Kaliumlosartan HCTZ axcount 100/25 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

HYDROCHLOORTHIAZIDE 25 mg/stuk ; LOSARTAN KALIUM 100 mg/stuk SAMENSTELLING overeenkomend met ; LOSARTAN 91,67 mg/stuk

Beschikbaar vanaf:

axcount Generika GmbH Max-Planck-Straße 36d D-61381 FRIEDRICHSDORF (DUITSLAND)

ATC-code:

C09DA01

INN (Algemene Internationale Benaming):

HYDROCHLOORTHIAZIDE 25 mg/stuk ; LOSARTAN KALIUM 100 mg/stuk SAMENSTELLING overeenkomend met ; LOSARTAN 91,67 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT (E468) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Losartan And Diuretics

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMZETMEELGLYCOLAAT (E468); TITAANDIOXIDE (E 171);

Autorisatie datum:

2008-04-23

Bijsluiter

1
V12
PACKAGE LEAFLET: INFORMATION FOR THE USER
KALIUMLOSARTAN HCTZ AXCOUNT 50/12,5 MG, FILMOMHULDE TABLETTEN
KALIUMLOSARTAN HCTZ AXCOUNT 100/25 MG, FILMOMHULDE TABLETTEN
LOSARTAN POTASSIUM AND 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.
WHAT IS IN THIS LEAFLET
1.
What Kaliumlosartan HCTZ axcount is and what it is used for
2.
What you need to know before you take Kaliumlosartan HCTZ axcount
3.
How to take Kaliumlosartan HCTZ axcount
4.
Possible side effects
5.
How to store Kaliumlosartan HCTZ axcount
6.
Contents of the pack and other information
1.
WHAT KALIUMLOSARTAN HCTZ AXCOUNT IS AND WHAT IT IS USED FOR
Kaliumlosartan HCTZ axcount 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 in the blood pressure. Hydrochlorothiazide works
by making the kidneys pass
more water and salt. This also helps to reduce blood pressure.
Kaliumlosartan HCTZ axcount is indicated for the treatment of
essential hypertension (high blood
pressure).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KALIUMLOSARTAN HCTZ AXCOUNT
DO NOT TAKE KALIUMLOSARTAN HCTZ AXCOUNT
−
if you are allergic to losartan, hydrochlorothiazide or any of the
other ingredients of this
medicine (listed in section 6).
−
if you

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Kaliumlosartan HCTZ axcount 100/25 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of losartan potassium and 25
mg of hydrochlorothiazide
(HCTZ).
Excipient with known effect:
Each film-coated tablet contains 123.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, oblong, biconvex tablets measuring approximately 15.3 × 6.7 mm
with a scoreline on both
sides.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kaliumlosartan HCTZ axcount is indicated for the treatment of
essential hypertension in patients
whose blood pressure is not adequately controlled on losartan or
hydrochlorothiazide alone (see
sections 4.3, 4.4, 4.5 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Kaliumlosartan HCTZ axcount may be administered with other
antihypertensive agents (see sections
4.3, 4.4, 4.5 and 5.1).
Kaliumlosartan HCTZ axcount should be swallowed with a glass of water.
Kaliumlosartan HCTZ axcount may be administered with or without food.
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 Kaliumlosartan HCTZ axcount is one
tablet of Kaliumlosartan
HCTZ axcount 50 mg/12.5 mg (losartan 50 mg/HCTZ 12.5 mg) once daily.
For patients who do
not respond adequately to Kaliumlosartan HCTZ axcount 50 mg/12.5 mg,
the dosage may be
increased to one tablet of Kaliumlosartan HCTZ axcount 100 mg/25 mg
(losartan 100 mg/HCTZ
25 mg) once daily. The maximu