Micardis
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
03-11-2022
Charakterystyka produktu
(SPC)
03-11-2022
Sprawozdanie z oceny publicznego
(PAR)
06-11-2015
Składnik aktywny:
Telmisartan
Dostępny od:
Boehringer Ingelheim International GmbH
Kod ATC:
C09CA07
INN (International Nazwa):
telmisartan
Grupa terapeutyczna:
Angiotensin II antagonists, plain
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: 27
Status autoryzacji:
Authorised
Data autoryzacji:
1998-12-16
Ulotka dla pacjenta
44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
MICARDIS 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 Micardis is and what it is used for
2.
What you need to know before you take Micardis
3.
How to take Micardis
4.
Possible side effects
5.
How to store Micardis
6.
Contents of the pack and other information
1.
WHAT MICARDIS IS AND WHAT IT IS USED FOR
Micardis 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. Micardis blocks the effect of angiotensin II so that
the blood vessels relax, and your
blood pressure is lowered.
MICARDIS 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 attack, heart or kidney failure, stroke, 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.
MICARDIS IS ALSO USED TO reduce cardiovascular events (i.e. heart
attack or stroke) in adults who are at
risk because they have a reduced or blocked blood supply to the heart
or legs, or have had a stroke or
have high risk diabetes. Your doctor can tell you if you are
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Charakterystyka produktu
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Micardis 20 mg tablets
Micardis 40 mg tablets
Micardis 80 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Micardis 20 mg tablets
Each tablet contains 20 mg telmisartan.
Micardis 40 mg tablets
Each tablet contains 40 mg telmisartan.
Micardis 80 mg tablets
Each tablet contains 80 mg telmisartan.
Excipients with known effect
Each 20 mg tablet contains 84 mg sorbitol (E420).
Each 40 mg tablet contains 169 mg sorbitol (E420).
Each 80 mg tablet contains 338 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Micardis 20 mg tablets
White round tablets of 2.5 mm engraved with the code number '50H' on
one side and the company
logo on the other side.
Micardis 40 mg tablets
White oblong tablets of 3.8 mm engraved with the code number '51H' on
one side and the company
logo on the other side.
Micardis 80 mg tablets
White oblong tablets of 4.6 mm engraved with the code number '52H' on
one side and the company
logo on the other side.
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 pressure is not achieved, the
dose of telmisartan can be
increased to a maximum of 80 mg once daily. Alternatively, telmisartan
may be used in combination
with thiazide-type 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
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