Nitrofurantoin 100mg capsules

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Nitrofurantoin

Tersedia dari:

Morningside Healthcare Ltd

Kode ATC:

J01XE01

INN (Nama Internasional):

Nitrofurantoin

Dosis:

100mg

Bentuk farmasi:

Oral capsule

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 05011300; GTIN: 5055132714634

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
Nitrofurantoin
50mg and 100mg Capsules
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 further questions, ask your doctor or
pharmacist.
•
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 or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Nitrofurantoin Capsules are and what they are
used for
2. What you need to know before you take
Nitrofurantoin Capsules
3. How to take Nitrofurantoin Capsules
4. Possible side effects
5. How to store Nitrofurantoin Capsules
6. Contents of the pack and other information
1. WHAT NITROFURANTOIN CAPSULES ARE AND
WHAT THEY ARE USED FOR
Nitrofurantoin (the active substance in Nitrofurantoin
Capsules) 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
NITROFURANTOIN CAPSULES
Do not take Nitrofurantoin Capsules if:
•
you are allergic to nitrofurantoin, other medicines
containing nitrofurantoin or to any of the other
ingredients of this medicine (listed in Section 6).
•
you have a disease of the kidneys which is severely
affecting the way they work (ask your doctor if you
are not sure).
•
you are in the final stages of pregnancy (labour or
delivery) as there is a risk that it 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 child is under three months of age.
•
you are breast feeding a baby with suspected
or known deficiency in an enzyme called G6PD
(glucose-6-pho

Karakteristik produk

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 or pyelitis
either spontaneous
or following surgical procedures. It is indicated in adults, children
and infants over 3
months old.
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.
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 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 renal dysfunction
and in patients
with an eGFR