Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Perindopril, Indapamide
Box of 30
PARATERAX is indicated for the treatment of essential hypertension, in substitution, in patients already controlled with perindopril and indapamide taken simultaneously at the same dosage.
Dosage PARATERAX 8 mg / 2.5 mg Tablet Box of 30
One tablet of PARATERAX per day in one daily dose, preferably in the morning and before the meal.
Elderly (see section Warnings and precautions for use )
In the elderly, serum creatinine should be adjusted for age, weight and sex. In the elderly, treatment may be initiated if the renal function is normal and after taking into account the blood pressure response.
Patients with renal impairment (see Warnings and Precautions section )
In moderate or severe renal impairment (creatinine clearance <60 ml / min), treatment is contraindicated.
The usual medical follow-up will include a periodic check 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.
Child and teenager
PARATERAX should not be used in children and adolescents because the efficacy and safety of perindopril in children and adolescents, alone or in combination, have not been established.
Related to perindopril:
Hypersensitivity to perindopril or other inhibitors 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 other sulfonamides,
· Hepatic encephalopathy,
· Severe liver failure,
· 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 PARATERAX:
Hypersensitivity to any of the excipients,
· Moderate or severe renal impairment (creatinine clearance <60 ml / min).
Due to lack of data, PARATERAX should not be used at:
· Dialysis patients,
· Patients with untreated decompensated heart failure.
Paraterax side effects
The administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by indapamide. Six percent of patients treated with PARATERAX 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 based available data).
Blood and lymphatic system disorders
Very rare :
· Thrombocytopenia, leukopenia / neutropenia, agranulocytosis, aplastic anemia, hemolytic 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.
Common: orthostatic hypotension or not (see Warnings and Precautions section ).
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 sections Warnings and precautions for use and Interactions with other medicinal products and other forms of interaction ).
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.
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 for Use 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 ).
Musculoskeletal and systemic 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 and administration site conditions
Frequent : asthenia.
Uncommon : sweating.
· QT prolongation of 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,
· Elevated levels of liver enzymes,
· 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.
Metabolism and nutrition disorders
Rare : hypercalcemia
· Potassium depletion with hypokalemia, particularly severe in some high-risk populations (see Warnings and precautions for use ),
· 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. Healthcare 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