PUGRITEX 10 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:

10 Milligram

Pharmaceutical form:

Capsules Gastro-Resistant

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
PUGRITEX 10 MG & 20 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 Pugritex Gastro-resistant Capsules are and what they are used
for 
2. What you need to know before you take Pugritex Gastro-resistant
Capsules 
3. How to take Pugritex Gastro-resistant Capsules 
4. Possible side effects 
5. How to store Pugritex Gastro-resistant Capsules 
6. Contents of the pack and other information 

1. WHAT PUGRITEX GASTRO-RESISTANT CAPSULES ARE AND WHAT THEY ARE USED
FOR 

Pugritex
  Gastro-resistant 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.  

 Pugritex Gastro-resistant 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 medi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pugritex 10 mg Gastro-resistant Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg of Omeprazole.
Excipient with known effect:
Each 10mg capsule contains 44.16 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsules, hard.
Opaque red cap and opaque orange body, containing white to beige granules.
Size 3 capsule marked with O10.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pugritex 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
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/11/2013_
_CRN 2139507_
_page number: 1_
_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 in adults
_Treatment of duodenal ulcers_
The recommended dose in patients with an active duodenal ulcer is Pugritex 20 mg once dai