Telmisartan Teva Pharma
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-10-2021
Charakterystyka produktu
(SPC)
26-10-2021
Sprawozdanie z oceny publicznego
(PAR)
19-06-2015
Składnik aktywny:
Telmisartan
Dostępny od:
Teva B.V.
Kod ATC:
C09CA07
INN (International Nazwa):
telmisartan
Grupa terapeutyczna:
Agents acting on the renin-angiotensin system
Dziedzina terapeutyczna:
Hypertension
Wskazania:
Treatment of essential hypertension in adults.
Podsumowanie produktu:
Revision: 10
Status autoryzacji:
Authorised
Data autoryzacji:
2011-10-03
Ulotka dla pacjenta
44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELMISARTAN TEVA PHARMA 20 MG TABLETS
Telmisartan
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 Telmisartan Teva Pharma is and what it is used for
2.
What you need to know before you take Telmisartan Teva Pharma
3.
How to take Telmisartan Teva Pharma
4.
Possible side effects
5.
How to store Telmisartan Teva Pharma
6.
Contents of the pack and other information
1.
WHAT TELMISARTAN TEVA PHARMA IS AND WHAT IT IS USED FOR
Telmisartan Teva Pharma belongs to a class of medicines known as
angiotensin-II receptor antagonists.
Angiotensin II is a substance occurring in the body, which causes your
blood vessels to narrow, thus
increasing your blood pressure. Telmisartan Teva Pharma blocks this
effect of angiotensin II so that the
blood vessels relax, and your blood pressure is lowered.
Telmisartan Teva Pharma is used to treat essential hypertension (high
blood pressure) in adults. ‘Essential’
means that the high blood pressure is not caused by any other
condition.
High blood pressure, if not treated, can damage blood vessels in
several organs, which could lead sometimes
to heart attacks, heart or kidney failure, strokes or blindness. There
are usually no symptoms of high blood
pressure before damage occurs. Thus it is important to regularly
measure blood pressure to verify if it is
within the normal range.
Telmisartan Teva Pharma is also used to reduce cardiovascular events
(i.e. heart attack or stroke) in adults
who are at risk becaus
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Telmisartan Teva Pharma 20 mg tablets
Telmisartan Teva Pharma 40 mg tablets
Telmisartan Teva Pharma 80 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Telmisartan Teva Pharma 20 mg tablets
Each tablet contains 20 mg telmisartan.
Telmisartan Teva Pharma 40 mg tablets
Each tablet contains 40 mg telmisartan.
Telmisartan Teva Pharma 80 mg tablets
Each tablet contains 80 mg telmisartan.
Excipients with known effect
Telmisartan Teva Pharma 20 mg tablets
Each tablet contains 21.4 mg sorbitol (E420)
Telmisartan Teva Pharma 40 mg tablets
Each tablet contains 42.8 mg sorbitol (E420)
Telmisartan Teva Pharma 80 mg tablets
Each tablet contains 85.6 mg sorbitol (E420)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Telmisartan Teva Pharma 20 mg tablets
White to off white, oval shaped tablet; one side of the tablet is
debossed with the number
"93". The other side of the tablet is debossed with the number "7458".
Telmisartan Teva Pharma 40 mg tablets
White to off white, oval shaped tablet; one side of the tablet is
debossed with the number
"93". The other side of the tablet is debossed with the number "7459".
Telmisartan Teva Pharma 80 mg tablets
White to off white, oval shaped tablet; one side of the tablet is
debossed with the number
"93". The other side of the tablet is debossed with the number "7460".
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension in adults.
3
Cardiovascular prevention
Reduction of cardiovascular morbidity in adults with:
•
manifest atherothrombotic cardiovascular disease (history of coronary
heart disease, stroke, or peripheral
arterial disease) or
•
type 2 diabetes mellitus with documented target organ damage
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment of essential hypertension
The usually effective dose is 40 mg once daily. Some patients may
already benefit at a daily dose of 20 mg.
In cases where the target blood
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