Esomeprazol Renantos 40 mg, maagsapresistente tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ESOMEPRAZOL MAGNESIUM 2-WATER SAMENSTELLING overeenkomend met ; ESOMEPRAZOL

Beschikbaar vanaf:

Renantos Pharmavertriebsgesellschaft mbH

ATC-code:

A02BC05

INN (Algemene Internationale Benaming):

ESOMEPRAZOLE MAGNESIUM 2-WATER COMPOSITION corresponding to ; ESOMEPRAZOLE

farmaceutische vorm:

Maagsapresistente tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; GLYCEROLMONOSTEARAAT 40-55 (E 471) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 4000 ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL ; NATRIUMSTEARYLFUMARAAT ; PARAFFINE, HARD (E 905) ; POLYSORBAAT 80 (E 433) ; POVIDON K 90 (E 1201) ; SACCHAROSE ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Esomeprazole

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); GLYCEROLMONOSTEARAAT 40-55 (E 471); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 4000; MAÏSZETMEEL; MANNITOL (D-) (E 421); NATRIUMSTEARYLFUMARAAT; PARAFFINE, HARD (E 905); POLYSORBAAT 80 (E 433); POVIDON K 90 (E 1201); SACCHAROSE; SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505);

Autorisatie datum:

2012-05-21

Bijsluiter

pil esomeprazol renantos
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESOMEPRAZOL RENANTOS 20 MG, MAAGSAPRESISTENTE TABLETTEN
ESOMEPRAZOL RENANTOS 40 MG, MAAGSAPRESISTENTE TABLETTEN
esomeprazole
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Esomeprazole Renantos is and what it is used for
2.
Before you take Esomeprazole Renantos
3.
How to take Esomeprazole Renantos
4.
Possible side effects
5.
How to store Esomeprazole Renantos
6.
Further information
1. WHAT ESOMEPRAZOLE RENANTOS IS AND WHAT IT IS USED FOR
Esomeprazole Renantos 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.
Esomeprazole Renantos is used to treat the following conditions:
ADULTS AND YOUNG PEOPLE 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

Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs).
Esomeprazole Renantos can also be used to stop stomach ulcers from
forming if you are taking
NSAIDs.

Too much acid in the stomach caused by a growth in the pancreas
(Zollinger-Ellison sy

Productkenmerken

spc esomeprazol renantos
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SUMMARY OF THE PRODUCT CHARACTERISTICS
1
NAAM VAN HET GENEESMIDDEL
Esomeprazol Renantos 20 mg, maagsapresistente tabletten
Esomeprazol Renantos 40 mg, maagsapresistente tabletten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: 20 mg or 40 mg esomeprazole (as magnesium
dihydrate).
Excipients:
Esomeprazole Renantos 20 mg contains 3.796 mg mannitol and 12.394 mg
sucrose.
Esomeprazole Renantos 40 mg contains 7.591 mg mannitol and 24.788 mg
sucrose.
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablet
20 mg: Pink, oval shaped film-coated tablets with average dimensions
14.0 mm x 7.0 mm.
40 mg: Pink, oval shaped film-coated tablets with average dimensions
17.6 mm x 8.8 mm.
_ _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Esomeprazole Renantos gastro-resistant tablets are indicated for:
_ADULTS _
GASTROESOPHAGEAL REFLUX DISEASE (GERD)

treatment of erosive reflux oesophagitis

long-term management of patients with healed oesophagitis to prevent
relapse

symptomatic treatment of gastro-oesophageal 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
Healing of gastric ulcers associated with NSAID therapy.
Prevention of gastric and duodenal ulcers associated with NSAID
therapy, in patients at risk.
PROLONGED TREATMENT AFTER I.V. INDUCED PREVENTION OF REBLEEDING OF
PEPTIC ULCERS.
TREATMENT OF ZOLLINGER ELLISON SYNDROME
_ADOLESCENTS FROM THE AGE OF 12 YEARS _
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
-
treatment of erosive reflux esophagitis
spc esomeprazol renantos
2
-
long-term management of patients with healed esophagitis to prevent
relapse
-
symptomatic treatment of gastroesophageal reflux disease (GERD)
IN COMBINATION WITH ANTIBIOTICS