Amlessa 8mg/5mg Tablets - CÔNG TY CỔ PHẦN GLOBAL PHARMACEUTICAL

Amlessa 8mg/5mg Tablets - CÔNG TY CỔ PHẦN GLOBAL PHARMACEUTICAL

Amlessa 8mg/5mg Tablets - CÔNG TY CỔ PHẦN GLOBAL PHARMACEUTICAL

Amlessa 8mg/5mg Tablets - CÔNG TY CỔ PHẦN GLOBAL PHARMACEUTICAL

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Amlessa 8mg/5mg Tablets
Amlessa 8mg/5mg Tablets

Amlessa 8mg/5mg Tablets

Present

3 Blisters x10 tablets

Ingredient

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

Point

Amlessa is indicated as a replacement medicine for the treatment of essential hypertension and / or stable coronary artery disease in patients who already have well-controlled blood pressure by taking perindopril and amlodipine at the same time with the same strength combination
   
DETAIL

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

 

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