Furadantin 50 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nitrofurantoin

Available from:

Amdipharm Limited

ATC code:

J01XE; J01XE01

INN (International Name):

Nitrofurantoin

Dosage:

50 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Nitrofuran derivatives; nitrofurantoin

Authorization status:

Not marketed

Authorization date:

1977-04-01

Patient Information leaflet

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 nitrofurans 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 3 months
of age.
WARNING

Summary of Product characteristics

Health Products Regulatory Authority
19 March 2021
CRN00C7CK
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furadantin 50 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg nitrofurantoin.
Excipient(s) with known effect
Each tablet contains 149.16 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 ‘50’ 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)*
50mg four
times daily
7 days
Severe Chronic
Recurrent
Infections**
Children (10years and over) & Adults (18 – 64 years)
100mg four
times daily**
7 days
​
Elderly (65years and over)*
100mg four
times daily
7 days
Surgical
Prophylaxis
Children (10years and over) & Adults (18 – 64 years)
50mg four
times daily
on the day
of the
procedure
and three
days
H