Sprimeo

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

aliskiren

Saatavilla:

Novartis Europharm Ltd.

ATC-koodi:

C09XA02

INN (Kansainvälinen yleisnimi):

aliskiren

Terapeuttinen ryhmä:

Agents acting on the renin-angiotensin system

Terapeuttinen alue:

Hypertension

Käyttöaiheet:

Treatment of essential hypertension.

Tuoteyhteenveto:

Revision: 5

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2007-08-22

Pakkausseloste

56
B. PACKAGE LEAFLET
Medicinal product no longer authorised
57
PACKAGE LEAFLET: INFORMATION FOR THE USER
SPRIMEO 150 MG FILM-COATED TABLETS
Aliskiren
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Sprimeo is and what it is used for
2.
Before you take Sprimeo
3.
How to take Sprimeo
4.
Possible side effects
5.
How to store Sprimeo
6.
Further information
1.
WHAT SPRIMEO IS AND WHAT IT IS USED FOR
Sprimeo belongs to a new class of medicines called renin inhibitors.
Sprimeo helps to lower high
blood pressure. 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.
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.
BEFORE YOU TAKE SPRIMEO
DO NOT TAKE SPRIMEO
-
if you are allergic (hypersensitive) to aliskiren or any of the other
ingredients of Sprimeo. If you
think you may be allergic, ask your doctor for advice.
-
if you have experienced the following forms of angioedema
(difficulties in breathing or
swallowing, or swelling of the face, hands and feet, eyes, lips and/or
tongue):
-
angioedema when taking aliskiren.
-
hereditary angioedema.
-
angioedema without any known cause.
-
during

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Sprimeo 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Light-pink, biconvex, round tablet, imprinted “IL” on one side and
“NVR” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of Sprimeo 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.
Sprimeo 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).
Sprimeo should be taken with a light meal once a day, preferably at
the same time each day.
Grapefruit juice should not be taken together with Sprimeo.
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). Sprimeo is not recommended in patients with
severe renal impairment (GFR
< 30 ml/min/1.73 m
2
). Concomitant use of Sprimeo with ARBs or ACEIs is contraindicated in
patients with renal impairment (GFR < 60 ml/min/1.73 m
2
) (see section 4.3).
Hepatic impairment
No adjustment of the initial dose is required for patients with mild
to severe hepatic impairment (see
section 5.2).
Elderly patients (over 65 years)
The recommended starting dose of aliskiren in elderly patients is 150
mg. No clinically meaningful
a