Monuril 3 g granules for oral solution

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Fosfomycin

Saadav alates:

Lexon Pharmaceuticals (Ireland) Limited

ATC kood:

J01XX; J01XX01

INN (Rahvusvaheline Nimetus):

Fosfomycin

Ravimvorm:

Granules for oral solution

Terapeutiline ala:

Other antibacterials; fosfomycin

Loa andmise kuupäev:

2022-06-24

Infovoldik

MONURIL 3 G GRANULES FOR ORAL SOLUTION
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:
What Monuril is and what it is used for
What you need to know before you take Monuril
How to take Monuril
Possible side effects
How to store Monuril
Contents of the pack and other information
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.
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 diarrhoea 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
its safety
and efficacy have not been established i

Toote omadused

Health Products Regulatory Authority
24 June 2022
CRN00CVYH
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).
Excipient(s) with known effect: sucrose and sulphites
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
_Product imported from Spain_
_ _
Granules for oral solution.
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 sucrose and sulphites (E 220 and E 222))
Orange flavour (contains corn starch and sulphites (E 220 and E 222))
Saccharin (E 954)
Sucrose
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for 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 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
24 June 2022
CRN00CVYH
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
Lexon Pharmaceuticals (Ireland) Limited
Block 3,
Harcourt Centre,
Harcourt Road,
Dublin 2,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/044/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 24
th
June 2022
10 DATE OF REVISION OF THE TEXT