Expiration date: 02/2026

The composition and form of issue:

Tablets. 1 tablet contains:

active substance: 

candesartan cilexetil 8, 16 or mg

32 mg

excipients: calcium carmellose (carmellose calcium salt) of hyprolose (hydroxypropyl cellulose) iron oxide E172 lactose monohydrate magnesium stearate maize starch macrogol 

in blister PVC/aluminium 14 PCs the paper cartons 2 blister.

Description pharmaceutical form:

Atacand 8 mg: light pink, round biconvex tablets scored and engraved A/CG on one side and 008 on the other.

Atacand 16 mg: pink, round biconvex tablets scored and engraved A/CH on one side and 016 on the other.

Atacand 32 mg: pink, round biconvex tablets scored and engraved A/CL on one side and 032 on the other.

Indications:

• hypertension
  
• chronic heart failure and systolic dysfunction of the left ventricle (reduced ejection fraction of the left ventricle &le40%) as additional therapy to ACE inhibitors or intolerance to ACE inhibitors.
  

Contraindications:

• hypersensitivity to candesartan cilexetil or other components included in the drug
  
• the human liver and/or cholestasis
  
• pregnancy and lactation (see "pregnancy and breastfeeding").
  

With caution: in patients with severe renal insufficiency (Cl creatinine <30 ml/min) bilateral renal artery stenosis or stenosis of the artery only kidneys with hemodynamically significant stenosis of the aortic and mitral valves, after a kidney transplant in history, in patients with cerebrovascular diseases and ischemic heart disease, hyperkalemia, in patients with reduced BCC, primary hyperaldosteronism (no sufficient data on clinical studies), hypertrophic cardiomyopathy, at the age of 18 years (efficacy and safety not established). For tablets, 32 mg additionally, patients with end-stage renal disease (creatinine Cl <15 ml/min) and severe hepatic impairment and/or cholestasis (clinical application experience is limited).

Application of pregnancy and breast-feeding:

The human embryo is the circulatory system of the kidney, which depends on the development of the renin-angiotensin-aldosterone system, begins to form in the II and III trimester of pregnancy. Thus, the risk to the fetus increases with the appointment of Atacand in II and III trimestrah pregnancy. Drugs have a direct effect on the renin-angiotensin-aldosterone system, can cause abnormalities of fetal development or have an adverse effect on a newborn up to a lethal outcome in applying the drug in II and III trimestrah pregnancy.

In studies on animals revealed kidney damage in the embryonic and neonatal periods with the use of candesartan in has cilexetil. It is assumed that the mechanism of damage due to the pharmacological effects of the drug on the renin-angiotensin-aldosterone system.

Based on this information, you should not use Atacand during pregnancy. If pregnancy is detected during treatment with Atacand, therapy should be discontinued (see section "Contraindications").

Lactation

At present it is not known whether candesartan penetrates in breast milk. In connection with possible adverse effects on infants, Atacand should not be used during breast-feeding.

Side effects:

Hypertension

Side effects during clinical trials carried moderate and transient in nature and were comparable in frequency with the placebo group. The overall incidence of side effects in patients receiving Atacand not dependent on the dose and age of the patient. The incidence of discontinuation of therapy due to side effects was similar when using candesartan in has cilexetil (2.4%) and placebo (2.6 percent).

During data analysis of the conducted studies reported the following side effects, often (>1/100) occurring in patients receiving candesartan in has cilexetil. Described adverse effects were observed with a frequency of at least 1% more than in the placebo group.

CNS: dizziness, weakness, headache.

From the side of musculoskeletal system and connective tissue: back pain.

Infection: respiratory infections.

Laboratory findings: in General, when applying Atacand was not observed clinically relevant changes in standard laboratory parameters. As the use of other inhibitors of the renin-angiotensin-aldosterone system, you may experience a slight decrease in hemoglobin concentration. An increase in the content of creatinine, urea or potassium and reducing sodium. The increased ALT was observed more often when using Atacand compared to placebo (1.3 instead of 0.5%). When applying Atacand not usually require regular control of laboratory parameters. However, in patients with impaired renal function it is recommended to periodically monitor the level of potassium and creatinine in serum.

Chronic heart failure

Side effects identified on the background of the application of Atacand in patients with chronic heart failure, consistent with the pharmacological properties of the drug and was dependent on the condition of the patient. In clinical trials, a CHARM, a comparison was made of Atacand in doses up to 32 mg (n=3803) with placebo (n=3796), 21% of patients from group of patients treated with candesartan had cilexetil, and 16.1% patients from group of patients, receiving placebo, stopped treatment because of adverse reactions occurrence.

The most common side effects (&ge1/100, <1/10):

From the CCC: expressed lower AD.

For tablets, 32 mg additionally

Violation of metabolism and diseases caused by metabolic disorder: hyperkalemia.

From the side of urinary system: violation of kidney function.

Laboratory changes: increased creatinine, urea and potassium. It is recommended to monitor serum creatinine and potassium in blood serum.

About the following side effects during post-marketing use of the drug were reported very rarely (<1/10000):

From the hematopoietic and lymphatic system: leukopenia, neutropenia and agranulocytosis.

Violation of metabolism and diseases caused by metabolic: hyperkalemia, hyponatremia.

From nervous system: dizziness, weakness (for tablets 8 and 16 mg), and headache.

Gastrointestinal: nausea.

The liver and biliary tract: increased liver enzymes, abnormal liver function or hepatitis.

With the skin: angioneurotic edema, skin rash, urticaria, pruritus.

From the side of musculoskeletal system and connective tissue: back pain, arthralgia, myalgia.

From the side of urinary system: impaired renal function including renal failure in susceptible patients.

Method of application and dose:

Inside, 1 times per day regardless of the meal.

Hypertension

The recommended starting and maintenance dose of Atacand is 8 mg 1 times per day. Patients requiring further reduction in blood pressure, it is recommended to increase the dose to 16 mg 1 time per day. The maximum antihypertensive effect is achieved within 4 weeks of starting treatment. Patients who failed to sufficiently blood pressure reduction after 4 weeks of reception of Atacand at a dose of 16 mg/day, consider increasing the dose to 32 mg 1 time per day.

If therapy Atacando does not reduce blood pressure to an optimal level, it is recommended to add to the therapy thiazide diuretic.

Elderly patients

In patients of advanced age not necessary to adjust the initial dose of the drug.

Patients with impaired renal function

In patients with easy or moderate impaired renal function (Cl creatinine &ge30 ml/min/1,73m2 surface area of the body) no alteration to the initial dose of the drug. The initial daily dose in patients with slight or moderate impairment of renal function, including patients on hemodialysis is 4 mg (the use of tablets in dosage form of 8 and 16 mg).

Clinical experience with the drug in patients with severe impaired renal function (Cl creatinine <30 ml/min/1.73 m2 of body surface) is limited in this case, you should consider beginning treatment with a daily dose of 4 mg. Clinical experience with the drug in patients with severe impairment of renal function or renal insufficiency (creatinine Cl <15 ml/min) is limited.

Patients with abnormal liver function

In patients with hepatic impairment mild and moderate severity is recommended to start treatment with a daily dose of 2 mg 1 time per day. Can increase dose if necessary. Clinical experience in patients with severe liver and/or cholestasis is limited.

Concomitant therapy

The use of Atacand together with thiazide-type diuretics (e.g., hydrochlorothiazide) may enhance the hypotensive effect Atacand.

Chronic heart failure

The recommended starting dose of Atacand is 4 mg 1 time per day. Increase the dose to 32 mg 1 time per day or until maximum tolerated dose is held by doubling at intervals of not less than 2 weeks (see "Special instructions").

Special groups of patients

Elderly patients and patients with impaired kidney or liver does not require modification of the initial dose.

Use in children and adolescents

The safety and efficacy of Atacand in children and adolescents (under 18 years) is not installed.

Concomitant therapy

Atacand can be assigned in conjunction with other agents used in the treatment of chronic heart failure, e.g. ACE inhibitors, beta-adrenoblokatorami, dioretikami and cardiac glycosides (see "Special instructions").

Overdose:

Symptoms: analysis of pharmacological properties of the drug suggests that the main manifestation of an overdose may be clinically significant decrease in blood pressure and dizziness. Described isolated cases of overdose (up to 672 mg candesartan in has cilexetil), which ended in the recovery of patients without severe consequences.

Treatment: with the development of clinically expressed arterial hypotension should be symptomatic treatment and monitor the patient's condition. To lay the patient on his back, lift his legs. If necessary, increase the volume of circulating plasma, for example by in/with the introduction of isotonic solution of sodium chloride. If necessary, can be assigned sympathomimetic drugs. The excretion of candesartan in by hemodialysis is unlikely.

Special instructions:

Violation of kidney function

On the background of therapy with Atacand, as the use of other means, oppressive of the renin-angiotensin-aldosterone system, some patients may experience dysfunction of the kidneys.

When applying Atacand in patients with hypertension and renal insufficiency is recommended to periodically monitor the level of potassium and creatinine in serum. Clinical experience with the drug in patients with severe impairment of renal function or end-stage renal failure is limited (creatinine Cl <15 ml/min).

In patients with chronic heart failure it is necessary to periodically monitor renal function, especially in patients aged 75 years and older, and in patients with impaired renal function. With increasing doses of Atacand also recommended to monitor the level of potassium and creatinine.

In clinical studies of Atacand in chronic heart failure excluded patients with creatinine >265 µmol/l (>3 mg/DL).

Combined use with ACE inhibitors in chronic heart failure

When using candesartan in combination with ACE inhibitors may increase the risk of side effects, especially renal dysfunction and hyperkalemia (see "Side effects"). In these cases, careful monitoring and control of laboratory parameters.

Renal artery stenosis

In patients with bilateral renal artery stenosis or stenosis of artery only kidneys drugs that affect the renin-angiotensin-aldosterone system, in particular ACE inhibitors, can cause increased levels of urea and creatinine in the serum. Similar effects can be expected in the appointment of antagonists of angiotensin II receptors.

Kidney transplant

Data on the use of Atacand in patients who recently had a kidney transplant, no.

Hypotension

In patients with chronic heart failure on therapy with Atacand may develop hypotension. As the use of other drugs affecting the renin-angiotensin-aldosterone system, the cause of arterial hypotension in patients with arterial hypertension can be a decrease in BCC, as observed in patients receiving high doses of diuretics. Therefore, at the beginning of therapy should be used with caution and, if necessary, correction of hypovolemia.

General anesthesia and surgery

Patients receiving antagonist of angiotensin II during General anesthesia and during surgery may develop hypotension due to the blockade of the renin-angiotensin system. Very rarely observed cases of severe hypotension requiring I/V administration of fluids and/or vasopressors.

Stenosis of the aortic and mitral valve (obstructive hypertrophic cardiomyopathy)

When you assign Atacand, as with other vasodilators patients with obstructive hypertrophic cardiomyopathy or hemodynamically significant aortic stenosis or mitral valve should be used with caution.

Primary hyperaldosteronism

Patients with primary hyperaldosteronism is usually resistant to treatment with antihypertensive drugs that affect the renin-angiotensin-aldosterone system. In this regard, Atacand not recommended for such patients.

Hyperkalemia

Clinical experience with the use of other drugs that affect the system of the renin-angiotensin-aldosterone, shows that the simultaneous appointment of Atacand with potassium-sparing diuretics, potassium supplements or salt substitutes containing potassium, or other drugs that may increase potassium levels (e.g. heparin) may lead to the development of hyperkalemia in patients with hypertension.

In patients with chronic heart failure on therapy with Atacand, can develop hyperkalemia. When you assign Atacand patients with chronic heart failure it is recommended that regular monitoring of potassium level in the blood, especially with a joint appointment with ACE inhibitors and potassium-sparing diuretics.

Common

Patients in whom vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or kidney disease, including renal artery stenosis), are particularly sensitive to drugs acting on the renin-angiotensin-aldosterone system. The purpose of such funds is accompanied by these patients, abrupt hypotension, azotemia, oliguria and rarely acute renal failure. The possibility of the development of the listed effects may not be excluded and the use of antagonists of angiotensin II receptors. A sharp decrease in blood pressure in patients with ischaemic cardiopathy or cerebrovascular diseases ischemic in the use of any antihypertensive drugs, can lead to the development of myocardial infarction or stroke.

Effects on ability to drive or work with machinery. Not studied, but the pharmacodynamic properties of the drug indicate that such influence is absent.

When driving vehicles and activities potentially hazardous activities, require high concentration and psychomotor speed reactions, should be aware that in applying the drug may occur dizziness and fatigue.

Review:

Before using the drug you must read the instructions for use.