Twynsta
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
11-07-2023
Charakterystyka produktu
(SPC)
11-07-2023
Sprawozdanie z oceny publicznego
(PAR)
08-10-2015
Składnik aktywny:
Telmisartan, amlodipine
Dostępny od:
Boehringer Ingelheim International GmbH
Kod ATC:
C09DB04
INN (International Nazwa):
telmisartan, amlodipine
Grupa terapeutyczna:
Agents acting on the renin-angiotensin system
Dziedzina terapeutyczna:
Hypertension
Wskazania:
Treatment of essential hypertension in adults:Add-on therapyTwynsta 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 Twynsta containing the same component doses.
Podsumowanie produktu:
Revision: 13
Status autoryzacji:
Authorised
Data autoryzacji:
2010-10-07
Ulotka dla pacjenta
114
B. PACKAGE LEAFLET
115
PACKAGE LEAFLET: INFORMATION FOR THE USER
TWYNSTA 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 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 Twynsta is and what it is used for
2.
What you need to know before you take Twynsta
3.
How to take Twynsta
4.
Possible side effects
5.
How to store Twynsta
6.
Contents of the pack and other information
1.
WHAT TWYNSTA IS AND WHAT IT IS USED FOR
Twynsta 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 blockers”.
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.
TWYNSTA IS USED TO treat high blood pressure
in adult patients whose blood pressure is not controlled enough with
amlodipine alone.
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 convenience.
High bloo
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Twynsta 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 of approximately 14 mm
length engraved with the product
code A1 and the company logo on the white layer.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults:
Add on therapy
Twynsta 40 mg/5 mg is indicated in adults whose blood pressure is not
adequately controlled on
amlodipine 5 mg alone.
Replacement therapy
Adult patients receiving telmisartan and amlodipine from separate
tablets can instead receive tablets of
Twynsta containing the same component doses.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of this medicinal product is one tablet per day.
The maximum recommended dose is one tablet 80 mg telmisartan/10 mg
amlodipine per day. This
medicinal product 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_
Twynsta 40 mg/5 mg may be administered in patients whose blood
pressure is not adequately controlled
on 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.
3
Patients treated with 10 mg amlodipine who experience any dose
limiting adverse reactions such as
oedema, may be switched to Twynsta 40 mg/5 mg once daily, reducing the
dose of amlodipine without
reducing the overall expected an
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