Medicinal Products

PERINDOPRIL ARROW 4 mg

Generic drug of Coversyl
Therapeutic class: Cardiology and angiology
Active ingredients: Perindopril
laboratory: Arrow Generic

Tablet breackable
Box of 30
All forms

Indication

Hypertension

Treatment of hypertension.

Heart failure

Treatment of symptomatic heart failure.

Stable coronary disease

Reduced risk of cardiac events in patients with a history of myocardial infarction and / or revascularization.

Dosage PERINDOPRIL ARROW 4 mg scored tablet Box of 30

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 ).

Hypertension:

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) .

Symptomatic heart failure:

It is recommended that treatment with PERINDOPRIL ARROW, generally used in combination with a non-potassium-sparing diuretic and / or digoxin and / or a beta-blocker, be used under strict medical supervision at the initial dose of 2 mg once daily. morning. Depending on the tolerance, this dosage may be increased by observing a minimum interval of 2 weeks, from 2 mg to 4 mg per day. The dosage will be adapted according to the patient's response to the treatment.

In patients with severe heart failure, and in those considered at high risk (patients with renal failure and a tendency to have electrolyte disturbances, patients receiving concomitant treatment with diuretics and / or vasodilators), treatment should be under strict medical supervision (see section 4.4 ).

Patients at high risk of symptomatic hypotension, such as patients with water-soluble depletion with or without hyponatremia, patients with hypovolemia or patients treated with high-dose diuretics should be equilibrated, if possible before initiation of treatment with perindopril. Blood pressure, renal function and serum potassium should be tightly controlled, both before and during treatment with perindopril (see section 4.4 Special warnings and precautions for use ).

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)

Recommended dosage

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 ).

Pediatric use:

Efficacy and safety of use have not been established in children. As a result, use in children is not recommended.

Against indications

· 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.

Psychiatric disorders:

Uncommon: mood or sleep disorders

Nervous system disorders:

Common: headache, dizziness, vertigo, paresthesia.

Very rarely: confusion.

Eye disorders:

Frequent: visual disturbances.

Hearing disorders:

Frequent: tinnitus.

Cardiovascular disorders:

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.

Uncommon: bronchospasm.

Very rare: eosinophilic pneumonia, rhinitis.

Gastrointestinal disorders:

Frequent: nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhea, constipation.

Uncommon: dry mouth.

Very rare: pancreatitis.

Hepatobiliary disorders:

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:

Uncommon: impotence

General disorders:

Frequent: asthenia.

Uncommon: sweating.

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 ).

Biological examinations:

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).

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