MicardisPlus
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)
10-11-2015
Składnik aktywny:
Telmisartan, hydrochlorothiazide
Dostępny od:
Boehringer Ingelheim International GmbH
Kod ATC:
C09DA07
INN (International Nazwa):
telmisartan / hydrochlorothiazide
Grupa terapeutyczna:
Agents acting on the renin-angiotensin system
Dziedzina terapeutyczna:
Hypertension
Wskazania:
Treatment of essential hypertension.MicardisPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.MicardisPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on MicardisPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Podsumowanie produktu:
Revision: 33
Status autoryzacji:
Authorised
Data autoryzacji:
2002-04-19
Ulotka dla pacjenta
60
B. PACKAGE LEAFLET
61
PACKAGE LEAFLET: INFORMATION FOR THE USER
MICARDISPLUS 40 MG/12.5 MG TABLETS
telmisartan/hydrochlorothiazide
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 MicardisPlus is and what it is used for
2.
What you need to know before you take MicardisPlus
3.
How to take MicardisPlus
4.
Possible side effects
5.
How to store MicardisPlus
6.
Contents of the pack and other information
1.
WHAT MICARDISPLUS IS AND WHAT IT IS USED FOR
MicardisPlus is a combination of two active substances, telmisartan
and hydrochlorothiazide in one
tablet. Both of these substances help to control high blood pressure.
-
Telmisartan belongs to a group of medicines called 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 blocks the effect of
angiotensin II so that the
blood vessels relax, and your blood pressure is lowered.
-
Hydrochlorothiazide belongs to a group of medicines called thiazide
diuretics, which cause your
urine output to increase, leading to a lowering of your blood
pressure.
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.
MicardisPlus is used to treat high blood pre
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
MicardisPlus 40 mg/12.5 mg tablets
MicardisPlus 80 mg/12.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MicardisPlus 40 mg/12.5 mg tablets
Each tablet contains 40 mg telmisartan and 12.5 mg
hydrochlorothiazide.
MicardisPlus 80 mg/12.5 mg tablets
Each tablet contains 80 mg telmisartan and 12.5 mg
hydrochlorothiazide.
Excipients with known effect
MicardisPlus 40 mg/12.5 mg tablets
Each tablet contains 112 mg of lactose monohydrate equivalent to 107
mg lactose anhydrous.
Each tablet contains 169 mg sorbitol (E420).
MicardisPlus 80 mg/12.5 mg tablets
Each tablet contains 112 mg of lactose monohydrate equivalent to 107
mg lactose anhydrous.
Each tablet contains 338 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
MicardisPlus 40 mg/12.5 mg tablets
Red and white oblong shaped two layer tablet of 5.2 mm engraved with
the company logo and the
code 'H4'.
MicardisPlus 80 mg/12.5 mg tablets
Red and white oblong shaped two layer tablet of 6.2 mm engraved with
the company logo and the
code 'H8'.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
MicardisPlus fixed dose combination (40 mg telmisartan/12.5 mg
hydrochlorothiazide (HCTZ) and
80 mg telmisartan/12.5 mg HCTZ) is indicated in adults whose blood
pressure is not adequately
controlled on telmisartan alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The fixed dose combination should be taken in patients whose blood
pressure is not adequately
controlled by telmisartan alone. Individual dose titration with each
of the two components is
recommended before changing to the fixed dose combination. When
clinically appropriate, direct
change from monotherapy to the fixed combination may be considered.
3
•
MicardisPlus 40 mg/12.5 mg may be administered once daily in patients
whose blood pressure
is not adequately controlled by Micardis 40 mg
•
MicardisPlus 80 mg/12.5 mg may be administered o
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