Rasilez

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

aliskiren

Available from:

Noden Pharma DAC

ATC code:

C09XA02

INN (International Name):

aliskiren

Therapeutic group:

Agents acting on the renin-angiotensin system

Therapeutic area:

Hypertension

Therapeutic indications:

Treatment of essential hypertension.

Product summary:

Revision: 27

Authorization status:

Authorised

Authorization date:

2007-08-22

Patient Information leaflet

40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
RASILEZ 150 MG FILM-COATED TABLETS
RASILEZ 300 MG FILM-COATED TABLETS
Aliskiren
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rasilez is and what it is used for
2.
What you need to know before you take Rasilez
3.
How to take Rasilez
4.
Possible side effects
5.
How to store Rasilez
6.
Contents of the pack and other information
1.
WHAT RASILEZ IS AND WHAT IT IS USED FOR
This medicine contains an active substance called aliskiren. Aliskiren
belongs to a class of medicines
called renin inhibitors. Renin inhibitors reduce the amount of
angiotensin II the body can produce.
Angiotensin II causes blood vessels to tighten, which increases the
blood pressure. Reducing the
amount of angiotensin II allows the blood vessels to relax, which
lowers blood pressure.
This helps to lower high blood pressure in adult patients. High blood
pressure increases the workload
of the heart and arteries. If this continues for a long time, it can
damage the blood vessels of the brain,
heart and kidneys, and may result in a stroke, heart failure, heart
attack or kidney failure. Lowering the
blood pressure to a normal level reduces the risk of developing these
disorders.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASILEZ
DO NOT TAKE RASILEZ
-
if you are allergic to aliskiren or any of the other ingredients of
this medicine (listed in
section 6). If you think you may be allergic, ask your doctor for
advice.
-
if you have experienced the following forms of angioe

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Rasilez 150 mg film-coated tablets
Rasilez 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rasilez 150 mg film-coated tablets
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
Rasilez 300 mg film-coated tablets
Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Rasilez 150 mg film-coated tablets
Light-pink, biconvex, round tablet, imprinted “IL” on one side and
“NVR” on the other side.
Rasilez 300 mg film-coated tablets
Light-red, biconvex, ovaloid tablet, imprinted “IU” on one side
and “NVR” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Rasilez 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.
Rasilez may be used alone or in combination with other
antihypertensive agents with the exception of
use in combination with angiotensin converting enzyme inhibitors
(ACEI) or angiotensin II receptor
blockers (ARB) in patients with diabetes mellitus or renal impairment
(glomerular filtration rate
(GFR) < 60 ml/min/1.73 m
2
) (see sections 4.3, 4.4 and 5.1).
_Special populations _
_ _
_Renal impairment _
No adjustment of the initial dose is required for patients with mild
to moderate renal impairment (see
sections 4.4 and 5.2). Aliskiren is not recommended in patients with
severe renal impairment (GFR
< 30 ml/min/1.73 m
2
).
3
_Hepatic impairment _
No adjustment of the initial dose is required for patients with mild
to severe hepatic impairment (see
section 5.2).
_Elderly patients aged 65 years and over_
The recommended starting