Irbesartan BMS
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-11-2009
Charakterystyka produktu
(SPC)
26-11-2009
Sprawozdanie z oceny publicznego
(PAR)
26-11-2009
Składnik aktywny:
irbesartan
Dostępny od:
Bristol-Myers Squibb Pharma EEIG
Kod ATC:
C09CA04
INN (International Nazwa):
irbesartan
Grupa terapeutyczna:
Agents acting on the renin-angiotensin system
Dziedzina terapeutyczna:
Hypertension
Wskazania:
Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 5.1).
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Withdrawn
Data autoryzacji:
2007-01-19
Ulotka dla pacjenta
87
B. PACKAGE LEAFLET
Medicinal product no longer authorised
88
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN BMS 75 MG 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 Irbesartan BMS is and what it is used for
2.
Before you take Irbesartan BMS
3.
How to take Irbesartan BMS
4.
Possible side effects
5.
How to store Irbesartan BMS
6.
Further information
1.
WHAT IRBESARTAN BMS IS AND WHAT IT IS USED FOR
Irbesartan BMS 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.
Irbesartan BMS prevents the binding of
angiotensin-II to these receptors, causing the blood vessels to relax
and the blood pressure to lower.
Irbesartan BMS slows the decrease of kidney function in patients with
high blood pressure and type 2
diabetes.
Irbesartan BMS is used
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 IRBESARTAN BMS
DO NOT TAKE IRBESARTAN BMS
if you are
ALLERGIC
(hypersensitive) to irbesartan or any other ingredients of Irbesartan
BMS
if you are
MORE THAN 3 MONTHS PREGNANT
. (It is also better to avoid Irbesartan BMS in early
pregnancy – see pregnancy section)
Irbesartan BMS should not be given to children and adolescents (under
18 years).
TAKE SPECIAL CARE WITH IRBESARTAN BMS
TELL YOUR DOCTOR
if any of the following apply to
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Irbesartan BMS 75 mg tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg of irbesartan.
Excipient: 15.37 mg of lactose monohydrate per tablet.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, biconvex, and oval-shaped with a heart debossed on
one side and the number 2771
engraved on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Treatment of renal disease in patients with hypertension and type 2
diabetes mellitus as part of an
antihypertensive medicinal product regimen (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The usual recommended initial and maintenance dose is 150 mg once
daily, with or without food.
Irbesartan BMS 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 Irbesartan BMS can be
increased to 300 mg, or other antihypertensive agents can be added. In
particular, the addition of a
diuretic such as hydrochlorothiazide has been shown to have an
additive effect with Irbesartan BMS
(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 Irbesartan BMS 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 section 5.1).
Renal impairment
: no dosage adjustment is necessary in patients with impaired renal
function. A lower
starting dose (75 mg) should be consider
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