Substance: Republic of Croatia
Candesartan-NAN
International non-proprietary name: Candesartan
Read carefully before use
Candesartan-NAN
Candesartan
Tablets
Candesartan-NAN 8 mg: white round tablets, flat on one side and convex on the other side, with a score and a bevel on the flat side. The tablet can be divided into two equal halves.
Candesartan-NAN 16 mg: white round biconvex tablets.
Candesartan-NAN 32 mg: white round biconvex tablets.
Each tablet contains:
Active substances: candesartan cilexetil 8 mg, 16 mg, or 32 mg;
Excipients: lactose monohydrate, corn starch, hydroxypropylcellulose, croscarmellose sodium, macrogol 8000, magnesium stearate.
Agents affecting the renin-angiotensin system. Angiotensin II antagonists.
C09CA06
Candesartan is a selective angiotensin II receptor blocker (ARB II). Candesartan does not inhibit angiotensin-converting enzyme (ACE), which converts angiotensin I to angiotensin II and destroys bradykinin. It does not affect ACE and does not lead to accumulation of bradykinin or substance P. When comparing candesartan with ACE inhibitors, the development of cough was less common in patients treated with candesartan cilexetil. Candesartan does not bind to other hormone receptors and does not block ion channels involved in the regulation of the functions of the cardiovascular system. As a result of blocking the AT1 receptors of angiotensin II, a dose-dependent increase in the level of renin, angiotensin I, angiotensin II and a decrease in the concentration of aldosterone in the blood plasma occur.
In arterial hypertension, candesartan causes a dose-dependent long-term decrease in blood pressure (BP). The antihypertensive effect of Candesartan-NAN is due to a decrease in the total peripheral vascular resistance without changing the heart rate. There were no cases of severe arterial hypotension after taking the first dose of Candesartan-NAN, as well as withdrawal syndrome (rebound syndrome) after stopping therapy.
The onset of hypotensive action after taking the first dose of candesartan cilexetil usually develops within 2 hours. Against the background of ongoing therapy with Candesartan-NAN in a fixed dose, the maximum reduction in blood pressure is usually achieved within 4 weeks and persists throughout treatment. Candesartan cilexetil, given once a day, provides an effective and smooth decrease in blood pressure for 24 hours with slight fluctuations in blood pressure in the intervals between doses of the next dose of Candesartan-NAN. The use of candesartan cilexetil together with hydrochlorothiazide leads to an increase in the hypotensive effect. The combined use of candesartan cilexetil and amlodipine or felodipine leads to an increase in the antihypertensive effect.
Candesartan cilexetil increases renal blood flow and/or has no effect on glomerular filtration rate, while renal vascular resistance and filtration fraction are reduced. Administration of candesartan cilexetil at a dose of 8–16 mg for 12 weeks does not adversely affect glucose levels and lipid profiles in patients with arterial hypertension and type 2 diabetes mellitus.
In patients with chronic heart failure and reduced left ventricular systolic function (left ventricular ejection fraction ≤ 40%), candesartan reduces total peripheral vascular resistance and capillary pressure in the lungs, increases renin activity and angiotensin II concentration in blood plasma, and also reduces the level aldosterone.
- Treatment of arterial hypertension in adults;
- Treatment of hypertension in children and adolescents aged 6 to 18 years;
- Treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) with intolerance to angiotensin-converting enzyme (ACE) inhibitors or as adjunctive therapy to ACE inhibitors in patients with symptomatic heart failure, despite optimal therapy, with intolerance to mineralocorticoid receptor antagonists (see Sections Dosage and administration, Warnings and precautions, Interaction with other medicines, and Pharmacological properties).
Tablets should be taken orally once a day, without chewing and with a sufficient amount of chilled boiled water, regardless of the meal. A tablet with a dosage of 8 mg can be divided into two equal parts by pressing fingers on both sides of the line.
Arterial hypertension
The recommended initial and maintenance dose of Candesartan-NAN is 8 mg once daily. The dose may be increased to 16 mg once daily. Patients who have not been able to sufficiently reduce blood pressure after 4 weeks of taking Candesartan-NAN at a dose of 16 mg per day, it is recommended to increase the dose to 32 mg once a day. If therapy with Candesartan-NAN does not lead to a decrease in blood pressure to an optimal level, it is recommended to change the treatment regimen.
Therapy should be adjusted according to the level of blood pressure. The maximum antihypertensive effect is achieved within 4 weeks from the start of treatment. Candesartan-NAN can be combined with other antihypertensive agents, such as hydrochlorothiazide, to enhance the hypotensive effect.
Elderly patients
In elderly patients, there is no need to adjust the initial dose of Candesartan-NAN.
Patients with impaired renal function
The initial daily dose in patients with impaired renal function, including patients on hemodialysis, is 4 mg.
Experience with the use of Candesartan-NAN in patients with very severe renal impairment or end-stage renal disease (creatinine clearance < 15 ml / min) is limited.
Simultaneous use of Candesartan-NAN with aliskiren is contraindicated in patients with renal insufficiency (glomerular filtration rate (GFR) < 60 ml/min / 1.73 m2) (see Section Contraindications).
Patients with impaired liver function
The initial daily dose of Candesartan-NAN in patients with mild to moderate hepatic impairment is 4 mg. The dose of Candesartan-NAN should be adjusted depending on the response. Clinical experience with Candesartan-NAN in patients with severe hepatic impairment and/or cholestasis is limited. Candesartan-NAN is contraindicated in this category of patients.
Patients with hypovolemia
In patients with intravascular fluid volume deficiency, the recommended starting dose of Candesartan-NAN is 4 mg once daily.
Dark-skinned population
The antihypertensive effect of candesartan in dark-skinned patients is less severe than in individuals of other races. Therefore, to control blood pressure in patients of black race, it may be more necessary to increase the dose of Candesartan-NAN and take concomitant medicines than in patients of other ethnic origin.
Children and adolescents aged 6 to 18
The recommended starting dose of Candesartan-NAN is 4 mg once daily. In patients weighing < 50 kg, if therapy is ineffective, it is possible to increase the dose to 8 mg once a day. In patients weighing ≥ 50 kg, with treatment failure, it is possible to increase the dose to 8 mg once a day and then, if necessary, up to 16 mg once a day.
Doses above 32 mg have not been studied in the pediatric population.
The maximum antihypertensive effect is achieved within 4 weeks from the start of treatment.
In children with possible intravascular fluid volume deficit (e.g. when taking diuretics, especially in patients with impaired renal function), treatment with Candesartan-NAN should be initiated under close medical supervision, and a lower initial dose than the total initial dose should be considered.
Candesartan has not been studied in children with GFR < 30 ml/min/1.73 m2.
The antihypertensive effect of candesartan in dark-skinned children is less severe than in persons of other races.
Safety and efficacy in children under 6 years of age have not been checked.
Heart failure
The recommended starting dose of Candesartan-NAN is 4 mg once daily. Gradual escalation to reach the target dose of 32 mg once daily or the maximum tolerated dose is performed by doubling the dosage at intervals of at least 2 weeks. Evaluation of patients with heart failure should always include assessment of renal function and monitoring of serum potassium and creatinine levels. Candesartan-NAN may be co-administered with other drugs for the treatment of heart failure, including ACE inhibitors, beta-blockers, diuretics and cardiac glycosides. Combination of ACE inhibitors, potassium-sparing diuretics (e.g. spironolactone) and Candesartan-NAN is not recommended and should only be used after a careful assessment of the potential benefits and risks.
Special population
Adjustment of the initial dose of Candesartan-NAN is not required in elderly patients and in patients with hypovolemia, impaired renal function, or impaired liver function of mild to moderate severity.
Concomitant therapy
Candesartan can be used simultaneously with other medicines for treatment of heart failure, including ACE inhibitors (increased risk of side effects), beta-blockers, diuretics, and cardiac glycosides, or with a combination of these medicines.
Children and adolescents
Safety and efficacy of candesartan in children and adolescents (under 18 years of age) in the treatment of heart failure have not been checked.
Frequency of side effects: very common (≥ 1/10); common (≥ 1/100, but < 1/10); uncommon (≥ 1/1000, but < 1/100); rare (≥ 1/10000 but < 1/1000), very rare (< 1/10000). Based on clinical trial data and post-marketing experience, the following side effects have been registered.
Treatment of arterial hypertension:
Infectious and parasitic diseases: respiratory tract infection (common).
Blood and lymphatic system disorders: leukopenia, neutropenia, and agranulocytosis (very rare).
Metabolism and nutritional disorders: hyperkalemia, hyponatremia (very rare).
Nervous system disorders: dizziness/vertigo, headache (common).
Respiratory, thoracic and mediastinal disorders: cough (very rare).
Gastrointestinal disorders: nausea (very rare); diarrhea (frequency unknown).
Hepatobiliary disorders: increased activity of liver enzymes, abnormal liver function or hepatitis (very rare).
Skin and subcutaneous tissue disorders: angioedema, rash, urticaria, and pruritus (very rare).
Musculoskeletal and connective tissue disorders: back pain, arthralgia, and myalgia (very rare).
Renal and urinary disorders: impaired renal function, including renal failure in susceptible patients (very rare).
Laboratory tests and instrumental studies interaction: in general, when using candesartan, there were no clinically significant changes in standard laboratory parameters. As with other RAAS inhibitors, a slight decrease in hemoglobin levels was observed. When using Candesartan-NAN, regular monitoring of laboratory parameters is usually not required. However, in patients with impaired renal function it is recommended to periodically monitor the level of potassium and creatinine in the blood serum.
Pediatric population
Safety of candesartan was monitored in 255 children and adolescents with arterial hypertension, aged 6 to 18 years, during 4 weeks of clinical efficacy studies and 1 year of an open study. The frequency of side effects in children in almost all classes of organ systems is in the range of common/uncommon. While the nature and severity of side effects are similar to those in adults, the incidence of all side effects is higher in children and adolescents, especially the following:
- Headache, dizziness and upper respiratory infections are very common (≥ 1/10) in children and common (≥ 1/100 to < 1/10) in adults. – Cough is very common (> 1/10) in children and very rare (< 1/10,000) in adults.
- Rash is common (≥ 1/100 to < 1/10) in children and very rare (< 1/10,000) in adults.
- Hyperkalemia, hyponatremia, and hepatic dysfunction are uncommon (≥ 1/1000 to < 1/100) in children and very rare (< 1/10000) in adults.
- Sinus arrhythmia, nasopharyngitis, and pyrexia are common (≥ 1/100 to < 1/10) and oropharyngeal pain is very common (≥ 1/10) in children but none of these side effects have been reported in adults. However, these diseases are temporary and widespread in children.
The overall safety profile of candesartan cilexetil in pediatric patients is not significantly different from that in adults.
Treatment for heart failure:
Blood and lymphatic system disorders: leukopenia, neutropenia, and agranulocytosis (very rare).
Metabolism and nutritional disorders: hyperkalemia (common); hyponatremia (very rare).
Nervous system disorders: dizziness, and headache (very rare).
Vascular disorders: hypotension (common).
Respiratory, thoracic and mediastinal disorders: cough (very rare).
Gastrointestinal disorders: nausea (very rare); cough (frequency unknown).
Hepatobiliary disorders: increased activity of liver enzymes, abnormal liver function or hepatitis (very rare).
Skin and subcutaneous tissue disorders: angioedema, rash, urticaria, and pruritus (very rare).
Musculoskeletal and connective tissue disorders: back pain, arthralgia, and myalgia (very rare).
Renal and urinary disorders: impaired renal function, including renal failure in susceptible patients (very rare).
Laboratory tests and instrumental studies interaction: hyperkalemia and impaired renal function are often observed in patients with chronic heart failure taking candesartan. It is recommended to monitor the concentration of creatinine and potassium in the blood serum in such patients.
If any of the side effects listed in this leaflet get worse, or if you notice any other side effects not listed in this leaflet, inform your healthcare provider.
- Hypersensitivity to candesartan cilexetil or other components of Candesartan-NAN;
- Severe liver dysfunction and/or cholestasis;
- Pregnancy and breast-feeding;
- Concomitant use of ARB II, including Candesartan-NAN, or ACE inhibitors with aliskiren in patients with diabetes mellitus or renal failure (GFR < 60 ml/min / 1.73 m2);
- Children under 6 years old.
When taking a larger dose than prescribed by a healthcare provider, immediately seek medical advice for timely medical assistance!
Symptoms: an overdose of Candesartan-NAN can cause symptomatic hypotension and dizziness. In some reports of overdose cases recovery of patients occurred without complications.
Treatment: in the event of symptomatic hypotension it is necessary to carry out symptomatic therapy and monitor the main indicators of vital organs. Such patients should be placed in a supine position with legs elevated. If this is not enough, the volume of circulating plasma should be increased, for example by infusion of isotonic sodium chloride solution. If the above measures are ineffective, sympathomimetic drugs can be prescribed. Candesartan is not excreted from the body by hemodialysis.
If you forget to take Candesartan-NAN, you should not make up for the missed dose by taking a double dose, just take the usual dose of Candesartan-NAN.
Do not stop taking Candesartan-NAN without consulting your healthcare provider. When you stop taking Candesartan-NAN, your blood pressure may rise again. You should continue taking Candesartan-NAN even if you feel well.
There were no clinically significant interaction of candesartan with other medicinal products such as hydrochlorothiazide, warfarin, digoxin, oral contraceptives (ethinyl estradiol/levonorgestrel), glibenclamide, nifedipine, and enalapril.
Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other medicines that can increase potassium levels: combined with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other medicines that can increase serum potassium levels (e.g. heparin), can lead to development of hyperkalemia. If necessary, combined use of medicines that can affect levels of potassium in the blood serum, it is recommended to control the level of potassium in the blood serum when taking Candesartan-NAN.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): based on available data, dual blockade of the RAAS with an ACE inhibitor, an ARB II (candesartan) or aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy.
In patients with diabetes mellitus or moderate/severe renal impairment (GFR < 60 ml/min/1.73 m2), concomitant use of aliskiren with an ACE inhibitor or an ARB II (candesartan) is contraindicated.
In some cases, when the combined use of ACE inhibitors, ARB II (candesartan) is invariably indicated, careful observation of a specialist and mandatory monitoring of renal function, water and electrolyte balance, and blood pressure are necessary.
Lithium: A reversible increase in serum lithium concentration and the appearance of toxic effects have been reported with simultaneous administration of lithium preparations with ACE inhibitors. A similar effect may occur with the use of lithium salts with ARB II, so it is not recommended to use candesartan together with lithium preparations. If simultaneous administration of such medicines is necessary, careful monitoring of lithium concentration in the blood serum is recommended.
Non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors, acetylsalicylic acid (more than 3 g/day) and other non-selective NSAIDs: when ARB II and NSAIDs (i.e. selective COX inhibitors), acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs are taken together, it may lead to weakening of the antihypertensive effect.
As with ACE inhibitors, concomitant use of ARBs II and NSAIDs may increase the risk of impaired renal function, including acute renal failure, elevated serum potassium concentrations, especially in patients with reduced renal function. Caution should be exercised when using these medicines together, especially in elderly patients. Patients should be compensated for fluid loss and carefully monitor renal function after initiation of combination therapy, and periodically during such a therapy.
Based on the available data, dual blockade of the RAAS with ACE inhibitors, ARB II, or aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy.
In patients with diabetes mellitus or moderate/severe renal insufficiency (GFR < 60 ml/min/1.73 m2), concomitant use of aliskiren with ACE inhibitors and ARB II is contraindicated.
In some cases, when combined use of ACE inhibitors and ARB II is invariably indicated, careful observation of a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary.
Pediatric population
Studies in interaction with other medicinal products have only been performed in adult patients.
Your healthcare provider should be informed about all medicines you are taking. Talk to your healthcare provider before taking any medicine while taking Candesartan-NAN.
Impaired kidney function
As with the use of other agents that suppress the renin-angiotensin-aldosterone system (RAAS), during therapy with Candesartan-NAN, renal function may be impaired in susceptible patients.
When using Candesartan-NAN in patients suffering from arterial hypertension and impaired renal function, it is recommended to periodically monitor the concentration of potassium and creatinine in the blood serum. Experience with the use of Candesartan-NAN in patients with very severe renal impairment or end-stage renal disease (creatinine clearance < 15 ml/min) is limited. In this category of patients, the dose of Candesartan-NAN should be increased with caution, combined with constant monitoring of blood pressure. In patients with heart failure, it is necessary to periodically monitor renal function, especially in patients aged 75 years and older, as well as in patients with impaired renal function. When increasing the dose of Candesartan-NAN, it is also recommended to control the concentration of potassium and creatinine in the blood serum. Clinical studies in patients with chronic heart failure did not include individuals with serum creatinine > 265 µmol/L (> 3 mg/dL).
Simultaneous use of Candesartan-NAN with aliskiren is contraindicated in patients with renal insufficiency (GFR < 60 ml/min / 1.73 m2) (see Sections Contraindications and Dosage and administration).
Use in the pediatric population, including children with impaired renal function
Candesartan has not been studied in children with GFR < 30 ml/min/1.73 m2 (see Section Dosage and administration).
Double blockade of the renin-angiotensin-aldosterone system (RAAS)
Dual RAAS blockade is associated with an increased risk of hypotension, hyperkalemia, and renal impairment (including acute renal failure) compared with monotherapy. Dual RAAS blockade with an ACE inhibitor, an ARB II (candesartan), or aliskiren cannot be recommended for any patient, especially those with diabetic nephropathy.
In some cases, when the combined use of ACE inhibitors and ARB II (candesartan) is invariably indicated, careful observation of a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. This refers to the use of candesartan or valsartan as add-on therapy to ACE inhibitors in patients with chronic heart failure. Conducting a double blockade of the RAAS under close supervision of a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure is possible in patients with chronic heart failure with intolerance to aldosterone antagonists (spironolactone), who have persistent symptoms of chronic heart failure, despite another adequate therapy.
Concomitant use of ACE inhibitors and ARB II with aliskiren in patients with diabetes mellitus or moderate/severe renal insufficiency (GFR < 60 ml/min/1.73 m2) is contraindicated.
Hemodialysis
During hemodialysis, as a result of a decrease in blood plasma volume and activation of the RAAS, the ability of angiotensin antagonists to influence blood pressure can significantly increase. Therefore, in patients on hemodialysis, the dose of Candesartan-NAN should be increased carefully against the background of constant monitoring of blood pressure.
Renal artery stenosis
Medicinal products that affect the RAAS, including ARBs II, may cause an increase in serum urea and creatinine in patients with bilateral renal artery stenosis or stenosis of an artery to a solitary kidney.
Kidney transplant
There is no experience of using Candesartan-NAN in patients who have recently undergone a kidney transplant.
Arterial hypotension
In patients suffering from heart failure, arterial hypotension may develop during drug therapy. It is also possible to develop arterial hypotension in patients with hypertension and a deficit in the volume of intravascular fluid, for example, in patients receiving high doses of diuretics. In such patients, caution should be exercised at the beginning of therapy and, if necessary, correction of hypovolemia should be carried out.
Anesthesia and surgery
Hypotension may develop in patients receiving ARB II during general anesthesia and during surgery due to blockade of the renin-angiotensin system. On very rare occasions, cases of severe arterial hypotension may occur, requiring intravenous fluid and/or vasoconstrictor agents.
Aortic and mitral valve stenosis (obstructive hypertrophic cardiomyopathy)
As with other vasodilators, special care should be taken in patients with hemodynamically significant aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy.
Primary hyperaldosteronism
Patients with primary hyperaldosteronism are usually resistant to therapy with antihypertensive medicines that affect the RAAS. Therefore, Candesartan-NAN is not recommended for such patients.
Hyperkalemia
Concomitant use of Candesartan-NAN and potassium-sparing diuretics, potassium preparations, salt substitutes containing potassium, and other medicines that can increase serum potassium levels (e.g. heparin, co-trimaxazole, also known as trimethoprim/sulfamethoxazole) may lead to development of hyperkalemia in patients with arterial hypertension. In such cases it is necessary to control the level of potassium in the blood serum.
Hyperkalemia may develop in patients suffering from heart failure during therapy with Candesartan-NAN. Periodic monitoring of serum potassium levels is recommended. The combination of ACE inhibitors, potassium-sparing diuretics (e.g. spironolactone) and Candesartan-NAN is not recommended and should only be used after a careful assessment of the potential benefits and possible risks.
General instructions
Patients in whom vascular tone and renal function are predominantly dependent on the RAAS activity (e.g. patients with severe congestive heart failure or concomitant kidney disease, including renal artery stenosis), treatment with other medicines that affect this system was accompanied by acute arterial hypotension , azotemia, oliguria and, less commonly, acute renal failure. The possibility of development of these effects cannot be ignored when using ARB II. As with any other antihypertensive medicine, a sharp decrease in blood pressure in patients with coronary heart disease or atherosclerotic cerebrovascular disease can lead to myocardial infarction or stroke.
The antihypertensive effect of Candesartan-NAN may be enhanced by other antihypertensive drugs.
Pregnancy
Taking ARB II is unacceptable during pregnancy. When treated with ARB II, patients planning a pregnancy should switch to alternative treatment with antihypertensive medicines that have a proven safety profile in pregnancy. If pregnancy is diagnosed, ARB II should be discontinued immediately and, if possible, switched to an alternative therapy.
Patients in the post-menarcheal period should be regularly examined for pregnancy. The results of the examination should be taken into account when prescribing antihypertensive therapy in order to prevent the risk of taking ARB II during pregnancy.
Special information on excipients
Candesartan-NAN contains lactose, so it is not recommended for patients with lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome.
Consult your healthcare provider before taking Candesartan-NAN if you have one of the listed diseases or conditions.
The use of ARB II is not recommended in the first trimester of pregnancy and is contraindicated in the second and third trimesters of pregnancy.
Epidemiological data on the risk of teratogenicity when taking ACE inhibitors during the first trimester of pregnancy have not been confirmed. But, nevertheless, such a risk cannot be ignored. There are no data from controlled clinical trials regarding the risk associated with the use of ARBs II. However, such risks may occur with the use of medicines of this class. When treated with ARB II, patients planning pregnancy should switch to alternative treatment with antihypertensive medicines that have a checked safety profile in pregnancy. If pregnancy is diagnosed, ARB II treatment should be stopped immediately and, if possible, switched to alternative therapy. It has been checked that taking ARB II in the second and third trimesters of pregnancy causes fetotoxicity (suppression of kidney function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, arterial hypotension, hyperkalemia). If an ARB II is taken during the second trimester of pregnancy, an ultrasound examination of the kidneys and bones of the fetal skull should be performed. Newborns whose mothers took ARB II should be under close medical supervision due to the possible development of arterial hypotension.
Due to insufficient data on the use of candesartan during lactation, where possible Candesartan-NAN should be replaced by other antihypertensive medicines with checked safety profiles when used during lactation, especially when feeding a newborn or premature baby.
Studies evaluating the effect of Candesartan-NAN on the ability to drive a car and work with mechanisms have not been conducted. When driving vehicles or working with mechanisms, the possibility of dizziness or weakness should be considered.
During the period of treatment, patients must be careful when driving vehicles and engaging in other potentially hazardous activities that require concentration and speed of psychomotor reactions.
8 mg tablets.
25 tablets in a blister pack. 1 blister packs with a patient information leaflet in an outer carton.
30 tablets in a blister pack. 1 blister packs with a patient information leaflet in an outer carton.
16 mg tablets.
15 tablets in a blister pack. 2 blister packs with a patient information leaflet in an outer carton.
25 tablets in a blister pack. 1 blister packs with a patient information leaflet in an outer carton.
32 mg tablets.
10 tablets in a blister pack. 3 blister packs with a patient information leaflet in an outer carton.
15 tablets in a blister pack. 2 blister packs with a patient information leaflet in an outer carton.
Protect from light and moisture. Store at a temperature not exceeding 25°C.
Keep out of the reach of children.
2 years. Do not use after the expiry date.
State enterprise ACADEMPHARM
220141, 5/3 Kuprevicha Street, Minsk, Belarus
Phone / Fax +375 17 268 63 64
production@academpharm.by
To report adverse reactions use the electronic application form on the manufacturer’s website: https://academpharm.by/en