Actelsar HCT
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)
26-03-2013
Składnik aktywny:
Telmisartan, hydrochlorothiazide
Dostępny od:
Actavis Group hf
Kod ATC:
C09DA07
INN (International Nazwa):
telmisartan, hydrochlorothiazide
Grupa terapeutyczna:
Agents acting on the renin-angiotensin system, Angiotensin II antagonists and diuretics
Dziedzina terapeutyczna:
Essential Hypertension
Wskazania:
Treatment of essential hypertension.Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.Actelsar HCT fixed-dose combination (80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.Actelsar HCT fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg / 12.5 mg (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Podsumowanie produktu:
Revision: 17
Status autoryzacji:
Authorised
Data autoryzacji:
2013-03-13
Ulotka dla pacjenta
73
B. PACKAGE LEAFLET
74
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTELSAR HCT 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 Actelsar HCT is and what it is used for
2.
What you need to know before you take Actelsar HCT
3.
How to take Actelsar HCT
4.
Possible side effects
5.
How to store Actelsar HCT
6.
Contents of the pack and other information
1.
WHAT ACTELSAR HCT IS AND WHAT IT IS USED FOR
Actelsar HCT 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.
ACTELSAR HCT IS USED TO
treat high blood pr
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Actelsar HCT 40 mg/12.5 mg tablets
Actelsar HCT 80 mg/12.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Actelsar HCT 40 mg/12.5 mg tablets
Each tablet contains 40 mg telmisartan and 12.5 mg
hydrochlorothiazide.
Actelsar HCT 80 mg/12.5 mg tablets
Each tablet contains 80 mg telmisartan and 12.5 mg
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Actelsar HCT 40 mg/12.5 mg tablets
White or almost white, 6.55 x 13.6 mm oval-shaped and biconvex tablets
marked with “TH” on one
side.
Actelsar HCT 80 mg/12.5 mg tablets
White or almost white, 9.0 x 17.0 mm capsule-shaped tablets marked
with “TH 12.5” on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Actelsar HCT fixed dose combination (40 mg telmisartan/12.5 mg
hydrochlorothiazide and
80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults
whose blood pressure is not
adequately controlled on telmisartan alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
Actelsar HCT 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.
-
Actelsar HCT 40 mg/12.5 mg may be administered once daily in patients
whose blood pressure
is not adequately controlled by telmisartan 40 mg
-
Actelsar HCT 80 mg/12.5 mg may be administered once daily in patients
whose blood pressure
is not adequately controlled by telmisartan 80 mg
Actelsar HCT is also available at the dose strength 80 mg/25 mg
3
_Special populations: _
_Patients with renal impairment _
Periodic monitoring of renal function is advised (see section 4.4).
_Patients with hepatic impairment _
In patients with mild to moderate hepatic impairment the po
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