Telmisartan Actavis
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
24-10-2023
Charakterystyka produktu
(SPC)
24-10-2023
Sprawozdanie z oceny publicznego
(PAR)
28-07-2015
Składnik aktywny:
Telmisartan
Dostępny od:
Actavis Group PTC ehf
Kod ATC:
C09CA07
INN (International Nazwa):
telmisartan
Grupa terapeutyczna:
Agents acting on the renin-angiotensin system
Dziedzina terapeutyczna:
Hypertension
Wskazania:
HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients 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.
Podsumowanie produktu:
Revision: 13
Status autoryzacji:
Authorised
Data autoryzacji:
2010-09-29
Ulotka dla pacjenta
42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELMISARTAN ACTAVIS 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 Actavis is and what it is used for
2.
What you need to know before you take Telmisartan Actavis
3.
How to take Telmisartan Actavis
4.
Possible side effects
5.
How to store Telmisartan Actavis
6.
Contents of the pack and other information
1.
WHAT TELMISARTAN ACTAVIS IS AND WHAT IT IS USED FOR
Telmisartan Actavis contains the active substance telmisartan which
belongs to a class of medicines
known as angiotensin II receptor antagonists.
Angiotensin II is a substance produced in your body, which causes your
blood vessels to narrow, thus
increasing your blood pressure. Telmisartan Actavis blocks the effect
of angiotensin II so that the
blood vessels relax, and your blood pressure is lowered.
Telmisartan Actavis tablets are 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 Actavis is also used to
reduce cardiovascular events (i.e. heart attack or stroke) in
adults who a
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Telmisartan Actavis 20 mg tablets
Telmisartan Actavis 40 mg tablets
Telmisartan Actavis 80 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Telmisartan Actavis 20 mg tablets
Each tablet contains 20 mg telmisartan
Telmisartan Actavis 40 mg tablets
Each tablet contains 40 mg telmisartan
Telmisartan Actavis 80 mg tablets
Each tablet contains 80 mg telmisartan
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Telmisartan Actavis 20 mg tablets
White, round, flat tablets with logo T on one side.
Telmisartan Actavis 40 mg tablets
White, oval, biconvex tablets with a break line and logo T on one
side. The tablet can be divided into
equal halves.
Telmisartan Actavis 80 mg tablets
White, oval, biconvex tablets with logo T1 on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension in adults.
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 pressure is not achieved, the
dose of telmisartan can be
3
increased to a maximum of 80 mg once daily. Alternatively, telmisartan
may be used in combination
with thiazidetype diuretics such as hydrochlorothiazide which has been
shown to have an additive
blood pressure lowering effect with telmisartan. When considering
raising the dose, it must be borne
in mind that the maximum antihypertensive effect is generally attained
four to eight weeks after the
start of treatment (see section 5.1).
_Cardiovascular prevention _
The recommended dose is 80 mg once daily. It is not known
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