Medicinal Products

PERINDOPRIL BIOGARAN 8 mg

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

Compressed
Box of 30
All forms

Indication

Hypertension:

Treatment of high blood pressure.

Stable coronary disease:

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

Dosage PERINDOPRIL BIOGARAN 8 mg Tablet Box of 30

It is recommended to take PERINDOPRIL BIOGARAN 8 mg, once daily in the morning before meals.

The dosage should be appropriate to the patient's profile (see "Special warnings and special precautions for use") and to his or her blood pressure response.

Hypertension:

PERINDOPRIL BIOGARAN 8 mg tablets can be used alone or in combination with other antihypertensive medicines.

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 BIOGARAN 8 mg tablet; especially 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 before starting treatment with PERINDOPRIL BIOGARAN 8 mg tablet (see "Special warnings and special precautions for use").

In hypertensive patients for whom the diuretic can not be stopped, treatment with PERINDOPRIL BIOGARAN tablet should be initiated at a dose of 2 mg. Renal function and serum potassium should be monitored. The dosage of PERINDOPRIL BIOGARAN, tablet 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 and then it may be gradually increased to 4 mg after one month of treatment and then to 8 mg if necessary, depending on the state of renal function (see table below). -Dessous).

Stable coronary disease:

Treatment with PERINDOPRIL BIOGARAN should be initiated 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 daily for one week, then 4 mg once daily the following week, then the dose will be increased to 8 mg once daily depending on renal function (see Table 1, kidney failure "). The dosage will be increased only if the previous dose is well tolerated.

Dosage adjustment in renal failure

The dosage in patients with renal impairment should be adjusted according to creatinine clearance as outlined in Table 1 below:

Table 1: Dosage Adjustment in Renal Failure

Clearance of creatinine

(Ml / min)

Recommended dosage

Cl cr ≥ 60

4 mg daily

30 <Cl cr <60

2 mg daily

15 <Cl cr <30

2 mg, 1 day out of 2

Hemodialysis patients *

Cl cr <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 hepatic insufficiency

No dose adjustment is required for patients with hepatic impairment (see "Special warnings and special precautions for use" and "Pharmacokinetic properties").

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 related to taking an ACE;

· Hereditary or idiopathic angioedema;

· 2nd and 3rd trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).

Side effects Perindopril Biogaran

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, 1/1000, 1/10000, <1/1000); very rare (<1/10000), including isolated cases.

Psychiatric disorders:

Uncommon: mood or sleep disorders

Nervous system disorders:

Frequent: 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 "Special warnings and special precautions for use").

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 Warnings and Precautions section "Special warnings and special 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 "Special warnings and special precautions for use").

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 "Special warnings and special precautions for use").

Biological examinations:

Increases in uremia and serum creatinine, reversible hyperkalaemia upon discontinuation of therapy may occur, particularly in the presence of renal insufficiency, 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 on perindopril and 12 (0.2%) of 6, 107 patients on 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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