Talliton - instructions for use, doses, side effects, contraindications

Excipients: lactose monohydrate 50 mg, crospovidone 15 mg, sucrose 12.5 mg, silicon dioxide colloid 6 mg, povidone K-25 2 mg, magnesium stearate 2 mg, dyes: tablets of 6.25 mg contain quinoline yellow dye 0.003 mg, tablets of 12.5 mg - dye sunset yellow 0.006 mg.

Description:

Tablets 6.25 mg: Light-yellow, flat, oblong tablets with beveled, with the mark on one side and engraving E 341 on the other side, no or almost odorless.

Tablets 12.5 mg: light orange (may be blotches of a darker color), flat, round, with a bevel of the tablet, with a risk on one side and engraved on E 342 on the other side, with little or no odor.

Tablets 25 mg: White or almost white, flat, round, beveled tablets with the mark on one side and engraving E 343 on the other side, no or almost odorless.

Pharmacotherapeutic group:Alpha- and beta-blocker

ATX: & nbsp

C.07.A.G.02 Carvedilol

Pharmacodynamics:

Carvedilol - blocker of alpha1, beta1 and beta2-adrenoreceptors, has an organoprotective effect,is an antioxidant that removes free oxygen radicals, has an antiproliferative effect against smooth muscle cells of the vessel walls. Carvedilol is a racemic mixture R(+) and S(-) stereoisomers, each of which has the same alpha-adrenoblocking and antioxidant properties. Beta-adrenoblokiruyuschee action carvedilol is non-selective and is due to levorotatory S(-) stereoisomer.

Carvedilol has no internal sympathomimetic activity and has membrane-stabilizing properties. Blocking beta-adrenoreceptors, it reduces the activity of the renin-angiotensin-aldosterone system, reducing the release of renin, so fluid retention (characteristic of selective alpha-blockers) occurs rarely.

Selectively blocking alpha 1-adrenergic receptors, carvedilol reduces the overall peripheral vascular resistance.

Carvedilol does not adversely affect the lipid profile, maintaining a normal ratio of high and low density lipoproteins (HDL / LDL).

Efficiency

Arterial hypertension

In patients with arterial hypertension carvedilol lowers blood pressure (BP) due to the combined blockade of beta and alpha 1-adrenergic receptors. Reduction of blood pressure is not accompanied by a simultaneous increase in the total peripheral vascular resistance, which is observed when taking non-selective beta-blockers. The heart rate (heart rate) decreases somewhat. Kidney blood flow and kidney function in patients with hypertension persist. Shown, that carvedilol does not change the shock volume of blood and reduces the overall peripheral vascular resistance; does not impair blood supply to organs and peripheral blood flow, including in skeletal muscles, forearms, lower extremities, skin, brain and carotid arteries. Coldness of limbs and increased fatigue during exercise are rare. The antihypertensive effect of carvedilol in hypertension persists for a long time.

Cardiac ischemia

In patients with ischemic heart disease carvedilol has anti-ischemic and antianginal action (an increase in the total duration of exercise, time to development of the segment depression ST depth of 1 mm and the time before the onset of an attack of angina pectoris), persisting with prolonged therapy. Carvedilol reliably reduces the need for myocardium in oxygen and the activity of the sympathoadrenal system. Also reduces preload (pulmonary wedge wedge pressure and pulmonary capillary pressure) and postnagruzka (general peripheral vascular resistance).

Chronic heart failure

Carvedilol lowers the mortality 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

After oral administration carvedilol quickly absorbed. Carvedilol is a carrier protein that serves as a pump in the lumen of the intestine, glycoprotein R. Glycoprotein P plays a major role in the bioavailability of certain drugs. The maximum concentration in the blood plasma (C_mOh) is reached after about 1 hour. Absolute bioavailability of carvedilol is approximately 25%.

Distribution

Carvedilol has a high lipophilicity. About 98-99% of carvedilol binds to blood plasma proteins. Its volume of distribution is approximately 2 l / kg. 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 by oxidation is stereoselective. R(+) 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 R(+) stereoisomer in plasma is approximately 2 times greater than that for S(-) stereoisomer.

RThe (+) stereoisomer is metabolized mainly by hydroxylation. In metabolizers of isoenzyme CYP2D6 it is possible to increase the plasma concentration of carvedilol, first of all, R(+) stereoisomer, which is reflected 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 of the hydroxycarbazole metabolites of 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.

Pharmacokinetics in special groups of patients

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 arterial hypertension and renal dysfunction, the area under the concentration-time curve (AUC), half-life and maximum plasma concentrations do not change. Renal excretion of unchanged drug in patients with renal insufficiency decreases, but changes in pharmacokinetic parameters are not very pronounced.

Carvedilol is an effective treatment for patients with renovascular hypertension, including in patients with chronic renal failure, as well as in patients on hemodialysis or who have undergone kidney transplantation. Carvedilol causes a gradual decrease in blood pressure both on the day of dialysis and on days without dialysis, and its antihypertensive effect is comparable to that in patients with normal renal function. During the course of dialysis carvedilol is not excreted because it does not pass through the dialysis membrane, due to the fact that it strongly binds to blood plasma proteins.

Based on the results obtained in comparative studies in patients on hemodialysis, it was concluded that carvedilol is more effective with better tolerability compared with blockers of "slow" calcium channels.

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.

Patients with heart failure

In a study in 24 patients with heart failure, clearance R(+) and S(-) stereoisomers of carvedilol was significantly lower compared to the previously observed clearance in healthy volunteers. These results

indicate that pharmacokinetics R(+) and S(-) stereoisomers of carvedilol in heart failure significantly changes.

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.

Children

Data on the pharmacokinetics of the drug in patients under 18 years of age are currently limited.

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 level of glycosylated hemoglobin (HbA₁) or a dose of hypoglycemic agents for oral administration. In some 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 arterial 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

Essential hypertension (in monotherapy or in combination with other antihypertensive drugs).

Cardiac ischemia

Prevention of attacks of stable angina.

Chronic heart failure

Treatment of stable and symptomatic chronic heart failure (II-IV functional classes forNYHA classification) ischemic or non-ischemic genesis in combination with angiotensin-converting enzyme (ACE) inhibitors and diuretics, with or without cardiac glycosides (standard therapy), in the absence of contraindications.

Contraindications:

Hypersensitivity to the drug; heart failure in the stage of decompensation; conduction disorders (syndrome of sinus node weakness, sinoatrial block, atrioventricular block II-III degree), except for patients with an artificial pacemaker; severe bradycardia (heart rate less than 50 beats per minute); arterial hypotension (systolic blood pressure less than 85 mm Hg); pheochromocytoma without simultaneous use of alpha-blockers; cardiogenic shock; pulmonary hypertension, pulmonary heart; bronchial asthma (in the anamnesis); severe violations of liver function; metabolic acidosis; pregnancy and lactation; children under 18 years of age (due to lack of clinical experience); fructose intolerance and glucose / galactose absorption disorder or sugarase / isomaltase deficiency (the preparation contains sucrose); lactose intolerance, lactase deficiency, glucose-galactose malabsorption (the preparation contains lactose monohydrate).

Joint intravenous administration of verapamil, diltiazem or other antiarrhythmic drugs (especially anti-arrhythmic drugs of the first class) (see also section "Interaction with other drugs").

Simultaneous administration of monoamine oxidase inhibitors (MAO) (except for MAO-B inhibitors) (see also the section "Interaction with other drugs").

Carefully:

Chronic obstructive pulmonary disease; angina of Prinzmetal; diabetes; hypoglycemia; thyrotoxicosis; pheochromocytoma, occlusive diseases of peripheral vessels; atrioventricular blockade of the 1st degree; unstable angina; psoriasis; impaired renal function; depression; myasthenia gravis; when used simultaneously with alpha1-adrenoblockers or alpha2-adrenomimetics; with extensive surgical interventions and general anesthesia.

Pregnancy and lactation:

Beta-adrenoblockers reduce placental blood flow, which can lead to intrauterine fetal death and premature birth. In addition, the fetus and newborns can develop unwanted reactions (in particular, hypoglycemia and bradycardia, complications from the heart and lungs). Sufficient experience in the use of the preparation of Talliton® in pregnant women is not available. Carvedilol contraindicated in pregnancy, except when the possible benefits of its use in women exceed the potential risk to the fetus.

If you need to use the drug Talliton ® during lactation should stop breastfeeding.

Dosing and Administration:

Inside, squeezed with enough liquid.

Essential hypertension

The recommended initial dose is 12.5 mg once a day for the first 2 days of therapy, then 25 mg once a day. If necessary, in the future, the dose can be increased at intervals of at least 2 weeks, bringing to the maximum recommended dose of 50 mg once a day (or divided into 2 divided doses).

Cardiac ischemia

The recommended initial dose is 12.5 mg twice a day for the first 2 days, then 25 mg 2 times a day. If necessary, the dose can then be increased at intervals of at least 2 weeks, leading to a maximum daily dose of 100 mg divided into 2 divided doses.

Chronic heart failure

The dose is selected individually, careful monitoring of the doctor is necessary. In patients receiving cardiac glycosides, diuretics and ACE inhibitors, their doses should be adjusted before treatment with the Tallitone® drug.

The recommended initial dose is 3.125 mg (1/2 tablet at 6.25 mg) 2 times a day for 2 weeks. With good tolerability increase dose at intervals of at least 2 weeks up to 6.25 mg 2 times a day, then to 12.5 mg 2 times a day, then to 25 mg 2 times a day. The dose should be increased to the maximum dose, which is well tolerated by the patient. The recommended maximum dose is 25 mg 2 times a day for all patients with chronic heart failure IV functional class by classification NYHA and for patients with CHF II and III classes with a patient's body weight less than 85 kg. In patients with chronic heart failure of II and III classes and a body weight of more than 85 kg - the recommended maximum dose is 50 mg 2 times a day. Before each increase in the dose, the physician should examine the patient to identify a possible increase in symptoms of chronic heart failure or vasodilation. When transient exacerbation of symptoms of chronic heart failure or fluid retention should increase the dose of diuretics, although sometimes it is necessary to reduce the dose or temporarily Talliton® cancel it.

Symptoms of vasodilation can be eliminated by reducing the dose of diuretics.If symptoms persist, you can reduce the dose of an ACE inhibitor (if the patient takes it), and then, if necessary, the dose of the Talliton® preparation. In such a situation, the dose of Tallitone® should not be increased until the symptoms of chronic heart failure or hypotension are reduced.

If treatment with Talliton® is interrupted for more than 1 week, then its use is resumed at a lower dose, and then increased in accordance with the recommendations given above. If treatment with Talliton® is interrupted for more than 2 weeks, its administration should be resumed at a dose of 3.125 mg (1/2 tablet at 6.25 mg) twice a day, then the dose is selected in accordance with the recommendations given above.

Dosing in special groups of patients

Impaired renal function

Existing data on the pharmacokinetics in patients with varying degrees of renal impairment (including renal failure) suggest that patients with moderate to severe renal insufficiency do not need to adjust the dose of Talliton®.

Impaired liver function

Talliton® is contraindicated in patients with clinical manifestations of liver dysfunction (see "Contraindications"),

Elderly patients

Data that indicate the need for dose adjustment are not available.

Side effects:

Determination of the frequency of side effects: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10000, <1 / 1000), very rarely (<1/10000), including individual messages.

The incidence of adverse events is not dose dependent, with the exception of dizziness, visual impairment, and bradycardia.

In patients with chronic heart failure

central nervous system: very often - dizziness, headache (usually mild and occurring more often at the beginning of treatment); asthenia (including, increased fatigue), depression.

The cardiovascular system: often - bradycardia, postural hypotension, marked decrease in blood pressure, edema (including generalized, peripheral, depending on the position of the body, edema of the perineum, edema of the lower extremities, hypervolemia, fluid retention); infrequently - syncope (including presyncopal), atrioventricular block and heart failure during the period of dose increase.

Gastrointestinal tract: often - nausea, diarrhea, vomiting.

Hemopoietic system: rarely - thrombocytopenia; very rarely - leukopenia.

Metabolic disorders: often - weight gain, hypercholesterolemia; in patients with existing diabetes mellitus - hyperglycemia or hypoglycemia, violations of glycemic control (see section "Special instructions").

Other: often - visual impairment; rarely renal failure and renal dysfunction in patients with diffuse vasculitis and / or renal dysfunction (see section "Special instructions").

In patients with hypertension and ischemic heart disease

The nature of side effects from the cardiovascular system in the treatment of hypertension and prolonged therapy of coronary heart disease is similar to that of chronic heart failure, but their frequency is somewhat less.

central nervous system: often - dizziness, headache and general weakness, usually light and emerging, in particular, at the beginning of treatment; infrequently - mood lability, sleep disturbances, paresthesia.

The cardiovascular system: often - bradycardia, postural hypotension, syncopal conditions (infrequently), especially at the beginning of therapy; infrequently - violations of peripheral circulation (cold extremities,aggravation of the syndrome of "intermittent" lameness and Raynaud's syndrome), atrioventricular blockade, angina (pain in the chest), development or aggravation of symptoms of chronic heart failure and peripheral edema.

Respiratory system: often - bronchospasm and shortness of breath in predisposed patients; rarely - nasal congestion.

Gastrointestinal tract: often - dyspeptic disorders (including nausea, abdominal pain, diarrhea); infrequently - constipation, vomiting.

Skin covers: infrequently - skin reactions (skin rash, dermatitis, urticaria and skin itching).

Laboratory indicators: very rarely - an increase in the activity of "hepatic" transaminases - alanine aminotransferase (ALT), aspartate aminotransferase (ACT) and gamma glutamyltransferase, thrombocytopenia and leukopenia.

Other: often - pain in the limbs, reducing tear and eye irritation; infrequent - decreased potency, visual impairment; rarely - dryness of the oral mucosa and urination disorders; very rarely - exacerbation of psoriasis, sneezing, flu-like syndrome.

Separate cases of allergic reactions.

There are rare cases of urinary incontinence in women reversible after withdrawal.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, bradycardia, heart failure, cardiogenic shock, cardiac arrest; possible respiratory disorders, bronchospasm, vomiting, confusion and generalized convulsions.

Treatment: in addition to general activities, it is necessary to monitor and correct vital signs, if necessary, in the intensive care unit. You can use the following activities:

- put the patient on his back (with raised legs);

- with severe bradycardia - atropine 0.5-2 mg intravenously;

- for the maintenance of cardiovascular activity - glucagon 1-10 mg intravenously struino, then 2-5 mg per hour in the form of a long infusion;

- sympathomimetics (dobutamine or epinephrine (epinephrine) in various doses, depending on body weight and response to treatment.

If the clinical picture of an overdose is dominated by hypotension, norepinephrine (noradrenaline); he is appointed in conditions of continuous monitoring of blood circulation parameters.

In the case of bradycardia resistant to treatment, an artificial pacemaker is shown.

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.

The duration of maintenance / detoxification therapy depends on the severity of the overdose, it should continue until the patient's clinical condition is stabilized.

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 such interactions are listed below.

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 on the appointment of carvedilol to patients who have undergone a kidney and heart transplant and have been taken internally ciclosporin, 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 cyclosporine, careful monitoring of its concentration after the initiation of carvedilol therapy and, if necessary,appropriate correction of the daily dose of cyclosporine. In the case of intravenous administration of cyclosporine, no interaction with carvedilol is expected.

Rifampicin

Rifampicin reduced the plasma concentration of carvedilol, likely through induction of P-glycoprotein, resulting in decreased absorption of carvedilol in the gut and reduce its antihypertensive action.

Amiodarone

In patients with heart failure amiodarone reduced ground clearance S(-) stereoisomer of carvedilol, suppressing the isoenzyme CYP2C9. Average concentration R(+) stereoisomer of carvedilol did not change. Consequently, in connection with the increase in concentration S(-) stereoisomer of carvedilol, the risk of an increase in beta-adrenergic blocking action is possible.

Fluoxetine

In a study in patients with chronic heart failure, simultaneous administration of fluoxetine (an isoenzyme inhibitor CYP2D6) led to stereoselective suppression of carvedilol metabolism - an increase in the average AUC for R (+) by 77%. However, there were no differences in the side effect, magnitude of AD or heart rate between the two groups.

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 because of the risk of arterial hypotension and / or bradycardia.

Digoxin

Simultaneous reception 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 administration of clonidine with drugs with beta-adrenoblocking properties may potentiate an antihypertensive 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 the simultaneous administration of carvedilol and diltiazem, there were isolated cases of conduction disorders (rarely - with disturbances in hemodynamic parameters). As with other drugs with beta-adrenergic blocking properties, the appointment of carvedilol along with BMPC like 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 may enhance the effect of other concurrently taken antihypertensive agents (eg, alpha 1-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)

Simultaneous 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 interfere with the bronchodilating 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 chronic heart failure during the selection of a dose of the drug Talliton®, 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 to increase the dose of the Talliton® preparation to stabilize the hemodynamic parameters.Sometimes it is necessary to reduce the dose of the drug Talliton® or, in rare cases, temporarily cancel the drug. Such episodes do not prevent further correct selection of the dose of the drug Talliton®. Tallitone® is used with caution in combination with cardiac glycosides (possibly excessive deceleration AV conductivity).

Kidney function in chronic heart failure

Patients with chronic heart failure and low blood pressure (systolic blood pressure less than 100 mm Hg), coronary heart disease and vascular diffuse changes and / or renal insufficiency, had a reversible impairment of renal function when patients were prescribed Talliton®. The dose of the drug is selected depending on the functional state of the kidneys.

COPD

Patients with COPD (including bronchospastic syndrome) who do not receive oral or inhaled antiasthmatics, Talliton® are prescribed only if the possible benefits of its use exceed the potential risk. If there is an initial predisposition to bronchospastic syndrome, with the reception of the Talliton® drug, as a result of increasing airway resistance, dyspnea may develop.At the beginning of admission and with an increase in the dose of the drug, Talliton® of these patients should be carefully observed, reducing the dose of the drug when the initial signs of bronchospasm appear.

Diabetes

FROM caution, the drug is prescribed to people with diabetes, because it can mask or relieve symptoms of hypoglycemia (especially tachycardia). In patients with chronic heart failure and diabetes mellitus, the use of the Talliton® drug may be accompanied by impaired glycemic control.

Diseases of peripheral vessels

Caution is necessary when administering Talliton® to patients with peripheral vascular disease (including Reynaud's syndrome), since beta-blockers may increase the symptoms of arterial insufficiency.

Thyrotoxicosis

Like other beta-blockers, Tallitone® can reduce the 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 the Tallitone® preparation and the means for general anesthesia.

Bradycardia

Talliton® can cause bradycardia, with a heart rate of less than 55 beats per minute, the dose of the Tallitone® drug should be reduced.

Hypersensitivity

Caution should be exercised when administering Talliton® to patients with anamnestic indications of severe hypersensitivity reactions or a course of desensitization, since beta-blockers may increase sensitivity to allergens and the severity of anaphylactic reactions.

Psoriasis

Patients with anamnestic indications of the appearance or exacerbation of psoriasis with the use of beta-blockers, Talliton® can be prescribed only after a careful analysis of the possible benefits and risks.

Pheochromocytoma

A patient with pheochromocytoma before starting any beta-blocker should appoint an alpha-blocker. Although Tallitone® has both beta and alpha-adrenergic blocking properties, there is no experience of its use in such patients, so it should be cautiously administered to patients with suspected pheochromocytoma.

Angina pectoris

Non-selective beta-blockers can provoke the appearance of pain in patients with angina prinzmetal.These patients do not have experience with the appointment of Talliton®. Although its alpha-adrenergic blocking properties can prevent this symptomatology, it is necessary to administer Thallitone® in such cases 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 Talliton® 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 with general anesthesia is required, the anesthetist should be alerted to prior therapy with Tallitone®.

Tablets contain lactose monohydrate, so the drug should not be administered to patients with rare hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption. Since the tablets contain sucrose, the drug is not recommended for patients with rare hereditary effects of fructose intolerance, impaired absorption of glucose-g lactose,as well as insufficiency of sugar / isomaltase.

During the treatment, alcohol consumption is excluded.

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

At the beginning of treatment with Talliton®, patients may experience dizziness, fatigue. In this case, they should refrain from driving vehicles and practicing potentially dangerous activities that require increased concentration and speed of psychomotor reactions. In the future, the determination of the safe dose is carried out individually.

Form release / dosage:

Tablets 6.25 mg, 12.5 mg, 25 mg.

Packaging:

Tablets 6.25 mg: 20 or 30 tablets are packaged in bottles of brown glass with a PE cap with an accordion damper, with the control of the first autopsy. The bottle is packed together with instructions for use in a cardboard box.

Or 7 tablets in a blister of polyamide / al.folga / PVC / / al.folga.

2 or 4 blisters together with instructions for use are packed in a cardboard box.

Tablets 12.5 mg and 25 mg: 20 or 30 tablets are packaged in bottles of brown glass with a PE cap with an accordion damper, with the control of the first autopsy. The bottle is packed together with instructions for use in a cardboard box.

Or 14 tablets in a blister of polyamide / al.folga / PVC / al.foil.

1 or 2 blisters together with instructions for use are packed in a cardboard box.

Storage conditions:

In a dry, dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015970 / 01

Date of registration:26.08.2009

The owner of the registration certificate:EGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary

Manufacturer: & nbsp

EGIS PHARMACEUTICALS, Plc Hungary

Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary

Information update date: & nbsp13.01.2015

Illustrated instructions

Instructions

Talliton® (Talliton® )