Omeprazole Mylan 20 mg Gastro-resistant capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Omeprazole

Available from:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC code:

A02BC; A02BC01

INN (International Name):

Omeprazole

Dosage:

20 milligram(s)

Pharmaceutical form:

Gastro-resistant capsule

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors; omeprazole

Authorization status:

Marketed

Authorization date:

2011-05-06

Patient Information leaflet

Colours
Non-Print
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Date:
Time:
Equate CMYK
with
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Main Font
Body Text Size
9 pt
9 pt
Min Text Size used
Times New Roman
1
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1/2
No. of colours
Pharma Code
SAP No.
Vendor Job No.
Trackwise Proof No.
Glams Proof No.
Client Market
Keyline/Drawing No.
Barcode Info
Description
Component Type
Superceded Affiliate Item Code
TrackWise PR No.
MA No.
Packing Site/Printer
Supplier Code
Sign-offs
1120783
PA0577/150/001-003
Zenara Pharma Pvt.,
Hyderabad, IN
TBC
TBC
N/A
2
Ireland
N/A
470959
N/A
12:06
26 May 17
180 x 500 mm
Affiliate Item Code
v1/May 2015
Omeprazole 40 mg,10 mg,20 mg 14,28
Leaflet
1120783
1010810
Black
Technical
Info
N/A
1. WHAT OMEPRAZOLE MYLAN IS AND WHAT IT IS
USED FOR
Omeprazole belongs to a group of medicines called ‘proton
pump inhibitors’. They work by reducing the amount of acid
that your stomach produces.
Omeprazole is used to treat the following conditions:
In adults:
• ‘Gastro-esophageal reflux disease’ (GERD). 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 upper part of the intestines (duodenal ulcer) or
stomach (gastric ulcer).
• To stop ulcers in the upper part of the intestines (duodenal
ulcer) and stomach (gastric ulcer) from coming back.
• Ulcers which are also infected with a 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.
• Ulcers caused by medicines called NSAIDs (non-steroidal
anti-inflammatory drugs). Omeprazole can also be used to
stop ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a growth in the
pancreas (Zollinger-Ellison syndrome).
In children:
_Children over 1 year of age and 10 kg_
• ‘Gastro-esophageal reflux disease’ (GERD). This is where
acid from the stomach escapes into the gullet (the tube
which connects your throat to your stomach) causing pain,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole Mylan 20 mg Gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mg Gastro-resistant capsule, hard contains 20 mg omeprazole
Excipients with known effect
Each 20 mg Gastro-resistant capsule, hard contains 33.8 mg sucrose
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant capsules, hard
Capsule with dark pink opaque cap and white opaque body, hard shell
gelatine capsule filled with white to off-white
pellets.
The capsule is axially printed with ‘MYLAN’ over ‘OM20’ in
black ink on cap and body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Omeprazole is indicated in adults and children over 1 year of age and
10kg.
Omeprazole gastro-resistant capsules are indicated in:
Adults:
Treatment of duodenal ulcers
Prevention of relapse of duodenal ulcers
Treatment of gastric ulcers
Prevention of relapse of gastric ulcers
In combination with appropriate antibiotics,_ Helicobacter pylori_
(_H. pylori)_ eradication in peptic ulcer disease
Treatment of NSAID associated gastric and duodenal ulcers
Prevention of NSAID associated gastric and duodenal ulcers in patients
at risk
Treatment of reflux esophagitis
Long term management of patients with healed reflux esophagitis
Treatment of symptomatic gastro-esophageal reflux disease,
Treatment of Zollinger-Ellison syndrome
Paedriatric population
_Children over 1 year of age and_
_10 kg_
Treatment of reflux esophagitis
Symptomatic treatment of heartburn and acid regurgitation in
gastro-esophageal reflux disease
_CHILDREN AND ADOLESCENTS OVER 4 YEARS OF AGE_
In combination with antibiotics in the treatment of duodenal ulcer
caused by_ H. pylori_
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