Medicinal Products

PERINDOPRIL / INDAPAMIDE RATIOPH 4 mg / 1.25 mg

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

Compressed
Box of 30
All forms

Indication

Treatment of Essential Arterial Hypertension, Perindopril / INDAPAMIDE RATIOPHARM 4 mg / 1.25 mg is indicated in patients for whom blood pressure is insufficiently controlled by perindopril alone.

Dosage PERINDOPRIL / INDAPAMIDE RATIOPH 4 mg / 1.25 mg Tablet Box of 30

Oral way.

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

The usual dosage is one tablet Perindopril / INDAPAMIDE RATIOPHARM 4 mg / 1.25 mg once daily, preferably in the morning and before the meal.

Whenever possible, it is recommended that the components of the combination be administered individually.

In clinically appropriate cases, direct switching from perindopril / INDAPAMIDE RATIOPHARM 4 mg / 1.25 mg monotherapy may be considered.

Elderly (see section Warnings and precautions for use )

The treatment is started at the usual dosage of one tablet Perindopril / INDAPAMIDE RATIOPHARM 4 mg / 1.25 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 4 mg / 1.25 mg daily.

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 4 mg / 1.25 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 medicine is not recommended when used 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 RATIOPHARM 4 mg / 1.25 mg:

Hypersensitivity to any of the excipients

Due to lack of data, PERINDOPRIL / INDAPAMIDE RATIOPHARM 4 mg / 1.25 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 4 mg / 1.25 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,

purpura

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

investigations

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.

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