Telpres Plus pills 80mg+12.5mg, 98pcs

Composition

Each 12.5 mg + 80 mg tablet contains: active ingredients: hydrochlorothiazide-12.50 mg, telmisartan-80.00 mg; excipients: mannitol – 327,70 mg, povidone-To 25 – 21,60 mg crospovidone – 40,0 mg, magnesium stearate – of 8.50 mg, meglumin – 24,00 mg, sodium hydroxide – of 6.70 mg, lactose monohydrate – 49,84 mg, microcrystalline cellulose – of 32.00 mg, hypromellose – 3,00 mg, carboximetilkrahmal sodium type a – 2,00 mg, iron oxide red (E 172) and 0.17 mg.

Pharmacological properties

Pharmacotherapeutic group: Combined antihypertensive agent (angiotensin II receptor antagonist + diuretic)ATX: C. 09. D. A. 07 Telmisartan in combination with diuretics Pharmacodynamics : Telpres Plus is a combination of telmisartan (an angiotensin II receptor antagonist) and a hydrochlorothiazide-thiazide diuretic. The simultaneous use of these components leads to a more pronounced antihypertensive effect than the use of each of them separately. Taking Telpres Plus once a day leads to a significant gradual decrease in blood pressure (BP). Telmisartan Telmisartan is a specific angiotensin II receptor antagonist (type AT1) 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 having an agonist effect on 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. Reduces the concentration of aldosterone in the blood, does not inhibit renin in the blood plasma and does not block ion channels. Telmisartan does not inhibit the angiotensin-converting enzyme (kininase II) (an enzyme that also breaks down bradykinin). Therefore, an increase in the side effects caused by bradykinin 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 hypertension, telmisartan reduces systolic and diastolic blood pressure( BP) 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. 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. The maximum antihypertensive effect of Telpres Plus is usually achieved 4-8 weeks after the start of treatment. Pharmacokinetics: The combined use of telmisartan and hydrochlorothiazide does not affect the pharmacokinetics of each of the components of the drug. Telmisartan: Absorption: When taken orally, it is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 50%. When taken simultaneously with food, the decrease in AUC (area under the concentration-time curve) ranges from 6% (at a dose of 40 mg) to 19% (at a dose of 160 mg). After 3 hours after ingestion, the concentration in the blood plasma is equalized regardless of food intake. Distribution due to plasma proteins – 99.5%, mainly with albumin and alpha-1 glycoprotein. The average apparent volume of distribution at equilibrium concentration is 500 liters. Metabolismmetabolized by conjugation with glucuronic acid. The metabolites are pharmacologically inactive. Elimination Half-life (T 1/2) – more than 20 hours. It is excreted through the intestines in unchanged form, excretion by the kidneys – less than 2% of the dose taken. Total plasma clearance is high (900 ml / min) compared to “hepatic blood flow” (about 1500 ml / min). Pharmacokinetics in special patient groups Gender differencesdifference in plasma concentrations in men and women is observed. Cmax (maximum concentration) and AUC were approximately 3 and 2 times higher in women compared to men, respectively, with no significant effect on efficacy. No dose adjustment is required. Elderly patientsthe pharmacokinetics of telmisartan in elderly patients do not differ from young patients. No dose adjustment is required. Patients with impaired renal function In patients with mild to moderate renal impairment, no dose adjustment of telmisartan is required. A lower initial dose of 20 mg / day is recommended for patients with severe renal insufficiency and patients undergoing hemodialysis. Telmisartan is not eliminated by hemodialysis. Patients with hepatic impairment pharmacokinetic studies in patients with hepatic insufficiency have shown an increase in the absolute bioavailability of telmisartan to almost 100%. With hepatic insufficiency, T 1/2 does not change. In patients with mild to moderate hepatic impairment (Child-Pugh class A and B), the daily dose of the drug should not exceed 40 mg. Hydrochlorothiazide: After oral use of Telpres Plus, the maximum concentrations of hydrochlorothiazide in plasma are reached within 1-3 hours. Absolute bioavailability, based on total renal excretion, is about 60%.64% of hydrochlorothiazide is bound by plasma proteins, 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. Renal clearance is about 250-300 ml/min. T 1 L of hydrochlorothiazide – 10-15 hours. There is a difference in plasma concentrations in men and women. In women, the concentration of telmisartan in the blood plasma is 2-3 times higher than in men, and in women there is a tendency to increase the concentration of hydrochlorothiazide in the blood plasma clinically insignificant. Patients with impaired renal function In patients with impaired renal function, the rate of elimination of hydrochlorothiazide is reduced. Studies conducted in patients with creatinine clearance (creatinine clearance) of 90 ml / min showed that T 1/2 of hydrochlorothiazide increases. In patients with reduced renal function, T 1/2 is about 34 hours.

Indications

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

Contraindications

-Hypersensitivity to active substances or auxiliary components of the drug or other derivatives of sulfonamides;- Pregnancy;- Breast-feeding period;- 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 in patients with diabetes mellitus and / or impaired renal function (glomerular filtration rate less than 60 ml / min/1.73 m2); – Concomitant use of ACE inhibitors in patients with diabetic nephropathy;- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;- 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 (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 functional class III-IV (FC) according to the classification of the New York Heart Association;- 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);- Diabetes mellitus;- Primary hyperaldosteronism;- Gout, hyperuricemia;- Systemic lupus erythematosus; – Secondary angle-closure glaucoma (due to the presence of hydrochlorothiazide);- Use in patients of the black race;- Experience with use in patients with renal impairment (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;- Concomitant use with ACE inhibitors or aliskiren; – Concomitant use with potassium preparations, potassium-sparing diuretics.

Side effects

1) expected on the basis of experience with telmisartan 2) expected on the basis of 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 Telpres metatarsal respiratory system disorders:respiratory distress syndrome (including pneumonia and non-cardiogenic pulmonary edema, shortness of breath). Cardiac disorders:arrhythmias 3), tachycardia 3), bradycardia 1). Vascular disorders:marked decrease in blood pressure (including orthostatic hypotension)3). Nervous system disorders:syncope / syncope 3), paresthesia 3), sleep disorders 3), insomnia 3), dizziness 3), increased excitability 2), headache 2). Mental disorders:anxiety 3), depression 3). Disorders of the gastrointestinal tract:Diarrhea 3), dry oral mucosa 3), flatulence 3), abdominal pain 3), constipation 3), vomiting 3), gastritis 3), decreased appetite 2), anorexia 2), hyperglycemia 2), hypercholesterolemia 2), pancreatitis 2), dyspepsia 1),2),3). Liver and biliary tract disorders:impaired liver function 3), jaundice (hepatocellular or cholestatic)2). Skin and subcutaneous tissue disorders:Eczema 1), drug rash 1),2), toxic epidermal necrosis 1),2), erythema 3), pruritus 3), rash 3), increased sweating 3), photosensitization reaction 2). Musculoskeletal and connective tissue disorders:back pain 3), muscle spasms 3), myalgia 3), arthralgia 3), calf muscle cramps 3), osteoarthritis 1), tendinitis-like symptoms 1), chest pain 3). Disorders of the blood and lymphatic system:iron deficiency anemia 1), aplastic anemia 2), hemolytic anemia 2), thrombocytopenia 1), eosinophilia 1), leukopenia 2), neutropenia/agranulocytosis 2), thrombocytopenia 2). Kidney and urinary tract disorders:renal failure 1),2), including acute renal failure 1), interstitial nephritis 2), glucosuria 2). Visual disorders:visual impairment 3), transient blurred vision 3), xanthopsia 2), acute angle-closure glaucoma 2), acute myopia 2). Genital and breast disorders:Impotence 3). Infectious and parasitic diseases:sepsis, including fatal cases 1), upper respiratory tract infections (bronchitis, pharyngitis, sinusitis)1),3), urinary tract infections (including cystitis)1), inflammation of the salivary glands 2). Influence on the results of laboratory and instrumental studies:increased plasma creatinine concentration 3), increased activity of “liver” enzymes 3), increased activity of creatine phosphokinase 3), increased activity of blood uric acid concentration 3), hypertriglyceridemia 2), hypokalemia 2),3), hypomagnesemia 2), hyperkalemia 1), hyponatremia 2),3), hyperuricemia 3), decreased BCC 2), hypoglycemia (in patients with diabetes mellitus)1), impaired glucose tolerance 2), decreased hemoglobin in the blood 1). Immune system disorders:angioedema (including fatal cases)3), anaphylactic reactions 1),2), lupus-like reactions 2), exacerbation or worsening of symptoms of systemic lupus erythematosus 3), necrotic vasculitis 2), systemic vasculitis 2), relapse of systemic lupus erythematosus 2), vasculitis 2). General disorders and disorders at the injection site:flu-like syndrome 3), fever 2), weakness 1),2).

Interaction

Telmisartan may increase the antihypertensive effect of other antihypertensive agents. Other types of interactions of clinical significance have not been identified. Co-use with digoxin, warfarin, hydrochlorothiazide, glibenclamide, ibuprofen, paracetamol, simvastatin and amlodipine did not result in clinically significant interactions. Double blockade of the renin-angiotensin-aldosterone system (RAAS)Concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal insufficiency (GFR less than 60 ml / min/1.73 m2 of body surface area) and is not recommended for other patients. Concomitant use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy. Data from clinical studies have shown that double blockade of the RAAS due to the combined use of ACE inhibitors, ARA II or aliskiren is associated with an increased frequency of adverse events, such as hypotension, hyperkalemia and impaired renal function (including acute renal failure), compared with the use of only one drug acting on the RAAS. The risk of hyperkalemia may increase when co-administered with other medications that may cause hyperkalemia (potassium-containing dietary supplements and salt substitutes containing potassium and potassium-sparing diuretics (spironolactone, eplerenone, triamterene or amiloride), nonsteroidal anti-inflammatory drugs (NSAIDs, including selective cyclooxygenase-2 (COX) inhibitors), heparin, immunosuppressants (cyclosporine, tacrolimus, trimethoprim)). If necessary, against the background of documented hypokalemia, the combined use of drugs should be carried out with caution and the content of potassium in blood plasma should be regularly monitored. Digoxin When telmisartan was co-administered with digoxin, an increase in the average Cmax of digoxin in blood plasma by 49% and the minimum concentration by 20% was noted. At the beginning of treatment, when selecting the dose and stopping treatment with telmisartan, the concentration of digoxin in the blood plasma should be carefully monitored to maintain it within the therapeutic range. Potassium-sparing diuretics or potassium-containing dietary supplementationsangiotensin II receptor antagonists, such as telmisartan, reduce the diuretic-induced potassium loss. Potassium-sparing diuretics, such as spironolactone, eplerenone, triamterene or amiloride, potassium-containing dietary supplements or salt substitutes can lead to a significant increase in the potassium content in blood plasma. If concomitant use is indicated, because there is documented hypokalemia, they should be used with caution and against the background of regular monitoring of potassium in the blood plasma. Lithium preparations When lithium preparations were co-administered with ACE and ARA II inhibitors, including telmisartan, a reversible increase in the concentration of lithium in blood plasma and its toxic effect occurred. If it is necessary to use this combination of drugs, it is recommended to carefully monitor the concentration of lithium in the blood plasma. Nonsteroidal anti-inflammatory drugs (NSAIDs)NSAIDs (including acetylsalicylic acid in doses used for anti-inflammatory treatment, COX-2 inhibitors and non-selective NSAIDs) may weaken the antihypertensive effect of ARA II. In some patients with impaired renal function (for example, patients with dehydration, elderly patients with impaired renal function), the combined use of ARA II and drugs that inhibit cyclooxygenase-2 may lead to further deterioration of renal function, including the development of acute renal failure, which is usually reversible. Therefore, the combined use of drugs should be carried out with caution, especially in elderly patients. Proper fluid intake should be ensured, and renal function indicators should also be monitored at the beginning of co-use and periodically thereafter. Diuretics (thiazide or loop diuretics)Previous treatment with high-dose diuretics, such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic), may lead to hypovolemia and the risk of hypotension at the start of telmisartan treatment. Other antihypertensive agents The effect of telmisartan may be enhanced by the combined use of other antihypertensive drugs. Based on the pharmacological properties of baclofen and amifostine, it can be assumed that they will enhance the therapeutic effect of all antihypertensive drugs, including telmisartan. In addition, orthostatic hypotension may increase with alcohol, barbiturates, narcotic drugs or antidepressants. Corticosteroids (for systemic use)Corticosteroids weaken the effect of telmisartan. Hydrochlorothiaz Ide when used concomitantly with: – ethanol, barbiturates or narcotic analgesics: risk of orthostatic hypotension; – hypoglycemic agents for oral use and insulin: dose adjustment of hypoglycemic agents for oral use and insulin may be required; – metformin: risk of 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 (for example, norepinephrine): it is possible to weaken the effect of pressor amines; – non-depolarizing muscle relaxants (for example, tubocurarin chloride): hydrochlorothiazide may enhance the effect of non-depolarizing muscle relaxants;- anti-gouty agents: the concentration of uric acid in the blood serum may increase and therefore it may be necessary to change the dose of uricosuric agents. 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 blood calcium content and, if necessary, change the dose of calcium supplements; – beta-blockers and diazoxide: thiazide diuretics can increase hyperglycemia caused by beta-blockers and diazoxide;- m-holinoblokatorami (for example, atropine, biperidine): reduction of motility of the gastrointestinal tract, increased bioavailability of thiazide diuretics;- amantadine: the clearance of amantadine may be reduced by hydrochlorothiazide, which leads to an increase in the concentration of amantadine in blood plasma and possible toxicity; – cytotoxic agents (for example, cyclophosphamide, methotrexate): a decrease in the renal excretion of cytotoxic agents and an increase in their myelosuppressive effect;- NSAIDs: combined 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 (for example, diuretics that remove potassium; laxatives; glucocorticosteroids, calcitonin, ACTH (adrenocorticotropic hormone), glycyrrhizic acid (found in licorice root), amphotericin B; carbenoxolone; benzylpenicillin; acetylsalicylic acid derivatives): 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 lead to an increased risk of arrhythmias associated with hypokalemia;- potassium-sparing diuretics, potassium preparations, other agents 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. Periodic monitoring of the potassium content in the blood plasma is recommended in cases where Telpres Plus is prescribed together with drugs that can cause hypokalemia, as well as with drugs that can increase the potassium content in the blood serum.

How to take, course of use and dosage

Inside, regardless of the meal time. The drug Telpres Plus should be taken 1 time a day. – Telpres Plus 12.5/40 mg may be prescribed to patients in whom the use of telmisartan 40 mg or hydrochlorothiazide does not lead to adequate blood pressure control. – Telpres Plus 12.5/80 mg may be prescribed to patients in whom the use of telmisartan 80 mg or Telpres Plus 12.5/40 mg does not lead to adequate blood pressure control. – Telpres Plus 25/80 mg may be prescribed to patients in whom the use of telmisartan 80 mg or Telpres Plus 12.5/40 mg does not lead to adequate blood pressure control. Telpres Plus 12.5 / 80 mg does not lead to adequate blood pressure control, or in patients whose condition was previously stabilized by telmisartan or hydrochlorothiazide when administered separately. In patients with severe hypertension, the maximum daily dose of telmisartan is 160 mg in combination with hydrochlorothiazide in a daily dose of 12.5-25 mg. Renal dysfu Nctionthe current limited experience with Telpres Plus in patients with mild to moderate renal impairment does not require a change in the dose of the drug 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 Telpres Plus should not exceed 12.5 / 40 mg per day (see section “Pharmacokinetics”). Elderly patients The dosage regimen does not require any changes.

Overdose

Information regarding overdose is limited. Possible symptoms of overdose consist of symptoms from the individual components of the drug. Telmisartan – the most significant – a pronounced decrease in blood pressure and tachycardia, bradycardia, dizziness, increased serum creatinine concentration and acute renal failure may also occur. 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. It is necessary to regularly monitor the content of electrolytes and creatinine in the blood serum. Hemodialysis is not effective.

Special instructions

Hepatic impairment The use of Telpres Plus is contraindicated in patients with cholestasis, biliary tract obstruction, or severe hepatic impairment (Child-Pugh Class C) (see section “Contraindications”), since telmisartan is mainly excreted in the bile. It is assumed that the hepatic clearance of telmisartan is reduced in such patients. In patients with mild or moderate hepatic impairment (Child-Pugh Class A and B), Telpres Plus should be used with caution (see section “With caution”). Renovascular hypertension: When treated with drugs acting on the RAAS, patients with bilateral arterial stenosis or stenosis of the artery of a single functioning kidney have an increased risk of severe hypotension and renal failure. Impaired renal function and kidney transplantationwith the use of Telpres Plus in patients with impaired renal function, periodic monitoring of the content of potassium and creatinine in blood plasma is recommended. There is no experience of clinical use of Telpres Plus in patients who have recently undergone kidney transplantation. The use of thiazide diuretics in patients with impaired renal function may lead to azotemia. Periodic monitoring of renal function is recommended. Decreased blood circulationsymptomatic hypotension, especially after the first use of Telpres Plus, may occur in patients with reduced BCC and / or plasma sodium levels during previous diuretic treatment, restriction of salt intake, diarrhea or vomiting. Such conditions (fluid and/or sodium deficiency) should be corrected before taking Telpres Plus. Dual blockade of the renin-angiotensin-aldosterone systemthe non-concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal insufficiency (glomerular filtration rate less than 60 ml / min/1.73 m2) (see section “Contraindications”). Concomitant use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy (see section “Contraindications”). As a result of RAAS suppression, hypotension, syncope, hyperkalemia, and impaired renal function (including acute renal failure) were noted in predisposed patients, especially with the combined use of several medications that also affect this system. Therefore, double blockade of RAAS (for example, while taking telmisartan with other RAAS antagonists) is not recommended. In cases where vascular tone and renal function depend primarily on the activity of the RAAS (for example, in patients with chronic heart failure or kidney disease, including renal artery stenosis, or stenosis of the artery of a single kidney), the appointment of drugs that affect this system may be accompanied by the development of acute arterial hypotension, hyperazotemia, oliguria, and in rare cases acute renal failure. Primary aldosteronism in patients with primary aldosteronism, treatment with antihypertensive drugs, the effect of which is carried out by inhibiting the RAAS, is usually ineffective. Aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathies Caution should be exercised when using Telpres Plus (as well as other vasodilators) in patients with aortic or mitral stenosis, as well as hypertrophic obstructive cardiomyopathy. 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. 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. Violations of the water-electrolyte balance When using the drug Telpres Plus, 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 (crampi), muscle weakness, marked decrease in blood pressure, oliguria, tachycardia, and gastrointestinal disorders such as nausea or vomiting. Hypokalaemia may occur with thiazide diuretics, but concomitant use of telmisartan may increase blood potassium levels. The risk of hypokalemia is most increased in patients with cirrhosis of the liver, with increased diuresis, with a salt-free diet, as well as in the case of simultaneous use of glucocorticosteroids, calcitonin, ACTH (adrenocorticotropic hormone), glycyrrhizic acid (found in licorice root), Telmisartan, which is part of the drug Telpres Plus, on the contrary, can lead to hyperkalemia due to antagonism to angiotensin II receptors (subtype AT 1). Although no clinically significant hyperkalemia has been reported with Telpres Plus, 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 Telpres Plus can reduce or prevent hyponatremia caused by 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 reactions 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. Ethnic differences ACE inhibitors, telmisartan, and other ARA II drugs seem to reduce blood pressure less effectively in black patients than in other races, possibly due to a greater predisposition to a decrease in renin activity in the population of these patients. However, as with other antihypertensive agents, an excessive decrease in blood pressure in patients suffering from ischemic cardiomyopathy or coronary heart disease can lead to the development of myocardial infarction or stroke. Influence on the ability to drive vehicles and mechanisms:No specific clinical studies have been conducted to evaluate the effect of Telpres Plus on the ability to drive vehicles and work with mechanisms that require increased attention. However, when driving vehicles and engaging in potentially dangerous activities, the possibility of dizziness and drowsiness should be taken into account, which requires caution.

Form of production

Tablets

Storage conditions

At a temperature not exceeding 25 °C, in the original packaging. Keep out of reach of children!

Shelf

life is 2 years.

Active ingredient

Hydrochlorothiazide, Telmisartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension