Medicinal Products

ENALAPRIL BIOGARAN 5 mg

Generic drug from Renitec
Therapeutic class: Cardiology and angiology
active ingredients: Enalapril
laboratory: Biogaran

Tablet breackable
Box of 28
All forms

Indication

· Hypertension

· Heart failure

Enalapril treatment versus placebo:

a) In patients with symptomatic heart failure:

· Delay the progression of heart failure,

· Decreases the number of hospitalizations for heart failure,

· Increases survival.

b) In asymptomatic patients with demonstrated left ventricular dysfunction:

· Delay the development of symptomatic heart failure,

· Decreases the number of hospitalizations for heart failure.

Dosage ENALAPRIL BIOGARAN 5 mg scored tablet Box of 28

Enalapril, in tablet form, can be taken before, during or after meals, as food does not alter its bioavailability.

Enalapril is given once or twice daily.

ARTERIAL HYPERTENSION

In the absence of prior hydrosodium depletion or renal failure (in common practice):

The effective dosage is 20 mg once daily.

Depending on the response to the treatment, the dosage should be adjusted, within 3-4 weeks, up to 40 mg / day once.

In arterial hypertension previously treated with a diuretic:

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

· Either give initial doses of 5 mg or less, and adjust for the blood pressure response.

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

In the elderly, possibly initiate treatment with a lower dosage adapted to the patient's renal function, appreciated before the start of treatment, if it is less than 80 ml / min (see table below) .

The value of creatinine clearance (Cl cr ) calculated from serum creatinine and adjusted for age, weight, and sex, as per the Cockroft * formula, for example, correctly reflects the state of renal function in this type of patient.

* Clcr = (140 - age) x weight / 0.814 x serum creatinineWith

· Age in years,

· The weight in kg,

· Creatinine in micromol / l.

·

This formula is valid for male subjects, and must be corrected for women by multiplying the results by 0.85.

In renovascular hypertension, it is recommended that treatment be initiated at a dose of 5 mg per day or less, and subsequently adjusted to the patient's blood pressure response (see Warnings and Precautions for Use section) Precautions job). Most patients respond to a dosage of 10 to 20 mg per day in one or two doses.

Serum creatinine and serum potassium will be monitored for the presence of possible functional renal failure (see section 4.5 ). Interactions with other medicinal products and other forms of interaction Precautions for use.

In renal impairment, the dosage of enalapril is adjusted to the degree of this deficiency.

Creatinine clearance (ml / min)

Initial dosage (mg / day)

30 <Clcr <80

5-10

10 - 30

2.5 to 5

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

In these patients, normal medical practice includes a periodic control of potassium and creatinine, for example every two months during periods of therapeutic stability (see section Warnings and precautions for use Precautions).

In hypertensive hemodialysis

Enalapril is dialysable (see Warnings and Precautions section Warnings ). The clearance of dialysis is 62 ml / min.

The dosage is 2.5 mg on the day of dialysis.

On days when patients are not dialysed, the dosage should be adjusted according to the results obtained on the blood pressure.

HEART FAILURE

The initial dose should be low, especially in case of:

· Normal or low blood pressure at baseline,

· renal failure,

· Hyponatremia, iatrogenic (diuretic) or not.

Enalapril can be used in combination with diuretic therapy with, if necessary, digitalis treatment.

It is recommended to initiate treatment with 2.5 mg under blood pressure monitoring and increase gradually (within 2 to 4 weeks) to the usual 20 mg daily maintenance dose divided into 1 or 2 sockets.

The dose chosen should not lower systolic blood pressure to orthostatism below 90 mmHg.

Symptomatic hypotension may occur in patients with heart failure treated with high doses of diuretics: in this case, the initial dose should be reduced by half (see Warnings and Precautions for Use Precautions).

Assays of creatinine and serum potassium should be done at each dose increase, then every 3 to 6 months depending on the stage of heart failure, in order to control the tolerance to treatment.

Against indications

This medicine should never be used in case of:

Hypersensitivity to enalapril or any of the excipients,

· History of angioedema (angioedema) associated with the use of an angiotensin converting enzyme inhibitor and / or hereditary or idiopathic angioedema,

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

This medicine is generally not recommended in case of:

· Combinations with potassium diuretics, potassium salts, lithium and estramustine (see section 4.5, Interactions with other medicinal products and other forms of interaction )

Bilateral stenosis of the renal artery or functionally unique kidney,

· Hyperkalemia,

Adverse effects Enalapril Biogaran

Clinically

· Headache, asthenia, dizziness, syncope,

Hypotension, orthostatic or not (see Warnings and Precautions for Use Precautions),

· Rash, rash, photosensitization, erythema multiforme, exfoliative dermatitis, Stevens Johnson syndrome, pemphigus, urticaria, alopecia, pruritus

· Nausea, diarrhea, constipation, abdominal pain, vomiting, anorexia, cholestatic or cytolytic hepatitis, liver failure, pancreatitis, jaundice,

· Muscle cramps, dysgeusia,

· Depression, confusion nervousness, bronchospasm, dyspnea,

· 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 section Warnings ),

· Very rarely: impotence, flushing, tinnitus, glossitis, blurred vision;

· Also association of symptoms including fever, inflammation of the serosae, vasculitis, myalgia, arthralgia, antinuclear anti-body, elevation of sedimentation rate, eosinophilia, leukocytosis;

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.

· Increased liver enzymes and / or bilirubin.

· Neutropenia and agranulocytosis, when administered at high doses in areas of renal failure and collagenosis (SLE, scleroderma) (see Warnings and Precautions Warnings section).

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

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