Ipreziv
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
19-12-2014
Charakterystyka produktu
(SPC)
19-12-2014
Sprawozdanie z oceny publicznego
(PAR)
19-12-2014
Składnik aktywny:
Azilsartan medoxomil
Dostępny od:
Takeda Pharma A/S
Kod ATC:
C09CA09
INN (International Nazwa):
azilsartan medoxomil
Grupa terapeutyczna:
Agents acting on the renin-angiotensin system
Dziedzina terapeutyczna:
Hypertension
Wskazania:
Ipreziv is indicated for the treatment of essential hypertension in adults.
Podsumowanie produktu:
Revision: 4
Status autoryzacji:
Withdrawn
Data autoryzacji:
2011-12-07
Ulotka dla pacjenta
51
B. PACKAGE LEAFLET
Medicinal product no longer authorised
52
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
IPREZIV 20 MG TABLETS
IPREZIV 40 MG TABLETS
IPREZIV 80 MG TABLETS
azilsartan medoxomil
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Ipreziv is and what it is used for
2.
What do you need to know before you take Ipreziv
3.
How to take Ipreziv
4.
Possible side effects
5.
How to store Ipreziv
6.
Contents of the pack and other information
1.
WHAT IPREZIV IS AND WHAT IT IS USED FOR
Ipreziv contains an active substance called azilsartan medoxomil and
belongs to a class of medicines
called angiotensin II receptor antagonists (AIIRAs). Angiotensin II is
a substance which occurs
naturally in the body and which causes the blood vessels to tighten,
therefore increasing your blood
pressure. Ipreziv blocks this effect so that the blood vessels relax,
which helps lower your blood
pressure.
This medicine is used for treating high blood pressure (essential
hypertension) in adult patients (over
18 years of age).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IPREZIV
DO NOT TAKE IPREZIV IF YOU
-
are
ALLERGIC
(hypersensitive) to azilsartan medoxomil or any of the other
ingredients of Ipreziv
(see section 6).
-
are
MORE THAN 3 MONTHS PREGNANT.
(It is also better to avoid Ipreziv in ea
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Charakterystyka produktu
1
_ _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Ipreziv 20 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of azilsartan medoxomil (as potassium).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to nearly white round tablets, 6.0 mm in diameter, debossed
“ASL” on one side and “20” on the
other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ipreziv is indicated for the treatment of essential hypertension in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose is 40 mg once daily. The dose may be
increased to a maximum of
80 mg once daily for patients whose blood pressure is not adequately
controlled at the lower dose.
Near-maximal antihypertensive effect is evident at 2 weeks, with
maximal effects attained by
4 weeks.
If blood pressure is not adequately controlled with Ipreziv alone,
additional blood pressure reduction
can be achieved when Ipreziv is coadministered with other
antihypertensive medicinal products,
including diuretics (such as chlortalidone and hydrochlorothiazide)
and calcium channel blockers (see
sections 4.3, 4.4, 4.5 and 5.1).
_ _
Special populations
_Older people (65 years and over) _
No initial dose adjustment with Ipreziv is necessary in elderly
patients (see section 5.2), although
consideration can be given to 20 mg as a starting dose in the very
elderly (≥ 75 years), who may be at
risk of hypotension.
Medicinal product no longer authorised
3
_Renal impairment _
Caution should be exercised in hypertensive patients with severe renal
impairment and end stage renal
disease as there is no experience of use of Ipreziv in these patients
(see sections
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