Monuril 3 g granules for oral solution

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Fosfomycin

Prieinama:

IMED Healthcare Ltd.

ATC kodas:

J01XX01

INN (Tarptautinis Pavadinimas):

Fosfomycin

Vaisto forma:

Granules for oral solution

Gydymo sritis:

fosfomycin

Leidimo data:

2023-10-13

Pakuotės lapelis

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 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 age,
as it

Prekės savybės

Health Products Regulatory Authority
13 October 2023
CRN00DMVC
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 3 g of fosfomycin (as fosfomycin
trometamol)
Excipients with known effect: sucrose and sulfites.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral solution.
_Product imported from Spain:_
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 flavor (contains sucrose and sulfites (E 220 and E 222))
Orange flavor (contains corn starch and sulfites (E220 and E 222))
Saccharin
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
This medicinal product does not require any special storage
conditions.
Store in the original packaging.
6.5 NATURE AND CONTENTS OF CONTAINER
Sachets are supplied in cardboard outer containing 1 sachet.
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
Health Products Regulatory Authority
13 October 2023
CRN00DMVC
Page 2 of 2
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
IMED Healthcare Ltd,
Unit 625 Kilshane Avenue,
Northwest Business Park,
Ballycoolin,
Dublin 15,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/213/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 13
th
October 2023
10 DATE OF REVISION OF THE T