Preterax

Preterax Adverse Reactions

perindopril + indapamide

Manufacturer:

Servier

Distributor:

Maxxcare
Full Prescribing Info
Adverse Reactions
Linked to Perindopril: The administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by indapamide.
During clinical trials, a reduction in potassium levels was observed in some cases. This was <3.4 micromol/L after 12 weeks of treatment and concerns 2% of patients taking Preterax. After 12 weeks of treatment, the mean reduction in potassium levels was 0.2 micromol/L.
Gastrointestinal Tract: Common (>1/100, <1/10): Constipation, dry mouth, nausea, epigastric pain, anorexia, abdominal pains, taste disturbance.
Very Rare (<1/10,000): Pancreatitis.
In case of hepatic insufficiency, there is a possibility of onset of hepatic encephalopathy (see Contraindications, Warnings and Precautions).
Respiratory System: Common (>1/100, <1/10): Dry cough has been reported with the use of angiotensin-converting enzyme inhibitors. It is characterised by its persistence and by its disappearance when treatment is withdrawn. An iatrogenic aetiology should be considered in the presence of this symptom.
Cardiovascular System: Uncommon (>1/1000, <1/100): Hypotension whether orthostatic or not (see Warnings and Precautions).
Skin Appendages: Uncommon (>1/1000, <1/100): Hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions; maculopapular eruptions, purpura, possible aggravation of preexisting acute disseminated lupus erythematosus; skin rash.
Very Rare (<1/10,000): Angioneurotic oedema (Quincke's oedema) (see Warnings and Precautions).
Nervous System: Uncommon (>1/1000, <1/100): Headache, asthenia, feelings of dizziness, mood disturbances and/or sleep disturbances.
Muscular System: Uncommon (>1/1000, <1/100): Cramps, paresthesia.
Hemic System: Very Rare: (<1/10,000): Thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia hemolytic anaemia; anaemia (see Warnings and Precautions) has been reported with angiotensin-converting enzyme inhibitors in specific circumstances (patients who have had kidney transplant, patients undergoing haemodialysis).
Syndrome of inappropriate antidiuretic hormone secretion (SIADH) can be considered as a very rare but possible complication associated with ACE inhibitor therapy.
Laboratory Parameters: 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. The undesirable effects are mainly dose-dependent: Potassium depletion with particularly serious reduction in levels of potassium in some at risk populations (see Precautions); reduced sodium levels with hypovolaemia causing dehydration and orthostatic hypotension. The concomitant loss of chloride ions may lead to compensatory metabolic alkalosis: the incidence and extent of this effect are low; an increase in uric acid levels and in blood glucose levels during treatment: the use of these diuretics should be carefully discussed in patients with gout or diabetes; rare (>1/10,000; <1/1000): raised plasma calcium levels.
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