Rasilez HCT

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

aliskiren, hydrochlorothiazide

Available from:

Noden Pharma DAC

ATC code:

C09XA52

INN (International Name):

aliskiren, hydrochlorothiazide

Therapeutic group:

Agents acting on the renin-angiotensin system

Therapeutic area:

Hypertension

Therapeutic indications:

Treatment of essential hypertension in adults.Rasilez HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.Rasilez HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.

Product summary:

Revision: 17

Authorization status:

Withdrawn

Authorization date:

2009-01-16

Patient Information leaflet

92
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
93
PACKAGE LEAFLET: INFORMATION FOR THE USER
RASILEZ HCT 150 MG/12.5 MG FILM-COATED TABLETS
RASILEZ HCT 150 MG/25 MG FILM-COATED TABLETS
RASILEZ HCT 300 MG/12.5 MG FILM-COATED TABLETS
RASILEZ HCT 300 MG/25 MG FILM-COATED TABLETS
Aliskiren/hydrochlorothiazide
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 HCT is and what it is used for
2.
What you need to know before you take Rasilez HCT
3.
How to take Rasilez HCT
4.
Possible side effects
5.
How to store Rasilez HCT
6.
Contents of the pack and other information
1.
WHAT RASILEZ HCT IS AND WHAT IS IT USED FOR
WHAT RASILEZ HCT IS
This medicine contains two active substances, called aliskiren and
hydrochlorothiazide. Both of these
active substances help to control high blood pressure (hypertension).
Aliskiren is a renin inhibitor. It reduces the amount of angiotensin
II the body can make.
Angiotensin II causes blood vessels to tighten, which makes blood
pressure higher. Lowering the
amount of angiotensin II allows the blood vessels to relax; this
lowers blood pressure.
Hydrochlorothiazide belongs to a group of medicines called thiazide
diuretics. Hydrochlorothiazide
increases urine output, which also 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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Rasilez HCT 150 mg/12.5 mg film-coated tablets
Rasilez HCT 150 mg/25 mg film-coated tablets
Rasilez HCT 300 mg/12.5 mg film-coated tablets
Rasilez HCT 300 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rasilez HCT 150 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate)
and 12.5 mg hydrochlorothiazide.
_Excipients with known effect: _
Each tablet contains 25 mg lactose (as monohydrate) and 24.5 mg wheat
starch.
Rasilez HCT 150 mg/25 mg film-coated tablets
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate)
and 25 mg hydrochlorothiazide.
_Excipients with known effect: _
Each tablet contains 50 mg lactose (as monohydrate) and 49 mg wheat
starch.
Rasilez HCT 300 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 300 mg aliskiren (as hemifumarate)
and 12.5 mg hydrochlorothiazide.
_Excipients with known effect: _
Each tablet contains 25 mg lactose (as monohydrate) and 24.5 mg wheat
starch.
Rasilez HCT 300 mg/25 mg film-coated tablets
Each film-coated tablet contains 300 mg aliskiren (as hemifumarate)
and 25 mg hydrochlorothiazide.
_Excipients with known effect: _
Each tablet contains 50 mg lactose (as monohydrate) and 49 mg wheat
starch.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Rasilez HCT 150 mg/12.5 mg film-coated tablets
White, biconvex, ovaloid film-coated tablet imprinted with “LCI”
on one side and “NVR” on the
other.
Rasilez HCT 150 mg/25 mg film-coated tablets
Pale yellow, biconvex, ovaloid film-coated tablet imprinted with
“CLL” on one side and “NVR” on
the other.
Rasilez HCT 300 mg/12.5 mg film-coated tablets
Violet white, biconvex, ovaloid film-coated tablet imprinted with
“CVI” on one side and “NVR” on
the other.
Rasilez HCT 300 mg/25 mg film-coated tablets
Light yellow, biconvex, ovaloid film-coated tablet imprinted