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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
LOSEC MUPS TABLET
Omeprazole (10mg, 20mg)
WHAT IS IN THIS LEAFLET
1.
What LOSEC MUPS is used for
2.
How LOSEC MUPS works
3.
Before you use LOSEC MUPS
4.
How to use LOSEC MUPS
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of LOSEC MUPS
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
11.
Serial Number
WHAT LOSEC MUPS IS USED FOR
Losec MUPS is used to treat the following
health conditions:
•
Ulcers in the upper part of the intestine
(Duodenal ulcer).
•
Stomach ulcers (Gastric ulcer).
•
Stomach ulcers or ulcers in the upper
part of the intestine caused by your
medicine for pain and inflammation
(NSAID associated gastric and duodenal
ulcers or erosions).
•
Ulcers which are infected with bacteria
called
_Helicobacter pylori _
(
_Helicobacter _
_pylori _
eradication in peptic ulcer
disease).
•
Disease with symptoms caused by a
return flow of fluid from the stomach
(Symptomatic gastro-oesophageal reflux
disease or reflux oesophagitis).
•
Acid related upper abdominal pain or
discomfort (Acid related indigestion).
•
Hormone producing tumours in the
pancreas causing excess acid in the
stomach (Zollinger-Ellison syndrome).
HOW LOSEC MUPS WORKS
Losec MUPS is a type of medicine called
a ‘proton pump inhibitor’. It reduces the
production of acid in your stomach.
BEFORE YOU USE LOSEC MUPS
_-_
_ _
_When you must not use it _
Do not take Losec MUPS if you are
allergic to omeprazole or similar
medication or any of the other ingredients.
_-_
_ _
_Before you start to use it _
Inform your health care professional if,
•
you have any alarming symptoms (e.g.
significant unintentional weight loss,
recurrent vomiting, difficulty
swallowing, severe or persistent
diarrhoea, vomiting blood or blood in
your stools)
•
you are taking medicines for Human
Immunodeficiency Virus (HIV), such as
atazanavir or if you have reduced
vitamin B12 (cyanocobalamin)
absorption or body stores
•
you have hereditary problem
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产品特点
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg: Each gastro-resistant tablet contains 10.3 mg
omeprazole magnesium equivalent to 10 mg omeprazole.
20 mg: Each gastro-resistant tablet contains 20.6 mg
omeprazole magnesium equivalent to 20 mg omeprazole.
For a full list of excipients, see “List of excipients”.
PHARMACEUTICAL FORM
Losec MUPS tablets 10 mg : Light-pink, oblong,
biconvex, film-coated tablets engraved with on one
side and 10 mg on the other side. Each tablet contains
omeprazole magnesium 10.3 mg as enteric coated pellets.
Losec MUPS tablets 20 mg: Pink, oblong, biconvex,
film-coated tablets, engraved with on one side and
20 mg on the other side. Each tablet contains
omeprazole magnesium 20.6 mg as enteric coated pellets.
THERAPEUTIC INDICATIONS
Losec MUPS is indicated for the treatment of:
Duodenal ulcer
Gastric ulcer
NSAID associated gastric and duodenal ulcers or erosions
_Helicobacter pylori_ eradication in peptic ulcer disease
Reflux oesophagitis
Symptomatic gastro-oesophageal reflux disease
Acid related dyspepsia
Zollinger-Ellison syndrome
_POSOLOGY AND METHOD OF ADMINISTRATION_
The tablets must be swallowed whole with at least
½ glass of liquid. They must not be chewed or crushed.
The tablets may also be dispersed in water or any acidic
drink (e.g. juice). The dispersion must then be taken
within 30 minutes.
_DUODENAL ULCER_
The recommended dosage in patients with an active
duodenal ulcer is Losec MUPS 20 mg once daily.
Symptom resolution is rapid and in most patients
healing occurs within 2 weeks. For those patients who
may not be fully healed after the initial course, healing
usually occurs during a further 2 week treatment period.
In patients with poorly responsive duodenal ulcer
Losec MUPS 40 mg once daily is recommended and
healing is usually achieved within 4 weeks.
For the prevention of relapse in patients with duodenal
ulcer disease the recommended dose is Losec MUPS
10 mg once daily. If needed the dose can be increased
to Losec MUPS 20-40mg once daily.
For NSAID associated duodenal
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