Telmista, tablets 80 mg 84 pcs

Hypertension (high blood pressure)

Essential hypertension.

Reduction in mortality and cardiovascular events in adult patients:

– with cardiovascular diseases of atherothrombotic genesis (coronary heart disease, stroke or peripheral artery disease in the anamnesis);

– with type 2 diabetes mellitus with target organ damage.

Active ingredient

Telmisartan

Composition

1 tablet 40 mg/80 mg contains:

Active substance:

Telmisartan 40.00 mg/80.00 mg

Supplementary substances:

Meglumine, sodium hydroxide, povidone-K30, lactose monohydrate, sorbitol (E420), magnesium stearate

How to take, the dosage

Orally, once daily with liquid, regardless of the time of the meal.

Telmisartan tablets with a dosing option of 20 mg (for example, 20 mg tablets or 40 mg tablets with a rice) are required to provide the dosing regimen below, particularly to provide initial doses of the drug in certain patient groups.

Essential hypertension

The initial recommended dose of Telmista^® is 40 mg (1 40 mg tablet) once daily. In some patients it may be effective to take 20 mg daily. In cases where the therapeutic effect is not achieved, the maximum recommended dose of Telmista^® may be increased to 80 mg once daily. Alternatively, Telmista^® may be taken in combination with thiazide diuretics such as hydrochlorothiazide, which had an additional antihypertensive effect when used simultaneously. When deciding to increase a dose it should be considered that the maximal antihypertensive effect is usually reached during 4-8 weeks after the treatment start.

Reduction in mortality and incidence of cardiovascular disease

The recommended dose is 1 tablet of Telmista^® 80 mg once daily.

In the initial period of treatment, additional BP adjustment may be needed.

Special patient populations

Kidney function disorders

Limited experience with telmisartan in patients with severe renal impairment or patients on hemodialysis.

A lower starting dose of 20 mg daily is recommended for these patients (see section “Special Indications”). No dose adjustment is required for patients with mild to moderate renal impairment.

Simultaneous use of Telmista^® with drugs containing aliskiren in patients with diabetes mellitus and/or moderate to severe renal dysfunction (GFR less than 60 ml/min/1.73 m² body surface area) is contraindicated (see “Contraindications” section). ^{is contraindicated (see section “Contraindications”).}

Simultaneous use of Telmista^® with ACE inhibitors is contraindicated in patients with diabetic nephropathy (see “Contraindications” section).

Liver function impairment

Telmista^® is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see section “Contraindications”). In patients with mild and moderate hepatic insufficiency (Child-Pugh grades A and B, respectively), Telmista^® is indicated with caution and the dose should not exceed 40 mg once daily (see section “Caution”).

Elderly patients

No dose adjustment is required for elderly patients.

children and adolescents

The use of the drug in children and adolescents younger than 18 years is contraindicated due to lack of safety and effectiveness data (see “Contraindications” section).

Interaction

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

The concomitant use of telmisartan with drugs containing aliskiren is contraindicated in patients with diabetes and/or with moderate to severe renal impairment (FFR less than 60 ml/min/1.73 m² body surface area) and not recommended in other patients.

Simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy (see “Contraindications”) and is not recommended in other patients.

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

The risk of hyperkalemia may increase with concomitant use with other drugs that can cause hyperkalemia (potassium-containing supplements and salt substitutes containing potassium, potassium-saving diuretics [e.g, spironolactone, eplerenone, triamterene, or amiloride], nonsteroidal anti-inflammatory drugs [NSAIDs], including selective cyclooxygenase-2 (COX-2) inhibitors, heparin, immunosuppressants [cyclosporine or tacrolimus], and trimethoprim). If necessary, against the background of documented hypokalemia, concomitant use of drugs should be performed with caution and the potassium content in plasma should be regularly monitored.

Digoxin

When telmisartan was used concomitantly with digoxin, there was an average 49% increase in plasma C_max of digoxin and a 20% minimum concentration. At the start of treatment, during dose selection and discontinuation of telmisartan treatment, plasma digoxin concentrations should be carefully monitored to maintain them within the therapeutic range.

Kalium-saving diuretics or potassium-containing supplements

APAs II, 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, they should be used with caution and with regular monitoring of plasma potassium.

Lithium preparations

The simultaneous use of lithium drugs with ACE inhibitors and APA II inhibitors, including telmisartan, resulted in a reversible increase in plasma lithium concentration and its toxic effects. If it is necessary to use this combination of drugs, it is recommended to carefully monitor plasma lithium concentrations.

DNAPs

NSAIDs (i.e., acetylsalicylic acid at doses used for anti-inflammatory treatment, COX-2 inhibitors, and nonselective 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), concomitant use of APA II and COX-2 inhibitors may lead to further deterioration of renal function, including development of acute renal failure, which is usually reversible. Therefore, concomitant use 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 concomitant use and periodically thereafter.

Diuretics (thiazide or “loop”)

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

Other hypotensive agents

The effects of telmisartan may be enhanced with the simultaneous use of other hypotensive drugs.

Based on the pharmacological properties of baclofen and amifostine, it can be assumed that they will enhance the therapeutic effect of all hypotensive drugs, including telmisartan. In addition, orthostatic hypotension may be increased with alcohol, barbiturates, narcotics or antidepressants.

Corticosteroids (for systemic use)

Corticosteroids weaken the effects of telmisartan.

Special Instructions

bilateral renal artery stenosis or single renal artery stenosis.

Disorders of liver and/or renal function (see “Special Indications”).

Decreased circulating blood volume (CBC) due to previous diuretic therapy, restricted intake of table salt, diarrhea, or vomiting.

Hyponatremia.

Hyperkalemia.

Conditions after renal transplant (no experience of use).

Chronic heart failure (CHF).

Aortic and/or mitral valve stenosis.

Hypertrophic obstructive cardiomyopathy (HCMP).

Primary hyperaldosteronism (effectiveness and safety not established).

Use in patients of Negro race.

The use of the drug in children and adolescents younger than 18 years is contraindicated due to the lack of data on safety and efficacy.

Kidney function impairment

Limited experience with telmisartan in patients with severe renal impairment or patients on hemodialysis.

A lower starting dose of 20 mg daily is recommended for these patients (see section “Special Indications”). No dose adjustment is required for patients with mild to moderate renal impairment.

Simultaneous use of Telmista^® with drugs containing aliskiren in patients with diabetes mellitus and/or moderate to severe renal dysfunction (GFR less than 60 ml/min/1.73 m² body surface area) is contraindicated (see “Contraindications” section). ^{is contraindicated (see section “Contraindications”).}

Simultaneous use of Telmista^® with ACE inhibitors is contraindicated in patients with diabetic nephropathy (see section “Contraindications”).

Liver function impairment

Telmista^® is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see section “Contraindications”). In patients with mild and moderate hepatic insufficiency (Child-Pugh grades A and B, respectively), Telmista^® is indicated with caution and the dose should not exceed 40 mg once daily (see section “Caution”).

Elderly patients

No dose adjustment is required for elderly patients.

Liver function impairment

The use of Telmistâ^® is contraindicated in patients with cholestasis, biliary obstruction or severe liver function impairment (Child-Pugh class C) (see section “Contraindications”) because telmisartan is mainly eliminated 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), Telmista^® should be used with caution (see section “Caution”).

Renovascular Hypertension

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

Kidney function impairment and renal transplantation

When using Telmista^® in patients with impaired renal function, periodic monitoring of potassium and plasma creatinine concentration is recommended. There is no experience with the clinical use of Telmisartan in patients who have recently undergone a kidney transplant.

CPU reduction

Symptomatic arterial hypotension, especially after the first administration of Telmist^® may occur in patients with decreased RBC and/or plasma sodium content against a background of previous diuretic treatment, restriction of table salt intake, diarrhea or vomiting. Such conditions (hypovolemia and hyponatremia) should be eliminated before initiating the drug Telmist®.

Double RAAS blockade

The concomitant use of telmisartan with drugs containing aliskiren is contraindicated in patients with diabetes and/or with moderate to severe renal impairment (FFR 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 (see “Contraindications”) and is not recommended in other patients.

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 concurrently. Therefore dual RAAS blockade (e.g. against the background of taking telmisartan with other RAAS antagonists) is not recommended.

When vascular tone and renal function depend predominantly on RAAS activity (e.g., in patients with CHF or renal disease, including renal artery stenosis or artery stenosis of the single kidney), the administration of drugs that affect this system may be accompanied by the development of acute arterial hypotension, hyperazotemia, oliguria, and in rare cases of acute renal failure.

Primary hyperaldosteronism

In patients with primary hyperaldosteronism, treatment with hypotensive drugs whose action is performed by inhibiting the RAAS is usually ineffective. Due to this fact, the use of Telmista^® is not recommended.

Aortic or mitral valve stenosis, GOCMP

As with other vasodilators, patients with aortic or mitral stenosis and GOCMP should exercise extreme caution when using Telmista^®.

Patients with diabetes mellitus receiving insulin or oral hypoglycemic agents

These patients may develop hypoglycemia during treatment with Telmista^®. Glycemic control should be strengthened in such patients as it may be necessary to adjust the dose of insulin or hypoglycemic agent.

Hyperkalemia

Medications acting on RAAS may cause hyperkalemia. In elderly patients, patients with renal insufficiency or diabetes mellitus, patients also taking medicines that increase plasma potassium content and/or patients with concomitant diseases hyperkalemia may lead to lethal outcome.

The risk-benefit ratio should be assessed when deciding on concomitant use of drugs acting on the RAAS. The main risk factors for hyperkalemia that should be considered are:

diabetes mellitus, renal failure, age (patients older than 70 years);

concomitant use with one or more RAAS-acting drugs and/or potassium-containing dietary supplements. Drugs or therapeutic classes of drugs that may cause hyperkalemia include potassium-containing salt substitutes, potassium-saving diuretics, ACE inhibitors, ARA II, NSAIDs including selective COX-2 inhibitors, heparin, immunosuppressants (cyclosporine or tacrolimus) and trimethoprim;

intercurrent diseases, especially dehydration, acute heart failure, metabolic acidosis, impaired renal function, cytolysis syndrome (e.g., acute limb ischemia, rhabdomyolysis, extensive trauma).

Patients at risk are recommended to carefully monitor plasma potassium levels (see section “Interaction with other medicinal products”).

Ethnic differences

As noted for ACE inhibitors, telmisartan and other APA II appear to reduce BP less effectively in patients of the Negro race than in other races, perhaps because of a greater predisposition to lower renin activity in these patient populations.

Other

As with other hypotensive agents, a pronounced decrease in BP in patients with ischemic cardiomyopathy or CHD can lead to myocardial infarction or stroke.

Special information on excipients

Patients with rare hereditary fructose or lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome Telmista^® is contraindicated because it contains lactose and sorbitol (E420).

Special clinical trials to study the effect of the drug on the ability to drive and operate machinery have not been conducted. Caution should be used while driving motor transport and operating mechanisms requiring high concentration, because dizziness and somnolence may occur rarely while taking the drug Telmista^®.

Synopsis

Tablets 40 mg: oval, biconvex, white or almost white.

80 mg tablets: capsule-shaped, biconvex tablets, white or nearly white.

Contraindications

Hypersensitivity to the active substance or excipients of the drug.

Pregnancy.

Breastfeeding period.

Obstructive biliary tract diseases.

Severe liver function disorders (Child-Pugh class C).

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

Concurrent use with ACE inhibitors in patients with diabetic nephropathy.

Fructose or lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome (the drug Telmista^® contains lactose and sorbitol [E420]).

Age under 18 years (effectiveness and safety not established).

Side effects

According to the World Health Organization (WHO), adverse effects are classified according to their frequency as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), infrequent (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), frequency unknown – the incidence could not be determined from available data.

Within each group, adverse reactions are presented in descending order of severity according to frequency of occurrence.

Infectious and parasitic diseases

infrequent: urinary tract infections, including cystitis, upper respiratory tract infections, including pharyngitis and sinusitis;

rare: sepsis, including fatal.

Blood and lymphatic system disorders

infrequent: anemia;

rare: eosinophilia, thrombocytopenia.

immune system disorders

rare: anaphylactic reaction, hypersensitivity.

Disorders of metabolism and nutrition

infrequent: hyperkalemia;

rare: hypoglycemia (in patients with diabetes).

Mental disorders

infrequently: insomnia, depression;

rarely: anxiety.

Nervous system disorders

infrequent: fainting;

rare: drowsiness.

Visual disorders

rare: visual disturbances.

Hearing organ and labyrinth disorders

infrequent: vertigo.

Cardiac disorders

infrequent: bradycardia;

rare: tachycardia.

vascular disorders

infrequent: significant decrease of BP, orthostatic hypotension.

Disorders of the respiratory system, thorax and mediastinum

infrequent: shortness of breath, cough;

very rare: interstitial lung disease.

Gastrointestinal tract disorders

infrequent: abdominal pain, diarrhea, dyspepsia, flatulence, vomiting;

seldom: dry mucous membrane of the mouth, discomfort in the stomach, taste disorders.

Liver and biliary tract disorders

rare: liver malfunction/liver damage.

Skin and subcutaneous tissue disorders

infrequent: skin itching, hyperhidrosis, skin rash;

rarely: angioedema (also fatal), eczema, erythema, urticaria, drug rash, toxic skin rash.

Muscular and connective tissue disorders

infrequent: back pain (ischialgia), muscle spasms, myalgia;

rare: arthralgia, pain in extremities, tendon pain (tendinitis-like syndrome).

Renal and urinary tract disorders

infrequent: impaired renal function, including acute renal failure.

General disorders and disorders at the site of administration

infrequent: chest pain, asthenia (weakness);

rare: flu-like syndrome.

Laboratory and instrumental studies

infrequent: increased plasma creatinine concentration;

seldom: decrease of hemoglobin, increase of concentration of uric acid in plasma, increase of activity of “liver” enzymes and creatine phosphokinase (CPK) in plasma.

Overdose

Symptoms:The most prominent manifestations of overdose were marked BP decrease and tachycardia, bradycardia, dizziness, increased serum creatinine concentration and acute renal failure were also reported.

Treatment: telmisartan is not excreted by hemodialysis. Patients should be closely monitored and symptomatic as well as supportive treatment should be implemented. The treatment approach depends on the time since the drug was taken and the severity of symptoms. Recommended interventions include inducing vomiting and/or gastric lavage, and administration of activated charcoal is advisable. Electrolytes and plasma creatinine concentration should be regularly monitored. If marked BP decrease occurs, the patient should assume horizontal position with elevated legs, and the BCC volume and electrolytes content should be quickly replenished.

Pregnancy use

Pregnancy

The use of Telmist ^® is contraindicated in pregnancy. Administration of ARA II in the first trimester of pregnancy is not recommended, these drugs should not be used in pregnancy. If pregnancy is diagnosed, Telmista^® should be discontinued immediately. If necessary, alternative hypotensive therapy (other classes of hypotensive drugs approved for use in pregnancy) should be prescribed.

The use of ARA II in the second-third trimester of pregnancy is contraindicated.

In preclinical studies of telmisartan no teratogenic effects were identified, but fetotoxicity was established. The use of APA II in the second to third trimesters of pregnancy is known to cause fetotoxicity (decreased renal function, oligohydramnios, delayed ossification of fetal skull bones) and neonatal toxicity (renal failure, arterial hypotension, hyperkalemia) in humans. Alternative therapy should be used in patients planning pregnancy. If APA II was nevertheless used in the second-third trimester of pregnancy, an ultrasound examination of the fetal kidneys and skull bones should be performed.

Newborns whose mothers took ARA II during pregnancy should be monitored as arterial hypotension may develop in the newborn.

Breastfeeding period

Telmisartan during breastfeeding is not reported. Administration of Telmista^® during breastfeeding is contraindicated (see section “Contraindications”), an alternative hypotensive drug with a more favorable safety profile should be used, especially when nursing a newborn or premature baby.

There have been no studies on the effect on human fertility.