Ifirmasta (previously Irbesartan Krka)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

irbesartan hydrochloride

Available from:

Krka, d.d., Novo mesto

ATC code:

C09CA04

INN (International Name):

irbesartan

Therapeutic group:

Agents acting on the renin-angiotensin system

Therapeutic area:

Hypertension

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.

Product summary:

Revision: 14

Authorization status:

Authorised

Authorization date:

2008-12-01

Patient Information leaflet

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IFIRMASTA 75 MG FILM-COATED 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 Ifirmasta is and what it is used for
2.
What you need to know before you take Ifirmasta
3.
How to take Ifirmasta
4.
Possible side effects
5.
How to store Ifirmasta
6.
Contents of the pack and other information
1.
WHAT IFIRMASTA IS AND WHAT IT IS USED FOR
Ifirmasta 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. Ifirmasta
prevents the binding of angiotensin-II
to these receptors, causing the blood vessels to relax and the blood
pressure to lower. Ifirmasta slows
the decrease of kidney function in patients with high blood pressure
and type 2 diabetes.
Ifirmasta 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 IFIRMASTA
DO NOT TAKE IFIRMASTA
-
if you are ALLERGIC to irbesartan or any of the other ingredients of
this medicine (listed in
section 6),
-
if you are MORE THAN 3 MONTHS PREGNANT. (It is also better to avoid
Ifirmasta in early pregnancy
– see pregnancy section),
-
if you have diabetes or impaired kidney function and you are treated

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ifirmasta 75 mg film-coated tablets
Ifirmasta 150 mg film-coated tablets
Ifirmasta 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Ifirmasta 75 mg film-coated tablets_
Each film-coated tablet contains 75 mg irbesartan (as hydrochloride).
_Ifirmasta 150 mg film-coated tablets_
Each film-coated tablet contains 150 mg irbesartan (as hydrochloride).
_Ifirmasta 300 mg film-coated tablets_
Each film-coated tablet contains 300 mg irbesartan (as hydrochloride).
Excipient with known effect
_Ifirmasta 75 mg film-coated tablets_
Each film-coated tablet contains 4 mg castor oil.
_Ifirmasta 150 mg film-coated tablets_
Each film-coated tablet contains 8 mg castor oil.
_Ifirmasta 300 mg film-coated tablets_
Each film-coated tablet contains 16 mg castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, oval tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ifirmasta 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.
Ifirmasta 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.
3
In patients insufficiently controlled with 150 mg once daily, the dose
of Ifirmasta 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 Ifirmasta (see section