Omeprazol (als magnesium) Sandoz MUT 10 mg, maagsapresistente tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

OMEPRAZOL MAGNESIUM 10,3 mg/stuk SAMENSTELLING overeenkomend met ; OMEPRAZOL 10 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

A02BC01

INN (Algemene Internationale Benaming):

OMEPRAZOL MAGNESIUM 10,3 mg/stuk SAMENSTELLING overeenkomend met ; OMEPRAZOL 10 mg/stuk

farmaceutische vorm:

Maagsapresistente tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOVIDON (E 1208) ; CROSPOVIDON (E 1202) ; DIMETICON (E 900) ; GLUCOSE, VLOEIBAAR ; GLYCEROLMONOSTEARAAT 40-55 (E 471) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; STEARINEZUUR (E 570) ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOVIDON ; CROSPOVIDON (E 1202) ; DIMETICON (E 900) ; GLUCOSE, VLOEIBAAR ; GLYCEROLMONOSTEARAAT 40-55 (E 471) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; STEARINEZUUR (E 570) ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOVIDON ; CROSPOVIDON (E 1202) ; DIMETICON (E 900) ; GLUCOSE, VLOEIBAAR ; GLYCEROLMONOSTEARAAT 40-55 (E 471) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SILICIUMDI

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Omeprazole

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); COPOVIDON; CROSPOVIDON (E 1202); DIMETICON (E 900); GLUCOSE, VLOEIBAAR; GLYCEROLMONOSTEARAAT 40-55 (E 471); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; POLYSORBAAT 80 (E 433); POVIDON K 25 (E 1201); PROPYLEENGLYCOL (E 1520); SACCHAROSE; SILICIUMDIOXIDE (E 551); SILICIUMDIOXIDE, GEHYDRATEERD (E 551); STEARINEZUUR (E 570); SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2010-09-03

Bijsluiter

Sandoz B.V.
Page 1/12
Omeprazol (als magnesium) Sandoz MUT 10/20/40
mg
RVG 105000-1-2
V15
1.3.1.3 Bijsluiter
maart 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OMEPRAZOL (ALS MAGNESIUM) SANDOZ MUT 10 MG, MAAGSAPRESISTENTE
TABLETTEN
OMEPRAZOL (ALS MAGNESIUM) SANDOZ MUT 20 MG, MAAGSAPRESISTENTE
TABLETTEN
OMEPRAZOL (ALS MAGNESIUM) SANDOZ MUT 40 MG, MAAGSAPRESISTENTE
TABLETTEN
Omeprazole
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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] gastro-resistant tablets contains the
active substance omeprazole. It
belongs to a group of medicines called ‘proton pump inhibitors’.
They work by reducing the
amount of acid that your stomach produces.
[Nationally completed name] is used to treat the following conditions:
In adults:
•
‘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 upper part of the intestine (duodenal ulcer) or stomach
(gastric ulcer).
Sandoz B.V.
Page 2/12
Omeprazol (als magnesium) Sandoz MUT 10/20/40
mg
RVG 105000-1-2
V15
1.3.1.3 Bijsluiter
m

Productkenmerken

Sandoz B.V.
Page 1/19
Omeprazol (als magnesium) Sandoz MUT 10/20/40
mg
RVG 105000-1-2
V14
1.3.1.1 Samenvatting van de Productkenmerken
maart 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Omeprazol (als magnesium) Sandoz MUT 10 mg, maagsapresistente
tabletten
Omeprazol (als magnesium) Sandoz MUT 20 mg, maagsapresistente
tabletten
Omeprazol (als magnesium) Sandoz MUT 40 mg, maagsapresistente
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Nationally completed name, 10 mg, gastro-resistant tablets]
Each gastro-resistant tablet contains 10 mg omeprazole (as omeprazole
magnesium).
[Nationally completed name, 20 mg, gastro-resistant tablets]
Each gastro-resistant tablet contains 20 mg omeprazole (as omeprazole
magnesium).
[Nationally completed name, 40 mg, gastro-resistant tablets]
Each gastro-resistant tablet contains 40 mg omeprazole (as omeprazole
magnesium)
Excipients with known effect
glucose, sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet
[Nationally completed name, 10 mg, gastro-resistant tablets]
Light pink oval film-coated tablet (11.2x5.8 mm).
[Nationally completed name, 20 mg, gastro-resistant tablets]
Pink, oval film-coated tablet with a breaking notch on both sides. The
tablet can be divided into equal
doses(14.2x7.2 mm).
[Nationally completed name, 40 mg, gastro-resistant tablets]
Reddish oval film-coated tablet with a score line on both sides. The
tablet can be divided into equal doses
(18.2x9.0 mm).
4.
CLINICAL PARTICULARS
Sandoz B.V.
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Omeprazol (als magnesium) Sandoz MUT 10/20/40
mg
RVG 105000-1-2
V14
1.3.1.1 Samenvatting van de Productkenmerken
maart 2023
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] gastro-resistant tablets are indicated in:
Adults
•
Treatment of duodenal ulcers
•
Prevention of relapse of duodenal ulcers
•
Treatment of gastric ulcers
•
Prevention of relapse of gastric ulcers
•
In combination with appropriate antibiotics, Helicobacter pylori (H.
pylori) eradication