Monuril 3 g granules for oral solution

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

FOSFOMYCIN TROMETAMOL

Pieejams no:

PCO Manufacturing Ltd.

ATĶ kods:

J01XX; J01XX01

SNN (starptautisko nepatentēto nosaukumu):

FOSFOMYCIN TROMETAMOL

Zāļu forma:

Granules for oral solution

Ārstniecības joma:

Other antibacterials; fosfomycin

Autorizācija datums:

2022-01-28

Lietošanas instrukcija

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONURIL
® 3 G GRANULES FOR ORAL SOLUTION
fosfomycin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
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. Do not
pass it on to others. It may harm them, even if their
symptoms 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 Monuril is and what it is used for
2.
What you need to know before you take Monuril
3.
How to take Monuril
4.
Possible side effects
5.
How to store Monuril
6.
Further information
1.
WHAT MONURIL IS AND WHAT IT IS USED FOR
Monuril contains the active substance fosfomycin (as
fosfomycin trometamol). It is an antibiotic that works by
killing bacteria which can cause infections.
Monuril is used to treat uncomplicated infection of the
bladder in women and female adolescents.
Monuril is used as antibiotic prophylaxis for transrectal
prostate biopsy in adult man.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MONURIL
DO NOT TAKE MONURIL IF YOU:
•
are allergic to fosfomycin or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using
Monuril if you suffer from one of the following disorders:
−
persistent infections of the bladder,
−
previously had diarrhea after taking any other
antibiotics.
Conditions you need to look out for
Monuril can cause serious side effects. These include
allergic reactions and an inflammation of the large
intestine. You must look out for certain symptoms while
you are taking this medicine, to reduce the risk of any
problems. See “Serious side effects” in Section 4.
CHILDREN AND ADOLESCENTS
Do not give this medicine to children less than 12 years of

Produkta apraksts

Health Products Regulatory Authority
31 January 2022
CRN00CP84
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Monuril 3 g granules for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose sachet contains 5.631 g fosfomycin – trometamol
(1:1) equivalent to 3 g fosfomycin.
Excipient(s) with known effect: sucrose and sulphites.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral solution.
_Product imported from the Netherlands:_
White granular powder with a characteristic odour of mandarin flavour.
4 CLINICAL PARTICULARS
As per PA1441/002/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1441/002/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Mandarin flavour (contains sulphites)
Orange flavour
Saccharin (E 954)
Sucrose
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the sachet and outer package of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
No special precautions for storage.
6.5 NATURE AND CONTENTS OF CONTAINER
Sachets are a four layer laminate: paper, polyethylene, aluminium,
polyethylene.
Sachets are supplied in cardboard outer containing 1 sachet.
Health Products Regulatory Authority
31 January 2022
CRN00CP84
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
The dose must be dissolved in a glass of water and administered soon
after dissolving.
Any unused product or waste material should be disposed of in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/485/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of last authorisation: 28
th
January 2022
10 DATE OF REVISION OF THE TEXT