Nitrofurantoin 100mg capsules

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Nitrofurantoin

Dostopno od:

DE Pharmaceuticals

Koda artikla:

J01XE01

INN (mednarodno ime):

Nitrofurantoin

Odmerek:

100mg

Farmacevtska oblika:

Oral capsule

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 05011300

Navodilo za uporabo

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.
The name of your medicine is Nitrofurantoin 50mg or 100mg capsules,
Hard. It will be referred to as Nitrofurantoin capsules for ease
hereafter.
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 nitrofurans or to 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 suffer from a blood disorder called porphyria
•
if you are deficient in an enzyme called G6PD (glucose-6-phosphate
dehydrogenase)
•
if your child under three months of age
•
if you are breast feeding a baby with suspected or k

Lastnosti izdelka

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