Tabulated list of adverse reactions The table below shows all the adverse reactions that have been reported during clinical practice in patients treated with ZOFENIL. 5) Rare The following adverse reactions have been observed associated with ACE inhibitors therapy.
Blood and lymphatic system disorders In a few patients agranulocytosis and pancytopenia may occur. There are reports of haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase deficiency. Metabolism and nutrition disorders Very rare hypoglycaemia Endocrine disorders Not known, inappropriate antidiuretic hormone secretion.
Psychiatric disorders Rarely, depression, mood altered, sleep disorders, confusional state. Nervous system disorders Occasionally paraesthesia, dysgeusia, balance disorder. Eye disorders Rarely, vision blurred. Ear and labyrinth disorders Rarely, tinnitus.
Cardiac disorders Individual cases of tachycardia, arrhythmias, angina pectoris, myocardial infarction have been reported for ACE inhibitors in association with hypotension. Vascular Disorders Severe hypotension has occurred after initiation or increase of therapy.
This occurs especially in certain risk groups (see Special warnings and precautions for use). In association with hypotension, symptoms like dizziness, feeling of weakness, impaired vision. Rarely flushing occurs. Respiratory, thoracic and mediastinal disorders Rarely dyspnoea, sinusitis, rhinitis, glossitis, bronchitis and bronchospasm have been reported.
ACE inhibitors have been associated with the onset of angioneurotic oedema in a small subset of patients involving the face and oropharyngeal tissues. In isolated cases angioneurotic oedema involving the upper airways has caused fatal airway obstruction.
Gastro-intestinal disorders Occasionally, abdominal pain, diarrhoea, constipation and dry mouth can occur. Individual cases of pancreatitis and ileus have been described in association with ACE inhibitors. Very rare small bowel angioedema Hepatobiliary disorders Individual cases of cholestatic jaundice and hepatitis have been described in association with ACE inhibitors.
Skin and subcutaneous tissue disorders Occasionally allergic and hypersensitivity reactions can occur like erythema multiforme, Stevens-Johnson syndrome, toxic epidermic necrolysis, psoriasis-like efflorescences, alopecia. This can be accompanied by fever, myalgia, arthralgia, eosinophilia and/or increased ANA- titers.
Rarely hyperhidrosis occurs. Musculoskeletal and connective tissue disorders Occasionally, myalgia can occur. Renal and urinary disorders Renal insufficiency may occur or be intensified. Acute renal failure has been reported (see Special warnings and precautions for use).
Rarely micturition disorders occur. Reproductive system and breast disorders Rarely, erectile dysfunction. General disorders and administration site conditions. Very rarely oedema peripheral and chest pain. Investigations Increases in blood urea and creatinine, reversible on discontinuation may occur, especially in the presence of renal insufficiency, severe heart failure and renovascular hypertension.
In a few patients, decreases in haemoglobin, haematocrit, platelets and white-cell count have been reported. Increases in serum levels of hepatic enzymes and bilirubin have also been reported.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.