Carvedilol Zentiva - instructions for use, dose, side effects, contraindications

ExcipientsSucrose - 13,285 / 12,500 / 25,000 mg, povidone 30 - 0,638 / 0,600 / 1,200 mg, lactose monohydrate 200 - 90,193 / 84,865 / 169,730 mg, silicon dioxide colloid - 0,531 / 0,500 / 1,000 mg, croscarmellose sodium - 2,444 / 2,300 / 4,600 mg, magnesium stearate - 1.594 / 1.500 / 3,000 mg, iron oxide yellow - 0.065 / 0.230 / 0.460 mg, iron oxide red - 0 / 0.005 / 0.010 mg.

Description:

Tablets 6.25 mg

Yellow tablets with inclusions, with a risk for division on one side and with engraving of the number "6" on the other side.

Tablets 12.5 mg

Brownish-yellow tablets with patches, with a risk for dividing on one side and engraving the number "12" on the other side.

Tablets 25 mg

Brownish-yellow tablets with inclusions, with a risk for division on one side and with engraving of the number "25" on the other side.

Pharmacotherapeutic group:Alpha- and beta-blocker

ATX: & nbsp

C.07.A.G.02 Carvedilol

Pharmacodynamics:

It blocks alpha1, beta1 and beta2-adrenergic receptors. Has vasodilating, antianginal and antiarrhythmic action. Carvedilol is a racemic mixture R(+) and S(-) stereoisomers, each of which has the same a-adrenergic blocking properties. Beta-adrenoblokiruyuschee action carvedilol is non-selective and is due to levorotatory S(-) stereoisomer.

The drug does not have its own sympathomimetic activity, it has membrane-stabilizing properties.

The vasodilating effect is mainly due to the blockade of alpha 1-adrenergic receptors. Due to vasodilation reduces the overall peripheral resistance of the vessels (OPSS). Efficiency

Arterial hypertension

In patients with arterial hypertension, lowering blood pressure (BP) is not accompanied by an increase in OPSS, peripheral blood flow (unlike beta-blockers) does not decrease. Carvedilol suppresses the activity of the renin-angiotensin-aldosterone system through blockade β-adrenoceptor kidney, causing a decrease in renin plasma activity. The heart rate (heart rate) decreases slightly.

Ischemic heart disease (CHD)

In patients with coronary heart disease has an antianginal effect. Reduces pre- and postnagruzku on the heart.It has no pronounced effect on the lipid metabolism and the content of potassium, sodium and magnesium ions in the blood plasma. When using the drug, the ratio of high and low density lipoproteins (HDL / LDL) remains normal.

In patients with impaired left ventricular function and / or heart failure, the hemodynamic parameters favorably affect and improve the ejection fraction and the size of the left ventricle.

Chronic heart failure (CHF)

Carvedilol lowers the death rate and reduces the frequency of hospitalizations, reduces symptoms and improves left ventricular function in patients with chronic heart failure of ischemic and non-ischemic origin. The effects of carvedilol are dose-dependent.

Pharmacokinetics:

Suction

Carvedilol is rapidly absorbed from the gastrointestinal tract. Has high lipophilicity. The maximum concentration in the blood plasma (C_mOh) is achieved approximately 1 hour after ingestion. Bioavailability of the drug is 25%. Eating does not affect bioavailability.

Distribution

Carvedilol has a high lipophilicity. It binds to blood plasma proteins by 98-99%.The volume of distribution is about 2 l / kg and increases in patients with cirrhosis of the liver. The enterohepatic circulation of the starting material in animals was demonstrated.

Metabolism

Carvedilol undergoes biotransformation in the liver by oxidation and conjugation to form a number of metabolites. 60-75% of the absorbed drug is metabolized by "primary passage" through the liver. The existence of intestinal-hepatic circulation of the starting material is shown.

The metabolism of carvedilol as a result of oxidation is stereoselective. RThe stereoisomer is metabolized mainly by isoenzymes CYP2D6 and CYP1A2, a S- stereoisomer - mainly by isoenzyme CYP2D9 and to a lesser extent by means of isoenzyme CYP2D6. Other isoenzymes P450 involved in the metabolism of carvedilol include isoenzymes CYP3A4, CYP2E1 and CYP2C19. Maximum concentration Ris approximately 2 times higher than that for Slt; / RTI & gt;

RThe stereoisomer is metabolized mainly by hydroxylation. In slow isoenzyme metabolizers CYP2D6 it is possible to increase the plasma concentration of carvedilol, first of all, R-stereoisomer, which is manifested in an increase in alpha-adrenergic blocking activity of carvedilol.

As a result of demethylation and hydroxylation of the phenolic ring, 3 metabolites are formed (their concentrations are 10 times lower than the concentration of the starting material) with beta-adrenoblocking activity (in the 4'-hydroxyphenol metabolite it is approximately 13 times stronger than in carvedilol itself). 3 active metabolites have less pronounced vasodilating properties than carvedilol. 2 hydroxycarbazole metabolite carvedilol are extremely powerful antioxidants, and their activity in this respect is 30-80 times greater than that of carvedilol.

Excretion

The half-life of carvedilol is about 6 hours, the plasma clearance is about 500-700 ml / min. Excretion occurs mainly through the intestine, the main way of excretion is with bile. A small part of the dose is excreted by the kidneys in the form of various metabolites.

Carvedilol penetrates the placental barrier.

Pharmacokinetics in specific patient groups

Patients with impaired renal function

With prolonged therapy with carvedilol, the intensity of renal blood flow is maintained, the glomerular filtration rate does not change.

In patients with hypertension and moderate (creatinine clearance 20-30 ml / min) or severe (KC <20 ml / min) renal failure, carvedilol concentration in the blood plasma was approximately 40-55% higher than in patients with hypertension and moderate normal kidney function. However, the data obtained are highly variable. Given the fact that excretion of carvedilol occurs mainly through the intestine, a significant increase in its concentration in the blood plasma of patients with impaired renal function is unlikely.

Existing data on pharmacokinetics in patients with varying degrees of renal dysfunction suggest that patients with moderate to severe renal insufficiency do not need to adjust doses of carvedilol.

Patients with impaired hepatic function

In patients with cirrhosis of the liver, the systemic bioavailability of the drug is increased by 80% due to a decrease in the expression of metabolism in the "primary passage" through the liver. Consequently, carvedilol is contraindicated in patients with clinically manifested impairment of liver function (see section "Contraindications").

Patients with heart failure

In a study in 24 patients with heart failure, the clearance R- and Scarbo-idyl is significantly lower compared to the previously observed clearance in healthy volunteers. These results suggest that pharmacokinetics R- and SThe stereoisomers of carvedilol in heart failure change significantly.

Patients of elderly and senile age

Age does not have a statistically significant effect on the pharmacokinetics of carvedilol in patients with arterial hypertension. According to clinical studies, the tolerability of carvedilol in patients with hypertension or ischemic heart disease of the elderly and senile does not differ from that in patients of younger age.

Patients with diabetes mellitus

In patients with type 2 diabetes and hypertension, carvedilol does not affect the concentration of glucose in the blood on an empty stomach and after eating, the concentration of glycosylated hemoglobin (HbA₁) in the blood or a dose of hypoglycemic agents. In clinical studies, it was shown that in patients with type 2 diabetes mellitus carvedilol does not cause a decrease in glucose tolerance. In patients with hypertension who had insulin resistance (syndrome X), but without concomitant diabetes mellitus, carvedilol improves insulin sensitivity. Similar results were obtained in patients with arterial hypertension and type 2 diabetes mellitus.

Indications:

- Arterial hypertension;

- ischemic heart disease: stable angina;

- chronic heart failure (as part of combination therapy).

Contraindications:

- Hypersensitivity to carvedilol or other components of the drug;

- aboutstria and chronic heart failure in the stage of decompensation (IV functional class by classification NYHA), requiring intravenous injection of inotropes;

- clinically significant violations of liver function;

- atrioventricular (AV) blockade II-III degree (except for patients with an artificial pacemaker);

- atAcute bradycardia (heart rate less than 50 beats per minute);

- fromthe weakness of the sinus node (including the sinoatrial blockade);

- tHeavy arterial hypotension (systolic blood pressure less than 85 mm Hg);

- toardiogenic shock;

- bronhospazm and bronchial asthma (in the anamnesis);

- atozrast to 18 years (efficiency and safety not established);

- bVariability;

- Mr.fructose intolerance, lactose, lactase deficiency, sucrose / isomaltase, glucose-galactose malabsorption (the preparation contains lactose and sucrose).

Carefully:

Chronic obstructive pulmonary disease, prinzmetal angina, thyrotoxicosis, peripheral vascular occlusive diseases, pheochromocytoma, psoriasis, renal failure, atrioventricular blockade AV I degrees, extensive surgical interventions and general anesthesia, diabetes mellitus, hypoglycemia, depression, myasthenia gravis.

Pregnancy and lactation:

Data from animal studies are insufficient to determine the effect on pregnancy, embryo / fetal development, childbirth, or postnatal development. A potential risk to a person is not known. Beta-adrenoblockers reduce placental blood flow, which can lead to intrauterine fetal death and premature birth. In addition, the fetus and newborn can develop unwanted reactions (in particular, hypoglycemia and bradycardia,complications from the heart and lungs).

Sufficient experience in the use of the drug CARVEDILOL ZENTIVA in pregnant women is not. CARVEDILOL ZENTIVA is contraindicated for use in pregnancy, except when the possible benefits of its use in the mother exceed the potential risk to the fetus.

Data on the penetration of carvedilol into breast milk in humans are absent, therefore, if taking CARVEDYLOL ZENTIVA is needed during lactation, then breastfeeding should be discontinued.

Dosing and Administration:

Inside, regardless of food intake, with enough liquid.

Arterial hypertension

The initial dose of CARVEDYLOL ZENTIVA is 12.5 mg once a day for the first two days of treatment. Then 25 mg once a day. It is possible to gradually increase the dose at intervals of not less than 2 weeks.

If the hypotensive effect is inadequate after 2 weeks of therapy, the dose can be increased 2 times. The maximum recommended daily dose of the drug is 50 mg once a day (possibly divided into 2 receptions).

Ischemic heart disease: stable angina

The initial dose of the drug is 12.5 mg twice a day for the first two days of treatment. Then 25 mg twice a day. If the antianginal effect is inadequate after 2 weeks of therapy, the dose may be increased 2-fold. The maximum recommended daily dose of the drug is 100 mg per day, divided into 2 doses.

Application in elderly patients

The recommended initial dose during the first two days of treatment with CARVEDYLEN ZENTIVA is 12.5 mg 2 times a day.

Then the treatment is continued at the maximum recommended daily dose for elderly patients at 25 mg twice daily.

Use in children

Safety and effectiveness of use in children (age 18 years) are not established.

Chronic heart failure

The dose is selected individually, under the careful supervision of the doctor.

Carvedilol can be used as a supplement to standard therapy, but it can also be used in patients who do not tolerate ACE inhibitors, or in patients who do not receive cardiac glycosides, hydralazine or nitrates.

Doses of digoxin, diuretics and ACE inhibitors should be stabilized before treatment with carvedilol.

The recommended initial dose is 3,125 mg (1/2 tablet of CARVEDYLOL ZENTIVA in a dose of 6.25 mg with a risk) 2 times a day for 2 weeks. With good tolerability, the dose is increased at intervals of at least 2 weeks to 6.25 mg twice a day, then to 12.5 mg twice a day, then to 25 mg twice a day. The dose should be increased to the maximum, which is well tolerated by the patient.

The recommended maximum dose is 25 mg twice a day for all patients with severe CHF, as well as for patients with mild to moderate CHF with a body weight of less than 85 kg. In patients with mild to moderate CHF with a body weight of more than 85 kg, the recommended maximum dose is 50 mg twice daily.

At the beginning of treatment or with increasing doses, transiently increased symptoms of heart failure, especially in patients with severe CHF and / or receiving large doses of diuretics. As a rule, it is not necessary to cancel treatment, however, the dose of the drug should not be increased. After the carvedilol dose is started or increased, the doctor / cardiologist should monitor the patient's condition. Before each dose increase, athe detection of a possible increase in symptoms of heart failure or excessive vasodilation (including the determination of indicators of kidney function, body weight, blood pressure, heart rate and rhythm). With the progression of symptoms of heart failure or fluid retention, a dose of diuretics is increased; In such a situation, the dose of carvedilol should not be increased until the patient's condition stabilizes. If there is bradycardia or if the time of atrioventricular conduction is prolonged, first of all it is necessary to control the dose of digoxin. In some cases, it may be necessary to reduce the dose of carvedilol or to temporarily discontinue treatment. However, even in such cases, it is often possible to successfully continue titrating the dose of carvedilol.

During the titration of the dose, regular monitoring of renal function, platelet count and glycemia should be performed (in the case of type 1 or type 2 diabetes). After the titration of the dose, the monitoring frequency can be reduced.

Application in elderly patients

Older patients may be more sensitive to the action of carvedilol, so their condition should be watched especially carefully.

Use in children

Safety and effectiveness of use in children (under 18 years) are not established.

Patients with hepatic insufficiency

Carvedilol should not be used in patients with severe liver dysfunction. Patients with moderate hepatic impairment may require dose adjustment. Renal insufficiency

The dose of carvedilol should be selected individually, however, based on pharmacokinetic parameters, dose adjustment in patients with renal insufficiency is usually not required.

Discontinuation of treatment

Carvedilol treatment should not be discontinued suddenly, especially in patients with ischemic heart disease. Treatment should be discontinued gradually, within 7-10 days, for example, reducing the daily dose of the drug twice every 3 days.

Side effects:

This section presents the adverse reactions reported with carvedilol, divided into groups according to the terminology MedDRA and the following frequency categories according to the classification of the World Health Organization: very frequent - more than 1/10, frequent - more than 1/100 to less than 1/10, infrequent - more than 1/1000 to less than 1/100, rare - from more than 1 / 10000 to less than 1/1000, very rare - from less than 1/10000, including individual messages.

Violations of the blood and lymphatic system: frequent - anemia; rare - thrombocytopenia; very rare - leukopenia.

Immune system disorders: very rare - hypersensitivity (allergic reactions).

Disorders from the metabolism and nutrition: frequent - weight gain, hypercholesterolemia, hyperglycemia or hypoglycemia in patients with diabetes mellitus. Mental disorders: frequent - depression, depressed mood; infrequent - sleep disorders.

Infectious and parasitic diseases: frequent - bronchitis, pneumonia of the upper respiratory tract infection, urinary tract infection.

Impaired nervous system: very frequent - dizziness, headache; infrequent - pre-fainting condition, fainting, paresthesia.

Disturbances on the part of the organ of sight: frequent - impaired vision, reduced tearing (dry eyes), eye irritation.

Heart Disease: very frequent - heart failure in the period of increasing the dose; frequent - bradycardia, edema, hypervolemia, fluid retention; infrequent - atrioventricular blockade II-III degree, angina pectoris.

Vascular disorders: very frequent - marked decrease in blood pressure; frequent - orthostatic hypotension, violations of peripheral circulation (cold extremities, peripheral vascular disease, aggravation of the syndrome of "intermittent" lameness and Raynaud's syndrome).

Disturbances from the respiratory system, chest and mediastinal organs: frequent - shortness of breath, pulmonary edema, asthma in predisposed patients; rare - nasal congestion.

Disorders from the gastrointestinal tract: frequent - nausea, diarrhea, vomiting, indigestion, abdominal pain; infrequent - constipation, dryness of the oral mucosa. Disorders from the liver and bile ducts: very rare - increased activity of alanine aminotransferase (ALT), aspartate aminotransferase (ACT) and gamma-glutamyl transferase (GGT).

Disturbances from the skin and subcutaneous tissues: infrequent - skin reactions (for example, allergic exanthema, dermatitis, urticaria, skin itching, psoriasis-like and lichen-like skin lesions, alopecia); very rare - erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Disturbances from musculoskeletal and connective tissue: frequent - pain in the limbs.

Disorders from the kidneys and urinary tract: frequent - violation of urination, kidney failure and renal dysfunction in patients with diffuse vasculitis and / or renal dysfunction; very rarely - urinary incontinence in women (reversible after drug withdrawal).

Violations of the genitals and mammary gland: infrequent - erectile dysfunction.

General disorders and disorders at the site of administration: very frequent - asthenia, increased fatigue.

Dizziness, fainting, headache and asthenia are usually mild in the first place with CARVEDYLOL ZENTIVA.

When CARVEDILOL ZENTYVA was used in patients with CHF and low arterial pressure (systolic blood pressure less than 100 mm Hg), coronary heart disease and diffuse vessel changes and / or renal insufficiency, renal impairment of renal function was noted.

Presence of beta-adrenoblocking properties in the preparation does not exclude the possibility of manifestation of latent diabetes mellitus, decompensation of already existing diabetes mellitus or oppression of the contrinular system.

Overdose:

Symptoms: marked decrease in blood pressure (accompanied by dizziness or fainting), bradycardia; due to bronchospasm may cause dyspnoea, vomiting. In severe cases, breathing disorders, confusion, generalized convulsions, heart failure, cardiac conduction abnormalities, cardiogenic shock, cardiac arrest are possible.

Treatment: symptomatic. It is necessary to monitor and maintain vital body functions, if necessary - in the intensive care unit.

With severe bradycardia, intravenous use of m-holinoblokatorov (atropine on 0,5-2 mg) for maintenance of cardiovascular activity; glucagon 1-10 mg intravenously struino, then 2-5 mg per hour in the form of a long infusion.

If the clinical picture of an overdose is dominated by a marked decrease in blood pressure, sympathomimeticsnorepinephrine (norepinephrine), epinephrine (adrenalin), dobutamine), in different doses, depending on body weight and response to ongoing therapy, under the conditions of continuous monitoring of blood circulation parameters.

With resistance to bradycardia treatment, the use of an artificial pacemaker is indicated.

When bronhospazme enter beta-adrenomimetiki in the form of an aerosol (if ineffectiveness - intravenously) or aminophylline intravenously.

When convulsions are intravenously slowly injected diazepam or clonazepam.

Since a severe overdose with symptoms of shock may prolong the half-life of carvedilol and remove the drug from the depot, it is necessary to continue supporting therapy for a long time.

Interaction:

Pharmacokinetic interaction

Because the carvedilol is both a substrate and an inhibitor of glycoprotein P, when it is simultaneously administered with preparations transported with glycoprotein P, the bioavailability of the latter can increase. In addition, the bioavailability of carvedilol can be altered by the action of inducers or inhibitors of the glycoprotein P.

Inhibitors and inducers of isoenzymes CYP2D6 and CYP2C9 can stereoselectively alter the systemic and / or presystemic metabolism of carvedilol, leading to an increase or decrease in concentrations R- and S-stereoisomers of carvedilol in blood plasma. Some examples of similar interactions observed in patients or in healthy volunteers are listed below, but this list is not complete.

Digoxin

With simultaneous administration of carvedilol and digoxin, digoxin concentrations increase by about 15%. At the beginning of therapy with carvedilol, when selecting its dose or canceling the drug, regular monitoring of the concentration of digoxin in the blood plasma is recommended.

Cyclosporin

In two studies using carvedilol in patients who underwent kidney and heart transplant and who received ciclosporin Inside, there was an increase in the concentration of cyclosporine in the blood plasma. It turned out that due to inhibition of the activity of glycoprotein P in the intestine, carvedilol increases the absorption of cyclosporine when it is ingested. To maintain concentrations of cyclosporine in the therapeutic range, it was required to reduce the dose of cyclosporine by an average of 10-20%. In connection with the expressed individual fluctuations in the concentration of cyclosporin, careful monitoring of its concentration after the initiation of carvedilol therapy and, if necessary, appropriate correction of the daily dose of cyclosporine is recommended. In the case of intravenous administration of cyclosporine, no interaction with carvedilol is expected.

Rifampicin

In a study involving 12 healthy volunteers rifampicin reduced plasma concentrations of carvedilol, most likely by induction of glycoprotein P, leading to a decrease in carvedilol absorption in the intestine and a decrease in its hypotensive effect.

Amiodarone

In patients with heart failure amiodarone reduced ground clearance S stereoisomer of carvedilol, suppressing the isoenzyme CYP2C9. Average concentration R-fromthe carrageenol isotope is unchanged. Consequently, in connection with the increase in concentration S stereoisomer of carvedilol, the risk of an increase in beta-adrenergic blocking effect is possible.

Fluoxetine

In a randomized, cross-design study in 10 patients with heart failure, simultaneous administration of fluoxetine (an isoenzyme inhibitor CYP2D6) led to stereoselective suppression of carvedilol metabolism - an increase in the average area under the "concentration-time" curve (AUC) for R (+) by 77%. However, there were no differences in side effects, blood pressure or heart rate between the two groups.

Pharmacodynamic interaction

Insulin or hypoglycemic agents for oral administration

Drugs with beta-adrenoblocking properties may increase the hypoglycemic effect of insulin or hypoglycemic agents for oral administration. Symptoms of hypoglycemia, especially tachycardia, can be masked or weakened. Patients receiving insulin or hypoglycemic agents for oral administration are encouraged to regularly monitor blood glucose concentrations.

Drugs that reduce the content of catecholamines

Patients taking concomitantly with beta-adrenergic blocking properties and catecholamine-lowering agents (for example, reserpine and monoamine oxidase inhibitors) should be carefully monitored for the risk of arterial hypotension and / or severe bradycardia.

Digoxin

Combination therapy of agents with beta-adrenergic blocking properties and digoxin can lead to an additional delay in atrioventricular conduction.

Verapamil, diltiazem, amiodarone or other antiarrhythmic agents

Simultaneous administration with carvedilol may increase the risk of atrioventricular conduction.

Clonidine

Simultaneous use of clonidine with drugs with beta-adrenoblocking properties can potentiate the hypotensive and bradycardic effect. If you plan to stop combination therapy with a drug with beta-adrenergic blocking properties and clonidine, you should first cancel the beta-blocker, and in a few days you can cancel clonidine, gradually reducing its dose.

Blocks of "slow" calcium channels (BCCI)

With simultaneous use of carvedilol and diltiazem, there were isolated cases of cardiac conduction disorders (rarely - with violations of hemodynamics). As in the case of other drugs with beta-adrenergic blocking properties, the use of carvedilol along with BCCC such as verapamil or diltiazem is recommended to be performed under the control of ECG and AD.

Hypotensive drugs

Like other drugs with beta-adrenergic blocking activity, carvedilol can enhance the effect of other concurrently taken antihypertensive drugs (eg, alpha-blockers) or drugs that cause arterial hypotension as a side effect.

Means for general anesthesia

It should be carefully monitored for the main indicators of life of the body during general anesthesia in connection with the possibility of a synergistic negative inotropic action of carvedilol and funds for general anesthesia.

Non-steroidal anti-inflammatory drugs (NSAIDs)

Joint reception of NSAIDs and beta-blockers can lead to an increase in blood pressure and a decrease in blood pressure control.

Bronchodilators (beta-adrenergic agonists)

Since noncardioselective beta-blockers inhibit the bronchodilatory effect of bronchodilators, which are beta-adrenergic receptor stimulants, careful monitoring of patients receiving these drugs is necessary.

Special instructions:

Chronic heart failure

In patients with CHF during the selection of the dose of CARVEDYL ZENTIVE, there may be an increase in symptoms of chronic heart failure or fluid retention. If such symptoms occur, it is necessary to increase the dose of diuretics and not increase the dose of CARVEDILOL ZENTIVA until the hemodynamic parameters stabilize.Sometimes it is necessary to reduce the dose of CARVEDYLOL ZENTIVA or, in rare cases, temporarily cancel the drug. Such episodes do not prevent further correct selection of the dose of CARVEDYLOL ZENTIVA.

CARVEDYLOL ZENTIVA is used with caution in combination with cardiac glycosides (possibly excessive deceleration AV conductivity).

Kidney function in chronic heart failure

When CARVEDYLOL ZENTIVA was administered to patients with chronic heart failure and low blood pressure (systolic blood pressure less than 100 mm Hg), coronary heart disease and diffuse vessel changes and / or kidney failure, renal impairment of renal function was noted. The dose of the drug is selected depending on the functional state of the kidneys.

Chronic obstructive pulmonary disease (COPD)

Patients with COPD (including bronchospastic syndrome) who are not receiving inhalation or preparations for ingesting antiasthmatic drugs, CARVEDYLOL ZENTIVA preparation is prescribed only if the possible advantages of its use exceed the potential risk.

In the presence of the initial predisposition to bronchospastic syndrome with the drug CARVEDILOL ZENTYVA as a result of increased resistance to the airways may develop shortness of breath. At the beginning of admission and with increasing the dose of CARVEDYLOL ZENTYVA, these patients should be carefully observed, reducing the dose of the drug when the initial signs of bronchospasm appear.

Diabetes

With caution, the drug is prescribed to patients with diabetes, because it can mask or relieve the symptoms of hypoglycemia (especially tachycardia). In patients with chronic heart failure and diabetes mellitus, the use of the drug CARVEDILOL ZENTIVA may be accompanied by fluctuations in glycemia.

Diseases of peripheral vessels

Caution is needed when using CARVEDYL® ZENTIVA in patients with peripheral vascular disease (including Reynaud's syndrome), since beta-blockers may increase the symptoms of arterial insufficiency.

Thyrotoxicosis

Like other beta-blockers, the drug CARVEDILOL ZENTIVA can reduce the severity of symptoms of thyrotoxicosis.

General anesthesia and extensive surgery

Caution is required in patients undergoing general surgery under general anesthesia, because of the possibility of summing up the negative effects of CARVEDYLOL ZENTIVA and the means for general anesthesia.

Bradycardia

The drug CARVEDILOL ZENTIVA can cause a bradycardia, with a decrease in heart rate of less than 55 beats per minute. The dose of CARVEDYLOL ZENTIVA should be reduced.

Hypersensitivity to allergens

Caution should be exercised when using CARVEDYLOL ZENTIVA in patients with anamnestic indications of severe hypersensitivity reactions or undergoing desensitization, since beta-blockers may increase sensitivity to allergens and severity of anaphylactic reactions.

Psoriasis

Patients with anamnestic indications of the occurrence or exacerbation of psoriasis with beta-blockers, CARVEDILOL ZENTIVA preparation can be prescribed only after a careful analysis of the possible benefits and risks.

Simultaneous reception of blockers of "slow" calcium channels

In patients who simultaneously take BCCC such as verapamil or diltiazem, as well as other antiarrhythmics, it is necessary to regularly monitor the ECE and BP.

Pheochromocytoma

Patients with pheochromocytoma before starting any beta-blocker should appoint an alpha-blocker. Although CARVEDYLOL ZENTIVA has both beta and alpha-adrenergic blocking properties, there is no experience of its use in such patients, so it should be used with caution in patients with suspected pheochromocytoma.

Angina pectoris

Non-selective beta-blockers can provoke the appearance of pain in patients with Prinzmetal angina. The experience of using the drug CARVEDILOL ZENTYVA in these patients is not. Although its alpha-adrenergic blocking properties can prevent similar symptoms, prescribe carvedilol in such cases should be done with caution.

Contact lenses

Patients who use contact lenses should remember the possibility of reducing the amount of tear fluid.

The "cancellation" syndrome

Treatment with CARVEDYLOL ZENTIVA is carried out for a long time.It should not be stopped abruptly, it is necessary to gradually reduce the dose of the drug at weekly intervals. This is especially important in patients with ischemic heart disease.

If surgical intervention is required with general anesthesia, an anesthesiologist must be warned about the previous therapy with CARVEDYLOL ZENTIVA.

During the treatment, alcohol consumption is excluded.

Care must be taken in patients with depression, metabolic acidosis and malignant myasthenia gravis (myasthenia gravis).

Sucrose

The drug CARVEDYLOL ZENTIVA contains sucrose. Patients with rare hereditary diseases associated with intolerance to galactose, glucose-galactose malabsorption syndrome and insulinase malase deficiency should not take this drug.

Lactose Monohydrate

The drug CARVEDYLOL ZENTIVA contains lactose. Patients with rare hereditary diseases associated with intolerance to galactose, deficiency of Lappa lactase, or impaired absorption of glucose-galactose, should not take this drug.

Effect on the ability to drive transp. cf. and fur:

Special studies of the effect of CARVEDYLOL ZENTIVA on the ability to drive vehicles and work with mechanisms have not been carried out.

In connection with the possibility of developing such adverse reactions as dizziness and fatigue, the ability to drive vehicles and work with mechanisms can be disrupted. Especially it should be considered at the beginning of treatment, after increasing the dose, with the change of drugs, as well as with the use of alcohol.

Form release / dosage:

Tablets 6.25, 12.5 mg and 25 mg.

Packaging:

Tablets 6.25 mg and 12.5 mg: 15 tablets each in a PVC / PVDC / Al blister.

For 1 or 2 blisters are placed in a cardboard box along with instructions for use.

Tablets 25 mg: 10 tablets in a blister of PVC / PVDC / A1.

For 3 blisters are placed in a cardboard box together with instructions for use.

Storage conditions:

Store at a temperature not exceeding 30 ° C. Keep out of the reach of children.

Shelf life:

2 years.

The drug should not be used after the expiry date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-000134

Date of registration:14.03.2012

The owner of the registration certificate:Zentiva c.s.Zentiva c.s. Czech Republic

Manufacturer: & nbsp

ZENTIVA, k.s. Czech Republic

Representation: & nbspZENTIVA ZENTIVA Czech Republic

Information update date: & nbsp10.07.2014

Illustrated instructions

Instructions

Carvedilol Zentiva (Carvedilol Zentiva)