Adverse reactions : תופעות לוואי

4.8. Undesirable effects
Undesirable effects reported for Enalapril include:

Very common (≥1/10); common (≥1/100, to <1/10); uncommon (≥1/1,000, to <1/100); rare (≥1/10,000, to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Blood and the lymphatic system disorders: uncommon:            anaemia (including aplastic and hemolytic) rare:                neutropenia, decreases in haemoglobin, decreases in haematocrit, thrombocytopenia, agranulocytosis, bone marrow depression, pancytopenia, lymphadenopathy,
autoimmune diseases

Endocrine disorders: not known:           syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Metabolism and nutrition disorders: uncommon:             hypoglycaemia (see section 4.4)

Psychiatric disorders: common:                depression uncommon:              confusion, insomnia, nervousness rare:                  dream abnormality, sleep disorders 

Nervous system disorders: very common:        dizziness common:             headache, syncope, taste alteration uncommon:           somnolence, paresthesia, vertigo
Eye disorders: very common:                     blurred vision

Ear and labyrinth disorders: uncommon:             tinnitus

Cardiac disorders: common:                chest pain, rhythm disturbances, angina pectoris, tachycardia uncommon:              palpitations, myocardial infarction or cerebrovascular accident*, possibly secondary to excessive hypotension in high-risk patients (see Section 4.4)
Vascular disorders: common:                hypotension (including orthostatic hypotension) uncommon               flushing, orthostatic hypotension rare:                  Raynaud's phenomenon


Respiratory, thoracic and mediastinal disorders: very common:           cough common:                dyspnoea uncommon:              rhinorrhoea, sore throat and hoarseness, bronchospasm/asthma rare:                  pulmonary infiltrates, rhinitis, allergic alveolitis/eosinophilic pneumonia

Gastro-intestinal disorders: very common:           nausea common:                diarrhoea, abdominal pain uncommon:              ileus, pancreatitis, vomiting, dyspepsia, constipation, anorexia, gastric irritations, dry mouth, peptic ulcer rare:                  stomatitis/aphthous ulcerations, glossitis very rare:             intestinal angioedema.

Hepatobiliary disorders: rare:                 hepatic failure, hepatitis – either hepatocellular or cholestatic, hepatitis including necrosis, cholestasis
(including jaundice)

Skin and subcutaneous tissue disorders: common:             rash, hypersensitivity/angioneurotic oedema: angioneurotic oedema of the face, extremities, lips,
tongue, glottis and/or larynx has been reported (see section 4.4) uncommon:           diaphoresis, pruritus, urticaria, alopecia rare:               erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis,
pemphigus, erythroderma
 not known:             A symptom complex has been reported which may include some or all of the following: fever, serositis,
vasculitis, myalgia/myositis, arthralgia/arthritis, a positive ANA, elevated ESR, eosinophilia, and leukocytosis. Rash, photosensitivity or other dermatologic manifestations may occur.

Musculoskeletal, connective tissue, and bone disorders
Uncommon:            muscle cramps

Renal and urinary disorders: uncommon:             renal dysfunction, renal failure, proteinuria rare:                 oliguria

Reproductive system and breast disorders: uncommon:           impotence rare:               gynecomastia
General disorders and administration site conditions: very common:         asthenia common:              fatigue uncommon:            malaise, fever

Investigations: common:               hyperkalaemia, increases in serum creatinine uncommon:             increases in blood urea, hyponatraemia rare:                 elevations of liver enzymes, elevations of serum bilirubin.
*
Incidence rates were comparable to those in the placebo and active control groups in the clinical trials

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il