OMEPRAZOLE 20 Milligram Capsules Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OMEPRAZOLE

Available from:

Laboratorios LICONSA, S.A.

ATC code:

A02BC01

INN (International Name):

OMEPRAZOLE

Dosage:

20 Milligram

Pharmaceutical form:

Capsules Gastro-Resistant

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors

Authorization status:

Authorised

Authorization date:

2015-06-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OMEPRAZOLE 20 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:
In adults:

‘Gastro-oesophageal 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).
In children:
_Children over 1 year of age and ≥ 10 kg _

‘Gastro-oesoph

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole 20 mg gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Omeprazole 20 mg capsules: one capsule contains 20 mg of omeprazole.
•
Excipient(s) with known effect:Each 20mg omeprazole capsule contains
102 to 116mg of sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsules, hard.
Opaque yellow capsule containing off-white to cream-white
enteric-coated spherical microgranules.
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 oesophagitis
Treatment of symptomatic gastro-oesophageal reflux disease
Treatment of Zollinger-Ellison syndrome
Paediatric use
_Children over 1 year of age and_
_10 kg_
Treatment of reflux oesophagitis
Symptomatic treatment of heartburn and acid regurgitation in
gastro-oesophageal 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
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