Sabervel
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
29-09-2014
Charakterystyka produktu
(SPC)
29-09-2014
Sprawozdanie z oceny publicznego
(PAR)
23-04-2012
Składnik aktywny:
irbesartan
Dostępny od:
Pharmathen S.A.
Kod ATC:
C09CA04
INN (International Nazwa):
irbesartan
Grupa terapeutyczna:
Agents acting on the renin-angiotensin system
Dziedzina terapeutyczna:
Hypertension
Wskazania:
Sabervel is indicated in adults for the treatment of essential hypertension.It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.
Podsumowanie produktu:
Revision: 2
Status autoryzacji:
Withdrawn
Data autoryzacji:
2012-04-13
Ulotka dla pacjenta
B. PACKAGE LEAFLET
48
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
SABERVEL 75 MG FILM-COATED TABLETS
irbesartan
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 Sabervel is and what it is used for
2.
Before you take Sabervel
3.
How to take Sabervel
4.
Possible side effects
5.
How to store Sabervel
6.
Further information
1.
WHAT SABERVEL IS AND WHAT IT IS USED FOR
Sabervel belongs to a group of medicines known as angiotensin-II
receptor antagonists. Angiotensin-II
is a substance produced in the body which binds to receptors in blood
vessels causing them to tighten.
This results in an increase in blood pressure. Sabervel prevents the
binding of angiotensin-II to these
receptors, causing the blood vessels to relax and the blood pressure
to lower. Sabervel slows the
decrease of kidney function in patients with high blood pressure and
type 2 diabetes.
Sabervel is used in adult patients
•
to treat high blood pressure
_(essential hypertension) _
•
to protect the kidney in patients with high blood pressure, type 2
diabetes and laboratory
evidence of impaired kidney function.
2.
BEFORE YOU TAKE SABERVEL
DO NOT TAKE SABERVEL
•
if you are
ALLERGIC
(hypersensitive) to irbesartan or any other ingredients of Sabervel
•
if you are
MORE THAN 3 MONTHS PREGNANT
. (It is also better to avoid Sabervel in early pregnancy
– see pregnancy section)
•
if you have diabetes or impaired kidney function and you are treated
with a blood pressure
lowering medicine containing aliskiren.
WARNINGS AND PRECAUTIONS TELL YOUR DOCTOR
if any of the fol
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Charakterystyka produktu
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Sabervel 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of irbesartan
Excipient with known effect:
20 mg of lactose monohydrate per film-coated tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, concave, round, film-coated tablet with 7 mm diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sabervel is indicated in adults for the treatment of essential
hypertension.
It is also indicated for the treatment of renal disease in adult
patients with hypertension and type 2
diabetes mellitus as part of an antihypertensive medicinal product
regimen (see sections 4.3, 4.4, 4.5
and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual recommended initial and maintenance dose is 150 mg once
daily, with or without food.
Sabervel at a dose of 150 mg once daily generally provides a better 24
hour blood pressure control
than 75 mg. However, initiation
of therapy with 75 mg could be considered, particularly in
haemodialysed patients and in the elderly over 75 years.
In patients insufficiently controlled with 150 mg once daily, the dose
of Sabervel can be increased to
300 mg, or other antihypertensive agents can be added (see sections
4.3, 4.4,
_ _
4.5
_ _
and 5.1). In
particular, the addition of a diuretic such as hydrochlorothiazide has
been shown to have an additive
effect with Sabervel (see section
_ _
4.5).
In hypertensive type 2 diabetic patients, therapy should be initiated
at 150 mg irbesartan once daily
and titrated up to 300 mg once daily as the preferred maintenance dose
for treatment of renal disease.
The demonstration of renal benefit of Sabervel in hypertensive type 2
diabetic patients is based on
studies where irbesartan was used in addition to other
antihypertensive agents, as needed, to reach
target blood pressure (see sections 4.3, 4.4, 4.5 and
_ _
5.1).
Spec
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