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Telsartan N tablets 40mg/12.5mg No. 7x4

Name

Telsartan N tab. 40 mg/12.5 mg per bl. in pack No. 7x4

Description

Capsule-shaped tablets, biconvex, two-layer, chamfered, one layer - from light pink to pink, sometimes interspersed with a darker color, the second layer - white, sometimes interspersed with 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 opposite sides of it.

Main active ingredient

Telmisartan

Release form

Pills

Dosage

40 mg/12.5 mg per bl. in pack No. 7x4

Pharmacodynamics

Telsartan N is a combination of telmisartan (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 Telsartan N once a day leads to a significant gradual decrease in blood pressure (BP). Telmisartan Telmisartan is a specific angiotensin II receptor antagonist (AT1 type), 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 binding to the receptor without having an agonist effect on this receptor. Telmisartan binds only to the AT1 subtype of angiotensin II receptors. The binding is long lasting. 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, have not been studied. Telmisartan reduces plasma aldosterone levels. Telmisartan does not inhibit plasma renin and ion channels, does not inhibit angiotensin-converting enzyme, and does not inactivate bradykinin. In patients with arterial hypertension, telmisartan at a dose of 80 mg completely blocks the hypertensive effect of angiotensin II. The onset of antihypertensive action is observed within 3 hours after the first oral administration of telmisartan. The effect of the drug lasts for 24 hours and remains significant for up to 48 hours. A pronounced antihypertensive effect usually develops 4 weeks after regular use of the drug. In patients suffering from arterial hypertension, telmisartan reduces systolic and diastolic blood pressure without affecting heart rate (HR). In case of abrupt withdrawal of telmisartan, blood pressure gradually returns to the initial level without the development of withdrawal syndrome. The telmisartan study assessed incidence of cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, or hospitalization due to congestive heart failure. Has been shown to reduce cardiovascular morbidity and mortality in patients at high cardiovascular risk (with coronary artery disease, stroke, peripheral artery disease, or diabetes mellitus with concomitant end-organ damage such as retinopathy, left ventricular hypertrophy, history of macro- or microalbuminuria ) over the age of 55 years. Hydrochlorothiazide Hydrochlorothiazide is a thiazide diuretic. Thiazide diuretics affect the reabsorption of electrolytes in the renal tubules, directly increasing the excretion of sodium and chloride (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 consequence, a decrease in the potassium content in the blood plasma. With simultaneous administration of telmisartan, there is a tendency to stop the loss of potassium caused by thiazide diuretics, presumably due to 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 lasts 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 between hydrochlorothiazide use and the development of non-melanoma skin cancer has been identified. 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 1,430,833 and 172,462 cases, respectively. High-dose hydrochlorothiazide (total dose ≥50,000 mg) had an 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. A significant cumulative dose-response relationship was observed in basal cell carcinoma and squamous cell carcinoma. Another study showed a possible association between breast cancer (squamous cell carcinoma) and hydrochlorothiazide exposure: 633 cases of lip cancer matched by 63,067 cases in the control group (risk-adjusted sampling strategy was used). A cumulative dose-response relationship was demonstrated by an adjusted odds ratio of 2.1 (95% CI: 1.7–2.6). The index increased to 3.9 (3.0-4.9) when using high doses of hydrochlorothiazide (approximately 25,000 mg) and to 7.7 (5.7-10.5) when using the highest cumulative doses of the drug (approximately 100,000 mg).

Pharmacokinetics

The simultaneous use of hydrochlorothiazide and telmisartan does not affect the pharmacokinetics of each of the components of the drug. Absorption: Telmisartan: when taken orally, maximum concentrations of telmisartan are achieved within 0.5 -1.5 hours after administration. The absolute bioavailability of telmisartan in doses from 40 to 160 mg was 42% and 58%, respectively. When taken simultaneously with food, the bioavailability of telmisartan is slightly reduced 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. 3 hours after oral administration, 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 nonlinear 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 N, maximum plasma concentrations of hydrochlorothiazide are achieved within 1-3 hours. Absolute bioavailability, assessed by the cumulative renal excretion of hydrochlorothiazide, is about 60%. Distribution: Telmisartan: binding to 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 is bound to plasma proteins, and the volume of distribution is 0.8±0.3 l/kg. Metabolism and elimination: Telmisartan: the majority of the administered dose (>97%) is excreted in bile and then in feces. In small quantities the drug is excreted by the kidneys. Telmisartan is metabolized by conjugation with glucuronic acid. The metabolite (acyl glucuronide) is pharmacologically inactive. Glucuronide is the main metabolite that is detected 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 the dose taken orally is eliminated within 48 hours. Renal clearance is about 250 - 300 ml/min. T1/2 of hydrochlorothiazide is 10 - 15 hours. Gender There is a difference in plasma concentrations between men and women. In women, plasma concentrations of telmisartan are 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 is not observed in women. Elderly patients The pharmacokinetic parameters of telmisartan do not differ significantly between young and elderly patients. Patients with renal impairment 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, average 50 ml/min), no dosage adjustment is required. Telmisartan is not removed by dialysis. In patients with impaired renal function, the rate of elimination of hydrochlorothiazide is reduced. Studies conducted in 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 impairment Pharmacokinetic studies in patients with hepatic impairment have shown an increase in absolute bioavailability of almost 100%. In liver failure, the half-life does not change. The drug penetrates the placental barrier and is detected in the umbilical cord blood.

Indications for use

Treatment of essential arterial hypertension in adults if telmisartan monotherapy does not provide adequate blood pressure control.

Directions for use and doses

Telsartan N is recommended for use in patients in whom telmisartan monotherapy does not provide adequate blood pressure control. Before using a fixed combination, individual titration of the dose of each of the two components is recommended. A direct switch from monotherapy to a fixed combination may be considered when clinically appropriate. Telsartan N 40 mg/12.5 mg is recommended for use in patients with insufficient effectiveness of telmisartan at a dose of 40 mg. Telsartan N 80mg/12.5mg is recommended for use in patients with insufficient effectiveness of telmisartan at a dose of 80 mg. Telsartan N should be taken once a day, regardless of meals, with liquid. Patients with impaired renal function. The drug is not prescribed to patients with severe renal impairment (creatinine clearance

Use during pregnancy and lactation

Pregnancy Angiotensin II receptor antagonists are not recommended for use in the first trimester of pregnancy; these drugs are contraindicated in the second and third trimesters. There is insufficient data on the use of telmisartan/hydrochlorothiazide in pregnant women. Reproductive toxicity has been observed in animal studies. Epidemiological data do not clearly 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. There are no data from controlled studies on the risks of teratogenic effects during treatment with angiotensin II receptor antagonists, but the same risks as with the use of ACE inhibitors cannot be ruled out. If continued therapy with angiotensin II receptor antagonists is not considered vital, women planning pregnancy are switched to an alternative antihypertensive drug, the safety profile of which in pregnant women is well established. If pregnancy is established, angiotensin II receptor antagonists should be immediately discontinued and, if necessary, alternative therapy should be prescribed. When treated with angiotensin II receptor antagonists during the second and third trimesters of pregnancy, toxic effects have been described in the human fetus (deterioration of renal function, oligohydramnios, delayed ossification of the skull bones) and the newborn (renal failure, arterial hypotension, hyperkalemia). If a pregnant woman took drugs of the class of angiotensin II receptor antagonists in the second trimester or later, it is recommended to conduct an ultrasound assessment of the condition of the skull bones and fetal renal function. Infants born to mothers taking angiotensin II receptor antagonists should be closely monitored for the development of hypotension. Experience with the use of hydrochlorothiazide in pregnant women is limited, especially in the first trimester. Data from animal studies are insufficient. Hydrochlorothiazide penetrates the placental barrier. Considering the pharmacological features of the mechanism of action of hydrochlorothiazide, it can be assumed that its use in the second and third trimesters will worsen fetoplacental blood flow and can lead to jaundice, electrolyte imbalance and thrombocytopenia in the fetus and newborn. Hydrochlorothiazide should not be used in the treatment of edema of pregnancy, hypertension and preeclampsia in pregnancy as 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 N 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 drug, the safety profile of which in nursing mothers has been well studied, especially when feeding newborns and premature infants. Hydrochlorothiazide is excreted in small quantities into breast milk. Thiazide diuretics in large doses can cause an increase in diuresis and suppression of lactation. Telsartan N should not be prescribed to women during breastfeeding. If treatment with Telsartan N is necessary, the lowest effective dose of the drug should be used.

Precautionary measures

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 considered. recommended for any patient, especially patients with diabetic nephropathy. In some cases, when the combined use of ACE inhibitors and ARB II is absolutely indicated, careful supervision by a specialist and mandatory monitoring of renal function, water and electrolyte balance, and blood pressure are necessary. Other conditions that promote stimulation of the renin-angiotensin-aldosterone system. In patients whose vascular tone and renal function depend primarily 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 arterial stenosis of a single functioning kidney, when using drugs that affect the RAAS, the risk of developing severe arterial hypotension and renal failure increases, Impaired liver function In patients with impaired liver function or progressive liver diseases, the combination of hydrochlorothiazide/ Telmisartan should be used with caution, since even slight changes in water and electrolyte balance can contribute to the development of hepatic coma. Effect on metabolism and endocrine gland function In patients with diabetes mellitus, changes in the dose of insulin or oral hypoglycemic agents may be required. During therapy with thiazide diuretics, latent diabetes mellitus may manifest. In some cases, when using thiazide diuretics, hyperuricemia and exacerbation of gout may develop. Diabetes mellitus In patients with diabetes mellitus and additional cardiovascular risk, such as patients with diabetes mellitus and coronary artery disease (CAD), the risk may be increased when taking blood pressure-lowering drugs such as angiotensin II receptor antagonists or ACE inhibitors. fatal myocardial infarction and sudden cardiovascular death. In patients with diabetes mellitus, CAD may be asymptomatic and therefore may be undiagnosed. In patients with diabetes mellitus, before starting the use of Telsartan N, appropriate diagnostic studies, including exercise testing, should be carried out to identify and treat coronary artery disease. 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 include a sudden decrease in visual acuity or eye pain that occurs within a few hours to several weeks after starting to use the drug. If left untreated, acute angle-closure glaucoma can lead to vision loss. The main treatment is to stop hydrochlorothiazide as quickly as possible. It is important to keep in mind that if intraocular pressure remains uncontrolled, emergency medical or surgical treatment may be required. Risk factors for the development of acute angle-closure glaucoma include a history of allergies to sulfonamides or penicillin. Disturbances in 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-electrolyte balance and acid-base status (hypokalemia, hyponatremia and hypochloremic alkalosis). Warning signs for these disorders are dryness of the oral mucosa, a feeling of thirst, general weakness, drowsiness, anxiety, myalgia or convulsive twitching of the calf muscles (cramps), muscle weakness, a marked decrease in blood pressure, oliguria, tachycardia and such gastrointestinal tract. intestinal disturbances such as nausea or vomiting. Hypokalemia may develop when using thiazide diuretics, but concomitantly used telmisartan may increase serum potassium levels. The risk of developing hypokalemia increases in patients with liver cirrhosis, with increased diuresis, while following 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 N, on the contrary, can lead to hyperkalemia due to antagonism to angiotensin II receptors (AT1 subtype). Although clinically significant hyperkalemia has not been reported with Telsartan N, it should be taken into account that risk factors for its development include renal and/or heart failure and diabetes mellitus. There is no data that Telsartan N can reduce or prevent diuretic-induced symptoms. 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 disturbances in calcium metabolism) a transient and slight increase in serum calcium. More severe hypercalcemia may be a sign of hidden hyperparathyroidism. Before assessing parathyroid function, thiazide diuretics should be discontinued. Thiazide diuretics have been shown to increase renal excretion of magnesium, which may lead to hypomagnesemia. In patients with coronary artery disease, the use of any antihypertensive drug, 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 when prescribed telmisartan was observed in most cases in Japanese residents. The drug Telsartan N is less effective in patients of the Negroid race. Renal failure and kidney transplantation Telsartan N should not be administered to patients with severe renal failure (creatinine clearance of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) after the use of higher total doses of hydrochlorothiazide. The photosensitizing effect of hydrochlorothiazide may act as a possible mechanism for the development of NMSC. Patients Patients taking hydrochlorothiazide should be informed of the risk of developing NMSC, the need to regularly check the skin for new lesions, and to promptly report any suspicious skin growths.To reduce the risk of developing skin cancer, patients should be advised of 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. In patients with a history of NMSC, the use of hydrochlorothiazide may also need to be reconsidered.

Interaction with other drugs

Telmisartan When telmisartan is used simultaneously with: other antihypertensive drugs: the antihypertensive effect may be enhanced. In one study, with the combined use of telmisartan and ramipril, an increase in AUC0-24 and Cmax of ramipril and ramiprilat was observed by 2.5 times. 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 trial, it was found that cough and angioedema were more often observed with ramipril therapy, while arterial hypotension was more common on therapy with telmisartan. Cases of hyperkalemia, renal failure, arterial hypotension and syncope were observed significantly more often with the combined use of telmisartan and ramipril; lithium preparations: a reversible increase in the concentration of lithium in the blood plasma was observed, 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. When using lithium preparations and ARA II simultaneously, it is recommended to determine the lithium content in the blood; non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid in doses used as an anti-inflammatory agent (not 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 OCC. Drugs that affect the RAAS may have a synergistic effect. In patients receiving NSAIDs and telmisartan, blood volume should be compensated and renal function monitored at the beginning of treatment. A decrease in the effect of antihypertensive agents, such as telmisartan, through inhibition of the vasodilatory effect of prostaglandins, has been observed when used together with NSAIDs. When telmisartan was taken concomitantly with ibuprofen or paracetamol, no clinically significant effect was observed; digoxin, warfarin, hydrochlorothiazide, glibenclamide, simvastatin and amlodipine: no clinically significant interaction was detected. There was an increase in the average concentration of digoxin in the blood plasma by an average of 20% (in one case by 39%). When using telmisartan and digoxin simultaneously, it is advisable to periodically determine the concentration of digoxin in the blood plasma. potassium-sparing diuretics, potassium supplements, other drugs that can increase the potassium level in the blood serum (for example, heparin), or replacing sodium in table salt with potassium salts can lead to hyperkalemia. Hydrochlorothiazide When used simultaneously with: ethanol, barbiturates or narcotic analgesics: 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 anion 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 (for example, norepinephrine): the effect of pressor amines may be weakened; non-depolarizing muscle relaxants (for example, tubocurarine chloride): hydrochlorothiazide may enhance the effect of non-depolarizing muscle relaxants; Antigout drugs: The concentration of uric acid in the blood serum may increase, and therefore changes in the dose of uricosuric drugs may be required. The use of thiazide diuretics increases the incidence of hypersensitivity reactions to allopurinol; calcium preparations: thiazide diuretics can increase the level 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 calcium level in the blood serum and, if necessary, change the dose of calcium supplements; beta-blockers and diazoxide: thiazide diuretics may potentiate the hyperglycemia caused by beta-blockers and diazoxide; m-anticholinergic blockers (for example, atropine, biperidine): decreased gastrointestinal motility, increased bioavailability of thiazide diuretics; amantadine: Thiazide diuretics may increase the risk of adverse effects caused by amantadine; cytotoxic drugs (for example, cyclophosphamide, methotrexate): reducing the renal excretion of cytotoxic drugs and enhancing their myelosuppressive effect; NSAIDs: simultaneous use with thiazide diuretics may lead to a decrease in diuretic and antihypertensive effect; drugs that lead to potassium excretion 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 potassium content in the blood plasma when using Telsartan N simultaneously with drugs that can cause hypokalemia, as well as with drugs that can increase the potassium content in the blood serum. Dual 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 (digitalis glycosides, antiarrhythmic drugs), the level of potassium in the blood serum should be regularly monitored and changes on the ECG should be monitored. 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, trifluoroperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol and droperidol) other drugs (bepridil, cisapride, difemanil, erythromycin for intravenous administration, halofantine, mizolastine, pentamidine, sparfloxacin, terfenadine, vincamine for intravenous administration) A predisposing factor for the development of polymorphic ventricular tachycardia of the “pirouette” type is hypokalemia, Impact on the ability to drive vehicles and work with mechanisms that require increased attention Special clinical studies to assess the effect The drug Telsartan N has not been tested on the ability to drive vehicles and operate mechanisms that require increased attention. However, when driving vehicles and engaging in hazardous activities, the possibility of 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 hypocapemia, hypercalcemia. Persistent hypokalemia, hypercalcemia. In case of rare hereditary intolerance to any of the components of the drug. Concomitant use with drugs containing aliskiren in patients with diabetes mellitus or impaired renal function (GFR

Compound

Active ingredients: telmisartan - 80 mg (for dosage 80/12.5 mg) or 40 mg (for dosage 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 a telmisartan overdose may be a pronounced decrease in blood pressure, tachycardia and/or bradycardia. An overdose of hydrochlorothiazide is accompanied by 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 may lead to muscle spasms and/or worsen cardiac arrhythmias caused by concomitant use of cardiac glycosides or certain antiarrhythmic drugs. Treatment: symptomatic and supportive therapy, the nature of which depends on the time elapsed since taking the drug and the severity of the symptoms. It is recommended to induce vomiting and/or perform gastric lavage and take activated charcoal. Frequent monitoring of electrolyte levels and serum creatinine concentrations is necessary. If arterial hypotension develops, the patient should be placed on his back and quickly undergo therapy aimed at replacing electrolytes and blood volume. Telmisartan is not removed by hemodialysis. The extent to which hydrochlorothiazide is removed during hemodialysis has not been established.

Side effect

1) expected based on experience with telmisartan; 2) expected based on experience with hydrochlorothiazide; 3) side effects that were not observed in clinical studies with the simultaneous use of telmisartan and hydrochlorothiazide, but are expected during the use of the drug Telsartan N. Allergic reactions: angioedema (including fatal cases)3) erythema3), pruritus3), rash3) , urticaria3), anaphylactic reactions1),2), allergic reactions1), eczema1), drug rash1),2), toxic epidermal necrosis1),2), toxic skin rash1), lupus-like skin manifestations2), exacerbation or intensification of skin symptoms of systemic erythematosus lupus3), necrotizing vasculitis2), cutaneous vasculitis2), photosensitivity reaction2), worsening or exacerbation of systemic lupus erythematosus2) necrotizing angiitis (vasculitis)2). From the central nervous system: fainting/presyncope3), paresthesia3) sleep disturbances3), insomnia3), dizziness2)3), anxiety3), depression3), increased excitability2) From the skin: increased sweating3) From the urinary system: renal failure , including acute renal failure1), interstitial nephritis2),