Acertil Plus Adverse Reactions

2.5/0.625 mg FC tab: Summary of safety profile: The administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by indapamide.
Two percent of the patients on treatment with ACERTIL PLUS 2.5 mg/0.625 mg experience hypokalaemia (potassium level <3.4 mmol/l).
The most commonly reported adverse reactions observed are: With perindopril: dizziness, headache, paraesthesia, dysgeusia, visual impairment, vertigo, tinnitus, hypotension, cough, dyspnoea, abdominal pain, constipation, dyspepsia, diarrhoea, nausea, vomiting, pruritus, rash, muscle cramps and asthenia.
With indapamide: hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions and maculopapular rashes.
Tabulated list of adverse reactions: The following undesirable effects have been observed during clinical trials and/or post-marketing use and ranked under the following frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data). (See Tables A and B.)

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Cases of SIADH have been reported with other ACE inhibitors. SIADH can be considered as a very rare but possible complication associated with ACE inhibitor therapy including perindopril.
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 national reporting system.
5/1.25 mg FC tab: The administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by indapamide. Four percent of the patients on treatment with ACERTIL PLUS 5 mg/1.25 mg experience hypokalaemia (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 (≥1/10000, <1/1000); very rare (<1/10000); not known (cannot be estimated from the available data).
Blood and the lymphatic system disorders: Very rare: Thrombocytopenia, leucopenia/neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia.
Anaemia (see Warnings) has been reported with angiotensin-converting enzyme inhibitors in specific circumstances (patients who have had kidney transplants, patients undergoing haemodialysis).
Psychiatric disorders: Uncommon: Mood or sleep disturbances.
Nervous system disorders: Common: Paraesthesia, headache, dizziness, vertigo, asthenia.
Very rare: Confusion.
Not known: Syncope.
Eye disorders: Common: Vision disturbance.
Ear and labyrinth disorders: Common: Tinnitus.
Vascular disorders: Common: Hypotension whether orthostatic or not (see Warnings and 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 Warnings and Precautions).
Not known: Torsades de pointes (potentially fatal) (see Precautions and Interactions).
Respiratory, thoracic and mediastinal disorders: Common: A 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.
Uncommon: Bronchospasm.
Very rare: Eosinophilic pneumonia, rhinitis.
Gastrointestinal disorders: Common: Constipation, dry mouth, nausea, vomiting, abdominal pain, dyspepsia, diarrhoea, epigastric pain, anorexia, taste disturbance.
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 Warnings).
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 Warnings); Hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions; Purpura; Possible aggravation of pre-existing acute disseminated lupus erythematosus.
Very rare: Erythema multiforme, toxic epidermic necrolysis, Stevens-Johnson syndrome.
Cases of photosensitivity reactions have been reported (see Warnings).
Musculoskeletal, connective tissue and bone 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: Not known: Electrocardiogram QT prolonged (see Precautions and Interactions); Blood glucose increased and blood uric acid increased during treatment; Elevated liver enzyme levels.
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.
Metabolism and nutrition disorders: Rare: Hypercalcemia.
Not known: Potassium depletion with hypokalaemia, particularly serious in certain high-risk populations (see Warnings and Precautions); Increased levels of potassium, usually transitory; Hyponatraemia with hypovolaemia responsible for dehydration and orthostatic hypotension.