Carvedilol - Teva tablets 25mg, No. 30

- Arterial hypertension (in monotherapy or in combination with other antihypertensive drugs);

- Ischemic heart disease: prevention of attacks of stable angina pectoris;

- Chronic heart failure of II and III functional class according to NYHA classification (as part of combination therapy with diuretics, digoxin or angiotensin-converting enzyme inhibitors).

Inside, after meals with water.
The dose of the drug is selected individually. Treatment should be started with low doses, gradually increasing until optimal clinical effect is achieved. After the first intake of Carvedilol-Teva and after each dose increase, in order to exclude possible arterial hypotension, it is recommended to measure blood pressure 1 hour after taking the drug.
Therapy with Carvedilol-Teva should be discontinued gradually, reducing the dose within 1-2 weeks.
If more than 2 weeks have passed after discontinuation of therapy, it is recommended to resume taking the drug, again starting with a low dose.
Arterial hypertension
The initial dose is 12.5 mg 1 time per day in the morning for the first 2 days, then 25 mg 1 time per day. In the future, if necessary, the dose can be increased at intervals of at least 2 weeks, bringing to a maximum daily dose of 50 mg per day (divided into 2 doses).
Coronary artery disease: prevention of attacks of stable angina pectoris Initial dose - 12.5 mg 2 times a day for the first 2 days, then 25 mg twice (morning and evening) a day.
Chronic heart failure II and III functional class according to NYHA classification
The dose is selected individually; close medical supervision is necessary. The patient's condition should be monitored for the first 2-3 hours after the first dose of the drug or after the first dose increase. The dose and use of other drugs, such as digoxin, diuretics and angiotensin-converting enzyme (ACE) inhibitors, should be adjusted before starting therapy with Carvedilol-Teva. Patients should take the tablets with meals (to reduce the risk of orthostatic hypotension). The recommended starting dose is 3.125 mg 2 times a day. If this dose is well tolerated, it can be gradually (with an interval of 2 weeks) increased to 6.25 mg 2 times a day, then up to 12.5 mg 2 times a day, then up to 25 mg 2 times a day. Patients take the maximum tolerated dose.The maximum recommended dose for patients weighing up to 85 kg - 25 mg 2 times a day and for patients weighing more than 85 kg - 50 mg 2 times a day. In order to prevent orthostatic hypotension, patients with chronic heart failure are advised to take the drug with meals. Before each dose increase, the physician should examine the patient for a possible increase in symptoms of chronic heart failure or vasodilation. With a transient increase in symptoms of chronic heart failure or fluid retention in the body, the dose of diuretics should be increased, although sometimes a decrease in the dose of Carvedilol-Teva or its temporary withdrawal is required. The dose of Carvedilol-Teva should not be increased,until symptoms of increasing heart failure or arterial hypotension stabilize. If treatment with Carvedilol-Teva is interrupted for more than 1 week, then its use is resumed at a lower dose, and then increased in accordance with the above recommendations. If treatment with Carvedilol-Teva was suspended for more than 2 weeks, then therapy should be resumed with a dose of 3.125 mg 2 times a day, then selecting the dose in accordance with the above recommendations.125 mg 2 times a day, then adjusting the dose in accordance with the recommendations above.125 mg 2 times a day, then adjusting the dose in accordance with the recommendations above.
Elderly patients
No dose adjustment required.
Patients with impaired renal function
Existing data on pharmacokinetics in patients with varying degrees of impaired renal function (including renal failure) suggest that dose adjustment of Carvedilol-Teva is not required in moderate to severe renal failure.

1 tablet contains -
active ingredient: carvedilol - 25 mg
excipients: microcrystalline cellulose, lactose monohydrate, low-substituted hyprolose, corn starch, talc, colloidal silicon dioxide, magnesium stearate.

Hypersensitivity to carvedilol or other components of the drug; chronic obstructive pulmonary disease (COPD); bronchial asthma or bronchospasm (in history); chronic heart failure IV functional class according to NYHA classification, acute and chronic heart failure (CHF) in the stage of decompensation, requiring intravenous administration of inotropic drugs; Prinzmetal's angina; cardiogenic shock; severe bradycardia (less than 50 beats / min at rest), sick sinus syndrome (including sinoauricular block), atrioventricular (AV) block II-III degree (except for patients with an artificial pacemaker); terminal stage of peripheral vascular occlusive disease; clinically significant liver dysfunction, metabolic acidosis; the patients,receiving intravenous therapy with verapamil or diltiazem, due to the possibility of developing severe bradycardia (less than 40 beats / min) and arterial hypotension; severe arterial hypotension (systolic blood pressure less than 85 mm Hg); lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome; breastfeeding period; age up to 18 years (safety and efficacy have not been established), pheochromocytoma (without the simultaneous use of alpha-blockers).pheochromocytoma (without the simultaneous use of alpha-blockers).pheochromocytoma (without the simultaneous use of alpha-blockers).
1st degree AV block, diabetes mellitus, hypoglycemia, thyrotoxicosis, occlusive peripheral vascular disease, pheochromocytoma (with the simultaneous use of alpha-blockers), depression, myasthenia gravis, psoriasis, major surgical interventions, general anesthesia, renal failure, pregnancy.

Trade name : Carvedilol-Teva

International non-proprietary name : Carvedilol

Chemical name : (2RS) -1- (9H-Carbazol-4-yloxy) -3 - ((2- (2-methoxyphenoxy) ethyl) amino) -2-propanol

Dosage form : tablets

Composition : 1 tablet contains -
active ingredient: carvedilol 3.125 mg, 6.25 mg, 12.5 mg or 25.0 mg;
auxiliary substances: microcrystalline cellulose, lactose monohydrate, low-substituted hyprolose, corn starch, talc, colloidal silicon dioxide, magnesium stearate.

Description :
Tablets 3.125 mg
Round biconvex tablets of white or almost white color with 'SAZ' engraving on one side.
Tablets 6.25 mg
Round biconvex tablets of white or off-white color with УCA6Ф engraving on one side.
Tablets 12.5 mg
Round biconvex tablets of white or off-white color with УCA12Ф engraving on one side.
Tablets 25 mg
Round biconvex tablets of white or off-white color with CA25 engraving on one side.

Famacotherapeutic group : alpha and beta-blocker

ATX code : C07AG02

Pharmacological properties
Pharmacodynamics
Carvedilol - blocker of alpha1-, beta1-, beta2-adrenergic receptors, has an organoprotective effect. It has antiproliferative properties against smooth muscle cells of the vessel walls, is a racemic mixture of R (+) and S (-) stereoisomers, each of which has the same alpha-adrenergic blocking properties. Due to the cardio-selective blocking of adrenergic receptors caused by the S (-) stereoisomer, carvedilol lowers blood pressure (BP), decreases heart rate (HR) and cardiac output, and reduces pressure in the pulmonary arteries and in the right atrium. Due to the blockade of alpha1-adrenergic receptors, it causes peripheral vasodilation and decreases peripheral vascular resistance (PSS). Reduces the load on the heart muscle and prevents the development of angina attacks.In patients with chronic heart failure (CHF), it increases the left ventricular ejection fraction and reduces the severity of the symptoms of the disease. Similar effects were observed in patients with impaired left ventricular function.
Carvedilol has no intrinsic sympathomimetic activity and, like propranolol, has the property of membrane stabilization. The activity of the renin-angiotensin-aldosterone system (RAAS) decreases, decreasing the release of renin, so fluid retention (characteristic of selective alpha-blockers) rarely develops. The effect on blood pressure and heart rate is most pronounced 1 - 2 hours after taking the drug.
Carvedilol does not adversely affect the lipid profile, maintaining a normal high-to-low density lipoprotein ratio (HDL / LDL).
In patients with arterial hypertension and kidney disease, carvedilol reduces the resistance of the renal vessels, while there is no significant change in the glomerular filtration rate of the renal plasma flow or the excretion of electrolytes. Peripheral blood flow persists, so coldness of the arms and legs, often seen with beta-blockers, rarely develops.
Pharmacokinetics
Carvedilol is rapidly absorbed after oral administration.
The maximum concentration of carvedilol in blood plasma (Cmax) is reached after 1 hour. The absolute bioavailability of carvedilol is about 25%: 30% for the R-form and 15% for the S-form.
Carvedilol is highly lipophilic. Approximately 98-99%) it binds to blood plasma proteins. The volume of distribution is approximately 2 L / kg and increases in patients with cirrhosis by reducing the effect of 'primary passage' through the liver.
Carvedilol is metabolized primarily in the liver by oxidation and conjugation to form a number of metabolites. It is metabolized during the 'first pass' through the liver.
The oxidative metabolism of carvedilol is stereoselective. The R (+) isomer is metabolized mainly by the isoenzymes CYP2D6 and CYP1A2, and the S (-) isomer is mainly metabolized by the isoenzyme CYP2D9 and, to a lesser extent, by the isoenzyme CYP2D6. Other cytochrome P450 isoenzymes involved in the metabolism of carvedilol include isoenzymes CYP3A4, CYP2E1, CYP2C19.
As a result of demethylation and hydroxylation of the phenolic ring, 3 metabolites are formed, which have less pronounced vasodilating properties than carvedilol.
The half-life (T / 4) is about 6 hours, plasma clearance is about 500-700 ml / min. Carvedilol is excreted mainly in the bile through the intestines and partly by the kidneys in the form of metabolites.
The patient's age does not have a statistically significant effect on the pharmacokinetics of carvedilol.
In patients with cirrhosis of the liver, the bioavailability of carvedilol increases by 80% due to a decrease in the severity of metabolism during the 'first pass' through the liver.
Carvedilol crosses the placental barrier and into breast milk. Carvedilol is hardly eliminated from blood plasma by hemodialysis.

Indications for use

- Arterial hypertension (in monotherapy or in combination with other antihypertensive drugs);

- Ischemic heart disease: prevention of attacks of stable angina pectoris;

- Chronic heart failure of II and III functional class according to NYHA classification (as part of combination therapy with diuretics, digoxin or angiotensin-converting enzyme inhibitors).

Contraindications
Hypersensitivity to carvedilol or other components of the drug; chronic obstructive pulmonary disease (COPD); bronchial asthma or bronchospasm (in history); chronic heart failure IV functional class according to NYHA classification, acute and chronic heart failure (CHF) in the stage of decompensation, requiring intravenous administration of inotropic drugs; Prinzmetal's angina; cardiogenic shock; severe bradycardia (less than 50 beats / min at rest), sick sinus syndrome (including sinoauricular block), atrioventricular (AV) block II-III degree (except for patients with an artificial pacemaker); terminal stage of peripheral vascular occlusive disease; clinically significant liver dysfunction, metabolic acidosis; the patients,receiving intravenous therapy with verapamil or diltiazem, due to the possibility of developing severe bradycardia (less than 40 beats / min) and arterial hypotension; severe arterial hypotension (systolic blood pressure less than 85 mm Hg); lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome; breastfeeding period; age up to 18 years (safety and efficacy have not been established), pheochromocytoma (without the simultaneous use of alpha-blockers).pheochromocytoma (without the simultaneous use of alpha-blockers).pheochromocytoma (without the simultaneous use of alpha-blockers).
1st degree AV block, diabetes mellitus, hypoglycemia, thyrotoxicosis, occlusive peripheral vascular disease, pheochromocytoma (with the simultaneous use of alpha-blockers), depression, myasthenia gravis, psoriasis, major surgical interventions, general anesthesia, renal failure, pregnancy.

Application during pregnancy and during breastfeeding
Data on the use of the drug Carvedilol-Teva during pregnancy are limited.
Beta-blockers reduce placental blood flow, have an adverse effect on the development of the embryo, and can cause arterial hypotension, bradycardia and hypoglycemia in the fetus.
The drug Carvedilol-Teva should not be used during pregnancy, unless absolutely necessary, if the potential benefit to the mother justifies the risk to the fetus.
Since carvedilol is excreted in breast milk, breastfeeding should be discontinued during therapy with Carvedilol-Teva.

Method of administration and dosage
Inside, after meals, with water.
The dose of the drug is selected individually. Treatment should be started with low doses, gradually increasing until optimal clinical effect is achieved. After the first intake of Carvedilol-Teva and after each dose increase, in order to exclude possible arterial hypotension, it is recommended to measure blood pressure 1 hour after taking the drug.
Therapy with Carvedilol-Teva should be discontinued gradually, reducing the dose within 1-2 weeks.
If more than 2 weeks have passed after discontinuation of therapy, it is recommended to resume taking the drug, again starting with a low dose.
Arterial hypertension
The initial dose is 12.5 mg 1 time per day in the morning for the first 2 days, then 25 mg 1 time per day. In the future, if necessary, the dose can be increased at intervals of at least 2 weeks, bringing to a maximum daily dose of 50 mg per day (divided into 2 doses).
Coronary artery disease: prevention of attacks of stable angina pectoris Initial dose - 12.5 mg 2 times a day for the first 2 days, then 25 mg twice (morning and evening) a day.
Chronic heart failure II and III functional class according to NYHA classification
The dose is selected individually; close medical supervision is necessary. The patient's condition should be monitored for the first 2-3 hours after the first dose of the drug or after the first dose increase. The dose and use of other drugs, such as digoxin, diuretics and angiotensin-converting enzyme (ACE) inhibitors, should be adjusted before starting therapy with Carvedilol-Teva. Patients should take the tablets with meals (to reduce the risk of orthostatic hypotension). The recommended starting dose is 3.125 mg 2 times a day. If this dose is well tolerated, it can be gradually (with an interval of 2 weeks) increased to 6.25 mg 2 times a day, then up to 12.5 mg 2 times a day, then up to 25 mg 2 times a day. Patients take the maximum tolerated dose.The maximum recommended dose for patients weighing up to 85 kg - 25 mg 2 times a day and for patients weighing more than 85 kg - 50 mg 2 times a day. In order to prevent orthostatic hypotension, patients with chronic heart failure are advised to take the drug with meals. Before each dose increase, the physician should examine the patient for a possible increase in symptoms of chronic heart failure or vasodilation. With a transient increase in symptoms of chronic heart failure or fluid retention in the body, the dose of diuretics should be increased, although sometimes a decrease in the dose of Carvedilol-Teva or its temporary withdrawal is required. The dose of Carvedilol-Teva should not be increased,until symptoms of increasing heart failure or arterial hypotension stabilize. If treatment with Carvedilol-Teva is interrupted for more than 1 week, then its use is resumed at a lower dose, and then increased in accordance with the above recommendations. If treatment with Carvedilol-Teva was suspended for more than 2 weeks, then therapy should be resumed with a dose of 3.125 mg 2 times a day, then selecting the dose in accordance with the above recommendations.125 mg 2 times a day, then adjusting the dose in accordance with the recommendations above.125 mg 2 times a day, then adjusting the dose in accordance with the recommendations above.
Elderly patients
No dose adjustment required.
Patients with impaired renal function
Existing data on pharmacokinetics in patients with varying degrees of impaired renal function (including renal failure) suggest that dose adjustment of Carvedilol-Teva is not required in moderate to severe renal failure.

Side effect
The incidence of side effects developing when taking carvedilol is classified according to the recommendations of the World Health Organization: very often - at least 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%, including individual messages.
The incidence of some side effects, such as dizziness, marked decrease in blood pressure, bradycardia and visual disturbances, is dose-dependent.
These effects are more common in patients with CHF. The most common side effect of carvedilol is dizziness with or without orthostatic hypotension, which occurs in about 6% of patients.
If serious side effects develop, drug treatment should be discontinued.
From the hematopoietic and lymphatic system: rarely - thrombocytopenia; very rarely - leukopenia.
From the nervous system: very often - dizziness, headache (especially at the beginning of treatment); rarely - sleep disturbances, changes in mood / thinking, paresthesia, myasthenia gravis, loss of consciousness.
From the senses: often - reduction of tearing and eye irritation (pay attention when using contact lenses); very rarely - visual disturbances, eye irritation.
On the part of the cardiovascular system:very often - orthostatic hypotension; often - bradycardia; rarely - worsening of the course of heart failure (especially with an increase in the dose), cold hands and feet, lowering blood pressure, fainting; rarely - conduction disturbance, palpitations, worsening of angina pectoris, occlusive disorders of peripheral circulation, 'intermittent' claudication, peripheral edema.
From the respiratory system: rarely - shortness of breath, bronchospasm (in predisposed patients), nasal congestion.
From the digestive system:often - nausea, abdominal pain (up to 2%), diarrhea, dryness of the oral mucosa; rarely - decreased appetite, vomiting, flatulence, constipation; very rarely - dryness of the oral mucosa, increased activity of 'hepatic' transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (ACT), gamma-glutamyl transferase).
On the part of the skin: very rarely - exacerbation of the course of psoriasis, alopecia, exfoliative dermatitis.
From the side of the musculoskeletal system: rarely - pain in muscles, bones, spine.
From the urinary system: rarely - urination disorders; very rarely - severe renal impairment.
From the side of metabolism:often - an increase in body weight, hypercholesterolemia, in patients with already existing diabetes mellitus - hyperglycemia or hypoglycemia; rarely - an increase in the concentration of triglycerides
Others: often - general weakness; infrequently - hypersensitivity reactions (itching, rash, urticaria), decreased potency; very rarely - 'hot flushes' of blood to the skin of the face, sneezing, flu-like syndrome.
There have been rare cases of urinary incontinence in women that are reversible after drug withdrawal.

Overdose
Symptoms: a pronounced decrease in blood pressure (systolic blood pressure 80 mm Hg or less), severe bradycardia (less than 50 beats / min), impaired respiratory function (including bronchospasm), heart failure, cardiogenic shock, cardiac arrest, generalized convulsions, vomiting, confusion.
Treatment: it is necessary to monitor and correct the vital functions of the body, if necessary, in the intensive care unit.
During the first hours after an overdose, induce vomiting and wash out the stomach. Lay the patient on his back (with raised legs), with severe bradycardia - atropine 0.5-2 mg intravenously, with therapy-resistant bradycardia, an operation of setting an artificial pacemaker is indicated; with a pronounced decrease in blood pressure - norepinephrine (norepinephrine); with bronchospasm, beta-adrenergic agonists are used for inhalation (if ineffective intravenously) or aminophylline intravenously.
For convulsions, diazepam or clonazepam is slowly administered intravenously.
Since in severe overdose with symptoms of shock, it is possible to lengthen the half-life of carvedilol and remove carvedilol from the depot, it is necessary to continue maintenance therapy for a sufficiently long time.
The duration of maintenance therapy depends on the severity of the overdose, it should be continued until the patient's clinical condition stabilizes.

Interaction with other medicinal products
During treatment with Carvedilol-Teva, patients are not recommended to consume alcohol, because ethanol can potentiate the side effects of carvedilol.
With the simultaneous administration of carvedilol and digoxin, the concentration of digoxin in the blood plasma increases by approximately 16% and the AV conduction time may increase. At the beginning of therapy with carvedilol, when selecting its dose or discontinuing the drug, it is recommended to regularly monitor the concentration of digoxin in the blood plasma.
Carvedilol can potentiate the action of insulin and hypoglycemic agents for oral administration, including sulfonylurea derivatives, while the symptoms of hypoglycemia (especially tachycardia) can be masked, therefore, in patients with diabetes mellitus, regular monitoring of the blood glucose concentration is recommended.
Carvedilol enhances the effect of antihypertensive drugs (ACE inhibitors, thiazide diuretics, vasodilators).
Simultaneous use with drugs that reduce the content of catecholamines (reserpine, monoamine oxidase inhibitors) increases the risk of a pronounced decrease in blood pressure and severe bradycardia.
When carvedilol was used in renal transplant patients who developed chronic vascular graft rejection, there was a moderate increase in mean trough cyclosporine concentrations. In order to maintain the concentration of cyclosporine in the therapeutic range, the dose of cyclosporine had to be reduced in about 30% of patients (on average by 20%), the rest of the patients did not need dose adjustment. Due to the pronounced individual fluctuations in the required daily dose of cyclosporine, it is recommended to carefully monitor the concentration of cyclosporine in the blood plasma after starting therapy with carvedilol and, if necessary, adjust the daily dose of cyclosporine accordingly.
The simultaneous use of carvedilol with blockers of 'slow' calcium channels (derivatives of the dihydropyridine series) can lead to severe heart failure and severe arterial hypotension. Sympathomimetics with alpha and beta adrenomimetic effects, when used simultaneously with carvedilol, increases the risk of arterial hypertension and severe bradycardia.
Verapamil, diltiazem and other antiarrhythmics (propranolol, amiodarone), when used simultaneously with carvedilol, may increase the risk of AV conduction disturbances.
With the simultaneous use of carvedilol and diltiazem, there have been isolated cases of conduction disturbances (rarely - with disturbances in hemodynamic parameters). As in the case of other drugs with beta-adrenergic blocking properties, the use of carvedilol together with blockers of 'slow' calcium channels such as verapamil and diltiazem is recommended to be carried out under the control of ECG and blood pressure.
Concomitant use with clonidine can potentiate the antihypertensive and negative chromotropic effects of carvedilol.
Inhibitors of microsomal oxidation (cimetidine, ketoconazole, fluoxetine, haloperidol, verapamil, erythromycin) increase, and inducers (barbiturates, rifampicin) weaken the hypotensive effect of carvedilol.
Nitrates and beta-blockers (eg, in the form of eye drops) can potentiate the antihypertensive effect of carvedilol.
General anesthetics enhance the negative inotropic and hypotensive effects of carvedilol.
Ergotamine enhances vasoconstriction when used simultaneously with carvedilol.
Non-steroidal anti-inflammatory drugs reduce the antihypertensive effect of carvedilol.

Special instructions
The drug Carvedilol-Teva is recommended to be taken for the treatment of CHF, as an addition to the standard therapy of CHF with diuretics, ACE inhibitors or cardiac glycosides, only after selecting the dose of the diuretic. It can also be used in patients with ACE inhibitor intolerance.
At the beginning of therapy with the drug Carvedilol-Teva or after an increase in its dose, orthostatic hypotension and dizziness, sometimes with fainting, may sometimes develop, especially in patients with heart failure, elderly patients and simultaneously taking other antihypertensive drugs or diuretics. These effects can be prevented by using an initial low dose of Carveldilol-Teva and a gradual increase to a maintenance dose, as well as taking the drug during meals. Patients need to explain how orthostatic hypotension can be avoided (gently get up from a 'lying' or 'sitting' position; if dizziness develops, sit or lie down).
Patients with CHF can take the drug Carvedilol-Teva only if their condition is successfully controlled by drugs of the group of cardiac glycosides and / or diuretics. If the course of CHF worsens during treatment, it is necessary to increase the dose of the diuretic, and reduce the dose of Carvedilol-Teva or temporarily stop its use (see section 'Dosage and Administration'). Alpha- and beta-blockers can mask the symptoms of hypoglycemia in patients with diabetes mellitus, as well as manifestations of thyrotoxicosis in patients with thyroid diseases, reducing the manifestations of tachycardia. In patients with CHF, the concentration of glucose in the blood may increase or decrease. When conducting general anesthesia, patients taking alpha and beta blockers should use narcotic analgesics with minimal inotropic action,or previously (gradually!) cancel the alpha and beta blocker.
In some cases, carvedilol can cause liver dysfunction. With the development of liver failure, the use of the drug Carvedilol-Teva should be discontinued. As a rule, after discontinuation of the drug, liver function is normalized.
Alpha- and beta-blockers in COPD can aggravate bronchial obstruction, so they should not be used in patients with COPD. Alpha- and beta-blockers can worsen the clinical picture of peripheral arteriopathy, psoriasis and anaphylactic reactions and enhance the body's response during allergy testing.
Alpha and beta blockers can provoke pain in patients with Prinzmetal's angina.
Patients with pheochromocytoma can take alpha and beta-blockers only after starting alpha-blocker therapy. With a sharp cessation of therapy with the drug Carvedilol-Teva (like other alpha and beta-blockers), increased sweating, tachycardia, shortness of breath and worsening of angina pectoris may develop. Patients with angina pectoris, who may develop myocardial infarction, are most at risk of these reactions. When Carvedilol-Teva is discontinued, the dose is gradually reduced over a period of 1-2 weeks.
If more than 2 weeks have passed after discontinuation of therapy, it is recommended to resume taking the drug with low doses.
Patients wearing contact lenses should be aware that the drug may cause a decrease in lacrimation.
In case of a decrease in the number of heart contractions to 50 beats / min, the drug should be canceled.
The drug Carvedilol-Teva is not recommended for patients under 18 years of age, because the efficacy and safety of Carvedilol-Teva in this group of patients has not been established.

Influence on the ability to drive a car and other complex mechanisms
Care must be taken when driving vehicles and engaging in potentially hazardous activities, due to the fact that side effects may develop that can affect concentration and psychomotor reactions.

Release form
Tablets 3.125 mg; 6.25 mg; 12.5 mg
14 or 15 tablets in a PVC / PVDC / aluminum foil blister.
2 blisters with instructions for use in a cardboard box.
25 mg
tablets 28 or 30 tablets in a PVC / PVDC / aluminum foil blister.
1 blister with instructions for use in a cardboard box.

Storage conditions
At a temperature not exceeding 25 ? —. Keep out of the reach of children.

Shelf life is
3 years.
Do not use after the expiration date printed on the package.

Pharmacy
Dispensing Conditions Prescription.