PERINDOPRIL ARGININE/INDAPAMIDE KRKA

25 mg tablet per day as a single dose, preferably to be taken in the morning, and before a meal. When possible individual dose titration with the components is recommended. 25 mg tablet). 25 mg tablets may be considered. 25 mg tablet should be initiated after considering blood pressure response and renal function.

4) In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contraindicated. In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), it is recommended to start treatment with the adequate dosage of the free combination.

In patients with creatinine clearance greater than or equal to 60 ml/min, no dose modification is required. Usual medical follow-up will include frequent monitoring of creatinine and potassium. 2) In severe hepatic impairment, treatment is contraindicated.

In patients with moderate hepatic impairment, no dose modification is required. Paediatric population The safety and efficacy of perindopril arginine/indapamide in the paediatric population have not yet been established. No data are available.

Perindopril arginine/indapamide Krka should not be used in children and adolescents. Method of administration Oral use.

a. Summary of the safety profile The administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by indapamide. 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 spasms and asthenia.

- with indapamide: hypokalaemia, hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions and maculopapular rashes. b. 5) - Not known Injury, Poisoning and Procedural Complications Fall Uncommon* - * Frequency calculated from clinical trials for adverse events detected from spontaneous report.

2 mmol/l in 4% of patients […]

5).

Linked to perindopril:

Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).

1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

5). Neutropenia/agranulocytosis/thrombocytopenia/anaemia Neutropenia/agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors. In patients with normal renal function and no other complicating factors, neutropenia occurs rarely.

Perindopril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function.

Some of these patients developed serious infections which in a few instances did not respond to intensive antibiotic therapy. g. 8). 3). Treatment with diuretics may be a contributory factor. Loss of renal function may occur with only minor changes in serum creatinine even in patients with unilateral renal artery stenosis.

8). This may occur at any time during treatment. In such cases perindopril should be discontinued promptly and appropriate monitoring should be instituted to ensure complete resolution of symptoms prior to dismissing the patient. In those instances where swelling has been confined to the face and lips the condition generally resolved without treatment, although antihistamines have been useful in relieving symptoms.

1); − Concomitant use with sacubitril/valsartan. 4). Linked to indapamide: − Hypersensitivity to the active substance or to any other sulfonamides; − Severe renal impairment (creatinine clearance below 30 ml/min); − Hepatic encephalopathy; − Severe hepatic impairment; − Hypokalemia.

1 Due to the lack of sufficient therapeutic experience, Perindopril arginine/indapamide Krka tablets should not be used in: − Dialysis patients − Patients with untreated decompensated heart failure.