Esomeprazol Aurobindo 40 mg, maagsapresistente tabletten

国家: 荷兰

语言: 荷兰文

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

有效成分:

ESOMEPRAZOL MAGNESIUM 2-WATER SAMENSTELLING overeenkomend met ; ESOMEPRAZOL

可用日期:

Aurobindo Pharma B.V.

ATC代码:

A02BC05

INN（国际名称）:

ESOMEPRAZOLE MAGNESIUM 2-WATER COMPOSITION corresponding to ; ESOMEPRAZOLE

药物剂型:

Maagsapresistente tablet

组成:

BASISCH GEBUTYLEERD METHACRYLAAT COPOLYMEER ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN MACROGOL (25,0)-POLY(VINYL ALCOHOL) (75,0) ; CROSPOVIDON (E 1202) ; GLYCEROLMONOSTEARAAT 40-55 (E 471) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMSTEARYLFUMARAAT ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; SACCHAROSE ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505),

给药途径:

Oraal gebruik

治疗领域:

Esomeprazole

產品總結:

Hulpstoffen: BASISCH GEBUTYLEERD METHACRYLAAT COPOLYMEER; CELLULOSE, MICROKRISTALLIJN (E 460); COPOLYMEER VAN MACROGOL (25,0)-POLY(VINYL ALCOHOL) (75,0); CROSPOVIDON (E 1202); GLYCEROLMONOSTEARAAT 40-55 (E 471); HYPROLOSE (E 463); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 400; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMSTEARYLFUMARAAT; POLYSORBAAT 80 (E 433); POVIDON K 30 (E 1201); SACCHAROSE; SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505);

授权日期:

2013-05-15

资料单张

ESOMEPRAZOL AUROBINDO 20 MG EN 40 MG, MAAGSAPRESISITENTE TABLETTEN RVG 110819 , RVG 110820
MODULE 1 Administrative information and prescribing information
1.3.1 BIJSLUITER
Rev.nr. 1801
Pag. 1 van 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESOMEPRAZOL AUROBINDO 20 MG, MAAGSAPRESISTENTE TABLETTEN
ESOMEPRAZOL AUROBINDO 40 MG, MAAGSAPRESISTENTE TABLETTEN
esomeprazole
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 Esomeprazol Aurobindo is and what it is used for
2.
What you need to know before you take Esomeprazol Aurobindo
3.
How to take Esomeprazol Aurobindo
4.
Possible side effects
5.
How to store Esomeprazol Aurobindo
6.
Contents of the pack and other information
1.
WHAT ESOMEPRAZOL AUROBINDO IS AND WHAT IT IS USED FOR
Esomeprazol Aurobindo contains a medicine called esomeprazole. This
belongs to a group of
medicines called ’proton pump inhibitors’. They work by reducing
the amount of acid that your
stomach produces.
Esomeprazol Aurobindo is used to treat the following conditions:
Adults and adolescents aged 12 years and above
-
‘Gastro-oesophageal reflux disease’ (GORD). This is where acid
from the stomach escapes into
the gullet (the tube which connects your throat to your stomach)
causing pain, inflammation and
heartburn.
-
Ulcers in the stomach or upper part of the gut (intestine) that are
infected with bacteria called
‘_Helicobacter pylori_’. If you have this condition, your doctor
may also prescribe antibiotics to
treat the infection and allow the ulcer to heal.
Adults
-

产品特点

ESOMEPRAZOL AUROBINDO 20 MG EN 40 MG, MAAGSAPRESISTENTE TABLETTEN RVG 110819 , RVG 110820
MODULE 1 Administrative information and prescribing information
1.3.1 SAMENVATTING VAN DE PRODUCTKENMERKEN
Rev.nr. 1801
Pag. 1 van 19
1.
NAME OF THE MEDICINAL PRODUCT
Esomeprazol Aurobindo 20 mg, maagsapresistente tabletten
Esomeprazol Aurobindo 40 mg, maagsapresistente tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gastro-resistant tablet contains 20 mg of esomeprazole
(corresponding to 21.75 mg esomeprazole
magnesium dihydrate).
Excipient with known effect:
Each tablet contains no more than 5.65 mg of sucrose.
One gastro-resistant tablet contains 40 mg of esomeprazole
(corresponding to 43.5 mg esomeprazole
magnesium dihydrate).
Excipient with known effect:
Each tablet contains no more than 11.3 mg of sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
20 mg: A light pink, elliptically shaped, biconvex film-coated tablet,
6.55 x 13.6 mm.
40 mg: A pink, elliptically shaped, biconvex film-coated tablet, 8.2 x
17 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
<[_Esomeprazol Aurobindo 20 mg tablets:_]>
Esomeprazol Aurobindo 20 mg tablets are indicated in adults for:
Gastro-esophageal Reflux Disease (GERD)
-
treatment of erosive reflux oesophagitis
-
long-term management of patients with healed oesophagitis to prevent
relapse
-
symptomatic treatment of gastro-esophageal reflux disease (GERD)
In combination with appropriate antibacterial therapeutic regimens for
the eradication of _Helicobacter _
_pylori _and
-
healing of _Helicobacter pylori _associated duodenal ulcer and
-
prevention of relapse of peptic ulcers in patients with _Helicobacter
pylori _associated ulcers
Patients requiring continued NSAID therapy
ESOMEPRAZOL AUROBINDO 20 MG EN 40 MG, MAAGSAPRESISTENTE TABLETTEN RVG 110819 , RVG 110820
MODULE 1 Administrative information and prescribing information
1.3.1 SAMENVATTING VAN DE PRODUCTKENMERKEN
Rev.nr. 1801
Pag. 2 van 19
-
healing of gastric ulce