Esomeprazole 20 mg gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Esomeprazole

Available from:

Brillpharma (Ireland) Limited

ATC code:

A02BC; A02BC05

INN (International Name):

Esomeprazole

Dosage:

20 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Therapeutic area:

Proton pump inhibitors; esomeprazole

Authorization status:

Not marketed

Authorization date:

2018-03-29

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESOMEPRAZOLE 20 MG GASTRO-RESISTANT TABLETS
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 Esomeprazole is and what it is used for
2.
What you need to know before you take Esomeprazole
3.
How to take this Esomeprazole
4.
Possible side effects
5.
How to store Esomeprazole
6.
Contents of the pack and other information
1.
WHAT ESOMEPRAZOLE IS AND WHAT IT IS USED FOR
The name of your medicine is Esomeprazole Gastro-Resistant Tablets.
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 _
•
‘Gastro-oesophageal reflux disease’ (GERD). 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.
•
Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-
Inflammatory Drugs). This medicine can also be used to stop stomach
ulcers
from forming if you are taking NSAIDs.
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•
Too much acid in the stomach caused by a growth in the pancreas
(Zollinger-
Ellison syndrome).
•
Prolonged treatment after prevention o

Summary of Product characteristics

Health Products Regulatory Authority
28 October 2022
CRN00D00P
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole 20 mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg of esomeprazole (as
magnesium dihydrate).
Excipients with known effect: Each gastro-resistant tablet contains
sucrose 8.74 mg and lactose monohydrate approximately
37.35 mg.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant tablet (tablet)
Light pink coloured oval shaped, bevel edged tablets debossed with
‘H’ on one side and ‘186’ on the other side. The tablet
dimensions are 14.2mm x 7.1mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Esomeprazole tablets are indicated in adults for:
GASTRO-OESOPHAGEAL REFLUX DISEASE (GERD)
- treatment of erosive reflux esophagitis
- long-term management of patients with healed esophagitis to prevent
relapse
- symptomatic treatment of gastro-esophageal reflux disease (GERD)
IN COMBINATION WITH AN APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMEN
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
Esomeprazole tablets are indicated in adolescents from the age of 12
years for:
GASTRO-OESOPHAGEAL REFLUX DISEASE (GERD)
- treatment of erosive reflux esophagitis
- long-term management of patients with healed esophagitis to prevent
relapse
- symptomatic treatment of gastro-esophageal reflux disease (GERD)
IN COMBINATION WITH ANTIBIOTICS IN TREATMENT OF DUODENAL ULCER CAUSED
BY _HELICOBACTER PYLORI_
4.2 P