OMEPRAZOLE 20 Milligram Capsules Gastro-Resistant

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

OMEPRAZOLE

Disponível em:

Laboratorios Velvian S.L

DCI (Denominação Comum Internacional):

OMEPRAZOLE

Dosagem:

20 Milligram

Forma farmacêutica:

Capsules Gastro-Resistant

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Status de autorização:

Authorised

Data de autorização:

0000-00-00

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER 

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 takeOmeprazole  
3. 
How to take Omeprazole  
4. 
Possible side effects 
5. 
How to store Omeprazole  
6. 
Contents of the pack and other information 

1.  WHAT  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-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 NS

Características técnicas

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 esophagitis
Treatment of symptomatic gastro-esophageal reflux disease
Treatment of Zollinger-Ellison syndrome
Paediatric population
_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
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 09/04/2014_
_CRN 2138808_
_page number: 1_
_Adults_
_Treatment of duodenal ulcers_
The recommended dose in patients with an active duo