Telsartan H tablets 40mg/12.5mg №7×4

Name:
Telsartan H tab. 40mg/12.5mg in bl. in pack. No. 7×4
Description:
Capsule-shaped, biconvex, two-layer, beveled tablets, one layer is from light pink to pink, sometimes with patches of a darker color, the second layer is white, sometimes with patches of pink, with a dividing line and embossed “T” and “1” (for a dosage of 40/12.5 mg) or “2” (for a dosage of 80/12.5 mg) on either side of it. The main active ingredient Telmisartan Release form Tablets Dosage 40 mg / 12.5 mg in bl. in pack. No. 7×4 Pharmacodynamics Telsartan N is a combination of telmisartan (an angiotensin II receptor antagonist) and hydrochlorothiazide, a thiazide diuretic. The simultaneous use of these components leads to a greater antihypertensive effect than the use of each of them separately. Taking the drug Telsartan H once a day, leads to a significant gradual decrease in blood pressure (BP). Telmisartan Telmisartan is a specific angiotensin II receptor antagonist (type AT1), effective when taken orally. It has a high affinity for the AT1 subtype of angiotensin II receptors, through which the action of angiotensin II is realized. Telmisartan displaces angiotensin II from its association with the receptor, without having an agonist effect on this receptor. Telmisartan binds only to the AT1 angiotensin II receptor subtype. The bond is long term. Telmisartan has no affinity for other receptors, including the AT2 receptor and other, less studied angiotensin receptors. The functional significance of these receptors, as well as the effect of their possible excessive stimulation by angiotensin II, the concentration of which increases with the use of telmisartan, has not been studied. Telmisartan reduces the level of aldosterone in the blood plasma. Telmisartan does not inhibit plasma renin and ion channels, does not inhibit angiotensin-converting enzyme, does not inactivate bradykinin. In patients with arterial hypertension, telmisartan at a dose of 80 mg completely blocks the hypertensive action of angiotensin II. The onset of antihypertensive action is noted within 3 hours after the first oral administration of telmisartan. The effect of the drug persists for 24 hours and remains significant up to 48 hours. A pronounced antihypertensive effect usually develops 4 weeks after regular administration of the drug. In patients suffering from arterial hypertension, telmisartan reduces systolic and diastolic blood pressure without affecting the heart rate (HR). In the case of abrupt withdrawal of telmisartan, blood pressure gradually returns to its original level without the development of a “withdrawal” syndrome. The study with telmisartan evaluated cases of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization due to congestive heart failure. Reduced CV morbidity and mortality has been shown in patients at high CV risk (with coronary artery disease, stroke, peripheral arterial disease, or diabetes mellitus with concomitant target organ damage such as retinopathy, left ventricular hypertrophy, or a history of macro- or microalbuminuria). ) over the age of 55. Hydrochlorothiazide Hydrochlorothiazide is a thiazide diuretic. Thiazide diuretics affect the reabsorption of electrolytes in the renal tubules, directly increasing the excretion of sodium and chlorides (in approximately equivalent amounts). The diuretic effect of hydrochlorothiazide leads to a decrease in circulating blood volume (CBV), an increase in plasma renin activity, an increase in aldosterone secretion and is accompanied by an increase in the content of potassium and bicarbonates in the urine and, as a result, a decrease in the content of potassium in the blood plasma. With the simultaneous administration of telmisartan, there is a tendency to stop the loss of potassium caused by thiazide diuretics, presumably due to the blockade of the renin-angiotensin-aldosterone system. After taking hydrochlorothiazide, diuresis increases after 2 hours, and the maximum effect is observed after about 4 hours. The diuretic effect of the drug persists for approximately 6-12 hours. Long-term use of hydrochlorothiazide reduces the risk of complications of cardiovascular diseases and mortality from them. The maximum antihypertensive effect of Telsartan N is usually achieved 4 weeks after the start of treatment. Non-melanoma skin cancer: Based on data from epidemiological studies, a cumulative dose-dependent relationship was found between hydrochlorothiazide intake and the development of non-melanoma skin cancer. One study included a population of 71,533 cases of basal cell carcinoma and 8,629 cases of squamous cell carcinoma, with a control group of 1430,833 and 172,462 cases, respectively. The use of high doses of hydrochlorothiazide (total dose ?50000 mg) was characterized by the following adjusted odds ratio of 1.29 (95% CI: 1.23-1.35) for basal cell carcinoma and 3.98 (95% CI: 3.68-4.31) for squamous cell carcinoma. In basal cell carcinoma and squamous cell carcinoma, a pronounced cumulative dose-response relationship was observed. Another study showed a possible relationship between breast cancer (squamous cell carcinoma) and exposure to hydrochlorothiazide: 633 cases of lip cancer corresponded to 63,067 cases in the control group (a risk-based sampling strategy was used). A cumulative dose-response relationship was demonstrated with an adjusted odds ratio of 2.1 (95% CI: 1.7-2.6). The index increased to 3.9 (3.0-4.9) with high doses of hydrochlorothiazide (approximately 25,000 mg) and to 7.7 (5.7-10.5) with the highest cumulative doses of the drug (approximately 100,000 mg). Pharmacokinetics Simultaneous use of hydrochlorothiazide and telmisartan does not affect the pharmacokinetics of each of the components of the drug. Absorption: Telmisartan: when taken orally, the maximum concentration of telmisartan is reached within 0.5-1.5 hours after application. The absolute bioavailability of telmisartan at doses of 40 to 160 mg was 42% and 58%, respectively. When taken simultaneously with food, the bioavailability of telmisartan slightly decreases with a decrease in the area under the concentration-time curve (AUC) by 6% at a dose of 40 mg and about 19% at a dose of 160 mg. After 3 hours after ingestion, the concentration in the blood plasma levels off, regardless of whether the drug was taken with food or on an empty stomach. The pharmacokinetics of telmisartan when administered orally is non-linear at doses of 20-160 mg with a more than proportional increase in plasma concentrations (Cmax and AUC) with increasing doses. Hydrochlorothiazide: After oral administration of Telsartan H, the maximum plasma concentrations of hydrochlorothiazide are reached within 1-3 hours. Absolute bioavailability, estimated from the cumulative renal excretion of hydrochlorothiazide, is about 60%. Distribution: Telmisartan: the relationship with plasma proteins is significant (> 99.5%), mainly albumin and alpha-1-glycoprotein. The volume of distribution for telmisartan is approximately 500 liters. Hydrochlorothiazide: 64% of hydrochlorothiazide binds to plasma proteins, and the volume of distribution is 0.8 ± 0.3 l / kg. Metabolism and excretion: Telmisartan: most of the administered dose (> 97%) is excreted in the bile, and then in the feces. In small quantities, the drug is excreted by the kidneys. Telmisartan is metabolized by conjugation with glucuronic acid. The metabolite (acylglucuronide) is pharmacologically inactive. Glucuronide is the main metabolite, which is determined only in humans. The total plasma clearance is more than 1500 ml / min. The half-life (T1 / 2) is more than 20 hours. Hydrochlorothiazide is not metabolized in the human body and is excreted by the kidneys almost unchanged. About 60% of an oral dose is eliminated within 48 hours. Renal clearance is about 250 – 300 ml / min. T1 / 2 hydrochlorothiazide is 10 – 15 hours. Gender There is a difference in plasma concentration between men and women. In women, the concentration of telmisartan in plasma is 2-3 times higher than in men, and in women there is a tendency to increase plasma concentrations of hydrochlorothiazide. However, an increase in the antihypertensive effect in women is not observed. Elderly patients The pharmacokinetic parameters of telmisartan do not differ significantly between young and elderly patients. Patients with renal insufficiency Renal excretion does not affect the clearance of telmisartan. Based on the level of excretion in patients with mild to moderate renal impairment (creatinine clearance 30-60 ml / min, mean 50 ml / min), no adjustment of the dosing regimen is required. Telmisartan is not removed by dialysis. In patients with impaired renal function, the rate of elimination of hydrochlorothiazide is reduced. Studies conducted with the participation of patients with a creatinine clearance of 90 ml / min have shown that T1 / 2 of hydrochlorothiazide is prolonged. In patients with reduced renal function T1 / 2 is about 34 hours. Patients with hepatic insufficiency Pharmacokinetic studies in patients with hepatic insufficiency have shown an increase in absolute bioavailability of almost 100%. With liver failure, the half-life does not change. The drug crosses the placental barrier and is determined in the blood of the umbilical cord. Indications for use Treatment of essential arterial hypertension in adults, if telmisartan monotherapy does not provide adequate control of blood pressure. Dosage and administration Telsartan H is recommended for use in patients in whom telmisartan monotherapy does not provide adequate blood pressure control. Before using the fixed combination, individual dose titration of each of the two components is recommended. A direct switch from monotherapy to a fixed combination may be considered when clinically warranted. Telmisartan H 40mg/12.5mg is recommended for patients with insufficient efficacy of telmisartan at a dose of 40 mg. Telmisartan H 80mg/12.5mg is recommended for patients with insufficient efficacy of telmisartan at a dose of 80 mg. Telsartan H should be taken once a day, regardless of the meal, with a liquid. Patients with impaired renal function. The drug is not prescribed to patients with severely impaired renal function (creatinine clearance <30 ml / min). In patients with mild or moderate impairment, periodic monitoring of renal function is recommended. Patients with impaired liver function. For patients with mild to moderate hepatic impairment, the daily dose of the telmisartan/hydrochlorothiazide combination should not exceed 40 mg/12.5 mg. The drug is not prescribed to patients with severe hepatic impairment. In patients with impaired liver function, thiazide diuretics should be administered with caution. Elderly patients. There is no need for dose adjustment for elderly patients. Children. Efficacy and safety in children and adolescents under 18 years of age have not been established. Application during pregnancy and lactation Pregnancy Angiotensin II receptor antagonists are not recommended for use in the first trimester of pregnancy, in the second and third trimesters these drugs are contraindicated. There are insufficient data on the use of telmisartan/hydrochlorothiazide in pregnant women. Reproductive toxicity has been observed in animal studies. Epidemiological data do not unequivocally indicate a risk of teratogenic effects when treated with ACE inhibitors in the first trimester of pregnancy; however, a slight increase in such risk cannot be ruled out. Data from controlled studies on the risks of teratogenic effects in the treatment of angiotensin II receptor antagonists are not available, but the same risks as with the use of ACE inhibitors cannot be ruled out. If continued angiotensin II receptor antagonist therapy is not considered life-saving, women planning pregnancy should be switched to an alternative antihypertensive drug whose safety profile in pregnant women is well established. When pregnancy is established, angiotensin II receptor antagonists should be immediately discontinued and, if necessary, alternative therapy should be prescribed. In the treatment of angiotensin II receptor antagonists during the second and third trimesters of pregnancy, toxic effects have been described in the human fetus (deterioration of kidney function, oligohydramnios, slowing of ossification of the skull bones) and the newborn (renal failure, arterial hypotension, hyperkalemia). If a pregnant woman has taken an angiotensin II receptor antagonist class of drugs in the second trimester or later, an ultrasound assessment of the condition of the skull bones and fetal kidney function is recommended. Infants born to mothers taking angiotensin II receptor antagonists are closely monitored for the development of arterial hypotension. Experience with the use of hydrochlorothiazide in pregnant women is limited, especially in the first trimester. Data from animal studies are insufficient. Hydrochlorothiazide crosses the placental barrier. Given the pharmacological features of the mechanism of action of hydrochlorothiazide, it can be assumed that its use in the second and third trimesters will impair fetoplacental blood flow and may lead to jaundice, electrolyte imbalance and thrombocytopenia in the fetus and newborn. Hydrochlorothiazide should not be used in the treatment of pregnancy edema, hypertension, and preeclampsia in pregnancy because it is not effective in these conditions and may cause plasma volume depletion and placental hypoperfusion. It is also not recommended to prescribe the drug for the treatment of essential hypertension in pregnant women, except in rare cases when alternative therapy is not possible. Breastfeeding period Telsartan H is not recommended for nursing mothers, since there are no data on the use of telmisartan / hydrochlorothiazide during breastfeeding; it is preferable to use an alternative antihypertensive agent, the safety profile of which in nursing mothers is well established, especially when feeding newborns and premature infants. Hydrochlorothiazide is excreted in small amounts in breast milk. Thiazide diuretics in high doses can cause an increase in diuresis and suppression of lactation. Telsartan H should not be administered to women during breastfeeding. If treatment with Telsartan H is necessary, the lowest effective dose of the drug should be used. Precautions Conditions that increase the activity of the RAAS Double blockade of the renin-angiotensin-aldosterone system. Dual blockade of the renin-angiotensin-aldosterone system (RAAS) is associated with an increased risk of hypotension, hyperkalemia, and renal dysfunction (including acute renal failure) compared with monotherapy. Dual blockade of the RAAS with ACE inhibitors, ARB II, or Aliskiren cannot be recommended for any patient, especially those with diabetic nephropathy. In some cases, when the combined use of ACE inhibitors and ARB II is absolutely indicated, careful observation of a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. Other conditions contributing to the stimulation of the renin-angiotensin-aldosterone system. In patients whose vascular tone and renal function depend mainly on the activity of the RAAS (for example, patients with congestive heart failure or kidney disease, including renal artery stenosis), treatment with other drugs that affect the RAAS may lead to the development of acute arterial hypotension, hyperazotemia, oliguria or, in rare cases, acute renal failure. Renovascular hypertension In patients with bilateral renal artery stenosis or stenosis of the artery of the only functioning kidney, the use of drugs that affect the RAAS increases the risk of severe arterial hypotension and renal failure, Impaired liver function In patients with impaired liver function or progressive liver disease, the hydrochlorothiazide / telmisartan should be used with caution, since even small changes in the water and electrolyte balance can contribute to the development of "hepatic" coma. Influence on the metabolism and function of the endocrine glands In patients with diabetes mellitus, it may be necessary to change the dose of insulin or hypoglycemic agents for oral administration. During therapy with thiazide diuretics, latent diabetes mellitus may manifest. In some cases, the use of thiazide diuretics may develop hyperuricemia and exacerbate the course of gout. Diabetes mellitus In patients with diabetes mellitus and additional cardiovascular risk, such as patients with diabetes mellitus and coronary artery disease (CHD), when using drugs that lower blood pressure, such as angiotensin II receptor antagonists or ACE inhibitors, the risk may be increased fatal myocardial infarction and sudden cardiovascular death. In patients with diabetes, CAD may be asymptomatic and therefore may go undiagnosed. In patients with diabetes mellitus, before starting the use of the drug Telsartan N for the detection and treatment of coronary artery disease, appropriate diagnostic studies, including an exercise test, should be carried out. Acute myopia and secondary angle-closure glaucoma Hydrochlorothiazide, being a sulfonamide derivative, can cause an idiosyncratic reaction in the form of acute transient myopia and acute angle-closure glaucoma. Symptoms of these disorders are an unexpected decrease in visual acuity or pain in the eyes, which occur within a few hours to several weeks after the start of the drug. If left untreated, acute angle-closure glaucoma can lead to vision loss. The main treatment is to stop hydrochlorothiazide as soon as possible. It must be borne in mind that if intraocular pressure remains uncontrolled, urgent conservative or surgical treatment may be required. Risk factors for the development of acute angle-closure glaucoma include a history of allergy to sulfonamides or penicillin. Violations of the water and electrolyte balance When using the drug Telsartan N, as in the case of diuretic therapy, periodic monitoring of the content of electrolytes in the blood serum is necessary. Thiazide diuretics, including hydrochlorothiazide, can cause disturbances in water and electrolyte balance and acid-base balance (hypokalemia, hyponatremia and hypochloremic alkalosis). Warning signs in relation to these disorders are dryness of the oral mucosa, thirst, general weakness, drowsiness, anxiety, myalgia or convulsive twitching of the calf muscles (crampy), muscle weakness, a pronounced decrease in blood pressure, oliguria, tachycardia, and such gastrointestinal intestinal disturbances like nausea or vomiting. When using thiazide diuretics, hypokalemia may develop, but concomitantly used telmisartan may increase the content of potassium in the blood serum. The risk of developing hypokalemia increases in patients with cirrhosis of the liver, with increased diuresis, while observing a salt-free diet, as well as in the case of simultaneous use of gluco- and mineralocorticosteroids or corticotropin. Telmisartan, which is part of the drug Telsartan H, on the contrary, can lead to hyperkalemia due to antagonism to angiotensin II receptors (subtype AT1). Although clinically significant hyperkalemia has not been reported with the use of Telsartan N, it should be taken into account that the risk factors for its development include renal and / or heart failure and diabetes mellitus. There is no evidence that Telsartan N can reduce or prevent diuretic-induced reactions. Hypochloremia is usually minor and does not require treatment. Thiazide diuretics can reduce the excretion of calcium by the kidneys and cause (in the absence of obvious disorders of calcium metabolism) a transient and slight increase in serum calcium. More pronounced hypercalcemia may be a sign of latent hyperparathyroidism. Before assessing the function of the parathyroid glands, thiazide diuretics should be canceled. It has been shown that thiazide diuretics increase the excretion of magnesium by the kidneys, which can lead to hypomagnesemia. In patients with coronary artery disease, the use of any antihypertensive agent, in case of excessive reduction in blood pressure, can lead to myocardial infarction or stroke. There are reports of the development of systemic lupus erythematosus with the use of thiazide diuretics. The drug Telsartan N can, if necessary, be used in conjunction with other antihypertensive drugs. Liver dysfunction in the appointment of telmisartan in most cases was observed in residents of Japan. Telsartan H is less effective in black patients. Renal failure and kidney transplantation Telsartan H should not be prescribed to patients with severe renal insufficiency (creatinine clearance <30 ml / min) (see Section "Contraindications"). There is no experience with the use of the drug in patients with severe renal insufficiency or recent kidney transplantation. The experience of using the drug in patients with mild to moderate renal insufficiency is limited, therefore periodic monitoring of the level of potassium, creatinine and uric acid in blood plasma is recommended. In patients with impaired renal function while taking thiazide diuretics, azotemia may develop. Intravascular hypovolemia Symptomatic hypotension may develop in patients with a deficiency in circulating blood volume and / or sodium caused by intensive use of diuretics, salt restriction in the diet, diarrhea or vomiting, especially after taking the first dose of the drug. It is not recommended to take the drug until these disorders are compensated. Primary aldosteronism As a rule, therapy with RAAS inhibitors is ineffective in primary hyperaldosteronism. In this connection, it is not recommended to prescribe the drug to this category of patients. Stenosis of the aorta and mitral valve, obstructive hypertrophic cardiomyopathy. As with other vasodilators, special care is needed in the treatment of patients suffering from aortic and mitral valve stenosis or obstructive hypertrophic cardiomyopathy. Hypersensitivity reactions to hydrochlorothiazide may occur even in the absence of a aggravated allergic history, but are more likely to occur in patients with allergies or bronchial asthma. When using thiazide diuretics, cases of photosensitivity reactions were observed. If photosensitivity occurs during treatment, it is recommended to stop using the drug. If the use of a diuretic is necessary, it is recommended to protect exposed areas from exposure to the sun or artificial ultraviolet radiation. Due to the lactose content, the drug should not be used in patients with rare congenital galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Non-melanoma skin cancer Two epidemiological studies based on data from the Danish National Cancer Registry found an increased risk of developing non-melanoma skin cancer (NMSC) basal cell carcinoma (BCC) and squamous cell carcinoma (PSC) after higher total doses of hydrochlorothiazide. The photosensitizing effect of hydrochlorothiazide may act as a possible mechanism for the development of NMSC. Patients taking hydrochlorothiazide should be informed of the risk of developing NMSC, of the need for regular skin checks for new lesions, and prompt reporting of any suspicious skin lesions. To reduce the risk of developing skin cancer, patients should be informed about possible preventive measures, such as limiting exposure to sunlight and UV rays, and in case of exposure, adequate protection of the skin. It is necessary to examine suspicious skin lesions as soon as possible, including histological examination of biopsy material. Patients with previous NMSC may also need to reconsider the use of hydrochlorothiazide. Interaction with other drugs Telmisartan With the simultaneous use of telmisartan with: other antihypertensive drugs: it is possible to increase the antihypertensive effect. In one study, with the combined use of telmisartan and ramipril, an increase in AUC0-24 and Cmax of ramipril and ramiprilat by 2.5 times was observed. The clinical significance of this interaction has not been established. In the analysis of adverse events leading to discontinuation of treatment and the analysis of serious adverse events obtained during the clinical study, it was found that cough and angioedema were more often observed on ramipril therapy, while arterial hypotension was more common on telmisartan therapy. Cases of hyperkalemia, renal failure, arterial hypotension and syncope were observed significantly more often with the combined use of telmisartan and ramipril; lithium preparations: there was a reversible increase in the concentration of lithium in the blood plasma, accompanied by toxic effects when taking ACE inhibitors. In rare cases, such changes have been reported with the use of angiotensin II receptor antagonists, in particular, telmisartan. With the simultaneous use of lithium preparations and ARA II, it is recommended to determine the content of lithium in the blood; non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid at doses used as an anti-inflammatory agent (no more than 3 g / day), cyclooxygenase-2 (COX-2) inhibitors and non-selective NSAIDs, can cause the development of acute renal failure in patients with reduced BCC. Drugs that affect the RAAS may have a synergistic effect. In patients receiving NSAIDs and telmisartan, BCC should be compensated at the beginning of treatment and renal function should be monitored. A decrease in the effect of antihypertensive drugs, such as telmisartan, by inhibiting the vasodilating effect of prostaglandins, was observed when used together with NSAIDs. While taking telmisartan with ibuprofen or paracetamol, there was no clinically significant effect; digoxin, warfarin, hydrochlorothiazide, glibenclamide, simvastatin and amlodipine: no clinically significant interaction was found. There was an increase in the average concentration of digoxin in the blood plasma by an average of 20% (in one case by 39%). With the simultaneous use of telmisartan and digoxin, it is advisable to periodically determine the concentration of digoxin in the blood plasma. potassium-sparing diuretics, potassium preparations, other drugs that can increase the content of potassium in the blood serum (for example, heparin), or the replacement of sodium in table salt with potassium salts can lead to hyperkalemia. Hydrochlorothiazide When used simultaneously with: ethanol, barbiturates or narcotic analgesics: the risk of developing orthostatic hypotension; hypoglycemic agents for oral administration and insulin: dose adjustment of hypoglycemic agents for oral administration and insulin may be required; metformin: risk of developing lactic acidosis; cholestyramine and colestipol: in the presence of anionic exchange resins, the absorption of hydrochlorothiazide is impaired; cardiac glycosides: the risk of developing hypokalemia or hypomagnesemia caused by thiazide diuretics, the development of arrhythmias caused by taking cardiac glycosides; pressor amines (eg, norepinephrine): possible weakening of the effect of pressor amines; non-depolarizing muscle relaxants (for example, tubocurarine chloride): hydrochlorothiazide may enhance the effect of non-depolarizing muscle relaxants; anti-gout drugs: the concentration of uric acid in the blood serum may increase, and therefore changes in the dose of uricosuric agents may be required. The use of thiazide diuretics increases the incidence of hypersensitivity reactions to allopurinol; calcium preparations: thiazide diuretics can increase the content of calcium in the blood serum due to a decrease in its excretion by the kidneys. If you need to use calcium supplements, you should regularly monitor the content of calcium in the blood serum and, if necessary, change the dose of calcium supplements; beta-blockers and diazoxide: thiazide diuretics may increase hyperglycemia caused by beta-blockers and diazoxide; m-anticholinergics (for example, atropine, biperidine): a decrease in motility of the gastrointestinal tract, an increase in the bioavailability of thiazide diuretics; amantadine: thiazide diuretics may increase the risk of adverse effects caused by amantadine; cytotoxic agents (for example, cyclophosphamide, methotrexate): a decrease in renal excretion of cytotoxic agents and an increase in their myelosuppressive effect; NSAIDs: simultaneous use with thiazide diuretics may lead to a decrease in the diuretic and antihypertensive effect; means that lead to the excretion of potassium and hypokalemia (for example, diuretics that remove potassium, laxatives; gluco- and mineralocorticosteroids; corticotropin; amphotericin B; carbenoxolone; benzylpenicillin, acetylsalicylic acid derivatives): increased hypokalemic effect. Hypokalemia caused by hydrochlorothiazide is compensated by the potassium-sparing effect of telmisartan. It is recommended to periodically monitor the content of potassium in the blood plasma while using the drug Telsartan H with drugs that can cause hypokalemia, as well as with drugs that can increase the content of potassium in the blood serum. Double blockade of the renin-angiotensin-aldosterone system (RAAS) The simultaneous use of telmisartan and aliskiren is contraindicated in diabetes mellitus or impaired renal function (GFR less than 60 ml / min / 1.73 m2) and is not recommended in other patients. Drugs whose effect changes with fluctuations in the level of potassium in the blood When used simultaneously with drugs whose effect changes against the background of fluctuations in the level of potassium in the blood (digitis glycosides, antiarrhythmic drugs), you should regularly monitor the level of potassium in the blood serum and monitor changes on the ECG. The same applies to cases when Telsartan N is used in combination with drugs that cause polymorphic ventricular tachycardia of the "pirouette" type (including antiarrhythmic drugs): class IA antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide) class III antiarrhythmic drugs (amiodarone, sotalol, dofetilide, ibutilide) - some antipsychotics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol and droperidol) other drugs (bepridil, cisapride, diphemanil, erythromycin for intravenous administration, halofanthin, mizolastine, pentamidine, sparfloxacin, terfenadine, vincamine for intravenous administration) A predisposing factor for the development of polymorphic ventricular tachycardia of the "pirouette" type is hypokalemia, Influence on the ability to drive vehicles and work with mechanisms requiring increased attention Special clinical studies to evaluate the impact drug Telsartan N on the ability to control lyat motor transport and work with mechanisms that require increased attention, was not carried out. However, when driving vehicles and engaging in hazardous activities, the possibility of developing dizziness and drowsiness should be taken into account, which requires caution. Contraindications Hypersensitivity to active substances or auxiliary components of the drug or other sulfonamide derivatives. Pregnancy (II and III trimester). breastfeeding period. Cholestasis and obstructive diseases of the biliary tract. Severe liver dysfunction. Severe renal dysfunction (creatinine clearance less than 30 ml / min). Refractory hypokapyemia, hypercalcemia. Persistent hypokalemia, hypercalcemia. In case of rare hereditary intolerance to any of the components of the drug. Simultaneous use with drugs containing aliskiren in patients with diabetes mellitus or impaired renal function (GFR <60 ml / min / 1.73 m2). Composition Active ingredients: telmisartan - 80 mg (for a dosage of 80/12.5 mg) or 40 mg (for a dosage of 40/12.5 mg); hydrochlorothiazide - 12.5 mg. Excipients: meglumine, sodium hydroxide, povidone-KZ0, polysorbate-80, mannitol, lactose monohydrate, magnesium stearate, red iron oxide (E 172). Overdose The most likely symptoms of an overdose of telmisartan may be a pronounced decrease in blood pressure, tachycardia and / or bradycardia. An overdose of hydrochlorothiazide is accompanied by a loss of electrolytes (hypokalemia, hypochloremia) and dehydration resulting from massive diuresis. The most common signs and symptoms of hydrochlorothiazide overdose are nausea and drowsiness. Hypokalemia can lead to muscle spasms and / or increase cardiac arrhythmias caused by the simultaneous use of cardiac glycosides or certain antiarrhythmic drugs. Treatment: symptomatic and supportive therapy, the nature of which depends on the time elapsed since the drug was taken and on