Generic drug from Preterax
Therapeutic class: Cardiology and angiology
active ingredients: Perindopril, Indapamide
Box of 90
Dosage PERINDOPRIL / INDAPAMIDE MYLAN 2 mg / 0.625 mg Tablet Box of 90
The usual dose is one tablet of PERINDOPRIL / INDAPAMIDE MYLAN per day, in one dose, preferably in the morning and before the meal. If blood pressure is not controlled with PERINDOPRIL / INDAPAMIDE after one month of treatment, the dosage may be doubled.
Elderly ( See Warnings and Precautions section )
Treatment should be initiated at the usual dosage of one PERINDOPRIL / INDAPAMIDE MYLAN 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 MYLAN tablet per day.
In patients with a 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.
The safety and efficacy of PERINDOPRIL / INDAPAMIDE MYLAN in children and adolescents have not been established. PERINDOPRIL / INDAPAMIDE MYLAN, tablet should not be used in children and adolescents.
Related to perindopril:
Hypersensitivity to perindopril or any other ACE inhibitor.
· History of angioedema (angioedema) associated with the use of a conversion 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.
· 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 ).
Related to PERINDOPRIL / INDAPAMIDE MYLAN tablet:
Hypersensitivity to any of the excipients
Due to the lack of therapeutic follow-up, PERINDOPRIL / INDAPAMIDE MYLAN should not be used in:
· Dialysis patients.
· Patients with untreated decompensated heart failure.
Perindopril / Indapamide Mylan 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 MYLAN 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 to <1/10).
Uncommon (≥ 1/1000 to <1/100).
Rare (≥ 1/10 000 to <1/1000).
Very rare (<1 / 10, 000), unknown (can not be estimated from the 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).
Metabolism and eating disorders
· Hyponatremia with hypovolemia causing dehydration and orthostatic hypotension.
· Potassium depletion with particularly significant decrease in serum potassium in certain populations at risk (see Warnings and precautions for use ).
· Elevation of plasma potassium levels, usually transient.
· Concurrent loss of chloride ions may result in compensatory secondary metabolic alkalosis: the incidence and degree of this effect are low.
Uncommon: Mood or sleep disorders.
Nervous system disorders
Common: Paresthesia, headache, dizziness, vertigo.
Very rare: Confusion.
Common: Vision disorders.
Affections of the ear and labyrinth
Common: Hypotension orthostatic or not (see section Warnings and precautions for use ).
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 ).
Unknown: Torsades de pointes (potentially life-threatening) (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.
Very rare: Eosinophilic pneumonia, rhinitis.
Common: Constipation, dry mouth, nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhea.
Very rare: Pancreatitis.
Hepatic and biliary disorders
Very rare: Cytolytic or cholestatic hepatitis (see Warnings and precautions for use ).
Unknown frequency: In case of hepatic insufficiency, hepatic encephalopathy is possible (see sections Contraindications and Warnings and precautions for use ).
Skin and tissue disorders
Common: Rash, pruritus, maculopapular rashes.
Uncommon: 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 for Use section ).
Musculoskeletal and connective tissue disorders
Common: Muscle cramps.
Kidney and urinary disorders
Uncommon: Renal insufficiency.
Very rare: Acute renal failure.
Disorders of reproductive organs and breast
General disorders and affecting the administration site
· QT prolongation to the ECG (see Warnings and Precautions and Interactions with other medicinal products and other forms of interactions ) sections.
· Increased uric acid and blood glucose levels 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.