Medicinal Products

PERINDOPRIL / INDAPAMIDE ZYDUS 4 mg / 125 mg

Generic drug of Bipreterax
Therapeutic class: Cardiology and angiology
Active ingredients: [PÃ © rindopril + Indapamide, 4495]
laboratory: Zydus France

ComprimÚ
box of 90
All forms

Indication

Treatment of essential arterial hypertension. PERINDOPRIL / INDAPAMIDE ZYDUS 4 mg / 1.25 mg, tablet is indicated in patients whose blood pressure is insufficiently controlled by perindopril alone.

DOSAGE PERINDOPRIL / INDAPAMIDE ZYDUS 4 mg / 125 mg tablet box of 90

Treatment of essential arterial hypertension. PERINDOPRIL / INDAPAMIDE ZYDUS 4 mg / 1.25 mg, tablet is indicated in patients whose blood pressure is insufficiently controlled by perindopril alone.

Against indications

Liaisons with přindopril

To hypersensitivity to perindopril or other inhibitors of the conversion enzyme (IEC).

Angio-oedeal Antarctic (Quincke oedîme) related to "taking an IEC.

At hereditary or idiopathic angioedoid.

Second and third trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and breast-feeding ).

Liaison to indapamide

Hypersensitivity to indapamide or other sulfonamides.

Severe renal insufficiency (clearance of creatinine <30 ml / min).

Hepatic encephalopathy.

To hepatic insufficiency sèvÞre.

At HypokaliÃÂmie.

As a rule, this drug is not recommended when combined with non-anti-arrhythmic drugs that may cause torsades de pointes (see section Interactions with other medicinal products and other forms of interaction ).

Breast-feeding (see section Pregnancy and breast-feeding ).

Binders to PERINDOPRIL / INDAPAMIDE ZYDUS 4 mg / 1.25 mg, tablets

Hypersensitivity to any of the excipients.

Due to the lack of data, PERINDOPRIL / INDAPAMIDE ZYDUS 4 mg / 1.25 mg tablets should not be used at:

To dialysis patients,

To patients in untreated heart failure untreated.

Adverse effects Perindopril / indapamide Zydus

The administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce indapamide-induced potassium loss. Two percent of patients treated with PERINDOPRIL / INDAPAMIDE ZYDUS 4 mg / 1.25 mg tablets had hypokalemia (potassium level <3.4 mmol / l).

The following undesirable effects could be observed during treatment and classified according to the following frequencies:

Very often (≥1 / 10); frequent (≥1 / 100, <1/10); not very frequent (≥1 / 1, 000, <1/100); rare (≥1 / 10, 000, <1/1000); very rare (<1 / 10, 000); indefinite frequency (can not be estimated from the available data).

Blood and lymphatic system disorders

Very rare:

Thrombocytopenia, leukopenia, neutropenia, agranulocytosis, medullary aplasia, hemolytic anemia.

An anemia (see Warnings and Precautions section ) has been reported with angiotensin-converting enzyme inhibitors, on particular sites (renal transplant, hematodialysis).

Psychiatric disorders

Few frequent: mood or sleep disorders.

Nervous System Affections

Frequent: paresthesia, cephalès, dizziness, vertigo.

Very rare: confusion.

Eye disorders

Frequent: blurred vision.

Affections of the ear and labyrinth

Frequent: tinnitus.

Vascular disorders

Frequent: postural hypotension or not (see Warnings and Precautions section ).

Heart conditions

Very rare: arrhythmias including bradycardia, ventricular tachycardia, atrial fibrillation, angina pectoris, and myocardial infarction, possibly secondary to "excessive hypotension in high-risk patients (see Warnings and Precautions section ).

Respiratory, thoracic and mediastinal disorders

Frequent: a dry cough has been reported with the use of ACE inhibitors. It is characterized by its persistence, as well as by its disappearance at the end of treatment. Iatrogenic Ãtology should be considered in the presence of this symptom. DyspnÚe.

Not very common: bronchospasm.

Very rare: esosinophilic pneumonia, rhinitis.

Gastrointestinal disorders

Frequent: constipation, dry mouth, nausea, epigastric pain, anorexia, vomiting, abdominal pain, eating disorders, dyspepsia, diarrhea.

Very rare: pancreasitis.

Hepato-biliary disorders

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

Frequency unknown: In case of hepatic insufficiency, the occurrence of a hepatic encephalopathy is possible (see sections Contraindications and Warnings and Precautions for use ).

Skin and subcutaneous tissue disorders

Frequent: rash, pruritus, maculopapular eruptions.

Few frequent:

Angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx, urticaria (see section Warnings and Precautions )

Reactions of hypersensitivity, mainly dermatological, in subjects prone to allergic or asthmatic reactions.

In Purpura

Possible aggravation of lupus erythematous dissemina preexisting.

Very rare: šrythÃme multiforme, toxic epidermal necrosis, Steven Johnson syndrome.

Cases of photosensitivity have been reported (see section Warnings and Precautions ).

Muscular, Connective Tissue and Bone Disorders

Frequent: cramps.

Renal and urinary disorders

Few frequent: renal insufficiency.

Very rare: acute renal failure.

Disorders of reproductive organs and breast

Few: impotence.

General disorders

Frequent: asthenia.

Not very frequent: sweating.

Biological parameters

• Potassium drop with a significant decrease in kalaemia in some populations at risk (see Warnings and Precautions section ).

Hyponatremia with hypovolemia at the origin of dehydration and orthostatic hypotension.

Elevation of uricemia and glycemia during treatment.

Moderate increase in plasma urea and creatinine, reversible at the end of treatment. This increase is more frequently encountered in case of stenosis of the renal artery, of arterial hypertension treated by diuretics, of renal insufficiency.

Elevation of plasma potassium levels, usually transient.

Rare: increased calcemia.

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