Valsartan Plus tablets p/o 80mg/12.5mg №15×2

Name:
Valsartan Plus tablet, p / o, 80 mg / 12.5 mg in a cont cell pack No. 10×3
Description:
Tablets 80 mg / 12.5 mg: round biconvex tablets, coated with a white film. The main active substance Valsartan + hydrochlorothiazide Release formCoated tablets Dosage 80 mg / 12.5 mg Pharmacological action The active substances of the drug are valsartan and hydrochlorothiazide. Both of these active substances help control high blood pressure (hypertension). Valsartan belongs to a class of drugs known as angiotensin II receptor antagonists. Angiotensin II is a substance in the body that causes blood vessels to constrict, thereby increasing blood pressure. Valsartan blocks the action of angiotensin II. As a result, blood vessels relax (dilate) and blood pressure decreases. Hydrochlorothiazide belongs to the group of so-called thiazide diuretics (diuretics). Hydrochlorothiazide increases urine output, which also lowers blood pressure. Valsartan Plus is used to treat high blood pressure that is not sufficiently controlled by one of the other ingredients, valsartan or hydrochlorothiazide. High blood pressure puts more stress on the heart and arteries. If left unchecked, blood vessels in the brain, heart, and kidneys can be damaged, leading to stroke, heart failure, or kidney failure. High blood (blood) pressure increases the risk of heart attacks. Reducing blood pressure to normal reduces the risk of developing these disorders. Indications for use Treatment of essential hypertension in adults. Valsartan Plus is indicated for use in patients whose blood pressure is not adequately controlled by valsartan or hydrochlorothiazide monotherapy. If you have any doubts or questions, please consult your doctor. Dosing and Administration Tablets are taken orally, without chewing, with a sufficient amount of water, regardless of the meal. The recommended dose of Valsartan Plus is 1 tablet per day. Depending on clinical parameters, a dosage of 80 mg of valsartan and 12.5 mg of hydrochlorothiazide or 160 mg of valsartan and 12.5 mg of hydrochlorothiazide may be prescribed. If necessary, 160 mg of valsartan and 25 mg of hydrochlorothiazide can be prescribed. Dose titration of the individual components is recommended. In each case, it is necessary to control the titration with an increase in the dose of individual components in order to reduce the risk of hypotension and other side effects. If clinically warranted, a direct switch from monotherapy to a fixed-dose combination may be considered in patients whose blood pressure is not adequately controlled by valsartan or hydrochlorothiazide alone, provided that the recommended dose titration sequence for the individual components is followed. If blood pressure remains uncontrolled when assessing clinical parameters, then the dose may be increased by increasing the maximum dose of any or each of the active substances to 320 mg / 25 mg. The antihypertensive effect is achieved within 2 weeks. In most patients, the maximum antihypertensive effect is achieved within 4 weeks. However, for some patients, 4-8 weeks of treatment may be required. This should be taken into account when titrating the dose. Special groups of patients Patients with impaired renal function Dose adjustment is not required in patients with mild to moderate renal insufficiency (GFR> 30 ml / min / 1.73 m2), dose adjustment is not required. The drug is contraindicated in patients with severe renal insufficiency (GFR <30 ml / min / 1.73 m2) and anuria, since it contains hydrochlorothiazide. The simultaneous use of valsartan with aliskiren is contraindicated in patients with moderate / severe renal insufficiency (GFR <60 ml / min / 1.73 m2) (see section "Contraindications"). Patients with diabetes The simultaneous use of valsartan with aliskiren is contraindicated in patients with diabetes (see section "Contraindications"). Patients with impaired liver function In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg. Dose modification of hydrochlorothiazide is not required in patients with mild to moderate hepatic impairment. The drug Valsartan Plus is contraindicated in patients with severe hepatic impairment, biliary cirrhosis and patients with cholestasis, because it contains valsartan. Children The drug Valsartan Plus is not recommended for use in children under 18 years of age due to the lack of data on efficacy and safety. Elderly patients Elderly patients do not need to change the dose of Valsartan Plus. If you have any doubts or questions, please consult your doctor. Use during pregnancy and lactation Pregnancy Angiotensin II receptor antagonists are not recommended during the first trimester of pregnancy and are contraindicated in the second and third trimesters of pregnancy. Epidemiological data have shown an increased risk of teratogenic effects with the use of ACE inhibitors in the first trimester of pregnancy. A similar risk may also exist when taking angiotensin II receptor antagonists. In patients planning a pregnancy, if necessary, an alternative antihypertensive treatment that has an established safety profile for use during pregnancy should be prescribed. When pregnancy is detected, treatment with angiotensin II receptor antagonists should be stopped immediately and, if necessary, alternative treatment should be initiated. It is known that exposure to angiotensin II receptor antagonists in the second and third trimesters causes fetotoxicity (decreased renal function, oligohydramnios, delayed skull ossification) and neonatal toxicity (renal failure, arterial hypotension, hyperkalemia). If a woman took angiotensin II receptor antagonists in the second trimester of pregnancy, ultrasound monitoring of kidney and fetal skull function is necessary. Newborns whose mothers have taken angiotensin II receptor antagonists should be closely monitored because of possible hypotension. There is limited experience with the use of hydrochlorothiazide during pregnancy, especially during the first trimester. Animal studies are insufficient. Hydrochlorothiazide crosses the placenta. Based on the pharmacological mechanism of action of hydrochlorothiazide, its use in the second and third trimesters of pregnancy may impair fetoplacental perfusion and lead to fetal and neonatal effects such as jaundice, electrolyte imbalance and thrombocytopenia. Lactation period It is not known whether the drug passes into breast milk. Hydrochlorothiazide crosses the placenta and is also excreted in breast milk. Therefore, Valsartan Plus is not recommended for breastfeeding mothers. Children The safety and efficacy of Valsartan Plus in children have not been established. Influence on the ability to drive vehicles or potentially dangerous mechanisms No studies have been conducted to evaluate the effect of the drug Valsartan Plus on the ability to drive a car and work with mechanisms. When driving vehicles or working with mechanisms, the possibility of dizziness or weakness should be considered. As with the appointment of other antihypertensive drugs, care must be taken when driving and working with moving mechanisms. Precautions Talk to your doctor before taking this medicine if you have had skin cancer or have an unexpected skin lesion during treatment. The use of hydrochlorothiazide, especially long-term use of high doses, may increase the risk of developing certain types of skin and lip cancer (non-melanoma skin cancer). If you are taking hydrochlorothiazide, you must protect your skin from exposure to sunlight and ultraviolet rays. Changes in electrolyte balance It is not recommended to co-administer valsartan with potassium preparations, salt substitutes containing potassium, potassium-sparing diuretics or other drugs that can increase the concentration of potassium in the blood serum (heparin, etc.). Cases of hypokalemia have been reported during treatment with thiazide diuretics. It is recommended to control the level of potassium in the blood serum. Treatment with thiazide diuretics is often associated with the occurrence of hyponatremia and hypochloremic alkalosis. Thiazides, including hydrochlorothiazide, increase the excretion of magnesium in the urine, which can lead to the development of hypomagnesemia. Thiazides reduce urinary calcium excretion, which can lead to the development of hypercalcemia. Periodic monitoring of the concentration of electrolytes in the blood serum is recommended. Patients with sodium deficiency and / or reduced circulating blood volume (CBV) In patients with severe sodium deficiency and / or reduced BCC, for example, receiving high doses of diuretics, in rare cases, symptomatic hypotension may occur at the beginning of treatment with Valsartan Plus. Before starting treatment, it is necessary to correct the content of sodium and / or BCC in the body. Heart failure/Post myocardial infarction As a consequence of inhibition of the renin-angiotensin-aldosterone system (RAAS), impaired renal function may occur in hypersensitive individuals. In patients with severe heart failure, in whom renal function depends on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors or angiotensin receptor antagonists could cause oliguria and / or progressive azotemia, acute renal failure (rarely) and / or death. Evaluation of patients with heart failure or in the post-MI state should always include monitoring of renal function. Renal artery stenosis Valsartan Plus should not be used to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. it is possible to increase the concentration of urea in the blood and the concentration of creatinine in the blood serum in these patients. Primary hyperaldosteronism Valsartan Plus is not recommended for patients with primary hyperaldosteronism because their renin-angiotensin system is inactive. Aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special care should be taken when using Valsartan Plus in patients with aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy. Impaired renal function In patients with mild or moderate renal insufficiency (creatinine clearance> 30 ml / min), dose adjustment is not required. Valsartan Plus should be used with caution in patients with severe renal insufficiency (creatinine clearance <30 ml/min) due to the content of hydrochlorothiazide in the formulation. Thiazide diuretics may precipitate the development of azotemia in patients with chronic kidney disease. They are not effective as monotherapy in severe renal impairment, but may be useful when used with due caution in conjunction with loop diuretics, even in patients with creatinine clearance <30 ml/min. Kidney transplantation There are currently no data on the safety of using Valsartan Plus in patients who have recently undergone kidney transplantation. Impaired liver function In patients with mild or moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg. The maximum dose in these patients is one 80 mg/12.5 mg tablet (80 mg valsartan and 12.5 mg hydrochlorothiazide). Valsartan Plus should be taken with extreme caution in patients with biliary obstruction and in patients with severe renal insufficiency. Thiazide diuretics should be used with caution in patients with impaired hepatic function or advanced liver disease, as mild hypovolemia and electrolyte imbalance may precipitate hepatic coma. History of angioedema Angioedema, including laryngeal and glottic edema leading to airway obstruction and/or swelling of the face, lips, pharynx and/or tongue, has been reported in patients treated with valsartan. Some of these patients had a history of developing angioedema after taking other drugs, including ACE inhibitors. In the event of angioedema, patients should immediately stop taking the drug Valsartan Plus, its re-appointment is not allowed. Systemic lupus erythematosus Thiazide diuretics have been reported to exacerbate or activate manifestations of systemic lupus erythematosus. Other metabolic disorders Thiazide diuretics, including hydrochlorothiazide, may cause changes in glucose tolerance and increase in serum cholesterol, triglycerides and uric acid. Patients with diabetes may need to adjust the dose of insulin or oral hypoglycemic agents. Thiazides can reduce the excretion of calcium ions in the urine and cause a temporary and slight increase in serum calcium concentration. Severe hypercalcemia may be a symptom of latent hyperparathyroidism. Before conducting a study of the function of the parathyroid glands, thiazides should be discontinued. When taking thiazide diuretics, cases of photosensitivity reactions have been reported. If these reactions occur, it is recommended to stop treatment. If resumption of intake is necessary, it is recommended to avoid exposure to sunlight and artificial ultraviolet rays. Patients with primary hyperaldosteronism are not recommended to take valsartan. Photosensitivity Taking thiazide diuretics can provoke the development of photosensitivity reactions. If a photosensitivity reaction develops, it is recommended to stop treatment with Valsartan Plus. If it is necessary to take diuretics again, it is recommended to protect exposed skin from sunlight and UV radiation. General disorders Caution should be exercised in patients with hypersensitivity to other angiotensin II receptor antagonists. Hypersensitivity reactions to hydrochlorothiazide are most common in patients with allergies or asthma. Acute angle-closure glaucoma Hydrochlorothiazide, being a sulfonamide derivative, can cause an idiosyncratic reaction in the form of acute transient myopia and acute angle-closure glaucoma. Symptoms of these disorders include an unexpected decrease in visual acuity or pain in the eyes, which occur within a few hours to several weeks after the start of the drug. If left untreated, acute angle-closure glaucoma can lead to vision loss. If these symptoms appear, the drug should be discontinued. If intraocular pressure remains uncontrolled, urgent conservative or surgical treatment may be required. Risk factors for the development of acute angle-closure glaucoma may include a history of allergy to sulfonamides or penicillin. Dual blockade of the RAAS Co-administration of angiotensin receptor antagonists, including valsartan, with an ACE inhibitor or aliskiren should be avoided, especially in patients with diabetic nephropathy. In some cases, when the combined use of ACE inhibitors and angiotensin receptor antagonists is absolutely indicated, careful observation of a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. This applies to the appointment of valsartan as an adjunctive therapy to an ACE inhibitor in patients with chronic heart failure with intolerance to aldosterone antagonists (spironolactone), who have persistent symptoms of chronic heart failure, despite other adequate therapy. Auxiliary components The drug contains sodium in an amount of less than 1 mmol (23 mg) per dose, i.e. practically "sodium-free". Interactions with other drugsAlways tell your doctor what medicines you are taking or have recently taken, even if they are over-the-counter medicines. Interactions related to valsartan and hydrochlorothiazide Concomitant use is not recommended Lithium: a reversible increase in serum lithium concentration and an increase in toxicity have been reported when used simultaneously with ACE inhibitors, angiotensin II receptor antagonists and thiazides. The experience of the simultaneous use of valsartan and lithium preparations is limited, therefore it is not recommended to combine these drugs. If the simultaneous administration of these drugs is necessary, careful monitoring of serum lithium concentrations is recommended. Simultaneous use requiring caution Other antihypertensive drugs: the drug Valsartan Plus may enhance the effect of other antihypertensive drugs (guanethidine, methyldopa, vasodilators, ACE inhibitors, beta-blockers, calcium channel blockers). Sympathomimetics (adrenaline, norepinephrine): possible weakening of the therapeutic response to sympathomimetics. Non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (COX-2), acetylsalicylic acid (more than 3 g / day) and other non-selective NSAIDs: with simultaneous administration, a weakening of the antihypertensive effect is possible. In addition, in elderly patients, malnourished (including those on diuretic therapy), or with impaired renal function, the simultaneous use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening renal function. Thus, monitoring of renal function is recommended when initiating or making changes to valsartan therapy in patients taking NSAIDs concomitantly. Interactions that occur during treatment with individual active components of the drug may also occur during treatment with this drug. Interactions related to valsartan Dual blockade of the renin-angiotensin-aldosterone system (RAAS) by ARB II, ACE inhibitors or aliskiren: the simultaneous use of angiotensin receptor antagonists, including valsartan, with other substances acting on the RAAS is associated with an increase in the incidence of hypotension, hyperkalemia, and changes in renal function compared with monotherapy. It is recommended to monitor blood pressure, kidney function and electrolyte levels in patients using the drug Valsartan Plus and other substances that affect the RAAS. Based on the available data, dual blockade of the RAAS with ACE inhibitors, angiotensin receptor antagonists, or aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy. Concomitant use of ARBs II, including valsartan, or ACE inhibitors with aliskiren is contraindicated in patients with diabetes mellitus or moderate/severe renal insufficiency (GFR <60 ml/min/1.73 m2). Use of potassium-sparing diuretics, potassium-sparing diuretics and salt substitutes containing potassium is not recommended: caution and monitoring of serum potassium levels is required when using this drug with potassium salts, potassium-sparing diuretics, salt substitutes containing potassium, or with other drugs that may increase serum potassium level (heparin, etc.). Transporters: In vitro data indicate that valsartan is a substrate for the OATP1B1/OATP1B3 and MRP2 transport proteins. Simultaneous use with inhibitors of OATP1B1 / OATP1B3 carrier proteins (rifampicin, cyclosporine) or the efflux carrier protein MRP2 (ritonavir) may increase systemic exposure and enhance the effect of valsartan. Special precautions should be taken at the beginning or end of co-therapy with these medicinal products. Others: no clinically significant interactions with drugs such as cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine and glibenclamide have been identified. Interactions related to hydrochlorothiazide Concomitant use requiring caution Drugs that affect the level of potassium in the blood: the hypokalemic effect of the diuretic may be enhanced by concomitant use of other kaliuretic diuretics, corticosteroids, laxatives, adrenocorticotropic hormone, amphotericin, carbenoxolone, penicillin G, salicylic acid and salicylates), it is recommended to regularly monitor the concentration of potassium in the plasma. Drugs that cause cardiac arrhythmias: Due to the risk of hypokalemia, caution should be exercised with the simultaneous use of drugs that cause cardiac arrhythmias of the "torsades de pointes" type: class 1a antiarrhythmic drugs (for example, quinidine, hydroquinidine, disopyramide), class III antiarrhythmic drugs (eg, amiodarone, sotalol), some antipsychotics (eg, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, sulpiride, tiapride, pimozide, haloperidol, droperidol), other drugs (eg, bepridil, cisapride, intravenous erythromycin, halofantrine, ketanserin, mizolastine, pentamidine, sparfloxacin, terfenadine, vincamine intravenously). Medicines affecting blood sodium levels: The hyponatraemic effect of diuretics may be enhanced when used concomitantly with certain medicines such as antidepressants, antipsychotics and antiepileptics. Caution is advised in the long-term use of these medicinal products. Cardiac glycosides: Hypokalemia and hypomagnesemia caused by taking thiazide diuretics contribute to the development of cardiac arrhythmias when taking cardiac glycosides. Calcium salts and vitamin D: The use of thiazide diuretics, including hydrochlorothiazide, with vitamin D or calcium salts can lead to an increase in serum calcium concentration and the development of hypercalcemia in patients with a predisposition (for example, with hyperparathyroidism) due to increased tubular reabsorption of calcium. Antidiabetic agents (oral hypoglycemic agents and insulin): Thiazides may impair glucose tolerance. When using thiazide diuretics, dose adjustment of antidiabetic agents may be required. Caution should be exercised when using metformin, because. it is possible to develop lactic acidosis due to the development of functional renal failure while taking hydrochlorothiazide. Medicines for the treatment of gout (probenecid, sulfinpyrazone and allopurinol): dose adjustment of medicines for the treatment of gout may be required due to the possible increase in serum uric acid concentrations of hydrochlorothiazide. If necessary, increase the dose of probenecid or sulfinpyrazone. The simultaneous use of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol. Anticholinergics and other drugs that affect gastrointestinal motility: Anticholinergics (atropine, biperiden) may increase the bioavailability of thiazide diuretics, apparently due to inhibition of gastrointestinal motility and a decrease in the rate of gastric emptying. Conversely, prokinetics such as cisapride may decrease the bioavailability of thiazide diuretics. Amantadine: Thiazide diuretics may increase the risk of adverse effects of amantadine. Ion exchange resins: The absorption of hydrochlorothiazide is impaired in the presence of cholestyramine and colestipol. It is recommended to take hydrochlorothiazide 4 hours before or 4-6 hours after taking ion exchange resins. Cytotoxic agents: hydrochlorothiazide may reduce the renal excretion of cytotoxic drugs (cyclophosphamide, methotrexate) and potentiate their myelosuppressive effect. Non-depolarizing muscle relaxants (tubocurarine): Hydrochlorothiazide potentiates the action of curare-like muscle relaxants. Cyclosporine: when used simultaneously with cyclosporine, the risk of developing hyperuricemia and complications such as gout increases. Alcohol, barbiturates and narcotic drugs: the combined use of thiazide diuretics with substances that have an antihypertensive effect may increase the risk of orthostatic hypotension. Methyldopa: isolated cases of hemolytic anemia have been reported in patients receiving hydrochlorothiazide and methyldopa concomitantly. Iodine-containing contrast agents: with dehydration caused by the use of thiazide diuretics, there is an increased risk of developing acute renal failure, especially when using high doses of iodine-containing drugs. Patients require rehydration prior to administration of iodine-containing drugs. Contraindications Hypersensitivity to valsartan, hydrochlorothiazide, sulfonamides or any other component of the drug; pregnancy and lactation; severe liver dysfunction, biliary cirrhosis and cholestasis; anuria, severe renal failure (GFR <30 ml / min / 1.73 m2) ; refractory hypokalemia, hyponatremia, hypercalcemia and symptomatic hyperuricemia; simultaneous use of ARA II (angiotensin II receptor antagonists), including valsartan, or ACE inhibitors with aliskiren in patients with diabetes mellitus or moderate / severe renal insufficiency (GFR <60 ml / min / 1 ,73 m2). Composition One tablet of the drug Valsartan Plus 80 mg / 12.5 mg contains: active substances: valsartan - 80 mg, hydrochlorothiazide - 12.5 mg; excipients: sodium starch glycolate (type A), sodium stearyl fumarate, crospovidone (type B), anhydrous colloidal silicon dioxide, microcrystalline cellulose, calcium hydrogen phosphate dihydrate; shell composition: white opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol 4000 / PEG, talc). OverdoseSymptoms: An overdose of valsartan can cause severe hypotension, which in turn can lead to impaired consciousness, circulatory collapse and/or shock. With an overdose of hydrochlorothiazide, nausea, drowsiness, hypovolemia, electrolyte imbalance, accompanied by cardiac arrhythmias and muscle spasms, may develop. Treatment: therapeutic measures depend on the duration of the overdose, as well as the type and severity of symptoms, while the primary measure is the stabilization of the cardiovascular system. In case of overdose, depending on the time elapsed after taking the drug, the measures taken should include induction of vomiting, gastric lavage and / or activated charcoal. In case of hypotension, the patient should be placed in a horizontal position and immediately ensure the restoration of the water-salt balance by injecting isotonic saline. Valsartan is not excreted by hemodialysis due to its strong binding to plasma proteins, however, hemodialysis is effective for removing hydrochlorothiazide from the body. Side effects Listed below are side effects for which a possible association with the use of valsartan in combination with hydrochlorothiazide has been recognized. Classification of the incidence of side effects: very often? 1/10, often from? 1/100 to <1/10, infrequently from? 1/1000 to <1/100, rarely from? 1/10,000 to < 1/1,000, very rare < 1/10,000, frequency unknown (cannot be estimated from available data). Metabolic and nutritional disorders: infrequently - dehydration. Nervous system disorders: infrequently - paresthesia; very rarely - dizziness; the frequency is unknown - fainting (when used after myocardial infarction). On the part of the organ of vision: infrequently - blurred vision. On the part of the organ of hearing: infrequently - tinnitus. Vascular disorders: infrequently - hypotension. Respiratory, thoracic and mediastinal disorders: infrequently - cough; frequency unknown - non-cardiogenic pulmonary edema. Disorders from the gastrointestinal tract (GIT): very rarely - diarrhea. Musculoskeletal and connective tissue disorders: infrequently - myalgia; very rarely - arthralgia. Renal and urinary disorders: frequency unknown - impaired renal function. General disorders and disorders at the injection site: infrequently - increased fatigue. Influence on the results of laboratory and instrumental studies: the frequency is unknown - an increase in the concentration of uric acid, creatinine and bilirubin in serum, hypokalemia, hyponatremia, an increase in the content of urea nitrogen in the blood, neutropenia. Adverse events previously noted with the use of each of the components may occur with the use of the drug Valsartan Plus, even if they were not observed in clinical studies. Valsartan The following adverse events have been reported with valsartan monotherapy. On the part of the blood and lymphatic system: the frequency is unknown - a decrease in the concentration of hemoglobin and hematocrit, thrombocytopenia. Immune system disorders: frequency unknown - hypersensitivity reactions, including serum sickness. Metabolic and nutritional disorders: the frequency is unknown - an increase in the concentration of potassium in the blood serum, hyponatremia. Hearing disorders: infrequently - vertigo. Vascular disorders: frequency unknown - vasculitis. Gastrointestinal disorders: infrequently - abdominal pain. Liver and biliary tract disorders: frequency unknown - an increase in indicators characterizing liver function. Skin and subcutaneous tissue disorders: frequency unknown - angioedema, skin rash, pruritus. Renal and urinary tract disorders: frequency unknown - renal failure. Hydrochlorothiazide The following adverse events have been reported with hydrochlorothiazide monotherapy. Blood and lymphatic system disorders: rarely - thrombocytopenia (sometimes with purpura); very rarely - agranulocytosis, leukopenia, hemolytic anemia, depression of bone marrow function; frequency unknown - aplastic anemia. Immune system disorders: very rarely - hypersensitivity reactions. Metabolic and nutritional disorders: very often - hypokalemia, increased blood lipid levels (mainly when taking high doses of the drug); often - hyponatremia, hypomagnesemia, hyperuricemia; rarely - hypercalcemia, hyperglycemia, glucosuria and worsening of the state associated with metabolism in patients with diabetes; very rarely - hypochloremic alkalosis. Mental disorders: rarely - depression, sleep disorder. Nervous system disorders: rarely - headache, dizziness, paresthesia. On the part of the organ of vision: rarely - visual impairment; frequency unknown - acute angle-closure glaucoma. Cardiac disorders: rarely - arrhythmia. Vascular disorders: often - orthostatic hypotension. Respiratory, thoracic and mediastinal disorders: Very rare Respiratory disorders including pneumonia and pulmonary edema. Gastrointestinal disorders: often - loss of appetite, nausea, vomiting; rarely - constipation, discomfort in the gastrointestinal tract, diarrhea; very rarely - pancreatitis. Liver and biliary tract disorders: rarely - intrahepatic cholestasis or jaundice. Renal and urinary disorders: frequency unknown - impaired renal function, acute renal failure. Skin and subcutaneous tissue disorders: often - urticaria and other forms of rash; rarely - photosensitivity reactions; very rarely - necrotizing vasculitis, toxic epidermal necrolysis (Lyell's syndrome), skin reactions resembling systemic lupus erythematosus (SLE), exacerbation of skin manifestations of SLE; frequency unknown - erythema multiforme. General disorders and disorders at the injection site: the frequency is unknown - fever, asthenia. Musculoskeletal and connective tissue disorders: frequency unknown - muscle spasms. Violations of the genital organs and mammary gland: often - erectile dysfunction. Benign, malignant and unspecified neoplasms (including cysts and polyps): frequency unknown - cancer of the skin and lips (non-melanoma skin cancer). In the event of adverse reactions, including those not listed in this leaflet, you must stop taking the drug and consult a doctor. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Valsartan Plus tablets p/o 80mg/12.5mg No. 15x2 №15х2