ESOMEPRAZOLE MYLAN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESOMEPRAZOLE

Available from:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC code:

A02BC05

INN (International Name):

ESOMEPRAZOLE

Dosage:

40 Milligram

Pharmaceutical form:

Gastro-resistance capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

esomeprazole

Authorization status:

Not marketed

Authorization date:

2011-04-01

Patient Information leaflet

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESOMEPRAZOLE MYLAN 20 MG GASTRO-RESISTANT HARD CAPSULES
ESOMEPRAZOLE MYLAN
40 MG GASTRO-RESISTANT HARD CAPSULES
esomeprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
-
If any of the side effects gets serious, talk to your doctor or
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What Esomeprazole Mylan is and what it is used for
2.
What you need to know before you take Esomeprazole Mylan
3.
How to take Esomeprazole Mylan
4.
Possible side effects
5.
How to store Esomeprazole Mylan
6.
Contents of the pack and other information
1.
WHAT ESOMEPRAZOLE MYLAN IS AND WHAT IT IS USED FOR
Esomeprazole 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.
Esomeprazole 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
infection and allow the ulcer to heal.
Adults

Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs).
Esomeprazole Mylan can also be used to stop stomach ulcers from
forming if you are taking NSAIDs.

Too much acid in the stomach caused by a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole Mylan 40 mg Gastro-resistant Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40 mg esomeprazole (as esomeprazole magnesium).
Excipient with known effect
Each capsule contains up to 91.16 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant hard capsule
White to cream coloured pellets filled in hard gelatin capsules of
length 19.3 mm ± 0.4 mm and width 6.93 ± 0.03
(approx) with brown cap and brown body, imprinted with ‘Mylan’
over ‘EM 40’ in black ink on cap and body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Esomeprazole Mylan is indicated for:
Adults
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_
- 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
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
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