Medicinal Products

ENALAPRIL ZENTIVA 5 mg

Generic drug from Renitec
Therapeutic class: Cardiology and angiology
active ingredients: Enalapril
laboratory: Sanofi-Aventis France

Tablet breackable
Box of 28
All forms

Indication

· Treatment of high blood pressure

· Treatment of symptomatic heart failure

· Prevention of symptomatic heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction ≤ 35%) (see section 5.1 Pharmacodynamic properties ).

Dosage ENALAPRIL ZENTIVA 5 mg scored tablet Box of 28

The absorption of ENALAPRIL ZENTIVA 5 mg, scored tablet is not affected by food.

The dose will be adjusted according to the patient's profile (see section Warnings and precautions for use ) and the blood pressure response.

Hypertension

The initial dose is 5 to 20 mg maximum, depending on the degree of hypertension and the patient's condition (see below). ENALAPRIL ZENTIVA 5 mg, scored tablet is taken once a day. In mild hypertension, the recommended starting dose is 5 to 10 mg. Patients with highly stimulated renin angiotensin-aldosterone system (eg, renovascular hypertension, fluid and / or sodium depletion, cardiac decompensation, or severe hypertension) may experience an excessive drop in blood pressure following the initial dose. An initial dose of 5 mg or less is recommended in such patients and initiation of treatment should be under medical supervision.

Pretreatment with high doses of diuretics may result in fluid depletion and a risk of hypotension when initiating enalapril therapy. An initial dose of 5 mg or lower is recommended for such patients. If possible, diuretic therapy will be discontinued 2-3 days before starting treatment with ENALAPRIL ZENTIVA 5 mg scored tablet. Renal function and serum potassium will be controlled.

The usual maintenance dose is 20 mg daily. The maximum maintenance dose is 40 mg daily.

Heart failure / asymptomatic left ventricular dysfunction

In the management of heart failure, ENALAPRIL ZENTIVA 5 mg, scored tablet is used in addition to diuretics and, if necessary, digitalis or beta-blockers. The initial dose of ENALAPRIL ZENTIVA 5 mg, scored tablet in patients with symptomatic heart failure or asymptomatic left ventricular dysfunction is 2.5 mg and should be administered under close medical supervision to assess the initial effect on the arterial pressure. In the absence of symptomatic hypotension that follows the initiation of treatment with ENALAPRIL ZENTIVA 5 mg, breakable tablet in heart failure or after effective management of it, the dose should be increased gradually until the dose usual maintenance dose of 20 mg, given as a single dose or twice, depending on the patient's tolerance. It is recommended to make this adjustment of the dose over a period of 2 to 4 weeks. The maximum dose is 40 mg daily administered in two divided doses.

Approximate dosage schedule of ENALAPRIL ZENTIVA 5 mg, scored tablet in patients with heart failure / asymptomatic left ventricular dysfunction

Week

Dose in mg / day

Week 1

Days 1 to 3: 2.5 mg / day * in a single shot
Days 4 to 7: 5 mg / day divided into two doses

Week 2

10 mg / day in a single dose or divided into two doses

Weeks 3 and 4

20 mg / day in a single dose or divided into two doses

* Special precautions should be taken in patients with impaired renal function or taking diuretics (see Warnings and Precautions ).

Both blood pressure and renal function should be closely monitored before and after initiation of treatment with ENALAPRIL ZENTIVA 5 mg, scored tablet (see Warnings and Precautions ) as hypotension and (more rarely) consecutive renal failure have been reported. In patients treated with diuretics, the dose should be reduced, if possible, before starting treatment with ENALAPRIL ZENTIVA 5 mg scored tablet. The occurrence of hypotension after the initial dose of ENALAPRIL ZENTIVA 5 mg, scored tablet does not imply that hypotension may occur again during maintenance treatment with ENALAPRIL ZENTIVA 5 mg, scored tablet and prevents not the continuation of treatment with the drug. Serum potassium and renal function will also be monitored.

Dosage in case of renal failure

In general the interval between intake of enalapril should be increased and / or the dosage reduced.

Creatinine clearance (Clcr) ml / min

Initial dose mg / day

<Clr <80 ml / min

5-10 mg

10 <Clcr ≤ 30 ml / min

2.5 mg

Clcr ≤ 10 ml / min

2.5 mg on days of dialysis *

* See section Warnings and precautions for use - Hemodialysis patients

Enalaprilat is dialysable. On days when patients are not dialysed, the dosage should be adjusted according to the blood pressure response.

Elderly

The dose should take into account the renal function of the elderly patient (see Warnings and Precautions section ).

Use in pediatrics

Clinical experience is limited on the use of ENALAPRIL ZENTIVA 5 mg, scored tablet in hypertensive children (see sections Warnings and Precautions, Pharmacodynamic Properties and Pharmacokinetic Properties ).

For patients who can swallow tablets, the dose will be adjusted according to the patient's profile and blood pressure response. The recommended starting dose is 2.5 mg in patients weighing 20 to <50 kg and 5 mg in patients weighing more than 50 kg. ENALAPRIL ZENTIVA 5 mg, scored tablet is administered once a day. The dosage will be adjusted according to the patient's needs to a maximum of 20 mg per day in patients of 20 to <50 kg and 40 mg in patients ≥ 50 kg (see section 4.4). employment ).

ENALAPRIL ZENTIVA 5 mg, scored tablet is not recommended in neonates and children with a glomerular filtration rate <30 ml / min / 1.73 m 2, as there is no data available.

Against indications

· Hypersensitivity to enalapril, any of the components of the drug or any other ACE inhibitor.

· History of angioedema associated with previous treatment with an IEC.

· Hereditary or idiopathic angioedema.

· Second and third trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).

Side effects Enalapril Zentiva

The side effects reported with enalapril are:

[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 calculated from the available data).

Blood and lymphatic disorders

Uncommon: Anemia (including refractory and haemolytic).

Rare: neutropenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, agranulocytosis, bone marrow suppression, pancytopenia, lymphadenopathy, autoimmune disease.

Endocrine disorders

Unknown: syndrome of inappropriate secretion of antidiuretic hormone (SIADH).

Metabolism and nutrition disorders

Uncommon: hypoglycemia (see Warnings and Precautions ) section.

Nervous system and psychiatric disorders

Common: headache, depression

Uncommon: confusion, drowsiness, insomnia, nervousness, paresthesia, vertigo.

Rare: abnormalities of the dream, sleep disorders.

Eye disorders

Very common: blurred vision.

Cardiac disorders and vascular disorders

Very common: dizziness.

Common: hypotension (including orthostatic hypotension), syncope, chest pain, arrhythmias, angina pectoris, tachycardia.

Uncommon: orthostatic hypotension, palpitations, myocardial infarction, or cerebrovascular accident *, which may be secondary to excessive hypotension in high-risk patients (see Warnings and Precautions section ).

Rare: Raynaud's syndrome.

Respiratory, thoracic and mediastinal disorders

Very common: cough.

Common: dyspnoea

Uncommon: rhinorrhea, sore throat and hoarseness, bronchospasm / asthma.

Rare: pulmonary infiltrate, rhinitis, allergic alveolitis / eosinophilic pneumonia.

Gastrointestinal disorders

Very common: nausea.

Common: diarrhea, abdominal pain, dysgeusia.

Uncommon: ileus, pancreatitis, vomiting, dyspepsia, constipation, anorexia, gastric irritation, dry mouth, peptic ulcer.

Rare: stomatitis / aphthous ulcers, glossitis.

Very rare: intestinal angioedema.

Hepatobiliary disorders

Rare: liver failure, hepatitis - either hepatocellular or cholestatic, hepatitis including necrosis, cholestasis (including jaundice).

Skin and subcutaneous tissue disorders

Common: rash, hypersensitivity / angio-neurotic edema: angio-neurotic edema of the face, extremities, lips, tongue, glottis and / or larynx has been reported (see Warnings and precautions for use section) ).

Uncommon: diaphoresis, pruritus, urticaria, alopecia.

Rare: erythema multiforme, Stevens Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma.

An association of symptoms has been reported that may involve some or all of the following: fever, serous inflammation, vasculitis, myalgia / myositis, arthralgia / arthritis, positive antinuclear antibodies, elevated sedimentation rate, eosinophilia, and leukocytosis.

Rash, photosensitivity and other dermatological manifestations may occur.

Renal and urinary disorders

Uncommon: renal dysfunction, renal failure, proteinuria.

Rare: oliguria.

Disorders of the reproductive organs and breasts

Uncommon: impotence

Rare: Gynecomastia.

General disorders and accidents related to the site of administration

Very common: asthenia.

Frequent: tiredness

Uncommon: muscle cramps, flushing, tinnitus, malaise, fever.

investigations

Frequent: hyperkalemia, increased serum creatinine.

Uncommon: increased blood urea, hyponatremia.

Rare: Elevated liver enzymes, elevated serum bilirubin.

* Incidents were comparable between placebo and active control groups in clinical trials.

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