ESOMEPRAZOLE PENSA 20 Milligram Tablets Gastro-Resistant

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

ESOMEPRAZOLE SODIUM

थमां उपलब्ध:

Pensa Pharma AB

ए.टी.सी कोड:

A02BC05

INN (इंटरनेशनल नाम):

ESOMEPRAZOLE SODIUM

डोज़:

20 Milligram

फार्मास्यूटिकल फॉर्म:

Tablets Gastro-Resistant

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

Proton pump inhibitors

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2012-02-10

सूचना पत्रक

1
1. PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESOMEPRAZOLE PENSA 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.
WHAT IS IN THIS LEAFLET
1.
What Esomeprazole Pensa is and what it is used for
2.
What you need to know before you take Esomeprazole Pensa
3.
How to take Esomeprazole Pensa
4.
Possible side effects
5.
How to store Esomeprazole Pensa
6.
Contents of the pack and other information
1.
WHAT ESOMEPRAZOLE PENSA IS AND WHAT IT IS USED FOR
Esomerazole Pensa 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 Pensa 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).
Esomeprazol Pensa 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 syndrome).
2.
W

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole Pensa 20mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg esomeprazole (as sodium
salt).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Light blue oval biconvex coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
Esomeprazole Pensa 20 mg gastro-resistant tablets are indicated for:
GASTRO-OESOPHAGEAL
REFLUX DISEASE (GORD)
-
treatment of erosive reflux oesophagitis
-
long-term management of patients with healed oesophagitis to prevent
relapse
-
symptomatic treatment of gastro-oesophageal
reflux disease (GORD)
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.
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 oesophagitis to prevent
relapse
-
symptomatic treatment of gastro-oesophageal
reflux disease (GORD)
IN COMBINATION WITH ANTIBIOTICS IN TREATMENT OF DUODENAL ULCER CAUSED
BY HELICOBACTER PYLORI
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be swallowed whole with liquid. The tablets should
not be chewed or crushed.
For patients who have difficulty in swallowing the tablets can also be
dispersed in half a glass of non-carbonated water.
No other liquids should be used as the enteric coating may be
dissolved. Stir until the tablets disintegrate and drink the
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