Telprez, tablets 80 mg 28 pcs

Hypertension (high blood pressure)

• Arterial hypertension;

• Reduction in cardiovascular morbidity and mortality in patients aged 55 years and older with a high risk of cardiovascular disease.

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Indications

Arterial hypertension;

Reduce cardiovascular morbidity and mortality in patients aged 55 years and older at high risk of cardiovascular disease.

Pharmacological effect

Angiotensin II receptor antagonist.

Special instructions

Liver dysfunction

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

Renovascular hypertension

When treated with drugs acting on the RAAS, in patients with bilateral arterial stenosis or arterial stenosis of a single functioning kidney, the risk of severe arterial hypotension and renal failure increases.

Renal dysfunction and kidney transplant

When using the drug Telpres in patients with impaired renal function, periodic monitoring of potassium and creatinine levels in the blood plasma is recommended. There is no clinical experience with the use of Telpres in patients who have recently undergone kidney transplantation.

Decrease in circulating blood volume

Symptomatic arterial hypotension, especially after the first dose of Telpres, may occur in patients with low blood volume and/or sodium content in the blood plasma due to previous treatment with diuretics, restriction of salt intake, diarrhea or vomiting. Such conditions (fluid and/or sodium deficiency) must be eliminated before taking Telpres.

Dual blockade of the renin-angiotensin-aldosterone system

Concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal failure (glomerular filtration rate less than 60 ml/min/1.73 m2) (see section “Contraindications”).
The simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy (see section “Contraindications”).

As a result of inhibition of the RAAS, the following were observed: arterial hypotension, fainting, hyperkalemia and impaired renal function (including acute renal failure) in patients predisposed to this, especially with the combined use of several drugs that also act on this system. Therefore, double blockade of the RAAS (for example, while taking telmisartan with other RAAS antagonists) is not recommended.

In cases where vascular tone and renal function depend primarily on the activity of the RAAS (for example, in patients with chronic heart failure or kidney disease, including renal artery stenosis, or stenosis of the artery of a single kidney), the prescription of drugs that affect this system may be accompanied by the development of acute arterial hypotension, hyperazotemia, oliguria and, in rare cases, acute renal failure.

Primary aldosteronism

In patients with primary aldosteronism, treatment with antihypertensive drugs that act by inhibiting the RAAS is usually ineffective.

Aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathy

Caution must be exercised when using Telpres (as well as other vasodilators) in patients with aortic or mitral stenosis, as well as hypertrophic obstructive cardiomyopathy.

Hyperkalemia

Taking medications that act on the RAAS can cause hyperkalemia. In elderly patients, patients with renal failure or diabetes mellitus, patients also taking medications that increase plasma potassium levels, and/or patients with underlying medical conditions, hyperkalemia can be fatal.

When deciding on the concomitant use of drugs acting on the RAAS, it is necessary to assess the risk-benefit ratio.

The main risk factors for hyperkalemia that should be considered are:
– diabetes mellitus, renal failure, age (patients over 70 years old);
– combination with one or more drugs acting on the RAAS and/or potassium-containing nutritional supplements.

Drugs or therapeutic classes of drugs that may cause hyperkalemia include potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, nonsteroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressants (cyclosporine or tacrolimus), and trimethoprim;
– intercurrent diseases, especially dehydration, acute heart failure, metabolic acidosis, renal dysfunction, cytolysis syndrome (for example, acute limb ischemia, rhabdomyolysis, major trauma).

Patients at risk are advised to carefully monitor the level of potassium in the blood plasma (see section “Interaction with other drugs”).

Ethnic differences

ACE inhibitors, telmisartan, and other receptor antagonists appear to be less effective in lowering blood pressure in black patients than in other races, possibly due to a greater predisposition to decreased renin activity in these patient populations.

Other

As with the use of other antihypertensive drugs, an excessive decrease in blood pressure in patients suffering from ischemic cardiomyopathy or coronary heart disease can lead to the development of myocardial infarction or stroke.

Impact on the ability to drive vehicles. Wed and fur.:

No special clinical studies have been conducted on the effect of the drug on the ability to drive a car or use machinery. When driving a car or operating machinery that requires increased concentration, caution should be exercised, as dizziness and drowsiness may rarely occur while taking telmisartan.

Active ingredient

Telmisartan

Composition

Active ingredient:

Telmisartan – 80.00 mg;

Excipients:

Sodium hydroxide – 6.70 mg;

Povidone-K25 – 21.60 mg;

Meglumine – 24.00 mg;

Mannitol – 327.70 mg;

Magnesium stearate – 8.00 mg;

Crospovidone – 12.00 mg.

Pregnancy

Medicines that act directly on the RAAS can cause serious damage and death to the developing fetus, therefore, when planning or establishing the fact of pregnancy, the drug should be immediately discontinued and, if necessary, alternative antihypertensive therapy should be prescribed that has an established safety profile when used during pregnancy. The use of the drug during pregnancy is contraindicated.

In preclinical studies of telmisartan, no teratogenic effects were identified, but fetotoxicity was established. Exposure to angiotensin II receptor antagonists during the second and third trimesters of pregnancy is known to cause human fetotoxicity (decreased renal function, oligohydramnios, delayed cranial ossification) as well as neonatal toxicity (renal failure, hypotension, hyperkalemia). Patients planning pregnancy should be prescribed alternative therapy. If treatment with angiotensin II receptor antagonists occurred during the second trimester of pregnancy, ultrasound examination of the renal function and condition of the skull in the fetus is recommended.

Neonates whose mothers received angiotensin II receptor antagonists should be closely monitored for hypotension.

Therapy with Telpres is contraindicated during breastfeeding. No studies have been conducted on the effects on human fertility.

Contraindications

Hypersensitivity to the active ingredients or auxiliary components of the drug or other sulfonamide derivatives;

Pregnancy;

Breastfeeding period;

Obstructive diseases of the biliary tract;

Severe liver dysfunction (class C according to the Child-Pugh classification);

Severe renal dysfunction (creatinine clearance less than 30 ml/min);

Refractory hypokalemia, hypercalcemia;

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

Concomitant use of ACE inhibitors in patients with diabetic nephropathy;

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

Age up to 18 years (efficacy and safety have not been established).

With caution:

Bilateral renal artery stenosis or stenosis of the artery of a single kidney (see section “Special instructions”);

Liver dysfunction (class A and B according to the Child-Pugh classification) (see section “Special instructions”);

Decreased blood volume due to previous diuretic therapy, restriction of salt intake, diarrhea or vomiting;

Hyperkalemia;

Condition after kidney transplantation (no experience of use);

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

Hypercalcemia;

Hypercholesterolemia;

Hypertriglyceridemia;

Coronary heart disease;

Progressive liver diseases (risk of developing hepatic coma);

Stenosis of the aortic and mitral valve;

Idiopathic hypertrophic subaortic stenosis (hypertrophic obstructive cardiomyopathy);

Diabetes mellitus;

Primary hyperaldosteronism;

Gout, hyperuricemia;

Systemic lupus erythematosus;

Secondary angle-closure glaucoma (due to the presence of hydrochlorothiazide in the composition);

Use in patients of the Negroid race;

Experience with use in patients with renal impairment (creatinine clearance more than 30 ml/min) is limited, but does not confirm the development of side effects from the kidneys and dose adjustment is not required;

Concomitant use with ACE inhibitors or aliskiren;

Simultaneous use with potassium preparations, potassium-sparing diuretics.

Side Effects

In general, the incidence of adverse reactions noted for telmisartan is comparable to that for placebo. The observed incidence of side effects did not correlate with the gender, age or race of the patients. World Health Organization (WHO) classification of the frequency of adverse reactions: very common (>1/10); often (from >1/100 to 1/1000 to 1/10,000 to <1/1000); very rare (<1/10,000); frequency unknown (it is not possible to determine the frequency of occurrence based on available data).Infectious and parasitic diseases: uncommon: upper respiratory tract infections, including pharyngitis and sinusitis, urinary tract infections (including cystitis); unknown frequency: sepsis, including fatal sepsis.Blood and lymphatic system disorders: uncommon: anemia; rarely: thrombocytopenia; unknown frequency: eosinophilia.Mental disorders: uncommon: depression; rarely: anxiety.Nervous system disorders: uncommon: insomnia, syncope, vertigo; rarely: fainting.Visual disturbances: rare: visual disturbances.Cardiac disorders: uncommon: bradycardia; rarely: tachycardia.Vascular disorders: uncommon: marked decrease in blood pressure*, orthostatic hypotension;
* frequently observed in patients with controlled blood pressure who were treated with telmisartan to reduce the risk of cardiovascular mortality in addition to standard treatment.

Respiratory, thoracic and mediastinal disorders: uncommon: shortness of breath, cough.

Gastrointestinal disorders:
uncommon: abdominal pain, diarrhea, dyspepsia, flatulence, vomiting;
rarely: upset stomach, discomfort, dry mouth, liver dysfunction/liver disease.

Immune system disorders:
rarely: hypersensitivity, angioedema (including fatal); unknown frequency: anaphylactic reactions.

Skin and subcutaneous tissue disorders: uncommon: hyperhidrosis, itching, rash;
rare: erythema, drug rash, toxic skin rash, eczema, unknown frequency: urticaria.

Musculoskeletal and connective tissue disorders: uncommon: myalgia, back pain (eg, sciatica), muscle spasms; rarely: arthralgia, pain in the extremities; unknown frequency: pain in the tendon area (tendinitis-like symptoms).

Renal and urinary tract disorders: uncommon: renal failure, including acute renal failure.

Nutritional and metabolic disorders:
uncommon: hyperkalemia.

Common disorders:
uncommon: chest pain, asthenia (weakness); rarely: influenza-like condition.

Impact on the results of laboratory parameters and instrumental studies: infrequently: increased concentration of creatinine in the blood; rarely: increased concentration of uric acid in the blood, liver enzymes, creatine phosphokinase activity in the blood serum, decreased hemoglobin, hypoglycemia (in patients with diabetes mellitus).

Interaction

Telmisartan may increase the antihypertensive effect of other antihypertensive agents. Other types of interactions of clinical significance have not been identified. Combination use with digoxin, warfarin, hydrochlorothiazide, glibenclamide, ibuprofen, paracetamol, simvastatin and amlodipine does not lead to clinically significant interactions.

Overdose

Information regarding overdose is limited.

Symptoms: the most significant are a pronounced decrease in blood pressure and tachycardia; bradycardia, dizziness, an increase in serum creatinine concentration and acute renal failure may also be observed.

Treatment: symptomatic and supportive. Suggested measures include: inducing vomiting and/or gastric lavage, taking activated charcoal, replenishing fluids and salts. Constant monitoring of electrolytes and creatinine in the blood serum. Hemodialysis is not effective.

Recommendations for use

Inside, regardless of food intake.

Arterial hypertension

The initial recommended dose of Telpres is 1 tablet. (40 mg) once a day. In cases where the therapeutic effect is not achieved, the maximum recommended dose of Telpres can be increased to 80 mg once a day. When deciding whether to increase the dose, it should be taken into account that the maximum antihypertensive effect is usually achieved within 4-8 weeks after the start of treatment.

Reducing cardiovascular morbidity and mortality

The recommended dose is 1 tablet of Telpres 80 mg once a day.

During the initial period of treatment, monitoring of blood pressure (BP) levels is recommended; adjustment of antihypertensive therapy may be required.

Renal dysfunction

In patients with severely impaired renal function and patients on hemodialysis, experience with use is limited. In such patients, the recommended starting dose is 20 mg per day. In patients with mild to moderate renal impairment, no dose adjustment is required.

Liver dysfunction

In patients with mild to moderate liver dysfunction (class A and B on the Child-Pugh scale, respectively), the daily dose of Telpres should not exceed 40 mg.

Elderly patients

In elderly patients, no dose adjustment is required.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of the reach of children!

Shelf life

2 years.
Do not use after expiration date.

Manufacturer

Laboratorios Likonsa S.A., Spain