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Riprazo is a brand name for Aliskiren. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of essential hypertension in adults.
Verbatim from this product's EMA label. Tap a section to expand.
Posology The recommended dose of Riprazo 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). 3). 2). Elderly patients aged 65 years and over The recommended starting dose of aliskiren in elderly patients is 150 mg. Medicinal product no longer authorised 3 Paediatric population The safety and efficacy of Riprazo in children aged below 18 years have not yet been established.
No data are available. Method of administration Oral use. The tablets should be swallowed whole with some water. Riprazo should be taken with a light meal once a day, preferably at the same time each day. 5).
Summary of the safety profile Riprazo 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 incidence of adverse reactions showed no association with gender, age, body mass index, race or ethnicity.
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).
Medicinal product no longer authorised 8 Tabulated list of adverse reactions:
The adverse drug reactions (Table 1) 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).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table 1 Immune system disorders Rare:
Anaphylactic reactions, hypersensitivity reactions Nervous system disorders Common: Dizziness Cardiac disorders Uncommon: Palpitations Vascular disorders Uncommon: Hypotension Respiratory, thoracic and mediastinal disorders Uncommon: Cough Gastrointestinal disorders Common: Diarrhoea 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 General disorders and administration site conditions Uncommon: Oedema peripheral Investigations Common: Hyperkalaemia Uncommon: Liver enzyme increased Rare: Haemoglobin decreased, haematocrit decreased, blood creatinine increased Description of selected adverse reactions Hypersensitivity reactions including anaphylactic reactions and angioedema have occurred during treatment with aliskiren.
8). Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association [NYHA] functional class III-IV). 1). Dual blockade of the renin-angiotensin-aldosterone system by combining aliskiren with an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB) is therefore not recommended.
3). 8). As with other medicinal products acting on the renin-angiotensin system, angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have been reported in patients treated with aliskiren.
8). Special caution is necessary in patients with a hypersensitivity predisposition. 8). 8) especially at the beginning of the treatment. If anaphylactic reactions or angioedema occur, Riprazo should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Patients should be informed to report to the physician any signs suggestive of allergic reactions, in particular difficulties in breathing or swallowing, swelling of face, extremities, eyes, lips or tongue. Where there is involvement of the tongue, glottis or larynx adrenaline should be administered.
In addition, measures necessary to maintain patent airways should be provided. g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Riprazo. This condition should be corrected prior to administration of Riprazo, or the treatment should start under close medical supervision.
73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension. 73 m2). As for other medicinal products acting on the renin-angiotensin system, caution should be exercised when aliskiren is given in the presence of conditions pre-disposing to kidney dysfunction such as hypovolaemia (eg.
1. - History of angioedema with aliskiren. - Hereditary or idiopathic angioedema. 6). g. 5). 1).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Aliskiren in European Union.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
In controlled clinical trials, angioedema and hypersensitivity reactions occurred rarely during treatment with aliskiren with rates comparable to treatment with placebo or comparators. Cases of angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have also been reported in post-marketing experience.
A number of these patients had a history of angioedema or symptoms suggestive of angioedema which in some cases was associated with the administration of other medicines known to cause angioedema, including RAAS blockers (ACEIs or ARBs).
4). 4). Arthralgia has been reported in post-marketing experience. In some cases this occurred as part of a hypersensitivity reaction. 4). Laboratory findings In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Riprazo.
In clinical studies in hypertensive patients, Riprazo had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid. 16 volume percent, respectively) were observed.
No patients discontinued therapy due to anaemia. This effect is also seen with other agents acting on the renin- angiotensin system, such as ACEIs and ARBs.
Serum potassium:
Increases in serum potassium have been observed with aliskiren and these may be exacerbated by concomitant use of other agents acting on the RAAS or by NSAIDs. Consistent with standard medical practice, periodic determination of renal function including serum electrolytes is advised if co-administration is considered necessary.
1).
), heart disease, liver disease, diabetes mellitus or kidney disease. 73 m2). 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 Riprazo in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney. However, as with other medicinal products acting on the renin-angiotensin system, 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. Medicinal product no longer authorised 5