Amprilan 10 mg N30 Tablet

AMPRİLAN, 1.25 mg, 2.5 mg, 5 mg or 10 mg      

Amprilan tcomposition

Active substance: 1 tablet contains 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril. Excipients: sodium hydrogencarbonate, lactose monohydrate, sodium croscarmellose,  gelatinized starch, sodium stearyl fumarate, for the 2.5 mg dose - yellow iron oxide (E172), for the 5 mg dose - red iron oxide (E172), yellow iron oxide (E172).

Indications:

  Arterial hypertension - Cardiovascular prevention: in patients suffering from the following diseases, reduction of cardiovascular disease and mortality: -  atherothrombotic cardiovascular diseases (history of ischemic heart disease, stroke, or peripheral vascular disease) and/or -  diabetes accompanied by at least one cardiovascular risk factor - Diabetic nephropathy and chronic diffuse kidney diseases (preclinical and clinical stages) with nephropathy, including overt proteinuria, in the setting of glomerulonephritis; - Chronic kidney failure -  during the initial stage of diabetic glomerular nephropathy (characterized by the presence of microalbuminuria) -  during diabetic glomerular nephropathy accompanied by one of the cardiovascular risk factors (characterized by the presence of macroproteinuria) -  during non-diabetic glomerular nephropathy (characterized by the presence of macroproteinuria ≥ 3 g/day) - Chronic heart failure - Secondary prevention after acute myocardial infarction (AMI): reduction of mortality in patients with clinical signs of heart failure during the acute phase of myocardial infarction (after AMI >48 hours).

Contraindications:

  Hypersensitivity to ramipril, to any other ingredient of the product, or to other ACE inhibitors - Angioedema in the medical history - Extracorporeal treatment leading to contact of blood with a negatively charged surface - Hemodynamically significant bilateral stenosis of the renal arteries, stenosis of a single renal artery - The second and third trimesters of pregnancy - Patients with hypotension or unstable hemodynamics - Concomitant use of Amprilan with aliskiren-containing medicinal products is contraindicated in patients with diabetes mellitus or moderate/severe renal impairment (GFR < 60 ml/min/1.73 m2).

Use during pregnancy and lactation:

 In patients who are taking pregnancy, the use of Amprilan® during the first trimester is not recommended; during the second and third trimesters it is contraindicated. ACE inhibitor treatment should be discontinued during pregnancy and, if necessary, alternative therapy should be started. Inhibition of the angiotensin-converting enzyme / angiotensin II receptor antagonists (AIIRAs) during the second and third trimesters, as is known, causes fetotoxicity in humans (impaired kidney function, oligohydramnios, delayed ossification of the fetal skull) and toxicity in newborns (renal failure, hypotension, hyperkalemia). In infants whose mothers take ACE inhibitors, cases of hypotension, oliguria, and hyperkalemia should be carefully monitored. If the patient becomes pregnant while taking Amprilan®, the administration of the medicinal product should be stopped as soon as possible and the patient should be switched to other medicinal products that pose less risk to the baby during use. Due to insufficient information regarding the use of ramipril during lactation, Amprilan® is not recommended during breastfeeding. If treatment with Amprilan® is necessary during lactation, breastfeeding should be discontinued.

Amprilan iusage instructions, dosage

 The product is taken orally. It is recommended to swallow the tablet whole with sufficient liquid at the same time every day, without chewing or crushing. The product is taken regardless of food intake.