ESOMEPRAZOLE PENSA 40 Milligram Tablets Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESOMEPRAZOLE SODIUM

Available from:

Pensa Pharma AB

ATC code:

A02BC05

INN (International Name):

ESOMEPRAZOLE SODIUM

Dosage:

40 Milligram

Pharmaceutical form:

Tablets Gastro-Resistant

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors

Authorization status:

Authorised

Authorization date:

2012-02-10

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESOMEPRAZOLE PENSA 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.
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
Esomeprazole 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:

‘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.

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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESOMEPRAZOLE PENSA
DO NOT TAKE ESOMEPRAZOLE PENSA

If you are allergic to esomeprazole or any of the other ingredients of
this medicine (listed in
Section 6).

If you are allergic to other proton pump inhibitor medicines (e.g.
pantoprazole, lansoprazole,
rabeprazole, omeprazole).

If you are taking a medicine containing nelfinavir (used to treat
HIV).
Do no

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole Pensa 40mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 40 mg esomeprazole (as sodium
salt).
Excipients with known effect: sunset yellow FCF (E-110) 0.003 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Dark blue oval biconvex coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Esomeprazole Pensa 40 mg gastro-resistant tablets are indicated for:
GASTRO-OESOPHAGEAL
REFLUX DISEASE (GORD)
-
treatment of erosive reflux oesophagitis
PROLONGED TREATMENT AFTER I.V. INDUCED PREVENTION OF REBLEEDING OF
PEPTIC ULCERS.
TREATMENT OF ZOLLINGER ELLISON SYNDROME
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
liquid with the pellets immediately or within 30 minutes. Rinse the
glass with half a glass of water and drink. The
pellets must not be chewed or crushed.
For patients who cannot swallow, the tablets can be dispersed in
non-carbonated water and administered through a
gastric tube. It is important that the appropriateness of the selected
syringe and tube is carefully tested. For preparation
and administration instructions see section 6.6.
Adults and adolescents from the age of 12 years
GASTRO-OESOPHAGEAL
REFLUX DISEASE (GORD)
-
treatment of erosive reflux esophagitis
40 mg once daily for 4 weeks.
An additional 4 weeks treatment is recommended for patients in whom
oesophagitis has not healed or who have
persistent symptoms.
Adults
PROLONGED TREATMENT AFTER I.V. INDUCED PREVENTION OF REBLEEDING OF
PEPTIC ULCERS.
40 mg once daily for 4 weeks after i.v. induced prevention of
rebleeding of peptic