LOPRAZ 20 Milligram Capsules Gastro-Resistant

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

OMEPRAZOLE

Dostupné z:

Teva Pharma B.V.

INN (Medzinárodný Name):

OMEPRAZOLE

Dávkovanie:

20 Milligram

Forma lieku:

Capsules Gastro-Resistant

Typ predpisu:

Product subject to prescription which may be renewed (B)

Stav Autorizácia:

Authorised

Dátum Autorizácia:

0000-00-00

Príbalový leták

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LOPRAZ (OMEPRAZOLE) 10MG/ 
20MG/40MG GR CAPS ALL (V5) 
TEI (CHEMO DIRECT)
23-1-14
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LOPRAZ 10 MG GASTRO-
RESISTANT CAPSULES
LOPRAZ 20MG GASTRO-
RESISTANT CAPSULES
LOPRAZ 40MG GASTRO-
RESISTANT CAPSULES
OMEPRAZOLE
PACKAGE LEAFLET: INFORMATION FOR 
THE USER
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE 
YOU START TAKING THIS MEDICINE BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU.
•  Keep this leafl et. 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 leafl et. See section 4.
WHAT IS IN THIS LEAFLET
1.  
WHAT LOPRAZ IS AND WHAT IT IS USED FOR
2.  
WHAT YOU NEED TO KNOW BEFORE YOU 
TAKE LOPRAZ 
3.  HOW TO TAKE LOPRAZ 
4.  POSSIBLE SIDE EFFECTS
5.  HOW TO STORE LOPRAZ 
6.  
CONTENTS OF THE PACK AND OTHER 
INFORMATION
   WHAT LOPRAZ IS AND WHAT 
IT IS USED FOR
Lopraz contains the active substance 
omeprazole. It belongs to a group of 
medicines called ‘proton pump 

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lopraz 20 mg Gastro-resistant Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 20 mg of omeprazole.
Excipient(s) with known effect:
Each 20mg capsule contains 102 to 116mg of sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Opaque yellow capsule containing off-white to cream-white spherical microgranules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lopraz 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
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
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/03/2014_
_CRN 2140238_
_page number: 1_
Posology
_Adults_
_Treatment of duodenal ulcers_
The recommended dose in patients with an active duodenal ulcer is Lopraz 20 mg once daily. In most patients healing
occurs�