Furadantin 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nitrofurantoin

Available from:

Advanz Pharma

ATC code:

J01XE01

INN (International Name):

Nitrofurantoin

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05011300; GTIN: 5021691400141

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FURADANTIN
®
50MG AND 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 side effects, talk to your doctor, pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
This product will be referred to as Furadantin Tablets for ease
hereafter.
WHAT IS IN THIS LEAFLET
1. What Furadantin Tablets are and what they are used for
2. What you need to know before you take Furadantin Tablets
3. How to take Furadantin Tablets
4. Possible side effects
5. How to store Furadantin Tablets
6. Contents of the pack and other information
1. WHAT FURADANTIN TABLETS ARE AND WHAT THEY ARE USED FOR
Nitrofurantoin (the active substance in Furadantin Tablets) is an
antibiotic.
It is used to prevent and treat infections of the bladder, kidney and
other parts of the urinary tract.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FURADANTIN TABLETS
DO NOT TAKE FURADANTIN TABLETS:
• if you are allergic to Nitrofurantoin, other medicines containing
nitrofurantoin or any of the
other ingredients of this medicine (listed in Section 6)
• if you have a disease of the kidneys which is severely affecting
the way they work (ask your
doctor if you are not sure)
• if you are in the final stages of pregnancy (labour or delivery)
as there is a risk that it might
affect the baby
• if you have porphyria (blood disorder)
• if you are a patient with G6PD (glucose-6-phosphate dehydrogenase)
deficiency
• if your child is under three months of age
• if you are breast-feeding a baby with suspected or known
defic

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Furadantin 50mg Tablets
Nitrofurantoin 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg Nitrofurantoin.
Excipients with known effect
Lactose-157mg per tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Yellow, pentagonal tablets with a break line on one face and the
tablet strength
on the opposite face.
The score line is not intended for breaking the tablet.
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_.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
Acute Uncomplicated Urinary Tract Infections: 50mg four times daily
for
seven days
Severe Chronic Recurrence: 100mg four times a day for seven days
Long Term Suppression: 50mg - 100mg once a day.
Prophylax
i
s: 50mg four times daily for the duration of procedure and 3 days
thereafter.
_ _
_Paediatric population _
_ _
CHILDREN AND INFANTS OVER THREE MONTHS OF AGE
Acute Urinary Tract Infections: 3mg/kg/day in four divided doses for
seven
days.
Suppressive: 1mg/kg, once a day.
For children under 25kg body weight consideration should be given to
the use
of Furadantin Suspension.
ELDERLY
Provided there is no significant renal impairment, in which
Nitrofurantoin is
contraindicated, the dosage should be that for any normal adult. See
precaution
and risks to elderly patients associated with long-term therapy (see
section
4.8).
RENAL IMPAIRMENT
Nitrofurantoin is contraindicated in patients with renal dysfunction
and in
patients with an eGFR of less than 45 ml/minute (see sections 4.3 &
4.4).
Method of administration
For oral use. This medicine should alwa