Omeprazole Teva Pharma 20 mg Gastro-resistant capsules, hard

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Omeprazole

Διαθέσιμο από:

Teva Pharma B.V.

Φαρμακολογική κατηγορία (ATC):

A02BC; A02BC01

INN (Διεθνής Όνομα):

Omeprazole

Δοσολογία:

20 milligram(s)

Φαρμακοτεχνική μορφή:

Gastro-resistant capsule

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Proton pump inhibitors; omeprazole

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2007-06-01

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OMEPRAZOLE TEVA PHARMA 10 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE TEVA PHARMA 20 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE TEVA PHARMA 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 Teva Pharma is and what it is used for
2.
What you need to know before you take Omeprazole Teva Pharma
3.
How to take Omeprazole Teva Pharma
4.
Possible side effects
5.
How to store Omeprazole Teva Pharma
6.
Contents of the pack and other information
1. WHAT OMEPRAZOLE TEVA PHARMA IS AND WHAT IT IS USED FOR
Omeprazole Teva Pharma 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 Teva Pharma is used to treat the following conditions:
In 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 Teva Pharma can also be

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
13 January 2020
CRN008WPW
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole Teva Pharma 20 mg Gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg omeprazole.
EXCIPIENT WITH KNOWN EFFECT:
Each 20 mg capsule contains 80 mg sucrose.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
20 mg 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 Teva Pharma gastro-resistant 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 oesophagitis

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
Health Products Regulatory Authority
13 January 2020
CRN008WPW
Page 2 of 12
_Adults_
_Treatment of duodenal ulcers_
The recommended dose in patients with an active duodenal ulcer is 20
mg omeprazole once daily. In most patients healing
occurs within two weeks. For those patients who may not be fully
healed after the i