ESOMEPRAZOLE MYLAN 40 Milligram Tablets Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESOMEPRAZOLE MAGNESIUM (AMORPHOUS)

Available from:

McDermott Laboratories Ltd t/a Gerard Laboratories

INN (International Name):

ESOMEPRAZOLE MAGNESIUM (AMORPHOUS)

Dosage:

40 Milligram

Pharmaceutical form:

Tablets Gastro-Resistant

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

PAGE 1 OF 7 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

ESOMEPRAZOL MYLAN 20 MG GASTRO-RESISTANT TABLETS 
ESOMEPRAZOL MYLAN 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 or nurse. 
- 
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 or nurse. This includes any possible
side 
effects not listed in this leaflet. 

WHAT IS IN THIS LEAFLET:  
1. 
What Esomeprazol Mylan is and what it is used for 
2. 
What you need to know before_ _you take Esomeprazol Mylan 
3. 
How to take Esomeprazol Mylan 
4. 
Possible side effects 
5. 
How to store Esomeprazol Mylan 
6. 
Contents of the pack and other information 

1. 
WHAT ESOMEPRAZOL MYLAN IS AND WHAT IT IS USED FOR 

Esomeprazol Mylan 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. 
Esomeprazol Mylan 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 
infec

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole Mylan 40 mg Gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 40 mg esomeprazole (as esomeprazole magnesium).
Excipient with known effect:
Each gastro-resistant tablet also contains no more than 41.073 mg Sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
A pink, film-coated, 19mm x 9mm, oblong, biconvex tablet debossed with “M” on one side of the tablet and “EM4” on
the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
Esomeprazol Mylan gastro-resistant tablets are indicated for:
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
- treatment of erosive reflux esophagitis
- long-term management of patients with healed esophagitis to prevent relapse
- symptomatic treatment of gastro-oesophageal reflux disease (GORD)
IN COMBINATION WITH 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.
40MG ONLY:
PROLONGED TREATMENT AFTER I.V. INDUCED PREVENTION OF REBLEEDING OF PEPTIC ULCERS.
TREATMENT OF ZOLLINGER ELLISON SYNDROME
Adolescents from the age of 12 years
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
- treatment of erosive reflux esophagitis
- long-term management of patients with healed esophagitis to prevent relapse
- symptomatic treatment of gastro-oesophageal reflux disease (GEOD)
IN COMBINATION WITH ANT