Telzap Plus pills 12.5mg+80mg, 90pcs

Composition

of 1 tab. : telmisartan 80 mghydrochlorothiazide 12.5 mgcompetitive substances: sorbitol – 348.3 mg, sodium hydroxide-6.8 mg, povidone 25-40 mg, magnesium stearate-4.9 mg

Pharmacological action

Telzap® Plus is a combination of telmisartan (an angiotensin II receptor antagonist (ARA II)) and hydrochlorothiazide (a thiazide diuretic). The combination of these components provides a more pronounced antihypertensive effect, while the blood pressure level decreases more strongly than against the background of monotherapy with these components.

The drug, used 1 time/day in therapeutic doses, effectively and gradually reduces blood pressure.

Telmisartan

Telmisartan is a specific angiotensin II receptor antagonist (AT_{1 subtype}) that is effective when taken orally. Telmisartan has a high affinity for the AT1 subtype_{of angiotensin II}receptors, through which the action of angiotensin II is realized. Telmisartan displaces angiotensin II from binding to the receptor, without showing the properties of an AT1-receptor agonist. Telmisartan selectively and persistently binds to the AT₁receptor. Telmisartan has no affinity for other receptors, including AT₂ and other less well-studied AT receptors. The functional role of these receptors, as well as the effect of their possible increased stimulation with angiotensin II, the concentration of which increases under the action of telmisartan, have not been studied. Telmisartan reduces the concentration of aldosterone in blood plasma, does not inhibit renin and does not block ion channels. Telmisartan does not inhibit ACE (kininase II), which also destroys bradykinin. This avoids the side effects associated with the action of bradykinin.

In healthy subjects, telmisartan 80 mg almost completely blocks the hypertensive effect of angiotensin II. The suppressive effect lasts for more than 24 hours and lasts up to 48 hours.

The onset of antihypertensive action is observed within the first 3 hours after oral use of telmisartan. The duration of the therapeutic effect of the drug is more than 24 hours and includes the last 4 hours before taking the next dose according to daily blood pressure monitoring. This is confirmed by measurements taken at the time of maximum effect and immediately before taking the next dose (the ratio of residual effect to maximum is higher than 80% for dosages of 40 and 80 mg of telmisartan in placebo-controlled studies). The maximum antihypertensive effect develops after 4-8 weeks of regular use of telmisartan and persists during long-term therapy.

In hypertensive patients, telmisartan reduces both systolic and diastolic blood pressure without affecting heart rate. According to the results of clinical studies, the effectiveness of the antihypertensive effect of telmisartan is comparable to the therapeutic effect of drugs of other classes, such as amlodipine, atenolol, enalapril, hydrochlorothiazide and lisinopril. In case of abrupt discontinuation of telmisartan treatment, blood pressure gradually returns to its original parameters, without the development of “withdrawal”syndrome.

The incidence of dry cough was significantly lower with telmisartan compared to ACE inhibitors.

Hydrochlorothiazide

Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the reabsorption of electrolytes in the renal tubules, thereby increasing the excretion of sodium and chloride ions in approximately equivalent amounts. The diuretic effect of hydrochlorothiazide leads to a decrease in BCC, an increase in plasma renin activity, an increase in aldosterone production, followed by an increase in the content of potassium and bicarbonates in the urine and a decrease in the content of potassium in the blood plasma. Concomitant use of telmisartan reduces the potassium loss caused by this diuretic, probably due to RAAS blockade. After taking hydrochlorothiazide, diuresis increases in 2 hours, the maximum effect develops in about 4 hours, the effect lasts about 6-12 hours.

Epidemiological studies have shown that long-term hydrochlorothiazide therapy reduces the risk of cardiovascular morbidity and mortality.

Children’s and adolescent patients

The safety and efficacy of telmisartan in children and adolescents under 18 years of age have not been established.

Indications

-arterial hypertension (if telmisartan or hydrochlorothiazide monotherapy is not effective).

Use during pregnancy and lactation

Pregnancy

Treatment of ARA II during pregnancy is contraindicated. The use of ARA II is not recommended in the first trimester of pregnancy and is contraindicated in the second and third trimesters of pregnancy.

Telmisartan

Adequate data on the use of telmisartan in pregnant women have not been obtained. Animal studies have found its reproductive toxicity. Epidemiological evidence for the risk of teratogenic effects after taking ACE inhibitors in the first trimester of pregnancy was not convincing, however, this risk cannot be excluded. Until data from controlled epidemiological studies have been obtained regarding the risk of taking ARA II, a similar risk may exist for this class of drugs. Unless long-term treatment for ARA II is absolutely necessary, patients planning pregnancy should choose an alternative antihypertensive drug with a proven safety profile for use during pregnancy. Once pregnancy is established, ARA II treatment should be stopped immediately and alternative treatment should be initiated if necessary.

Treatment of ARA II in the second and third trimesters of pregnancy has a toxic effect on the fetus (deterioration of renal function, oligohydramnion, delayed ossification of the skull) and the newborn (renal failure, hypotension and hyperkalemia). When using ARA II from the second trimester of pregnancy, ultrasound of the fetal kidneys and skull is recommended. Children whose mothers have taken ARA II should be carefully evaluated for hypotension.

Hydrochlorothiazide

Experience with the use of hydrochlorothiazide during pregnancy, especially in the first trimester, is limited. Hydrochlorothiazide passes through the BBB. Based on the pharmacological mechanism of action of hydrochlorothiazide, its use in the second and third trimesters may impair fetoplacental blood flow and cause jaundice, impaired water-electrolyte balance and thrombocytopenia in the fetus/newborn. Do not use hydrochlorothiazide for the treatment of edema in pregnant women, hypertension in pregnant women, or preeclampsia due to the risk of BCC reduction and deterioration of placental blood flow without proper therapeutic effect on the course of the disease.

Do not use hydrochlorothiazide for the treatment of essential hypertension in pregnant women, except in rare cases when other treatment is not possible.

Breast-feeding period

Taking Telzap® Plus during breastfeeding is contraindicated, alternative treatment with more favorable safety profiles should be used.

Fertility

The effect of the combination of telmisartan and hydrochlorothiazide on human fertility has not been studied.

Contraindications

— obstructive cholestasis and bile duct diseases;

— disorders of the liver;

— severe renal dysfunction (CC less than 30 ml/min);

— simultaneous use with drugs containing aliskiren in patients with diabetes mellitus or renal impairment (GFR less than 60 ml/min/1.73 m 2);

— concomitant use with ACE inhibitors in patients with diabetic nephropathy;

refractory hypokalemia, hypercalcemia;

— hereditary fructose intolerance (contains sorbitol).

— pregnancy;

– breast-feeding period;

– age up to 18 years (efficacy and safety have not been established)—

– hypersensitivity to the Active ingredient or any excipients of the drug and to other sulfonamide derivatives.

With caution, the drug should be prescribed for bilateral renal artery stenosis or stenosis of the artery of a single kidney, severe renal dysfunction; BCC reduction against the background of previous diuretic therapy, restriction of salt intake, diarrhea or vomiting; hyperkalemia; condition after kidney transplantation (no experience); chronic heart failure III-IV FC according to NYHA classification; aortic and mitral valve stenosis; idiopathic hypertrophic subaortic stenosis; hypertrophic obstructive cardiomyopathy; IHD and cerebrovascular diseases; diabetes mellitus; primary hyperaldosteronism; gout; water and electrolyte balance disorders (including hypokalemia, hyponatremia, hypochloremic alkalosis, hypomagnesemia); hyperuricemia; angle-closure glaucoma (due to the presence of hydrochlorothiazide); systemic lupus erythematosus; in patients of the black race; elderly patients (over 70 years of age).

Experience with use in patients with renal insufficiency (creatinine clearance more than 30 ml/min) is limited, but does not confirm the development of side effects from the kidneys, no dose adjustment is required.

Side effects

The most commonly reported adverse reaction was dizziness. Serious angioedema was rare (≥1/10 000,

Telzap Plus 80 mg+12.5 mg: the overall incidence of adverse reactions was comparable to that of telmisartan monotherapy. The dependence of the development of adverse reactions on the dose of the drug was not established, there was no relationship with the gender, age or race of patients.

Adverse reactions are divided into systemic-organ classes according to MedDRA. The frequency of side effects was determined according to the WHO classification: very common (≥1/10), common (≥1/100,

Infectious and parasitic diseases: rarely – bronchitis, pharyngitis, sinusitis.

From the immune system: rarely-increased symptoms or exacerbation of systemic lupus erythematosus (during post-marketing surveillance).

From the side of metabolism and nutrition: infrequently-hypokalemia; rarely-hyperuricemia, hyponatremia.

Mental disorders: infrequently-anxiety; rarely-depression.

Nervous system disorders: often – dizziness; infrequently-fainting, paresthesia; rarely-insomnia, sleep disorders.

From the side of the visual organ: rarely-visual impairment, transient visual acuity disorder.

From the side of the hearing organ: infrequently – vertigo.

From the cardiovascular system: infrequently-tachycardia, arrhythmia, hypotension, orthostatic hypotension.

Respiratory system disorders: infrequently-shortness of breath; rarely-respiratory distress syndrome (including pneumonitis and pulmonary edema).

From the digestive system: infrequently – diarrhea, dry mouth, flatulence; rarely-abdominal pain, constipation, dyspepsia, vomiting, gastritis.

Liver and biliary tract disorders: rarely-impaired liver function, liver diseases.

Skin and subcutaneous tissue disorders: rarely-angioedema (also fatal), erythema, pruritus, skin rash, increased sweating, urticaria.

Musculoskeletal and connective tissue disorders: infrequently-back pain, muscle spasms, myalgia; rarely-joint pain, muscle spasms, pain in the extremities.

From the genitals and breast: infrequently – erectile dysfunction.

General disorders and disorders at the injection site: infrequently-chest pain; rarely-flu-like syndrome, pain.

From the side of laboratory and instrumental studies: rarely-an increase in the concentration of creatinine in blood plasma, an increase in the activity of CPK, an increase in the activity of hepatic transaminases.

Additional information about individual components

Side effects reported with the use of one of the components, the development of which can be expected with the use of a combination of telmisartan and hydrochlorothiazide.

Telmisartan

The frequency of adverse reactions with telmisartan reported in controlled clinical trials was comparable to the frequency of adverse reactions reported in the placebo group (41.4% and 43.9%, respectively). The following adverse reactions were reported in a clinical trial of telmisartan, including a group of high-risk cardiovascular patients over the age of 50 years.

Infectious and parasitic diseases: infrequently-upper respiratory tract infections, urinary tract infections, including cystitis; rarely-sepsis, including with a fatal outcome.

From the hematopoietic system: infrequently-anemia; rarely-eosinophilia, thrombocytopenia.

From the immune system: rarely – hypersensitivity reactions, anaphylactic reactions.

From the side of metabolism and nutrition: infrequently-hyperkalemia; rarely-hypoglycemia (in patients with diabetes mellitus).

Nervous system disorders: rarely-drowsiness.

From the cardiovascular system: infrequently – bradycardia.

Respiratory system disorders: infrequently-cough; very rarely – interstitial lung diseases.

From the digestive system: rarely-a feeling of discomfort in the stomach.

Skin and subcutaneous tissue disorders: rarely – eczema, drug rash, toxic skin rash.

Musculoskeletal disorders: rarely-osteoarthritis, pain in the tendon area.

From the urinary system: infrequently-impaired renal function (including acute renal failure).

General disorders and disorders at the injection site: infrequently-asthenia.

From the side of laboratory and instrumental studies: rarely-a decrease in hemoglobin content.

Hydrochlorothiazide

Hydrochlorothiazide can cause or increase hypovolemia, which can lead to a violation of the water-electrolyte balance. Adverse reactions reported with hydrochlorothiazide are listed below.

Infectious and parasitic diseases: frequency unknown-sialoadenitis.

From the hematopoietic system: frequency unknown-aplastic anemia, hemolytic anemia, bone marrow suppression, leukopenia, neutropenia, agranulocytosis, thrombocytopenia.

From the immune system: frequency unknown – anaphylactic reactions, hypersensitivity reactions.

From the endocrine system: frequency unknown – lack of proper glycemic control in diabetes mellitus.

From the side of metabolism and nutrition: the frequency is unknown – anorexia, loss of appetite, impaired water and electrolyte balance, hypovolemia.

Mental disorders: frequency unknown – excited state.

Nervous system disorders: frequency unknown – pre-fainting state.

From the side of the visual organ: frequency unknown – xanthopsy, acute myopia, acute angle-closure glaucoma.

From the side of blood vessels: frequency unknown-necrotizing vasculitis.

From the digestive system: the frequency is unknown-pancreatitis, a feeling of discomfort in the stomach.

Liver and biliary tract disorders: frequency unknown-jaundice (parenchymal or cholestatic).

Skin and subcutaneous tissue disorders: frequency unknown-lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic epidermal necrolysis (Lyell’s syndrome).

From the urinary system: frequency unknown-interstitial nephritis, impaired renal function, glucosuria.

Musculoskeletal and connective tissue disorders: frequency unknown-weakness.

General disorders and disorders at the injection site: frequency unknown-hyperthermia.

From the side of laboratory and instrumental studies: the frequency is unknown-hypertriglyceridemia, hypercholesterolemia, hyperglycemia.

Interaction

Double blockade of the RAAS

Concomitant use of telmisartan with drugs containing aliskiren is contraindicated in patients with diabetes mellitus or renal insufficiency (GFR 2) and is not recommended for other patients.

Concomitant use of ACE inhibitors with ARA II or drugs containing aliskiren is characterized by an increased risk of hypotension, hyperkalemia and decreased renal function (including acute renal failure) in patients compared to the use of each drug separately.

In patients with diabetic nephropathy, the use of a combination of ACE inhibitors and ARA II is contraindicated.

Digoxin

When telmisartan was co-administered with digoxin, an average increase in peak plasma concentrations (49%) and minimum digoxin concentrations (20%) was observed. With simultaneous use, at the beginning of treatment, when selecting the dose and stopping treatment with telmisartan, the concentration of digoxin in the blood should be monitored to maintain it within the therapeutic range.

Medications that cause potassium loss and hypokalemia

Other potassium-lowering diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium salt, salicylic acid and its derivatives. If it is necessary to simultaneously use these drugs with a combination of telmisartan/hydrochlorothiazide, it is recommended to monitor the potassium content in the blood plasma. These medications may increase potassium loss when used concomitantly with hydrochlorothiazide.

Drugs that cause an increase in the content of potassium in the blood plasma

As with other drugs acting on the RAAS, the use of a combination of telmisartan/hydrochlorothiazide may cause hyperkalemia. The risk may increase when used concomitantly with other medications that may cause hyperkalemia (table salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, ARA II, NSAIDs, including selective COX-2 inhibitors, heparin, immunosuppressants (cyclosporine or tacrolimus) and trimethoprim).

With strict precautions, the combination with ACE inhibitors or NSAIDs is associated with a lower risk.

If it is necessary to simultaneously use these drugs with a combination of telmisartan/hydrochlorothiazide, it is recommended to monitor the potassium content in the blood plasma.

Lithium

When lithium preparations were co-administered with ACE inhibitors and rarely with ARA II, including the combination of telmisartan/hydrochlorothiazide, there was a reversible increase in the concentration of lithium in blood plasma and its toxic effect. When they are used concomitantly with lithium preparations, it is recommended to carefully monitor the concentration of lithium in the blood plasma.

NSAIDs

NSAIDs (including acetylsalicylic acid in doses used for anti-inflammatory treatment (no more than 3 g / day), COX-2 inhibitors and non-selective NSAIDs) can weaken the antihypertensive effect of ARA II and weaken the diuretic, natriuretic effect of thiazide diuretics.

In some patients with impaired renal function (for example, in dehydrated patients with reduced BCC, elderly patients), the simultaneous use of ARA II and drugs that inhibit COX can lead to further deterioration of renal function, up to the development of acute renal failure, which is usually reversible. Therefore, the concomitant use of telmisartan/hydrochlorothiazide with NSAIDs should be carried out with caution, especially in elderly patients.Patients should be provided with adequate fluid intake, and renal function should be monitored at the beginning of concomitant use and periodically thereafter.

When telmisartan was co-administered with ibuprofen or paracetamol, there was no clinically significant interaction effect.

Medicinal products that are affected by changes in the potassium content in blood plasma

It is recommended to periodically monitor the level of potassium in the blood plasma and perform an ECG while using drugs that depend on changes in the concentration of potassium in the blood plasma (for example, with cardiac glycosides, antiarrhythmic agents), as well as after an attack of ventricular tachycardia, including those caused by drugs (including some antiarrhythmic drugs). Hypokalemia was a provoking factor for the development of ventricular tachycardia of the “pirouette” type (torsade de pointes):

– antiarrhythmic drugs of class IA (e. g. quinidine, gedragingen, disopyramide);

– anti-arrhythmic drugs class III (e. g., amiodarone, sotalol, dofetilide, ibutilide);

some antipsychotics (e. g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol);

– other preparations (e. g., bepridil, cisapride, was diphemanil, erythromycin [intravenous injection], halofantrine, mizolastine, pentamidine, sparfloxacin, terfenadine, vincamine has [b/injection]).

Cardiac Glycosides

Hypokalemia or hypomagnesemia caused by hydrochlorothiazide may contribute to arrhythmia during cardiac glycoside therapy.

Other antihypertensive drugs

Telmisartan may increase the effect of other antihypertensive drugs.

Antidiabetic drugs (oral medications and insulin)

Dosage adjustments of antidiabetic medications may be required.

Metformin

Metformin should be used with caution due to the risk of lactic acidosis caused by possible functional renal failure while taking hydrochlorothiazide.

Cholestyramine and colestipol

Absorption of hydrochlorothiazide decreases in the presence of anion exchange resins.

Pressor amines (e. g., norepinephrine (norepinephrine))

The effect of vasopressor amines may be weakened.

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

The effect of non-depolarizing muscle relaxants can be enhanced by hydrochlorothiazide.

Anti-gouty agents (e. g. probenecid, sulfinpyrazone and allopurinol)

It may be necessary to adjust the dose of drugs that promote the elimination of uric acid, since hydrochlorothiazide can increase the content of uric acid in the blood plasma. It may be necessary to increase the dose of probenecid or sulfinpyrazone. Concomitant use of a thiazide diuretic may increase the incidence of hypersensitivity reactions to allopurinol.

Calcium Salts

Hydrochlorothiazide may increase the level of calcium in the blood plasma due to a decrease in its excretion. If it is necessary to prescribe calcium supplements, the concentration of calcium in the blood plasma should be monitored and the dose adjusted accordingly.

Due to their effect on calcium metabolism, thiazides can distort the results of tests to assess parathyroid function.

Beta-blockers and diazoxide

The hyperglycemic effect of beta-blockers and diazoxide may be enhanced by hydrochlorothiazide.

Anticholinergic agents (for example, atropine, biperiden)

Cholinolytic agents may increase the bioavailability of hydrochlorothiazide by reducing gastrointestinal motility and gastric emptying rate.

Amantadine

Hydrochlorothiazide may increase the risk of adverse reactions caused by amantadine.

Glycyrrhizic Acid

The interaction of hydrochlorothiazide and licorice root (glycyrrhizic acid) can lead to the development of hypokalemia.

Cytotoxic drugs (e. g. cyclophosphamide, methotrexate)

Hydrochlorothiazide may reduce renal excretion of cytotoxic drugs and enhance their myelosuppressive effect.

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 increase with alcohol, barbiturates, narcotic drugs or antidepressants.

Corticosteroids (for systemic use)

Corticosteroids weaken the antihypertensive effect of telmisartan.

How to take, course of use and dosage

The drug is taken orally 1 time/day, washed down with liquid, regardless of food intake.

Patients whose blood pressure cannot be properly controlled with telmisartan or hydrochlorothiazide monotherapy should take Telzap Plus. Before switching to a fixed-dose combination, individual titration of the dose of each of the components is recommended. In some clinical situations, a direct transition from monotherapy to treatment with a fixed-dose combination may be considered.

The drug Telzap® Plus,80 mg+12.5 mg, can be used 1 time / day in patients whose blood pressure cannot be properly controlled when taking telmisartan at a dose of 80 mg / day.

Dose adjustment in patients with mild or moderate renal impairment (creatinine clearance greater than 30 ml / min) not required. Periodic monitoring of renal function indicators is recommended.

Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal insufficiency (GFR less than 60 ml / min/1.73 m2).

The drug Telzap® Plus is contraindicated in patients with impaired liver function.

For elderly patients (over 70 years of age) no dose adjustment is required.

The drug Telzap® Plus is contraindicated in children and adolescents under 18 years of age due to the lack of safety and efficacy data.

Overdose

No cases of overdose have been identified. Possible symptoms consist of symptoms of overdose of individual components.

Symptoms

Hypotension and tachycardia are the most common symptoms of telmisartan overdose, and bradycardia, dizziness, vomiting, elevated serum creatinine, and acute renal failure have also been reported.

An overdose of hydrochlorothiazide is associated with a decrease in the content of electrolytes (hypokalemia, hypochloremia) and hypovolemia against the background of excessive diuresis. The most common symptoms of overdose are nausea and drowsiness. Hypokalemia can lead to muscle spasm and / or exacerbation of arrhythmia when used concomitantly with cardiac glycosides or certain antiarrhythmic agents.

Treatment

Telmisartan is not eliminated by hemodialysis. The degree of elimination of hydrochlorothiazide by hemodialysis has not been established. Patients ‘ condition should be carefully monitored and symptomatic as well as supportive treatment should be provided. The approach to treatment depends on the time elapsed after taking the drug, and the severity of symptoms. Recommended measures include provoking vomiting and / or gastric lavage, and taking activated charcoal is advisable. The patient should be placed on his back, legs raised. If necessary, it is recommended to fill the BCC, for example, by intravenous use of 0.9% sodium chloride solution. Sympathomimetic medications may be prescribed.

Special instructions

Impaired liver function

Application of the drug Telzap® Plus is contraindicated in patients with cholestasis, biliary tract obstruction, and / or impaired liver function, as telmisartan is mainly excreted in the bile. There is reason to believe that these patients have reduced hepatic clearance of telmisartan.

Renovascular hypertension

Patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are at increased risk of significantly lowering blood pressure and developing acute renal failure when treated with drugs acting on the RAAS.

Double blockade of the RAAS

Data on the concomitant use of ACE inhibitors with ARA II or with drugs containing aliskiren confirm an increased risk of a sharp decrease in blood pressure, hyperkalemia, and decreased renal function (including acute renal failure). Therefore, the use of this drug combination is contraindicated. If it is necessary to implement a double blockade of the RAAS, each case should be considered individually and renal function, water-electrolyte balance and blood pressure indicators should be carefully monitored.

In patients with diabetic nephropathy, the use of a combination of ACE inhibitors and ARA II is contraindicated.

Other conditions associated with RAAS stimulation

In patients whose vascular tone and renal function depend primarily on the activity of the RAAS (for example, patients with severe chronic heart failure or existing kidney disease, including renal artery stenosis), the use of drugs acting on this system, such as telmisartan, is associated with the occurrence of acute blood pressure reduction, hyperazotemia, oliguria, or rarely with the development of acute renal failure.

Primary hyperaldosteronism

In patients with primary hyperaldosteronism, treatment with antihypertensive drugs, the effect of which is carried out by inhibiting the RAAS, is usually ineffective. In this regard, the use of the drug Telzap®Plus not recommended.

Impaired kidney function and kidney transplantation

Application of the drug Telzap® Plus is contraindicated in patients with severe renal impairment (CC). If the risk is limited in patients with mild to moderate renal impairment, it is recommended to periodically monitor the content of potassium, creatinine and uric acid in blood plasma, as well as indicators of renal function. Patients with impaired renal function may experience azotemia associated with the use of thiazide diuretics.

BCC reduction

Reduced blood pressure, especially after the first dose of Telzap® Plus, it may occur in patients with a reduced BCC and / or low blood sodium content in the background of previous treatment with diuretics, restriction of table salt intake, diarrhea or vomiting. Such conditions (fluid and/or sodium deficiency) should be corrected before starting Telzap Plus.

Aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy

As with other vasodilators, special care should be taken in patients with aortic or mitral stenosis, as well as hypertrophic obstructive cardiomyopathy.

Effects on metabolism and endocrine function

The use of hydrochlorothiazide may impair glucose tolerance, and patients with diabetes mellitus may develop hypoglycemia against the background of simultaneous use of insulin or hypoglycemic agents and telmisartan. It may be necessary to adjust the dose of hypoglycemic agents, including insulin. During treatment with thiazides, patients with impaired glucose tolerance may manifest latent diabetes mellitus. With treatment with thiazide diuretics, an increase in the concentration of cholesterol and triglycerides in blood plasma is associated. However, when using a drug containing 12.5 mg of hydrochlorothiazide, this effect is minimal or absent. Some patients taking hydrochlorothiazide may develop hyperuricemia or develop a sudden exacerbation of gout.

Violation of the water-electrolyte balance

When using the drug Telzap® Plus, it is necessary to periodically monitor the content of electrolytes in the blood plasma.

Thiazides, including hydrochlorothiazide, can cause disturbances in the water-electrolyte balance (hypokalemia, hyponatremia, and hypochloremic alkalosis) and changes in the acid-base state. Signs of violations of the water-electrolyte balance are: dry mouth, thirst, general weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscle weakness, decreased blood pressure, oliguria, tachycardia, and gastrointestinal disorders such as nausea and vomiting.

Hypokalemia

Although hypokalemia may occur due to the use of hydrochlorothiazide, concomitant therapy with telmisartan may compensate for a decrease in the concentration of potassium in the blood plasma. The risk of hypokalemia increases in patients with cirrhosis of the liver, patients with severe diuresis, with a salt-free diet, in patients who do not properly compensate for the loss of electrolytes, as well as in patients receiving concomitant therapy with corticosteroids or ACTH.

Hyperkalemia

Taking telmisartan may cause hyperkalemia. However, there is no clinically significant hyperkalemia associated with the use of Telzap® Plus, it wasn’t marked. The main risk factors for hyperkalemia are:

– diabetes mellitus, renal failure, heart failure, elderly age (patients over 70 years of age);

– combination with one or more drugs acting on the RAAS, and/or supplements containing potassium. Drugs that can cause hyperkalemia, are potassium-sparing diuretics, ACE inhibitors, ARA II, NSAIDs, including selective COX-2 inhibitors, heparin, immunosuppressants (cyclosporine or tacrolimus), trimethoprim, as well as salt substitutes containing potassium;

– concomitant diseases, in particular dehydration, acute cardiac decompensation, metabolic acidosis, acute renal failure (e. g., infectious diseases), the cytolysis syndrome (e. g. acute limb ischemia, rhabdomyolysis, extensive trauma).

Patients at risk are advised to carefully monitor the potassium content in the blood plasma.

Hyponatremia and hypochloremic alkalosis

Evidence that the drug Telzap® Plus reduces or prevents the development of hyponatremia caused by diuretics, none. Minor chlorine deficiency usually does not require correction.

Hypercalcemia

Hydrochlorothiazide can reduce urinary calcium excretion and cause periodic and slight increases in blood plasma calcium levels in the absence of any calcium metabolism disorders. Severe hypercalcemia may be a sign of latent hyperparathyroidism. Hydrochlorothiazide should be discontinued prior to parathyroid function testing.

Hypomagnesemia

While taking hydrochlorothiazide, an increase in the excretion of magnesium in the urine was noted, which can lead to hypomagnesemia.

Sorbitol

This medicinal product contains sorbitol (E 420). Use of Telzap in patients with rare hereditary problems of fructose intolerance Plus it is contraindicated.

Ethnic differences

Like all other ARA II drugs, telmisartan is less effective in reducing blood pressure 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. During post-marketing use, most cases of hepatic functional impairment or liver damage occurred in Japanese patients. Japanese people are more likely to develop these adverse reactions.

CHD and cerebrovascular disease

As with any other antihypertensive medication, excessive lowering of blood pressure in patients with CHD or cerebrovascular disease can lead to the development of myocardial infarction or stroke.

Heart failure

As with other drugs that affect the RAAS, patients with heart failure (whether or not accompanied by impaired renal function) are at risk of developing a significant decrease in blood pressure, as well as impaired renal function (often acute).

General violations

Hypersensitivity reactions to hydrochlorothiazide are most likely to occur in patients with a history of allergic reactions or bronchial asthma. It is known that the use of thiazide diuretics, including hydrochlorothiazide, can lead to an exacerbation or increase in the symptoms of systemic lupus erythematosus. Photosensitivity reactions have been reported with hydrochlorothiazide. If a photosensitivity reaction occurs, it is recommended to stop taking Telzap Plus. If the use of diuretics is still necessary, it is recommended to protect exposed areas of the skin from exposure to sunlight or artificial ultraviolet radiation.

Acute myopia and angle-closure glaucoma

Taking hydrochlorothiazide can cause an idiosyncratic reaction, leading to acute transient myopia and acute angle-closure glaucoma. Symptoms of these disorders include a sudden decrease in visual acuity or pain in the eyes and usually occur between a few hours and several weeks after the start of treatment. Acute angle-closure glaucoma that is not treated in a timely manner can lead to permanent vision loss. First of all, you should immediately stop taking Telzap Plus. If intraocular pressure is not controlled, urgent conservative or surgical treatment may be required. Risk factors for acute angle-closure glaucoma include a history of allergic reactions to sulfonamides or penicillin.

Interstitial lung diseases

In the course of clinical use, cases of interstitial lung diseases have been described while taking telmisartan.

Influence on the ability to drive motor vehicles and manage mechanisms

When driving vehicles and engaging in potentially dangerous activities, it should be taken into account that while taking the drug Telzap® Plus, dizziness and drowsiness may occur, which requires caution.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf

life is 2 years. Do not use after the expiration date indicated on the package.

Active ingredient

Hydrochlorothiazide, Telmisartan

Conditions of release from pharmacies

By prescription

Purpose

For adults as directed by your doctor

Indications

Hypertension