Kaliumlosartan axcount 100 mg, filmomhulde tabletten

Country: Belanda

Bahasa: Belanda

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

Bahan aktif:

LOSARTAN KALIUM 100 mg/stuk

Boleh didapati daripada:

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

Kod ATC:

C09CA01

INN (Nama Antarabangsa):

LOSARTAN KALIUM 100 mg/stuk

Borang farmaseutikal:

Filmomhulde tablet

Komposisi:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; 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 ; 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),

Laluan pentadbiran:

Oraal gebruik

Kawasan terapeutik:

Losartan

Ringkasan produk:

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

Tarikh kebenaran:

2008-04-21

Risalah maklumat

1
V06
PACKAGE LEAFLET: INFORMATION FOR THE USER
KALIUMLOSARTAN AXCOUNT 12,5 MG, FILMOMHULDE TABLETTEN
KALIUMLOSARTAN AXCOUNT 25 MG, FILMOMHULDE TABLETTEN
KALIUMLOSARTAN AXCOUNT 50 MG, FILMOMHULDE TABLETTEN
KALIUMLOSARTAN AXCOUNT 100 MG, FILMOMHULDE TABLETTEN
LOSARTAN POTASSIUM
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 Kaliumlosartan axcount is and what it is used for
2.
What you need to know before you take Kaliumlosartan axcount
3.
How to take Kaliumlosartan axcount
4.
Possible side effects
5.
How to store Kaliumlosartan axcount
6.
Contents of the pack and other information
1.
WHAT KALIUMLOSARTAN AXCOUNT IS AND WHAT IT IS USED FOR
Losartan belongs to a group of medicines known as angiotensin-II
receptor antagonists.
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.
Losartan slows the decrease of kidney function in patients with high
blood pressure and type 2 diabetes.
Kaliumlosartan axcount is used
-
to treat high blood pressure (hypertension) in adults and in children
and adolescents 6 - 18 years of
age
-
to protect the kidney in hypertensive type 2 diabetic patients with
laboratory evidence of impaired renal
function and proteinuria ≥ 0.5 g per day (a condition in which urine
contains an abnormal amount of
protein)

Ciri produk

1
V04
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Kaliumlosartan axcount 12,5 mg, filmomhulde tabletten
Kaliumlosartan axcount 25 mg, filmomhulde tabletten
Kaliumlosartan axcount 50 mg, filmomhulde tabletten
Kaliumlosartan axcount 100 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Kaliumlosartan axcount 12.5 mg Tablet contains 12.5 mg of
losartan potassium equivalent to
11.44 mg of losartan.
Each Kaliumlosartan axcount 25 mg Tablet contains 25 mg of losartan
potassium equivalent to
22.9 mg of losartan.
Each Kaliumlosartan axcount 50 mg Tablet contains 50 mg of losartan
potassium equivalent to
45.8 mg of losartan.
Each Kaliumlosartan axcount 100 mg Tablet contains 100 mg of losartan
potassium equivalent to
91.6 mg of losartan.
Excipient with known effect:
Kaliumlosartan axcount 12.5 mg tablets
Each tablet contains 5.85 mg of lactose monohydrate/film-coated
tablet.
Kaliumlosartan axcount 25 mg tablets
Each tablet contains 11.70 mg of lactose monohydrate/film-coated
tablet.
Kaliumlosartan axcount 50 mg tablets
Each tablet contains 23.40 mg of lactose monohydrate/film-coated
tablet.
Kaliumlosartan axcount 100 mg tablets
Each tablet contains 46.80 mg of lactose monohydrate/film-coated
tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Kaliumlosartan axcount 12.5 mg tablet
White, round, biconvex film-coated tablets with a diameter of 5.1 mm
approximately.
Kaliumlosartan axcount 25 mg tablet
White, round, biconvex film-coated tablets with a diameter of 5.1 mm
approximately.
Kaliumlosartan axcount 50 mg tablet
2
V04
White, round, biconvex film-coated tablets with a diameter of 7.6 mm
approximately, bearing a
breakline on one side. The tablet can be divided into equal doses.
Kaliumlosartan axcount 100 mg tablet
White, round, biconvex film-coated tablets with a diameter of 9.1 mm
approximately, bearing a
breakline on one side. The tablet can be divided into equal doses._ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS