Medicinal Products


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

Tablet breackable
Box of 90
All forms


Essential hypertension.

Dosage PERINDOPRIL / INDAPAMIDE RATIOPH 2 mg / 0.625 mg Breakable tablet Box of 90

Oral way.

The tablet should be swallowed with a sufficient amount of liquid (eg a glass of water).

The usual dose is one tablet of Perindopril / INDAPAMIDE RATIOPHARM 2 mg / 0.625 mg 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 is started at the usual dosage of one tablet Perindopril / INDAPAMIDE RATIOPHARM 2 mg / 0.625 mg per day.

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), the maximum dosage should be one tablet of Perindopril / INDAPAMIDE RATIOPHARM 2 mg / 0.625 mg per day.

In patients with a creatinine clearance greater than or equal to 60 ml / min, no dose adjustment is required.

Routine medical 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

In case of severe hepatic impairment, treatment is contraindicated.

In patients with moderate hepatic impairment, no dose adjustment is required.

Child and teenager (under 18 years old)

Perindopril / INDAPAMIDE RATIOPHARM 2 mg / 0.625 mg should not be used in children and adolescents because the efficacy and safety of perindopril have not been established.

Against indications

Related to perindopril:

Hypersensitivity to perindopril or any other angiotensin-converting enzyme inhibitor (CEI),

· History of angioedema (angioedema) associated with the use of an angiotensin-converting enzyme inhibitor,

· Hereditary or idiopathic angioedema,

· 2nd and 3rd trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).

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 ).


Hypersensitivity to any of the excipients

Due to lack of data, PERINDOPRIL / INDAPAMIDE RATIOPHARM 2 mg / 0.625 mg should not be used in:

· Dialysis patients,

· Patients with untreated decompensated heart failure.

Adverse effects Perindopril / Indapamide Ratioph

Administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce indapamide-induced potassium loss. Two per cent of patients treated with Perindopril / INDAPAMIDE RATIOPHARM 2 mg / 0.625 mg experienced hypokalaemia (potassium level <3.4 mmol / l).

The following side effects have been observed during treatment and are classified in the following order of frequency:

very common (> 1/10);

frequent (≥ 1/100 - <1/10);

infrequent (≥ 1/1000 - <1/100);

rare (≥ 1/10 000 - <1/1 000);

very rare (<1 / 10, 000)

unknown (can not be estimated from available data)

Blood and lymphatic system disorders

Very rare:

Thrombocytopenia, leukopenia / neutropenia, agranulocytosis, medullary aplasia, haemolytic 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 disorders, sleep disturbances.

Nervous system disorders

Frequent: paresthesia, headache, dizziness, vertigo.

Very rare: confusion.

Eye disorders

Frequent: visual disturbances.

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 that may be secondary to excessive hypotension in high-risk patients (see Warnings and Precautions 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 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

Frequent: constipation, dry mouth, nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhea.

Very rare: pancreatitis, intestinal angioedema.

Hepatobiliary disorders

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

Not known: in case of hepatic insufficiency, possibility of occurrence of hepatic encephalopathy (see sections Contraindications and Warnings and precautions for use ).

Skin and subcutaneous tissue disorders

Common: rash, pruritus, maculopapular rash

Uncommon: 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 and asthmatic manifestations,


Possibility of aggravation of pre-existing disseminated acute lupus erythematosus.

Very rare: erythema multiforme, toxic epidermal necrosis, Steven Johnson syndrome.

Cases of photosensitivity have been reported (see Warnings and Precautions section ).

Musculoskeletal and systemic 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 and administration site conditions

Frequent: asthenia.

Uncommon: sweats.


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.

Elevation of serum uric acid and blood glucose during treatment.

Moderate increase in urea and serum creatinine, reversible upon discontinuation of treatment. This increase is more frequently encountered in cases of renal artery stenosis, diuretic-treated hypertension, and renal failure.

Hyperkalemia, usually transient.

Rare: increased serum calcium.

Popular Posts

Category Medicinal Products, Next Article