OMEPRAZOLE 40 Milligram Capsules Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OMEPRAZOLE

Available from:

Laboratorios Davur S.L.U.

INN (International Name):

OMEPRAZOLE

Dosage:

40 Milligram

Pharmaceutical form:

Capsules Gastro-Resistant

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Withdrawn

Authorization date:

2013-12-20

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
OMEPRAZOLE 10 MG GASTRO-RESISTANT CAPSULES  
OMEPRAZOLE 20 MG GASTRO-RESISTANT CAPSULES  
OMEPRAZOLE 40 MG GASTRO-RESISTANT CAPSULES  
(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 symptoms 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 Capsules are and what they are used for 
2. What you need to know before you take Omeprazole Capsules 
3. How to take Omeprazole Capsules  
4. Possible side effects 
5. How to store Omeprazole Capsules 
6. Contents of the pack and other information 

1. WHAT OMEPRAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR 

Omeprazole Capsules 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 makes.  

Omeprazole Capsules are used for treating 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
pylor_i’. 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-S

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole 40 mg Gastro-resistant Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40 mg of Omeprazole.
Excipient with known effect:
Each 40 mg capsule contains 176.64 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsules, hard.
Opaque blue cap and opaque orange body, containing white to beige granules.
Size 0 capsule marked with O40
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Omeprazole 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 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_
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/11/2013_
_CRN 2140456_
_page number: 1_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY IN ADULTS:
_Treatment of duodenal ulcers_
The recommended