Amlesa tablets 8mg + 10mg are used in patients with essential hypertension and/or stable coronary artery disease who require treatment with both perindopril and amlodipine.
Each tablet contains 8 mg of perindopril erbumine and 10 mg of amlodipine (in blister packaging).
Amlesa is indicated for the treatment of essential hypertension and/or stable coronary artery disease in patients requiring therapy with both perindopril and amlodipine.
Related to perindopril:
Hypersensitivity to perindopril or any other ACE (angiotensin-converting enzyme) inhibitors
History of angioedema associated with ACE inhibitor therapy
Hereditary or idiopathic angioedema
Second or third trimester of pregnancy
For oral use.
The recommended dose is one tablet once daily, preferably in the morning before meals.
The fixed-dose combination is not suitable for initiating antihypertensive therapy. If a dose adjustment is necessary, it is recommended to adjust the doses of the individual components separately.
Patients with renal impairment and elderly patients:
Since perindopril elimination is reduced in this population, regular medical monitoring should include checking creatinine and potassium levels.
Amlesa is appropriate for patients with creatinine clearance ≥60 mL/min and should not be used in patients with clearance <60 mL/min. In such cases, individual titration of each component is recommended.
Changes in plasma concentration of amlodipine do not correlate with the degree of renal impairment.
Patients with hepatic impairment:
There is no established dosage regimen for this patient population. Caution is advised when prescribing this fixed-dose combination.
Children and adolescents:
Not recommended, as the safety, efficacy, and tolerability of perindopril and amlodipine, either as monotherapy or in combination, have not been established in this population.
Store below 30°C in the original package, protected from light and moisture. Keep out of reach of children.
