Telsartan N - instructions for use, doses, side effects, contraindications

meglumine 12.00 mg, sodium hydroxide 3.36 mg, povidone K30 13.55 mg, polysorbate 80 mg 0.65 mg, mannitol 235.94 mg, lactose monohydrate 43.75 mg, magnesium stearate 6.07 mg, iron dye oxide red (E172) 0.18 mg.

1 tablet of 12.5 mg + 80 mg contains:

Active substances: hydrochlorothiazide 12.50 mg telmisartan 80.00 mg

Excipients:

meglumine 24.00 mg, sodium hydroxide 6.72 mg, povidone K30 27.10 mg, polysorbate 80 mg 1.30 mg, mannitol 479.38 mg, lactose monohydrate 92.50 mg, magnesium stearate 12.15 mg, iron dye oxide red (E172) 0.35 mg.

Description:

Tablets 12.5 mg + 40 mg

Oval-shaped, biconcave, two-layered tablets, one layer from light pink to pink, another layer from white to almost white with possible inclusions of pink. On the white surface of the tablets there is a risk of stamping "T" and "1" on either side of it.

Tablets 12.5 mg + 80 mg

Oval-shaped, biconcave, two-layered tablets, one layer from light pink to pink, another layer from white to almost white with possible inclusions of pink. On the white surface of the tablets, there is a risk of stamping "T" and "2" on either side of it.

Pharmacotherapeutic group:A combined hypotensive drug (angiotensin II receptor antagonist + diuretic)

ATX: & nbsp

C.09.D.A.07 Telmisartan in combination with diuretics

Pharmacodynamics:

Telsartan® H 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. The administration of the drug Telsartan® H once a day leads to a significant gradual decrease in blood pressure (BP).

Telmisartan

Telmisartan is a specific angiotensin II receptor antagonist (type AT1), effective at ingestion. Has a high affinity for the subtype AT1 receptors of angiotensin II, through which the action of angiotensin II is realized.It displaces angiotensin II from the bond to the receptor without exhibiting the properties of an agonist for this receptor. Telmisartan binds only to a subtype AT1 receptors of angiotensin II. Communication is of a lasting nature. 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 with angiotensin II, whose concentration 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 the ion channels. Telmisartan does not inhibit the angiotensin-converting enzyme (kininase II), which also catalyzes the degradation of bradykinin. Therefore, the enhancement of bradykinin-induced side effects is not expected.

In patients with hypertension telmisartan in 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 reception of telmisartan inside. The effect of the drug persists for 24 hours and remains significant up to 48 hours.The pronounced antihypertensive effect usually develops 4 weeks after a regular intake preparation.

In patients with hypertension telmisartan reduces systolic and diastolic blood pressure, without affecting the heart rate (heart rate).

In the case of a sharp cancellation of telmisartan, blood pressure gradually returns to the initial level without the development of the "withdrawal" syndrome.

The telmisartan study evaluated cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, or hospitalization due to chronic heart failure. Cardiovascular morbidity and mortality have been shown to decrease in patients with high cardiovascular risk (coronary artery disease, stroke, peripheral arterial disease, or diabetes mellitus with concomitant lesion of target organs 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 chlorides (approximately in equivalent amounts).The diuretic effect of hydrochlorothiazide leads to a decrease in the volume of circulating blood (BCC), an increase in renin plasma activity, an increase in aldosterone secretion, followed by an increase in the potassium and hydrocarbonate levels in urine and, consequently, a decrease in potassium in the blood plasma. With simultaneous administration with telmisartan, there is a tendency to stop the loss of potassium caused by these diuretics, presumably due to the blockade of the renin-angiotensin-aldosterone system (RAAS). After intake, diuresis is intensified 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.

Prolonged use of hydrochlorothiazide reduces the risk of complications of cardiovascular diseases and mortality from them.

The maximum antihypertensive effect of Telsartan® H is usually reached 4 weeks after the start of treatment.

Pharmacokinetics:

The combined use of telmisartan and hydrochlorothiazide does not affect the pharmacokinetics of each component of the drug.

Telmisartan

When ingested quickly absorbed from the gastrointestinal tract. Bioavailability - approximately 50%. The peak concentration occurs in about 0.5-1.5 hours. When taken simultaneously with food, a decrease in the area under the pharmacokinetic curve "concentration-time" (AUC) ranges from 6% (when taking a dose of 40 mg) to 19% (with a dose of 160 mg). After 3 hours after ingestion, the concentration in the blood plasma levels out regardless of food intake. There is a difference in the concentrations of telmisartan in the blood plasma in men and women. The maximum concentration in the blood plasma (Cmah) approximately 3 times and AUC approximately 2 times higher in women than in men without a significant effect on efficacy. Nevertheless, there is no increase in the hypotensive effect in women.

The association with blood plasma proteins is significant (more than 99.5%), mainly with albumin and alpha-1-acid glycoprotein. The distribution volume is approximately 500 liters. Telmisartan is metabolized by conjugation with glucuronic acid. Metabolites are pharmacologically inactive. The half-life (T1 / 2) is more than 20 hours. Output through the intestine in an unchanged form, excretion by the kidneys - less than 2%. The total plasma clearance is high (about 900 ml / min).

Elderly patients

The pharmacokinetics of telmisartan in elderly patients does not differ from young patients. Dose correction is not required.

Patients with renal insufficiency

A change in the dose of telmisartan in patients with renal insufficiency is not required, including patients on hemodialysis. Telmisartan not removed by hemodialysis.

Patients with hepatic insufficiency

Studies of pharmacokinetics in patients with hepatic insufficiency showed an increase in absolute bioavailability to almost 100%. With hepatic insufficiency, T1 / 2 does not change {cm. See section "Dosing and Administration").

Hydrochlorothiazide

After ingestion of Telsartan® H, the maximum plasma concentrations of hydrochlorothiazide are reached within 1-3 hours. Absolute bioavailability is about 60% (based on total excretion by the kidneys). Proteins of blood plasma 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 ingested dose is eliminated within 48 hours.Kidney clearance is about 250-300 ml / min. 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 clinically insignificant increase in blood plasma concentrations of hydrochlorothiazide.

Patients with renal insufficiency

In patients with impaired renal function, the rate of excretion of hydrochlorothiazide is reduced.

Studies with patients with creatinine clearance of 90 ml / min showed that T1 / 2 hydrochlorothiazide increased. In patients with reduced renal function T1 / 2, about 34 hours.

Indications:

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

Contraindications:

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

- Pregnancy.

- Breastfeeding period

- Obstructive diseases of the biliary tract.

- Severe violations of liver function (class C on the Child-Pugh scale).

- Severe violations of kidney function (creatinine clearance less than 30 ml / min).

- Refractory hypokalemia, hypercalcemia.

- Simultaneous therapy with aliskiren in patients with diabetes mellitus and renal insufficiency (glomerular filtration rate (GFR) <60 ml / min / 1.73 m²).

- Deficiency of lactase, lactose intolerance, glucose-galactose malabsorption syndrome.

- Age to 18 years (effectiveness and safety not established).

Carefully:

- Two-sided stenosis of the renal arteries or stenosis of the artery of a single kidney (see section "Special instructions").

- Dysfunction of the liver or progressive liver disease (class A and B on the Child-Pugh scale) (see section "Special instructions").

- Reduction of BCC due to previous therapy with diuretics, limitations reception of table salt, diarrhea or vomiting.

- Hyperkalemia.

- Condition after kidney transplantation (no experience of application).

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

- Hypercalcemia.

- Hypercholesterolemia.

- Hypertriglyceridemia.

- Cardiac ischemia.

- Progressive liver disease (risk of hepatic coma).

- Stenosis of the aortic and mitral valve.

- Idiopathic hypertrophic subaortic stenosis.

- Hypertrophic obstructive cardiomyopathy (GOKMP).

- Diabetes.

- Primary aldosteronism.

- Gout, hyperuricemia.

- Systemic lupus erythematosus.

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

- The use of Negroid race in patients.

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

Pregnancy and lactation:

Tessartan® H is contraindicated during pregnancy.

Telmisartan

The use of angiotensin II receptor antagonists during the first trimester of pregnancy is not recommended, these drugs should not be administered during pregnancy. When diagnosing pregnancy, taking the drug should be stopped immediately. If necessary, alternative therapy should be used (other classes of antihypertensive drugs permitted for use during pregnancy). The use of angiotensin II receptor antagonists during the second and third trimesterspregnancy is contraindicated.

In preclinical studies of telmisartan, there was no teratogenic effect, but established fetotoxicity. It is known that the effect of angiotensin II receptor antagonists during the second and third trimesters of pregnancy causes a person to have fetotoxicity (decreased kidney function, oligohydramnion, slowing ossification of the skull bones), and neonatal toxicity (kidney failure, arterial hypotension, hyperkalemia). Patients planning a pregnancy should be prescribed alternative therapy. If treatment with angiotensin II receptor antagonists occurred during the second trimester of pregnancy, it is recommended to perform ultrasound examination of the kidneys and bones of the fetal skull.

Newborns whose mothers received angiotensin II receptor antagonists should be carefully monitored for arterial hypotension.

Hydrochlorothiazide

The experience with hydrochlorothiazide during pregnancy, especially during the first trimester, is limited.

Hydrochlorothiazide penetrates the placental barrier.Given the pharmacological mechanism of action of hydrochlorothiazide, it is expected 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, disturbances in water electrolyte balance and thrombocytopenia.

Hydrochlorothiazide should not be used for edema pregnant women with arterial hypertension in pregnant women or during pre-eclampsia, as there is a risk of reducing the volume of blood plasma and decrease placental perfusion, and a beneficial effect in these clinical situations absent.

Hydrochlorothiazide should not be used to treat essential hypertension in pregnant women, except in those rare situations when other types of treatment can not be used.

H Telsartan® drug therapy is contraindicated during breastfeeding.

In animal studies, the effects of telmisartan and hydrochlorothiazide on fertility were not observed. Studies of the impact on human fertility have not been conducted.

Dosing and Administration:

Inside, regardless of food intake.

Tetsartan® H should be taken once a day.

- Tetsartan® H (12.5 mg + 40 mg) can be given to patients in whom monotherapy with telmisartan 40 mg or monotherapy with hydrochlorothiazide does not lead to adequate control of blood pressure.

- Tetsartan® H (12.5 mg + 80 mg) can be given to patients in whom telmisartan monotherapy in a dose of 80 mg or with Telsartan® H (12.5 mg + 40 mg) does not lead to adequate control of blood pressure.

In patients with severe arterial hypertension, the maximum daily dose of telmisartan is 160 mg / day. This dose was well tolerated and effective.

Impaired renal function

The limited experience with the combination of hydrochlorothiazide and telmisartan in patients with small or moderate renal impairment does not require a dose change in these cases. In such patients, kidney function should be monitored (for creatinine clearance less than 30 ml / min, see "Contraindications").

Dysfunction of the liver

In patients with mild to moderate liver impairment (class A and B according to the Child-Pugh classification), the daily dose of Telsartan® H should not exceed 12.5 mg / 40 mg per day (see section "Pharmacokinetics").

Elderly patients

Dosing regimen does not require any changes.

Side effects:

Side effects reported by the combination of telmisartan and hydrochlorothiazide

The overall incidence of side effects reported with the combination of telmisartan and hydrochlorothiazide was comparable to the incidence of adverse events observed with telmisartan monotherapy in controlled trials involving 1471 patients randomized to the groups receiving telmisartan + hydrochlorothiazide (835 patients) or patients receiving only telmisartan (636). The dependence of side effects on dose, sex, age or race of patients is not established.

All the side effects associated with the use of a combination of telmisartan and hydrochlorothiazide with a frequency exceeding the placebo frequency (p <0.05) are presented below in accordance with the system-organ classes.

Frequency of occurrence: very often (≥1 / 10); often (≥1 / 100 - <1/10); infrequently (≥1 / 1000 - <1/100); rarely (≥1 / 10000 - <1/1000); very rarely (<1/10000); frequency is unknown (can not be determined from available data). Adverse reactions are presented in descending order of severity.

Infectious and parasitic diseases

Rarely: bronchitis, pharyngitis, sinusitis.

Immune system disorders

Rarely: exacerbation or exacerbation of symptoms of systemic lupus erythematosus¹.

Disorders from the metabolism and nutrition

Infrequent: hypokalemia.

Rarely: hyperuricemia, hyponatremia.

Disorders of the psyche

Infrequently: anxiety.

Rarely: depression.

Disturbances from the nervous system

Often: dizziness.

Infrequently: syncope / syncope, paresthesia.

Rarely: insomnia, sleep disturbances.

Disturbances on the part of the organ of sight

Rarely: visual impairment, transient blurred vision.

Hearing disorders and labyrinthine disorders

Infrequently: vertigo.

Heart Disease

Infrequent: tachycardia, arrhythmia.

Vascular disorders

Infrequent: hypotension, orthostatic hypotension.

Disturbances from the respiratory system, chest and mediastinal organs

Infrequent: shortness of breath.

Rarely: respiratory distress syndrome (including pneumonia and non-cardiogenic pulmonary edema.

Disorders from the gastrointestinal tract

Infrequent: diarrhea, dry mouth, flatulence.

Rarely: abdominal pain, constipation, indigestion, vomiting, gastritis.

Disturbances from the liver and bile ducts

Rarely: a dysfunction of the liver².

Disorders from the rut and subcutaneous tissues

Rarely: angioedema (including fatal cases), erythema, pruritus, rash, increased sweating, urticaria.

Disturbances from musculoskeletal and connective tissue

Infrequent: back pain, muscle spasms, myalgia.

Rarely: arthralgia, muscle cramps, pain in the calf muscles.

Violations of the genitals and mammary gland

Infrequent: erectile dysfunction.

General disorders and disorders at the site of administration

Infrequent: chest pain.

Rarely: flu-like syndrome, pain.

Laboratory and instrumental data

Infrequent: increased concentration of uric acid in the blood plasma.

Rarely: increasing the concentration of creatinine in the blood plasma, increasing the activity of creatine phosphokinase in the blood plasma, increasing the activity of "liver" enzymes.

¹- Based on the experience of post-marketing application.

²- see subsection "Description of individual adverse reactions".

Additional information on the experience of using individual active substances

Adverse reactions, observed previously with the use of each of the components of the drug,can potentially be observed with the use of a combination of telmisartan and hydrochlorothiazide, even if they have not been observed in the study of this combination.

Telmisartan

The incidence of side effects with telmisartan is similar to that of placebo.

In placebo-controlled trials, the overall incidence of adverse events observed with telmisartan (41.4%) is usually comparable to the incidence of adverse events with placebo (43.9%). The following side effects are based on the results of all clinical trials involving patients who received telmisartan for arterial hypertension or for the results of the use of telmisartan in patients 50 and older with a high risk of developing cardiovascular events.

Infectious and parasitic diseases

Infrequent: upper respiratory tract infections, urinary tract infections, including cystitis.

Rarely: sepsis, including fatal cases.

Violations of the blood and lymphatic system

Infrequently: anemia.

Rarely: eosinophilia, thrombocytopenia.

Immune system disorders

Rarely: hypersensitivity reactions, anaphylactic reactions

Disorders from the metabolism and nutrition

Infrequent: hyperkalemia.

Rarely: hyperglycemia (in patients with diabetes mellitus).

Heart Disease

Infrequent: bradycardia.

Disturbances from the nervous system

Rarely: drowsy.

Disturbances from the respiratory system, chest and mediastinal organs

Infrequently: cough.

Very often: interstitial lung disease³.

Disorders from the gastrointestinal tract

Rarely: a feeling of discomfort in the stomach.

Disturbances from the skin and subcutaneous tissues

Rarely: eczema, drug and toxic rash.

Disturbances from musculoskeletal and connective tissue

Rarely: arthrosis, pain in the tendons.

Disorders from the kidneys and urinary tract

Infrequent: impaired renal function (including acute renal failure).

General disorders and disorders at the site of administration

Infrequently: asthenia.

Laboratory and instrumental data

Rarely: a decrease in the level of hemoglobin.

³- see subsection "Description of individual adverse reactions".

Hydrochlorothiazide

The use of hydrochlorothiazide can lead to the emergence or aggravation of hypovolemia, which can cause electrolyte imbalance.

The following are the side reactions noted with the use of hydrochlorothiazide in monotherapy. The frequency of occurrence of such reactions can not be determined.

Infectious and parasitic diseases

Sialadenitis.

Violations of the blood and lymphatic system

Aplastic anemia, hemolytic anemia, impaired bone marrow function, leukopenia, neutropenia, agranulocytosis, thrombocytopenia.

Immune system disorders

Anaphylactic reactions, hypersensitivity.

Disorders from the endocrine system

Uncontrolled diabetes mellitus.

Disorders from the metabolism and nutrition

Anorexia, decreased appetite, electrolyte balance disorder, hypercholesterolemia, hyperglycemia, hypovolemia.

Disorders of the psyche

Restlessness.

Disturbances from the nervous system

Slight dizziness.

Disturbances on the part of the organ of sight

Xantopsy, acute myopia, acute closed angle glaucoma.

Vascular disorders

Necrotizing vasculitis.

Disorders from the gastrointestinal tract

Pancreatitis, a feeling of discomfort in the stomach.

Disturbances from the liver and bile ducts

Hepatic jaundice, cholestatic jaundice.

Disorders from the rut and subcutaneous tissues

Lupus-like syndrome, photosensitivity reactions, cutaneous vasculitis, toxic epidermal necrolysis.

Disturbances from musculoskeletal system and connective tissue

Weakness.

Disorders from the kidneys and urinary tract

Interstitial nephritis, impaired renal function, glucosuria.

General disorders and disorders at the site of administration

Pyrexia.

Laboratory and instrumental data

Increase in the level of triglycerides.

Description of individual adverse reactions

Impaired liver function

The majority of cases of liver dysfunction in postemergent use of telmisartan is described in patients in Japan. Apparently, these undesirable effects are more typical for this group of patients.

Sepsis

In the study PRoFESS an increased incidence of sepsis was observed with telmisartan compared with placebo.The obtained data can be considered a random finding, since the mechanism of the relationship is unknown.

Interstitial lung disease

Cases of interstitial lung disease were recorded with postmigration application of telmisartan and coincided with the period of its appointment. However, a causal relationship between these events is not established.

Overdose:

Cases of overdose have not been identified. Possible symptoms of an overdose consist of symptoms from the individual components of the drug.

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

Hydrochlorothiazide - violations of water-electrolyte balance of blood (hypokalemia, hypochloraemia), decreased bcc, which can lead to muscle spasms and / or increase cardiovascular disorders: arrhythmias caused by simultaneous application of cardiac glycosides or some antiarrhythmic agents.

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

Interaction:

Telmisartan

Hypotensive drugs

It is possible to increase the antihypertensive effect. One study showed an increase in AUC_0-24and Ramaxpril and ramiprilata Cmax 2.5 times with combined use of telmisartan and ramipril. The clinical significance of this interaction is not established.

In the analysis of adverse events that led to discontinuation of treatment and analysis of serious adverse events in a clinical trial, it was found that cough and angioedema were more often observed with ramipril therapy, while arterial hypotension was more common on telmisartan therapy. Cases of hyperkalemia, renal insufficiency, arterial hypotension and syncope were significantly more frequent when combined use of telmisartan and ramipril.

Lithium preparations

There was a reversible increase in the concentration of lithium in the blood plasma, accompanied by toxic effects when taking ACE inhibitors. In rare cases, such changes were registered with the use of angiotensin II receptor antagonists, in particular telmisartan.With the simultaneous use of lithium drugs and angiotensin II receptor antagonists, it is recommended to determine the content of lithium in the blood.

Non-steroidal anti-inflammatory drugs (NSAIDs)

NSAIDs, including acetylsalicylic acid in doses used as an anti-inflammatory agent, cyclooxygenase-2 (COX-2) inhibitors and nonselective NSAIDs, can cause the development of acute renal failure in patients with reduced BCC. Drugs that affect RAAS may have a synergistic effect. In patients receiving NSAIDs and telmisartan, at the beginning of treatment should be compensated for BCC and kidney function monitoring performed.

Reduction of the effect of antihypertensive drugs, such as telmisartan, by inhibiting the vasodilating effect of prostaglandins was noted when combined with NSAIDs. With simultaneous administration of telmisartan with ibuprofen or paracetamol, there was no clinically significant effect.

Digoxin, warfarin, hydrochlorothiazide, glibenclamide, simvastatin and amlodipine

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

Aliskiren, aliskiren containing preparations

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

Hydrochlorothiazide

Ethanol, barbiturates or narcotic analgesics

The risk of orthostatic hypotension.

Hypoglycemic agents for oral administration and insulin

It may be necessary to correct the dose of hypoglycemic agents for oral and insulin intake.

Metformin

Risk of development of lactic acidosis.

Kolestyramine and colestipol

In the presence of anion exchange resins hydrochlorothiazide absorption is impaired.

Cardiac glycosides

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

Pressor amines (e.g., norepinephrine)

Possible weakening of the effect of pressor amines.

Non-depolarizing muscle relaxants (eg, tubocurarine chloride)

Hydrochlorothiazide can enhance the effect of nondepolarizing muscle relaxants.

Anti-gouty agents

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 development of hypersensitivity reactions to allopurinol.

Calcium and vitamin D preparations

Thiazide diuretics can increase the calcium content in the blood serum due to the decrease in its excretion by the kidneys. If you want to use calcium preparations, you should regularly monitor the calcium content in the blood serum and, if necessary, change the dose of calcium preparations.

Beta-blockers and diazoxide

Thiazide diuretics can increase hyperglycemia caused by beta-blockers and diazoxide.

M-holinoblokatory (for example, atropine, biperidene)

Reduction of motility of the gastrointestinal tract, increased bioavailability of thiazide diuretics.

Amantadine

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

Cytotoxic agents (e.g., cyclophosphamide, methotrexate)

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

NSAIDs

Simultaneous use with thiazide diuretics can lead to a decrease in diuretic and antihypertensive effect.

Means that lead to the excretion of potassium and hypokalemia

Such agents as diuretics, which excrete potassium; laxatives; glucocorticosteroids; calcitonin; adrenocorticotropic hormone (ACTH); glycyrrhizic acid (found in licorice root); amphotericin B; carbenoxolone; Benzylpenicillin: derivatives of acetylsalicylic acid) can lead to an increase in the hypokalemic effect. Hypokalemia caused by hydrochlorothiazide is compensated by the potassium-sparing effect of telmisartan.

Theophylline

Increased risk of hypokalemia.

Amiodarone

Simultaneous use with thiazide diuretics can lead to an increased risk of arrhythmias associated with hypokalemia.

Potassium-sparing diuretics, potassium preparations, other agents that can increase the serum potassium content (for example, heparin)

These remedies, as well as replacing sodium in table salt with potassium salts, can lead to hyperkalemia.

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

Special instructions:

The states that contribute to an increase in the activity of the RAAS

In some patients, due to inhibition of RAAS activity, especially with the simultaneous use of drugs acting on this system, renal function (including acute renal failure) is impaired. Therefore, therapy followed by such a double blockade of RAAS (eg, with the addition of ACE inhibitors or a direct inhibitor of renin-aliskiren to angiotensin II receptor antagonists),should be carried out strictly individually and with regular monitoring of kidney function, including periodic monitoring of potassium content and serum creatinine concentration (see section "Contraindications").

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

Renovascular hypertension

In patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single functioning kidney, the risk of development of severe arterial hypotension and renal failure increases with the use of drugs that affect RAAS.

Impaired liver function

In patients with impaired liver function or progressive liver disease, the combination of hydrochlorothiazide and telmisartan should be used with caution, since even small changes in the water-electrolyte balance can contribute to the development of a "hepatic" coma.

Effect on the metabolism and function of the endocrine glands

Patients with diabetes may require a change in the dose of insulin or hypoglycemic agents for oral administration.During the treatment with thiazide diuretics, it can manifest latent diabetes mellitus.

In some cases, with the use of thiazide diuretics, it is possible to develop hyperuricemia and exacerbation of gout.

Diabetes

In patients with diabetes mellitus and an additional cardiovascular risk, for example, in patients with diabetes mellitus and coronary heart disease (CHD), the use of drugs that lower blood pressure, such as angiotensin II receptor antagonists or ACE inhibitors, may increase the risk of fatal heart attack myocardial and sudden cardiovascular death. In patients with diabetes, IHD can be asymptomatic and therefore can be undiagnosed. In patients with diabetes mellitus, before starting the use of Telsartan® H, appropriate diagnostic tests should be performed to identify and treat coronary artery disease, including a physical exercise test.

Acute myopia and secondary closed angle glaucoma

Hydrochlorothiazide, being a sulfonamide derivative, can cause idiosyncratic reaction in the form of acute transient myopia and acute angle-closure glaucoma.Symptoms of these disorders are an unexpected reduction in visual acuity or eye pain that occurs within a few hours to several weeks after the start of the drug. If treatment is not performed, acute angle-closure glaucoma can lead to loss of vision. The main treatment is, as quickly as possible, the abolition of hydrochlorothiazide. It is necessary to have the kind that if intraocular pressure remains uncontrolled, emergency conservative or surgical treatment may be required. The risk factors for the development of acute closed-angle glaucoma include information about allergies to sulfonamides or penicillin in the anamnesis.

Violations of the water-electrolyte balance

When using the drug Telsartan ® H, 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 hypochloraemic alkalosis). Signs, alarming in respect of these disorders, are dryness of the oral mucosa,feeling of thirst, general weakness, drowsiness, anxiety, myalgia or convulsive twitching of the calf muscles, muscle weakness, marked decrease in blood pressure, oliguria, tachycardia and such gastrointestinal disturbances as nausea or vomiting.

With the use of thiazide diuretics hypokalemia may develop, but simultaneously it can be used telmisartan can increase the potassium content in the serum. The risk of hypokalemia increases in patients with cirrhosis of the liver, with increased diuresis, while observing a salt-free diet, as well as in the case of simultaneous use with glucocorticosteroids, calcitonin, ACTH, glycyrrhizic acid. Telmisartan, which is part of the drug Telsartan® H, on the contrary, can lead to hyperkalemia due to antagonism to angiotensin II receptors (subtype AT1). Although clinically significant hyperkalemia has not been documented with the use of a combination of hydrochlorothiazide and telmisartan, it should be borne in mind that renal and / or cardiac insufficiency and diabetes mellitus are at risk of developing it.

The data that the preparation Telsartan® H can reduce or prevent hyponatremia caused by the use of diuretics, no. 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 small increase in the serum calcium level. More pronounced hypercalcemia may be a sign of latent hyperparathyroidism. Before performing an evaluation of parathyroid function, thiazide diuretics should be discontinued.

It is shown that thiazide diuretics 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 blood pressure, can lead to myocardial infarction or stroke.

It requires increased monitoring of patients with impaired uric acid metabolism. Thiazides can reduce the amount of iodine that binds to serum proteins without showing signs of thyroid dysfunction.

There is information about cases of the development of photosensitivity reaction with the use of thiazide diuretics.If photosensitivity reaction occurs during treatment, it is recommended to suspend treatment. If it is decided that the diuretic should be resumed, it is necessary to protect areas of the body that can be exposed to sunlight or ultraviolet rays of type A and avoid sun exposure.

Hydrochlorothiazide can increase the concentration of cholesterol and triglycerides in the serum, hydrochlorothiazide can give a positive result in the conduct of doping control.

There are reports of the development of systemic lupus erythematosus with the use of thiazide diuretics. The drug Telsartan® H may, if necessary, be used in conjunction with other antihypertensive agents. Disorders of liver function in the appointment of telmisartan in most cases were observed in the inhabitants of Japan. The drug Telsartan® H is less effective in patients of the Negroid race.

Effect on the ability to drive transp. cf. and fur:

Special clinical studies to assess the effect of the drug Telsartan® H on the ability to drive vehicles and work with mechanisms that require increased attention, was not conducted.However, when driving and dealing with hazardous activities, it should take into account the possibility of developing dizziness and drowsiness, which requires caution.

Form release / dosage:

Tablets 12.5 / 40 mg and 12.5 / 80 mg.

Packaging:

7 tablets in a blister of (PVC / Al(PA) foil / aluminum foil. For 2 or 4 blisters together with instructions for use in a pack of cardboard.

For 6 or 10 tablets in a blister of (PVC / Al(PA) foil / aluminum foil. For 3 blisters together with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-004256

Date of registration:24.04.2017

Expiration Date:24.04.2022

The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India

Manufacturer: & nbsp

DR. REDDY`S LABORATORIES, LTD. India

Representation: & nbspDr. Reddy`c Laboratoris Ltd.Dr. Reddy`c Laboratoris Ltd.

Information update date: & nbsp08.06.2017

Illustrated instructions

Instructions

Telsartan® H (Telsartan® H)