Omeprazol Sandoz capsule 40, maagsapresistente capsules, hard, 40 mg

Land: Niederlande

Sprache: Niederländisch

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

Wirkstoff:

OMEPRAZOL

Verfügbar ab:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-Code:

A02BC01

INN (Internationale Bezeichnung):

OMEPRAZOLE

Darreichungsform:

Maagsapresistente capsule, hard

Zusammensetzung:

AMMONIA (E 527) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; GELATINE (E 441) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; ZWARTE INKT,

Verabreichungsweg:

Oraal gebruik

Therapiebereich:

Omeprazole

Produktbesonderheiten:

Hulpstoffen: AMMONIA (E 527); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); GELATINE (E 441); HYPROMELLOSE (E 464); IJZEROXIDE ZWART (E 172); KALIUMHYDROXIDE (E 525); MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); PROPYLEENGLYCOL (E 1520); SACCHAROSE; SCHELLAK (E 904); TALK (E 553 B); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505); ZWARTE INKT;

Berechtigungsdatum:

2002-03-19

Gebrauchsinformation

Sandoz B.V.
Pagina 1/10
Omeprazol Sandoz
®
capsule 10/20/40
1313-V21
RVG 25729-30-31
1.3.1.3 Bijsluiter
Maart 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OMEPRAZOL SANDOZ
® CAPSULE 10, MAAGSAPRESISTENTE CAPSULES, HARD, 10 MG
OMEPRAZOL SANDOZ
® CAPSULE 20, MAAGSAPRESISTENTE CAPSULES, HARD, 20 MG
OMEPRAZOL SANDOZ
® CAPSULE 40, MAAGSAPRESISTENTE CAPSULES, HARD, 40 MG
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] 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:
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).

Ulcers which are infected with bacteria called ‘_Helicobacter
pylori_’. If you have this condition,
your doctor may also prescribe antibiotics t

Fachinformation

Sandoz B.V.
Pagina 1/17
Omeprazol Sandoz capsule 10/20/40
1311-V24
RVG 25729-30-31
1.3.1.1 Samenvatting van de productkenmerken
Februari 2020
1
NAME OF THE MEDICINAL PRODUCT
Omeprazol Sandoz capsule 10, maagsapresistente capsules, hard, 10 mg
Omeprazol Sandoz capsule 20, maagsapresistente capsules, hard, 20 mg
Omeprazol Sandoz capsule 40, maagsapresistente capsules, hard, 40 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant capsule, hard contains 10 mg of omeprazole.
Excipients with known effect
Each gastro-resistant capsule, hard contains up to 61.63 mg of
sucrose.
Each gastro-resistant capsule, hard contains 20 mg of omeprazole.
Excipients with known effect
Each gastro-resistant capsule, hard contains up to 123.26 mg of
sucrose.
Each gastro-resistant capsule, hard contains 40 mg of omeprazole.
Excipients with known effect
Each gastro-resistant capsule, hard contains up to 246.52 mg of
sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Opaque white capsule, with imprint “OM 10”
Opaque white capsule, with imprint “OM 20”
Opaque white capsule, with imprint “OM 40”
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] capsules are indicated in:
Sandoz B.V.
Pagina 2/17
Omeprazol Sandoz capsule 10/20/40
1311-V24
RVG 25729-30-31
1.3.1.1 Samenvatting van de productkenmerken
Februari 2020
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 in peptic
ulcer disease
• Treatment of NSAID-associated gastric and duodenal ulcers
• Prevention of NSAID-associated gastric and duodenal ulcers in
patients at risk
• Treatment of reflux oesophagitis
• Long-term management of patients with healed reflux oesophagitis
• Treatment of symptomatic gastro-oesophageal reflux disease
• Treatment of Zollinger-Ellison sy