Rasilez

Posology The recommended dose of Rasilez is 150 mg once daily. In patients whose blood pressure is not adequately controlled, the dose may be increased to 300 mg once daily. The antihypertensive effect is substantially present within two weeks (85-90%) after initiating therapy with 150 mg once daily.

1). 2). 73 m2). 2). Elderly patients aged 65 years and over The recommended starting dose of aliskiren in elderly patients is 150 mg. No clinically meaningful additional blood pressure reduction is observed by increasing the dose to 300 mg in the majority of elderly patients.

Paediatric population Rasilez is contraindicated in children from birth to less than 2 years. 3). The safety and efficacy of Rasilez in children aged 6 to 17 years have not yet been established. 2. Use of Rasilez is not recommended in this population.

Method of administration Oral use. The tablets should be swallowed whole with some water. Rasilez should be taken once a day, always with or always without food, preferably at the same time each day. Patients should establish a convenient daily schedule of medicinal product intake and maintain a steady temporal relationship with food intake.

5).

Summary of the safety profile Serious adverse reactions include anaphylactic reaction and angioedema which have been reported in post-marketing experience and may occur rarely (less than 1 case per 1,000 patients). The most common adverse reaction is diarrhoea.

Tabulated list of adverse reactions Aliskiren has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year. The adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).

9 Table 1 Immune system disorders Rare: Anaphylactic reactions, hypersensitivity reactions Nervous system disorders Common: Dizziness Ear and labyrinth disorders Not known: Vertigo Cardiac disorders Uncommon: Palpitations, oedema peripheral Vascular disorders Uncommon: Hypotension Respiratory, thoracic and mediastinal disorders Uncommon: Cough Not known: Dyspnoea Gastrointestinal disorders Common: Diarrhoea Not known: Nausea, vomiting Hepatobiliary disorders Not known: Liver disorder*, jaundice, hepatitis, liver failure** Skin and subcutaneous tissue disorders Uncommon: Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndrome, toxic epidermal necrolysis (TEN) and oral mucosal reactions, rash, pruritus, urticaria Rare: Angioedema, erythema Musculoskeletal and connective tissue disorders Common: Arthralgia Renal and urinary disorders Uncommon: Acute renal failure, renal impairment Investigations Common: Hyperkalaemia Uncommon: Liver enzyme increased Rare: Haemoglobin decreased, haematocrit decreased, blood creatinine increased Not known: Hyponatraemia *Isolated cases of liver disorder with clinical symptoms and laboratory evidence of more marked hepatic dysfunction.

8). 1). 5). 1). Dual blockade of the RAAS by combining aliskiren with an ACEI or an ARB 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.

g. those receiving high doses of diuretics) or - Combined use of aliskiren with other agents acting on the RAAS. The volume or salt depletion should be corrected prior to administration of Rasilez, or the treatment should start under close medical supervision.

73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension. 73 m2). g. ), heart disease, liver disease, diabetes mellitus or kidney disease. Acute renal failure, reversible upon discontinuation of treatment, has been reported in at-risk patients receiving aliskiren in post-marketing experience.

In the event that any signs of renal failure occur, aliskiren should be promptly discontinued. Increases in serum potassium have been observed with aliskiren in post-marketing experience and these may be exacerbated by concomitant use of other agents acting on the RAAS or by non-steroidal anti-inflammatory drugs (NSAIDs).

Consistent with standard medical practice, periodic determination of renal function including serum electrolytes is advised if co-administration is considered necessary. Renal artery stenosis No controlled clinical data are available on the use of aliskiren in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.

However, there is an increased risk of renal insufficiency, including acute renal failure, when patients with renal artery stenosis are treated with aliskiren. Therefore, caution should be exercised in these patients. If renal failure occurs, treatment should be discontinued.

8). Angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have been reported in patients treated with aliskiren. 8). 8). In a post-authorisation observational study, the co-administration of aliskiren with ACEIs or ARBs has been associated with an increased risk of angioedema.

1. - History of angioedema with aliskiren. - Hereditary or idiopathic angioedema. 6). g. 5). 1). 3).