Generic drug of Coversyl
Therapeutic class: Cardiology and angiology
Active ingredients: Perindopril
laboratory: Arrow Generic
Box of 90
Treatment of hypertension.
Stable coronary disease
Reduced risk of cardiac events in patients with a history of myocardial infarction and / or revascularization.
Dosage PERINDOPRIL ARROW 8 mg Tablet Box of 90
It is recommended to take PERINDOPRIL ARROW once daily in the morning before meals.
The dosage should be appropriate to the patient's profile and blood pressure response (see section 4.4 ).
PERINDOPRIL ARROW can be used alone or in combination with other antihypertensive medications.
The recommended starting dose is 4 mg daily in one morning dose.
Patients whose renin-angiotensin-aldosterone system is highly stimulated (in particular, renovascular hypertension, water-soluble depletion, cardiac decompensation or severe hypertension) may experience a sudden fall in blood pressure after the first dose. An initial dose of 2 mg is recommended in these patients and initiation of treatment will be under medical supervision.
The dosage may be increased to 8 mg once daily after one month of treatment.
Symptomatic hypotension may occur after the start of treatment with perindopril, particularly in patients treated with diuretics. Special attention is warranted in these patients who may experience water-soluble depletion. If possible, diuretic therapy should be discontinued 2 to 3 days prior to initiation of perindopril therapy (see section 4.4 Special warnings and precautions for use ).
In hypertensive patients for whom the diuretic can not be stopped, treatment with PERINDOPRIL ARROW should be initiated at a dose of 2 mg. Renal function and serum potassium should be monitored. The dosage of PERINDOPRIL ARROW will then be adjusted according to the blood pressure response. If necessary, treatment with diuretics will be reintroduced.
In the elderly, the treatment will be initiated at a dosage of 2 mg then it can be gradually increased to 4 mg after one month of treatment and then to 8 mg if necessary, according to the state of the renal function (see table below) .
Stable coronary disease:
Perindopril should be started at a dose of 4 mg once daily for two weeks, then increased to 8 mg once daily, depending on renal function and whether the 4 mg dose is well tolerated. Elderly patients will receive 2 mg once a day for one week, then 4 mg once a day the following week, then the dose will be increased to 8 mg once daily depending on renal function (see Table 1: Adjustment to kidney failure). The dosage will be increased only if the previous dose is well tolerated.
Dosage adjustment in case of renal insufficiency:
The dosage in patients with renal impairment should be adjusted according to creatinine clearance as shown in Table 1 below.
Table 1: Dosage Adjustment in Renal Failure:
Creatinine clearance (ml / min)
Clcr> = 60
4 mg / day
30 <Clcr <60
2 mg / day
15 <Clcr <30
2 mg, 1 day out of 2
Hemodialysis patients * Clcr <15
2 mg on days of dialysis
* The dialysis clearance of perindoprilat is 70 ml / min. For hemodialysis patients, the drug should be taken after dialysis.
Dosage adjustment in case of hepatic insufficiency:
No dose adjustment is required in patients with hepatic impairment (see sections 4.4 and 5.2 ).
Efficacy and safety of use have not been established in children. As a result, use in children is not recommended.
· Hypersensitivity to perindopril, any of the excipients, or other angiotensin-converting enzyme (ACE) inhibitors.
· History of angioedema associated with taking an ACE.
· Hereditary or idiopathic angioedema.
· Second and third trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).
Side effects Perindopril Arrow
The following side effects have been observed during treatment with perindopril and are classified according to their frequency.
Very common (> 1/10);
Frequent (≥ 1/100, <1/10);
Uncommon (≥ 1/1000, <1/100);
Rare (≥ 1/10 000, <1/1000);
Very rare (<1 / 10, 000), including isolated cases.
Uncommon: mood or sleep disorders
Nervous system disorders:
Common: headache, dizziness, vertigo, paresthesia.
Very rarely: confusion.
Frequent: visual disturbances.
Common: hypotension and effects related to hypotension.
Very rare: arrhythmia, angina pectoris, myocardial infarction and stroke, possibly secondary to high hypotension in patients at risk (see section 4.4 ).
Respiratory, thoracic and mediastinal disorders:
Frequent: cough, dyspnea.
Very rare: eosinophilic pneumonia, rhinitis.
Frequent: nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhea, constipation.
Uncommon: dry mouth.
Very rare: pancreatitis.
Very rare: Cytolytic or cholestatic hepatitis (see section 4.4 Special warnings and precautions for use ).
Skin and tissue disorders:
Frequent: rash, pruritus.
Uncommon: angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx, urticaria (see section 4.4 ).
Very rare: erythema multiforme.
Muscular, connective tissue and bone disorders:
Frequent: muscle cramps.
Renal and urinary disorders:
Uncommon: renal failure.
Very rare: acute renal failure.
Reproductive system disorders:
Blood and lymphatic system disorders:
Decreased hemoglobin and hematocrit, thrombocytopenia, leukopenia / neutropenia, and cases of agranulocytosis or pancytopenia have been reported very rarely. In patients with congenital G6P-DH deficiency, very rare cases of haemolytic anemia have been reported (see section 4.4 ).
Increases in plasma uremia and serum creatinine, reversible hyperkalaemia upon discontinuation of treatment may occur, particularly in the presence of renal failure, severe heart failure and renovascular hypertension. Elevated liver enzymes and bilirubinemia have been reported rarely.
Clinical tests :
During the randomisation period of the Europa study, only serious adverse events were collected. Few patients experienced serious adverse events: 16 (0.3%) of 6, 122 patients receiving perindopril and 12 (0.2%) of 6, 107 patients receiving placebo. In patients treated with perindopril, hypotension was observed in 6 patients, angioedema in 3 patients and cardiac arrest in 1 patient. Stopping treatment due to cough, hypotension or other intolerance was observed in more patients receiving perindopril than placebo, respectively 6% (n = 366) versus 2.1% (n = 366). = 129).