Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Perindopril, Indapamide
Box of 90
Treatment of essential hypertension. BIPRETERAX is indicated in patients for whom the blood pressure is insufficiently controlled by perindopril alone.
Dosage BIPRETERAX 5 mg / 1.25 mg Film-coated tablet Box of 90
A film-coated tablet of BIPRETERAX 5 mg / 1.25 mg daily in one daily dose, preferably in the morning and before the meal.
Whenever possible, it is recommended that the components of the combination be administered individually. BIPRETERAX 5 mg / 1.25 mg should be used when blood pressure is not adequately controlled with PRETERAX 2.5 mg / 0.625 mg film-coated tablets (if commercially available).
In clinically appropriate cases, direct switching from monotherapy to BIPRETERAX 5 mg / 1.25 mg may be considered.
Elderly (see section Warnings and precautions for use )
Treatment should be initiated according to the blood pressure response and the state of renal function.
Patients with renal impairment (see Warnings and Precautions section )
In severe renal impairment (creatinine clearance <30 ml / min), treatment is contraindicated. In patients with moderate renal impairment (creatinine clearance
30-60 ml / min), it is recommended to initiate treatment at the appropriate dose of free combination. In patients with a creatinine clearance greater than or equal to 60 ml / min, no dose adjustment is required.
Current medical practice includes periodic monitoring of creatinine and potassium.
Patients with hepatic impairment (see section 4.3). Contraindications, Warnings and Precautions for Use and Pharmacokinetic Properties
In case of severe hepatic impairment, treatment is contraindicated.
In patients with moderate hepatic impairment, no dose adjustment is required.
The safety and efficacy of perindopril arginine / indapamide in the pediatric population have not been established to date.
BIPRETERAX 5 mg / 1.25 mg should not be used in children and adolescents.
Administration mode :
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 and Pregnancy and Lactation ).
Linked to indapamide:
Hypersensitivity to indapamide or other sulfonamides.
· Severe renal impairment (creatinine clearance <30 ml / min).
· Hepatic encephalopathy.
· Severe liver failure.
· As a general rule, this medicinal product should not be used in combination with non-antiarrhythmic medicines that can cause torsades de pointes (see section 4.5 ).
· Breastfeeding (see section on Pregnancy and breastfeeding ).
BIPRETERAX-related 5 mg / 1.25 mg:
Hypersensitivity to any of the excipients
Due to lack of data, BIPRETERAX should not be used at:
· Dialysis patients.
· Patients with untreated decompensated heart failure.
Bipreterax side effects
Administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce indapamide-induced potassium loss. Four percent of patients treated with BIPRETERAX 5 mg / 1.25 mg 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 (³ 1/1 000, <1/100), rare (³ 1/10 000,
<1/1000), very rare (<1 / 10, 000), not known (can not be estimated from the 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).
Uncommon: mood or sleep disorders
Nervous system disorders
Frequent : paresthesia, headache, asthenia, dizziness, vertigo.
Very rare : confusion.
Not known : syncope
Common : blurred vision
Affections of the ear and labyrinth
Frequent : tinnitus.
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 ).
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.
Very rare: eosinophilic pneumonia, rhinitis.
Common : constipation, dry mouth, nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhea.
Very rare : pancreatitis.
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.
· Angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx, urticaria (see Warnings and Precautions ) section.
· Hypersensitivity reactions, mainly dermatological, in subjects predisposed to allergic or asthmatic reactions.
· 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
· 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 urica 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.
· Elevated levels of liver enzymes.
Metabolic and nutritional disorders
Rare : hypercalcemia.
· 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.