tablets Amlosartan are applied in essential hypertensia at adult patients whose arterial blood pressure is not regulated by means of monotherapy amlodipiny or valzartany.

Structure

Active ingredients: valsartan and amlodipina besilat;

:

• an amlodipin besilat (in terms of 100% anhydrous substance) - 6.94 mg that is equivalent an amlodipina - 5 mg of a valsartan (in terms of 100% anhydrous substance) - 80 mg;
• an amlodipin besilat (in terms of 100% anhydrous substance) - 6.94 mg that is equivalent an amlodipina - 5 mg of a valsartan (in terms of 100% anhydrous substance) - 160 mg;
• an amlodipin besilat (in terms of 100% anhydrous substance) - 13.88 mg that is equivalent an amlodipina - 10 mg of a valsartan (in terms of 100% anhydrous substance) - 160 mg;

Excipients: microcrystalline cellulose, krospovidon, silicon dioxide colloidal, magnesium stearate;

• a cover for tablets of 5 mg / 80 mg of Opadry II 85F 220,088 Yellow (polyvinyl alcohol, the titan dioxide (E 171), a macrogoal, talc, ferrous oxide yellow (E172), ferrous oxide red (E172));
• a cover for tablets of 5 mg / 160 mg of Opadry AI 85F 220 088 Yellow (polyvinyl alcohol, the titan dioxide (E 171), a macrogoal, talc, ferrous oxide yellow (E172), ferrous oxide red (E172));
• a cover for tablets of 10 mg / 160 mg of Opadry AI 85F 220 087 Yellow (polyvinyl alcohol, the titan dioxide (E 171), a macrogoal, talc, ferrous oxide yellow (E172), ferrous oxide red (E172)).

Contraindication

• hypersensitivity to active substance, derivatives of dihydropyridine or to any of medicament excipients;
• heavy abnormal liver functions, biliary cirrhosis or cholestasia;
• simultaneous use of the antagonists of receptors of angiotensin (ARA), including valsartan, or inhibitors of angiotensin-converting enzyme (APF) with aliskireny to patients with diabetes or with renal failures (SKF <60 mg/minute / 1.73 m ² );
• pregnancy and planning of pregnancy;
• heavy hypotension;
• shock (including cardiogenic shock);
• obstruction of an output path of a left ventricle (for example hypertrophic subaortic stenosis and stenosis of an aorta of heavy degree);
• hemodynamically unstable heart failure after an acute myocardial infarction.

Patients at whom arterial blood pressure is inadequately regulated monomedicament of an amlodipin or a valsartan can be transferred to

to combination therapy by the medicament Amlosartan. The recommended dose - one tablet a day. A pill can be taken irrespective of meal. The medicament is recommended to be taken, washing down it with a small amount of water.

Patients, accepting valsartan and amlodipin separately, it is possible to transfer to Amlosartan which contains the same doses of components.

to

Before transition to a combination of the fixed doses recommends individual selection of a dose with components (that is an amlodipina and a valsartana). In case of clinical need it is possible to consider the possibility of direct replacement of monotherapy by a combination with the fixed doses.

Pregnant

Medicine it is contraindicated to the pregnant women or women planning pregnancy to apply

Feature of use

Children

to treatment of children.

Drivers

patients who use medicament can have a dizziness or feeling of weakness after administration of medicament therefore they have to consider it at control of motor transport and during the work with potentially dangerous mechanisms.

Overdose

Still is absent experience of overdose of the medicament Amlosartan. The main symptom of overdose of a valsartan is probably the profound arterial hypotension with dizziness. The overdose of an amlodipin can lead to the accruing peripheral vazodilatation and probably to reflex tachycardia. It was reported about the considerable and potentially prolonged system hypotension, up to shock and a lethal outcome.

recently, it is necessary to cause vomiting or to wash out a stomach. Absorption of an amlodipin considerably decreases at use of activated carbon at once or within two hours after reception of an amlodipin.

Safety of the medicament Amlosartan was estimated by

during 5 controlled clinical trials with participation of 5175 patients from whom 2613 received valsartan in a combination with amlodipiny. Side reactions which were observed most often or were considerable or heavy: nasopharyngites, flu, hypersensitivity, headache, faint, orthostatic hypotension, hypostases, hypostases of soft tissues, face edemas, peripheral hypostases, increased fatigue, face reddening, asthenia and inflows.

Interaction

Aliskiren. At the patients sick with diabetes, or patients with impaired renal function the risk of emergence of a hyperpotassemia, deterioration in function of kidneys and cardiovascular incidence and mortality increases.

Medicines which cause a hyperpotassemia. Some medicines or therapeutic classes of medicines can cause a hyperpotassemia, namely: aliskiren, potassium salts, kaliysberegayushchy diuretics, APF inhibitors, antagonists of receptors of angiotensin II, non-steroidal anti-inflammatory medicaments (NPVS), heparin, immunosuppressors, such as cyclosporine or takrolimus, Trimethoprimum. The concomitant use of the specified medicines increases risk of emergence of a hyperpotassemia.

to Store

in original packing at a temperature not above 25 °C.

to Store

out of children's reach.

Expiration date - 2 years.