Omeprazole Capsules 20mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

OMEPRAZOLE

Available from:

Generics UK Limited Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

ATC code:

A02BC01

INN (International Name):

OMEPRAZOLE 20 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

OMEPRAZOLE 20 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Withdrawn

Authorization date:

2006-11-10

Patient Information leaflet

 
COLOURS:
Black
PL 4569/0487
0474 & 0488
APPROVED TO PRINT:
Marketing
Registration
Production
Customer
Quality Assurance
Generics [UK] Limited, Design Department
Albany Gate, Darkes Lane, Potters Bar, Herts, EN6 1AG
CUSTOMER:
  ANY OLS
DESIGNER:
  Fleur Albrecht
PRODUCT:
  Omeprazole capsules 10, 20 & 40 mg x 28's & 7's 
ITEM CODE:
  (OU-I) 302428
PHARMACODE:
  n/a
DIMENSIONS:
  170 x 210 mm
PROOF NO & DATE:
  2   07/03/05
REVISION:
 Updating Esteve code to match Esteve proof.
SUPERSEDES:
  OU-I01          
ARTWORK FOR SUBMISSION
BEFORE YOU TAKE YOUR MEDICINE PLEASE 
READ THIS LEAFLET CAREFULLY. You should keep 
this leaflet as you may need to read it again. If you 
have any further questions, please ask your doctor or 
your pharmacist. This leaflet contains a summary of 
the information about your medicine, Omeprazole
Capsules.
YOUR MEDICINE 
Your medicine is in the form of a capsule. Each 
capsule contains 10, 20 or 40 mg of the active 
ingredient omeprazole as gastro-resistant granules. 
Each capsule also contains hypromellose, talc, 
titanium dioxide (E171), methacrylic acid copolymer, 
triethylcitrate, sucrose and maize starch. The capsule 
shell contains gelatin, iron oxide (E172), titanium 
dioxide (E171). The 20 and 40 mg shells also 
contain erythrosine (E127). The black ink on the 
capsule shell contains iron oxide (E172), propylene 
glycol, ammonium hydroxide, potassium hydroxide 
and shellac. Omeprazole 10 and 20 mg Capsules 
are available in blister packs containing 28 capsules. 
Omeprazole 40 mg Capsules are available in blister 
packs containing 7 capsules. Your pharmacist will 
dispense the number of capsules as prescribed by 
your doctor.
Product Licence Holder and Manufacturer: Generics 
[UK] Limited, Station Close, Potters Bar, Herts, EN6

Summary of Product characteristics

Page 1 of 11 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  
TRADE NAME OF THE MEDICINAL PRODUCT 

Omeprazole Capsules 20mg (territory dependent). 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each hard gelatin capsule contains gastro-resistant granules
containing 20mg omeprazole. 
For a full list of excipients, see  section 6.1 

3. 
PHARMACEUTICAL FORM 

Gastro-resistant capsules, hard. 
_ _
_ _
Each capsule contains gastro-resistant granules. 

White/pale pink No.2 capsules with “G” and “OE20” printed in
black ink. 

4.  
CLINICAL PARTICULARS 

4.1  
THERAPEUTIC INDICATIONS 

-  Duodenal ulcers.  
-  Benign gastric ulcers. 
-  Reflux oesophagitis.   
-  Maintenance treatment of reflux oesophagitis to prevent
relapse. 
-  Zollinger-Ellison syndrome. 
-  Treatment of NSAID related gastric and duodenal ulcers. 
-  Maintenance treatment of NSAID related gastric and duodenal
ulcers to prevent relapse. 
-  Symptomatic treatment of gastro-oesophageal reflux disease. 
-  In combination with appropriate antibacterial therapeutic
regimens for the eradication of 
Helicobacter_ _pylori in patients with Helicobacter pylori
associated peptic ulcers (see 
section 4.2.) 
_ _
4.2  
POSOLOGY AND METHOD OF ADMINISTRATION 

Duodenal ulcers 
The usual dose is 20 mg of omeprazole once daily.  The duration
of the treatment is 2-4 
weeks. 

Benign gastric ulcers 
The usual dose is 20 mg of omeprazole once daily.  The duration
of the treatment is 4-8 
weeks. 

Reflux oesophagitis 
The usual dose is 20 mg of omeprazole once daily.  The duration
of the treatment is 4-8 
weeks. 

Page 2 of 11 
Notes: 
In isolated cases of duodenal ulcers, benign gastric ulcers and reflux
oesophagitis the dosage 
of omeprazole can be increased to 40 mg omeprazole once daily. 

Monotherapy with omeprazole in duodenal and gastric ulcers
should only be used in 
patients in whom eradicatio