Medicinal Products

PERINDOPRIL / INDAPAMIDE ARROW 2 mg / 0.625 mg

Generic drug from Preterax
Therapeutic class: Cardiology and angiology
active ingredients: Perindopril, Indapamide
laboratory: Arrow Generic

Tablet breackable
Box of 30
All forms

Indication

Essential hypertension.

Dosage PERINDOPRIL / INDAPAMIDE ARROW 2 mg / 0.625 mg Tablet scored 30

Oral way.

The usual dosage is one tablet of Perindopril / Indapamide Arrow 2mg / 0.625mg once daily, preferably in the morning and before meals. In case of no control of the blood pressure after one month of treatment, the dosage can be doubled.

Elderly (see section Warnings and precautions for use )

The treatment should be initiated at the usual dosage of one tablet of Perindopril / Indapamide Arrow 2mg / 0.625mg 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 tablet of Perindopril / Indapamide Arrow 2mg / 0.625mg per day. In patients with creatinine clearance greater than or equal to 60 ml / min, no dose adjustment is required. Current medical practice includes periodic monitoring of plasma 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 Arrow 2mg / 0.625mg 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 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 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 / Indapamide Arrow:

Hypersensitivity to any of the excipients

Due to the lack of sufficient therapeutic data, Perindopril / Indapamide Arrow should not be used at:

· Dialysis patients,

· Patients with untreated decompensated heart failure.

Adverse effects Perindopril / Indapamide Arrow

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 ARROW 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, <1/10); uncommon (≥1 / 1000, <1/100), rare (≥1 / 10, 000, <1/1000), very rare (<1 / 10, 000), unknown (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 ) has been reported with angiotensin-converting enzyme inhibitors on specific sites (kidney transplant, hemodialysis).

Psychiatric disorders

Rare :

· Mood or sleep disorders.

Nervous system disorders

Frequent

· Paresthesia, headache, dizziness, vertigo.

Very rare :

· Confusion.

Eye disorders

Frequent

· Vision disorders.

Affections of the ear and labyrinth

Frequent

· Tinnitus.

Vascular disorders

Frequent

Orthostatic or non-orthostatic hypotension (see 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 ).

Respiratory, thoracic and mediastinal disorders

Frequent

· 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.

Rare :

· Bronchospasm.

Very rare :

· Eosinophilic pneumonia, rhinitis.

Gastrointestinal disorders

Frequent

· Constipation, dry mouth, nausea, epigastric pain, abdominal pain, dysgeusia, vomiting, dyspepsia, diarrhea.

Very rare :

· Pancreatitis

Hepatobiliary disorders

Very rare :

· Cytolytic or cholestatic hepatitis (see Warnings and Precautions ) section.

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

Frequent

· 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

· Muscle cramps.

Renal and urinary disorders

Uncommon :

· Renal failure.

Very rare :

· Acute renal failure.

Disorders of reproductive organs and breast

Uncommon :

· Incapacity.

General Disorders and Administration Site

Frequent

· Asthenia.

Rare :

· Sweat.

investigations

· Potassium depletion with particularly severe 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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