Enviage

The recommended dose of Enviage 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). Enviage 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 Enviage. 2). 2). Elderly patients (over 65 years) No adjustment of the initial dose is required for elderly patients.

2).

Enviage 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 Enviage 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. 9%) patients. 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), including isolated reports.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 1 Gastrointestinal disorders Common:

Diarrhoea Skin and subcutaneous tissue disorders Uncommon: Rash Rare: Angioedema Angioedema has occurred during treatment with Enviage. In controlled clinical trials, angioedema occurred rarely during treatment with Enviage with rates comparable to treatment with placebo or hydrochlorothiazide.

Cases of angioedema have also been reported in post-marketing experience (frequency unknown). 4). Laboratory findings In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Enviage.

In clinical studies in hypertensive patients, Enviage 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.

Patients receiving other medicinal products inhibiting the renin-angiotensin system (RAS), and/or those with reduced kidney function and/or diabetes mellitus are at an increased risk of hyperkalaemia during aliskiren therapy. 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, Enviage therapy should be stopped. Angioedema As with other agents acting on the renin-angiotensin system, angioedema has been reported in patients treated with aliskiren. If angioedema occurs, Enviage 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. In addition, measures necessary to ensure patient airways should be provided. g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Enviage.

This condition should be corrected prior to administration of Enviage, or the treatment should start under close medical supervision. 00 mg/dl in men and/or estimated glomerular filtration rate (GFR) < 30 ml/min), history of dialysis, nephrotic syndrome or renovascular hypertension.

Caution should be exercised in hypertensive patients with severe renal impairment due to the lack of safety information for Enviage. 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 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.

Hypersensitivity to the active substance or to any of the excipients. 2Medicinal product no longer authorised History of angioedema with aliskiren. 6). 5).