Sumilar capsules are shown for treatment of arterial hypertension at patients whose arterial blood pressure is properly controlled by separate medicaments which are appointed at the same time in the same dose, as in a combination, but in the form of separate tablets.

Structure

Active ingredient: an amlodipin besilat, ramiprit;

: 5 mg / 5 to mg of 6.934 mg of an amlodipin besilat are equivalent to 5 mg of an amlodipin of the free basis and 5 mg of a ramipril or 10 mg / 10 to mg of 13.868 mg of an amlodipin besilat 10 mg of an amlodipin of the free basis, and 10 mg of a ramipril are equivalent, or 10 mg / 5 to mg of 13.868 mg of an amlodipin besilat are equivalent to 10 mg of an amlodipin of the free basis, and 5 mg of a ramipril, or 5 mg / 10 to mg of 6.934 mg of an amlodipin besilat are equivalent to 5 mg of an amlodipin of the free basis, and 10 mg of a ramipril;

Excipients:

• capsule Contents: microcrystalline cellulose, calcium hydrophosphate anhydrous, starch corn corn, starch corn corn (type A) of low humidity, starch sodium, the sodium stearylfumarating;
• Cover of the capsule of 10 mg / 5 mg of 5 mg / 5 mg of 5 mg / 10 mg of the titan dioxide (E 171), gelatin, ferrous oxide red (E172);
• Cover of the capsule of 10 mg / 10 mg iron oxide yellow (E 172), ferrous oxide red (E172), iron oxide black (E172), titan dioxide (E 171), gelatin.

Contraindication

• Simultaneous use of the medicaments containing aliskiren in case of existence at the patient of diabetes or a moderate or heavy renal failure (the glomerular filtration rate (GFR) <60 ml/min. / 1.73 m ² ).
• Quincke's disease in the anamnesis (the hereditary, idiopathic or earlier postponed Quincke's disease at intake of APF inhibitors or antagonists of receptors of angiotensin II).
• Extracorporal treatment which leads to contact of blood with negatively charged surfaces.
• Considerable bilateral stenosis of renal arteries or stenosis of renal arteries of the only kidney.
• Pregnancy or pregnancy planning.
• Hypotensive or hemodynamically unstable states.
• Heavy hypotension.
• Shock (including cardiogenic shock).
• Obstruction of outflow tracts from a left ventricle (for example, an aortal stenosis of heavy degree).
• Hemodynamically unstable heart failure after an acute myocardial infarction.
• Children's age.
• Hypersensitivity to an amlodipin, derivatives of dihydropyridine, a ramipril or the APF (APF) any other inhibitors, or any excipients of drug.
• Combination sakubitril/valsartan increases development of a Quincke's disease.

Route of administration

Recommended daily dose makes one capsule.

Sumilar should be accepted once a day, at the same time day, with food or without food. Capsules should be chewed or crushed.

for initial therapy.

In need of correction of a dose Sumilar's dose or to consider the possibility of individual titration of components of drug. Capsules should be washed down with enough liquid (for example drinking water).

Feature of use

Pregnant

It is contraindicated.

Children

It is contraindicated.

Drivers

Is recommended to be careful, especially in an initiation of treatment and at change of a dosage.

Overdose

Symptoms connected with overdose of APF inhibitors can include excessive expansion of peripheral vessels (from the profound arterial hypotension, shock), bradycardia, an electrolytic imbalance and a renal failure. For the patient it is necessary to establish careful observation. Treatment has to be symptomatic and supporting. The supporting actions include primary detoxication (gastric lavage, intake of absorbents) and measures for restoration of hemodynamic stability, in particular use of agonists of adrenoceptors alfa-1 or angiotensin II (Angiotensinamidum). Ramiprilat, an active metabolite of a ramipril, slightly leaves from general circulation by a hemodialysis.

Side effects

Ramipril.

Most frequent side effects at treatment ramiprily is the hyperpotassemia, a headache, dizziness, hypotension, orthostatic hypotension, a syncope, cough (unproductive cough), bronchitis, sinusitis, an asthma, inflammation of digestive tract, an indigestion, an abdominal pain, dyspepsia, diarrhea, nausea, vomiting, rash, in particular, makulopapulezny, muscular spasms, myalgia, a stethalgia, fatigue. Serious side effects include an agranulocytosis, a pancytopenia, a myocardial infarction, a Quincke's disease, a vasculitis, a bronchospasm, acute pancreatitis, a liver failure, an acute renal failure, hepatitis, exfoliative dermatitis, a toxic epidermal necrolysis, Stephens-Johnson's syndrome and a multiformny erythema.

Amlodipin.

Most frequent side effects at treatment amlodipiny are drowsiness, dizziness, a headache, a cardiopalmus, inflows, an abdominal pain, nausea, hypostases in anklebones, hypostases and fatigue. Serious side effects the leukopenia, thrombocytopenia, a myocardial infarction, fibrillation of auricles, ventricular tachycardia include, a vasculitis, acute pancreatitis, hepatitis, a Quincke's disease, multiformny an erythema, exfoliative dermatitis and Stephens-Johnson's syndrome.

Interaction

Contraindicated simultaneous use of the medicaments containing aliskiren in case of existence at the patient of diabetes or a moderate or heavy renal failure (the glomerular filtration rate (GFR) <60 ml/min. / 1.73 m ² ).

to Store

at a temperature not above 30 °C.

to Store

in original packing.

to Store

out of children's reach.

Expiration date - 3 years.