Caused by perindopril: hypersensitivity to the active substance or other ACE inhibitors; angioedema (angioneurotic edema) in history associated with previous treatment with ACE inhibitors; congenital or idiopathic angioedema; pregnant women or women who plan to become pregnant (see use during pregnancy and lactation); simultaneous use with preparations containing aliskiren in patients with diabetes mellitus or impaired renal function (glomerular filtration rate 60 ml / min / 1.73 m2) (see interactions and pharmacodynamics); extracorporeal therapies that result in blood coming into contact with negatively charged surfaces (see interactions); significant bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney (see special instructions).
Caused by indapamide: hypersensitivity to the active substance or other sulfonamides; severe renal failure (creatinine clearance 30 ml / min); hepatic encephalopathy; severe liver dysfunction; hypokalemia; As a general rule, this medicinal product should not be given in combination with non-arrhythmic agents that may cause torsades de pointes (see Interactions); the period of lactation (see Use during pregnancy and lactation).
Caused by the preparation Prestarium arginine Combi: hypersensitivity to any excipient. Due to the lack of sufficient clinical experience, Prestarium Arginine Combi should not be prescribed to patients on hemodialysis, as well as to patients with untreated decompensated heart failure.
The use of perindopril inhibits the renin-angiotensin-aldosterone system (RAAS) and helps to reduce the loss of potassium in the blood plasma caused by indapamide. 4% of patients treated with Prestarium Arginine Combi develop hypokalemia (potassium level 3.4 mmol/l). The most commonly reported adverse reactions were: dizziness, headache, paresthesia, dysgeusia, visual disturbances, vertigo, tinnitus, arterial hypotension, cough, shortness of breath, abdominal pain, constipation, dyspepsia, diarrhea, nausea , vomiting, itching, rash, muscle cramps and asthenia; when using indapamide - hypersensitivity reactions, mainly dermatological, in patients prone to the development of allergic and asthmatic reactions, and maculopapular rashes.
During clinical trials and / or post-registration use of the preparation, the following adverse reactions were observed, which are distributed according to frequency as follows: very often (≥1 / 10), often (from ≥1 / 100 to 1/10), infrequently (from ≥1 / 1000 to 1/100), rare (≥1/10,000 to 1/1000), very rare (1/10,000), frequency unknown (cannot be determined from the available data).
Infections and invasions: rhinitis (very rarely - perindopril).
From the blood and lymphatic system: eosinophilia (infrequently * - perindopril), agranulocytosis (very rarely - perindopril and indapamide) (see SPECIAL INSTRUCTIONS); aplastic anemia (very rarely - indapamide), pancytopenia (very rarely - perindopril), leukopenia (very rarely - perindopril and indapamide), neutropenia (very rarely - perindopril) (see SPECIAL INSTRUCTIONS); hemolytic anemia (very rarely - perindopril and indapamide), thrombocytopenia (very rarely - perindopril and indapamide) (see SPECIAL INSTRUCTIONS).
From the immune system: hypersensitivity (mainly dermatological reactions in patients prone to the development of allergic and asthmatic reactions) (often - indapamide).
From the side of metabolism and metabolism: hypoglycemia (infrequently * - perindopril) (see SPECIAL INSTRUCTIONS and INTERACTIONS); hyperkalemia reversible upon discontinuation of the preparation (see SPECIAL INSTRUCTIONS) (uncommon * - perindopril), hyponatremia (see SPECIAL INSTRUCTIONS) (infrequently * - perindopril, the frequency is unknown - indapamide), hypercalcemia (very rarely - indapamide), a decrease in the level of potassium in blood to a state of hypokalemia, in particular serious in some patients of the high-risk group (see SPECIAL INSTRUCTIONS) (frequency unknown - indapamide).
On the part of the psyche: mood changes (infrequently - perindopril), sleep disturbances (infrequently - perindopril), confusion (very rarely - perindopril).
From the nervous system: dizziness (often - perindopril), headache (often - perindopril, rarely - indapamide), paresthesia (often - perindopril, rarely - indapamide), dysgeusia (often - perindopril), drowsiness (infrequently * - perindopril), syncope (uncommon* - perindopril, frequency unknown - indapamide), due to excessive arterial hypotension in high-risk patients, stroke may occur (see SPECIAL INSTRUCTIONS) (very rarely - perindopril) in case of liver failure, hepatic encephalopathy may occur (see CONTRAINDICATIONS, SPECIAL INSTRUCTIONS) (frequency unknown - indapamide).
On the part of the organ of vision: visual impairment (often - perindopril, frequency unknown - indapamide), myopia (see SPECIAL INSTRUCTIONS) (frequency unknown - indapamide), blurred vision (frequency unknown - indapamide).
From the organ of hearing and vestibular apparatus: vertigo (often - perindopril, rarely - indapamide), tinnitus (often - perindopril).
From the side of the heart: palpitations (infrequently * - perindopril), tachycardia (infrequently * - perindopril), angina pectoris (see SPECIAL INSTRUCTIONS) (very rarely - perindopril), arrhythmia (including bradycardia, ventricular tachycardia, atrial fibrillation) (very rarely - perindopril and indapamide), due to excessive arterial hypotension in high-risk patients, myocardial infarction may occur (see SPECIAL INSTRUCTIONS) (very rarely - perindopril), paroxysmal ventricular tachycardia of the pirouette type (potentially fatal) (see SPECIAL INSTRUCTIONS, INTERACTIONS) ( frequency unknown - indapamide).
From the side of the vessels: arterial hypotension (and manifestations associated with arterial hypotension) (see SPECIAL INSTRUCTIONS) (often - perindopril, very rarely - indapamide), vasculitis (infrequently * - perindopril).
On the part of the respiratory system, chest and mediastinal organs: cough (see SPECIAL INSTRUCTIONS) (often - perindopril), shortness of breath (often - perindopril), bronchospasm (infrequently - perindopril), eosinophilic pneumonia (very rarely - perindopril).
From the gastrointestinal tract: pain in the abdominal region (often - perindopril), constipation (often - perindopril, rarely - indapamide), diarrhea (often - perindopril), dyspepsia (often - perindopril), nausea (often - perindopril, rarely - indapamide), vomiting (often - perindopril, infrequently - indapamide), dry mouth (infrequently - perindopril, rarely - indapamide), pancreatitis (very rarely - perindopril and indapamide).
From the hepatobiliary system: hepatitis (see SPECIAL INSTRUCTIONS) (very rarely - perindopril, the frequency is unknown - indapamide), abnormal liver function (very rarely - indapamide).
From the skin and subcutaneous tissue: itching (often - perindopril), rashes (often - perindopril), maculopapular rashes (often - indapamide), urticaria (see SPECIAL INSTRUCTIONS) (infrequently - perindopril, very rarely - indapamide), angioedema ( see SPECIAL INSTRUCTIONS) (infrequently - perindopril, very rarely - indapamide), purpura (infrequently - indapamide), hyperhidrosis (infrequently - perindopril), photosensitivity reactions (infrequently * - perindopril, the frequency is unknown - indapamide), pemphigoid (infrequently * - perindopril ), increased symptoms of psoriasis (rarely - perindopril), erythema multiforme (very rarely - perindopril), toxic epidermal necrolysis (very rarely - indapamide), Stevens-Johnson syndrome (very rarely - indapamide).
From the musculoskeletal system and connective tissue: muscle cramps (often - perindopril), possibly worsening of existing acute systemic lupus erythematosus (frequency unknown - indapamide), arthralgia (infrequently * - perindopril), myalgia (infrequently * - perindopril).
From the urinary system: renal failure (infrequently - perindopril), acute renal failure (very rarely - perindopril and indapamide).
From the reproductive system and mammary glands: erectile dysfunction (infrequently - perindopril).
General disorders and injection site reactions: asthenia (often - perindopril), chest pain (uncommon * - perindopril), malaise (uncommon * - perindopril), peripheral edema (uncommon * - perindopril), pyrexia (uncommon * - perindopril), fatigue (rarely - indapamide).
Laboratory findings: increased blood urea (uncommon* - perindopril), increased blood creatinine (uncommon* - perindopril), increased blood bilirubin (rare - perindopril), elevated liver enzymes (rare - perindopril, frequency unknown - indapamide), a decrease in hemoglobin and hematocrit (see SPECIAL INSTRUCTIONS) (very rarely - perindopril), an increase in blood glucose (frequency unknown - indapamide), an increase in uric acid in the blood (frequency unknown - indapamide), prolongation of the Q interval -T on ECG (see SPECIAL INSTRUCTIONS, INTERACTIONS) (frequency unknown - indapamide).
Injury, poisoning and procedural complications: Falling (uncommon* - perindopril).
*Frequency of manifestations of adverse reactions identified through spontaneous reports, calculated from clinical studies.
Report on suspected adverse reactions. Reporting suspected adverse reactions in the post-registration period of a medicinal product is important. This allows continuous monitoring of the benefit / risk ratio of the preparation. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system.
Overdose
Symptoms. in case of overdose, the most common adverse reaction is arterial hypotension, which can sometimes be accompanied by nausea, vomiting, convulsions, dizziness, drowsiness, confusion, oliguria, which can progress to anuria (due to hypovolemia), as well as circulatory shock. there may be disturbances in the water and electrolyte balance (decrease in the level of potassium and sodium in the blood plasma), renal failure, hyperventilation, tachycardia, rapid heartbeat (palpitation), bradycardia, anxiety, cough.
Treatment. First aid measures include the rapid elimination of the preparation from the body: gastric lavage and / or the appointment of activated charcoal, and after that - the restoration of water and electrolyte balance in a hospital setting. In the event of significant arterial hypotension, the patient must be given a horizontal position with a low headboard. If necessary, in / in the introduction of isotonic solution of sodium chloride or use any other method of restoring blood volume.
Perindoprilat, the active form of perindopril, can be removed from the body by hemodialysis (see Pharmacokinetics).
Storage conditions
Store tablets in a tightly closed container. does not require special storage conditions. Keep out of the reach of children.