Losec MUPS 20 mg gastro-resistant tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Omeprazole

Disponible depuis:

PCO Manufacturing Ltd.

Code ATC:

A02BC01

DCI (Dénomination commune internationale):

Omeprazole

Dosage:

20 milligram(s)

forme pharmaceutique:

Gastro-resistant tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

omeprazole

Statut de autorisation:

Authorised

Date de l'autorisation:

2017-01-20

Notice patient

_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LOSEC MUPS
® 10 MG GASTRO-RESISTANT TABLETS
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 an

Résumé des caractéristiques du produit

Health Products Regulatory Authority
19 July 2023
CRN00DPDH
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 mg omeprazole.
Excipient(s) with known effect: sucrose.
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 20 mg on
one side and a logo on the other side.
4 CLINICAL PARTICULARS
As per PA2239/009/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2239/009/002
5.1 PHARMACODYNAMIC PROPERTIES
A02BC
A02BC01
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Cellulose Microcrystalline,
Glyceryl 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
Health Products Regulatory Authority
19 July 2023
CRN00DPDH
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market 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
Blister packs of 7 tablets in a carton. Pack size: 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/423/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 20
th
January 2017
10 DATE OF REVISIO