Medicinal Products

PERINDOPRIL / INDAPAMIDE SANDOZ 4 mg / 1.25 mg

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

Compressed
Box of 30
All forms

Indication

Treatment of essential hypertension. PERINDOPRIL / INDAPAMIDE SANDOZ 4 mg / 1.25 mg tablet is indicated in patients whose blood pressure is insufficiently controlled by perindopril alone.

DOSAGE PERINDOPRIL / INDAPAMIDE SANDOZ 4 mg / 1.25 mg Tablet Box of 30

Oral way.

One tablet PERINDOPRIL / INDAPAMIDE SANDOZ 4 mg / 1.25 mg once daily, preferably in the morning and before meals.

If possible, it is recommended to individually adjust the dosages of each of the two components. PERINDOPRIL / INDAPAMIDE SANDOZ 4 mg / 1.25 mg should be used when blood pressure is insufficiently controlled by PERINDOPRIL / INDAPAMIDE SANDOZ 2 mg / 0.625 mg, tablet (if available). In clinically appropriate cases, direct switching from monotherapy to PERINDOPRIL / INDAPAMIDE combination 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), initiation of therapy at the appropriate dosage of free combination is recommended. 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.

Child and teenager

PERINDOPRIL / INDAPAMIDE SANDOZ 4 mg / 1.25 mg tablet 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.

Against indications

Perindopril-related

· Hypersensitivity to perindopril or other angiotensin-converting enzyme inhibitors (CEIs),

· History of angioedema (Quincke's edema) related to taking an ACE,

· Hereditary or idiopathic angioedema,

· Second and third trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).

Linked to indapamide

· Hypersensitivity to indapamide or other sulfonamides,

· Severe renal insufficiency (creatinine clearance <30 ml / min),

· Hepatic encephalopathy,

· Severe hepatic insufficiency,

· Hypokalemia,

· As a general rule, this medicine is not recommended when combined 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 SANDOZ 4 mg / 1.25 mg, tablet

· Hypersensitivity to any of the excipients.

Due to lack of data, PERINDOPRIL / INDAPAMIDE SANDOZ 4 mg / 1.25 mg tablets should not be used in the following cases:

· Dialysis patients,

· Patients with untreated decompensated heart failure.

Perindopril / Indapamide Sandoz side effects

Perindopril administration inhibits the renin-angiotensin-aldosterone axis and tends to reduce indapamide-induced potassium loss. Two per cent of patients treated with PERINDOPRIL / INDAPAMIDE SANDOZ 4 mg / 1.25 mg tablets 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), common (≥1 / 100, <1/10), uncommon (≥1 / 1, 000, <1/100), uncommon (≥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, medullary aplasia, hemolytic anemia.

· Anemia (see Warnings and Precautions ) has been reported with angiotensin-converting enzyme inhibitors on specific sites (kidney transplant, hemodialysis).

Psychiatric disorders

Uncommon: mood or sleep disorders

Nervous system disorders

Frequent: paresthesia, headache, dizziness, vertigo.

Very rare: confusion.

Eye disorders

Common: blurred vision

Affections of the ear and labyrinth

Frequent: tinnitus.

Vascular disorders

Common: orthostatic hypotension or not (see Warnings and Precautions section ).

Heart conditions

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.

Gastrointestinal disorders

Common: constipation, dry mouth, nausea, epigastric pain, anorexia, vomiting, abdominal pain, taste disturbances, dyspepsia, diarrhea.

Very rare: pancreatitis.

Hepatobiliary disorders

Very rare: cytolytic or cholestatic hepatitis (see Warnings and precautions for use ).

Unknown frequency: In case of hepatic insufficiency, 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.

Rare :

· 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 section ).

Muscular, Connective Tissue and Bone Disorders

Frequent: cramps.

Renal and urinary disorders

Uncommon: renal failure.

Very rare: acute renal failure.

Disorders of reproductive organs and breast

Uncommon: impotence

General disorders

Frequent: asthenia.

Uncommon: sweating.

Biological parameters

· 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.

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