Medicinal Products

PERINDOPRIL ARGININE BIOGARAN 10 mg

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

Coated tablet
Box of 1 Pill box of 90
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 ARGININE BIOGARAN 10 mg Film-coated tablet Box of 1 Pill box of 90

Dosage

The dosage should be appropriate to the patient's profile (see Warnings and Precautions section ) and his or her blood pressure response.

Hypertension

PERINDOPRIL ARGININE BIOGARAN can be used alone or in combination with other antihypertensive medications.

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 the start of treatment with PERINDOPRIL ARGININE BIOGARAN, 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 PERINDOPRIL ARGININE BIOGARAN treatment is started (see Warnings and Precautions ).

In hypertensive patients for whom the diuretic can not be stopped, treatment with PERINDOPRIL ARGININE BIOGARAN should be initiated at a dose of 2.5 mg. Renal function and serum potassium should be monitored. The dosage of PERINDOPRIL ARGININE BIOGARAN 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).

Stable coronary disease

Treatment with PERINDOPRIL ARGININE BIOGARAN should be initiated at a dose of 5 mg once daily for two weeks, then increased to 10 mg once daily, depending on renal function and whether the 5 mg dose 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.

Special populations

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)

Recommended dosage

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).

Pediatric population

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.

Administration mode

Oral way.

It is recommended to take PERINDOPRIL ARGININE BIOGARAN in one daily dose in the morning before the meal.

Against indications

· 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 ).

Adverse effects Perindopril Arginine Biogaran

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).

MedDRA classification

Class Organ System

Side effects

Frequency

Blood and lymphatic system disorders

eosinophilia

Rare*

Agranulocytosis or pancytopenia

Very rare

Decreased hemoglobin and hematocrit

Very rare

Leukopenia / neutropenia

Very rare

Hemolytic anemia in patients with congenital G6P-DH deficiency (see Warnings and precautions for use )

Very rare

thrombocytopenia

Very rare

Metabolism and nutrition disorders

Hypoglycaemia (see sections Warnings and precautions for use and Interactions with other medicinal products and other forms of interaction )

Rare*

Hyperkalemia, reversible upon discontinuation of treatment (see Warnings and Precautions section )

Rare*

hyponatremia

Rare*

Psychiatric disorders

Mood disorders

Rare

Sleeping troubles

Rare

Nervous system disorders

cephalalgia

Frequent

dizziness

Frequent

Fear of heights

Frequent

paresthesia

Frequent

Drowsiness

Rare*

Syncope

Rare*

Confusion

Very rare

Eye disorders

Visual disorders

Frequent

Affections of the ear and labyrinth

tinnitus

Frequent

Heart conditions

palpitations

Rare*

tachycardia

Rare*

Angina pectoris (see section Warnings and precautions for use )

Very rare

arrhythmia

Very rare

Myocardial infarction, possibly secondary to high hypotension in high-risk patients (see Warnings and precautions for use )

Very rare

Vascular disorders

Hypotension and effects related to hypotension

Frequent

vasculitis

Rare*

Stroke, possibly secondary to excessive hypotension in high-risk patients (see Warnings and Precautions section )

Very rare

Respiratory, thoracic and mediastinal disorders

Cough

Frequent

Dyspnea

Frequent

bronchospasm

Rare

Eosinophilic pneumonia

Very rare

rhinitis

Very rare

Gastrointestinal disorders

Abdominal pain

Frequent

Constipation

Frequent

Diarrhea

Frequent

dysgeusia

Frequent

Dyspepsia

Frequent

Nausea

Frequent

Vomiting

Frequent

Oral dryness

Rare

pancreatitis

Very rare

Hepatobiliary disorders

Cytolytic or cholestatic hepatitis (see section Warnings and precautions for use )

Very rare

Skin and subcutaneous tissue disorders

itching

Frequent

rash

Frequent

Urticaria (see section Warnings and precautions for use )

Rare

Angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx

Rare

Photosensitivity reactions

Rare*

Pemphygoïde

Rare*

Hyperhidrosis

Rare

Erythema multiforme

Very rare

Musculoskeletal and systemic disorders

Muscle cramps

Frequent

arthralgia

Rare*

myalgia

Rare*

Renal and urinary disorders

Renal failure

Rare

Acute renal failure

Very rare

Disorders of reproductive organs and breast

Incapacity

Rare

General disorders and administration site conditions

Asthenia

Frequent

Chest pain

Rare*

Discomfort

Rare*

Peripheral edema

Rare*

Fever

Rare*

investigations

Elevation of bilirubinemia

Rare

Elevation of liver enzymes

Rare

Increased blood urea

Rare*

Increased plasma creatinine

Rare*

Injury, poisoning and complications of an operation

Fall

Rare*

* Estimated frequency from clinical trial data for post-marketing adverse reactions (spontaneous reports).

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).

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. Health 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.

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