Nitrofurantoin 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nitrofurantoin

Available from:

Genesis Pharmaceuticals Ltd

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: 5060014441904 5060014442215

Patient Information leaflet

PATIENT LEAFLET: INFORMATION FOR THE USER
URANTOIN 50 & 100 MG 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
symptoms 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.
This product will be referred to as Nitrofurantoin Tablets for ease
hereafter.
WHAT IS IN THIS LEAFLET:
1. WHAT URANTOIN TABLETS ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE URANTOIN TABLETS
3. HOW TO TAKE URANTOIN TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE URANTOIN TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT URANTOIN TABLETS ARE AND WHAT THEY ARE USED FOR
Nitrofurantoin (the active substance in Urantoin 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 URANTOIN TABLETS
DO NOT TAKE URANTOIN TABLETS:
•
if you are allergic to Urantoin, 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 deficiency in
an

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
URANTOIN/Nitrofurantoin 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nitrofurantoin tablets contain 50mg of Nitrofurantoin BP
_Excipients with known effect_: Each tablet also contains 80.000 mg of
lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Nitrofurantoin tablets are flat, yellow bevelled and scored tablets.
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, when due to susceptible strains of Escherichia coli,
Enterococci,
Staphylococci, Citrobacter, Klebsiella and Enterobacter.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Poso
logy
Adu
lts
Acute uncomplicated urinary tract infections: 50 mg four times daily
for
7 days Severe chronic recurrence: 100 mg four times day for 7 days
Long term suppression: 50mg-100 mg once a day
Prophylaxis: 50 mg 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 Nitrofurantoin 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
(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 always be taken with food or milk.
Taking
Urantoin Tablets / Nitrofurantoin Tablets with a