Furadantin 100 mg Tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Nitrofurantoin

Dostępny od:

Mercury Pharmaceuticals Ltd

Kod ATC:

J01XE; J01XE01

INN (International Nazwa):

Nitrofurantoin

Dawkowanie:

100 milligram(s)

Forma farmaceutyczna:

Tablet

Typ recepty:

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

Dziedzina terapeutyczna:

Nitrofuran derivatives; nitrofurantoin

Status autoryzacji:

Not marketed

Data autoryzacji:

1997-04-01

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FURADANTIN
® 50MG TABLETS
FURADANTIN
® 100MG TABLETS
nitrofurantoin
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, pharmacist or
nurse.
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 of the side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Furadantin is and what it is used for
2.
What you need to know before you take Furadantin
3.
How to take Furadantin
4.
Possible side effects
5.
How to store Furadantin
6.
Contents of the pack and other information
1. WHAT FURADANTIN IS AND WHAT IT IS USED FOR
Nitrofurantoin is an antibacterial agent which is used to prevent and
treat infections of the bladder,
kidneys and other parts of the urinary tract.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FURADANTIN
DO NOT TAKE FURADANTIN:

If you are allergic (causing itching, reddening of the skin or
difficulty in breathing) to
nitrofurantoin, other medicines containing nitrofurantoin or any of
the other ingredients of
this medicine (listed in Section 6)

If you have been advised by your doctor that you have a low kidney
function (eGFR less
than 45ml per minute)

If you are in labour or delivering your baby or breastfeeding

If you are suffering from porphyria (group of blood disorders that
affect the nervous system
or skin, or both)

If
you
have
lack
of
an
enzyme
(body
chemical)
called
“glucose-6-phosphate
dehydrogenase”, which causes your red blood cells to be more easily
damaged (this is more
common in black people and people of Mediterranean, Near Eastern or
Asian origin, speak
with your doctor about this) Furadantin should not be given to infants
less than

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furadantin 100 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg nitrofurantoin.
Excipient(s) with known effect
Each tablet contains 113.05 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Yellow, pentagonal tablets imprinted with a monogram ‘100’ on one
face and a single breakline on the opposite face.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of and prophylaxis against acute or recurrent,
uncomplicated lower urinary tract infections or pyelitis
either
spontaneous
or
following surgical
procedures.
Nitrofurantoin is specifically indicated for
the treatment
of
infections
due to susceptible strains
of
Escherichia coli,
enterococci,
staphylococci,
Citrobacter,
Klebsiella and
Enterobacter. Most strains of Proteus and Serratia are resistant. All
Pseudomonas strains are resistant. Furadantin is not
indicated for the treatment of associated renal cortical or
perinephric abscesses (section 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Indication
Age group
Dose regimen
Duration
Acute or Recurrent
Uncomplicated UTI and Pyelitis
Children over 3 months
3mg/kg/day in four
divided doses
7 days
Children (10years and
over) & Adults (18 – 64
years)
50mg four times daily
7 days
Elderly (65years and over)
*
Severe Chronic Recurrent
Infections**
Children (10years and
over) & Adults (18 – 64
years)
100mg four times
daily**
7 days
Elderly (65years and over)
*
Surgical Prophylaxis
Children (10years and
over) & Adults (18 – 64
years)
50mg 4 times daily
on the day of the
procedure and three
days thereafter
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__