Kinzalkomb
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
14-09-2022
Fachinformation
(SPC)
14-09-2022
Öffentlichen Beurteilungsberichts
(PAR)
06-11-2015
Wirkstoff:
Telmisartan, hydrochlorothiazide
Verfügbar ab:
Bayer AG
ATC-Code:
C09DA07
INN (Internationale Bezeichnung):
telmisartan, hydrochlorothiazide
Therapiegruppe:
Agents acting on the renin-angiotensin system
Therapiebereich:
Hypertension
Anwendungsgebiete:
Treatment of essential hypertension.Kinzalkomb 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.Kinzalkomb fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on Kinzalkomb (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Produktbesonderheiten:
Revision: 39
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2002-04-19
Gebrauchsinformation
59
B. PACKAGE LEAFLET
60
PACKAGE LEAFLET: INFORMATION FOR THE USER
KINZALKOMB 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 Kinzalkomb is and what it is used for
2.
What you need to know before you take Kinzalkomb
3.
How to take Kinzalkomb
4.
Possible side effects
5.
How to store Kinzalkomb
6.
Contents of the pack and other information
1.
WHAT KINZALKOMB IS AND WHAT IT IS USED FOR
Kinzalkomb 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.
Kinzalkomb is used to treat high blood pressure (essential
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Kinzalkomb 40 mg/12.5 mg tablets
Kinzalkomb 80 mg/12.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kinzalkomb 40 mg/12.5 mg tablets
Each tablet contains 40 mg telmisartan and 12.5 mg
hydrochlorothiazide.
Kinzalkomb 80 mg/12.5 mg tablets
Each tablet contains 80 mg telmisartan and 12.5 mg
hydrochlorothiazide.
Excipients with known effect
Kinzalkomb 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).
Kinzalkomb 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.
Kinzalkomb 40 mg/12.5 mg tablets
Red and white oblong shaped two layer tablet of 5.2 mm engraved with
the code number 'H4'.
Kinzalkomb 80 mg/12.5 mg tablets
Red and white oblong shaped two layer tablet of 6.2 mm engraved with
the code number 'H8'.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Kinzalkomb 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
•
Kinzalkomb 40 mg/12.5 mg may be administered once daily in patients
whose blood pressure is
not adequately controlled by Kinzalmono 40 mg
•
Kinzalkomb 80 mg/12.5 mg may be administered once daily in patients
whose blood pressure is
no
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