Sartval plus tablets p/o 160mg/12.5mg №14×2

Name:
Sartval Plus (Valsartan Sandoz Plus) tablets 160 mg / 12.5 mg No. 28 Main active ingredient Valsartan + hydrochlorothiazide Release form tablets Composition Active ingredient: 1 tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide, or 160 mg of valsartan and 12.5 mg of hydrochlorothiazide, or 160 mg of valsartan and 25 mg of hydrochlorothiazide. Excipients: Sartval Plus 80 mg / 12.5 mg: colloidal anhydrous silicon dioxide; crospovidone; hypromellose; magnesium stearate; cellulose microcrystalline; polyethylene glycol 8000; talc; titanium dioxide (E 171); iron oxide red (E 172); iron oxide yellow (E 172); Sartval Plus 160 mg/12.5 mg: colloidal anhydrous silicon dioxide; crospovidone; hypromellose; magnesium stearate; cellulose microcrystalline; polyethylene glycol 8000; talc; titanium dioxide (E 171); iron oxide red (E 172); Sartval Plus 160 mg/25 mg: colloidal anhydrous silicon dioxide; crospovidone; hypromellose; magnesium stearate; cellulose microcrystalline; polyethylene glycol 4000; talc; titanium dioxide (E 171); iron oxide red (E 172); iron oxide yellow (E 172); iron oxide black (E172).
Description:
Sartval Plus 80 mg/12.5 mg: light orange oval tablets, slightly convex, debossed with “HGH” on one side and “CG” on the other side; Sartval Plus 160 mg / 12.5 mg: dark red oval tablets, slightly convex, with inscriptions (embossed) “HHH” on one side and “CG” on the other side; Sartval Plus 160 mg/25 mg: brown-orange oval tablets, slightly convex, debossed with “HXH” on one side and “NVR” on the other side. Indications for use Arterial hypertension. Sartval Plus is indicated for the treatment of hypertension in patients whose blood pressure is not controlled by monotherapy. Contraindications Hypersensitivity to any of the components of Sartval Plus, as well as to other drugs that are derivatives of sulfonamides. Pregnancy, lactation. Severe liver dysfunction, cirrhosis and cholestasis. Anuria, severe renal impairment (creatinine clearance < 30 ml/min). Refractory hypokalemia, hyponatremia, hypercalcemia, symptomatic hyperuricemia. Simultaneous use of angiotensin receptor antagonists, including valsartan, or angiotensin-converting enzyme inhibitors (ACE inhibitors) with aliskiren in patients with type 2 diabetes mellitus or moderate / severe renal insufficiency (GFR < 60 ml / min / 1.73 m2). Use during pregnancy and lactation 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. It is not known whether the drug passes into breast milk. Hydrochlorothiazide crosses the placenta and is also excreted in breast milk. Therefore, it is not recommended to take Sartwal Plus to mothers who are breastfeeding. Dosage and administration The recommended dose of Sartvala 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, or 320 mg of valsartan and 12.5 mg of hydrochlorothiazide may be prescribed. If necessary, 160 mg of valsartan and 25 mg of hydrochlorothiazide or 320 mg of valsartan and 25 mg of hydrochlorothiazide can be prescribed. In case of clinical necessity, in patients whose blood pressure is not controlled by monotherapy with valsartan or hydrochlorothiazide, a transition to combination therapy is possible. In order to reduce the risk of hypotension and other side effects, titration of individual components is recommended, including with increasing doses. The dose may be increased after 1-2 weeks of treatment to a maximum of 320 mg of valsartan and 25 mg of hydrochlorothiazide once a day by increasing the dosage of one of the components. The maximum daily dose is 320 mg of valsartan and 25 mg of hydrochlorothiazide. In most patients, the maximum antihypertensive effect is achieved within 2 to 4 weeks. However, for some patients, 4 to 8 weeks of treatment may be required. This should be taken into account when titrating the dose. Sartval Plus is not recommended as initial therapy in patients with circulating volume deficiency. Sartval Plus can be taken with or without food. The tablet should be taken with a small amount of water. In patients with mild to moderate renal impairment (creatinine clearance> 30 ml / min), dose adjustment is not required. The drug is contraindicated in patients with severe renal insufficiency. In patients with mild or moderate hepatic insufficiency without cholestasis, the dose of valsartan should not exceed 80 mg. The drug is contraindicated in patients with severe hepatic impairment. If the desired therapeutic effect is not observed within 8 weeks of using 320 mg of valsartan and 25 mg of hydrochlorothiazide per day, the use of additional or alternative antihypertensive drugs should be considered. Children Sartval Plus is not recommended for use in children under 18 years of age due to lack of efficacy and safety data. Elderly patients Elderly patients do not require dose adjustment. Side effects The following adverse reactions are classified by organs, systems and frequency of occurrence. Classification of the frequency of occurrence of adverse reactions: very often (? 1/10); often (> 1/100 – 1/10), infrequently (> 1/1000 – 1/100), rarely (> 1/10000 – 1/1000), very rarely (< 1/10000), including single messages, messages with unknown frequency (frequency cannot be estimated based on available data). For each frequency in the group, adverse reactions are arranged in decreasing order of severity. Metabolic disorders Uncommon Dehydration Nervous system disorders Uncommon Very rare Unknown Paresthesia Dizziness Syncope Visual disturbances Uncommon Blurred vision Hearing disturbances Uncommon Tinnitus Cardiovascular disorders Uncommon Hypotension Respiratory system disorders Uncommon Not known Cough Non-cardiogenic pulmonary edema Gastrointestinal disorders Very rare Diarrhea Musculoskeletal disorders Uncommon Very rare Myalgia Arthralgia Renal and urinary disorders Not known Renal function deterioration General disorders Uncommon Fatigue Laboratory effects Not known Increased urinary serum levels acid, creatinine, bilirubin, hypokalemia, hyponatremia, increased blood urea nitrogen, neutropenia The following side effects were noted in clinical trials in patients suffering from their hypertension, regardless of the causal relationship with the study drug: abdominal pain, upper abdominal pain, anxiety, arthritis, asthenia, back pain, bronchitis, acute bronchitis, chest pain, postural dizziness, dyspepsia, shortness of breath, dryness in the mouth, epistaxis, erectile dysfunction, gastroenteritis, headache, increased sweating, hypoesthesia, influenza, insomnia, muscle cramps, sprain, muscle strain, nasal congestion, nasopharyngitis, nausea, neck pain, edema, peripheral edema, otitis media , pain in the extremities, palpitations, pharyngolaryngial pain, pollakiuria, fever, congestion in the paranasal sinuses, sinusitis, drowsiness, tachycardia, upper respiratory tract infections, urinary tract infections, vertigo, viral infections, blurred vision. Additional information regarding components. Sartval Plus may cause adverse reactions previously noted for one of the individual components, even if such reactions were not observed in clinical trials and during post-marketing studies. Valsartan. Side effects obtained as a result of post-marketing and laboratory studies that cannot be classified by frequency: decrease in hemoglobin, decrease in hematocrit, thrombocytopenia, hypersensitivity, including serum sickness, increase in serum potassium concentration, hyponatremia, vasculitis, increased liver function, angioedema, rash, bullous dermatitis, itching, deterioration of renal function. Uncommon: vertigo, abdominal pain. The following additional adverse events were noted in clinical trials in patients with hypertension, regardless of causal relationship with the study drug: arthralgia, asthenia, back pain, diarrhea, dizziness, headache, insomnia, decreased libido, nausea, edema, pharyngitis, rhinitis, sinusitis, upper respiratory infections, viral infections. Hydrochlorothiazide. Very often: an increase in blood lipids (usually when taken in high doses), hypokalemia. Often: hypomagnesemia, hyperuricemia, urticaria and other forms of rash, decreased appetite, nausea, vomiting, orthostatic hypotension, the severity of which increases with alcohol, the use of anesthetics or sedatives, impotence. Rare: hypercalcemia, hyperglycemia, glucosuria and deterioration in diabetic patients, photosensitivity reactions, gastrointestinal discomfort, constipation and diarrhea, cholestasis or jaundice, arrhythmia, headache, dizziness, sleep disturbances, depression, paresthesia, visual disturbances (mainly in the first weeks treatment), thrombocytopenia, sometimes with purpura. Very rare: Hypochloremic alkalosis, necrotizing vasculitis and toxic epidermal necrosis, skin reactions resembling systemic lupus erythematosus, exacerbation of skin manifestations of systemic lupus erythematosus, pancreatitis, leukopenia, agranulocytosis, bone marrow suppression, hemolytic anemia, hypersensitivity reactions - disorders of the respiratory system, including pneumonia and pulmonary edema. Frequency unknown: erythema multiforme, acute angle-closure glaucoma, aplastic anemia, acute renal failure, impaired renal function, fever, asthenia, muscle spasms. Overdose Overdose of valsartan can cause severe hypotension, which, in turn, can lead to depression of consciousness, the development of heart failure and / or hypovolemic shock. In case of an overdose of hydrochlorothiazide, the following signs and symptoms may occur: nausea, drowsiness, hypovolemia, electrolyte imbalance, and as a result, arrhythmias and muscle spasms. Therapeutic measures depend on the duration of the overdose, as well as the type and severity of symptoms, while the primary measure is the normalization of hemodynamics. 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 cannot be removed from the body by hemodialysis due to its binding to plasma proteins, but hemodialysis is effective for removing hydrochlorothiazide from the body. Interaction with other drugs The antihypertensive effect of the drug may be enhanced when taken simultaneously with other antihypertensive drugs. 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 can increase serum potassium levels (heparin, etc.). With the simultaneous appointment of NSAIDs and angiotensin II antagonists, a weakening of the antihypertensive effect may occur. 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. Simultaneous administration of transfer inhibitors (rifampin, cyclosporine) or efflux transporters (ritonavir) may enhance the effect of valsartan. There were no clinically significant interactions during monotherapy with valsartan while taking the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide. Reversible increases in serum lithium levels and toxicity have been reported with concomitant administration of lithium preparations with ACE inhibitors, angiotensin II receptor antagonists, and thiazides. Since thiazides reduce the renal clearance of lithium, it can be assumed that there is an increased risk of lithium toxicity when using Sartvala Plus. Careful monitoring of the concentration of lithium in the blood serum is recommended when they are used simultaneously. Thanks to the thiazide component, which is part of Sartval Plus, the following drug interaction is possible: thiazides potentiate the action of curare derivatives. The use of non-steroidal anti-inflammatory drugs (for example, salicylic acid derivatives, indomethacin) can weaken the diuretic and antihypertensive activity of the thiazide diuretic, which is part of Sartval Plus. Concomitant hypovolemia can lead to the development of acute renal failure. The hypokalemic effect of diuretics can be increased by kaliuretic diuretics, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G, salicylic acid derivatives. When digitalis and thiazide diuretics are taken together, the likelihood of developing arrhythmia increases, since thiazide diuretics can cause hypokalemia and hypomagnesemia. Due to the risk of hypokalemia, hydrochlorothiazide should be used with caution with drugs that can cause torsades de pointes: class Ia antiarrhythmic drugs (eg, quinidine, hydroquinidine, disopyramide), class III antiarrhythmic drugs (eg, amiodarone, sotalol ), some antipsychotics (eg, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, sulpiride, tiapride, pimozide, haloperidol, droperidol), others (eg, bepridil, cisapride, IV erythromycin, halofantrine, ketanserin, mizolastine, pentamidine, sparfloxacin , terfenadine, vincamine intravenously). It may be necessary to adjust the dose of insulin or oral antidiabetic agents. The concomitant administration of thiazide diuretics may increase the frequency of hypersensitivity reactions to allopurinol, increase the risk of adverse reactions caused by amantadine, increase the hyperglycemic effect of diazoxide, and also reduce the renal excretion of cytotoxic drugs (eg, cyclophosphamide, methotrexate) and enhance their myelosuppressive effects. The bioavailability of thiazide diuretics can be increased by anticholinergics (eg, atropine, biperiden), apparently due to a decrease in gastric and intestinal motility and the rate of gastric emptying. There are reports of cases of hemolytic anemia, which occurred with the simultaneous use of hydrochlorothiazide and methyldopa. Absorption of thiazide diuretics slows down cholestyramine. As a result of the simultaneous use of thiazide diuretics and vitamin D or calcium salts, an increase in the concentration of calcium in the blood serum is possible. It is necessary to monitor the electrolyte balance of the blood serum when used together with drugs that cause hyponatremia (for example, antidepressants, antipsychotics, antiepileptics). With simultaneous use with cyclosporins, the risk of hyperuricemia and complications such as gout increases. The simultaneous use of thiazide diuretics with alcohol, barbiturates or drugs can lead to the development of orthostatic hypotension. Double blockade of the renin-angiotensin system (RAS) with angiotensin receptor antagonists, ACE inhibitors or aliskiren. The simultaneous use of angiotensin receptor antagonists, including valsartan, with other substances acting on the RAS 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 Sartval Plus and other substances that affect the RAS. 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 angiotensin receptor antagonists, including valsartan or an ACE inhibitor with aliskiren, is contraindicated in patients with diabetes mellitus or moderate/severe renal insufficiency (GFR < 60 ml/min/1.73 m2). Precautions Changes in electrolyte balance. Caution should be exercised when co-administering Sartval Plus with potassium salts, potassium-sparing diuretics, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (eg, heparin). Cases of hypokalemia have been reported during treatment with thiazide diuretics. It is recommended to control the content of potassium in the blood serum. Treatment with thiazide diuretics is often associated with the occurrence of hyponatremia and hypochloremic alkalosis. Thiazides increase the excretion of magnesium in the urine, which can result in hypomagnesemia. Calcium excretion is reduced by thiazide diuretics, which can lead to hypercalcemia. As with any patient receiving diuretic therapy, periodic monitoring of serum electrolytes is necessary. Patients with a deficiency in the body of sodium and / or circulating blood volume (CBV). In patients with a severe degree of deficiency of sodium and / or circulating blood volume in the body, for example, those receiving high doses of diuretics, in some cases, after the start of therapy with Sartval Plus, symptomatic hypotension may be observed. Therefore, before starting therapy with this drug, it is necessary to correct the sodium content in the body and / or the volume of circulating blood. In case of hypotension, the patient should be placed in a horizontal position and, if necessary, an intravenous infusion of saline should be given. Treatment can be continued immediately after stabilization of blood pressure. Stenosis of the renal artery. Sartval Plus should not be used for the treatment of arterial hypertension in patients with bilateral renal artery stenosis or unilateral stenosis of the artery of a single kidney. blood urea and serum creatinine levels may increase in these patients. Impaired kidney function. In patients with mild or moderate renal insufficiency (creatinine clearance ? 30 ml / min), dose adjustment is not required. Sartval Plus should be taken 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. There is no information on the use of Sartval Plus in patients with kidney transplantation. Impaired liver function. In patients with mild or moderate hepatic insufficiency 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). Sartval Plus should be taken with extreme caution in patients with biliary obstruction and in patients with severe renal insufficiency. Angioedema. Cases of angioedema have been reported, including swelling of the larynx and vocal cords, leading to airway obstruction and / or swelling of the face, lips, pharynx and / or tongue in patients treated with valsartan; some of these patients have previously developed angioedema while taking other drugs, including ACE inhibitors. The drug should be discontinued immediately in patients who develop angioedema and the drug should not be given again. Systemic lupus erythematosus. It has been reported that thiazide diuretics increase or activate the manifestations of systemic lupus erythematosus. Other metabolic disorders. Thiazide diuretics can alter glucose tolerance and increase serum levels of cholesterol, triglycerides, and uric acid. Thiazides can reduce renal calcium excretion and cause a slight increase in serum calcium levels in the absence of calcium metabolism disorders. Severe hypercalcemia may be a sign of 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. General disorders Hypersensitivity reactions to hydrochlorothiazide are most common in patients with allergies or asthma. Acute angle-closure glaucoma As a result of taking hydrochlorothiazide, acute temporary loss of vision and acute angle-closure glaucoma may occur. A risk factor for the development of acute angle-closure glaucoma is an allergy to sulfonamides or penicillins. Heart failure/Post myocardial infarction. As a consequence of the inhibition of the renin-angiotensin-aldosterone system (RAAS), impaired renal function may be observed 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. Stenosis of the aortic and mitral valves, hypertrophic cardiomyopathy. As with the use of other vasodilators, special care should be taken in patients with aortic or mitral stenosis, as well as hypertrophic cardiomyopathy. Double blockade of the renin-angiotensin system (RAS). The 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. Storage conditions Store at a temperature not exceeding 30 ° C, protect from moisture. Keep out of the reach of children. Buy Sartval plus tablets po 160mg/12.5mg No. 14x2 №14х2