Bioprexum Adverse Reactions

The following adverse reactions have been observed during treatment with perindopril and ranked under the following frequencies: Very common (1/10); common (1/100, <1/10); uncommon (1/1000, <1/100); rare (1/10,000, <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Blood and Lymphatic System Disorders: Decreases in haemoglobin and haematocrit, thrombocytopenia, leucopenia/neutropenia and cases of agranulocytosis or pancytopenia, have been reported very rarely. In patients with a congenital deficiency of G6PDH, very rare cases of haemolytic anaemia have been reported (see Precautions).
Metabolism and Nutrition Disorders: Not Known: Hypoglycaemia (see Precautions and Interactions).
Psychiatric Disorders: Uncommon: Mood or sleep disturbances.
Nervous System Disorders: Common: Headache, dizziness, vertigo, paraesthesia. Very Rare: Confusion.
Eye Disorders: Common: Visual disturbance.
Ear and Labyrinth Disorders: Common: Tinnitus.
Cardiac Disorders: Very Rare: Arrhythmia, angina pectoris and myocardial infarction, possibly secondary to excessive hypotension in high-risk patients (see Precautions).
Vascular Disorders: Common: Hypotension and effects related to hypotension. Very Rare: Stroke, possibly secondary to excessive hypotension in high-risk patients (see Precautions). Not Known: Vasculitis.
Respiratory, Thoracic and Mediastinal Disorders: Common: Cough, dyspnoea. Uncommon: Bronchospasm. Very Rare: Eosinophilic pneumonia, rhinitis.
Gastrointestinal Disorders: Common: Nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhoea, constipation. Uncommon: Dry mouth. Very Rare: Pancreatitis.
Hepatobiliary Disorders: Very Rare: Hepatitis either cytolytic or cholestatic (see Precautions).
Skin and Subcutaneous Tissue Disorders: Common: Rash, pruritus. Uncommon: Angioedema of face, extremities, lips, mucous membranes, tongue, glottis and/or larynx, urticaria (see Precautions). Very Rare: Erythema multiforme.
Musculoskeletal and Connective Tissue Disorders: Common: Muscle cramps.
Renal and Urinary Disorders: Uncommon: Renal insufficiency. Very Rare: Acute renal failure.
Reproductive System and Breast Disorders: Uncommon: Impotence.
General Disorders and Administration Site Conditions: Common: Asthenia. Uncommon: Sweating.
Investigations: Increases in blood urea and plasma creatinine, hyperkalaemia reversible on discontinuation may occur, especially in the presence of renal insufficiency, severe heart failure and renovascular hypertension. Elevation of liver enzymes and serum bilirubin have been reported rarely.
Clinical Trials: During the randomised period of the EUROPA study, only serious adverse events were collected. Few patients experienced serious adverse events: 16 (0.3%) of the 6122 perindopril patients and 12 (0.2%) of the 6107 placebo patients. In the perindopril-treated patients, hypotension was observed in 6 patients, angioedema in 3 patients and sudden cardiac arrest in 1 patient. More patients withdrew for cough, hypotension or other intolerance on perindopril than on placebo, 6.0% (n=366) versus 2.1% (n=129) respectively.