Medicinal Products

PERINDOPRIL / INDAPAMIDE MYLAN 4 mg / 1.25 mg

Generic drug of Bipreterax
Therapeutic class: Cardiology and angiology
active ingredients: Perindopril, Indapamide
laboratory: Mylan

Compressed
Box of 30
All forms

Indication

Essential hypertension.

Treatment of essential hypertension. PERINDOPRIL / INDAPAMIDE MYLAN is indicated in patients for whom blood pressure is insufficiently controlled by perindopril alone.

Dosage PERINDOPRIL / INDAPAMIDE MYLAN 4 mg / 1.25 mg Tablet Box of 30

Dosage

The usual dose is one tablet of PERINDOPRIL / INDAPAMIDE MYLAN 4 mg / 1.25 mg once daily, preferably in the morning and before meals.

Whenever possible, it is recommended to individually adjust the dosages of the components.

PERINDOPRIL / INDAPAMIDE MYLAN 4 mg / 1.25 mg tablet should be used if blood pressure is not adequately controlled by PERINDOPRIL / INDAPAMIDE MYLAN 2 mg / 0.625 mg (if available). Direct switching from monotherapy to PERINDOPRIL / INDAPAMIDE MYLAN 4 mg / 1.25 mg tablet 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.

Pediatric population

The safety and efficacy of PERINDOPRIL / INDAPAMIDE MYLAN 4 mg / 1.25 mg in children and adolescents have not been established. PERINDOPRIL / INDAPAMIDE MYLAN 4 mg / 1.25 mg, tablet should not be used in children and adolescents.

Administration mode

Oral way.

Against indications

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.

· Hypokalemia.

· 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

Rare: Hypercalcemia.

Unknown :

· 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.

Psychiatric disorders

Uncommon: Mood or sleep disorders.

Nervous system disorders

Common: Paresthesia, headache, dizziness, vertigo.

Very rare: Confusion.

Eye disorders

Common: Vision disorders.

Affections of the ear and labyrinth

Common: Tinnitus.

Vascular disorders

Common: Hypotension orthostatic or not (see section 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 ).

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.

Dyspnea.

Uncommon: Bronchospasm.

Very rare: Eosinophilic pneumonia, rhinitis.

Gastrointestinal disorders

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.

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 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

Uncommon: Impotence.

General disorders and affecting the administration site

Frequent: Asthenia.

Uncommon: Sweating.

exams

Frequency unknown:

· 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.

Popular Posts

Category Medicinal Products, Next Article