Omeprazole 10 mg Gastro-resistant Capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Omeprazole

Available from:

Generics (UK) Limited

ATC code:

A02BC; A02BC01

INN (International Name):

Omeprazole

Dosage:

10 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:

Not marketed

Authorization date:

2017-02-03

Patient Information leaflet

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Omeprazole 40 mg;10 mg;20 mg/14;28
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Esteve Quimica SA
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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-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 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).
Children aged over 1 year 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,
inflammation and heartburn.
In children, the symptoms of the condition can i

Summary of Product characteristics

Health Products Regulatory Authority
16 November 2018
CRN008M0X
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole 10 mg Gastro-resistant Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg omeprazole.
Excipient(s) with known effect:
Each capsule contains approximately 18.80 – 21.50 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 #4 (approximately 14.6 mm)
printed “OM
10”, 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
Health Products Regulatory Authority
16 November 2018
CRN008M0X
Page 2 of 18
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
_Treatment of duodenal ulcers_
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 dur