Medicinal Products

BENAZEPRIL 5 mg

Generic drug of Cibacene
Therapeutic class: Cardiology and angiology
Active ingredients: Benazepril
laboratory: EG Labo

Divisible coated tablet
Box of 30
All forms

Indication

Hypertension.

Dosage BENAZEPRIL EG 5 mg Film-coated tablet scored box of 30

Benazepril tablets may be taken before, during or after meals, as food does not alter bioavailability but delays absorption.

Benazepril is given once daily.

Essential hypertension

In the absence of prior water-soluble depletion or renal insufficiency (in common practice): The effective dosage is 10 mg daily in a single dose.

If necessary, a non-hyperkalaemic diuretic may be combined to achieve a further decrease in blood pressure.

In arterial hypertension previously treated with diuretics:

· Stop the diuretic 3 days ago to reintroduce it later if necessary,

· Either give initial doses of 2.5 mg and adjust them according to the blood pressure response.

It is recommended to dose plasma creatinine and serum potassium before treatment and within 15 days of starting therapy.

In subjects over 70 years of age (see Warnings and Precautions section ), start treatment with a lower dose (5 mg / day), increased, if necessary, to 10 mg / day after one month of treatment.

In renovascular hypertension, it is recommended to start treatment at a dose of 2.5 mg / day and subsequently adjust to the patient's blood pressure response.

Serum creatinine and serum potassium will be monitored for the presence of possible renal impairment (see Warnings and Precautions ).

In case of renal insufficiency, the dosage of benazepril is adjusted to the degree of this insufficiency:

· If the creatinine clearance is greater than or equal to 30 ml / min, no change in dosage is necessary.

· If creatinine clearance is less than 30 ml / min, a daily dose of 5 mg daily is recommended.

In these patients, normal medical practice includes a periodic control of potassium and creatinine, for example every two months in times of therapeutic stability.

The diuretics to be associated in this case are the so-called loop diuretics.

Benazeprilat is weakly dialyzable (see Warnings and precautions for use / hemodialysis section).

Against indications

This medicine should NEVER BE USED in case of:

Hypersensitivity to benazepril or to any of the excipients

· History of angioedema (Quincke's edema) related to the use of a conversion enzyme inhibitor,

· In the 2nd and 3rd trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and breast-feeding ).

· In case of bowel obstruction, due to the presence of castor oil.

This medicine is NOT RECOMMENDED for:

· Combinations with potassium-sparing diuretics, potassium salts, estramustine and lithium (see section Interactions with other medicinal products and other forms of interaction ),

· Bilateral stenosis of the renal artery or functionally unique kidney,

· Hyperkalemia.

· During the first trimester of pregnancy.

Adverse effects Benazepril EG

Clinically

Have been found:

· Headache, asthenia, vasomotor reactions, dizziness, palpitations,

Hypotension, orthostatic or not (see section Warnings and precautions for use / Precautions for use),

· Rash, pemphigus, Stevens Johnson syndrome,

· Digestive disorders especially due to the presence of castor oil (nausea, vomiting, abdominal pain), dysgeusia,

· Isolated cases of liver injury,

· 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.

Exceptionally:

· Angioedema (Quincke's edema) (see Warnings and precautions for use ).

Biologically

· Moderate increase in urea and plasma creatinine, reversible upon discontinuation of treatment. This increase is more frequently encountered in cases of stenosis of the renal arteries, arterial hypertension treated with diuretics, renal failure.

· In case of glomerular nephropathy, administration of a conversion enzyme inhibitor may cause proteinuria.

· Hyperkalemia, usually transient.

· Anemia (see Warnings and Precautions ) has been reported with angiotensin-converting enzyme inhibitors on specific sites (kidney transplant, hemodialysis). Hemolytic anemia has been observed.

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