Irbesartan STADA 75 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

IRBESARTAN 75 mg/stuk

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

C09CA04

INN (Algemene Internationale Benaming):

IRBESARTAN 75 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

COPOVIDON ; CROSCARMELLOSE (E 468) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), COPOVIDON ; CROSCARMELLOSE (E 468) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Irbesartan

Product samenvatting:

Hulpstoffen: COPOVIDON; CROSCARMELLOSE (E 468); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2010-02-22

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN STADA 75 MG, FILMOMHULDE TABLETTEN.
IRBESARTAN STADA 150 MG, FILMOMHULDE TABLETTEN.
IRBESARTAN STADA 300 MG, FILMOMHULDE TABLETTEN.
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 STADA is and what it is used for
2. What you need to know before you take Irbesartan STADA
3. How to take Irbesartan STADA
4. Possible side effects
5. How to store Irbesartan STADA
6. Contents of the pack and other information
1. WHAT IRBESARTAN STADA IS AND WHAT IT IS USED FOR
Irbesartan
STADA
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
STADA prevents the binding of angiotensin-II to these receptors,
causing the blood vessels to
relax and the blood pressure to lower. Irbesartan STADA slows the
decrease of kidney function
in patients with high blood pressure and type 2 diabetes.
Irbesartan STADA is used in adult patients to:
•
treat high blood pressure (essential hypertension)
•
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 STADA
DO NOT TAKE IRBESARTAN STADA
•
if you are allergic to irbesartan or any other ingredients of this
medicine (listed in section 6)
•
if you are MORE THAN 3 MONTHS PREGNAN

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Irbesartan STADA 75 mg, filmomhulde tabletten.
Irbesartan STADA 150 mg, filmomhulde tabletten.
Irbesartan STADA 300 mg, filmomhulde tabletten.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 75 mg film-coated tablet contains 75 mg of irbesartan.
Each 150 mg film-coated tablet contains 150 mg of irbesartan.
Each 300 mg film-coated tablet contains 300 mg of irbesartan.
Excipient with known effect
Each 75 mg film-coated tablet contains 17.08 mg of lactose
monohydrate.
Each 150 mg film-coated tablet contains 34.16 mg of lactose
monohydrate.
Each 300 mg film-coated tablet contains 68.32 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
75 mg film-coated tablets are white, biconvex, oval-shaped and
approximately 10 mm in
length.
150 mg film-coated tablets are white, biconvex, oval-shaped and
approximately 13 mm in
length.
300 mg film-coated tablets are white, biconvex, oval-shaped and
approximately 16 mm in
length.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irbesartan STADA 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
This medicinal product is available in 3 strengths: 75 mg, 150 mg and
300 mg. The usual
recommended initial and maintenance dose is 150 mg once daily.
Irbesartan STADA 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 STADA can
be increased to 300 mg, or other antihypertensive agents can be added
(see sect