Medicinal Products

PERINDOPRIL ISOMED 2 mg

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: [Perindopril, 1399], [Perindopril, 1399], [Perindopril, 1399]
laboratory: Teva Sante

© tablet
box of 90
All forms

Indication

Hypertension

Treatment of arterial 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 ISOMED 2 mg tablet box of 90

Hypertension

Treatment of arterial 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.

Against indications

· Hypersensitivity to perindopril, any of the excipients, or other angiotensin-converting enzyme (ACE) inhibitors;

· Anterior angioedema related to the intake of an IEC;

 · Hedonary or idiopathic angioedema;

· 2nd and 3rd trimesters of pregnancy (see sections Warnings and Precautions and Pregnancy and Lactation );

 · The combination of PERINDOPRIL ISOMED with medicinal products containing aliskiren is contraindicated in patients with diabetes mellitus or renal insufficiency (DFG [Glomerated Filtration Rate] <60 ml / min / 1.73 m 2 ) (see sections Interactions with other medicinal products and other forms of interaction and pharmacodynamic properties ).

Perindopril Isomed side effects

The following undesirable effects have been observed during treatment with perindopril and are categorized by frequency.

Very frequent (≥ 1/10); Frequency (≥ 1/100, <1/10) not very frequent (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (<1/10000); unknown (can not be estimated from available data).

Hematologic and lymphatic system disorders

A decrease in hemoglobin and hematocrit, thrombocytopenia, leukopenia / neutropenia, and cases of agranulocytosis or pancytopenia have been reported very rarely. © s. In patients with congenital G6-PDH deficiency, very rare cases of hemolytic anemia have been reported (see Warnings and Precautions section). employment ).

Metabolism and nutrition disorders

Unknown: Hypoglycaemia (see Warnings and Precautions and Interactions with other medicinal products and other forms of interactions sections).

Psychiatric disorders

Uncommon: mood or sleep disorders.

Nervous system disorders

Frequent: cephalated, dizziness, vertigo, paresthesia.

Very rare: confusion.

Eye disorders

Frequent: blurred vision.

Affections of the ear and labyrinth

Frequent: tinnitus.

Heart conditions

Very rare: arrhythmia, angina pectoris and myocardial infarction, possibly secondary to excessive hypotension in high-risk patients (see Warnings and Precautions section ).

Vascular disorders

Frequent: hypotension and effects related to hypotension.

Very rare: stroke, possibly secondary to excessive hypotension in high-risk patients (see Warnings and Precautions section ).

Unknown: vasculitis.

Respiratory, thoracic and mediastinal disorders

Frequent: cough, dyspnea.

Not very frequent: bronchospasm.

Very rare: erosinophilic pneumonia, rhinitis.

Gastrointestinal disorders

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

Not very common: dry mouth.

Very rare: pancreatitis.

Hereditary conditions

Very rare: Cytolytic or cholestatic hepatitis (see Warnings and Precautions section ).

Skin and subcutaneous tissue disorders

Frequent: rash, pruritus.

Uncommon: angio-edema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx, urticaria (see section 4.4). precautions for use ).

Very rare: multiform rhythm.

Musculoskeletal and systemic disorders

Frequent: muscle cramps.

Renal and urinary disorders

Not very frequent: renal insufficiency.

Very rare: acute renal failure.

Disorders of reproductive organs and breast

Not very common: impotence.

General disorders

Frequent: asthenia.

Not very frequent: sweating.

Biological parameters

Increases in urea and plasma creatinine, reversible hyperkalemia upon discontinuation of treatment may occur, particularly in the presence of renal insufficiency, heart failure Severe and Renovascular Hypertension. Anemia of hepatic enzymes and bilirubinemia has rarely been reported.

Clinical tests

During the randomization period of the EUROPA study, only serious adverse effects were collected. Few patients experienced serious adverse events: 16 (0.3%) of 6, 122 patients treated with perindopril and 12 (0.2%) of 6, 107 patients treated with placebo. In patients treated with perindopril, hypotension was observed in 6 patients, angioedema in 3 patients and cardiac arrest in 1 patient. Treatment discontinuation due to cough, hypotension, or other intolerance was observed in more patients on perindopril than placebo, respectively 6% (n = 366). ) versus 2.1% (n = 129).

Declaration of suspected untoward effects

The declaration of suspected adverse effects after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals disclose any suspected adverse effects via the national reporting system: National Health and Medical Products Safety Authority (Ansm) and Network Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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