Generic drug from Preterax
Therapeutic class: Cardiology and angiology
active ingredients: Perindopril, Indapamide
Box of 90
Dosage PERINDOPRIL / INDAPAMIDE BIOG 2 mg / 0.625 mg Breakable tablet Box of 90
The usual dosage is one tablet of PERINDOPRIL / INDAPAMIDE BIOGARAN per day in one dose, preferably in the morning and before the meal. In case of no control of the blood pressure after one month of treatment, the dosage can be doubled.
Elderly (see section Warnings and precautions for use )
Treatment should be initiated at the usual dose of one PERINDOPRIL / INDAPAMIDE BIOGARAN tablet per day.
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), the maximum dosage should be one PERINDOPRIL / INDAPAMIDE BIOGARAN tablet per day. 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 BIOGARAN 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 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,
· 2nd and 3rd trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation )
Linked to indapamide:
· Hypersensitivity to indapamide or any other sulfonamide,
· Severe renal impairment (creatinine clearance <30 ml / min),
· Hepatic encephalopathy,
· Severe liver failure,
In general, this drug is not recommended when used with non-antiarrhythmic drugs that can cause torsades de pointes (see section 4.5 ).
· Breastfeeding (see section on Pregnancy and breastfeeding ).
Related to PERINDOPRIL / INDAPAMIDE BIOGARAN:
Hypersensitivity to any of the excipients
Due to lack of data, PERINDOPRIL / INDAPAMIDE BIOGARAN should not be used at:
· Dialysis patients,
· Patients with untreated decompensated heart failure.
Perindopril / Indapamide Biog side effects
The administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by indapamide. Two percent of patients treated with PERINDOPRIL / INDAPAMIDE BIOGARAN 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 ) 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.
Common : blurred vision
Ear and labyrinth disorders
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 ).
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, epigastric pain, anorexia, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhea.
Very rare: pancreatitis.
Very rare: cytolytic or cholestatic hepatitis (see Warnings and precautions for use ).
Unknown: In case of hepatic insufficiency, the occurrence of hepatic encephalopathy is possible (see sections Contraindications and Warnings and precautions for use ).
Skin and 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 ).
Muscle, connective tissue and bone disorders
Renal and urinary disorders
Uncommon : renal failure.
Very rare : acute renal failure.
Disorders of the reproductive organs and breast
Uncommon : impotence
Frequent : asthenia.
Uncommon : sweating.
· Potassium depletion with significant decrease in serum potassium in some at-risk populations (see Warnings and Precautions for Use section ).
· 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.