Monuril 3 g granules for oral solution

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Fosfomycin trometamol

Prieinama:

Zambon S.p.A.

ATC kodas:

J01XX; J01XX01

INN (Tarptautinis Pavadinimas):

Fosfomycin trometamol

Dozė:

3 gram(s)

Vaisto forma:

Granules for oral solution

Recepto tipas:

Product subject to prescription which may not be renewed (A)

Gydymo sritis:

Other antibacterials; fosfomycin

Autorizacija statusas:

Marketed

Leidimo data:

1995-11-13

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
MONURIL
®
3G GRANULES FOR ORAL SOLUTION
Fosfomycin trometamol
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

Prekės savybės

Health Products Regulatory Authority
19 October 2023
CRN00DV8H
Page 1 of 6
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. Excipients: Each
single-dose sachet contains 2.213 g of sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral solution.
White granular powder with a characteristic odour of mandarin flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Monuril is indicated for (see section 5.1):
- the treatment of acute, uncomplicated cystitis in women and female
adolescents
- perioperative antibiotic prophylaxis for transrectal prostate biopsy
in adult man
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Acute, uncomplicated cystitis in women and female adolescents (>12
years of age):_ 3 g fosfomycin once
_Perioperative antibiotic prophylaxis for transrectal prostate
biopsy:_ 3 g fosfomycin 3 hours prior to the procedure and 3 g
fosfomycin 24 hours after the procedure.
_Renal impairment:_
Use of Monuril is not recommended in patients with renal impairment
(creatinin clearance < 10 ml/min, see section 5.2).
_Paediatric population:_
The safety and efficacy of Monuril in children aged below 12 years of
age have not been established.
Method of administration
For oral use.
For the indication of acute, uncomplicated cystitis in women and
female adolescents it should be taken on an empty stomach
(about 2-3 hours before or 2-3 hours after a meal), preferably before
bedtime and after emptying the bladder.
The dose should be dissolved into a glass of water and taken
immediately after its preparation.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hypersensitiv