Esomeprazole Aristo 20 mg gastro-resistant capsules, hard

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Esomeprazole magnesium dihydrate

थमां उपलब्ध:

Aristo Pharma GmbH

ए.टी.सी कोड:

A02BC; A02BC05

INN (इंटरनेशनल नाम):

Esomeprazole magnesium dihydrate

डोज़:

20 milligram(s)

फार्मास्यूटिकल फॉर्म:

Gastro-resistant capsule, hard

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

Proton pump inhibitors; esomeprazole

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2012-09-07

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESOMEPRAZOLE ARISTO 20 MG GASTRO-RESISTANT CAPSULES, HARD
ESOMEPRAZOLE ARISTO 40 MG GASTRO-RESISTANT CAPSULES, HARD
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 Aristo is and what it is used for
2.
What you need to know before you take Esomeprazole Aristo
3.
How to take Esomeprazole Aristo
4.
Possible side effects
5.
How to store Esomeprazole Aristo
6.
Contents of the pack and other information
1.
WHAT ESOMEPRAZOLE ARISTO IS AND WHAT IT IS USED FOR
Esomeprazole Aristo 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 Aristo
is used to treat the following conditions:
ADULTS
•
‘Gastro-esophageal 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):
Esomeprazole Aristo 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 t

उत्पाद विशेषताएं

Health Products Regulatory Authority
11 September 2023
CRN00DCCX
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole Aristo 20 mg gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant hard capsule contains: 20 mg esomeprazole (as
esomeprazole magnesium dihydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
_ _
White opaque body and a light yellow opaque cap containing white to
off-white gastro-resistant pellets and may have a
characteristic odour. Capsule size 3.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Esomeprazole Aristo _capsules are indicated in adults for:
_Gastro-esophageal 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 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_
_Esomeprazole Aristo _capsules are indicated in adolescents from the
age of 12 years for:
_GASTRO-ESOPHAGEAL 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)
Health Products Regulatory Authority
11 September 2023
CRN00DCCX
Page 2 of 13
_In combination with antibiotics in treatment of duodenal ulcer caused
by H