Preterax Warnings

Linked to Perindopril: Risk of Neutropenia/Agranulocytosis in Immuno-depressive Patients: Preterax 2.5 mg: The risk of neutropenia seems to be related to the dose and to the type of patient and depends on the patient's clinical condition. This condition is rarely encountered in patients who do not present with complications, but may occur in patients with renal insufficiency associated with collagen vascular disease eg, systemic lupus erythematosus or scleroderma, and who are on immunosuppressant therapy. This risk disappears when treatment with the angiotensin-converting enzyme inhibitor is stopped.
Preterax 5 mg: Angiotensin-converting enzyme inhibitors have exceptionally led to agranulocytosis and/or bone marrow depression when they were administered at high doses and to patients with renal insufficiency when it is associated to systemic auto-immune diseases (collagen vascular diseases eg, disseminated lupus erythematosus or scleroderma), receiving treatment with immunosuppressants or treatment causing leucopenia.
Strict compliance with the predetermined dose seems to be the best way to prevent the onset of these events. However, if an angiotensin-converting enzyme inhibitor is to be administered to this type of patient, the risk/benefit ratio should be evaluated carefully.
Renovascular hypertension: increased risk of hypotension and renal insufficiency in patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Diuretics may be a contributory factor. Loss of renal function may occur (minor changes in serum creatinine) even in patients with unilateral renal artery stenosis.
Angioneurotic Oedema (Quincke's Oedema): Angioneurotic oedema of the face, extremities, lips, tongue, glottis and/or larynx has rarely been reported in patients receiving treatment with an angiotensin-converting enzyme inhibitor, including perindopril. In such cases, treatment with perindopril should be stopped immediately and the patient should be monitored until oedema has disappeared.
When the oedema only affects the face and the lips, the effect generally recedes without treatment, even though antihistamines may be used to relieve symptoms.
Angioneurotic oedema combined with laryngeal oedema may be fatal. When the tongue, glottis or larynx are affected, leading to an obstruction of the airways, a subcutaneous injection of adrenaline at 1:1000 (0.3-0.5 mL) should be administered quickly and other appropriate treatments should be given.
The prescription of an angiotensin-converting enzyme inhibitor should not subsequently be considered in these patients (see Contraindications).
Patients with a previous history of Quincke's oedema which is not linked to taking an angiotensin-converting enzyme inhibitor have an increased risk of Quincke's oedema with an angiotensin-converting enzyme inhibitor.
Concomitant use of mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus): Patients taking concomitant mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) therapy may be at increased risk for angioedema (e.g. swelling of the airways or tongue, with or without respiratory impairment.
Anaphylactoid Reactions During Desensitisation: Preterax 2.5 mg: Rare cases of prolonged life-threatening anaphylactoid reactions have been reported in patients treated with an angiotensin-converting enzyme inhibitor while undergoing hymenoptera (bees, wasps) venom desensitisation. Treatment with an angiotensin-converting enzyme inhibitor should be initiated with caution in allergic patients undergoing desensitisation and must be avoided in patients following venom immunotherapy.
The occurrence of these reactions are avoided by temporarily discontinuing for at least 24 hrs the angiotensin-converting enzyme inhibitor treatment in patients necessitating both angiotensin-converting enzyme inhibitor treatment and desensitisation.
Combination with sacubitril/valsartan (contraindicated due to the increased risk of angioedema). Sacubitril/valsartan must not be initiated until 36 hours after taking the last dose of perindopril therapy. Sacubitril/valsartan must not be initiated until 36 hours after the last dose of PRETERAX. Concomitant use of other NEP inhibitors (e.g. racecadotril) and ACE inhibitors may also increase the risk of angioedema.
Anaphylactoid Reactions in Patients Exposed to Dialysis Membrane: Preterax 2.5 mg: Cases of prolonged life-threatening anaphylactoid reactions have been reported in patients receiving both an angiotensin-converting enzyme inhibitor and either dialysis with high-permeability membranes or low-density lipoprotein apheresis by adsorption on dextran sulphate. Treatment with angiotensin-converting enzyme inhibitors should be avoided in patients receiving dialysis with high permeability membranes or LDL apheresis by adsorption on dextran sulphate.
The occurrence of these reactions are avoided by temporarily discontinuing for at least 24 hrs the angiotensin-converting enzyme inhibitor treatment in patients necessitating both angiotensin-converting enzyme inhibitor treatment and an LDL apheresis.
Haemodialysis: Preterax 5 mg: Anaphylactoid reactions (oedema of the tongue and lips with dyspnoea and low blood pressure) have also been observed during haemodialysis with high-permeability membranes (polyacrylonitrile) in patients receiving treatment with angiotensin-converting enzyme inhibitors. This combination should therefore be avoided.
Linked to Indapamide: When liver function is impaired, thiazide diuretics and thiazide-related diuretics may cause hepatic encephalopathy. Administration of the diuretic should be stopped immediately if this occurs.
Primary aldosteronism: Use not recommended in patients with primary hyperaldosteronism (not responding to drugs acting through inhibition of the renin-angiotensin system).