Medicinal Products

PERINDOPRIL / INDAPAMIDE ZENTIVA 4 mg / 1.25 mg

Generic drug of Bipreterax
Therapeutic class: Cardiology and angiology
active ingredients: Perindopril, Indapamide
laboratory: Sanofi-Aventis France

Compressed
Box of 90
All forms

Indication

Treatment of essential hypertension. PERINDOPRIL / INDAPAMIDE ZENTIVA LAB 4 mg / 1.25 mg is indicated in patients for whom blood pressure is insufficiently controlled by perindopril alone.

DOSAGE PERINDOPRIL / INDAPAMIDE ZENTIVA 4 mg / 1.25 mg Tablet Box of 90

Oral way.

One tablet of PERINDOPRIL / INDAPAMIDE ZENTIVA LAB 4 mg / 1.25 mg per day taken daily, preferably in the morning and before the meal.

Whenever possible, it is recommended to individually adjust the dosages of the components. PERINDOPRIL / INDAPAMIDE ZENTIVA LAB 4 mg / 1.25 mg should be used if blood pressure is insufficiently controlled by PERINDOPRIL / INDAPAMIDE ZENTIVA LAB 2 mg / 0.625 mg.

Direct switching from PERINDOPRIL / INDAPAMIDE ZENTIVA LAB 4 mg / 1.25 mg monotherapy may be considered if clinically appropriate.

Elderly (see section Warnings and precautions for use )

Treatment should be initiated after taking into account the blood pressure response and renal function.

Patients with renal impairment (see Warnings and Precautions section )

Treatment is contraindicated in severe renal impairment (creatinine clearance <30 ml / min).

In patients with moderate renal impairment (creatinine clearance 30-60 ml / min) it is recommended to initiate treatment at the appropriate dosage of free combination. In patients with creatinine clearance greater than or equal to 60 ml / min, no dose adjustment is required. Routine monitoring includes periodic monitoring of creatinine and potassium.

Patients with hepatic impairment (see section 4.3). Contraindications, Warnings and Precautions for Use and Pharmacokinetic Properties

Treatment is contraindicated in patients with severe hepatic impairment.

In patients with moderate hepatic impairment, no dose adjustment is required.

Child and teenager

PERINDOPRIL / INDAPAMIDE ZENTIVA LAB 4 mg / 1.25 mg should not be used in children and adolescents because the efficacy and safety of perindopril in children and adolescents, alone or in combination, does not have not been established.

Against indications

Related to perindopril:

Hypersensitivity to perindopril or any other inhibitor of the converting enzyme,

· History of angioedema (angioedema) associated with the use of an angiotensin-converting enzyme inhibitor,

· Hereditary or idiopathic angioedema,

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

Linked to indapamide:

· Hypersensitivity to indapamide or any other sulfonamide,

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

· Hepatic encephalopathy,

· Severe liver failure,

· Hypokalemia,

· As a rule, this medicinal product should not be used in combination with non-antiarrhythmic medicines that can cause torsades de pointes (see section Interactions with other medicinal products and other forms of interaction ),

· Breastfeeding (see section on Pregnancy and breastfeeding ).

Related to PERINDOPRIL / INDAPAMIDE ZENTIVA LAB:

Hypersensitivity to any of the excipients

Due to the lack of sufficient therapeutic data, PERINDOPRIL / INDAPAMIDE ZENTIVA LAB should not be used in:

· Dialysis patients,

· Patients with untreated decompensated heart failure.

Perindopril / Indapamide Zentiva side effects

The administration of Perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by indapamide. Four percent of patients treated with PERINDOPRIL / INDAPAMIDE ZENTIVA LAB 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 (≥ 1/10) frequent (≥1 / 100, <1/10); uncommon (≥1 / 1000, <1/100), rare (≥1 / 10, 000, <1/1000), very rare (<1 / 10, 000), unknown (can not be estimated from available data) .

Blood and lymphatic system disorders

Very rare:

Thrombocytopenia, leukopenia / neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia.

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

Psychiatric disorders

Rare :

Mood or sleep disorders

Nervous system disorders

Frequent

Paresthesia, headache, dizziness, vertigo.

Very rare :

Confusion.

Eye disorders

Frequent

Vision disorders.

Affections of the ear and labyrinth

Frequent

Tinnitus.

Vascular disorders

Frequent

Orthostatic hypotension or not (see Warnings and precautions for use ).

Heart conditions

Very rare :

Arrhythmia 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 ).

Respiratory, thoracic and mediastinal disorders

Frequent

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.

Rare :

Bronchospasm.

Very rare :

Eosinophilic pneumonia, rhinitis.

Gastrointestinal disorders

Frequent

Constipation, dry mouth, nausea, epigastric pain, abdominal pain, dysgeusia, vomiting, dyspepsia, diarrhea.

Very rare :

Pancreatitis.

Hepatobiliary disorders

Very rare:

Cytolytic or cholestatic hepatitis (see Warnings and Precautions for Use section ).

Unknown:

In case of hepatic insufficiency, the occurrence of hepatic encephalopathy is possible (see sections Contraindications and Warnings and precautions for use ).

Skin and subcutaneous tissue disorders

Frequent

Rash, pruritus, maculopapular eruptions.

Rare :

Angio-edema 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

Rare :

Renal failure.

Very rare :

Acute renal failure.

Disorders of reproductive organs and breast

Rare :

Incapacity.

General Disorders and Administration Site

Frequent

Asthenia.

Rare :

Sweat.

investigations

Potassium depletion with particularly severe decrease in serum potassium in certain populations at risk (see Warnings and precautions for use ).

Hyponatremia with hypovolemia causing dehydration and orthostatic hypotension.

Elevation of serum uric acid and blood glucose 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 hypertension, and renal failure.

Elevation of plasma potassium levels, usually transient.

Rare:

Increased serum calcium

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