Tolucombi
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
24-08-2023
Valmisteyhteenveto
(SPC)
24-08-2023
Julkisesta arviointikertomuksesta
(PAR)
08-04-2013
Aktiivinen ainesosa:
Telmisartan, hydrochlorothiazide
Saatavilla:
Krka, d.d., Novo mesto
ATC-koodi:
C09DA07
INN (Kansainvälinen yleisnimi):
telmisartan, hydrochlorothiazide
Terapeuttinen ryhmä:
telmisartan and diuretics
Terapeuttinen alue:
Hypertension
Käyttöaiheet:
Tolucombi fixed-dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Tolucombi 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.
Tuoteyhteenveto:
Revision: 11
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2013-03-13
Pakkausseloste
57
B. PACKAGE LEAFLET
58
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TOLUCOMBI 40 MG/12.5 MG TABLETS
TOLUCOMBI 80 MG/12.5 MG TABLETS
TOLUCOMBI 80 MG/25 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 Tolucombi is and what it is used for
2.
What you need to know before you take Tolucombi
3.
How to take Tolucombi
4.
Possible side effects
5.
How to store Tolucombi
6.
Contents of the pack and other information
1.
WHAT TOLUCOMBI IS AND WHAT IT IS USED FOR
Tolucombi 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.
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tolucombi 40 mg/12.5 mg tablets
Tolucombi 80 mg/12.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tolucombi 40 mg/12.5 mg tablets
Each tablet contains 40 mg telmisartan and 12.5 mg
hydrochlorothiazide.
Tolucombi 80 mg/12.5 mg tablets
Each tablet contains 80 mg telmisartan and 12.5 mg
hydrochlorothiazide.
Excipient(s) with known effect
Each 40 mg/12.5 mg tablet contains 57 mg of lactose (as monohydrate)
and 147.04 mg sorbitol (E420).
Each 80 mg/12.5 mg tablet contains 114 mg of lactose (as monohydrate)
and 294.08 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Tolucombi 40 mg/12.5 mg tablets:
White to almost white or pinkish white on one side and pink marbled on
the opposite side of two-layer
biconvex oval tablet, tablet dimensions 15 mm x 7 mm.
Tolucombi 80 mg/12.5 mg tablets
White to almost white or pinkish white on one side and pink marbled on
the opposite side of two-layer
biconvex oval tablet, tablet dimensions 18 mm x 9 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Tolucombi 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
Tolucombi 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.
-
Tolucombi 40 mg/12.5 mg may be administered once daily in patients
whose blood pressure is
not adequately controlled by telmisartan 40 mg.
-
Tolucombi 80 mg/12.5 mg may be administered once daily in patients
whose blood pressure is
3
not adequately controlled
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