Medicinal Products

ENALAPRIL RANBAXY 20 mg

Generic drug from Renitec
Therapeutic class: Cardiology and angiology
active ingredients: Enalapril, Enalapril
laboratory: Ranbaxy Pharma Generic

Compressed
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 RANBAXY 20 mg tablet box of 28

· 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 ).

Against indications

· Hypersensitivity to enalapril, any of the constituents of the drug or any other inhibitor of the conversion enzyme (IEC).

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

· Hereditary or idiopathic angioedema.

· Second and third trimesters of pregnancy (see section on Pregnancy and lactation ).

Side effects Enalapril Ranbaxy

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 system 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 disorders 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 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 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 reproductive organs and breasts

Uncommon: impotence

Rare: Gynecomastia.

General disorders and administration site conditions

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.

* Incidence rates were comparable to those in the placebo group and active control groups in clinical trials.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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