Omeprazole Bluefish 20 mg gastro-resistant capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Omeprazole

Available from:

Bluefish Pharmaceuticals AB

ATC code:

A02BC; A02BC01

INN (International Name):

Omeprazole

Dosage:

20 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:

Marketed

Authorization date:

2007-06-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OMEPRAZOLE BLUEFISH 10 MG GASTRO-RESISTANT CAPSULES
OMEPRAZOLE BLUEFISH 20 MG GASTRO-RESISTANT CAPSULES
OMEPRAZOLE BLUEFISH 40 MG GASTRO-RESISTANT CAPSULES
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 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. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Omeprazole Bluefish is and what it is used for
2.
What you need to know before you take Omeprazole Bluefish
3.
How to take Omeprazole Bluefish
4.
Possible side effects
5.
How to store Omeprazole Bluefish
6.
Contents of the pack and other information
1. WHAT OMEPRAZOLE BLUEFISH IS AND WHAT IT IS USED FOR
Omeprazole Bluefish 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 Bluefish 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 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
Bluefish can also be used to stop ulcers from forming if you

Summary of Product characteristics

Health Products Regulatory Authority
13 April 2023
CRN00DHFY
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole Bluefish 20 mg gastro-resistant capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg of Omeprazole.
Excipient with known effect
Each 20 mg gastro-resistant capsule contains <80.02mg Sucrose (in
sugar spheres)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Hard gastro-resistant capsules.
Opaque blue cap and opaque orange body, containing white to beige
granules. Size 2 capsule marked with O20.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Omeprazole Bluefish capsules are indicated for:
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
Paediatric use
_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 treatment of duodenal ulcer caused
by _H. pylori_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology in adults
Health Products Regulatory Authority
13 April 2023
CRN00DHFY
Page 2 of 12
_Treatment of duodenal ulcers_
The recommended dose in patients with an active duodenal ulcer is
Omeprazole Bluefish 20 mg once daily. In most patients
healing occurs within two weeks. For those patients who may not be
fully healed after the initial c