Onduarp
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
02-04-2014
Svojstava lijeka
(SPC)
02-04-2014
Izvješće o ocjeni javnog
(PAR)
02-04-2014
Aktivni sastojci:
Telmisartan
Dostupno od:
Boehringer Ingelheim International GmbH
ATC koda:
C09DB04
INN (International ime):
telmisartan, amlodipine
Terapijska grupa:
Cardiovascular system
Područje terapije:
Hypertension
Terapijske indikacije:
Treatment of essential hypertension in adults:Add on therapyOnduarp is indicated in adults whose blood pressure is not adequately controlled on amlodipine.Replacement therapyAdult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Onduarp containing the same component doses.
Proizvod sažetak:
Revision: 2
Status autorizacije:
Withdrawn
Datum autorizacije:
2011-11-24
Uputa o lijeku
96
B. PACKAGE LEAFLET
Medicinal product no longer authorised
97
PACKAGE LEAFLET: INFORMATION FOR THE USER
ONDUARP 40 MG/5 MG TABLETS
Telmisartan/Amlodipine
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 of the side effects, talk to your doctor or pharmacist.
This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Onduarp is and what it is used for
2.
What you need to know before you take Onduarp
3.
How to take Onduarp
4.
Possible side effects
5.
How to store Onduarp
6.
Contents of the pack and other information
1.
WHAT ONDUARP IS AND WHAT IT IS USED FOR
_ _
Onduarp tablets contain two active substances called telmisartan and
amlodipine. Both of these
substances help to control your high blood pressure:
- Telmisartan belongs to a group of substances called
“angiotensin-II receptor antagonists”.
Angiotensin II is a substance produced in the body which causes blood
vessels to narrow, thus
increasing blood pressure. Telmisartan works by blocking the effect of
angiotensin II.
- Amlodipine belongs to a group of substances called “calcium
channel blockers”. Amlodipine stops
calcium from moving into the blood vessel wall which stops the blood
vessels from tightening.
This means that both of these active substances work together to help
stop your blood vessels
tightening. As a result, the blood vessels relax and blood pressure is
lowered.
ONDUARP IS USED TO treat high blood pressure
- in adult patients whose blood pressure is not controlled enough with
amlodipine.
- in adult patients who already receive telmisartan and amlodipine
from separate tablets and who wish
to take instead the same doses in one tablet for
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Svojstava lijeka
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Onduarp 40 mg/5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as
amlodipine besilate).
Excipient(s) with known effect
:
Each tablet contains 168.64 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Blue and white oval shaped two layer tablets engraved with the product
code A1 and the company
logo on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults:
Add on therapy
Onduarp is indicated in adults whose blood pressure is not adequately
controlled on amlodipine.
Replacement therapy
Adult patients receiving telmisartan and amlodipine from separate
tablets can instead receive tablets of
Onduarp containing the same component doses.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Onduarp is one tablet per day.
The maximum recommended dose is Onduarp 80 mg/10 mg, one tablet per
day. Onduarp is indicated
for long term treatment.
Administration of amlodipine with grapefruit or grapefruit juice is
not recommended as bioavailability
may be increased in some patients resulting in increased blood
pressure lowering effects (see section
4.5).
_Add on therapy_
_ _
Onduarp 40 mg/5 mg tablets may be administered in patients whose blood
pressure is not adequately
controlled with amlodipine 5 mg alone.
Individual dose titration with the components (i.e. amlodipine and
telmisartan) is recommended before
changing to the fixed dose combination. When clinically appropriate,
direct change from monotherapy
to the fixed combination may be considered.
Medicinal product no longer authorised
3
Patients treated with 10 mg amlodipine who experience any dose
limiting adverse reactions such as
oedema, may be switched to Onduarp 40 mg/5 mg once daily, reducing the
dose of amlodipine
without reducing the overall expected an
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