NITROFURANTOIN 100 MG TABLETS

Active substance: NITROFURANTOIN

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PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER

Pharma code 1606

Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Nitrofurantoin is and what it is used for
2. Before you take Nitrofurantoin
3. How to take Nitrofurantoin
4. Possible side effects
5. How to store Nitrofurantoin
6. Further information

1

WHAT NITROFURANTOIN IS AND
WHAT IT IS USED FOR

Nitrofurantoin is a broad-spectrum antibacterial
agent.
Nitrofurantoin is used to treat and prevent many
types of bacteria associated with infections in the
urinary tract. Examples of these infections are
cystitis, pyelitis, and infections of the
genito-urinary tract that may occur after an
operation.

2

BEFORE YOU TAKE NITROFURANTOIN

DO NOT take Nitrofurantoin if you:
• are allergic (hypersensitive) to nitrofurantoin
(or other nitrofurans) or any of the other
ingredients of this medicine
• have kidney problems
• are giving birth
• are suffering from porphyria, which is a
deficiency of certain enzymes in the body
• have glucose-6-phosphate dehydrogenase
deficiency (an inherited failure to metabolise
glucose)
• Nitrofurantoin should not be given to infants
under three months old.
Take special care with Nitrofurantoin
Talk to your doctor before you start to take this
medicine if you:
• have diabetes
• have anaemia (a reduction in red blood cells
which can make the skin pale and cause
weakness or breathlessness)
• have an imbalance of salts in the body
• have vitamin B or folate deficiency
• have peripheral neuropathy (damage to the
nerves)
• have lung problems
• have liver problems
• have allergies
• have any neurological disorders (disorders
of the nervous system)
• have any serious illness
• are elderly
• are breast-feeding.

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
It is especially important that you tell your doctor
if you are taking any of the following:
• any medicines that delay stomach emptying,
some examples of these include
• narcotic pain relievers (e.g. morphine
phosphate, codeine phosphate)
• anticholinergic/antimuscarinic medicines
(e.g. oxybutynin, tolterodine)
• tricyclic antidepressants (e.g. amitriptyline,
clomipramine)
• calcium channel blockers (e.g. verapamil,
nifedipine)
• proton pump inhibitors (e.g. omeprazole,
lansoprazole)
• probenecid or sulphinpyrazone, used for the
treatment of gout
• carbonic anhydrase inhibitors e.g.
acetazolamide, used to treat high fluid
pressure in the eye
• antacids containing magnesium trisilicate
• medicines which make the urine less acidic
e.g. potassium citrate mixture, used for relief
of discomfort in mild urinary-tract infections
• medicines used in the treatment of infections
(antibiotics) known as quinolones.
Important information about some of the
ingredients of Nitrofurantoin
• Patients who are intolerant to lactose should
note that Nitrofurantoin tablets contain a small
amount of lactose. If your doctor has told you
that you have an intolerance to some sugars,
talk to your doctor before taking this medicine.
Taking Nitrofurantoin with food and drink
• Certain types of food may cause higher levels
of Nitrofurantoin in the blood because they
delay stomach emptying. Examples of types of
food which may have this effect are:
• foods with a high fat content
• foods high in soluble fibre such as oats,
pulses (e.g. beans and lentils), and some
raw fruits and vegetables.
Ask your doctor for advice about this.
Pregnancy and breast-feeding
• Do not take Nitrofurantoin while you are
giving birth.
• If you are pregnant, planning to become
pregnant or breast-feeding, ask your doctor for
advice before taking this medicine.
Driving and using machines
Nitrofurantoin is not expected to affect your
ability to drive or operate machinery.

3

HOW TO TAKE NITROFURANTOIN

Always take Nitrofurantoin exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
It is important to complete the course of tablets to
prevent the infection returning, unless your
doctor advises otherwise.
The tablets are best taken with food and should
be swallowed preferably with a drink of water.
Taking Nitrofurantoin with food or milk may help
to reduce any stomach problems you may
experience. The usual dose is:

Adults (including the elderly)
• For treatment of infections:
Nitrofurantoin may interfere with some tests for
Either 50 mg or 100 mg four times a day for
glucose (sugar) in the urine. Make sure you have
seven days.
told the doctor you are taking this medicine if you
have a urine test.
• For prevention of further infections:
Either 50 mg or 100 mg once a day.
Your doctor may want to monitor you if you are
being treated for a long time with Nitrofurantoin.



For prevention of infections during surgical
procedures:
A 50 mg tablet four times a day on the day of
the procedure and three days thereafter.

Children and infants over 3 months old
The daily dosage depends on the weight of the
child. Your doctor will calculate the appropriate
dose. Follow your doctor’s instructions exactly.

Top of page cut-off to middle of registration mark: 44 mm.

NITROFURANTOIN 50 mg
AND 100 mg TABLETS

PAGE 2: REAR FACE (OUTSIDE OF REEL)

For children under 25 kg body weight, your doctor The following side effects have also been
reported:
may consider giving Nitrofurantoin as a
• muscle and joint pain
suspension.
• severe abdominal pain (due to inflammation of
the pancreas)
Infants under 3 months old
• facial pain (due to the inflammation of the
Nitrofurantoin should not be given to infants
salivary glands)
under three months old.
• feeling sick, being sick, loss of appetite,
diarrhoea, stomach pain
If you take more Nitrofurantoin than you should
• short-term hair loss
If you (or someone else) swallow a lot of the
• raised pressure in the skull, symptoms may
tablets all together, or if you think a child has
include severe headache which is not relieved
swallowed any of the tablets, contact your nearest
by anything, vision disturbance, disorientation,
hospital casualty department or your doctor
loss of memory or concentration, being sick,
immediately. An overdose is likely to cause
dizziness and pins and needles in the hands
stomach problems, feeling sick and being sick.
Please take this leaflet, any remaining tablets and • increased risk of urinary infection by germs
which are not affected by Nitrofurantoin.
the container with you to the hospital or doctor so
Symptoms of these infections may include a
that they know which tablets were consumed.
burning sensation on passing urine, needing
to pass urine more frequently than usual or
If you forget to take Nitrofurantoin
having the sensation of needing to pass urine
If you forget to take a tablet, take one as soon as
but being unable to do so, or having cloudy
you remember, unless it is more than two hours
foul smelling urine.
after the missed dose; if so, ignore the missed
dose and wait until it is time to take the next dose.
Your urine may become coloured dark yellow or
Do not take a double dose to make up for a
brown; this is normal and is not a reason to stop
forgotten dose.
taking the medicine.
If you stop taking Nitrofurantoin
Do not stop taking your medicine without talking If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
to your doctor first even if you feel better. It is
please tell your doctor or pharmacist.
important to complete the course of tablets,
unless your doctor advises otherwise.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

5

HOW TO STORE NITROFURANTOIN

Keep out of the reach and sight of children.
Do not store above 25°C. Protect the tablets from
light. Store in the original package.
4 POSSIBLE SIDE EFFECTS
Do not use Nitrofurantoin after the expiry date
that is stated on the outer packaging. The expiry
Like all medicines, Nitrofurantoin can cause side
date refers to the last day of that month.
effects, although not everybody gets them.
Serious side effects may occur, but they are rare. Medicines should not be disposed of via
wastewater or household waste. Ask your
They generally occur in the elderly, or in those
pharmacist how to dispose of medicines no
who have received continuous therapy for long
longer required. These measures will help to
periods (six months or longer).
It is expected that many of these reactions will get protect the environment.
better on stopping treatment, however, some of
these serious side effects may persist, even after
stopping the treatment.
FURTHER INFORMATION

6

Stop taking the tablets and tell your doctor
immediately or go to the casualty department at
your nearest hospital if any of the following
happen:
• an allergic reaction (swelling of the lips, face or
neck leading to severe difficulty in breathing;
skin rash, itching or hives)
• flaking skin or a severe rash with blistering.
These are very serious but rare side effects. You
may need urgent medical attention or
hospitalisation.
Tell your doctor immediately if any of the
following happen:
• lung problems causing shortness of breath,
fever, chills, chest pain and cough and rarely,
collapse or blue discolouration of skin. There
may also be changes to your ECG if you are
having this measured.
• asthma attacks, symptoms may include
coughing, shortness of breath, chest tightness,
or wheezing
• collapse
• blue discolouration of skin
• inflammation of the liver causing jaundice
(yellowing of the skin and whites of the eyes)
which has sometimes lead to death
• effects on the nerves that supply the eyes or
limbs, infrequently causing loss of feeling or
control of movement of a limb or blurred
vision
• loss of balance, headache, drowsiness,
dizziness, vertigo, weakness, depression,
increased feeling of wellbeing, confusion or
other mental disturbances
• anaemia, symptoms may include paleness of
the skin, tiredness, lethargy, feeling faint,
becoming easily breathless
• sore throat, fever, skin bruising or more prone
to colds, which may be signs of other effects
on the blood.
If you experience any of these effects, your doctor
will stop your treatment immediately.

What Nitrofurantoin tablets contain:
• The active ingredient is nitrofurantoin.
• The other ingredients are maize starch, lactose,
alginic acid and magnesium stearate (E572).
What Nitrofurantoin tablets look like and
contents of the pack:
• The 50 mg tablets are yellow, round, flat,
bevel-edged tablets. They are engraved ‘7N2’
on one side and a score line on the reverse.
• The 100 mg tablets are yellow, round, flat,
bevel-edged tablets. They are engraved ‘7N3’
on one side and a score line on the reverse.
• The product is available in pack sizes of 28, 50,
100, 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder and company
responsible for manufacture is TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: November 2009
PL 00289/0769-70

86149-T
160 x 323

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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