Generic drug of the therapeutic class: Cardiology and angiology
Active ingredients: Perindopril
Box of 30
Treatment of high blood pressure
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 ARGININE SERVIER 2.5 mg Film-coated tablet Box of 30
The dosage should be appropriate to the patient's profile (see Warnings and Precautions section ) and his or her blood pressure response.
PERINDOPRIL ARGININE SERVIER 2.5 mg can be used alone or in combination with other antihypertensive medicines.
The recommended starting dose is 5 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 2.5 mg is recommended in these patients and initiation of treatment will be under medical supervision.
The dosage may be increased to 10 mg once daily after one month of treatment.
Symptomatic hypotension may occur after initiation of treatment with PERINDOPRIL ARGININE SERVIER 2.5 mg, 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 before starting treatment with PERINDOPRIL ARGININE SERVIER 2.5 mg (see section Warnings and precautions for use ).
In hypertensive patients for whom the diuretic can not be stopped, treatment with PERINDOPRIL ARGININE SERVIER should be initiated at a dose of 2.5 mg. Renal function and serum potassium should be monitored. The dosage of PERINDOPRIL ARGININE SERVIER will then be adjusted according to the blood pressure response. If necessary, treatment with diuretics will be reintroduced.
In the elderly, treatment will be initiated at a dosage of 2.5 mg then it can be increased gradually to 5 mg after one month of treatment and then 10 mg if necessary, depending on the state of renal function (see table below).
Symptomatic heart failure
It is recommended to initiate treatment with PERINDOPRIL ARGININE SERVIER, generally used in combination with a non-potassium sparing diuretic and / or digoxin and / or a beta-blocker, under strict medical supervision, at the initial dosage of 2, 5 mg in one morning intake. Depending on the tolerability, this dosage may be increased with a minimum interval of 2 weeks from 2.5 mg to 5 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 established under strict medical supervision (see Warnings and precautions for use ).
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 PERINOPRIL ARGININE SERVIER. Blood pressure, renal function and serum potassium should be closely controlled, both before and during treatment with PERINDOPRIL ARGININE SERVIER 2.5 mg (see Warnings and Precautions ).
Stable coronary disease
Treatment with PERINDOPRIL ARGININE SERVIER should be initiated at the dose of 5 mg once daily for two weeks, then increased to 10 mg once daily, depending on renal function and if the dose of 5 mg is well tolerated.
Elderly patients will receive 2.5 mg once a day for one week, then 5 mg per day the following week, then the dose will be increased to 10 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.
Patients with renal insufficiency
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
Creatinine clearance (ml / min)
Cl CR ≥ 60
5 mg daily
< CR <60
2.5 mg daily
15 <Cl CR <30
2.5 mg every other day
Hemodialysis patients *
Cl CR <15
2.5 mg on days of dialysis
* The dialysis clearance of perindoprilat is 70 ml / min. For hemodialysis patients, the drug should be taken after dialysis.
Hepatic insufficiency patients
No dose adjustment is necessary in patients with hepatic impairment (see Warnings and Precautions and Pharmacokinetic Properties sections).
Efficacy and safety of use have not been established in children and adolescents (under 18 years of age). As a result, use in children and adolescents is not recommended.
It is recommended to take PERINDOPRIL ARGININE SERVIER in one daily intake in the morning before the meal.
· Hypersensitivity to the active substance, to any of the excipients listed under Composition or to another ACE inhibitor.
· History of angioedema associated with taking an ACE.
· Hereditary or idiopathic angioedema.
· 2nd and 3rd trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).
· Concomitant use of aliskiren in patients with diabetes or renal impairment (GFR <60 ml / min / 1.73 m²) (see Warnings and Precautions and Interactions with other medicinal products and other forms of interaction ).
Side effects Perindopril Arginine Servier
at. Summary of the security profile
The safety profile of perindopril corresponds to that of other IECs.
The most common adverse events reported in clinical trials and seen with perindopril are: dizziness, headache, paresthesia, dizziness, visual disturbances, tinnitus, hypotension, cough, dyspnea, abdominal pain, constipation, diarrhea, dysgeusia, dyspepsia, nausea, vomiting, pruritus, rash, muscle cramps and asthenia.
b. Table of adverse effects
The following adverse reactions have been observed in clinical trials and / or post-marketing use of perindopril and are classified according to their frequency.
Very common (³ 1/10); frequent (³ 1/100, <1/10); uncommon (³ 1/1000, <1/100); rare (³ 1/10000, <1/1000); very rare (<1/10000), unknown (can not be estimated from the available data).
Class Organ System
Blood and lymphatic system disorders
Agranulocytosis or pancytopenia
Decreased hemoglobin and hematocrit
Leukopenia / neutropenia
Hemolytic anemia in patients with congenital G6P-DH deficiency (see Warnings and precautions for use )
Metabolism and nutrition disorders
Hypoglycaemia (see sections Warnings and precautions for use and Interactions with other medicinal products and other forms of interaction )
Hyperkalemia, reversible upon discontinuation of treatment (see Warnings and Precautions section )
Nervous system disorders
Fear of heights
Affections of the ear and labyrinth
Angina pectoris (see section Warnings and precautions for use )
Myocardial infarction, possibly secondary to high hypotension in high-risk patients (see Warnings and precautions for use )
Hypotension and effects related to hypotension
Stroke, possibly secondary to excessive hypotension in high-risk patients (see Warnings and Precautions section )
Respiratory, thoracic and mediastinal disorders
Cytolytic or cholestatic hepatitis (see section Warnings and precautions for use )
Skin and subcutaneous tissue disorders
Urticaria (see section Warnings and precautions for use )
Angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx
Musculoskeletal and systemic disorders
Renal and urinary disorders
Acute renal failure
Disorders of reproductive organs and breast
General disorders and administration site conditions
Elevation of bilirubinemia
Elevation of liver enzymes
Increased blood urea
Increased plasma creatinine
Injury, poisoning and complications of an operation
* Estimated frequency from clinical trial data for post-marketing adverse reactions (spontaneous reports).
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).
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr