of the phosphinate group, is a specific competitive ACE inhibitor. Due to inhibition of ACE, fosinoprilat inhibits the conversion of angiotensin I into angiotensin II, which has a vasoconstrictive effect. Inhibition of ACE leads to a decrease in the concentration of angiotensin II in the blood plasma, which causes a decrease in its vasopressor activity and a decrease in the secretion of aldosterone.A decrease in the secretion of aldosterone can lead to an insignificant increase in the content of potassium ions in the blood serum (an average of 0.1 meq / L) and a decrease in the content of sodium ions and the volume of the liquid.

    Fosinoprilat slows the metabolism of bradykinin, which has a powerful vasodilating effect, due to this, its antihypertensive effect is enhanced. Reduction of blood pressure (BP) is not accompanied by a change in the volume of circulating blood (BCC), cerebral and renal blood flow, blood supply of internal organs, skeletal muscles, skin, reflex activity of the myocardium. After ingestion, the antihypertensive effect develops within 1 hour, reaches a maximum after 2-6 hours, and lasts for 24 hours. The antihypertensive effect of the drug is manifested to the same extent in the patient's position "standing" and "lying". Orthostatic hypotension and tachycardia are sometimes noted in patients with hypovolemia or who are on a salt-free diet. To achieve maximum therapeutic effect, it may take several weeks.

    The effectiveness of antihypertensive action does not depend on age, sex and body weight.

    The drug does not have the syndrome of "cancellation" even with a sharp cessation of treatment.

    In chronic heart failure (CHF), the positive effect of the drug is achieved, mainly due to inhibition of the renin-angiotensin-aldosterone system (RAAS). Suppression of ACE leads to a decrease in both preload and postload on the myocardium. The drug contributes to increased tolerance to physical activity, reducing the severity of CHF.

    Pharmacokinetics:

    After oral administration, the absorption is approximately 30-40%. The degree of absorption does not depend on the time of ingestion, but its speed can be slowed down by taking the drug in food intake time.

    The hydrolytic conversion of fosinopril under the action of enzymes to fosinoprilat occurs predominantly in the liver and mucosa of the gastrointestinal tract. If the liver function is impaired, the rate of hydrolysis can be slowed down, and the degree of transformation does not change noticeably. The maximum concentration in the blood plasma is reached approximately 3 hours after ingestion and does not depend on the dose taken. Fosinoprilat binds to blood proteins by 95%, has a relatively small volume of distribution and is slightly associated with cellular components of the blood.

    Fosinoprilat is excreted from the body equally with bile through the intestines and kidneys.

    In patients with arterial hypertension with normal renal and hepatic function, the half-life (T1/2) fosinoprilata is approximately 11.5 hours. In patients with CHF, the value of T1/2 is 14 hours. The clearance of fosinoprilat for hemodialysis and peritoneal dialysis is on average 2% and 7%, respectively, relative to the values ​​of urea clearance.

    In patients with renal insufficiency (glomerular filtration rate less than 80 ml / min / 1.73 m2), the total clearance of fosinoprilat is approximately half that of patients with normal renal function. At the same time, absorption, bioavailability and association with proteins do not change noticeably. Reduced excretion by the kidneys is compensated by increased excretion through the intestine with bile. A moderate increase in the area under the pharmacokinetic curve "concentration-time" (AUC) in blood plasma (less than twice as compared with the norm) is observed in patients with renal insufficiency of various degrees, including renal failure in the terminal stage (glomerular filtration rate is less than 10 ml / min / 1.73 m2).

    In patients with hepatic insufficiency (with alcoholic or biliary cirrhosis), the rate of hydrolysis of fosinopril may be reduced, but the degree of hydrolysis does not change noticeably. The total clearance of fosinoprilata from the body of such patients is approximately half that in patients with normal liver function.

    Indications:

    - Arterial hypertension: monotherapy or in combination with other antihypertensive drugs (in particular, with thiazide diuretics);

    - chronic heart failure (as part of combination therapy).

    Contraindications:

    - Hypersensitivity to fosinopril or any other substance included in the preparation;

    - increased sensitivity to any other ACE inhibitor in history;

    - hereditary angioedema and idiopathic angioedema, in the history, including after taking other ACE inhibitors;

    - pregnancy;

    - the period of breastfeeding;

    - Congenital intolerance of galactose, deficiency of lactase, glucose-galactose malabsorption;

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

    - simultaneous application with aliskiren and aliskiren-containing drugs in patients with diabetes mellitus and / or renal dysfunction (glomerular filtration rate less than 60 ml / min / 1.73 m2).

    Carefully:

    Renal failure; hyponatremia (risk of dehydration, arterial hypotension, chronic renal failure); bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney; aortic stenosis; condition after kidney transplantation; when conducting desensitization procedures; systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma) - increased risk of developing neutropenia or agranulocytosis; cerebrovascular diseases (including cerebral circulatory insufficiency); cardiac ischemia; chronic heart failure (III-IV functional class by classification NYHA); diabetes; oppression of bone marrow hematopoiesis; hyperkalemia; use in elderly patients; gout, diet with restriction of table salt; conditions, accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting, previous treatment with diuretics); hemodialysis using high-permeability membranes (for example, AN®69), apheresis of low density lipoproteins.

    Pregnancy and lactation:

    Fosinopril is contraindicated in pregnancy. The use of ACE inhibitors in pregnancy can cause developmental disorders or fetal death. Fosinopril has a teratogenic, fetotoxic effect - impaired fetal kidney development, decreased fetal and neonatal blood pressure, hyperkalemia, hypoplasia of the skull bones, oligohydramnion, limb contracture, lung hypoplasia.

    If the pregnancy is diagnosed against the background of drug treatment, it should be stopped as soon as possible, the patient should be informed of the potential harm of treatment for fetal development and a thorough ultrasound examination for fetal pathology and, if possible, switch to alternative treatment with a known safety profile during pregnancy.

    In newborns, whose mothers took ACE inhibitors during pregnancy, there were arterial hypotension, oliguria, hyperkalemia.

    If a newborn is marked with oliguria, efforts should be made to control blood pressure and support renal perfusion.Exchange blood transfusion or dialysis may be necessary to restore blood pressure and replace impaired renal function. Fosinopril is slowly excreted from circulating blood in adults during hemodialysis and peritoneal dialysis. Experience in removing fosinopril from circulating blood in newborns is not present.

    Because the fosinopril is found in breast milk, if necessary, during the lactation period, breastfeeding should be discontinued.

    Dosing and Administration:

    Inside. The dose of the drug should be selected individually. To divide the pills in half, a tablet is put at risk.

    Arterial hypertension

    The recommended initial dose of the drug is 10 mg once a day. The dose should be selected depending on the dynamics of lowering blood pressure. The usual dose is 10 to 40 mg once a day. In the absence of a sufficient antihypertensive effect, additional prescription of diuretics is possible.

    If treatment with the drug is initiated against the background of ongoing therapy with diuretics, then its initial dose should be no more than 10 mg with regular medical monitoring of the patient's condition.

    The maximum daily dose is 40 mg.

    Chronic heart failure

    The recommended initial dose of the drug is 5 mg 1 or 2 times a day. Treatment begins under compulsory medical supervision. If the initial dose is well tolerated, it can be gradually increased at weekly intervals up to 40 mg once a day (maximum daily dose).

    Application in renal / hepatic insufficiency

    The recommended initial dose is 10 mg.

    Since the removal of the drug from the body occurs in two ways, correction of doses to patients with renal / hepatic insufficiency is usually not required.

    Elderly patients

    Differences in efficacy and safety of treatment with the drug of patients aged 65 years and older and younger patients are not observed, so dose adjustment for elderly patients is usually not required. However, it is impossible to exclude a greater susceptibility in some elderly patients to fosinopril, due to possible overdose phenomena due to delayed excretion of fosinoprilat.

    Side effects:

    The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%,but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely (including individual messages) - less than 0.01%, the frequency is unknown (the frequency can not be estimated from available data).

    From the hemopoietic system and lymphatic system: infrequently - transient reduction of hemoglobin or hematocrit; rarely - eosinophilia, leukopenia, thrombocytopenia, neutropenia, lymphadenopathy, transient anemia; very rarely - agranulocytosis.

    From the side of metabolism: infrequent - a decrease in appetite, exacerbation of gout, hyperkalemia.

    From the central nervous system: often - dizziness, headache, mood lability, sleep disturbance and paresthesia; infrequently - depression, drowsiness, hemorrhagic stroke, cerebral ischemia, tremor, sleep disturbance, taste disorders, confusion; rarely - speech disturbance, memory impairment, disorientation, anxiety; unknown frequency - inadequate behavior, imbalance.

    From the side of the organ of vision: infrequently - a violation of the organ of vision.

    From the side of the hearing and vestibular organs: infrequently - noise in the ears, pain in the ears, vertigo.

    From the cardiovascular system: often - tachycardia, marked decrease in blood pressure, orthostatic hypotension, arrhythmia, angina pectoris; infrequently - myocardial infarction, palpitation, cardiac arrest, arrhythmia, increased blood pressure, peripheral edema, shock, transient ischemia; rarely - "tides" of blood to the skin of the face, hemorrhage, violation of peripheral circulation; unknown frequency - hypertensive crisis.

    From the respiratory system: often - dry cough; infrequently - shortness of breath, rhinitis, pharyngitis, tracheobronchitis, sinusitis; rarely - bronchospasm, pneumonia, pulmonary infiltrates, nosebleeds, dyspnea, laryngitis; unknown frequency - dysphonia pain in the area thorax.

    Infectious and parasitic diseases: often - infeccandand veRbreathlessatpathways, viral infection.

    From the digestive system: often - nausea, vomiting, diarrhea, abdominal pain; infrequently - constipation, dryness of the oral mucosa, flatulence, decreased appetite; rarely - stomatitis, pancreatitis, dysphagia; very rarely - angioedema, intestinal obstruction, impaired taste.

    From the liver and biliary tract: rarely - hepatitis; very rarely liver failure.

    From the skin and subcutaneous tissues: often - skin rash, angioedema, dermatitis; infrequently - increased sweating, itching, hives; rarely - hemorrhages in the skin (ecchymosis), exfoliative dermatitis.

    A symptom complex including fever, vasculitis, muscle pain, joints or arthritis, an increase in the titer of antinuclear antibodies, increased erythrocyte sedimentation rate, eosinophilia and leukocytosis, skin rash, photosensitivity and other skin manifestations has been described.

    From the musculoskeletal system: infrequently - myalgia; rarely - arthralgia, arthritis, convulsions; unknown frequency - muscle weakness.

    From the side of the urinary system: often - violation of urination; infrequently - proteinuria, development or aggravation of symptoms of chronic renal failure, violations of the prostate gland; rarely acute interstitial nephritis; very rarely acute renal failure.

    On the part of the reproductive system: often - sexual dysfunction; rarely - a violation of the prostate gland.

    Other: often - general weakness, pain of unspecified localization; infrequently - fever, sudden death, weight gain.

    From the laboratory indicators: often - increased activity of "liver" transaminases, lactate dehydrogenase and alkaline phosphatase, hyperbilirubinemia; infrequently - hypercreatininaemia, increased urea concentration, hyperkalemia; rarely - hyponatremia, a slight increase in hemoglobin, a decrease in hematocrit, and hyponatremia. Fosinopril can reduce the results of serum digoxin concentration.

    With simultaneous use of ACE inhibitors and preparations of gold (sodium aurotomy malate, intravenously), a symptom complex is described, which includes facial flushing, nausea, vomiting, and lowering blood pressure.

    Overdose:

    Symptoms: marked decrease in blood pressure, shock, stupor, bradycardia; Mr.arushaenande in one-elektrolitnogo balance, renal failure, temporary hyperventilation, tachycardia, palpitations, dizziness, anxiety and cough.

    Treatment: the patient should be placed in the intensive care unit, with careful monitoring of the content of electrolytes and creatinine.To reduce the absorption of the drug, it is necessary to wash the stomach, administer adsorbents and sodium sulfate within 30 minutes after taking fosinopril. In the case of a marked decrease in blood pressure, put the patient, raise the legs and make intravenous (iv) 0.9% solution of sodium chloride, iv injection of catecholamines. With severe bradycardia - the introduction of atropine, in some cases it may be necessary to use an artificial pacemaker. Fosinoprilat is not excreted during dialysis or peritoneal dialysis.

    Interaction:

    The simultaneous use of antacids (for example, aluminum or magnesium hydroxide, also the carminative Simethicone can reduce the absorption of fosinopril.Therefore, it is necessary to apply these drugs with an interval of at least 2 hours.

    With simultaneous use of ACE inhibitors with lithium salts, the content of lithium in the blood serum and the risk of lithium intoxication may increase, so simultaneously apply fosinopril and lithium preparations should be taken with caution. A careful monitoring of the lithium content in serum is recommended.

    It is known that a non-steroidal anti-inflammatory drug (NSAID) indomethacin can reduce the antihypertensive effect of ACE inhibitors, especially in patients with arterial hypertension and low renin activity in blood plasma. A similar effect may have other NSAIDs, for example, acetylsalicylic acid in a dose of 3 or more grams per day, and selective inhibitors of cyclooxygenase-2 (COX-2). In patients over 65 years of age, with hypovolemia (including diuretic treatment), renal dysfunction, simultaneous administration of NSAIDs, including selective inhibitors of COX-2 and ACE inhibitors (including fosinopril), can lead to impaired renal function, up to to acute renal failure.

    Usually this state is reversible. Kidney function should be closely monitored in patients taking fosinopril and NSAIDs.

    With the simultaneous use of fosinopril with diuretics, especially at the beginning of diuretic therapy, and also in combination with a strict diet limiting intake of table salt, or with dialysis, a marked decrease in blood pressure may develop, especially in the first hour after taking the initial dose of the drug.

    Preparations of potassium-sparing diuretics (amiloride, spironolactone, triamterene, spironolactone) increase the risk of hyperkalemia. In patients with heart failure; fromaharnam diabetom, simultaneously taking potassium-sparing diuretics, potassium, potassium-containing cleavers or other agents that cause hyperkalemia (eg, heparin), ACE inhibitors increase the risk of increasing serum potassium. The risk of hyperkalemia increases with simultaneous use with drugs containing trimethoprim.

    Patients taking enzyme inhibitors mTOR (eg, tessirolimus, sirolimus, everolimus) simultaneously with ACE inhibitors may be more likely to develop angioedema.

    Fosinopril enhances the hypoglycemic effect of sulfonylurea derivatives, insulin, the risk of developing leukopenia with simultaneous use with allopurinol, cytostatic agents, immunosuppressants, procainamide.

    Estrogens weaken the antihypertensive effect of fosinopril due to its ability to retain fluid.

    Hypotensive drugs, narcotic analgesics, medicines for general anesthesia increase the antihypertensive effect of fosinopril.Bioavailability of the drug with simultaneous use with chlorthalidone, nifedipine, propranolol, hydrochlorothiazide, cimetidine, metoclopramide, propanthelin bromide, digoxin and warfarin does not change.

    Simultaneous use of ACE inhibitors with aliskiren is contraindicated in patients with diabetes mellitus and moderate and severe renal dysfunction (glomerular filtration rate less than 60 ml / min / 1.73 m2).

    In the literature it was reported that in patients with diagnosed atherosclerotic disease, heart failure or diabetes with target organ damage, a double blockade of RAAS with the use of angiotensin II receptor antagonists ARAII), ACE inhibitors or aliskiren (direct renin inhibitor) is associated with an increased incidence of arterial hypotension, syncope, hyperkalemia and renal dysfunction (including acute renal failure) when compared with the use of a single drug that affects RAAS. Double blockade (eg, the appointment of an ACE inhibitor with an APAII or aliskiren) should be performed only in certain specific situations, regularly monitoring the kidney function.

    Special instructions:

    Before the beginning of treatment it is required to conduct an analysis of the previously conducted antihypertensive therapy, the degree of increase in blood pressure, limitations ration on cookery salt and / or fluid and other clinical circumstances. If possible should stop the previous antihypertensive therapy a few days before the start treatment with fosinopril.

    Patients with malignant hypertension or concomitant decompensation of chronic heart failure should begin treatment in a hospital.

    To reduce the likelihood of arterial hypotension, diuretics should be discontinued 2-3 days before the start of treatment with the drug Fosinopril.

    Prior to treatment and during therapy, it is necessary to monitor blood pressure, kidney function, creatinine, urea, control the content of electrolytes, especially potassium and the activity of "liver" enzymes in the blood.

    Angioedema. The development of angioedema of the extremities, face, lips, mucous membranes, tongue, throat or larynx in patients with fosinopril has been reported.When swelling of the tongue, throat or larynx, airway obstruction may develop with possible fatal outcome. In such cases, it is necessary to stop taking the drug and carry out emergency measures, including subcutaneous injection of epinephrine (adrenaline) solution (1: 1000), as well as taking other measures of emergency therapy. In most cases, edema of the face, oral mucosa, lips and extremities discontinuation of the drug led to the normalization of the condition; However, sometimes an appropriate therapy was required.

    Edema of the intestinal mucosa. During the administration of ACE inhibitors, edema of the intestinal mucosa was rarely observed. Patients complained of abdominal pain (with nausea and vomiting may not be), in some cases, the edema of the intestinal mucosa appeared without edema of the face, the activity of C1-esterase was normal. Symptoms disappeared after the cessation of the use of ACE inhibitors. Swelling of the intestinal mucosa should be included in the differential diagnosis of patients taking ACE inhibitors who complain of abdominal pain.

    Anaphylactic reactions during dialysis using high permeability membranes. Anaphylactic reactions can develop in patients taking ACE inhibitors during hemodialysis with high permeability membranes (for example, AN®69), as well as during apheresis of low-density lipoproteins with adsorption to dextran sulfate. In these cases, the use of dialysis membranes of a different type or the use of antihypertensive drugs of another class should be considered.

    Anaphylactic reactions during desensitization. In two patients, during the desensitization of Hepaticoptera with the use of an ACE inhibitor enalapril, life-threatening anaphylactoid reaction. Those the same patients were able to avoid these reactions with the timely suspension of the ACE inhibitor; but they appeared again after the involuntary resumption of the ACE inhibitor. Special care should be exercised in carrying out desensitization in patients taking ACE inhibitors.

    Neutropenia / agranulocytosis. Perhaps the development of agranulocytosis and suppression of bone marrow function during treatment with ACE inhibitors.These cases are more common in patients with impaired renal function, especially in the presence of systemic connective tissue diseases (systemic lupus erythematosus or scleroderma). Before the beginning of therapy with ACE inhibitors and during the treatment, the leukocytes and leukocyte formula are determined (once a month, during the first 3-6 months of treatment and in the first year of use in patients with an increased risk of neutropenia).

    Arterial hypotension. Patients with uncomplicated form of hypertension may develop arterial hypotension due to the use of Fosinopril.

    Symptomatic arterial hypotension with the use of ACE inhibitors often develops in patients on the background of intensive treatment with diuretics, a diet associated with restriction of table salt, or during dialysis. Transient arterial hypotension is not a contraindication for the use of the drug after taking measures to restore the volume of circulating blood.

    In patients with chronic heart failure, treatment with ACE inhibitors can cause an excessive antihypertensive effect, which can lead to oliguria or azotemia and, in rare cases, to acute renal failure with a fatal outcome.Therefore, in the treatment of chronic heart failure, fosinopril should carefully monitor patients, especially during the first 2 weeks of treatment, as well as with any increase in the dose of fosinopril or diuretic.

    It may be necessary to reduce the dose of a diuretic in patients with normal or low blood pressure who were previously treated with diuretics or who have hyponatraemia. Arterial hypotension as such is not a contraindication for the further use of the drug in chronic heart failure.

    Some reduction in systemic BP is a common and desirable effect at the beginning of the drug in chronic heart failure. The degree of this decrease is maximal at early stages of treatment and stabilizes within one or two weeks from the start of treatment. BP usually returns to baseline without reducing therapeutic effectiveness.

    Violation of the function of the liver. In rare cases with the use of ACE inhibitors there is a syndrome, the first manifestation of which is cholestatic jaundice. Then follows the fulminant necrosis of the liver, sometimes with a fatal outcome.The mechanism of development of this syndrome has not been studied. When there is a noticeable icterus and a marked increase in the activity of liver enzymes, treatment with fosinopril should be discontinued and appropriate treatment prescribed.

    In patients with impaired liver function, there may be an increased concentration of fosinopril in the blood plasma. With liver cirrhosis (including alcoholic), the apparent overall clearance of fosinoprilat is reduced, and the area under the curve AUC approximately 2 times higher than in patients without violations of liver function.

    Impaired renal function. In patients with arterial hypertension with unilateral or bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney during treatment with ACE inhibitors, the concentration of blood urea nitrogen and serum creatinine may increase. These effects are usually reversible and pass after discontinuation of treatment. It is necessary to monitor kidney function in such patients in the first weeks of treatment. In some patients, an increase in the concentration of blood urea nitrogen and blood serum creatinine (usually small and transient) can be observed even without an obvious impairment of kidney function with simultaneous use of the drug and diuretics.You may need to reduce the dose of Fosinopril.

    In patients with severe chronic heart failure, kidney function may depend on the activity of RAAS, so treatment with ACE inhibitors may be accompanied by oliguria and / or progressive azotemia, and in rare cases lead to acute renal failure and death.

    Hyperkalemia. There have been cases of increased potassium levels in the blood serum of patients taking ACE inhibitors, including fosinopril. The risk group in this respect is patients with renal insufficiency, type 1 diabetes, and also taking potassium-sparing diuretics, potassium-containing dietary supplements, or other drugs that increase serum potassium (for example, heparin).

    Cough. With the use of ACE inhibitors, including fosinopril, there was an unproductive, persistent cough, which occurs after the abolition of therapy. When cough occurs in patients taking ACE inhibitors, this therapy should be considered as a possible cause in the context of a differential diagnosis

    Surgical interventions / general anesthesia. ACE inhibitors can enhance the antihypertensive effect of agents used for general anesthesia. Before surgery (including dentistry), a physician / anesthesiologist should be warned about the use of ACE inhibitors.

    Caution should be exercised when exercising or in hot weather due to the risk of dehydration and arterial hypotension and reduce volume of the circulating fluid.

    Based on the results of epidemiological studies, it is assumed that the simultaneous administration of ACE inhibitors and insulin, as well as hypoglycemic agents for oral administration may lead to the development of hypoglycemia. The greatest risk of development is observed during the first weeks of combination therapy, as well as in patients with impaired renal function. Patients with diabetes require careful monitoring of glycemia, especially during the first month of therapy with an ACE inhibitor.

    Effect on the ability to drive transp. cf. and fur:

    Care must be taken when driving vehicles and performing potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions (risk of dizziness).

    Form release / dosage:

    Tablets, 5.0 mg, 10.0 mg and 20.0 mg.

    Packaging:

    By 10, 14, 25 or 50 tablets in a contour cell pack of film polyvinylchloride and aluminum foil printed lacquered.

    10, 20, 30, 40, 50 or 100 tablets in cans of polyethylene terephthalate for medicinal products sealed with caps screwed with a first opening control or a "push-turn" system made of polypropylene or polyethylene, or cans of polypropylene for medicinal products sealed with lids with the control of the first opening from polyethylene, or polypropylene cans for medicines, sealed with caps tightened with the control of the first opening of high pressure polyethylene.

    One jar or 1, 2, 3 or 10 contour squares, together with the instruction for use, are placed in a cardboard package (bundle).

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003603
    Date of registration:04.05.2016
    Expiration Date:04.05.2021
    The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspOZONE LLC OZONE LLC Russia
    Information update date: & nbsp10.07.2016
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