Nitrofurantoin 100mg capsules

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Nitrofurantoin

Tilgængelig fra:

Alliance Healthcare (Distribution) Ltd

ATC-kode:

J01XE01

INN (International Name):

Nitrofurantoin

Dosering:

100mg

Lægemiddelform:

Oral capsule

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 05011300

Indlægsseddel

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5
6
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NITROFURANTOIN 50MG AND 100MG
CAPSULES, HARD
Nitrofurantoin
5 mm
430 mm
5 mm
5 mm
5 mm
5 mm
60 mm
60 mm
140 mm
2
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.
WHAT IS IN THIS LEAFLET
What Nitrofurantoin is and what it is
used for
What you need to know before you
take Nitrofurantoin
How to take Nitrofurantoin
Possible side effects
How to store Nitrofurantoin
Contents of the pack and other
information
WHAT NITROFURANTOIN IS AND WHAT IT
IS USED FOR
Nitrofurantoin is an antibiotic. It is used to
prevent and treat infections of the bladder,
kidney and other parts of the urinary tract.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE NITROFURANTOIN
DO NOT TAKE NITROFURANTOIN IF:
!
you are allergic to nitrofurantoin or any of
the other ingredients of this medicine (see
section 6). An allergic reaction may include
rash,
itching,
difficulty
breathing
or
swelling of the face, lips, throat or tongue;
!
you
are
taking
any
other
medicines
containing nitrofurantoin;
!
you have a disease of the kidneys, which is
severely affecting the way that they work;
!
you are in the final stages of pregnancy
(labour or delivery), as there is a risk that
this medicine might affect the baby;
!
you suffer from a blood disorder called
porphyria;
!
you are deficient in an enzyme called G6PD
(glucose-6-phosphate dehydrogenase);
!
your infant is under three months of age
and has been prescribed this medicine;
!
you are breast feeding a baby who has
a suspected or a known G6PD (glucose-
6-phosphate

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nitrofurantoin 100mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg of Nitrofurantoin Ph Eur in
macrocrystalline form.
Excipient with known effect:
Each capsule contains 162mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Yellow coloured free flowing granules filled in hard gelatine capsule
with white body
printed with “100” in black and yellow cap printed with “NTF”
in black.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nitrofurantoin is indicated for the treatment of and prophylaxis
against acute or
recurrent, uncomplicated lower urinary tract infections when due to
susceptible
micro-organisms (see section 4.4 and 5.1)
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
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 (UTIs): 50 mg four times
daily for
seven days.
Severe chronic recurrence (UTIs): 100 mg four times daily for seven
days.
Long term suppression: 50-100 mg once a day.
Prophylaxis: 50 mg four times daily for the duration of procedure and
for three days
thereafter.
_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 other formulations of
nitrofurantoin should be
considered
_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 rena