Irbesartan Zentiva (previously Irbesartan Winthrop)
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
28-09-2022
Valmisteyhteenveto
(SPC)
28-09-2022
Julkisesta arviointikertomuksesta
(PAR)
23-09-2013
Aktiivinen ainesosa:
irbesartan
Saatavilla:
Zentiva k.s.
ATC-koodi:
C09CA04
INN (Kansainvälinen yleisnimi):
irbesartan
Terapeuttinen ryhmä:
Agents acting on the renin-angiotensin system
Terapeuttinen alue:
Hypertension
Käyttöaiheet:
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.
Tuoteyhteenveto:
Revision: 28
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2007-01-19
Pakkausseloste
104
B. PACKAGE LEAFLET
105
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN ZENTIVA 75 MG TABLETS
irbesartan
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 Irbesartan Zentiva is and what it is used for
2.
What you need to know before you take Irbesartan Zentiva
3.
How to take Irbesartan Zentiva
4.
Possible side effects
5.
How to store Irbesartan Zentiva
6.
Contents of the pack and other information
1.
WHAT IRBESARTAN ZENTIVA IS AND WHAT IT IS USED FOR
Irbesartan Zentiva 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 Zentiva prevents the binding
of angiotensin-II to these receptors, causing the blood vessels to
relax and the blood pressure to lower.
Irbesartan Zentiva slows the decrease of kidney function in patients
with high blood pressure and
type 2 diabetes.
Irbesartan Zentiva 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRBESARTAN ZENTIVA
DO NOT TAKE IRBESARTAN ZENTIVA
▪
if you are ALLERGIC to irbesartan or any other ingredients of this
medicine (listed in section 6)
▪
if you are MORE THAN 3 MONTHS PREGNANT. (It is also better to avoid
Irbesartan Zentiva in e
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Irbesartan Zentiva 75 mg tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg of irbesartan.
Excipient with known effect: 15.37 mg of lactose monohydrate per
tablet.
For the 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
Irbesartan Zentiva 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.
Irbesartan Zentiva 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 Zentiva 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 Irbesartan Zentiva (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 Zentiva 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 sectio
Lue koko asiakirja
