ESOMEPRAZOLE 20 Milligram Tablets Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESOMEPRAZOLE MAGNESIUM (AMORPHOUS)

Available from:

Ranbaxy Ireland Limited

INN (International Name):

ESOMEPRAZOLE MAGNESIUM (AMORPHOUS)

Dosage:

20 Milligram

Pharmaceutical form:

Tablets Gastro-Resistant

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

ESOMEPRAZOLE 20 MG GASTRO-RESISTANT TABLETS 
ESOMEPRAZOLE 40MG GASTRO-RESISTANT TABLETS 
esomeprazole  

WHAT IS IN THIS LEAFLET:  
1. 
What  Esomeprazole gastro-resistant tablets are
and what they are used for 
2. 
What you need to know before
you take Esomeprazole gastro-resistant tablets 
3. 
How to take Esomeprazole gastro-resistant tablets 
4. 
Possible side effects 
5.       How to store Esomeprazole gastro-resistant tablets 
6. 
Contents of the pack and other information 

1.    WHAT ESOMEPRAZOLE GASTRO-RESISTANT TABLETS ARE
AND WHAT THEY ARE USED FOR 

Esomeprazole  Tablets 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 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 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 Tablets can also be used to stop stomach ulcers
or ulcers in the upper part of the gut 
(intestine) from forming if you are taking NSAIDs. 
•  Too much acid in the stomach caused by a growth in
the pancreas (Zollinger-Ellison syndrome). 
•  Prolonged treatment after prevention
of rebleeding of ulcers with intravenous Esomeprazole. 

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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: 20 mg esomeprazole as esomeprazole magnesium (amorphous).
Excipient with known effect:
Each tablet also contains not more than 27.45 mg Sucrose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Light brick red to brown coloured, oval, biconvex, film-coated tablets with ‘E5’ debossed on one side and plain on
other side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Esomeprazole Gastro-resistant tablets are indicated for:
Gastroesophageal Reflux Disease (GORD)
treatment of erosive reflux esophagitis
long-term management of patients with healed esophagitis to prevent relapse
symptomatic treatment of gastroesophageal reflux disease (GORD)
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.
TREATMENT OF ZOLLINGER ELLISON SYNDROME
"
ADOLESCENTS FROM THE AGE OF 12 YEARS
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
treatment of erosive reflux oesophagitis
long-term management of patients with healed esophagitis to prevent relapse
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 09/09/2014_
_CRN 2151993_
_page number: 1_
symptomatic treatment of gastro-oesophageal reflux disease (GORD)
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