Losartankalium/HCT CF 100 mg/12,5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

HYDROCHLOORTHIAZIDE ; LOSARTAN KALIUM SAMENSTELLING overeenkomend met ; LOSARTAN

INN (Algemene Internationale Benaming):

HYDROCHLOROTHIAZIDE ; LOSARTAN POTASSIUM COMPOSITION corresponding to ; LOSARTAN

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYETHYLEENGLYCOL (E 1521) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2022-12-20

Bijsluiter

Centrafarm B.V., Breda, The Netherlands
MODULE 1
Administrative information
and prescribing information
_ _
_LOSARTANKALIUM/HCT CF 100 MG/12,5 MG, filmomhulde tabletten _
_IS/H/0472/002 _
_RVG 128779_
losartan / hydrochloorthiazide
1.3.1
SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET
1.3.1 / 1 VAN 10
Department of
Regulatory Affairs
DATE: 2022-12
AUTHORISATION
CASE MANAGER:
AO
REV. 1.0
APPROVED MEB
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTANKALIUM/HCT CF 100 MG/12,5 MG, FILMOMHULDE TABLETTEN
losartan potassium/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, pharmacist or
nurse.
•
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, pharmacist, or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
is a combination of an angiotensin II receptor
antagonist (losartan) and a diuretic
(hydrochlorothiazide). Angiotensin-II is a substance produced in the
body which binds to receptors in
blood vessels, causing them to tighten. This results in an increase in
blood pressure. Losartan prevents
the binding of angiotensin-II to these receptors, causing the blood
vessels to relax which in turn lowers
the blood pressure. Hydrochlorothiazide works by making the kidneys
pass more water and salt. This
also helps to reduce blood pressure.
is indicated for the treatment of es

Productkenmerken

Centrafarm B.V., Breda, The Netherlands
MODULE 1
Administrative information
and prescribing information
_ _
_LOSARTANKALIUM/HCT CF 100 MG/12,5 MG, filmomhulde tabletten _
_IS/H/0472/002 _
_RVG 128779_
losartan / hydrochloorthiazide
1.3.1
SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET
1.3.1 / 1 VAN 21
Department of
Regulatory Affairs
DATE: 2022-12
AUTHORISATION
CASE MANAGER:
AO
REV. 1.0
APPROVED MEB
1.
NAME OF THE MEDICINAL PRODUCT
Losartankalium/HCT CF 100 mg/12,5 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 100 mg of losartan potassium and 12.5
mg of hydrochlorothiazide.
Excipient with known effect
Each film-coated tablet contains 157.9 mg of lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
100 mg/12.5 mg tablet: Round, white film-coated tablet
of around 10.5 mm in
diameter, embossed with a “L” on one of the faces.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
is indicated for the treatment of essential
hypertension in patients whose blood
pressure is not adequately controlled on losartan or
hydrochlorothiazide alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION_ _
Posology
Hypertension
Losartan and hydrochlorothiazide is not for use as initial therapy,
but in patients whose blood pressure
is not adequately controlled by losartan potassium or
hydrochlorothiazide alone.
Dose titration with the individual components (losartan and
hydrochlorothiazide) is recommended.
When clinically appropriate direct change from monotherapy to the
fixed combination may be
considered in patients whose blood pressure is not adequately
controlled.
The usual maintenance dose of is one tablet of
50 mg/12.5 mg
(losartan potassium 50 mg/hydrochlorothiazide 12.5 mg) once daily. For
patients who do not respond
adequately to 50 mg/12.5 mg, the dosage ma