Losec MUPS 20 mg gastro-resistant tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
07-06-2017
Summary of Product characteristics
(SPC)
07-06-2017
Active ingredient:
Omeprazole magnesium
Available from:
AstraZeneca UK Limited
ATC code:
A02BC; A02BC01
INN (International Name):
Omeprazole magnesium
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
565631-A02
10-04-17
PS10339
AZL4004A
7514
NK
Losec MUPS 10mg, 20mg, 40mg
Leaflet: Patient Ireland-Malta
Black
Technical Info
Profile
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
al
Read the complete document
Summary of Product characteristics
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
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