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Sophtensif
Sophtensif
Each tablet contains Indapamide 2,5 mg.

Testimony
Essential hypertension.

Dosage
Orally in the morning on an empty stomach.

Adults - The recommended dose is 2,5 mg daily.
Patients with kidney and liver failure - it is necessary to monitor laboratory performance. In worsening - stopping treatment.

Children - no data on efficacy and safety of indapamid in children under 16 - age is therefore not recommended its use to them.

Contraindications
Hypersensitivity to indapamid to any of the excipients or to sulfonamide containing drugs.

Severe renal insufficiency.

Hepatic encephalopathy or severe hepatic insufficiency.

Relative contraindications: combined administration with products that contain lithium and neantiaritmichni agents that cause torsades de pointes.

Special warnings
Precautions:

Fluid and electrolyte balance: At the beginning of treatment to determine plasma concentrations of sodium and periodically monitored. Treatment with a diuretic - hyponatraemia. It is the monitoring of serum potassium in: the elderly, malnourished and / or polipragmaziya patients, patients with cirrhosis, ascites, edema, coronary artery disease, heart failure, patients with prolonged QT-interval. The risk of secondary hypokalemia, and increased when increasing the dose, rapid diuresis in joint use with kortikosterodi or ACTH, and in patients receiving cardiac glycosides. Determination of plasma potassium should be made one week after beginning treatment. Thiazide and related diuretics may decrease the excretion of calcium. Hypercalcemia may be due to an unspecified hyperparathyroidism - discontinuation of treatment and study of parathyroid function. In high doses or prolonged therapy - hypercalcaemia and hypophosphataemia, which leads to functional changes of parathyroid gland.

Blood sugar. Can manifest latent diabetes. In patients with diabetes may need adjustment of insulin dosage. More frequent monitoring of glucose.

Uric acid. The level of uric acid may increase, but not provoke gout attack. In mild forms of gout strictly monitor the level of uric acid. Should not be appointed by the potassium-losers diuretics, particularly in patients with gout.

Renal function
. At the beginning of treatment with diuretics secondary hypovolemia occurs due to loss of water and sodium, leading to a reduction in glomerular filtration rate - increased to creatinine. This functional renal failure may worsen existing kidney failure.

Warnings
In patients with systemic lupus erythematosus is possible exacerbation of the disease.
May positive results of doping control in athletes.
May increase the susceptibility of patients to sunlight.
Contains lactose - unsuitable for people with lactase deficiency, galactosemia or glucose / galactose malabsorption syndrome.
Contains wheat starch - a danger for people with tsyoliakiya (gluten enteropathy).

Drug Interactions
Contraindicated drug combinations

With lithium salts - slow renal clearance of lithium.
With drugs that can cause torsades de pointes (astemizole, terfenadine and other antihistamines affecting the QT interval), macrolide antibiotics intravenously (erythromicyn); vincamine, bepridil, halofantrine (antimalarien product), pentamidine (antiparasitic agent), sultoprid, carries the risk of seizures arrhythmias.

Drug combinations, a requirement which safeguards

Diuretic and antihypertensive activity - decreased by indomethacin or other NSAIDs, carbenoxolone. To monitor renal function.
Its antihypertensive effect is diminished by glucocorticoids.
With intravenous amphotericin B, corticosteroids, laxatives - the risk of hypokalemia.
In baclofen increases its antihypertensive effect - to monitor renal function.
With digitalis - enhance the toxic effects of digitalis, which is due to hypokalaemia.
With potassium-sparing diuretics (amiloride, spironolactone, triamterene) - hypokalemia
With ACE inhibitors - hypotension and / or acute renal failure. To monitor renal function (serum creatinine).
With antiarrhythmic drugs (sotalol and amiodarone) is required with attention to indapamid appoint - risk of seizure disorders of rhythm, especially in the case of hypokalemia, bradycardia or QT prolongation.
With Metformin and diuretics - to renal dysfunction (lactic acidosis)
Dehydrated patients after use of diuretics - risk of renal failure in iodine-containing contrast agents in high doses.

Interactions that must be taken into account

Neuroleptics, tricyclic antidepressants (imipramine group) potentiate its hypotensive effect, increasing the risk of orthostatic hypotension.
With calcium salts - hypercalcaemia, (reduced renal excretion of calcium).
In other antihypertensive drugs - additive effect - namlyava dose.
With alcohol, barbiturates or general anesthetics - risk of orthostatic hypotension.
May enhance neuromuscular blockade of skeletal muscle relaxants kurarepodobni.
With cyclosporine possible increases of creatinine.

Pregnancy and lactation
Pregnancy - not a risk of fetal hipotrofiya fetoplatsentarna result of ischemia, the occurrence of fetal or neonatal jaundice, thrombocytopenia, and adverse

Breastfeeding - if it is imperative that the adoption of the product is recommended cessation of breastfeeding.

Adverse drug reactions
Tolerated well.

Cardiovascular system - clinical and electrocardiographic changes associated with hypokalemia, prolonged QT interval, arrhythmias (bradycardia, atrial fibrillation), extrasystoles, palpitations, orthostatic hypotension.

CNS - headache, drowsiness or agitation, nervousness, feelings of tension and anxiety, irritability, vertigo, insomnia, depression. Rarely - blurred vision, adinamiya and muscle cramps or spasms associated with hypochloremia and alkalosis.

Gastrointestinal system - nausea, nausea, dry mouth, anorexia, constipation, stomach upset, diarrhea rarely - cholestatic jaundice; extremely rare - pancreatitis, abnormal liver function indicators, single cases of indapamid-induced hepatitis after prolonged treatment. When abnormal liver function thiazides and close in structure to those of diuretics may cause hepatic encephalopathy. In the event of such an application it must immediately be stopped.

Urogenital system - rapid urination, polyuria, nocturia, impotence and reduced libido, very rarely - increased serum urea and creatinine.

Skin and appendages - skin hypersensitivity reactions, rarely accompanied by fever, pruritus, vasculitis syndrome, Stevens-Johnson, pemphigus foliaceus, bullous eruptions, purpura, photosensitivity, svrahpigmentatsiya extremely rare.

Ophthalmic - Acute transitory myopia, photosensitivity, conjunctivitis and rarely xanthopsia.

Hematology - agranulocytosis, leukopenia, thrombocytopenia, aplastic anemia.

Respiratory system
- flu-like symptoms, rhinitis, cough, very rarely, pneumonitis, respiratory distress.

Metabolic and electrolyte disturbances
- hyperthermia, electrolyte and fluid imbalance - hypochloremia, hyponatremia, hypokalemia, hyperuricemia, hypercalcaemia.

Other - necrotizing angiitis, sialadeniti.

Formulation and packaging
Film-coated tablets.

Primary Packaging
15 tablets in a blister of solid, transparent, clear PVC film and aluminum foil.

Secondary packaging

In 2 blisters per carton.

Method of allocation
On prescription.