Expiration date: 11/2025

The composition and form of issue:

Tablets, film-coated 1 tablet contains:

eprosartan mesylate 490,55 mg

(corresponds to 400 mg of eprosartan) 

excipients: MKC — 179,05 mg lactose monohydrate — 28,75 mg corn starch jelatinizirovanny — 28,75 mg crospovidon — 32 mg magnesium stearate 6 mg, purified water — 34,9 mg 

the shell: Opadry pink (YS-1-14643-A) to 32 mg (hypromellose, macrogol, Polysorbate 80 dye: iron oxide yellow E172 iron oxide red E172 titanium dioxide E171) 

blistere in 14 PCs., in box 1, 2 or 4 blisters.

Tablets, film-coated 1 tablet contains:

eprosartan mesylate 735,8 mg

(corresponds to 600 mg of eprosartan) 

excipients: MKC — 43,3 mg lactose monohydrate — 43,3 mg corn starch jelatinizirovanny — 43,3 mg crospovidon — 38,5 mg of magnesium stearate and 7.2 mg purified water is 50.9 mg 

the shell: Opadry white (OY-S-9603) of 38.5 mg (hypromellose, macrogol, Polysorbate 80 dye: titanium dioxide E171) 

blistere in 14 PCs., in box 1, 2 or 4 blisters.

Description pharmaceutical form:

Pills 400 mg: tablets, film-coated light pink color, oval shape, biconvex, engraved with "5044" on one side of the tablet and "SOLVAY" on the other.

Tablets 600 mg: tablets, film-coated white color, oval shape, biconvex, engraved with "5046" on one side of the tablet and "SOLVAY" on the other .

Feature:

Blocker angiotensin II receptor.

Pharmacokinetics:

After ingestion of a single dose of 300 mg bioavailability of approximately 13%. Linking blood plasma proteins is high (98%) and remains constant throughout the therapeutic range of concentrations. The bonding with blood plasma proteins is not dependent on sex, age, liver function and does not change when slightly severe or moderate renal insufficiency, but may be reduced in severe renal failure. Cmax of the drug is determined after 1-2 hours after ingestion. When taking eprosartan at the same time food is observed clinically insignificant decrease in absorption (<25%), Cmax and AUC. T1/2 is 5-9 h. the Volume of distribution of 13 l, the Cl — 130 ml/min is Excreted mainly unchanged in the feces 90% urine and 7% when taken orally. A small part (less than 2%) is excreted by the kidneys in the form of glucuronides. 20% of the concentration in the urine is acylglucuronide eprosartan, 80% is unchanged drug. Almost not koumouliruet. Body mass, sexual and racial differences do not affect the pharmacokinetics of eprosartan. In individuals under 18 years of age the pharmacokinetics of not been studied. In old age the values of C Max and AUC increased by an average of 2 times, which, however, does not require correction of dosing regimen. When liver failure values of AUC (but not Cmax) are increased by an average of 40%, which does not require correction of dosing regimen. The treatment with eprosartan in patients with moderate renal insufficiency (Cl creatinine of 30 to 59 ml/min), AUC and Cmax 30%, and severe (creatinine Cl 5 to 29 ml/min) — 50% higher in comparison with healthy people.

Description pharmacological action:

Selectively acts on angiotensin receptors located in the blood vessels, heart, kidneys and adrenal cortex, forming with them a strong relationship with subsequent slow dissociation. Angiotensin II binds to AT1 receptors in many tissues (e.g. smooth muscles of blood vessels, adrenals, kidney, heart) and causes vasoconstriction, retention of sodium and release of aldosterone, the defeat of target organs — hypertrophy of the myocardium and blood vessels.

Eprosartan prevents the development or reduces the effects of angiotensin II. Reduces arterial vasoconstriction, peripheral vascular resistance, the pressure in the pulmonary circulation, reabsorption of water and sodium ions in the proximal segment of the renal tubules, aldosterone secretion. Long-term use suppresses the proliferative effect of angiotensin II on the cells of smooth muscles of vessels and myocardium. Permanent antihypertensive effect persists for 24 hours without the development of orthostatic hypotension in response to first dose. Stabilization antihypertensive effect when taken regularly occurs within 2-3 weeks without changing heart rate. In patients with hypertension eprosartan does not affect the concentration of triglycerides, total cholesterol or cholesterol in LDL composition in the blood, determined on an empty stomach. In addition, does not affect the concentration of glucose in fasting blood. Has an indirect diuretic and renal protection effect, reducing the excretion of albumin, while preserving renal autoregulation, regardless of degree of renal failure. Does not affect purine metabolism, has no significant effect on uric acid excretion with the urine. Eprosartan does not increase effects associated with bradykinin (enzyme-mediated), such as cough. The incidence of dry, persistent cough in patients receiving eprosartan and 1.5%. When you replace the ACE inhibitor with eprosartan in patients suffering from cough, frequency of dry persistent cough corresponds to placebo. Discontinuation of treatment with eprosartan is not accompanied by a syndrome "cancel".

Indications:

Hypertension.

Contraindications:

• hypersensitivity to the drug
  
• pregnancy
  
• breastfeeding
  
• the age of 18 years (efficacy and safety not established).
  

With caution:

• severe heart failure of III–IV FC (NYHA)
  
• bilateral renal artery stenosis, renal artery stenosis to a solitary kidney
  
• the decline in BCC from vomiting, diarrhea, ingestion of high doses of diuretics.
  

The company has no data on the safety Teveten in patients with end-stage renal insufficiency (Cl creatinine less than 5 ml/min, uremia II) and in patients on hemodialysis.

Application of pregnancy and breast-feeding:

Teveten should not be used during pregnancy. In the case of diagnosing pregnancy, the drug should be discontinued immediately and warn the patient about possible unwanted effects. Should not be administered eprosartan women during breastfeeding. If necessary, use Teveten, breastfeeding should be discontinued.

Side effects:

The overall incidence of side effects, registered in patients receiving eprosartan, comparable to when receiving placebo. These actions, as a rule, were mild and brief, so the cessation of treatment was required in only 4.1% of patients taking eprosartan during placebo-controlled clinical trials (6,5% in the placebo group).

CNS: rarely — headache, dizziness, asthenia.

From the side of cardiovascular system: very rarely — decreased blood pressure, including postural hypotension.

The skin and subcutaneous fat: rare — skin reactions (rash, itching and urticaria), rarely — swelling of the face, angioedema.

Other: rarely — cough.

Drug interactions:

Clinically significant drug interactions were observed. Eprosartan does not affect the pharmacokinetics of digoxin and the pharmacodynamics of warfarin or glibenclamide. Pharmacokinetic properties of eprosartan does not change in its simultaneous application with ranitidine, ketoconazole or fluconazole. Eprosartan can be used in combination with thiazide diuretics (including hydrochlorothiazide) and blokatorami "slow" calcium channels, including nifedipine prolonged action, not expecting clinically significant adverse events, while Teveten enhances their hypotensive effect. Teveten can be administered in combination with lipid-lowering drugs (e.g. lovastatin, simvastatin, pravastatin, fenofibrate, gemfibrozil, and nicotinic acid). When prescribing lithium at the same time with ACE inhibitors caused a reversible increase in concentration of lithium ions in blood serum. We cannot exclude a similar effect after the use of eprosartan, in this connection, in the case of concomitant treatment, it is recommended to carefully control the lithium content in the blood serum.

Method of application and dose:

Inside, regardless of meals. The recommended daily dose of 600 mg 1 time per day in the morning. The selection of the initial dose is required for elderly patients and for patients with hepatic insufficiency. For patients with moderate or severe renal insufficiency (Cl creatinine <60 ml/min) daily dose should not exceed 600 mg. the Duration of treatment Teverina not limited.

Overdose:

There are limited data on overdose. The drug is well tolerated when taken orally. Shows the effectiveness of daily doses up to 1200 mg, when taken for 8 weeks, and the absence of reports of explicit dependence of the frequency of adverse effects from the dose.

Symptoms: perhaps expressed lower AD.

Treatment: symptomatic therapy.

Precautions:

During treatment of hypertension must be careful when driving vehicles and occupation potentially hazardous activities, require high concentration and psychomotor speed reactions, due to the fact that there can be dizziness and weakness.

Special instructions:

Symptomatic hypotension. With a decrease in BCC or marked decrease in fluid volume and/or salt content in the body (including during the period of treatment with high doses of diuretics, repeated vomiting, prolonged diarrhea, when diet and greatly reduced sodium intake), the drug can cause a sharp decrease in blood pressure (symptomatic hypotension). Before the appointment Teveten such violations should be eliminated. A transient decrease in blood pressure is not a cause of discontinuation of the drug, because in this case, AD stabilability further reception.

Renal failure (severe heart failure). In patients with renal function which depends on the activity of the renin-angiotensin-aldosterone system (e.g. in severe heart failure III–IV FC NYHA, bilateral renal artery stenosis or renal artery stenosis to a solitary kidney), while treatment with ACE inhibitors may develop oliguria and/or progressive azotemia and, in rare cases, severe kidney failure. Due to insufficient experience in the application of antagonists of receptors of angiotensin II in patients with severe cardiac insufficiency or renal artery stenosis, it is impossible to rule out disorders of renal function on the background of the application Teveten, due to the suppression of the renin-angiotensin-aldosterone system. In patients with renal insufficiency before prescribing Teveten and, periodically, during the course of treatment should evaluate kidney function. If in this period there is a deterioration of renal function, treatment Teveten should be reconsidered.