Telsartan N pills 12.5mg+40mg, 28pcs

Composition

1 tablet 12.5 mg+40 mg contains: Active ingredients:

• Hydrochlorothiazide 12.50 mg
• Telmisartan 40.00 mg

Auxiliary substances:

• Meglumine
• Sodium Hydroxide
• Povidone K 30
• Polysorbate-80
• Mannitol
• Lactose monohydrate
• Magnesium Stearate
• Iron oxide red dye (E 172).

Pharmacological action

Pharmacodynamicatelsartan® H is a combination of telmisartan (an angiotensin II receptor antagonist) and a hydrochlorothiazide – thiazide diuretic. The simultaneous use of these components leads to a greater antihypertensive effect than the use of each of them separately. Taking Telsartan® H once a day leads to a significant gradual decrease in blood pressure (BP). Telmisartan Telmisartan is a specific angiotensin II receptor antagonist that is 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. Displaces angiotensin II from binding to the receptor, without showing agonist properties with respect to this receptor. Telmisartan binds only to the AT1 subtype of angiotensin II receptors. The relationship is long-term. It has no affinity for other receptors, including the AT2 receptor and other less well-studied angiotensin receptors. The functional significance of these receptors, as well as the effect of their possible overstimulation with angiotensin II, the concentration of which increases with the appointment of telmisartan, have not been studied. Telmisartan reduces the concentration of aldosterone in the blood plasma, does not inhibit renin in the blood plasma and does not block ion channels. Telmisartan does not inhibit the angiotensin-converting enzyme (kininase II), which also catalyzes the degradation of bradykinin. Therefore, an increase in bradykinin-induced side effects is not expected. 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 noted within 3 hours after the first oral use of telmisartan. The effect of the drug persists 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 with 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 “withdrawal”syndrome. The telmisartan trial evaluated cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for chronic heart failure. A reduction in cardiovascular morbidity and mortality has been shown in patients at high cardiovascular risk (with a history of coronary artery disease, stroke, peripheral artery disease, or diabetes mellitus with concomitant target organ damage, such as retinopathy, left ventricular hypertrophy, and macro – or microalbuminuria) over the age of 55 years. 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 the volume of circulating blood (BCC), an increase in plasma renin activity, an increase in aldosterone secretion, followed 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. When taken concomitantly with telmisartan, there is a tendency to stop the loss of potassium caused by these diuretics, presumably due to blockade of the renin-angiotensin-aldosterone system (RAAS). After oral use, 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 developing complications of cardiovascular diseases and mortality from them. Maximum antihypertensive effect of Telsartan® H is usually reached 4 weeks after the start of treatment. Pharmacokinetics The concomitant use of telmisartan and hydrochlorothiazide does not affect the pharmacokinetics of each of the components of the drug. Telmisartan is rapidly absorbed from the gastrointestinal tract when taken orally. Bioavailability is approximately 50%. The peak concentration occurs in about 0.5-1.5 hours. When taken simultaneously with food, the decrease in the area under the pharmacokinetic curve “concentration-time” (AUC) ranges from 6% (at a dose of 40 mg) to 19% (at a dose of 160 mg).3 hours after ingestion, the concentration in the blood plasma is equalized regardless of food intake. There is a difference in the plasma concentrations of telmisartan in men and women. The maximum plasma concentration (Cmax) is approximately 3-fold and the AUC is approximately 2-fold higher in women compared to men with no significant effect on efficacy. However, an increase in the hypotensive effect is not observed in women. The association with plasma proteins is significant (more than 99.5%), mainly with albumin and alpha-1-acid glycoprotein. The volume of distribution is approximately 500 liters. Telmisartan is metabolized by conjugation with glucuronic acid. The metabolites are pharmacologically inactive. The half-life (T1 / 2) is more than 20 hours. It is excreted through the intestines in unchanged form, excretion by the kidneys – less than 2%. Total plasma clearance is high (about 900 ml / min). Elderly patientsthe pharmacokinetics of telmisartan in elderly patients do not differ from young patients. No dose adjustment is required. Patients with renal insufficiency No dose adjustment of telmisartan is required in patients with renal insufficiency, including patients on hemodialysis. Telmisartan is not removed by hemodialysis. Patients with hepatic insufficiency pharmacokinetic studies in patients with hepatic insufficiency have shown an increase in absolute bioavailability to almost 100%. With hepatic insufficiency, T 1/2 does not change (see the section “Dosage and use”). Hydrochlorothiazide After oral use of Telsartan® H, the maximum concentration of hydrochlorothiazide in blood plasma is reached within 1-3 hours. Absolute bioavailability is about 60% (based on total renal excretion). Plasma proteins bind 64% of hydrochlorothiazide, and the volume of distribution is 0.8±0.3 l / kg. Hydrochlorothiazide is not metabolized in the body and is excreted by the kidneys almost unchanged. About 60% of the oral dose is eliminated within 48 hours. The renal clearance of about 250-300 ml / min of T1 / 2 hydrochlorothiazide is 10-15 hours. There is a difference in plasma concentrations in men and women. In women, the concentration of telmisartan in plasma is 2-3 times higher than in men; also, in women, there is a tendency to a clinically insignificant increase in blood plasma concentrations of hydrochlorothiazide. Patients with renal insufficiency 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 showed that T1 / 2 of hydrochlorothiazide increases. In patients with reduced renal function, T1 / 2 is about 34 hours.

Indications

Arterial hypertension (in case of ineffectiveness of telmisartan or hydrochlorothiazide in monotherapy).

Use during pregnancy and lactation

Use of Telsartan® H is contraindicated during pregnancy. Telmisartan The use of angiotensin II receptor antagonists during the first trimester of pregnancy is not recommended, and these drugs should not be prescribed during pregnancy. If pregnancy is diagnosed, the drug should be stopped immediately. If necessary, alternative therapy (other classes of antihypertensive drugs approved for use during pregnancy) should be used. The use of angiotensin II receptor antagonists during the second and third trimesters of pregnancy is contraindicated. In preclinical studies of telmisartan, no teratogenic effect was observed, but fetotoxicity was established. It is known that exposure to angiotensin II receptor antagonists during the second and third trimesters of pregnancy causes fetotoxicity in humans (decreased renal function, oligohydramnios, slowing of ossification of the skull bones), as well as neonatal toxicity (renal failure, hypotension, hyperkalemia). Patients planning pregnancy should be given alternative therapy. If treatment with angiotensin II receptor antagonists occurred during the second trimester of pregnancy, ultrasound examination of the fetal kidneys and skull bones is recommended. Newborns whose mothers have received angiotensin II receptor antagonists should be carefully monitored for hypotension. The experience of using hydrochlorothiazide during pregnancy, especially during the first trimester, is limited. Hydrochlorothiazide penetrates the placental barrier. Taking into account the pharmacological mechanism of action of hydrochlorothiazide, it is assumed that its use during the second and third trimesters of pregnancy can disrupt fetoplacental perfusion and cause such changes in the embryo and fetus as jaundice, impaired water-electrolyte balance and thrombocytopenia. Hydrochlorothiazide should not be used for edema of pregnant women, arterial hypertension of pregnant women, or during preeclampsia, since there is a risk of a decrease in blood plasma volume and a decrease in placental perfusion, and there is no favorable effect in these clinical situations. Hydrochlorothiazide should not be used for the treatment of essential hypertension in pregnant women, except in rare situations when other types of treatment cannot be used. Telsartan®therapy H is contraindicated during breastfeeding. In animal studies, the effects of telmisartan and hydrochlorothiazide on fertility were not observed. Studies of the effect on human fertility have not been conducted.

Contraindications

• Hypersensitivity to active substances or auxiliary components of the drug or other derivatives of sulfonamides.

• Obstructive diseases of the biliary tract.

• Severe hepatic impairment (Child-Pugh class C).

• Severe renal impairment (creatinine clearance less than 30 ml / min).

• Refractory hypokalemia, hypercalcemia.

• Concomitant use with aliskiren and drugs containing aliskiren in patients with diabetes mellitus and/or moderate to severe renal impairment (glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2 of body surface area).

• Concomitant use with angiotensin converting enzyme (ACE) inhibitors in patients with diabetic nephropathy.

• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.

• Pregnancy.

• Breast-feeding period.

• Age up to 18 years (efficacy and safety have not been established).

With caution:

• Bilateral renal artery stenosis or stenosis of the artery of a single kidney (see the section “Special

• instructions”).

• Impaired liver function or progressive liver disease (Child-Pugh class A and B) (see section “Special instructions”).

• Reduced BCC due to previous diuretic therapy, restriction of salt intake, diarrhea or vomiting.

• Hyperkalemia.

• Condition after kidney transplantation (no experience of use).

• Chronic heart failure (CHF) is functional class III-IV (FC) according to the classification of the New York Heart Association (NYHA).

• Hypercalcemia.

• Hypercholesterolemia.

• Hypertriglyceridemia.

• Coronary heart disease.

• Progressive liver diseases (risk of developing hepatic coma).

• Aortic and mitral valve stenosis.

• Idiopathic hypertrophic subaortic stenosis.

• Hypertrophic obstructive cardiomyopathy (HOCMP).

• Diabetes mellitus.

• Primary aldosteronism.

• Gout, hyperuricemia.

• Systemic lupus erythematosus.

• Secondary angle-closure glaucoma (due to the presence of hydrochlorothiazide in the composition).

• Use in patients of the black race.

• Experience with use in patients with renal insufficiency (creatinine clearance more than 30 ml/min) is limited, but does not confirm the development of side effects from the kidneys and dose adjustment is not required.

Side effects

Side effects reported with the combination of telmisartan and hydrochlorothiazi Dethe total frequency of side effects reported with the combination of telmisartan and hydrochlorothiazide was comparable to the frequency of side effects observed with telmisartan monotherapy in controlled trials involving 1,471 patients randomly assigned to telmisartan + hydrochlorothiazide (835 patients) or telmisartan alone (636). No dose, gender, age, or race-related side effects have been established. All side effects that occur when using a combination of telmisartan and hydrochlorothiazide with a frequency higher than that of placebo (p < 0.05) are presented below in accordance with the organ-system classes. Frequency of occurrence: very common (≥1/10); common (≥1/100 – <1/10); uncommon (≥1/1000 – <1/100); rare (≥1/10000 – <1/1000); very rare ( Adverse reactions are listed in descending order of severity. Infectious and parasitic diseases: bronchitis, pharyngitis, sinusitis. Immune system disorders Rarely: exacerbation or worsening of symptoms of systemic lupus erythematosus 1. Metabolic and nutritional disorders Infrequently: hypokalemia. Rarely: hyperuricemia, hyponatremia. Mental disorders often: anxiety. Rare: depression. Nervous system disorders often: syncope/syncope, paresthesia. Rare: insomnia, sleep disorders. Visual disturbances Occasionally: visual disturbances, transient blurred vision. Hearing disorders and labyrinthine disorders often: vertigo. Disorders of the heart often: tachycardia, arrhythmia. Vascular disorders often: hypotension, orthostatic hypotension. Respiratory, thoracic, and mediastinal disorders often: shortness of breath. Rare: respiratory distress syndrome (including pneumonia and non-cardiogenic pulmonary edema). Disorders of the gastrointestinal tract often: diarrhea, dry mouth, flatulence. Rare: abdominal pain, constipation, dyspepsia, vomiting, gastritis. Liver and biliary tract disorders Rare: impaired liver function 2. Skin and subcutaneous tissue disorders Rare: angioedema (including fatal cases), erythema, pruritus, rash, increased sweating, urticaria. Musculoskeletal and connective tissue disorders often include back pain, muscle spasms, and myalgia. Rare: arthralgia, muscle cramps, calf pain. Disorders of the genitals and mammary gland often: erectile dysfunction. General disorders and disorders at the injection site often: chest pain. Rare: flu-like syndrome, pain. Laboratory and instrumental datanecasto: increased uric acid concentration in blood plasma. Rarely: increased concentration of creatinine in blood plasma, increased activity of creatine phosphokinase in blood plasma, increased activity of “liver” enzymes. 1 – based on post-marketing experience. 2-see the section “Description of individual adverse reactions”. Additional information on experience with the use of individual active ingredients: Side effects previously observed with each of the components of the drug can potentially be observed with the use of a combination of telmisartan and hydrochlorothiazide, even if they were not observed in the study of this combination. Telmisartan The frequency of side effects with telmisartan is similar to that with placebo. In placebo-controlled trials, the overall frequency of side effects observed with telmisartan (41.4%) is usually comparable to the frequency of side effects with placebo (43.9%). The following side effects are based on the results of all clinical trials involving patients treated with telmisartan for hypertension or based on the results of telmisartan use in patients 50 years of age and older with a high risk of developing cardiovascular events. Infectious and parasitic diseases often: upper respiratory tract infections, urinary tract infections, including cystitis. Rare: sepsis, including fatal cases. Blood and lymphatic system disorders often: anemia. Rare: eosinophilia, thrombocytopenia. Immune system disorders Occasionally: hypersensitivity reactions, anaphylactic reactions. Metabolic and nutritional disorders often: hyperkalemia. Rare: hyperglycemia (in patients with diabetes mellitus). Disorders of the heart often: bradycardia. Disorders of the nervous system Occasionally: drowsiness. Respiratory, thoracic, and mediastinal disorders often: cough. Very common: interstitial lung disease 3. Disorders of the gastrointestinal tract Rare: feeling of discomfort in the stomach. Skin and subcutaneous tissue disorders Rarely: eczema, drug-induced and toxic rash. Musculoskeletal and connective tissue disorders Rarely: osteoarthritis, tendon pain. Renal and urinary tract disorders Often: impaired renal function (including acute renal failure). General disorders and disorders at the injection site often: asthenia. Laboratory and instrumental DATAEREDKO: reduction of hemoglobin levels. 3-see the section “Description of individual adverse reactions”. Hydrochlorothiazide The use of hydrochlorothiazide can lead to the occurrence or exacerbation of hypovolemia, which can cause an electrolyte imbalance. The following are the adverse reactions observed with the use of hydrochlorothiazide in monotherapy. It is not possible to determine the frequency of such reactions. Infectious and parasitic diseasessialoadenitis. Disorders of the blood and lymphatic systemaplastic anemia, hemolytic anemia, bone marrow dysfunction, leukopenia, neutropenia, agranulocytosis, thrombocytopenia. Disorders of the immune systemanaphylactic reactions, hypersensitivity. Endocrine system disorders Uncontrolled diabetes mellitus. Metabolic and nutritional disordersanorexia, decreased appetite, electrolyte imbalance, hypercholesterolemia, hyperglycemia, hypovolemia. Mental disorders: perseverance.Nervous system disorde Rshigh dizziness. Xanthopsy, acute myopia, acute angle-closure glaucoma. Vascular disorders necrotizing vasculitis. Disorders of the gastrointestinal tract Pancreatitis, feeling of discomfort in the stomach. Disorders of the liver and biliary tract: hepatic jaundice, cholestatic jaundice. Disorders of the skin and subcutaneous tissue Cell-like syndrome, photosensitivity reactions, cutaneous vasculitis, toxic epidermal necrolysis. Disorders of the musculoskeletal system and connective tissue weakness. Disorders of the kidneys and urinary tratesinterstitial nephritis, impaired renal function, glucosuria. General disorders and disorders at the injection site: Pyrexia. Laboratory and instrumental dataincrease of triglyceride levels. Description of selected adverse reactio Nshepatic impairment Most cases of hepatic impairment following post-marketing use of telmisartan have been reported in patients in Japan. Apparently, these undesirable effects are more typical for this group of patients. Sepsis In the PRoFESS study, an increased incidence of sepsis was observed with telmisartan compared to placebo. The data obtained can be considered a random find, since the mechanism of the relationship is unknown. Interstitial lung diseas Ecases of interstitial lung disease were recorded during post-marketing use of telmisartan and coincided in time with the period of its use. However, a causal relationship between these events has not been established.

Interaction

Telmisartan

Antihypertensive agents

It is possible to increase the antihypertensive effect. In one study, a 2.5-fold increase in AUC0-24 and Cmax of ramipril and ramiprilate was observed with the combined use of telmisartan and ramipril. The clinical significance of this interaction has not been established.

When analyzing the adverse events that led to discontinuation of treatment and analyzing the 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, hypotension, and syncope were significantly more common when telmisartan and ramipril were co-administered.

Lithium preparations

There was a reversible increase in the concentration of lithium in blood plasma, accompanied by toxic phenomena when taking ACE inhibitors.

In rare cases, such changes have been reported with the use of angiotensin II receptor antagonists, in particular, telmisartan. With simultaneous use of lithium preparations and angiotensin II receptor antagonists, it is recommended to determine the lithium content in the blood.

Nonsteroidal anti-inflammatory drugs (NSAIDs)

NSAIDs, including acetylsalicylic acid in doses used as an anti-inflammatory agent, cyclooxygenase-2 (COX-2) inhibitors, and non-selective NSAIDs, may cause 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 and renal function monitored at the beginning of treatment.

A reduction in the effect of antihypertensive agents, such as telmisartan, by inhibiting the vasodilating effect of prostaglandins was observed when combined with NSAIDs. No clinically significant effect was observed when telmisartan was co-administered with ibuprofen or paracetamol.

Digoxin, warfarin, hydrochlorothiazide, glibenclamide, simvastatin and amlodipine

There was no clinically significant interaction. There was an increase in the average concentration of digoxin in blood plasma by an average of 20% (in one case by 39%). With simultaneous use of telmisartan and digoxin, it is advisable to periodically determine the concentration of digoxin in blood plasma.

Aliskiren, aliskiren-containing drugs

Clinical data have shown that double blockade of the RAAS, through co-use with ACE inhibitors, angiotensin II receptor blockers or aliskiren, is associated with a high frequency of side effects, such as hypotension, hyperkalemia, decreased renal function (including acute renal failure), compared with the use of a single active RAAS blocker.

Hydrochlorothiazide

Ethanol, barbiturates or narcotic analgesics

Risk of orthostatic hypotension.

Hypoglycemic agents for oral use and insulin

Dose adjustment of oral hypoglycemic agents and insulin may be required.

Metformin

Risk of developing lactic acidosis.

Colestyramine and colestipol

In the presence of anionic exchange resins, the absorption of hydrochlorothiazide is disrupted.

Cardiac glycosides

The risk of hypokalemia or hypomagnesemia caused by thiazide diuretics, the development of arrhythmias caused by taking cardiac glycosides.

Pressor amines (e. g., norepinephrine)

The effect of pressor amines may be weakened.

Non-depolarizing muscle relaxants (e. g. tubocurarine chloride)

Hydrochlorothiazide may enhance the effect of non-depolarizing muscle relaxants.

Anti-gouty remedies

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 frequency of hypersensitivity reactions to allopurinol.

Calcium supplements and vitamin D

Thiazide diuretics may increase the serum calcium content due to a decrease in its excretion by the kidneys. If you need to use calcium supplements, you should regularly monitor the serum calcium content 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-holinoblokatorov (for example, atropine, biperidene)

Reduced gastrointestinal motility, increased bioavailability of thiazide diuretics.

Amantadine

Clearance of amantadine can be reduced by hydrochlorothiazide, which leads to an increase in the concentration of amantadine in blood plasma and possible toxicity.

Cytotoxic agents (e. g. cyclophosphamide, methotrexate)

Reduction of renal excretion of cytotoxic agents and enhancement of their myelosuppressive effect.

NSAIDs

Concomitant use with thiazide diuretics may lead to a decrease in the diuretic and antihypertensive effect.

Drugs that lead to the elimination of potassium and hypokalemia

Such drugs as diuretics that remove potassium; laxatives; glucocorticosteroids; calcitonin; adrenocorticotropic hormone (ACTH); glycyrrhizic acid (found in licorice root); amphotericin B; carbenoxolone; benzylpenicillin: acetylsalicylic acid derivatives) can lead to an increased hypokalemic effect. Hypokalemia caused by hydrochlorothiazide is compensated by the potassium-sparing effect of telmisartan.

Theophylline

Increased risk of hypokalemia.

Amiodarone

Concomitant use with thiazide diuretics may increase the risk of arrhythmias associated with hypokalemia.

Potassium-sparing diuretics, potassium preparations, and other drugs that can increase the level of potassium in the blood serum (for example, heparin)

These drugs, as well as the replacement of sodium in table salt with potassium salts, can lead to hyperkalemia.

It is recommended to periodically monitor the potassium content in the blood plasma with simultaneous use of Telsartan® H with drugs that can cause hypokalemia, as well as with drugs that can increase the content of potassium in the blood serum.

How to take, course of use and dosage

Inside, regardless of food intake. Telsartan® H should be taken once a day. Telsartan ® H (12.5 mg + 40 mg) can be prescribed to patients in whom monotherapy with telmisartan at a dose of 40 mg or monotherapy with hydrochlorothiazide does not lead to adequate blood pressure control. Telsartan ® H (12.5 mg + 80 mg) can be prescribed to patients in whom monotherapy with telmisartan at a dose of 80 mg or Telsartan® H (12.5 mg + 40 mg) does not lead to adequate blood pressure control. In patients with severe hypertension, the maximum daily dose of telmisartan is 160 mg / day. This dose was well tolerated and effective. Renal dysfunction The limited experience of using the combination of hydrochlorothiazide and telmisartan in patients with mild or moderate renal impairment does not require dose changes in these cases. In such patients, renal function should be monitored (if creatinine clearance is less than 30 ml / min, see section “Contraindications”). Hepatic impairment In patients with mild to moderate hepatic impairment (Child-Pugh Class A and B), the daily dose of Telsartan®is indicated. H should not exceed 12.5 mg + 40 mg per day (see section “Pharmacokinetics”). Elderly patients The dosage regimen does not require changes.

Overdose

No cases of overdose have been identified.

Possible symptoms of overdose consist of symptoms from the individual components of the drug.

Telmisartan – marked decrease in blood pressure, tachycardia, bradycardia.

Hydrochlorothiazide – disorders of the water-electrolyte balance of the blood (hypokalemia, hypochloremia), a decrease in BCC, which can lead to muscle spasms and / or increase disorders of the cardiovascular system: arrhythmias caused by the simultaneous use of cardiac glycosides or certain antiarrhythmic agents.

Treatment: symptomatic therapy, hemodialysis is ineffective. The degree of removal of hydrochlorothiazide during hemodialysis has not been established. Regular monitoring of the electrolyte content and serum creatinine concentration is necessary.

Description

Oval-shaped, biconvex, two-layer tablets, one layer from light pink to pink, the other layer from white to almost white with possible inclusions of pink color. On the white surface of the tablets there is a circle and embossed “T “and” 1 ” on different sides of it.

Special instructions

Conditions that increase the activity of RAASU in some patients, due to the suppression of RAAS activity, especially with the simultaneous use of drugs acting on this system, renal function is impaired (including acute renal failure). Therefore, therapy accompanied by such a double blockade of the RAAS (for example, when adding an angiotensin-converting enzyme (ACE) inhibitor or a direct renin-aliskiren inhibitor to angiotensin II receptor antagonists) should be carried out strictly individually and with regular monitoring of renal function, including periodic monitoring of serum potassium and creatinine levels. The use of thiazide diuretics in patients with impaired renal function may lead to azotemia. Periodic monitoring of renal function is recommended. Renovascular hypertension In patients with bilateral renal artery stenosis or stenosis of the artery of a single functioning kidney, the use of drugs that affect the RAAS increases the risk of developing severe arterial hypotension and renal failure. Impaired liver functionin patients with impaired liver function or progressive liver diseases, the drug containing hydrochlorothiazide and telmisartan should be used with caution, since even small changes in the water-electrolyte balance can contribute to the development of “hepatic” coma. Effects on metabolism and endocrine function patients with diabetes mellitus may need to change the dose of insulin or hypoglycemic agents for oral use. Latent diabetes mellitus may occur during therapy with thiazide diuretics. In some cases, the use of thiazide diuretics may lead to hyperuricemia and exacerbation of the course of gout. Patients with diabetes mellitus and additional cardiovascular risk, such as those with diabetes mellitus and coronary heart disease (CHD), may have an increased risk of myocardial infarction and sudden cardiovascular death when using blood pressure-lowering drugs such as angiotensin II receptor antagonists (ARA II) or ACE inhibitors. In patients with diabetes mellitus, CHD may be asymptomatic and therefore may be undiagnosed. In patients with diabetes mellitus, appropriate diagnostic tests, including an exercise test, should be performed before starting the use of a drug containing hydrochlorothiazide and telmisartan to detect and treat CHD. Acute myopia and secondary angle-closure glaucomahydrochlorothiazide, 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 an unexpected decrease in visual acuity or pain in the eyes, which typically occur within a few hours to several weeks after starting the drug. If left untreated, acute angle-closure glaucoma can lead to vision loss. The main treatment is to eliminate hydrochlorothiazide as quickly as possible. It should be borne in mind that if intraocular pressure remains uncontrolled, urgent conservative or surgical treatment may be required. Risk factors for acute angle-closure glaucoma include a history of allergy to sulfonamides or penicillin. Violations of the water-electrolyte balance When using a drug containing hydrochlorothiazide and telmisartan, 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 the water-electrolyte balance and acid-base state (hypokalemia, hyponatremia, and hypochloremic alkalosis). Warning signs for these disorders are dryness of the oral mucosa, thirst, general weakness, drowsiness, anxiety, myalgia or convulsive twitching of the calf muscles, muscle weakness, marked decrease in blood pressure, oliguria, tachycardia, and gastrointestinal disorders such as nausea or vomiting. Hypokalemia may occur with thiazide diuretics, but concomitant use of telmisartan may increase blood potassium levels. The risk of hypokalemia increases most in patients with cirrhosis of the liver, with increased diuresis, with a salt-free diet, as well as in the case of simultaneous use with glucocorticosteroids, calcitonin, ACTH (adrenocorthropic hormone), glycyrrhizic acid (found in licorice root). Telmisartan, which is part of the drug Telsartan®, on the contrary, can lead to hyperkalemia due to antagonism to angiotensin II receptors (subtype AT1). Although no clinically significant hyperkalemia has been reported with the combination of hydrochlorothiazide and telmisartan, it should be taken into account that risk factors for its development include renal and/or heart failure and diabetes mellitus. There is no evidence that a drug containing hydrochlorothiazide and telmisartan can reduce or prevent hyponatremia caused by taking diuretics. 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 violations of calcium metabolism) a transient and slight increase in the content of calcium in the blood serum. More severe hypercalcemia may be a sign of latent hyperparathyroidism. Thiazide diuretics should be discontinued before evaluating parathyroid function. Thiazide diuretics have been shown to increase the excretion of magnesium by the kidneys, which can lead to hypomagnesemia. In patients with ischemic heart disease, the use of any antihypertensive agent, in case of excessive lowering of blood pressure, can lead to myocardial infarction or stroke. Increased monitoring of patients with impaired uric acid metabolism is required; thiazides can reduce the amount of iodine binding to serum proteins, without showing signs of thyroid dysfunction; there is information about cases of photosensitivity when taking thiazide diuretics. If a photosensitivity reaction occurs during treatment, it is recommended to suspend treatment. If a decision is made to resume taking a diuretic, it is necessary to protect areas of the body that may be exposed to sunlight or ultraviolet rays of type A and avoid exposure to the sun; hydrochlorothiazide can increase the concentration of cholesterol and triglycerides in the blood; hydrochlorothiazide can give a positive result during doping control. Systemic lupus erythematosus has been reported with thiazide diuretics. Telsartan® H can, if necessary, be used in conjunction with other antihypertensive agents. Drugs containing hydrochlorothiazide and telmisartan are less effective in black patients. Special clinical trials to evaluate the effect of Telsartan® The ability to drive vehicles and work with mechanisms that require increased attention was not tested. However, when driving vehicles and engaging in dangerous activities, the possibility of dizziness and drowsiness should be taken into account, which requires caution.

Form of production

Tablets 12.5 / 40 mg and 12.5 / 80 mg.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children!

Shelf life

1 year

Active ingredient

Hydrochlorothiazide, Telmisartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension