Medicinal Products

ENALAPRIL ARROW 5 mg

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

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 Pharmacodynamic properties).

Dosage ENALAPRIL ARROW 5 mg scored tablet Box of 28

The absorption of ENALAPRIL ARROW is not affected by food.

The dose will be adjusted according to the patient's profile (see Special warnings and special 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 ARROW 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 ARROW. 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 ARROW is used in addition to diuretics and, if necessary, digitalis or beta-blockers. The initial dose of ENALAPRIL ARROW 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 blood pressure. In the absence of symptomatic hypotension following the initiation of ENALAPRIL ARROW treatment in heart failure or after effective management of the heart failure, the dose should be increased gradually up to the usual maintenance dose of 20 mg, given in a single dose or in two doses, 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.

Diagram indicative of ENALAPRIL ARROW 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 Special warnings and special precautions for use).

Both blood pressure and renal function should be closely monitored before and after initiation of ENALAPRIL ARROW (see Special warnings and special precautions for use) as hypotension and (more rarely) consecutive renal failure have occurred. been reported. In patients treated with diuretics, the dose should be reduced, if possible, before starting treatment with ENALAPRIL ARROW. The occurrence of hypotension after the initial dose of ENALAPRIL ARROW does not imply that hypotension may occur again during maintenance therapy with ENALAPRIL ARROW and does not preclude continued 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.

Clearance of Creatinine (Clcr)

ml / min

Initial dose

mg / day

30

5-10 mg

10 Clcr 30 ml / min

2.5 mg

Clcr £ 10 ml / min

2.5 mg

the days of dialysis *

* see Special warnings and special precautions for use - Hemodialysis patients

Enalaprilat is dialysable. On days when patients are not on dialysis, 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 Special warnings and special precautions for use, Impaired renal function).

Use in pediatrics

There is limited clinical experience with the use of ENALAPRIL ARROW in hypertensive children (see Special warnings and special precautions for use, Pharmacodynamic properties Pharmacodynamic properties and Pharmacokinetic properties 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 of 20 to <50 kg and 5 mg in patients of 50 kg. ENALAPRIL ARROW 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 of 50 kg (see Special warnings and special precautions for employment).

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

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,

· During the first trimester of pregnancy and in breastfeeding women (see section Pregnancy and breastfeeding ).

Undesirable effects Enalapril Arrow

The side effects reported with enalapril are:

[Very common (> 1/10); frequent (> 1 / 100.1 / 1000.1 / 10, 000, <1/1000); very rare <1 / 10, 000, of which isolated cases].

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.

Metabolism and nutrition disorders

Uncommon: hypoglycaemia (see Warnings and Precautions for Use Special Warnings and Precautions for Use, Diabetic Patients).

Nervous system and psychiatric disorders

Common: headache, depression

Uncommon: confusion, drowsiness, insomnia, nervousness, paresthesia, dizziness

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, myocardial infarction or stroke, which may be secondary to excessive hypotension in high-risk patients (see Warnings and Precautions Special warnings and special precautions for use), chest pain, rhythm disorders, angina pectoris, tachycardia

Uncommon: orthostatic hypotension, palpitations

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 Special warnings and special precautions for employment).

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 which may involve some or all of the following signs: fever, serous inflammation, vasculitis, myalgia / myositis, arthralgia / arthritis, antinuclear antibody positive, 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.

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