Novartis announces Aliskiren will continue to be available to appropriate patients, as FDA interim assessment is concluded; product information updated - Seite 3

whose blood pressure is not adequately controlled with aliskiren or
hydrochlorothiazide (HCTZ) monotherapy to TEKTURNA HCT. Switch a patient whose
blood pressure is not adequately controlled with aliskiren or amlodipine (or
another dihydropyridine calcium channel blocker [DHP-CCB]) alone to combination
therapy with TEKAMLO.

Use AMTURNIDE for patients not adequately controlled with any two of the
following: aliskiren, DHP-CCB, and thiazide diuretics. Switch a patient who
experiences dose-limiting adverse reactions attributed to an individual
component-while on any dual combination of components of AMTURNIDE-to AMTURNIDE
at a lower dose of that component to achieve similar blood pressure reductions.

TEKTURNA HCT, TEKAMLO, and AMTURNIDE may be substituted for their titrated
components.

Safety and efficacy of aliskiren in pediatric patients have not been
established.

Base the choice of TEKTURNA HCT or TEKAMLO as initial therapy on an assessment
of potential benefits and risks. Individualize the decision to use a combination
as initial therapy by weighing factors such as baseline blood pressure, the
target goal, and the incremental likelihood of achieving goal with a combination
compared to monotherapy.

IMPORTANT SAFETY INFORMATION

WARNING: AVOID USE IN PREGNANCY
When pregnancy is detected, discontinue TEKTURNA, TEKTURNA HCT, TEKAMLO, or
AMTURNIDE as soon as possible. Drugs that act directly on the renin-angiotensin-
aldosterone system can cause injury and even death to the developing fetus. See
Warnings and Precautions (5.1).

Contraindications: Do not use aliskiren with angiotensin receptor blockers
(ARBs) or ACE inhibitors (ACEIs) in patients with diabetes because of increased
risk of renal impairment, hyperkalemia, and hypotension.
Because of the HCTZ component, TEKTURNA HCT and AMTURNIDE are contraindicated in
patients with anuria or hypersensitivity to sulfonamide-derived drugs like HCTZ.
Hypersensitivity reactions may range from urticaria to anaphylaxis.

Angioedema: Angioedema of the face, extremities, lips, tongue, glottis and/or
larynx has been reported in patients treated with aliskiren and has necessitated
hospitalization and intubation. This may occur at any time during treatment and
has occurred in patients with and without a history of angioedema with ACEIs or
angiotensin receptor antagonists. Discontinue TEKTURNA, TEKTURNA HCT, TEKAMLO,
or AMTURNIDE immediately in patients who develop angioedema, and do not
readminister.
Hypotension: In patients with an activated renin-angiotensin-aldosterone system
(RAAS), such as volume- and/or salt-depleted patients receiving high doses of
diuretics, symptomatic hypotension may occur in patients receiving RAAS