Losec MUPS 40 mg gastro-resistant tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Omeprazole

זמין מ:

IMED Healthcare Ltd.

קוד ATC:

A02BC; A02BC01

INN (שם בינלאומי):

Omeprazole

כמות:

40 milligram(s)

טופס פרצבטיות:

Gastro-resistant tablet

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

Proton pump inhibitors; omeprazole

מצב אישור:

Authorised

תאריך אישור:

2018-06-14

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 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 _


מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losec MUPS 40 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains omeprazole magnesium equivalent
to 40 mg omeprazole.
Excipient(s) with known effect
Each gastro-resistant tablet contains sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
_Product imported from the United Kingdom_
Dark red-brown, oblong, biconvex, film-coated tablets, engraved with
on one side and 40 mg on the other side.
4 CLINICAL PARTICULARS
As per PA0970/044/008
5 PHARMACOLOGICAL PROPERTIES
As per PA0970/044/008
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Cellulose Microcrystalline
Glycerol monostearate 40-55
Hydroxypropylcellulose
Hypromellose
Magnesium stearate
Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 per cent
Sugar spheres
Synthetic paraffin (NF)
Macrogol (polyethylene glycol 6000)
Polysorbate 80
Crospovidone
Sodium hydroxide (for pH-adjustment)
Sodium stearyl fumarate
Talc
Triethyl citrate
Iron oxide E172
Titanium dioxide E171
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6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the count