LOSEPINE 10 Milligram Tablets Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OMEPRAZOLE PH. EUR.

Available from:

Pinewood Laboratories Ltd,

INN (International Name):

OMEPRAZOLE PH. EUR.

Dosage:

10 Milligram

Pharmaceutical form:

Tablets 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 

LOSEPINE 10 MG GASTRO-RESISTANT TABLETS 
LOSEPINE 20 MG GASTRO-RESISTANT TABLETS 

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 Losepine

is and what it is used for  
2. 
What you need to know before you take Losepine

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

1.  
WHAT LOSEPINE IS AND WHAT IT IS USED FOR  
Losepine gastro-resistant tablets 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.  
Losepine 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�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losepine 10 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 10 mg of omeprazole.
Excipients: each tablet contains 104.5 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Oval red-brown tablet (length 9.8 mm).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Losepine gastro-resistant tablets 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
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 Losepine 20 mg once daily. In most patients
healing occurs within two weeks. For those patients who may not be fully healed after the initial course, healing
usually occurs during a further two weeks treatmen