Telprez Plus, tablets 80 mg+25 mg 28 pcs

Indications

Hypertension (high blood pressure)Arterial hypertension (if telmisartan or hydrochlorothiazide is ineffective in monotherapy).

Active ingredient

Hydrochlorothiazide, Telmisartan

Composition

Each tablet of 25 mg + 80 mg contains:

Active ingredients:

Hydrochlorothiazide – 25.00 mg;

Telmisartan – 80.00 mg.

Auxiliary substances:

Mannitol – 327.70 mg;

Povidone-K25 – 21.60 mg;

Crospovidone – 20.0 mg;

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Magnesium stearate – 9.00 mg;

Meglumine – 24.00 mg;

Sodium hydroxide – 6.70 mg;

Lactose monohydrate – 99.67 mg;

Microcrystalline cellulose – 64.00 mg;

Hypromellose – 6.00 mg;

Sodium carboxymethyl starch;

Type A – 4.00 mg;

Iron oxide yellow (E 172) – 0.33 mg.

How to take, the dosage

Orally, regardless of the time of meals.

Telprez Plus must be taken once daily.

Telprez Plus 12.5/40 mg may be indicated in patients in whom the use of telmisartan 40 mg or hydrochlorothiazide does not adequately control BP.

– Telprez Plus 12.5/80 mg may be indicated in patients in whom the use of telmisartan 80 mg or Telprez Plus 12.5/40 mg does not adequately control BP.

– Telpres Plus 25/80 mg may be indicated in patients in whom the use of telmisartan 80 mg or Telpres Plus 12.5/80 mg does not adequately control BP, or in patients whose condition has previously been stabilized by telmisartan or hydrochlorothiazide when used separately.

In patients with severe arterial hypertension, the maximum daily dose of telmisartan is 160 mg in combination with hydrochlorothiazide at a daily dose of 12.5-25 mg.

Renal dysfunction

Limited experience with Telpras Plus in patients with mild to moderate renal dysfunction does not require a change in dose in these cases. Renal function should be monitored in such patients (if CK is less than 30 ml/min, see section “Contraindications”).

Hepatic disorders

In patients with mild to moderate hepatic impairment (Child-Pugh Class A and B), the daily dose of Telpras Plus should not exceed 12.5/40 mg daily (see “Pharmacokinetics” section).

Elderly patients

The dosing regimen does not need to be changed.

Interaction

Telmisartan

Telmisartan may increase the antihypertensive effect of other antihypertensive agents. Other interactions of clinical relevance have not been identified.

Combined use with digoxin, warfarin, hydrochlorothiazide, glibenclamide, ibuprofen, paracetamol, simvastatin and amlodipine does not lead to clinically significant interactions.

Double blockade of the renin-angiotensin-aldosterone system (RAAS)

The 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 body surface area) and is not recommended in other patients. Simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy.

The data from clinical studies have shown that dual RAAS blockade due to combined use of ACE inhibitors, ARA II or aliskiren is associated with an increased incidence of adverse events such as arterial hypotension, hyperkalemia and impaired renal function (including acute renal failure) compared to use of a single drug acting on RAAS alone.

The risk of hyperkalemia may increase when co-administered with Other medications that can cause hyperkalemia (potassium-containing supplements and salt substitutes containing potassium and potassium-saving diuretics (spironolactone, eplerenone triamterene or amiloride), nonsteroidal anti-inflammatory drugs (NSAIDs, including selective cyclooxygenase-2 (COX) inhibitors), heparin, immunosuppressants (cyclosporine, tacrolimus, trimethoprim)./i>. If necessary against the background of documented hypokalemia, co-administration of drugs should be performed with caution and plasma potassium content should be regularly monitored.

Digoxin

The co-administration of telmisartan with digoxin showed a 49% increase in mean plasma Cmax of digoxin and a 20% increase in minimum concentration. Plasma digoxin concentrations should be carefully monitored at initiation of treatment, dose selection, and discontinuation of telmisartan treatment to maintain them within the therapeutic range.

Kalium-saving diuretics or potassium-containing supplements

Angiotensin II receptor antagonists, such as telmisartan, reduce diuretic-induced potassium loss. Potassium-saving diuretics such as spironolactone, eplerenone, triamterene, or amiloride, potassium-containing supplements, or salt substitutes may result in a significant increase in plasma potassium. If concomitant use is indicated because there is documented hypokalemia, these should be used with caution and with regular monitoring of plasma potassium.

PLithium preparations

The co-administration of lithium preparations with ACE inhibitors and ARA II inhibitors, including telmisartan, has resulted in reversible increases in plasma lithium concentration and its toxic effects. It is recommended that plasma lithium concentrations be carefully monitored if this combination of drugs is necessary.

Non-steroidal anti-inflammatory drugs (NSAIDs)

. NSAIDs (including acetylsalicylic acid in doses used for anti-inflammatory treatment, COX-2 inhibitors and non-selective NSAIDs) may attenuate the antihypertensive effects of APA II. In some patients with impaired renal function (e.g., patients with dehydration, elderly patients with impaired renal function), coadministration of APA II and drugs that inhibit cyclooxygenase-2 may lead to further deterioration of renal function, including development of acute renal failure, which is usually reversible. Therefore, coadministration of drugs should be used with caution, especially in elderly patients. Adequate fluid intake should be ensured, and renal function parameters should be monitored at the beginning of coadministration and periodically thereafter.

Diuretics (thiazide or loop diuretics)

. Previous treatment with high doses of diuretics, such as furosemide (a loop diuretic) and hydrochlorothiazide (a thiazide diuretic), may lead to hypovolemia and risk of arterial hypotension at the start of telmisartan treatment.

Other antihypertensive agents

The effects of telmisartan may be enhanced by co-administration 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 agents, including telmisartan. In addition, orthostatic hypotension may be increased with alcohol, barbiturates, narcotics, or antidepressants.

Corticosteroids (for systemic use)

Corticosteroids impair the effects of telmisartan.

Hydrochlorothiazide

When used concomitantly with:

– ethanol, barbiturates, or narcotic analgesics: risk of orthostatic hypotension;

– hypoglycemic oral agents and insulin: dosage adjustment of oral hypoglycemic agents and insulin may be required;

–metformin: risk of developing lactic acidosis;

–colestyramine and colestipol: in the presence of anion exchange resins, absorption of hydrochlorothiazide is impaired;

– cardiac glycosides: risk of hypokalemia or hypomagnesemia caused by thiazide diuretics, development of arrhythmias caused by cardiac glycosides;

– presor amines (e.g., norepinephrine):possible attenuation of the effects of pressor amines;

– nondepolarizing myorelaxants (e.g., tubocurarine chloride): hydrochlorothiazide may increase the effect of nondepolarizing myorelaxants;

– antipodagric agents: serum uric acid concentrations may increase and therefore changes in the dose of uricosuric agents may be necessary. The use of thiazide diuretics increases the incidence of hypersensitivity reactions to allopurinol;

– ncalcium preparations and vitamin D: thiazide diuretics may increase serum calcium levels due to decreased renal excretion. If the use of calcium preparations is required, the calcium content in blood should be monitored regularly and, if necessary, the dose of calcium preparations should be changed;

Beta-adrenoblockers and diazoxide: thiazide diuretics may increase hyperglycemia caused by beta-adrenoblockers and diazoxide;

– choline blockers (e.g., atropine, biperidine): decreased gastrointestinal motility, increased bioavailability of thiazide diuretics;

– amantadine: clearance of amantadine may be reduced by hydrochlorothiazide, resulting in increased plasma concentrations of amantadine and possible toxicity;

– cytotoxic agents (e.g., cyclophosphamide, methotrexate): decreased renal excretion of cytotoxic agents and increased myelosuppressive effects;

– HPVP: co-administration with thiazide diuretics may result in decreased diuretic and antihypertensive effects;

– drugs that result in potassium excretion and hypokalemia (e.g., potassium withdrawing diuretics laxatives; glucocorticosteroids, calcitonin, ACTH (adrenocorticotropic hormone), glycyrrhizic acid (found in licorice root), amphotericin B; carbenoxolone; benzylpenicillin; acetylsalicylic acid derivatives)

– theophylline:increased risk of hypokalemia;

– amiodarone: concomitant use with thiazide diuretics may lead to increased risk of arrhythmias associated with hypokalemia;

– may lead to hyperkalemia.

Periodic monitoring of plasma potassium is recommended in cases where Telprez Plus is prescribed together with drugs that may cause hypokalemia, as well as with drugs that may increase serum potassium.

Special Instructions

Hepatic disorders

The use of Telpras Plus is contraindicated in patients with cholestasis, biliary obstruction or severe hepatic impairment (Child-Pugh class C) (see section “Contraindications”), since telmisartan is mainly excreted with bile. It is assumed that hepatic clearance of telmisartan is reduced in such patients. In patients with mild to moderate hepatic impairment (Child-Pugh grades A and B), Telpras Plus should be used with caution (see section “Caution”).

Renovascular Hypertension

The treatment with drugs acting on the RAAS increases the risk of severe arterial hypotension and renal failure in patients with bilateral arterial stenosis or arterial stenosis of the only functioning kidney.

Kidney dysfunction and renal transplantation

In patients with impaired renal function, periodic monitoring of plasma potassium and creatinine is recommended during use of Telprez Plus. There is no experience in the clinical use of Telprez Plus in patients with recent kidney transplantation.

The use of thiazide diuretics in patients with impaired renal function may lead to azotemia. Periodic monitoring of renal function is recommended.

Lower circulating blood volume

. Symptomatic arterial hypotension, especially after the first administration of Telprez Plus may occur in patients with reduced RBC and/or plasma sodium content on the background of previous treatment with diuretics, restriction of table salt intake, diarrhea or vomiting. Such conditions (fluid and/or sodium deficiency) should be eliminated before starting the drug Telprez Plus.

Double blockade of the renin-angiotensin-aldosterone system

. 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”).

The concomitant use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy (see section “Contraindications”).

As a result of RAAS inhibition, arterial hypotension, syncope, hyperkalemia and renal dysfunction (including acute renal failure) have been reported in predisposed patients, especially when several drugs that also act on this system are used together. Therefore, dual RAAS blockade (e.g., against the background of taking telmisartan with other RAAS antagonists) is not recommended.

. In cases when vascular tone and renal function are dependent predominantly on RAAS activity (e.g., in patients with chronic heart failure or renal disease, including renal artery stenosis or arterial stenosis of the sole kidney), the administration of agents affecting this system may be accompanied by development of acute arterial hypotension, hyperazotemia, oliguria, and in rare cases of acute renal failure.

Primary aldosteronism

In patients with primary aldosteronism, treatment with antihypertensive medications that work by inhibiting the RAAS is generally ineffective.

Aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathy

. Caution should be exercised when using Telpras Plus (as well as other vasodilators) in patients with aortic or mitral stenosis and hypertrophic obstructive cardiomyopathy.

Acute myopia and secondary closed-angle glaucoma

Hydrochlorothiazide, being a sulfonamide derivative, may cause an idiosyncratic reaction in the form of acute transient myopia and acute closed-angle glaucoma. Symptoms of these disorders are a sudden decrease in visual acuity or eye pain, which in typical cases occur within hours to weeks after the start of the drug. If left untreated, acute closed-angle glaucoma can lead to loss of vision. The main treatment is to withdraw hydrochlorothiazide as soon as possible. Keep in mind that if the intraocular pressure remains uncontrolled, urgent conservative or surgical treatment may be necessary. A history of allergy to sulfonamides or penicillin may be a risk factor for acute closed angle glaucoma.

Effects on metabolism and endocrine function

In patients with diabetes mellitus, a change in the dose of insulin or oral hypoglycemic agents may be required. Latent diabetes mellitus may manifest during therapy with thiazide diuretics.

In some cases thiazide diuretics may cause hyperuricemia and exacerbation of gout.

Disorders of water-electrolyte balance

When using Telpras Plus, as in case of diuretic therapy, periodic monitoring of serum electrolytes is required. Thiazide diuretics including hydrochlorothiazide may cause electrolyte and acid-base imbalance (hypokalemia, hyponatremia and hypochloremic alkalosis). Dry mouth, thirst, generalized weakness, sleepiness, restlessness, myalgia or cramping of the calves (crumpets), muscle weakness, markedly low blood pressure, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting are warning signs for these disorders.

The use of thiazide diuretics may result in hypokalemia, but concomitant use of telmisartan may increase blood potassium levels. The risk of hypokalemia is most increased in patients with cirrhosis, with increased diuresis, with a salt-free diet, as well as in case of concomitant use of glucocorticosteroids, calcitonin, ACTH (adrenocorticotropic hormone), glycyrrhizic acid (contained in licorice root), Telmisartan, a component of the drug Telprez Plus, on the contrary, may lead to hyperkalemia due to antagonism to angiotensin II receptors (AT1 subtype). Although clinically significant hyperkalemia has not been reported with the use of Telprez Plus, it should be taken into account that the risk factors of its development include renal and/or heart failure and diabetes mellitus.

There is no evidence that Telprez Plus can reduce or prevent hyponatremia caused by taking diuretics. Hypochloremia is usually mild and does not require treatment.

Thiazide diuretics may decrease renal calcium excretion and cause (in the absence of overt calcium metabolism disorders) a transient and small increase in serum calcium. More pronounced hypercalcemia may be a sign of hidden hyperparathyroidism. Thiazide diuretics should be discontinued before evaluation of parathyroid function.

Thiazide diuretics have been shown to increase renal excretion of magnesium, which may lead to hypomagnesemia.

In patients with coronary heart disease, use of any hypotensive agent, if the BP is reduced excessively, may lead to myocardial infarction or stroke.

Strengthened monitoring of patients with impaired uric acid metabolism is required; thiazides may decrease the amount of iodine bound to serum proteins without evidence of thyroid dysfunction; there are reported cases of photosensitivity reactions when taking thiazide diuretics. If a photosensitivity reaction occurs during treatment, it is recommended to suspend treatment. If it is decided that the diuretic should be restarted, areas of the body that could be exposed to sunlight or ultraviolet type A radiation should be protected and sun exposure should be avoided; hydrochlorothiazide can increase blood cholesterol and triglyceride concentrations; hydrochlorothiazide can test positive for doping control.

There have been reports of systemic lupus erythematosus when using thiazide diuretics.

Ethnic differences

The ACE inhibitors, telmisartan, and other ARAs II appear to be less effective in lowering blood pressure in black patients than in other races, perhaps because of a greater predisposition to lower renin activity in these patient populations.

Other

As with other antihypertensives, excessive BP lowering in patients with ischemic cardiomyopathy or coronary heart disease can lead to myocardial infarction or stroke.

Effects on ability to drive trans:

There have been no specific clinical studies evaluating the effect of Telprez Plus on the ability to drive motor vehicles and operate mechanisms requiring increased attention. However, when driving motor transport and engaging in potentially dangerous activities one should take into account the possibility of dizziness and somnolence, which requires caution.

Contraindications

• Hypersensitivity to the active ingredients or excipients of the drug or other sulfonamide derivatives;

• Pregnancy;

• Breastfeeding period;

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• Obstructive biliary tract disease;

• Severe liver function impairment (Child-Pugh class C);

• Severe renal dysfunction (CK less than 30 mL/min);

• Refractory hypokalemia, hypercalcemia;

• Concomitant use with aliskiren in patients with diabetes and/or impaired renal function (glomerular filtration rate less than 60 ml/min/1.73 m2);

• Concurrent use of ACE inhibitors in patients with diabetic nephropathy;

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

• Age <18 years (effectiveness and safety not established).

With caution:

• Bilateral renal artery stenosis or artery stenosis of the sole kidney (see

• Disorders of liver function (Child-Pugh Class A and B) (see section “Cautions”).

• Decreased blood pressure due to previous therapy with diuretics, restricted intake of table salt, diarrhea, or vomiting;

• Hyperkalemia;

• Status after kidney transplantation (no experience of use);

• Cronic heart failure III-IV functional class (FC) according to the classification of the New York Heart Association;

• Hypercalcemia;

• Hypercholesterolemia;

• Hypertriglyceridemia;

• Coronary heart disease;

• Progressive liver disease (risk of hepatic coma);

• Aortic and mitral valve stenosis;

• Idiopathic hypertrophic subaortic stenosis (hypertrophic obstructive cardiomyopathy); <

• Diabetes mellitus;

• Primary hyperaldosteronism;

• Gout, hyperuricemia;

• Systemic lupus erythematosus;

• Secondary closed angle glaucoma (due to the presence of hydrochlorothiazide);

• Use in non-HGM patients;

• Experience of use in patients with renal impairment (CK greater than 30 mL/min) is limited but does not support the development of renal adverse effects and no dose adjustment is required;

• Simultaneous use with ACE inhibitors or aliskiren;

• Simultaneous use with potassium preparations, potassium-saving diuretics.

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Side effects

1) expected based on experience with telmisartan;

2) expected based on experience with hydrochlorothiazide;

3) side effects not observed in clinical trials with simultaneous use of telmisartan and hydrochlorothiazide, but expected during administration of Telprez Plus.

Respiratory system disorders:

Respiratory distress syndrome (including pneumonia and noncardiogenic pulmonary edema)3), dyspnea3).

Cardiac disorders:

arrhythmias3), tachycardia3), bradycardia1).

Vascular disorders:

pronounced BP decrease (including orthostatic hypotension3).

Nervous system disorders:

syncope/fainting3), paresthesia3), sleep disturbances3), insomnia3), dizziness3), hyperexcitability2), headache2).

Mental disorders:

anxiety3), depression3).

Gastrointestinal disorders:

Diarrhea3), dry mouth3), flatulence3), abdominal pain3), constipation3), vomiting3), gastritis3), decreased appetite2), anorexia2), hyperglycemia2), hypercholesterolemia2), pancreatitis2), dyspepsia1),2),3).

Hepatic and biliary tract disorders:

Hepatic dysfunction3), jaundice (hepatocellular or cholestatic)2).

Hdisorders of the skin and subcutaneous tissue:

Eczema1), drug rash1),2), toxic epidermal necrosis1),2), erythema3), skin itching3), rash3), increased sweating3), photosensitization reaction2).

Muscular and connective tissue disorders:

back pain3), muscle spasms3), myalgia3), arthralgia3), calf muscle cramps3), arthrosis1), tendinitis-like symptoms1), chest pain3).

Disorders of the blood and lymphatic system:

Indeficiency anemia1), aplastic anemia2), hemolytic anemia2), thrombocytopenia1), eosinophilia1), leukopenia2), neutropenia/agranulocytosis2), thrombocytopenia2).

Renal and urinary tract disorders:

Renal failure1),2), including acute renal failure1), interstitial nephritis2), glucosuria2).

Visual disorders:

visual disturbances3), transient blurred vision3), xanthopsia2), acute closed-angle glaucoma2), acute myopia2).

Gender and mammary disorders:

Impotence3).

Infectious and parasitic diseases:

Sepsis, including fatal cases1), upper respiratory tract infections (bronchitis, pharyngitis, sinusitis)1),3), urinary tract infections (including cystitis)1), salivary gland inflammation2).

Influence on the results of laboratory and instrumental studies:

increased plasma creatinine concentration3), increased activity of “hepatic” enzymes3), increased activity of creatine phosphokinase3), increased activity of blood uric acid concentration3), hypertriglyceridemia2) hypokalemia2),3), hypomagnesemia2), hyperkalemia1), hyponatremia2),3), hyperuricemia3), decreased BOD2), hypoglycemia (in diabetic patients)1), impaired glucose tolerance2), decrease of hemoglobin in blood1).

Disorders of the immune system:

Angioneurotic edema (including fatal cases)3), anaphylactic reactions1),2), lupus-like reactions2), exacerbation or worsening of systemic lupus erythematosus symptoms3), necrotizing vasculitis2), systemic vasculitis2), relapse of systemic lupus erythematosus2), vasculitis2).

General disorders and disorders at the site of administration:

Flu-like syndrome3), fever2), weakness1),2).

Overdose

Information regarding overdose is limited. Possible symptoms of overdose consist of the symptoms of the individual components of the drug. Telmisartan – the most significant are marked BP decrease and tachycardia; bradycardia, dizziness, increased serum creatinine concentration and acute renal failure may also be observed.

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

Treatment: symptomatic therapy, hemodialysis is ineffective. The degree of removal of hydrochlorothiazide during hemodialysis has not been established. Regular monitoring of serum electrolytes and creatinine is necessary. Hemodialysis is not effective.

Similarities

Mycardis Plus, Telsartan N, Telprez, Telzap Plus, Telmista N, Mikafor