Amlessa 8mg/5mg Tablets
Keep out of reach of children. Read the manual carefully before use.
If need more information please consult with your doctor.
COMPOSITION:
Contains 8 mg perindopril tert-butylamine (corresponding to 6.68 mg perindopril) and 5 mg amlodipine (as amlodipine besylate) per tablet. Excipients q.s for 1 tablets
INDICATION:
Amlessa is indicated for the substitution treatment of essential hypertension and / or stable coronary heart disease in patients who are already taking the same dose of perindopril and amlodipine are in balance.
DOSAGE AND METHOD OF ADMINISTRATION:
Dosage
The fixed-dose combination is not suitable for initial therapy. If a dose adjustment is required, it is individualized to the components of the free combination titration.
Elderly patients with renal impairment
Elimination of perindoprilat is reduced in the elderly and patients with renal impairment, therefore frequent monitoring of creatinine and potassium levels will be part of routine medical monitoring. Amlessa can be used in patients with creatinine clearance ≥ 60 ml/min. Not suitable for patients with creatinine clearance <60 ml/min. In these patients on an individual basis tailored dose titration is recommended for each component separately. Changes in amlodipine plasma concentrations do not correlate with the degree of renal impairment.
Patients with hepatic impairment
No dosing regimen has been established for patients with hepatic impairment. As a result, Amlessa should be used with caution. An accurate dosing recommendation for patients with mild to moderate hepatic impairment, therefore, the dose should be selected with caution and with a lower dose range. For patients with hepatic impairment, the optimal starting and maintenance dose to find the dose individually, perindopril, and amlodipine components doses should be titrated individually. Amlodipine is used in patients with severe hepatic impairment pharmacokinetics have not been studied. In patients with severe hepatic impairment, amlodipine dosing should start with the lowest dose and be adjusted slowly.
Children and adolescents
Amlessa should not be used in children and adolescents because you are alone The efficacy and safety of perindopril in combination with amlodipine have not been established in children and adolescents.
Method of application
For oral use. Take one tablet once a day, preferably in the morning, before a meal.
Contraindications
In relation to perindopril:
Hypersensitivity to perindopril or any other ACE inhibitor.
History of angioedema associated with previous ACE inhibitor therapy
Hereditary or idiopathic angioedema,
Second and third trimesters of pregnancy
Concomitant use with saxitrile / valsartan combination
In the case of extracorporeal treatments, if the blood comes into contact with negatively charged membranes (see section 4.5) point),
Single functioning kidney in significant bilateral renal artery stenosis or renal artery stenosis
In relation to amlodipine:
Severe hypotension.
Hypersensitivity to amlodipine or any other dihydropyridine.
Shock, including cardiogenic shock.
Left ventricular outflow tract obstruction (e.g., severe aortic stenosis).
Haemodynamically unstable heart failure following acute myocardial infarction.
Related to Amlessa:
All contraindications detailed above for each monocomponent apply to Amlessa for a fixed combination as well.
Hypersensitivity to any of the excipients listed in section 6.1.
Concomitant use of Amlessa with aliskiren-containing products is contraindicated in diabetes in patients with diabetes mellitus or renal impairment (GFR <60 ml/min / 1.73 m)
OTHER INFORMATION: Please refer to the Instruction sheet included in the package
MANUFACTURED BY: KRKA, D.D., NOVO MESTO (SLOVENIA)
DISTRIBUTOR: GLOBAL PHARMACEUTICAL JOINT-STOCK COMPANY
