EDARBYCLOR® (azilsartan medoxomil/chlorthalidone) 40 mg/12.5 mg 28 tablets

The instruction for medical use of Edarbi® medicine of Klo the Trade name of Edarbi® of Klo Mezhdunarodnoye the unlicensed name Is not present the Dosage form of the Tablet, film coated 40 mg / 12.5 mg and 40 mg / 25 mg Structure 1 tablet of 40 mg / 12.5 mg contains active agents: an azilsartana of a medoksomil of potassium of 42.68 mg (it is equivalent an azilsartana of a medoksomil of free acid of 40.0 mg) Chlortalidonum of 12.5 mg excipients: Mannitolum, cellulose microcrystalline, fumaric acid, sodium hydroxide, hydroxypropyl cellulose, krospovidon, magnesium stearate Film cover: the gipromelloza 2910, the titan dioxide (E 171), talc, polyethyleneglycol 8000, ferrous oxide red (E 172), blackened gray F1 the mg cleaned * 1 tablet of 40 mg / 25 contains active agents: an azilsartana of a medoksomil of potassium of 42.68 mg (it is equivalent an azilsartana of a medoksomil of free acid of 40.0 mg) Chlortalidonum of 25 mg excipients: Mannitolum, cellulose microcrystalline, fumaric acid, sodium hydroxide, hydroxypropyl cellulose, krospovidon, magnesium stearate Film cover: the gipromelloza 2910, the titan dioxide (E 171), talc, polyethyleneglycol 8000, ferrous oxide red (E 172), blackened the gray F1 cleaned * * Composition of ink of the gray F1 cleaned for marking: shellac – 26%, ferrous oxide black – 10%, butanol – 38%, ethanol – 26%. The description Round biconvex tablets, film coated light pink color, with the inscription A/S and 40/12.5 on one party of a tablet (for a dosage of 40 mg / 12.5 mg). Round biconvex tablets, film coated se-rovato-pink color, with the inscription A/S and 40/25 on one party of a tablet (for a dosage of 40 mg / 25 mg). Pharmacotherapeutic group the Drugs influencing renin-angiotenzinovuyu a system. Angiotensin II antagonists in a combination with other drugs. Angiotensin II antagonists in a combination with diuretics. Azilsartana medoksimit also diuretics. The ATX C09DA09 code the Pharmacological Pharmacokinetics Absorption Later properties of reception Edarbi® of Klo inside, peak concentration of an azilsartan and Chlortalidonum in plasma are reached in 3 and 1 h respectively. Speed (Cmax and Tmax) and extent of absorption (AUC) of an azilsartan are similar at its reception together with Chlortalidonum and without it. AUC Chlortalidonum it is similar at its reception together with an azilsartan medical oxolovely and without it, however Chlortalidonum Cmax, in case of its reception together with an azilsartan medical oxolovely, was 45-47% higher. Elimination half-life (T1/2) of an azilsartan and Chlortalidonum makes about 12 and 45 hours respectively. Meal does not affect bioavailability of Edarbi® of Klo. Azilsartana medoksomit After oral administration of an azilsartan medoksomit is exposed to fast hydrolysis to an azilsartan, an active metabolite, in digestive tract during absorption. Azilsartana medoksomit it is not found in plasma after oral administration. The estimated absolute bioavailability of an azilsartan after reception of an azilsartan of a medoksomil is about 60%. After oral administration of an azilsartan of a medoksomil of Cmax of an azilsartan in plasma it is reached within 1.5-3 hours. Meal does not affect bioavailability of an azilsartan. Chlortalidonum the Approximate bioavailability of Chlortalidonum in 8 - 12 hours after reception is about 64%. In the conditions of reception of repeated daily doses of 50 mg the average equilibrium concentration of 7.2 mkg/ml (21.2 µmol/l) which was defined upon termination of a 24-hour interval between doses was reached in 1 - 2 weeks. Azilsartan's distribution was medoksomit by the Volume of distribution of an azilsartan is about 16 liters. Azilsartan strongly contacts proteins of plasma (& gt, 99%) mainly albumine. Binding of an azilsartan becomes constant if plasma concentration of an azilsartan are much higher than those which are reached after use recommended the dosed Chlortalidonum In whole blood Chlortalidonum contacts mainly karboangidrazy erythrocytes. In plasma about 75% of Chlortalidonum it is connected with proteins of plasma, mainly with albumine. Chlortalidonum gets through a placental barrier and gets to breast milk. Metabolism and Azilsartan's elimination medoksomit Azilsartan is metabolized to two main metabolites. The main metabolite in plasma is formed by O-dealkylation and is called a metabolite of M-II, other metabolite of M-I is formed in smaller concentration by decarboxylation. Systemic action of both metabolites in a human body makes about 50% and less than 1% respectively. M-I and M-II do not participate in pharmacological activity of an azilsartan of a medoksomil. The main enzyme which is responsible for metabolism of an azilsartan is CYP2C9. After an oral dose of a 14C-marked azilsartan of a medoksomil, about 55% of radioactive material were revealed to Calais and about 42% in urine, at the same time 15% of a dose were removed with urine in the form of an azilsartan. Elimination half-life of an azilsartan makes about 11 hours, and the renal clearance is about 2.3 ml/min. Stationary levels of an azilsartan are reached within 5 days, at the same time accumulation in plasma at repeated single daily introduction does not happen. Chlortalidonum the Minor way of removal of Chlortalidonum is metabolism and hepatic removal in bile. Within 120 hours about 70% of a dose are excreted in urine and kcal, mainly in not changed form. Chlortalidonum is removed from whole blood and plasma with the elimination half-life averaging 50 hours. In the conditions of long reception the elimination half-life does not change. The main part from the soaked-up dose of Chlortalidonum is removed by kidneys with average clearance of 60 ml/min. The pharmacodynamics of Edarbi® of Klo represents a combination from two antihypertensive drugs with complementary mechanisms of control of arterial blood pressure: medoksomit pro-medicine of an azilsartan, the antagonist of a receptor of angiotensin II of type 1 (AT1), and tiazidovy diuretic, Chlortalidonum. Azilsartan was medoksomit by Azilsartana medoksomit is pro-medicine for oral administration which is quickly converted by esterases in digestive tract and/or during absorption into active ingredient, azilsartan which is a selection antagonist of angiotensin II, blocking its linking with AT1 receptor in a set of fabrics. Angiotensin II is the main angiotonic component system renin-angiotensin-aldosteronovoy which effects are vasoconstriction, stimulation of synthesis and discharge of Aldosteronum, stimulation of warm activity and a renal reabsorption of sodium. Blockade of a receptor of AT1 inhibits negative feedback between angiotensin II and secretion of renin, but causes increase in activity of renin of plasma, and the circulating levels of angiotensin II are not capable to overcome antihypertensive effect of an azilsartan. Chlortalidonum Chlortalidonum causes a diuresis with the increased removal of sodium and chloride. A point of its application is an initial part of a wavy uric tubule of nephron. The diuretic effect of Chlortalidonum is caused by sodium reabsorption inhibition owing to what there is Na+Cl-reabsorption inhibition owing to antagonism with kotransportyory Na+Cl in this point that leads to strengthening of removal of sodium and water. Indications − Treatment of hypertensia at adults. Эдарби® Klo is the fixed combination of doses intended for treatment of adult patients, the level of arterial blood pressure at whom is inadequately controlled by monotherapy of an azilsartan medical oxolovely. A route of administration and doses the Recommended initial dose of the drug Edarbi® Klo makes 40/12.5 mg orally once a day. The antihypertensive effect, usually close to maximum, is reached within 1 - 2 weeks of reception, and the maximum effect is reached by 4th week. If necessary the dose can be raised to a maximum 40 mg / 25 by mg once a day. The drug Edarbi® of Klo is taken irrespective of meal once a day. Before an initiation of treatment the drug Edarbi® of Klo it is necessary to carry out correction of reduced volume of liquid, especially at patients with impaired renal function or at the patients receiving diuretics in high doses. Special groups of patients Elderly patients drug Edarbi® Dose adjustment of Klo is not required from patients of advanced age, the care and careful medical observation are recommended when using at very elderly patients (≥ 75 years), at whom the Children's age can be increased risk of development of the undesirable phenomena, Safety and efficiency of the drug Edarbi® Klo at patients aged up to 18 years is not established. Patients with a renal failure Chlortalidonum, a drug Edarbi® component Klo, it is impossible to use at patients with a heavy renal failure (SKF & lt, 30 ml/min. / 1.73 sq.m) and an anury. Experience of use of the drug Edarbi® Klo for the patients who recently transferred transplantation of a kidney no. Patients with poorly / a moderate renal failure (SKF ≥30 - & lt, 90 ml/min. / 1.73 sq.m) do not need dose adjustment. Patients with an abnormal liver function the Dose adjustment with abnormal liver functions of easy or moderate degree is not required from patients. Chlortalidonum, a drug Edarbi® component Klo, it is impossible to use at patients with a heavy liver failure. At patients with disturbance of hepatic function of a tiazida it is necessary to use with care. Minor changes of water and electrolytic balance owing to use of tiazidovy diuretics can provoke development of a hepatic coma. Careful monitoring is recommended. Reduction of volume of the circulating liquid At patients with reduction of volume of the circulating liquid or salts (for example, at patients with vomiting, diarrhea or at the patients receiving high doses of diuretics) use of the drug Edarbi® Klo should be begun under careful medical observation, only after correction of volume. Passing hypotensive reaction owing to reduction of volume of the circulating liquid does not interfere with continuation of treatment which can usually be continued without difficulties after stabilization of arterial blood pressure and volume of the circulating liquid. At patients with reduction of volume of the circulating blood and/or salts with arterial hypertension the hypotension can develop. Heart failure At patients it is necessary to be careful with arterial hypertension and stagnant heart failure as there is no experience of use of the drug Edarbi® Klo for these patients. Side effects On occurrence frequency undesirable reactions are distributed as follows: very often (≥ 1/10), it is frequent (from ≥ 1/100 to & lt, 1/10), infrequently (from ≥1/1000 to & lt, 1/100), is rare (from ≥1/10000 to & lt, 1/1000), is very rare (& lt, 1/10000), including separate messages. In each group of frequency of occurrence the undesirable reactions are provided as reduction of their gravity. Class of systems of bodies Frequency Undesirable reaction of Narusheniya from blood and lymphatic system Infrequently Narusheniya's Anemia from a metabolism and food the Increase in level of uric acid in blood, a hyperuricemia Infrequently the Hypopotassemia, increase in level of potassium of blood, a hyponatremia, decrease in level of sodium in blood is frequent, Narusheniya's gout from nervous system the Dizziness, postural dizziness Infrequently Syncopal state, Narusheniya's paresthesia is frequent from vessels Often Narusheniya's Hypotension from digestive tract Often Diarrhea, nausea Infrequently Narusheniya's Vomiting from skin and hypodermic fabrics Infrequently Rash, naggers Narusheniya from skeletal and muscular and connective tissue Often Muscular spasms the General disorders and disturbances in the injection site Often Fatigue Laboratory and tool data Very often Increased blood creatinine level Often Infrequently Increase in level of urea of blood Increase in level of glucose of blood Additional information on separate components during the Edarbi® drug treatment of Klo can develop the undesirable reactions observed during use of each of components separately, but which are not noted in clinical trials. Azilsartana medoksomit Besides the undesirable reactions noted above when using drug Edarbi® of Klo, when using an azilsartan of a medoksomil was reported about the following undesirable reactions: about peripheral hypostases, migraine and the increased level of a kreatinfosfokinaza of blood it was reported as about infrequent undesirable reactions In clinical trials it was seldom reported about cases of a renal failure. The serious Quincke's edema can seldom develop (from ≥ 1/10000 to & lt, 1/1000). Chlortalidonum Besides the undesirable reactions noted above when using drug Edarbi® of Klo when using Chlortalidonum it was reported about the following undesirable reactions: A class of systems of bodies Frequency Undesirable reaction of Narusheniya from blood and lymphatic system Seldom Thrombocytopenia, a leukopenia, an agranulocytosis, Narusheniya's eosinophilia from a metabolism and food Very often Growth of level of lipids of blood Often the Hypomagnesiemia Seldom the Hypercalcemia, a glucosuria, aggravation of symptoms of metabolism in diabetes Very seldom Gipokhloremichesky alkalosis of Narusheniya from nervous system Seldom the Headache of Narusheniya from heart Often Postural hypotension Seldom of Narusheniya of a warm rhythm of Narusheniya from the respiratory system, bodies of a thorax and mediastinum Seldom Allergic fluid lungs of Narusheniya from digestive tract Often Loss of appetite, small gastrointestinal disorder it is rare Very much seldom the Constipation, a stomach ache Narusheniya's Pancreatitis from a liver and biliary tract Seldom Intra hepatic cholestasia or Narusheniya's jaundice from skin and hypodermic fabrics Often the Small tortoiseshell Seldom of Fotosensibilization, the skin vasculitis of Narusheniya from kidneys and urinary tract Seldom Allergic interstitial nephrite of Narusheniya from genitals and a mammary gland Often Impotence Laboratory and tool data serum Creatinine Increase in level of creatinine of blood is the known pharmacological effect of blockers of RAAS, such as SCONCE and APF inhibitors, and is connected with severity of a lowering of arterial pressure. The Edarbi® drug treatment of Klo increased the frequency of occurrence of cases of increase in creatinine of blood in comparison with that when using an azilsartan of a medoksomil and Chlortalidonum. Increase was passing or not progressing and reversible, and was combined with the significant decrease in level of arterial blood pressure. Uric acid Use of the drug Edarbi® Klo was associated with increase in level of uric acid in serum that corresponds to the known pharmacological effects of diuretics. Increase in level of uric acid is depending on a dose, amplifying with increase in a dose of Chlortalidonum though from groups of treatment messages about cases of development of gout, even in long-term researches infrequently arrived. Hemoglobin and a hematocrit Use of the drug Edarbi® of Klo was associated with insignificant decrease in a hematocrit, levels of hemoglobin and insignificant reduction of quantity of erythrocytes that there corresponds to the known pharmacological effects of inhibitors system renin-angiotensin-aldosteronovoy. Experience of post-registration use When using the drug Edarbi® of Klo about cases of development of a Quincke's disease it was reported seldom. Post-registration spontaneous messages about other undesirable reactions it was revealed not. Contraindications - hypersensitivity to azilsartan or to any excipient - an anury - a refractory hyponatremia - a heavy liver failure - a heavy renal failure (SKF & lt, 30 ml/min. / 1.73 sq.m) - a hypercalcemia - a symptomatic hyperuricemia - simultaneous use with the drugs containing aliskiren is contraindicated to a medoksomil or Chlortalidonum at patients with diabetes or with a renal failure (SKF & lt, 60 ml/min. / 1.73 sq.m) - pregnancy and the period of a lactation - children's age up to 18 years medoksomit Medicinal interactions of Edarbi® of Klo Pharmakokinetik of an azilsartan and Chlortalidonum at joint reception does not change. Researches of interaction of the drug Edarbi® of Klo with other medicines were not conducted, however subjected to such researches an azilsartan medoksomit also Chlortalidonum. Azilsartana medoksomit no clinically significant medicinal interactions in researches
of an azilsartan of a medoksomil or azilsartan in combination with amlodipiny, antacids, Chlortalidonum, digoxin, flukonazoly, Glyburidum, ketokonazoly, metformin, pioglitazony and warfarin were observed. Non-steroidal anti-inflammatory drugs (NPVS), including selection inhibitors of cyclooxygenase-2 (TsOG-2 inhibitors) At patients of advanced age, patients with decrease in volume of liquid (including the patients receiving treatment by diuretics), or patients with impaired renal function, the accompanying introduction of NPVS, including selection TsOG-2 inhibitors, with antagonists of a receptor of angiotensin II, including azilsartan, can lead to deterioration in renal function, including, to a possible acute renal failure and increase in level of potassium of serum. Therefore in an initiation of treatment adequate compensation of volume of the circulating liquid and monitoring of renal function is recommended. The antihypertensive effect of the drug Edarbi® of Klo can be weakened under the influence of NPVS, including selection TsOG-2 inhibitors. Double blockade of Race double blockade of RAS blockers of receptors of angiotensin, APF inhibitors or aliskireny is connected with the increased risk of hypotension, a hyperpotassemia and change of function of kidneys (including an acute renal failure). Therefore double blockade of RAAS by the combined use of APF inhibitors, blockers of a receptor of angiotensin II or an aliskiren is not recommended It is necessary to provide careful monitoring of arterial blood pressure, function of kidneys and levels of electrolytes at the patients receiving the drug Edarbi® Klo and other agents influencing RAS. It is not necessary to appoint aliskiren together with the drug Edarbi® of Klo to patients with diabetes. Avoid use of an aliskiren with the drug Edarbi® of Klo at patients with a renal failure (SKF & lt, 60 ml/min.). Chlortalidonum Diuretics enhance effect of kurarepodobny drugs and antihypertensive drugs (for example, guanetidin, Methyldopum, beta-blockers, vazodilatator, antagonists of calcium, APF and SCONCE inhibitors). The Gipokaliyemichesky effect of Chlortalidonum can amplify use of corticosteroids, AKTG, β2-агонистов, Amphotericinum and a karbenolokson. Capable to increase potassium levels on the basis of experience of use of other medicines affecting RAAS, simultaneous use of the drug Edarbi® of Klo with potassium drugs, the salt substitutes containing potassium or with other medicines capable to increase potassium levels (for example, heparin) can lead potassium drugs, the salt substitutes containing potassium, and other substances to increase in serumal levels of potassium at patients with hypertensia. Digitalis drugs Simultaneous use of drugs of a digitalis can enhance undesirable effects of a hypopotassemia. Lithium Renal clearance of lithium under the influence of diuretics, such as Chlortalidonum, decreases, increasing risk of development of lithium toxicity. Because of lack of experience of simultaneous use of the drug Edarbi® of Klo and drugs of lithium, use of this combination is not recommended. If use of this combination is considered necessary, when using the drug Edarbi® of Klo it is necessary to carry out monitoring of serumal levels of lithium. Allopyrinolum Simultaneous use of Chlortalidonum can increase the frequency of occurrence of reactions of hypersensitivity to Allopyrinolum. Amantadin Chlortalidon is capable to increase risk of development of the undesirable effects caused by use of an amantadin. Anticholinergics (for example, atropine, Biperidinum) can increase bioavailability of Chlortalidonum by decrease in a vermicular movement of digestive tract and speed of gastric emptying. Antidiabetic medicines (drugs for oral administration and insulin) dose adjustment of antidiabetic medicines Can be required. Calcium salts Pharmacological effects of both calcium salts, and vitamin D can be raised to clinically significant levels in case of introduction together with Chlortalidonum. Cyclosporine Simultaneous treatment by cyclosporine can increase risk of development of a hyperuricemia and complications of type of gout. Holestiramin in the presence of the anion-exchange pitches absorption of Chlortalidonum can be broken. Decrease in pharmacological effect is possible. Cytotoxic means Simultaneous use of cytotoxic medicines (for example, cyclophosphamide, a methotrexate) can reduce their removal by kidneys and enhance their myelosuppressive effects. Chlortalidon's diazoxide can enhance hyper glycemic effect of diazoxide. The special instructions Activated renin-angiotensin-aldosteronovaya a system At patients whose vascular tone and renal function mainly depend on activity system renin-angiotensin-aldosteronovoy (for example, patients with stagnant heart failure or with initial damage of kidneys, including a bilateral stenosis of renal arteries), treatment by the medicines affecting this system such as APF inhibitors and blockers of a receptor of angiotensin II, was associated with development of acute hypotension, an azotemia, oliguria or, in rare instances, of an acute renal failure. When using the drug Edarbi® of Klo the likelihood of development of similar effects cannot be excluded. Inspection of patients with hypertensia from the activated RAAS has to include a periodic research of renal function and levels of electrolytes. Excessive decrease in level of arterial blood pressure with an ischemic cardiomyopathy or ischemic disturbance of cerebral circulation can cause development of a myocardial infarction or stroke in patients. The stenosis of the aortal and mitral valve, a subaortic hypertrophic stenosis As well as when using other drugs causing vasodilatation or reduction of volume of the circulating liquid, extra care is required from patients with a stenosis of the aortal or mitral valve and also with a hypertrophic subaortic stenosis (GOKM). A renal failure of Edarbi® Klo Chlortalidon, a component of the drug Edarbi® of Klo, it is impossible to use at patients with a heavy renal failure (SKF & lt, 30 ml/min. / 1.73 sq.m). Patients with poorly / a moderate renal failure do not need dose adjustment. It is necessary to monitor deterioration in renal function at patients with a renal failure by periodic monitoring of levels of creatinine of serum and electrolytes. At patients with a renal failure the probability of messages about abnormally high rates of serumal creatinine is higher. At such patients the drug Edarbi® of Klo should be titrated carefully in the conditions of monitoring of level of arterial blood pressure and parameters of renal function. At patients with a renal artery stenosis the renal function can worsen. At patients with a disease of kidneys, Chlortalidonum can provoke development of an azotemia. At obvious progressing of insufficiency of kidneys what the increased AMK level can testify to, it is necessary to consider a question of stay or the termination of therapy by diuretics. An electrolytic imbalance As well as at any patients receiving diuretics the determination of level of electrolytes of serum periodically has to be carried out. Use of tiazid can cause an imbalance of liquid or electrolytes (including a hypopotassemia, a hypercalcemia, a hyponatremia and a gipokhloremichesky alkalosis). The guarding signs of an imbalance of liquid or electrolytes are dryness in a mouth, thirst, weakness, block, drowsiness, concern, muscular pains or spasms, muscle weakness, hypotension, an oliguria, tachycardia and gastrointestinal disorders, such as nausea or vomiting. Before an initiation of treatment Klo drug Edarbi® the water and electrolytic imbalance should be corrected. The hypopotassemia Simultaneous use of an azilsartan of a medoksomil reduces expressiveness of the hypopotassemia caused by Chlortalidonum use. Simultaneous use of drugs of a digitalis can enhance undesirable effects of a hypopotassemia. Before an initiation of treatment Klo drug Edarbi® the hypopotassemia should be corrected. A hyperpotassemia Though documentary recorded facts of development of clinically significant hyperpotassemia when using the drug Edarbi® Klo were not, risk factors of development of a hyperpotassemia are the renal failure and/or heart failure and also diabetes. Kaliysberegayushchy diuretics, drugs of potassium or salt substitutes containing potassium along with the drug Edarbi® of Klo should be applied with care. A hypomagnesiemia It was shown that tiazida strengthen removal with magnesium urine that can cause development of a hypomagnesiemia. A hyponatremia and a gipokhloremichesky alkalosis It was shown that tiazida cause development of a hyponatremia. Эдарби® Klo cannot be used at patients with a refractory hyponatremia. Usually the deficiency of chlorides is mild and does not demand treatment. Tiazida's hypercalcemia are capable to reduce removal of calcium with urine and to cause periodic and easy increase in level of serumal calcium in the absence of the known disturbances of metabolism of calcium. The expressed hypercalcemia can be symptom of a latent hyperparathyreosis. Before carrying out a research of function of epithelial bodies the use of tiazid should be stopped. Эдарби® Klo cannot be used at patients with a hypercalcemia Primary hyper aldosteronism Usually patients with primary hyper aldosteronism do not respond to use of the antihypertensive medicines operating by inhibition system renin-angiotenzinovoy. Therefore, at these patients use of the drug Edarbi® Klo is not recommended. Metabolic and endocrine effects Treatment of a tiazidama can break tolerance to glucose. Therefore dose adjustment of insulin or antidiabetic treatment can be required. During treatment of a tiazidama the latent diabetes can be shown. Increase in levels of cholesterol and triglycerides was associated with treatment by tiazidovy diuretics. The hyperuricemia At some patients receiving Chlortalidonum or other diuretics can develop a hyperuricemia or become aggravated gout. Эдарби® Klo cannot be used at patients with a symptomatic hyperuricemia. Destky age Safety and efficiency of use of the drug Edarbi® Klo at children and teenagers up to 18 years is not established. Data are absent. Pregnancy and the period of a lactation of Edarbi® of Klo cannot be accepted during pregnancy. In case of detection of the fact of pregnancy it is necessary to cancel Klo's Edarbi® as soon as possible. Treatment by angiotensin II receptor blockers during the second and third trimesters of pregnancy causes development of a fetotoksichnost in the person (decrease in renal function, an oligoamnios, delay of ossification of a facial skeleton) and toxicity of newborns (renal failure, hypotension, a hyperpotassemia). Breastfeeding of Information on use of the drug Edarbi® Klo or an azilsartana of a medoksomil during pregnancy is not present. However Chlortalidonum gets into breast milk. Therefore drug Edarbi® use of Klo during breastfeeding is not recommended. During breastfeeding the use of alternative treatment with better the established safety profile, especially in case of breastfeeding of the newborn or premature child is preferable. It is necessary to make the decision on the termination of breastfeeding or administration of drug, based on need of drug of mother. It is considered features of influence of drug on ability to run the vehicle or potentially dangerous mechanisms Taking into account pharmakodinamichesky properties of the drug Edarbi® Klo that it has insignificant impact on ability to driving of the car and to control of mechanisms. However in the conditions of application of any antihypertensive drugs it is necessary to take a possibility of development of dizziness or fatigue into account. The overdose Information on overdose cases Klo drug Edarbi® at the person is insufficient. Azilsartana medoksomit Proceeding from pharmacological effects, probable main manifestation of overdose and
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