Losec MUPS 20 mg gastro-resistant tablets

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Omeprazole

Доступно од:

IMED Healthcare Ltd.

АТЦ код:

A02BC; A02BC01

INN (Међународно име):

Omeprazole

Дозирање:

20 milligram(s)

Фармацеутски облик:

Gastro-resistant tablet

Терапеутска област:

Proton pump inhibitors; omeprazole

Датум одобрења:

2006-09-08

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LOSEC
® MUPS
® 20 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 _
•
‘Gastro-oesophageal reflux dis

Карактеристике производа

Health Products Regulatory Authority
24 January 2022
CRN00CQT1
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losec MUPS 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20.6 mg omeprazole magnesium
equivalent to 20 mg omeprazole
Excipients with known effect: sucrose (contained in sugar spheres).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
_Product imported from Belgium_
Pink, oblong, biconvex, film-coated tablets engraved with a logo on
one side and '20 mg' on the other side containing enteric
coated pellets.
4 CLINICAL PARTICULARS
As per PA2239/009/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2239/009/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Glycerol monostearate
Hyprolose
Hypromellose
Magnesium stearate
Methacrylic acid co-polymer C
Sugar spheres (contain sucrose)
Paraffin
Macrogol
Polysorbate
Crospovidone
Sodium stearyl fumarate
Sodium hydroxide*
Talc
Triethyl citrate
Iron oxide (E172)
Titanium dioxide (E171)
* May be added as a pH adjuster
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
24 January 2022
CRN00CQT1
Page 2 of 2
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister and outer carton of the product as marketed in the
country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
_Belgium: _Blisters in an outer cardboard carton. Pack size: 28
tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/141/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 8th September 2006
Date of last renewal: 8th S