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Sprimeo 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.
Verbatim from this product's EMA label. Tap a section to expand.
The recommended dose of Sprimeo 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). Sprimeo should be taken with a light meal once a day, preferably at the same time each day. Grapefruit juice should not be taken together with Sprimeo. 2). 73 m2). 3). 2). Elderly patients (over 65 years) The recommended starting dose of aliskiren in elderly patients is 150 mg.
2).
Sprimeo 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.
Treatment with Sprimeo resulted in an overall incidence of adverse reactions similar to placebo up to 300 mg. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
The most common adverse drug reaction is diarrhoea. 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, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <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 Nervous system disorders Common:
Dizziness Vascular disorders Uncommon: Hypotension Gastrointestinal disorders Common: Diarrhoea Immune system disorders Rare: Hypersensitivity reactions Skin and subcutaneous tissue disorders Uncommon: Rash, severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN) and oral mucosal reactions Rare: Angioedema 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 Rare: Haemoglobin decreased, haematocrit decreased Rare: Blood creatinine increased Angioedema and hypersensitivity reactions have occurred during treatment with aliskiren.
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.
Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association [NYHA] functional class III-IV). In the event of severe and persistent diarrhoea, Sprimeo therapy should be stopped.
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). Angioedema As with other agents 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). 8). 8) especially at the beginning of the treatment. If angioedema occurs, Sprimeo should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Where there is involvement of the tongue, glottis or larynx adrenaline should be administered. g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Sprimeo. This condition should be corrected prior to administration of Sprimeo, or the treatment should start under close medical supervision.
73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension. 73 m2). As for other agents 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.
), 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.
Hypersensitivity to the active substance or to any of the excipients. 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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Medicinal product no longer authorised 8 Hypersensitivity reactions have also been reported in post-marketing experience. 4). Arthralgia has been reported in post-marketing experience. In some cases this occurred as part of a hypersensitivity reaction.
Laboratory findings In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Sprimeo. In clinical studies in hypertensive patients, Sprimeo 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 ACEI 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). 4). There have also been reports of peripheral oedema, increase in blood creatinine and severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN) and oral mucosal reactions.
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 Sprimeo in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney. However, as with other agents 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. If renal failure occurs, treatment should be discontinued. Moderate P-gp inhibitors Co-administration of aliskiren 300 mg with ketoconazole 200 mg or verapamil 240 mg resulted in a 76% or 97% increase in aliskiren AUC, respectively.
5).