When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Section 4.3: The following contraindication has been added:
· The concomitant use of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5 and 5.1).
Section 4.4: The following warning has been added:
· Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Hypotension, syncope, stroke, hyperkalaemia, and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system (see section 5.1). 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.
Section 4.8:
· Dizziness and Hypotension added as ADRs
Section 5.1 & 5.2:
· Details of the Altitude study findings added
· Inclusion of ‘arthralgia’ as a common adverse drug reaction in Section 4.8
· Inclusion of ‘severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN) and oral mucosal reactions’ as an uncommon adverse drug reaction in Section 4.8
Section 4.3 to remove contraindication for Verapamil Section 4.4. to add caution re Verapamil Section 4.5 to reflect new information on Verapamil interactions.
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 RAS blockers (ACE inhibitors or ARBs).
In the event of any signs suggesting a hypersensitivity reaction/angioedema (in particular difficulties in breathing, or swallowing, or swelling of the face, extremities, eyes, lips and/or tongue) patients should discontinue treatment and contact the physician (see section 4.4).