"Tiara Solo" is used in the treatment of arterial hypertension in adults and children from 6 years of age. Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after recent (12:00 - 10 days) myocardial infarction. Treatment of symptomatic heart failure in adult patients when ACE inhibitors cannot be used, or as adjunctive therapy with ACE inhibitors when β-blockers cannot be used.
Active substance: valsartan;
1 tablet contains valsartan 80 mg or 160 mg
Excipients: microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, opadry II 85F pink.
Hypersensitivity to valsartan or to an excipient.
Pregnancy or planning a pregnancy.
Congenital angioedema or such that developed during previous treatment with an ACE inhibitor or angiotensin II receptor antagonist.
Concomitant use of angiotensin receptor antagonists, including valsartan, or ACE inhibitors with aliskiren in patients with diabetes mellitus (type I or II) or impaired renal function (glomerular filtration rate (GFR) <60 ml / min).
There are no data on patients with severe renal impairment (creatinine clearance less than 10 ml / min).
Severe liver dysfunctions, biliary cirrhosis and cholestasis.
The preparation can be taken with or without food, the tablets should be taken with water.
Pregnancy
Angiotensin II receptor antagonists are contraindicated during pregnancy. If continued treatment with a preparation is considered necessary, patients planning a pregnancy should replace the preparation with alternative antihypertensive preparations with an established safety profile for use during pregnancy. If pregnancy is confirmed, treatment should be discontinued immediately and alternative therapy should be initiated if necessary.
Children
Caution is recommended with the simultaneous use of valsartan and other preparations that inhibit the RAAS, which can increase the level of potassium in the blood serum, in children and adolescents with arterial hypertension. Renal function and serum potassium levels should be closely monitored.
Drivers
Studies on the effect on the ability to drive vehicles and work with mechanisms have not been carried out. It should be borne in mind that dizziness or weakness may occur during treatment with this preparation.
There may be increased symptoms of side effects, a feeling of intense heat and burning. In case of accidental oral administration, abdominal pain, nausea, vomiting, diarrhea, headache, symptoms of central nervous system depression, dizziness, ataxia, convulsions, hot flashes, drowsiness, difficulty breathing, reflex respiratory arrest are possible.
The preparation usually does not have a systemic toxic effect when the recommended dose of the preparation is exceeded, however, excessive external use over large areas can potentially cause toxic symptoms, such as nephrotoxicity, disorders of the central nervous system (immediately after the use of camphor).
If the preparation accidentally gets into the nose or face of infants and children, apnea may occur due to spasm of the glottis (laryngospasm), this is a medical emergency.
Adverse Reactions
During controlled clinical trials in adult patients with arterial hypertension, the frequency of adverse reactions when using placebo corresponded to that when using valsartan. It turned out that the incidence of adverse reactions is not related to the dose or duration of treatment, and also does not depend on the gender, age or race of the patient.
The simultaneous use of ARB preparations, including valsartan, with other preparations acting on the RAAS, is associated with an increase in the incidence of arterial hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared with monotherapy. Dual blockade of RAAS due to the combined use of ACE inhibitors, ARBs, or aliskiren is therefore not recommended. If therapy with a double blockade of the RAAS is considered necessary, it should be carried out only under the supervision of a specialist and subject to careful monitoring of renal function, electrolyte levels and blood pressure.
The simultaneous use of angiotensin receptor antagonists, including valsartan, or ACE inhibitors with aliskiren in patients with diabetes mellitus or impaired renal function (FGF <60 ml / min) is contraindicated.
Concomitant use of ARBs, including valsartan, or ACE inhibitors with aliskiren is contraindicated in patients with type I and II diabetes.
ACE inhibitors, including valsartan, and ARBs should not be used concomitantly in patients with diabetic nephropathy.
Store in its original packaging at a temperature not exceeding 25 ° C. Do not freeze. Keep out of the reach of children.
Shelf life is 2 years.
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