Medicinal Products

PERINDOPRIL / INDAPAMIDE TEVA 4 mg / 1.25 mg

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

Compressed
Box of 90
All forms

Indication

Essential hypertension.

Treatment of essential hypertension. PERINDOPRIL / INDAPAMIDE TEVA 4 mg / 1.25 mg tablet is indicated in patients for whom the blood pressure is insufficiently controlled by perindopril alone.

DOSAGE PERINDOPRIL / INDAPAMIDE TEVA 4 mg / 1.25 mg Tablet Box of 90

Oral way.

The usual dose is one tablet of PERINDOPRIL / INDAPAMIDE TEVA 4 mg / 1.25 mg daily, all at once, preferably in the morning before the meal.

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

PERINDOPRIL / INDAPAMIDE TEVA 4 mg / 1.25 mg, tablet, should be used if blood pressure is insufficiently controlled by PERINDOPRIL / INDAPAMIDE TEVA 2 mg / 0.625 mg (if available). Direct switching from PERINDOPRIL / INDAPAMIDE TEVA 4 mg / 1.25 mg tablet monotherapy may be considered if clinically appropriate.

Elderly (See Warnings and Precautions section )

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.

Child and teenager

PERINDOPRIL / INDAPAMIDE TEVA 4 mg / 1.25 mg tablets should not be used in children and adolescents because the efficacy and safety of perindopril in children and adolescents, alone or in combination, may have not been established.

Against indications

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,

· 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 hepatic insufficiency;

· Hypokalemia;

· As a general rule, this medicinal product should not be used in combination 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 TEVA tablet:

Hypersensitivity to any of the excipients

Due to lack of therapeutic recurrence, PERINDOPRIL / INDAPAMIDE TEVA 4 mg / 1.25 mg tablets should not be used in:

· Dialysis patients,

· Patients with untreated decompensated heart failure.

Perindopril / Indapamide Teva side effects

Perindopril administration inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by Indapamide. Four per cent of patients treated with PERINDOPRIL / INDAPAMIDE TEVA 4 mg / 1.25 mg tablet 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).

Psychiatric disorders:

Uncommon: Mood or sleep disorders.

Very rare: Confusion.

Nervous system disorders:

Common: Paresthesia, headache, dizziness, vertigo.

Eye disorders:

Common: Vision disorders.

Ear and labyrinth disorders:

Common: Tinnitus.

Vascular disorders:

Common: Hypotension orthostatic or not (see section Warnings and precautions for use ).

Heart problems:

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 ).

Respiratory, thoracic and mediastinal disorders:

Frequent

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 the reproductive organs and breast:

Uncommon: Impotence.

General disorders and affecting the site of administration:

Frequent: Asthenia.

Uncommon: Sweating.

Exams:

Potassium depletion with significant decrease in serum potassium in certain populations at risk (see Warnings and precautions for use ).

Hyponatremia with hypovolemia causing dehydration and orthostatic hypotension.

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.

Elevation of plasma potassium levels, usually transient.

Rare : Hypercalcemia.

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