AM-Aliter tablets are indicated for arterial hypertension and/or ischemic heart disease (if treatment with perindopril and amlodipine is necessary).
Composition
Active ingredients: perindopril, amlodipine;
1 tablet contains perindopril tert-butylamine - 4 mg, which is equivalent to 3.338 mg of perindopril and amlodipine besylate 13.870 mg, which is equivalent to 10 mg of amlodipine;
Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone; sodium bicarbonate; colloidal silicon dioxide, magnesium stearate.
Contraindication
Hypersensitivity to the active substances (or to any other ACE inhibitors or to dihydropyridine derivatives) or to any of the excipients; history of angioedema associated with previous treatment with an ACE inhibitor; congenital or idiopathic angioedema; severe hypotension; shock, including cardiogenic shock; left ventricular outflow obstruction (e.g. severe aortic stenosis); heart failure after acute myocardial infarction with unstable haemodynamics; pregnancy or planning pregnancy; concomitant use with aliskiren-containing medicinal products in patients with diabetes mellitus or renal insufficiency (glomerular filtration rate <60 ml/min/1.73 m2); concomitant use with sacubitril/valsartan; extracorporeal treatments that result in blood coming into contact with negatively charged surfaces; significant bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
Method of application
For oral use.
Adults should be prescribed 1 tablet per day once, preferably in the morning before meals. The tablet cannot be divided.
The dose should be selected individually for each patient, taking into account the indications for use, the course of the disease and blood pressure. The maximum daily dose is 1 tablet of 8 mg / 10 mg per day.
AM-Aliter can be prescribed to patients with creatinine clearance ≥ 60 ml/min and should not be prescribed to patients with creatinine clearance < 60 ml/min. In such patients, individual dose selection of each component of the drug is recommended.
With good tolerability, the dose of amlodipine is the same for young and elderly patients. For elderly patients, the usual dosing regimen is recommended, but dose increases should be carried out with caution.
Application features
Pregnant women
The use of AM-Aliter is contraindicated during pregnancy.
Children
AM-Aliter is not recommended for use in children due to the lack of studies involving this group of patients.
Drivers
Caution is recommended, especially at the beginning of treatment.
Overdose
No cases of overdose with AM-Aliter have been reported.
Side effects
The most common adverse reactions with the separate use of perindopril and amlodipine are: edema, drowsiness, dizziness, headache (especially at the beginning of treatment), taste distortion (dysgeusia), paresthesia, visual disturbances (including diplopia), tinnitus, palpitations, flushing, hypotension (and related symptoms), shortness of breath, cough, abdominal pain, nausea, vomiting, dyspepsia, change in bowel habits, diarrhea, constipation, itching, rash, joint swelling (ankle swelling), smooth muscle spasms, fatigue, asthenia.
Interaction
Simultaneous use is contraindicated.
Aliskiren: In patients with diabetes mellitus or patients with impaired renal function, the risk of hyperkalemia, worsening of renal function, and cardiovascular morbidity and mortality is increased.
Extracorporeal therapies. Extracorporeal therapies that result in contact of blood with negatively charged surfaces, such as dialysis or hemofiltration using certain membranes with high hydraulic permeability (e.g. polyacrylonitrile) and low-density lipoprotein apheresis using dextran sulfate, due to an increased risk of severe anaphylactoid reactions. If such treatments are necessary, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.
Sacubitril/valsartan. Concomitant use of perindopril with sacubitril/valsartan is contraindicated because concomitant inhibition of neprilysin and ACE may increase the risk of angioedema. Sacubitril/valsartan should not be started until 36 hours after the last dose of perindopril. Perindopril therapy should not be started until 36 hours after the last dose of sacubitril/valsartan.
Storage conditions
Store at a temperature not exceeding 30 °C in the original packaging.
Keep out of reach of children.
Shelf life - 2 years.
