Rasitrio

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

aliskiren, amlodipine, hydrochlorothiazide

Available from:

Novartis Europharm Ltd.

ATC code:

C09XA54

INN (International Name):

aliskiren, amlodipine, hydrochlorothiazide

Therapeutic group:

Cardiovascular system

Therapeutic area:

Hypertension

Therapeutic indications:

Rasitrio is indicated for the treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of aliskiren, amlodipine and hydrochlorothiazide given concurrently at the same dose level as in the combination.

Product summary:

Revision: 1

Authorization status:

Withdrawn

Authorization date:

2011-11-22

Patient Information leaflet

191
B. PACKAGE LEAFLET
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192
PACKAGE LEAFLET: INFORMATION FOR THE USER
Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets
Aliskiren/amlodipine/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.
WHAT IS IN THIS LEAFLET
1.
What Rasitrio is and what it is used for
2.
What you need to know before you take Rasitrio
3.
How to take Rasitrio
4.
Possible side effects
5.
How to store Rasitrio
6.
Contents of the pack and other information
1.
WHAT RASITRIO IS AND WHAT IT IS USED FOR
WHAT RASITRIO IS
Rasitrio contains three active substances, called aliskiren,
amlodipine and hydrochlorothiazide. All of
these substances help to control high blood pressure (hypertension).

Aliskiren is a substance that belongs to a group of medicines called
renin inhibitors. These
reduce the amount of angiotensin II the body can make. Angiotensin II
causes blood vessels to
tighten, which raises blood pressure. Lowering the amount of
angiotensin II allows the blood
vessels to relax; this lowers blood pressure.

Amlodipine belongs to a group of medicines known as calcium channel
blockers, which help to
control high blood pressure. Amlodipine causes blood vessels to dilate
and relax; this lowers
blood pressure.

Hydrochlorothiazide belongs to a group of medicines called thiazide
diuretics.
Hydrochlorothiazide increases urine output, which also lowers blood
pressure.
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 bra

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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2
1.
NAME OF THE MEDICINAL PRODUCT
Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate), 5
mg amlodipine (as besylate)
and 12.5 mg hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Violet white, ovaloid convex film-coated tablet with bevelled edges,
with “YIY” debossed on one side
and “NVR” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rasitrio is indicated for the treatment of essential hypertension as
substitution therapy in adult
patients whose blood pressure is adequately controlled on the
combination of aliskiren, amlodipine
and hydrochlorothiazide given concurrently at the same dose level as
in the combination.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Rasitrio is one tablet per day.
Patients receiving aliskiren, amlodipine and hydrochlorothiazide from
separate tablets given
concurrently at the same time of the day may be switched to a fixed
combination tablet of Rasitrio
containing the same component doses.
The fixed dose combination should only be used after a stable effect
on the monocomponents, given
concurrently, has been established after dose titration. Dose should
be individualised and adjusted
according to the patient’s clinical response.
Special populations
_Elderly patients aged 65 years and over _
There is evidence of an increased risk of adverse events related to
hypotension in patients aged
65 years or older treated with Rasitrio. Therefore, particular caution
should be exercised when
administering Rasitrio in patients aged 65 years or over.
The recommended starting dose of aliskiren in this group of patients
is 150 mg. No clinically
meaningful additional blood pressure reduction is observed by
increasing the dose to 300 mg in the
majority of elderly patients._ _
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