Losamel 20 mg gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Omeprazole

Available from:

Clonmel Healthcare Ltd

ATC code:

A02BC; A02BC01

INN (International Name):

Omeprazole

Dosage:

20 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors; omeprazole

Authorization status:

Marketed

Authorization date:

2002-06-28

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSAMEL 20MG 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 Losamel is and what it is used for
2.
What you need to know before you take Losamel
3.
How to take Losamel
4.
Possible side effects
5.
How to store Losamel
6.
Contents of the pack and other information
1. WHAT LOSAMEL IS AND WHAT IT IS USED FOR
Losamel 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.
Losamel is used to treat the following conditions:
In adults:
‘Gastro-oesophageal reflux disease’ (GORD). 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 NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs). Losamel
can also be used to stop ulcers from forming if you are taking NSAIDs.
Too much acid in the stomach caused by a growth in the pancreas
(Zollinger-Ellison syndrome).
In children:
_Children over 1 year of age and ≥ 10 kg_
‘Gastro-oesophageal reflux disease’ (GORD). This is where a

Summary of Product characteristics

Health Products Regulatory Authority
04 April 2023
CRN00DH5G
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losamel 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gastro-resistant tablet contains 20.0 mg omeprazole.
Excipient(s) with known effect
Each gastro-resistant tablet contains 39.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablets
Round, light grey coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Omeprazole 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 oesophagitis
– Long-term management of patients with healed reflux oesophagitis
– Treatment of symptomatic gastro-oesophageal reflux disease
– Treatment of Zollinger-Ellison syndrome
Paediatric population
_Children over 1 year of age and ≥ 10 kg_
– Treatment of reflux oesophagitis
– Symptomatic treatment of heartburn and acid regurgitation in
gastro-oesophageal 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
Adults
_Treatment of duodenal ulcers_
The recommended dose in patients with an active duodenal ulcer is
Losamel 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 treatment period. In patients with poorly responsive
duodenal ulcer 40 mg omeprazole once daily is recommended
a