Название документа

Tablets "Perindopres ® And" are applied in arterial hypertension and/or coronary heart disease (if treatment perindoprily and amlodipiny is necessary).

Structure

One tablet contains (active ingredients):

  • a perindopril rubs - butylamine - 4 mg (that corresponds to 3.338 mg of a perindopril);
  • an amlodipin of the besilat - 6.935 mg (that corresponds to 5 mg of an amlodipin).

Excipients: lactose monohydrate, cellulose microcrystalline, silicon dioxide colloidal hydrophobic, magnesium stearate.

Contraindication

  • hypersensitivity to a perindopril (or to the APF any other inhibitors), to an amlodipin (or to dihydropyridine derivatives) or to any excipient;
  • Quincke's disease in the anamnesis connected with the previous treatment by APF inhibitors;
  • congenital or idiopathic Quincke's disease;
  • heavy arterial hypotension;
  • shock, including cardiogenic shock;
  • obstruction of an exit from a left ventricle (for example, a stenosis of an aorta of heavy degree);
  • heart failure after an acute myocardial infarction with an unstable hemodynamics;
  • pregnant women or women who are going to become pregnant;
  • simultaneous use with medicaments which contain active ingredient aliskiren, to patients with diabetes or a renal failure (glomerular filtration rate <60 ml/minute / 1.73 m 2 );
  • simultaneous use with sakubitrilom/valzartany;
  • extracorporal methods of treatment which lead to contact of blood with negatively charged surfaces;
  • a considerable bilateral stenosis of renal arteries or a stenosis of an artery of the only functioning kidney.

Route of administration

For oral administration.

Adult should appoint

on one tablet a day once, it is desirable in the morning before food. The tablet is not subject to the section.

Dose should be selected individually for each patient taking into account indications for use, a course of the disease and indicators of arterial blood pressure.

Maximum daily dose - one tablet "Perindopres ® And" 8 mg / 10 mg a day.

Patients with renal failures and patients of advanced age. Removal of the perindoprilat decreases at patients with a renal failure and at patients of advanced age therefore during treatment it is necessary to carry out regular control of level of creatinine and potassium.

"Perindopres ® And" patients can appoint by

with clearance of creatinine ≥ 60 ml/minute and it is not necessary to appoint to patients with clearance of creatinine <60 ml/minute. Individual selection of a dose of each of medicine components separately is recommended to such patients.

At good tolerance the dose of an amlodipin is identical to patients of young and advanced age. For patients of advanced age the usual mode of dosing is recommended, but increase in a dose needs to be carried out with care.

Concentration of an amlodipin in blood plasma does not depend on degree of a renal failure.

Amlodipin is not brought by

at dialysis.

Patients with abnormal liver functions. There are no recommendations about dosing for patients with slight and moderate abnormal liver functions therefore selection of a dose has to be careful, it is necessary to begin with the lowest doses. For the choice of an optimum initial and maintenance dose of medicine the patients with abnormal liver functions need to select a dose of an amlodipin and a perindopril separately. Researches of pharmacokinetics of an amlodipin at patients with heavy abnormal liver functions were not conducted. Patients with abnormal liver functions of heavy degree should begin reception of an amlodipin with low doses and to raise gradually.

to

Pregnant

to

medicine Use "Perindopres ® And" is contraindicated to

Feature of use

during pregnancy and it is not recommended to use during feeding by a breast. In case of need medicine uses feeding by a breast should be stopped.

Children

Drug children are not recommended to appoint

due to the lack of researches with the assistance of this group of patients.

Drivers

"Perindopres ® And" on ability to run vehicles and to work with mechanisms were not carried out by

Research about medicine influence. Amlodipin can have insignificant or moderate impact on ability to run vehicles and to work with mechanisms. Disturbance of reaction of the driver in case of developing of dizziness, a headache, weakness, fatigue or nausea is possible. It is recommended to be careful, especially in an initiation of treatment.

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Overdose

by

About medicine overdose cases "Perindopres ® And" it was not reported. Data on conscious overdose of an amlodipin are limited.

Symptoms

Available data allow to assume

that reception of very high doses can lead to an excessive peripheral vazodilatation and probable developing of reflex tachycardia. It was reported about expressed, perhaps, long system hypotension and shock with a lethal outcome.

Treatment

Clinically apparent hypotension caused by overdose of an amlodipin demands the active cardiovascular help, in particular frequent monitoring of function of heart and respiratory function, granting horizontal position to the patient with the raised lower extremities, and demands attentive observation of volume of the circulating blood and a mocheotdeleniye.

Purpose of a vasoconstrictor can be useful in restoration of a tone of vessels and arterial blood pressure if there are no contraindications. Administration of calcium of a gluconate can help elimination of consequences of blockade of calcium channels.

gastric lavage is In certain cases appropriate

. The research on healthy volunteers showed that intake of activated carbon in 2 hours after reception of 10 mg of an amlodipin reduces the speed of absorption of an amlodipin in an organism. In system blood circulation amlodipin has the high level of linking with blood proteins therefore purpose of a hemodialysis is inefficient.

Information on overdose of a perindopril is limited to

. At overdose of APF inhibitors there can be hypotension, circulator shock, disturbance of electrolytic balance, a renal failure, a hyperventilation, tachycardia, palpitation, bradycardia, dizziness, alarm and cough.

to

At overdose recommends administration of solution of sodium chloride of 0.9%. When developing hypotension the patient needs to give horizontal position. It is necessary to consider the possibility of performing infusion from angiotensin II and/or introductions of catecholamines. Perindopril can be brought from system blood circulation by means of a hemodialysis. When developing bradycardia, resistant to treatment, the use of an artificial pacemaker can be recommended. It is necessary to establish continuous monitoring on key indicators of activity, the level of concentration of electrolytes and creatinine in blood serum.

Side effects

Most frequent side reactions about which it was reported at separate use of a perindopril and amlodipin: hypostases, drowsiness, dizziness, a headache (especially in an initiation of treatment), disturbances of taste (dysgeusia), paresthesias, disorders of vision (including doubling in eyes), sonitus, vertigo, palpitation, inflows, hypotension (and the related symptoms), short wind, cough, an abdominal pain, nausea, vomiting, dyspepsia, change of a rhythm of defecation, diarrhea, a constipation, an itching, rash, a dieback, hypostasis of joints (hypostasis of anklebones), spasms of muscles, increased fatigue, an asthenia.

Storage conditions

to Store

in original packing at a temperature not above 25 °C, out of children's reach.

Expiration date - 1.5 years.

Characteristics
Active ingredients Amlodipin, Perindopril
Applicant Darnitsa
Code of automatic telephone exchange C09BB04 Perindopril and amlodipin
Interaction with food To
Light sensitivity Not sensitive
Market status The branded generic
Origin Chemical
Prescription status According to the prescription
Primary packing blister
Producer DARNITSA CIAO PHARMACEUTICAL. FIRM
Quantity in packing 30 tablets (3 blisters on 10 pieces)
Release form tablets for internal use
Route of administration Oral
Sign Domestic
Storage temperature from 5 °C to 25 °C
Trade name Perindopres

Reviews Perindopres And tab. 4mg/5mg No. 30

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Perindopres And tab. 4mg/5mg No. 30

  • Product Code: 182274
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