Medicinal Products

PERINDOPRIL ARGI / INDAP SERVIER 10 mg / 2.5 mg

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Perindopril, Indapamide
laboratory: Servier

Coated tablet
Box of 1 Pill box of 30
All forms

Indication

PERINDOPRIL ARGININE / INDAPAMIDE SERVIER is indicated for the treatment of essential hypertension, in substitution, in patients already controlled with perindopril and indapamide taken simultaneously at the same dosage.

Dosage PERINDOPRIL ARGI / INDAP SERVIER 10 mg / 2.5 mg Film-coated tablet Box of 1 Pill box of 30

Oral way.

One tablet of PERINDOPRIL ARGININE / INDAPAMIDE SERVIER per day in one daily dose, preferably in the morning and before the meal.

Elderly (see section Warnings and precautions for use )

In the elderly, serum creatinine should be adjusted for age, weight and sex. In the elderly, treatment may be initiated if the renal function is normal and after taking into account the blood pressure response.

Patients with renal impairment (see Warnings and Precautions section )

In moderate or severe renal impairment (creatinine clearance <60 ml / min), treatment is contraindicated.

The usual medical follow-up will include a periodic check 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 ARGININE / INDAPAMIDE SERVIER 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

Related to perindopril:

Hypersensitivity to perindopril or other inhibitors 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 other sulfonamides,

· Hepatic encephalopathy,

· Severe liver failure,

· Hypokalemia,

· As a rule, this medicinal product should not be used in combination with non-antiarrhythmic medicines that can cause torsades de pointes (see section Interactions with other medicinal products and other forms of interaction ),

· Breastfeeding (see section on Pregnancy and breastfeeding ).

Related to PERINDOPRIL ARGININE / INDAPAMIDE SERVIER:

Hypersensitivity to any of the excipients,

· Moderate or severe renal impairment (creatinine clearance <60 ml / min).

Due to the lack of data, PERINDOPRIL ARGININE / INDAPAMIDE SERVIER should not be used at:

· Dialysis patients,

· Patients with untreated decompensated heart failure.

Side effects Perindopril Argi / Indap Servier

The administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by indapamide. Six percent of patients treated with PERINDOPRIL ARGININE / INDAPAMIDE SERVIER 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 (³ 1/10); frequent (³ 1/100, <1/10); uncommon (1/1000, <1/100), rare (1/10 000, <1/1000), very rare (<1/10 000), not known (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 section ) 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, asthenia, 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, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhea.

Very rare: pancreatitis.

Hepatobiliary disorders

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 subcutaneous tissue disorders

Common: rash, pruritus, maculopapular eruptions.

Rare :

Angio-edema 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: muscle 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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