Instructions for Ramizes tablets 2.5 mg No. 30
Composition
active ingredient: ramipril;
1 tablet contains ramipril 1.25 mg or 2.5 mg, or 5 mg, or 10 mg;
excipients:
1.25 mg tablets: sodium bicarbonate, lactose monohydrate, croscarmellose sodium, pregelatinized starch 1500, magnesium stearate;
2.5 mg tablets: sodium bicarbonate, lactose monohydrate, croscarmellose sodium, pregelatinized starch 1500, magnesium stearate, yellow iron oxide (E 172);
5 mg tablets: sodium bicarbonate, lactose monohydrate, croscarmellose sodium, pregelatinized starch 1500, magnesium stearate, yellow iron oxide (E 172), red iron oxide (E 172);
10 mg tablets: sodium bicarbonate, lactose monohydrate, croscarmellose sodium, pregelatinized starch 1500, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties:
1.25 mg tablets: flat-cylindrical tablets, white or almost white in color with a bevel, with a weak specific odor or no odor. Slight marbling is allowed on the surface of the tablets;
2.5 mg tablets: flat-cylindrical tablets, light yellow in color with a bevel and a score, with a weak specific odor or no odor. Minor inclusions and marbling are allowed on the surface of the tablets;
5 mg tablets: flat-cylindrical tablets, light pink in color with a bevel and a score, with a weak specific odor or no odor. Minor inclusions and marbling are allowed on the surface of the tablets;
10 mg tablets: flat-cylindrical tablets, white or almost white in color with a bevel and a score, with a weak specific odor or no odor. Slight marbling is allowed on the surface of the tablets.
Pharmacotherapeutic group
Angiotensin-converting enzyme (ACE) inhibitors, monocomponent. Ramipril. ATC code C09A A05.
Pharmacological properties
Pharmacodynamics.
Ramizes is an antihypertensive agent, an ACE inhibitor. By inhibiting the synthesis of angiotensin II, the drug reduces its vasoconstrictor effect and stimulating effect on aldosterone secretion. It increases plasma renin activity and also inhibits the metabolism of bradykinin.
Ramipril administration causes a significant decrease in peripheral arterial resistance. In general, renal plasma flow and glomerular filtration rate do not change significantly.
Administration of ramipril to patients with arterial hypertension leads to a decrease in blood pressure in the supine and standing positions, without a compensatory increase in heart rate.
In most patients, the antihypertensive effect of a single oral dose is apparent within 1-2 hours. The maximum effect of a single dose is usually achieved within 3-6 hours and usually lasts for 24 hours.
The maximum antihypertensive effect of long-term treatment with ramipril is observed after 3-4 weeks. With long-term therapy, it is maintained for 2 years.
In response to abrupt discontinuation of ramipril, there is no rapid and severe increase in blood pressure.
In patients with clinical heart failure, treatment was initiated 3-10 days after acute myocardial infarction, ramipril reduced the risk of mortality by 27% compared with placebo. Reductions in other risks were also found, including the risk of sudden death (by 30%) and the risk of progression to severe/persistent heart failure (by 23%). In addition, the likelihood of subsequent hospitalization for heart failure was reduced by 26%.
In patients with non-diabetic or diabetic overt nephropathy, ramipril reduces the rate of progression of renal failure and the onset of end-stage renal failure, and consequently the need for dialysis or kidney transplantation. In patients with non-diabetic or diabetic initial nephropathy, ramipril reduces albumin excretion.
In patients at increased cardiovascular risk due to vascular disease or diabetes, ramipril reduces the incidence of myocardial infarction, stroke, or cardiovascular death. In addition, ramipril reduces overall mortality and the need for revascularization, and delays the onset and progression of congestive heart failure. Ramipril reduces the risk of nephropathy in the general population of diabetic patients. Ramipril also significantly reduces the incidence of microalbuminuria. These effects were observed in both hypertensive and normotensive patients.
Pharmacokinetics.
Presystemic metabolism of ramipril to the active metabolite ramiprilat occurs in the liver. In addition to this activation to ramiprilat, ramipril is glucuronidated to ramipril diketopiperazine (ester). Ramiprilat is also glucuronidated to ramipril diketopiperazine (acid).
The bioavailability of ramiprilat after oral administration of 2.5 mg and 5 mg ramipril is approximately 45%. Ramipril has been shown to pass into breast milk.
The maximum plasma concentration of ramipril is reached 1 hour after oral administration. The half-life of ramipril is approximately 1 hour. Peak plasma concentrations of ramiprilat are observed between 2 and 4 hours after oral administration of ramipril.
The decline in plasma ramiprilat concentrations occurs in several phases. The half-life of the initial distribution and elimination phase is approximately 3 hours. This is followed by a transitional phase (with a half-life of approximately 15 hours) and then a terminal phase during which plasma ramiprilat concentrations are very low, with a half-life of approximately 4-5 days.
The presence of the terminal phase is due to the slow dissociation of ramiprilat from the close but saturated bond with ACE.
Despite the long terminal elimination phase, after a single dose of ramipril at a dose of 2.5 mg and above, steady state is reached after about 4 days. After multiple doses, the "effective" half-life is 13-17 hours, depending on the dose. The half-life of ramiprilat from ACE is 10.7 hours, which indicates high activity.
The binding of ramipril and ramiprilat to serum proteins is approximately 73% and 56%, respectively.
In healthy volunteers aged 65 to 76 years, the kinetics of ramipril and ramiprilat are similar to those observed in young healthy volunteers.
In patients with reduced renal function, the elimination of ramiprilat is reduced, and the renal clearance of ramiprilat is reduced in proportion to creatinine clearance. This results in increased plasma concentrations of ramiprilat, which decrease much more slowly than in patients with normal renal function.
When administered at high doses (10 mg), in case of impaired liver function, the conversion of ramipril to ramiprilat occurs later, plasma concentrations of ramipril increase and the elimination of ramiprilat slows down.
As in healthy volunteers and hypertensive patients, no significant accumulation of ramipril and ramiprilat was observed in patients with congestive heart failure after oral administration of 5 mg ramipril once daily for 2 weeks.
Indication
Treatment of arterial hypertension.
Prevention of cardiovascular disease: reduction of cardiovascular morbidity and mortality in patients with:
– severe cardiovascular disease of atherothrombotic origin (history of ischemic heart disease or stroke or peripheral vascular disease);
– diabetes, who have at least one cardiovascular risk factor.
Treatment of kidney disease:
– initial glomerular diabetic nephropathy, as evidenced by the presence of microalbuminuria;
– severe glomerular diabetic nephropathy, as evidenced by the presence of macroproteinuria, in patients who have at least one cardiovascular risk factor (see section "Pharmacological properties");
– severe glomerular non-diabetic nephropathy, as evidenced by the presence of macroproteinuria ≥ 3 g/day.
Treatment of heart failure accompanied by clinical manifestations.
Secondary prevention after acute myocardial infarction: reduction of mortality during the acute stage of myocardial infarction in patients with clinical signs of heart failure, provided that treatment is started more than 48 hours after the onset of acute myocardial infarction.
Contraindication
Hypersensitivity to the active substance or to any of the excipients included in the preparation, or to other ACE inhibitors.
Pregnant women or women planning to become pregnant (see section “Use during pregnancy or breastfeeding”).
History of angioedema (hereditary, idiopathic or previously experienced while taking ACE inhibitors or angiotensin II receptor antagonists).
Significant bilateral renal artery stenosis or renal artery stenosis in the presence of a single functioning kidney.
Ramipril should not be used in patients with hypotension or hemodynamically unstable conditions.
Should not be used with aliskiren-containing drugs in patients with diabetes mellitus or moderate or severe renal impairment (GFR < 60 mL/min).
The concomitant use of ACE inhibitors and extracorporeal treatments that result in contact of blood with negatively charged surfaces should be avoided, as such use may lead to severe anaphylactoid reactions. Such extracorporeal treatments include dialysis or hemofiltration using certain membranes with high hydraulic permeability (e.g. polyacrylonitrile) and low-density lipoprotein apheresis using dextran sulfate.
Interaction with other medicinal products and other types of interactions
Extracorporeal therapy methods that result in contact of blood with negatively charged surfaces, such as dialysis or hemofiltration using certain high flux membranes (e.g. polyacrylonitrile membranes) and low density lipoprotein apheresis using dextran sulfate - due to the increased risk of severe anaphylactoid reactions (see section "Contraindications"). If such treatment is necessary, the use of a different dialysis membrane or the use of a different class of antihypertensive agents should be considered.
The combined use of Ramizes with aliskiren-containing medicinal products is contraindicated in patients with diabetes mellitus or severe renal impairment and is not recommended for other patient categories (see sections “Contraindications” and “Special warnings and precautions for use”).
Combinations requiring precautions.
Potassium salts, heparin, potassium-sparing diuretics and other active substances that increase plasma potassium levels (including angiotensin II antagonists, trimethoprim, tacrolimus, ciclosporin). Hyperkalaemia may occur, therefore careful monitoring of plasma potassium levels is necessary.
Antihypertensive drugs (e.g. diuretics) and other substances that may lower blood pressure (e.g. nitrates, tricyclic antidepressants, anaesthetics, alcohol, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin). An increased risk of arterial hypotension should be expected (see section "Special warnings and precautions for use" for diuretics).
Vasopressor sympathomimetics and other substances (e.g. isoproterenol, dobutamine, dopamine, epinephrine) that may reduce the antihypertensive effect of Ramizes. Close monitoring of blood pressure is recommended.
Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may cause changes in the blood picture.
Increased likelihood of hematological reactions (see section "Special warnings and precautions for use").
Lithium salts: ACE inhibitors may reduce lithium excretion, which may lead to increased lithium toxicity. Lithium levels should be carefully monitored.
Antidiabetic agents, including insulin. Hypoglycemic reactions may occur. Close monitoring of blood glucose levels is recommended.
Non-steroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid. A reduction in the antihypertensive effect of Ramizes is expected. Furthermore, concomitant use of ACE inhibitors and NSAIDs is associated with an increased risk of worsening of renal function and an increase in blood potassium levels.
Salt. Excessive salt consumption may weaken the hypotensive effect of the drug.
Specific hyposensitization. ACE inhibition increases the likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom. It is believed that this effect may also be observed for other allergens.
Application features
Special categories of patients.
Dual blockade of the renin-angiotensin-aldosterone system with aliskiren-containing drugs.
Dual blockade of the renin-angiotensin-aldosterone system by the combined use of Ramizes and aliskiren is not recommended, as there is an increased risk of developing arterial hypotension, hyperkalemia and changes in renal function.
The combined use of Ramizes and aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min).
Patients at particular risk of hypotension.
Patients with a strongly activated renin-angiotensin-aldosterone system. Patients with a strongly activated renin-angiotensin-aldosterone system are at risk of a sudden, severe fall in blood pressure and deterioration of renal function due to ACE inhibition, particularly when an ACE inhibitor or concomitant diuretic is given for the first time or when the dose is increased for the first time. A strongly activated renin-angiotensin-aldosterone system, requiring medical supervision, including regular monitoring of blood pressure, may be expected, for example, in patients:
– with severe arterial hypertension;
– with decompensated congestive heart failure;
– with hemodynamically significant obstruction to the inflow or outflow of blood from the left ventricle (for example, with aortic or mitral valve stenosis);
– with unilateral renal artery stenosis in the presence of a second functioning kidney;
– in whom there is or may develop a lack of fluid or electrolytes (including those receiving diuretics);
– with liver cirrhosis and/or ascites;
– who perform extensive surgical interventions or during anesthesia with the use of drugs that cause arterial hypotension.
In patients with impaired liver function, the response to treatment with Ramizex may be either enhanced or reduced. In addition, in patients with severe cirrhosis of the liver, accompanied by edema and/or ascites, the activity of the renin-angiotensin system may be significantly increased; therefore, special caution should be exercised when treating these patients.
Transient or persistent heart failure after myocardial infarction.
Patients at risk of cardiac or cerebral ischemia in the event of acute arterial hypotension. Special medical supervision is required in the initial phase of treatment.
Elderly patients.
See section "Method of administration and dosage".
Surgery: If possible, treatment with angiotensin-converting enzyme inhibitors such as ramipril should be discontinued 1 day before surgery.
Monitoring kidney function.
Renal function should be assessed before and during treatment and the dose adjusted, especially in the first weeks of treatment. Particularly careful monitoring is required in patients with impaired renal function (see section 4.2). There is a risk of worsening renal function, especially in patients with congestive heart failure or after kidney transplantation.
Angioedema.
Angioedema has been reported in patients treated with ACE inhibitors, including ramipril (see section 4.8). If angioedema develops, Ramizex should be discontinued. Emergency treatment should be initiated immediately. The patient should be kept under medical observation for at least 12-24 hours and may be discharged after complete resolution of symptoms.
Cases of intestinal angioedema have been reported in patients treated with ACE inhibitors, including Ramizex (see section 4.8). These patients presented with abdominal pain (with or without nausea/vomiting).
Anaphylactic reactions during desensitization. The use of ACE inhibitors increases the likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens. Ramizes should be temporarily discontinued prior to desensitization.
Hyperkalemia.
Hyperkalemia has been observed in some patients treated with ACE inhibitors, including Ramizex. Patients at risk for hyperkalemia include patients with renal insufficiency, patients over 70 years of age, patients with uncontrolled diabetes mellitus, patients taking potassium salts, potassium-sparing diuretics, or other active substances that increase plasma potassium levels, or patients with conditions such as dehydration, acute cardiac decompensation, or metabolic acidosis. If concomitant use of the above-mentioned drugs is considered appropriate, regular monitoring of plasma potassium levels is recommended (see section 4.5).
Neutropenia/agranulocytosis.
Cases of neutropenia/agranulocytosis, as well as thrombocytopenia and anemia have been observed rarely. Bone marrow suppression has also been reported. Monitoring of the white blood cell count is recommended to detect possible leukopenia. More frequent monitoring is advisable at the beginning of treatment and in patients with impaired renal function, concomitant collagen disease (e.g. systemic lupus erythematosus or scleroderma) or those taking other drugs that may cause changes in the blood picture (see sections “Interaction with other medicinal products and other forms of interaction” and “Adverse reactions”).
Ethnic differences. ACE inhibitors cause angioedema more frequently in black patients than in non-black patients. As with other ACE inhibitors, the antihypertensive effect of ramipril may be less pronounced in black patients than in non-black patients. This may be because black patients with hypertension are more likely to have low-renin hypertension.
Cough: Cough has been reported with ACE inhibitors. It is characteristic that the cough is non-productive, persistent and resolves after discontinuation of therapy. The possibility of cough due to ACE inhibitors should be considered in the differential diagnosis of cough.
The drug contains lactose, so it should not be administered to patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
Use during pregnancy or breastfeeding
Pregnancy. Ramizes should not be used by pregnant women or women planning to become pregnant. If pregnancy is confirmed during treatment with this medicine, its use should be discontinued immediately and replaced with another medicine approved for use in pregnancy.
Breastfeeding. Because of the lack of information regarding the use of ramipril during breastfeeding, this drug is not recommended for use in nursing mothers and alternative treatments with better established safety profiles during lactation are preferable, especially while nursing a newborn or preterm infant.
Ability to influence reaction speed when driving vehicles or other mechanisms
Some side effects (for example, some symptoms of low blood pressure, in particular dizziness) may adversely affect the patient's ability to concentrate and speed of psychomotor reactions, especially at the beginning of treatment or when switching from other drugs. After taking the first dose or a subsequent increase in the dose, it is undesirable to drive or operate other mechanisms for several hours.
Method of administration and doses
Drug for oral use.
It is recommended to take Ramize at the same time each day. The drug can be taken before, during, or after meals, as food intake does not affect the bioavailability of the drug. Ramize tablets should be swallowed whole with water. They should not be chewed or crushed.
Adults.
Patients receiving diuretics: Hypotension may occur at the beginning of treatment with Ramizex, and is more likely to occur in patients receiving concomitant diuretics. Caution is advised in such cases, as these patients may be at risk of volume depletion and/or electrolyte depletion.
It is advisable to discontinue the diuretic 2-3 days before starting treatment with Ramizes, if possible (see section "Special warnings and precautions for use").
In patients with arterial hypertension who cannot discontinue the diuretic, treatment with Ramizes should be initiated at a dose of 1.25 mg. Renal function and blood potassium levels should be closely monitored. Subsequent dosage of Ramizes should be adjusted depending on the target blood pressure level.
Arterial hypertension.
The dose should be selected individually, depending on the characteristics of the patient's condition (see section "Special instructions for use") and the results of control blood pressure measurements. Ramizes can be used as monotherapy or in combination with other classes of antihypertensive drugs.
Initial dose: Treatment with Ramizex should be initiated gradually, with the recommended initial dose of 2.5 mg per day.
Patients with a strongly activated renin-angiotensin-aldosterone system may experience a significant decrease in blood pressure after the initial dose. For such patients, a starting dose of 1.25 mg is recommended and treatment should be initiated under medical supervision.
Dose titration and maintenance dose. The dose may be doubled every 2-4 weeks until the target blood pressure is reached; the maximum dose of Ramize is 10 mg per day. The drug is usually taken once a day.
Prevention of cardiovascular diseases.
Starting dose. The recommended starting dose of Ramizes is 2.5 mg once daily.
Dose titration and maintenance dose. Depending on individual tolerability, the dose should be increased gradually. It is recommended to double the dose after 1-2 weeks of treatment and then increase it after another 2-3 weeks to the target maintenance dose of 10 mg once daily (see also the information above regarding dosing for patients receiving diuretics).
Treatment of kidney disease.
In patients with diabetes and microalbuminuria.
Starting dose: The recommended starting dose of Ramizes is 1.25 mg once daily.
Dose titration and maintenance dose. Depending on individual tolerability of the drug, the dose is increased during further treatment. After 2 weeks of treatment, it is recommended to double the daily dose to 2.5 mg, and then to 5 mg after another 2 weeks of treatment.
In patients with diabetes and at least one cardiovascular risk factor.
Starting dose. The recommended starting dose of Ramizes is 2.5 mg once daily.
Dose titration and maintenance dose. Depending on individual tolerability of the drug, the dose is increased during further treatment. After 1-2 weeks of treatment, it is recommended to double the daily dose of Ramizes to 5 mg, and then to 10 mg after another 2-3 weeks of treatment. The target daily dose is 10 mg.
In patients with non-diabetic nephropathy, as evidenced by macroproteinuria ≥ 3 g/day.
Starting dose: The recommended starting dose of Ramizes is 1.25 mg once daily.
Dose titration and maintenance dose. Depending on the individual patient's tolerance of the drug, the dose should be increased during further treatment. After 2 weeks of treatment, it is recommended to double the daily dose to 2.5 mg, and then to 5 mg after another 2 weeks of treatment.
Heart failure with clinical manifestations.
Initial dose: For patients stabilized on diuretic therapy, the recommended initial dose is 1.25 mg/day.
Dose titration and maintenance dose. The dose of Ramizes should be titrated by doubling it every 1-2 weeks until a maximum daily dose of 10 mg is reached. It is advisable to divide the dose into 2 doses.
Initial dose: 48 hours after myocardial infarction, patients who are clinically and hemodynamically stable should be given an initial dose of 2.5 mg twice daily for 3 days. If the initial dose of 2.5 mg is poorly tolerated, then 1.25 mg twice daily for 2 days should be used, followed by an increase to 2.5 mg and 5 mg twice daily. If the dose cannot be increased to 2.5 mg twice daily, treatment should be discontinued (see also the information above regarding dosing for patients receiving diuretics).
Dose titration and maintenance dose. Subsequently, the daily dose should be increased by doubling it at intervals of 1-3 days until the target maintenance dose of 5 mg 2 times a day is reached. Whenever possible, the maintenance daily dose should be divided into 2 doses. If the dose cannot be increased to 2.5 mg 2 times a day, treatment should be discontinued. Experience in treating patients with severe heart failure (NYHA class IV) immediately after myocardial infarction is still insufficient. If a decision is nevertheless made to treat such patients with this drug, it is recommended to start therapy with a dose of 1.25 mg 1 time a day and any increase should be carried out with extreme caution.
Special categories of patients.
Patients with renal impairment. The daily dose for patients with renal impairment depends on the creatinine clearance:
- if creatinine clearance is ≥ 60 ml/min, there is no need to adjust the initial dose (2.5 mg/day), and the maximum daily dose is 10 mg;
− if creatinine clearance is 30-60 ml/min, there is no need to adjust the initial dose (2.5 mg/day), and the maximum daily dose is 5 mg;
- if creatinine clearance is 10-30 ml/min, the initial daily dose is 1.25 mg/day, and the maximum daily dose is 5 mg;
- patients with arterial hypertension undergoing hemodialysis: ramipril is removed to a small extent during hemodialysis; the initial dose is 1.25 mg, and the maximum daily dose is 5 mg; the drug should be taken a few hours after the hemodialysis session.
Patients with hepatic impairment: Treatment with Ramizex in patients with hepatic impairment should be initiated under close medical supervision, and the maximum daily dose in such cases should be 2.5 mg.
Elderly patients: The initial dose should be lower and subsequent dose titration should be more gradual because of the higher likelihood of adverse effects, especially in very elderly and debilitated patients. In such cases, a lower initial dose of 1.25 mg ramipril should be prescribed.
Children
Ramizes is not recommended for use in children, as there is insufficient data on the efficacy and safety of this drug in such patients.
Overdose
Symptoms associated with overdose of ACE inhibitors may include excessive peripheral vasodilation (with pronounced hypotension, shock), bradycardia, electrolyte imbalance and renal failure. The patient should be closely monitored and symptomatic and supportive therapy should be administered. The proposed treatment measures include primary detoxification (gastric lavage, administration of adsorbents), as well as measures aimed at restoring stable hemodynamics, including the administration of alpha 1-adrenoceptor agonists or angiotensin II (angiotensinamide). Ramiprilat, the active metabolite of ramipril, is poorly removed from the systemic circulation by hemodialysis.
Adverse reactions
From the side of the cardiac system: myocardial ischemia, including angina pectoris or myocardial infarction, tachycardia, arrhythmia, feeling of increased heartbeat, peripheral edema.
From the vascular system: arterial hypotension, orthostatic hypotension, syncope, vascular stenosis, hypoperfusion, vasculitis, Raynaud's phenomenon, sensation of flushing.
On the part of the urinary system: impaired renal function, including acute renal failure, increased diuresis, worsening of background proteinuria, increased levels of urea and creatinine in the blood.
Respiratory system: non-productive irritating cough, bronchitis, sinusitis, shortness of breath, nasal congestion, bronchospasm, including exacerbation of asthma.
Gastrointestinal: gastrointestinal inflammation, indigestion, abdominal discomfort, dyspepsia, diarrhea, nausea, vomiting, pancreatitis (fatal outcomes have been reported with ACE inhibitors), increased pancreatic enzymes, angioedema of the small intestine, upper abdominal pain, gastritis, constipation, dry mouth, glossitis, aphthous stomatitis.
On the part of the hepatobiliary system: increased levels of liver enzymes and/or bilirubin conjugates, cholestatic jaundice, liver cell damage, acute liver failure, cholestatic or cytolytic hepatitis (in exceptional cases - with a fatal outcome).
Nervous system: headache, dizziness, vertigo, paresthesia, ageusia, dysgeusia, tremor, balance disorders, cerebral ischemia, including ischemic stroke and transient ischemic attack, impaired psychomotor functions, burning sensation, parosmia.
From the organs of vision: visual disturbances, including blurred vision, conjunctivitis.
Skin and subcutaneous tissue disorders: rash, particularly maculopapular, angioedema (airway obstruction due to angioedema may be fatal), pruritus, urticaria, hyperhidrosis, exfoliative dermatitis, onycholysis, photosensitivity reaction, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, exacerbation of psoriasis, psoriatic dermatitis, pemphigoid or lichenoid exanthema or enanthema, alopecia.
Musculoskeletal and connective tissue disorders: muscle spasms, myalgia, arthralgia.
On the part of the endocrine system: syndrome of inappropriate secretion of antidiuretic hormone.
Metabolism and nutrition disorders: increased blood potassium levels, anorexia, decreased appetite, decreased blood sodium levels.
Blood and lymphatic system disorders: eosinophilia, decreased white blood cell count (including neutropenia or agranulocytosis), decreased red blood cell count, decreased hemoglobin level, decreased platelet count, bone marrow failure, pancytopenia, hemolytic anemia.
On the part of the immune system: anaphylactic and anaphylactoid reactions, increased levels of antinuclear antibodies.
From the reproductive system: transient erectile impotence, decreased libido, gynecomastia.
On the part of the psyche: decreased mood, anxiety, nervousness, restlessness, sleep disturbances, including drowsiness, a state of confusion, impaired attention.
General disorders: chest pain, asthenia, pyrexia, fatigue.
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister. 1 or 3 blisters in a pack.
Vacation category
According to the recipe.
Producer
PJSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Frunze St., 74.
