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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Active ingredient

Telmisartan

Composition

Active ingredient:

Telmisartan – 80.00 mg;

Associates:

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.

Interaction

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

Directions for use

Orally, regardless of meals.

Arterial hypertension

The initial recommended dose of Telprez is 1 tablet (40 mg) once daily. In cases when therapeutic effect is not achieved, the maximum recommended dose of Telprez may be increased to 80 mg once daily. When deciding 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.

Lower cardiovascular morbidity and mortality

The recommended dose is 1 tablet of Telprez 80 mg once daily.

In the initial period of treatment, monitoring of blood pressure (BP) is recommended; correction of antihypertensive therapy may be necessary.

Renal dysfunction

In patients with severe renal dysfunction and patients on hemodialysis, experience with use is limited. In these patients, the recommended starting dose is 20 mg daily. No dose adjustment is required in patients with mild to moderate renal impairment.

Hepatic impairment

In patients with mild and moderate hepatic impairment (Child-Pugh grades A and B, respectively) the daily dose of Telpras should not exceed 40 mg.

Elderly patients

Dose adjustment is not necessary in elderly patients.

Special Instructions

Contraindications

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

• Pregnancy;

• Breastfeeding period;

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• Obstructive biliary tract disease;

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

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

• Refractory hypokalemia, hypercalcemia;

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

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

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

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

With caution:

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

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

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

• Hyperkalemia;

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

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

• Hypercalcemia;

• Hypercholesterolemia;

• Hypertriglyceridemia;

• Coronary heart disease;

• Progressive liver disease (risk of hepatic coma);

• Aortic and mitral valve stenosis;

• Idiopathic hypertrophic subaortic stenosis (hypertrophic obstructive cardiomyopathy);

• Diabetes mellitus;

• Primary hyperaldosteronism;

• Gout, hyperuricemia;

• Systemic lupus erythematosus;

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

• Use in non-HGM patients;

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

• Simultaneous use with ACE inhibitors or aliskiren;

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

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Side effects

In general, the incidence of adverse reactions noted for telmisartan is comparable to that of placebo. The observed incidence of adverse effects did not correlate with the gender, age, or race of patients. World Health Organization (WHO) adverse reaction frequency classification: Very common (>1/10); common (>1/100 to <1/10); infrequent (>1/1000 to <1/100); rare (>1/10 000 to <1/1000); very rare (<1/10 000); frequency unknown (the incidence could not be determined from available data).

Infectious and parasitic diseases: infrequent: upper respiratory tract infections, including pharyngitis and sinusitis, urinary tract infections (including cystitis); unknown frequency: sepsis, including sepsis with lethal outcome.

Blood and lymphatic system disorders: infrequent: anemia; rare: thrombocytopenia; unknown frequency: eosinophilia.

Mental disorders: infrequently: depression; rarely: anxiety.

Nervous system disorders: infrequent: insomnia, syncope, vertigo; rarely: syncope.

Visual organ disorders:seldom: visual impairment.

Chronic disorders: infrequently: bradycardia; rarely: tachycardia.

Vascular disorders: infrequent: marked BP decrease*, orthostatic hypotension;
* often observed in patients with controlled BP who received telmisartan treatment to reduce the risk of cardiovascular mortality in addition to standard treatment.

Disorders of the respiratory system, thoracic and mediastinal organs: infrequently: dyspnea, cough.

Gastrointestinal tract disorders: infrequently: abdominal pain, diarrhea, dyspepsia, flatulence, vomiting;
rarely: stomach upset, discomfort, dry oral mucosa, liver disorders / liver disease.

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

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

Muscular system and connective tissue disorders: infrequent: myalgia, back pain (e.g., sciatica), muscle spasms; rare: arthralgia, pain in the extremities; unknown frequency: tendon pain (tendinitis-like symptoms).

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

Hdisorders of diet and metabolism:infrequent: hyperkalemia.

General disorders: infrequently: chest pain, asthenia (weakness); rarely: flu-like condition.

Influence on the results of laboratory parameters and instrumental studies: infrequent: increase in blood creatinine concentration; rare: increase in blood uric acid concentration, “hepatic” enzymes, serum creatine phosphokinase activity, decrease in hemoglobin, hypoglycemia (in patients with diabetes).

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Overdose

Information regarding overdose is limited.

Csymptoms:the most significant are marked decrease in BP and tachycardia; bradycardia, dizziness, increased 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 fluid and salt deficiencies. Continuous monitoring of serum electrolytes and creatinine. Hemodialysis is not effective.

Pregnancy use

Drugs acting directly on the RAAS can cause serious damage and death to the developing fetus, so if pregnancy is planned or established, the drug should be immediately withdrawn and, if necessary, an alternative hypotensive therapy with an established safety profile for use during pregnancy should be prescribed. The use of the drug during pregnancy is contraindicated.

In preclinical studies of telmisartan no teratogenic effects were found, but fetotoxicity was established. It is known that exposure to angiotensin II receptor antagonists during the second and third trimesters of pregnancy causes fetotoxicity in humans (decreased renal function, oligohydramnios, delayed cranial ossification) and neonatal toxicity (renal failure, hypotension, hyperkalemia). Alternative therapy should be administered to patients planning pregnancy. If treatment with angiotensin II receptor antagonists occurred during the second trimester of pregnancy, an ultrasound check of renal function and fetal cranial status is recommended.

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

Telprez therapy is contraindicated during breastfeeding. Studies of the effect on human fertility have not been performed.

Similarities

Mycardis, Telsartan, Telzap, Telmista, Telpres, Telmisartan