The concomitant use of Irbegen with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR<60ml/min/1.73m2).
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). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended.
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.
Talk to the doctor before taking Irbegen and if any of the following applies: If the patient gets excessive vomiting or diarrhoea.
If the patient suffers from kidney problems.
If the patient suffers from heart problems.
If the patient receives Irbegen for diabetic kidney disease. In this case the doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function.
If the patient is going to have an operation (surgery) or be given anaesthetics.
If the patient is taking any of the following medicines used to treat high blood pressure: an ACE-inhibitor (for example enalapril, lisinopril, ramipril) in particular if having diabetes-related kidney problems; Aliskiren.
The doctor may check the kidney function, blood pressure, and the amount of electrolytes (e.g.potassium) in the blood at regular intervals.
See also information under Contraindications. The patient must tell the doctor if she thinks she is (or might become) pregnant. Irbegen is not recommended in early pregnancy, and must not be taken if the patient is more than 3 months pregnant, as it may cause serious harm to the baby if used at that stage (see Use in Pregnancy & Lactation).
Irbegen contains lactose: If the patient has an intolerance to some sugars (e.g. lactose), contact the doctor before taking this medicine.
Driving and using machines: No studies on the effects on the ability to drive and use machines have been performed. Irbegen is unlikely to affect the ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If any of these is experienced, talk to the doctor before attempting to drive or use machines.
Use in Children and adolescents: This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.