Bioprexum Plus Adverse Reactions

The administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by indapamide. Four percent (4%) of the patients on treatment with Bioprexum Plus experience hypokalemia (potassium level <3.4 mmol/L).
The following undesirable effects could be observed during treatment and ranked under the following frequency: 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) and not known (cannot be estimated from the available data).
Blood and Lymphatic System Disorders: Very Rare: Thrombocytopenia, leucopenia/neutropenia, agranulocytosis, aplastic anaemia, hemolytic anaemia.
Anaemia has been reported with ACE inhibitors in specific circumstances (patients who have had kidney transplants, patients undergoing hemodialysis). (See Precautions.)
Psychiatric Disorders: Uncommon: Mood or sleep disturbances.
Nervous System Disorders: Common: Paraesthesia, headache, asthenia, feelings of dizziness, vertigo. Very Rare: Confusion.
Eye Disorders: Common: Visual disturbance.
Ear and Labyrinth Disorders: Common: Tinnitus.
Vascular Disorders: Common: Hypotension, whether orthostatic or not (see Precautions).
Cardiac Disorders: Very Rare: Arrhythmia including bradycardia, ventricular tachycardia, atrial fibrillation, angina pectoris and myocardial infarction possibly secondary to excessive hypotension in high-risk patients (see Precautions).
Respiratory, Thoracic and Mediastinal Disorders: Common: A dry cough has been reported with the use of ACE inhibitors. It is characterised by its persistence and disappearance when treatment is withdrawn. An iatrogenic etiology should be considered in the presence of this symptom. Dyspnea. Uncommon: Bronchospasm. Very Rare: Eosinophilic pneumonia, rhinitis.
Gastrointestinal Disorders: Common: Constipation, dry mouth, nausea, epigastric pain, anorexia, vomiting, abdominal pain, taste disturbance, dyspepsia, diarrhea. Very Rare: Pancreatitis.
Hepatobiliary Disorders: Very Rare: Hepatitis either cytolytic or cholestatic (see Precautions). Not Known: In case of hepatic insufficiency, there is a possibility of onset of hepatic encephalopathy (see Contraindications and Precautions).
Skin and Subcutaneous Tissue Disorders: Common: Rash, pruritus, maculopapular eruptions. Uncommon: Angioedema of face, extremities, lips, mucous membranes, tongue, glottis and/or larynx, urticaria (see Precautions). Hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions; purpura. Possible aggravation of preexisting acute disseminated lupus erythematosus. Very Rare: Erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome. Cases of photosensitivity reactions have been reported (see Precautions).
Musculoskeletal, Connective Tissue and Bone Disorders: Common: 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: Potassium depletion with particularly serious reduction in levels of potassium in some at risk populations (see Precautions). Reduced sodium levels with hypovolemia causing dehydration and orthostatic hypotension. Increase in uric acid levels and in blood glucose levels during treatment. Slight increase in urea and in plasma creatinine levels, reversible when treatment is stopped. This increase is more frequent in cases of renal artery stenosis, arterial hypertension treated with diuretics, renal insufficiency. Increased levels of potassium, usually transitory. Rare: Raised plasma calcium levels.