Medicinal Products

PERINDOPRIL / INDAPAMIDE ZYDUS FRANCE 4 mg / 125 mg

Generic drug of Bipreterax
Therapeutic class: Cardiology and angiology
active ingredients: Perindopril + Indapamide
laboratory: Zydus France

Compressed
box of 90
All forms

Indication

Treatment of essential hypertension. PERINDOPRIL / INDAPAMIDE ZYDUS FRANCE is indicated in patients for whom the blood pressure is insufficiently controlled by perindopril alone.

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

Treatment of essential hypertension. PERINDOPRIL / INDAPAMIDE ZYDUS FRANCE is indicated in patients for whom the blood pressure is insufficiently controlled by perindopril alone.

Against indications

Related to perindopril:

Hypersensitivity to perindopril or other angiotensin converting enzyme inhibitors;

· History of angioedema (angioedema) associated with the use of a conversion enzyme inhibitor;

· Hereditary or idiopathic angioedema;

· Second and third trimesters of pregnancy (see Warnings and precautions for use and Pregnancy and lactation )

· The combination of PERINDOPRIL / INDAPAMIDE ZYDUS FRANCE with medicinal products containing aliskiren is contraindicated in patients with diabetes or renal impairment (GFR [Glomerular Filtration Rate] <60 ml / min / 1.73 m2 ) (see sections Interactions with other medicinal products and other forms of interaction and Pharmacodynamic properties ).

Linked to indapamide:

Hypersensitivity to indapamide or other sulfonamides;

· Severe renal impairment (creatinine clearance <30 ml / min);

· Hepatic encephalopathy;

· Severe hepatic insufficiency;

· Hypokalemia;

· As a general rule, this medicinal product should not be used in combination with non-antiarrhythmic drugs that can cause torsades de pointes (see section 4.5 ).

· Breastfeeding (see section on Pregnancy and breastfeeding ).

Linked to PERINDOPRIL / INDAPAMIDE ZYDUS FRANCE:

Hypersensitivity to any of the excipients

Due to the lack of data, PERINDOPRIL / INDAPAMIDE ZYDUS FRANCE should not be used at:

· Dialysis patients.

· Patients with untreated decompensated heart failure.

Adverse effects Perindopril / indap Zydus France

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 FRANCE experienced hypokalaemia (potassium level <3.4 mmol / l).

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

Very common (³ 1/10); frequent (³ 1/100, <1/10); uncommon (1/1000, <1/100), rare (1/10 000, <1/1000), very rare (<1/10 000), not known (can not be estimated from available data).

Blood and lymphatic system disorders

Very rare :

· Thrombocytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anemia, haemolytic anemia;

Anemia (see Warnings and Precautions ) has been reported with angiotensin-converting enzyme inhibitors on specific sites (kidney transplant, hemodialysis).

Psychiatric disorders

Uncommon: mood or sleep disorders

Nervous system disorders

Frequent: paresthesia, headache, asthenia, dizziness, vertigo.

Very rare: confusion.

Not known: syncope

Eye disorders

Common: blurred vision

Affections of the ear and labyrinth

Frequent: tinnitus.

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 for Use section ).

Not known: torsade de pointes (potentially fatal) (see Warnings and precautions for use and Interactions with other medicinal products and other forms of interaction ).

Vascular disorders

Common: orthostatic hypotension or not (see Warnings and Precautions section ).

Respiratory, thoracic and mediastinal disorders

Common: A dry cough has been reported with the use of angiotensin converting enzyme inhibitors. It is characterized by its persistence, as well as by its disappearance at the end of treatment. The iatrogenic etiology should be considered in the presence of this symptom. Dyspnea.

Uncommon: bronchospasm.

Very rare: eosinophilic pneumonia, rhinitis.

Gastrointestinal disorders

Common: constipation, dry mouth, nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhea.

Very rare: pancreatitis.

Hepatobiliary disorders

Very rare: cytolytic or cholestatic hepatitis (see Warnings and precautions for use ).

Not known: in case of hepatic impairment, the occurrence of hepatic encephalopathy is possible (see sections Contraindications and Warnings and precautions for use ).

Skin and subcutaneous tissue disorders

Common: rash, pruritus, maculopapular eruptions.

Rare :

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

· Hypersensitivity reactions, mainly dermatological, in subjects predisposed to allergic or asthmatic reactions;

· Purpura;

· Possible aggravation of pre-existing systemic lupus erythematosus.

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

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

Muscular, Connective Tissue and Bone Disorders

Frequent: muscle cramps.

Renal and urinary disorders

Uncommon: renal failure.

Very rare: acute renal failure.

Disorders of reproductive organs and breast

Uncommon: impotence

General disorders

Frequent: asthenia.

Uncommon: sweating.

investigations

Not known:

· Prolongation of the QT interval on the electrocardiogram (see sections Warnings and precautions for use and Interactions with other medicinal products and other forms of interaction );

Elevation of blood glucose and serum uric acid during treatment

· Moderate increase in plasma urea and creatinine, reversible upon discontinuation of treatment. This increase is more frequently encountered in cases of renal artery stenosis, diuretic-treated arterial hypertension, and renal failure;

· Elevated levels of liver enzymes.

Metabolic and nutritional disorders

Rare: hypercalcemia.

Not known:

· Potassium depletion with hypokalemia, particularly severe in some high-risk populations (see Warnings and Precautions section );

Elevation of plasma potassium levels, usually transient;

· Hyponatremia with hypovolemia leading to dehydration and orthostatic hypotension.

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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