Active substanceCaptoprilCaptopril
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  • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active substance: Captopril 6.25 mg; 12.5 mg; 25 mg; 50 mg or 100 mg;

    Excipients: cellulose microcrystalline 30.0 mg / 35.0 mg / 70.0 mg / 140.0 mg / 280.0 mg; cornstarch 2.5 mg / 5.0 mg / 10.0 mg / 20.0 mg / 40.0 mg; lactose monohydrate 45.0 mg / 25.0 mg / 50.0 mg / 100.0 mg / 200.0 mg; stearic acid 1.25 mg / 2.5 mg / 5.0 mg / 10.0 mg / 20.0 mg.

    Description:

    Dosage of 6.25 mg: white, round, biconvex tablets with a uniform surface. Dosage of 12.5 mg: white, round tablets with a uniform surface, convex on one side and with a separating risk on the other side (pressable tablet).

    Dosage of 25 mg: white, round tablets in the form of a quatrefoil with a uniform surface, with a facet and a cross-shaped risk on both sides.

    Dosage 50 mg: white, round tablets in the form of a quatrefoil with a uniform surface, with a facet and a cross-shaped risk on both sides.

    Dosage of 100 mg: white, round tablets, convex on one side and with a cross-shaped risk on the other side (pressable tablet).

    Pharmacotherapeutic group:Angiotensin converting enzyme inhibitor
    ATX: & nbsp

    C.09.A.A.01   Captopril

    Pharmacodynamics:Angiotensin-converting enzyme inhibitor. Reduces the formation of angiotensin II from angiotensin I. Reduction in angiotensin II leads to a direct reduction in the release of aldosterone. This reduces the overall peripheral vascular resistance, blood pressure, post- and preload on the heart. Expands arteries more than veins. It causes a decrease in the degradation of bradykinin (one of the effects of the angiotensin-converting enzyme) and an increase in the synthesis of prostaglandin. The hypotensive effect does not depend on the plasma renin activity, the decrease in arterial pressure is noted at a normal and even lowered level of the hormone, which is due to the effect on tissue renin-angiotensin systems. Strengthens coronary and renal blood flow. With prolonged use, reduces the severity of myocardial hypertrophy and the walls of arteries of the resistive type.Improves the blood supply of the ischemic myocardium. Reduces the aggregation of platelets. Helps reduce sodium ions in patients with cardiac insufficiency.

    Reduction of blood pressure in contrast to direct vasodilators (hydralazine, minoxidil, etc.) is not accompanied by reflex tachycardia and leads to a decrease in myocardial oxygen demand. With heart failure in an adequate dose does not affect the value of blood pressure. The maximum decrease in blood pressure after oral administration is observed after 60-90 minutes.

    The duration of the hypotensive effect is dose-dependent and reaches optimal values ​​within a few weeks.

    Temporary cancellation, captopril should not occur dramatically, as this can cause a significant increase in blood pressure.

    Pharmacokinetics:

    Absorption - fast, is about 75% of the dose. Eating reduces bioavailability by 30-40%. It binds to plasma proteins - 25-30%, mainly with albumin. Less than 0.002% of the accepted dose of captopril is secreted with the mother's milk, does not penetrate the blood-brain barrier.

    Metabolized in the liver with the formation of disulfide dimer captopril and captopril-cysteine ​​sulfide. Metabolites are pharmacologically inactive. The half-life of captopril is about 2-3 hours.

    About 95% is displayed kidneys during the first day, 40-50% of them in unchanged form, the rest - in the form of metabolites. After 4 hours after a single dose in urine contains about 38% unchanged captopril and 28% in the form of metabolites, after 6 hours - only in the form of metabolites; in daily urine - 38% of unchanged captopril and 62% - in the form of metabolites.

    As a result of the accumulation of captopril and its metabolites in the kidneys, a violation of their function may occur. Half-life with renal failure is 3.5-32 hours. Cumulates in chronic kidney failure. therefore patients with impaired renal function the dose of the drug should be reduced and / or the interval between doses taken.

    Indications:

    - Arterial hypertension, incl. Renovascular;

    - xheart failure (as part of complex therapy);

    - Mr.left heart failure after a myocardial infarction with a clinically stable condition;

    - dIabetic nephropathy against type 1 diabetes mellitus (for albuminuria more than 30 mg / day).

    Contraindications:

    - Hypersensitivity to captopril, other components of the drug or other ACE inhibitors (including in the anamnesis);

    - hereditary angioedema edema or idiopathic edema; angioedema (on the background of previous therapy with other ACE inhibitors in the anamnesis);

    - severe renal dysfunction, azotemia, hyperkalaemia, bilateral stenosis of the renal arteries or stenosis of a single kidney with progressive azotemia, condition after kidney transplantation, primary hyperaldosteronism;

    - pregnancy;

    - the period of breastfeeding;

    - lactose intolerance, lactase deficiency or glucose-galactose malabsorption;

    - simultaneous application ACE inhibitors (including captopril) or angiotensin II receptor antagonists with aliskiren and aliskiren-containing drugs in patients with type 2 diabetes or renal dysfunction (GFR) of less than 60 ml / min / 1.73 m2) (see the section "Interaction with other medicinal products");

    - age to 18 years (efficacy and safety not established).

    Carefully:

    Hypertrophic obstructive cardiomyopathy, connective tissue disease (especially systemic lupus erythematosus or scleroderma), inhibition of bone marrow blood (the risk of neutropenia and agranulocytosis), cerebrovascular disease, coronary artery disease, diabetes mellitus (increased risk of hyperkalemia), a diet with restriction of salt, state, accompanied by decrease in circulating blood volume (including diarrhea, vomiting, patients on hemodialysis), mitral valve stenosis, aortic stenosis and are similar e changes complicating outflow of blood from the left ventricle, angioedema history, hepatic dysfunction, chronic renal insufficiency, bilateral renal artery stenosis or artery stenosis single kidney, patients blacks, surgery / general anesthesia, hemodialysis using vysokoprotochnyh membranes ( e.g., AN69®), desensitizing therapy, apheresis low density lipoprotein (LDL), receiving potassium-sparing diuretics,potassium preparations, potassium-containing substitutes for salt and lithium, renovascular hypertension, and advanced age.

    Pregnancy and lactation:

    Application of the drug Captopril Sandoz® in pregnancy it is contraindicated.

    The use of ACE inhibitors for pregnancy can lead to the incidence and death of the fetus and / or newborn. Prolonged the use of captopril in the second and third trimesters is toxic to the fetus (decreased kidney function, low blood pressure, ossification of the skull bones) and newborns (neonatal kidney failure, arterial hypotension, hyperkalemia).

    In addition, the use of ACE inhibitors in the first trimester of pregnancy is associated with a potentially increased risk of congenital fetal defects.

    If the pregnancy occurred during the application of the drug Captopril Sandoz®, the drug should be discontinued as soon as possible and regularly monitored fetal development.

    Women planning a pregnancy should not use ACE inhibitors (including captopril). Women of childbearing age should be aware of the potential dangers of using ACE inhibitors (including captopril).Approximately 1% of the dose taken Captopril is found in breast milk. In connection with the risk of developing serious unwanted reactions in the child, breastfeeding should be stopped or the drug should be withdrawn Captopril Sandoz® at the mother for the period of breastfeeding.

    If the patient received the drug during the second and third trimester of pregnancy, it is recommended that an ultrasound be performed to assess the condition of the skull bones and the function of the kidneys of the fetus. If the use of an ACE inhibitor is considered necessary, patients planning a pregnancy should be transferred to alternative antihypertensive therapy that has an established safety profile for use during pregnancy.

    Dosing and Administration:

    Inside for 1 hour before meals. The dosage regimen is administered individually.

    With arterial hypertension treatment is started with the lowest effective dose of 12.5 mg 2 times a day. Pay attention to the tolerability of the first dose during the first hour. If the arterial hypotension develops, the patient should be transferred to a horizontal position (this reaction to the first dose should not be an obstacle to furthertherapy). If necessary, gradually increase the dose (with an interval of 2-4 weeks) until the optimal effect is achieved.

    With a mild or moderate degree of hypertension, the usual maintenance dose is 25 mg twice a day; the maximum dose can be increased to 50 mg three times a day. The maximum daily dose is 150 mg. In elderly patients, the initial dose is 6.25 mg twice a day.

    With chronic heart failure prescribe along with other diuretics and / or in combination with digitalis preparations (to avoid initial excessive reduction in blood pressure, prior to prescribing the drug is canceled taking a diuretic or decreasing the dose). The initial dose is 6.25 mg or 12.5 mg 3 times a day, with the dose is increased. The average maintenance dose is 25 mg 2-3 times a day, and the maximum -150 mg per day.

    In case of symptomatic hypotension in heart failure, the dose of diuretics and / or other concomitantly administered vasodilators can be reduced to achieve a steady dose effect of captopril.

    In cases of violations of left ventricular function after a myocardial infarction in patients in a clinically stable state,The use of captopril can begin as early as 3 days after myocardial infarction. The initial dose is 6.25 mg per day, then the daily dose can be increased to 37.5-75 mg for 2-3 doses (depending on the drug's tolerance) up to a maximum of 150 mg per day. Captopril may be administered in combination with other drugs in the treatment of myocardial infarction, such as thrombolytic agents, beta-blockers and acetylsalicylic acid.

    Patients with diabetes mellitus type I, complicated by nephropathy, the recommended daily dose of captopril is 75-100 mg in 2-3 doses. If you need further lowering of blood pressure captopril may be administered in combination with other drugs.

    In patients with impaired renal function, the dose of captopril should be adjusted: the dosage of the drug should be reduced or the intervals of admission increased. If necessary, additionally prescribed loop diuretics, and not diuretics thiazide series.

    Recommended dosage regimen for captopril in patients with impaired renal function

    Creatinine clearance

    (ml / min / 1.75 m2)

    Initial daily dose (mg)

    The maximum daily dose (mg)

    40

    25-50

    150

    21-40

    25

    100

    10-20

    12,5

    75

    <10

    6,25

    37,5

    Elderly patients captopril should be administered at an initial dose of 6.25 mg twice daily to prevent impaired renal function. The dose of captopril is recommended to be adjusted constantly depending on the patient's therapeutic response and maintained at the lowest possible level.
    Side effects:

    According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very often ((≥1 / 1000, <1/100), rarely (≥1 / 10000, <1/1000) and very rarely (<1 / 10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

    On the part of the blood and lymphatic system: very rarely: neutropenia; agranulocytosis; pancytopenia, especially in patients with impaired renal function; anemia (including aplastic, hemolytic), thrombocytopenia, lymphadenopathy, eosinophilia, autoimmune diseases and / or titer increase in antinuclear antibodies.

    From the side of metabolism and nutrition: rarely: anorexia; very rarely: hyperkalemia, hypoglycemia.

    From the nervous system: often: taste disorders, sleep disorders, dizziness; rarely: drowsiness, headache, paresthesia, asthenia; very rarely: depression, cerebrovascular disorders, including stroke, syncope, impaired consciousness.

    From the side of the organ of vision rarely: disturbance of visual acuity.

    From the side of the cardiovascular system: infrequently: tachycardia, tachyarrhythmia, palpitations, angina pectoris, arrhythmia, orthostatic hypotension, Raynaud's syndrome, "flushes" of blood to the face, pallor, peripheral edema; very rarely: cardiogenic shock, cardiac arrest.

    From the respiratory, thoracic and mediastinalI: often: dry, irritating (unproductive) cough, shortness of breath; very rarely: bronchospasm, rhinitis, allergic alveolitis, eosinophilic pneumonia.

    From the digestive system: often: dryness of the oral mucosa, nausea, vomiting, abdominal pain, diarrhea, constipation; rarely: stomatitis, aphthous ulcers of the inner surface of the mucous membrane of cheeks and tongue, anorexia; very rarely: glossitis, peptic ulcer, pancreatitis, liver dysfunction, cholestasis, jaundice, hepatitis, necrosis of the liver, increased activity of "liver" enzymes, increased serum bilirubin concentration, angioedema of the intestinal mucosa.

    From the skin and subcutaneous tissues often: itching of the skin with rashes and without, skin rash (maculopapular, less often vesicular or bullous nature), baldness; very rarely: urticaria, Stevens-Johnson syndrome, erythema multiforme, photosensitivity, exfoliative dermatitis, pemphigoid reactions.

    From the side of the musculoskeletal system: very rarely: myalgia, arthralgia.

    On the part of the genitourinary system is rare: impaired renal function, acute renal failure, polyuria, oliguria, increased frequency of urination; very rarely: nephrotic syndrome, impotence, gynecomastia.

    General violations and violations at the site of introduction: infrequently: chest pain, fatigue, weakness / very rarely: fever.

    Laboratory indicators: very rare: proteinuria, hyperkalemia, hyponatremia, increased concentration of urea nitrogen and creatinine in the blood plasma; increased activity of "hepatic" transaminases, increased serum bilirubin concentration, decreased hemoglobin, hematocrit, increased erythrocyte sedimentation rate (ESR), metabolic acidosis.

    Other: frequency is unknown: symptom complex, including facial flushing, nausea, vomiting and a decrease in blood pressure.
    Overdose:

    Symptoms: a marked decrease in blood pressure, including collapse, stupor, bradycardia, water-electrolyte imbalance, acute renal failure, myocardial infarction, acute cerebrovascular accident, thromboembolic complications.

    Treatment: gastric lavage, the use of absorbents not later than 30 minutes after taking the drug; transfer the patient to the "lying" position with raised legs; measures aimed at restoring blood pressure, replenishing the volume of circulating blood (for example, intravenous injection of 0.9% sodium chloride solution).

    When bradycardia or expressed vagus reactions should be used atropine. It is possible to use a temporary pacemaker.

    Symptomatic therapy: it is possible to use hemodialysis; peritoneal hemodialysis - not effective.

    Interaction:Double blockade of RAAS
    Simultaneous use of ACE inhibitors with other drugs that affect RAAS, including angiotensin II (ARA II) receptor antagonists and aliskiren,leads to an increase in the incidence of severe depression of blood pressure, hyperkalemia, renal dysfunction (including acute renal failure). It is necessary to monitor blood pressure, kidney function, and the content of plasma electrolytes when using captopril with other drugs that affect RAAS. Simultaneous use of ACE inhibitors (including captopril) with aliskiren and aliskiren-containing drugs should be avoided in patients with severe renal dysfunction (GFR less than 60 ml / min / 1.73 m2).

    Simultaneous use of ACE inhibitors (including captopril) with aliskiren and aliskirenoderzhaschimi drugs contraindicated in patients with type 2 diabetes mellitus.

    Combined application from potassium-sparing diuretics, potassium preparations, potassium supplements, salt substitutes (contain significant amounts of potassium ions) increases the risk of hyperkalemia. If necessary, their simultaneous use with captopril should monitor the plasma content of potassium.

    When using high doses of diuretics (thiazide diuretics, "loop" diuretics) concomitantly with captopril, due to reduced volume of circulating blood increases the risk of hypotension, especially at the beginning of treatment with captopril.

    Antihypertensive effect Captopril is potentiated when used simultaneously with aldesleukin, alprostadil, beta blockers, alpha 1-blockers, central alpha 2-agonists, diuretics, cardiotonics, blockers "slow" calcium channels, minoxidil, muscle relaxants, and vasodilators nitrates. Antidepressants, antipsychotics, anxiolytics and hypnotics can also enhance the antihypertensive effect of captopril.

    With prolonged use antihypertensive effect of captopril weakens indomethacin, and other non-steroidal anti-inflammatory drugs (NSAIDs), including: selective inhibitors of cyclooxygenase-2 (Delay sodium ions decrease the synthesis of prostaglandins, especially against low renin activity) and estrogens.

    It has been described that NSAIDs and ACE inhibitors have an additive effect on the increase in serum potassium content, while reducing the renal function. These effects are reversible.Rarely, acute renal failure may occur, especially in patients with previous renal dysfunction, in elderly patients or with a reduced volume of circulating blood (with dehydration).

    The use of ACE inhibitors in patients undergoing surgical intervention with the use of general anesthesia, can lead to a marked decrease in blood pressure, especially when using means for general anesthesia that have an antihypertensive effect.

    Slows down the excretion lithium preparations, increasing the concentration of lithium in the blood. If necessary simultaneous use of captopril and lithium preparations should be carefully monitored serum lithium concentration.

    When using captopril on the background of admission allopurinol or procainamide, increases the risk of Stevens-Johnson syndrome and neutropenia.

    With simultaneous use of ACE inhibitors and preparations of gold (in / in sodium aurotomy malate) describes a symptom complex, which includes facial flushing, nausea, vomiting and lowering blood pressure.

    Sympathomimetics can reduce the antihypertensive effect captopril.

    Insulin and hypoglycemic agents for oral administration increase the risk of hypoglycemia.

    Simultaneous reception of captopril with food or antacids slows the absorption of captopril in the gastrointestinal tract (GIT).

    During therapy with captopril, the use of ethanol, because the ethanol enhances the antihypertensive effect of captopril.

    Antihypertensive effect captopril is weakened epoetins, estrogen and combined oral contraceptives, carbenoxolone, glucocorticosteroids and naloxone.

    Probenecid reduces renal clearance of captopril and increases its serum concentrations in the blood.

    The use of captopril in patients taking immunosuppressants (eg, azathioprine or cyclophosphamide), increases the risk of hematological disorders.

    Increases concentration digoxin in blood plasma by 15-20%.

    Increases bioavailability propranolol.

    Cimetidine, slowing metabolism in the liver, increases the concentration of captopril in the blood plasma.

    Clonidine reduces the severity of antihypertensive effect.

    Special instructions:

    Before the beginning, and also regularly during the treatment with the drug Captopril Sandoz® should regularly monitor blood pressure and kidney function. In patients with chronic cardiac Insufficiency of the drug is used under close medical supervision.

    Arterial hypotension

    In patients with hypertension with the drug Captopril Sandoz®, severe arterial hypotension is observed only in rare cases, the probability of this condition increases when the volume of circulating blood decreases and the water-electrolyte balance is disturbed (for example, after treatment with high doses of diuretics), in patients with chronic heart failure or on hemodialysis. The possibility of a sharp drop in blood pressure can be minimized by first canceling (for 4-7 days) a diuretic or replenishing the volume of circulating blood (about a week before the application starts) or using the drug Captopril Sandoz® in small doses (6.25-12.5 mg / day) at the beginning of treatment.

    With the use of antihypertensive drugs, a marked decrease in blood pressure in patients with impaired brain blood circulation, cardiovascular diseases, may increase the risk of myocardial infarction or stroke. If arterial hypotension has developed, the patient should be given a "lying down" position on the back with raised legs. Sometimes, it may be necessary to replenish the volume of circulating blood.

    Renovascular hypertension

    There is an increased risk of developing arterial hypotension and renal failure in patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney using ACE inhibitors.

    Violation of kidney function can occur with a moderate change in the concentration of creatinine in the blood serum. In such patients, therapy should be started under close medical supervision from small doses, carefully titrating and controlling kidney function. The use of ACE inhibitors - including captopril - with aliskiren should be avoided in patients with severe renal failure (GFR less than 60 ml / min / 1.73 m).

    Proteinuria

    In patients, especially with impaired renal function or in combination with relatively high doses of ACE inhibitors taking the drug Captopril Sandoz®, there may be proteinuria. AT In most cases, proteinuria decreased or disappeared within 6 weeks, regardless of whether captopril treatment continued or not. Parameters of renal function such as residual blood nitrogen and creatinine in patients with proteinuria rarely changed.

    Hyperkalemia

    In some cases, when the drug is used Captopril Sandoz® there is an increase in potassium in the blood serum. The risk of developing hyperkalemia with ACE inhibitors is elevated in patients with renal insufficiency and diabetes, and also taking potassium-sparing diuretics, potassium preparations and other drugs that cause an increase in the potassium content in the blood (for example, heparin). You should avoid the simultaneous use of potassium-sparing diuretics and potassium preparations. With caution apply in patients on a low-salt or salt-free diet (an increased risk of developing hypotension) and hyperkalemia.

    Neutropenia / agranulocytosis

    In the first 3 months of therapy, the number of leukocytes in the blood is monitored monthly, then - once in 3 months. Neutropenia / agranulocytosis, anemia and thrombocytopenia have been reported in patients taking ACE inhibitors, including captopril. In patients with normal renal function and the absence of other complicating factors, neutropenia occurs rarely. A drug Captopril Sandoz® should be used with great care in patients with connective tissue diseases and simultaneously receiving immunosuppressive therapy (allopurinol or procainamide), especially with existing impairments of kidney function. Such patients in the first 3 months are monitored by a clinical blood test every 2 weeks, then every 2 months. If the number of white blood cells is below 4.0 x 109/ l, shows a general blood test once a week, below 1.0 x 109/ l - use of the drug Captopril Sandoz® is terminated. These patients can develop severe infections that are not amenable to intensive antibiotic therapy. During treatment, all patients should be instructed that if signs of infection (eg, sore throat, fever) occur, inform the attending physician and perform a clinical blood count with counting the leukocyte formula. In most patients, the number of white blood cells upon quitting captopril quickly returns to normal.

    Anaphylactoid reactions

    In patients taking the drug Captopril Sandoz® on the background of the desensitizing therapy conducted by the venom of Hymenoptera, etc., the risk of developing anaphylactoid reactions is increased. This can be avoided if the drug is temporarily interrupted.

    When conducting hemodialysis in patients receiving the drug Captopril Sandoz®, the use of dialysis membranes with high permeability (for example, AN69®), as in such cases the risk of developing anaphylactoid reactions.

    In rare cases, patients with ACE inhibitors may experience life-threatening anaphylactoid reactions during low-density lipoprotein (LDL) apheresis with dextran sulfate. To prevent anaphylactoid reactions, ACE inhibitor therapy should be discontinued before each apheresis procedure of LPNHT using high-flux membranes.

    Angioedema

    In patients taking the drug Captopril Sandoz® with the appearance of pain in the abdomen must be differentiated with intestinal angioedema.

    In the case of development of angioedema, the drug is canceled and provides thorough medical supervision. If the edema is localized on the face, special treatment is usually not required (to reduce the severity of symptoms can be used antihistamines); if the swelling spreads to the tongue, throat or larynx and there is a threat of development of airway obstruction and a threat to the life of the patient, you should immediately enter epinephrine (epinephrine) subcutaneously (0.5 ml in a dilution of 1: 1000), and also to be convinced of the free passableness of the airways. It is recommended to stop taking ACE inhibitors, including the drug Captopril Sandoz®, 12 hours prior to surgery, warning an anesthesiologist about the use of ACE inhibitors.

    Cough

    Development of unproductive, prolonged cough with the use of ACE inhibitors is reversible and is allowed after the withdrawal of treatment.

    Diabetes

    In patients with diabetes, who take hypoglycemic means for ingestion or insulin, should regularly monitor the concentration of glucose in the blood during the first month of treatment with the drug Captopril Sandoz®.

    Impaired liver function

    During therapy with ACE inhibitors, several cases of liver dysfunction with cholestatic jaundice, fulminant liver necrosis (in some cases) with a fatal outcome.

    If the background of drug therapy Captopril Sandoz® develops jaundice or the activity of "liver" transaminases increases, the drug Captopril Sandoz® should be immediately discontinued; the patient should be under close supervision and, if necessary, receive appropriate therapy.

    Hypokalemia

    The simultaneous use of an ACE inhibitor and a thiazide diuretic does not exclude the possibility of hypokalemia. Recommended regularly monitor the potassium content in the blood.

    Surgery / anesthesia

    Arterial hypotension may occur in patients undergoing extensive surgical interventions or during the use of anesthetics, which are known to lower blood pressure. When arterial hypotension occurs, it is recommended that the volume of circulating blood be replenished.

    Ethnic differences

    ACE inhibitors, including the drug Captopril Sandoz®, have a less pronounced antihypertensive effect in patients of the Negroid race, which is likely due to the frequent occurrence of low renin activity in this group of patients.

    Laboratory data

    Captopril may cause a false positive urine test for acetone.

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

    During the period of treatment it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions. possibly dizziness, especially after taking the initial dose.

    Form release / dosage:

    Tablets 6.25 mg, 12.5 mg, 25 mg, 50 mg, 100 mg.

    Packaging:For 10 tablets in a blister of PVC / A1 or PP / A1 foil.
    For 1,2,3,4,5 or 10 blisters together with instructions for use in a cardboard box.
    Storage conditions:Store at a temperature not exceeding 25 ° C.
    Keep out of the reach of children.
    Special precautions when destroying an unused preparation
    There is no need for special precautions when destroying an unused preparation.
    Shelf life:

    Dosage of 6.25 mg /25 mg / 50 mg: 3 years.

    Dosage 12.5 mg / 100 mg: 5 years.

    Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N011001
    Date of registration:24.04.2012 / 18.10.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia
    Manufacturer: & nbsp
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp07.12.2017
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