Esomeprazole Bristol Labs Gastro-Resistant Tablets 40mg

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

ESOMEPRAZOLE

Dostupné z:

Bristol Laboratories Limited

ATC kód:

A02BC05

INN (Medzinárodný Name):

ESOMEPRAZOLE

Forma lieku:

GASTRO-RESISTANT TABLET

Zloženie:

ESOMEPRAZOLE 40 milligram(s)

Typ predpisu:

POM

Terapeutické oblasti:

DRUGS FOR ACID RELATED DISORDERS

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2014-11-10

Príbalový leták

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESOMEPRAZOLE BRISTOL LABS 20 MG GASTRO-RESISTANT TABLETS
ESOMEPRAZOLE BRISTOL LABS 40 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 AND ADOLESCENTS AGED 12 YEARS AND OVER

‘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). This medicine can also be used to stop stomach
ulcers from
forming if you are taking NSAIDs.
Page 2 of 9

Too much acid in the sto

Súhrn charakteristických

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Esomeprazole Bristol Labs 20 mg Gastro-Resistant Tablets
Esomeprazole Bristol Labs 40 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.
Each gastro-resistant tablet contains 40 mg of esomeprazole (as
magnesium dihydrate).
Excipients with known effect: Each gastro-resistant tablet contains
sucrose 17.48 mg and
lactose monohydrate approximately 74.70 mg.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Gastro-resistant tablet (tablet)
Light pink colored 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.
Pink colored oval shaped, bevel edged tablets debossed with ‘H’ on
one side and ‘187’ on
the other side. The tablet dimensions are 16.2mm x 8.1mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Esomeprazole tablets are indicated in adults 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
Page 2 of 18
- 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