Omeprazole 40 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:

40 milligram(s)

Pharmaceutical form:

Gastro-resistant capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors; omeprazole

Authorization status:

Not marketed

Authorization date:

2017-02-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OMEPRAZOLE 10 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE 20 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE 40 MG GASTRO-RESISTANT CAPSULES, HARD
Omeprazole
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 Omeprazole is and what it is used for
2.
What you need to know before you take Omeprazole
3.
How to take Omeprazole
4.
Possible side effects
5.
How to store Omeprazole
6.
Contents of the pack and other information
1.
WHAT OMEPRAZOLE IS AND WHAT IT IS USED FOR
Omeprazole contains the active substance omeprazole. It 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:
Adults:
•
‘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 upper part of the intestine (duodenal ulcer) or stomach
(gastric ulcer).
•
Ulcers which 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.
•
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-Ell

Summary of Product characteristics

Health Products Regulatory Authority
25 April 2023
CRN00DC76
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole 40 mg Gastro-resistant Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40 mg omeprazole.
Excipient(s) with known effect:
Each capsule contains approximately 75.20 – 86.01 mg sucrose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard (gastro-resistant capsule)
Opaque white hard gelatine capsule size #1 (approximately 19.8 mm)
printed “OM 40”, containing spherical pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Omeprazole is 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
Children aged over 1 year and ≥ 10 kg

Treatment of reflux esophagitis

Symptomatic treatment of heartburn and acid regurgitation in
gastro-esophageal reflux disease
Children aged over 4 years and adolescents

In combination with antibiotics in treatment of duodenal ulcer caused
by _H. pylori. _
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
_Treatment of duodenal ulcers_
Health Products Regulatory Authority
25 April 2023
CRN00DC76
Page 2 of 12
The recommended dose in patients with an active duodenal ulcer is
Omeprazole 20 mg once daily. In most patients healing
occurs within two weeks. For those patients who may not be fully
healed after the initial course, healing usually occurs duri