Monuril 3g granules sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fosfomycin trometamol

Available from:

Zambon UK Ltd

ATC code:

J01XX01

INN (International Name):

Fosfomycin trometamol

Dosage:

3gram

Pharmaceutical form:

Granules for oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010700; GTIN: 5060045110008

Patient Information leaflet

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. Contents of the pack and other information.
1. WHAT MONURIL IS AND WHAT IT IS USED FOR
Monuril contains the active substance fosfomycin
trometamol. Fosfomycin trometamol is an antibiot­
ic that works by killing bacteria which can cause
infections.
Monuril is used to treat or prevent uncomplicated
infections of the bladder.
Monuril is not suitable for the treatment of children
below 12 years of age.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MONURIL
DO NOT TAKE MONURIL IF YOU:
-
are allergic to fosfomycin trometamol or any of
the other ingredients of this medicine (listed in
section 6)
-
have severe kidney problems (creatinine clear­
ance below 10 ml/min)
-
are undergoing haemodialysis.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Monuril if you have:
-
an
allergic
reaction
during
treatment
(see
section 4)
-
an intolerance to some sugars (see end of sec­
tion 2)
-
previously had diarrhoea after taking any other
antibiotics
-
kidney problems, but your creatinine clearance
is above 10 ml/min.
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 in this age group.
OTHER MEDICINES AND MONURIL
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medi­
cines, including medicines obtained without a pre­
scription.
This is especially important if you are taking:
-
METOCLOPRAMIDE or other drugs that increase
the movement of food through the stomach and
intestines, because they may reduce the uptake
of
fosfomycin
trometamol
by
your
body
-
ANTICOAGULANTS, as their ability to prevent your
blood from clotting might be altered by fosfomy­
cin trometamol and other antibiotics.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast­feeding, think you
may be pregnant or

Summary of Product characteristics

OBJECT 1
MONURIL 3G GRANULES FOR ORAL SOLUTION
Summary of Product Characteristics Updated 30-Jul-2016 | Profile
Pharma Limited
1. Name of the medicinal product
Monuril 3 g granules for oral solution
2. Qualitative and quantitative composition
One sachet contains 5.631 g of fosfomycin trometamol equivalent to 3.0
g fosfomycin
Excipient(s) with known effect:
One sachet contains 2.213 g of sucrose, see section 4.4.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Granules for oral solution.
4. Clinical particulars
4.1 Therapeutic indications
Monuril is indicated in the treatment of acute lower uncomplicated
urinary tract infections, caused by
pathogens sensitive to fosfomycin in adult and adolescent females.
Monuril is also indicated for prophylaxis in diagnostic and surgical
transurethral procedures.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Posology
Acute lower uncomplicated urinary tract infections:
_Adults: and adolescent females (>12 years of age):_ 1 sachet (3 g)
once
Prophylaxis of urinary tract infections for surgery and diagnostic
procedure involving the lower urinary
tract:
_Adults: _One Monuril 3 g sachet 3 hours before surgery. A second dose
of 3 g may be given 24 hours after
surgery.
Paediatric population
The safety and efficacy of Monuril 3 g in children below 12 years of
age have not been established.
Method of administration
Monuril is for oral administration. 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.
Patients with severe renal insufficiency (creatinine clearance < 10
ml/min).
Patients undergoing haemodialysis.
4.4 Special warnings and precautions for use
Hypersensitiv