Losec MUPS 20 mg gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Omeprazole

Available from:

AstraZeneca AB

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:

1999-09-17

Patient Information leaflet

BODY TEXT SIZE
9.0 pt
SMALLEST TEXT SIZE
6.0 pt
Profile
Technical Info
N/A
6469
AZL4004B
PS18998
17-09-2020
104366405/402048554 0020
Losec Leaflet patient 10mg, 20mg,
40mg IE MT
Black
Package leaflet: Information for the patient
Losec MUPS 10 mg gastro-resistant tablets
Losec MUPS 20 mg gastro-resistant tablets
Losec MUPS 40 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 Losec is and what it is used for
2.
What you need to know before you take Losec
3.
How to take Losec
4.
Possible side effects
5.
How to store Losec
6.
Contents of the pack and other information
1. What Losec is and what it is used for
Losec 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.
Losec 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). Losec can

Summary of Product characteristics

Health Products Regulatory Authority
11 January 2021
CRN009ZPC
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losec MUPS 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
20 mg: Each gastro-resistant tablet contains 20.6 mg omeprazole
magnesium equivalent to 20 mg omeprazole.
Excipient(s) with known effect
20 mg: Each gastro-resistant tablet contains 19–20 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Losec 20 mg gastro-resistant tablets: Pink, oblong, biconvex,
film-coated tablets, engraved with
on one side and 20 mg on
the other side containing enteric coated pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Losec gastro-resistant tablets are indicated in:
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 use
_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
Posology
Health Products Regulatory Authority
11 January 2021
CRN009ZPC
Page 2 of 12
_Adults_
_Treatment of duodenal ulcers_
The recommended dose in patients with an active duodenal ulcer is
Losec 20 mg once daily. In most patients he