Skip to Content

UK Edition. Click here for US version.

NITROFURANTOIN 50MG TABLETS

Active substance(s): NITROFURANTOIN

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Aratoin 50mg & 100mg Tablets
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 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 Aratoin Tablets are and what they
are used for
2. What you need to know before you take
Aratoin Tablets
3. How to take Aratoin Tablets
4. Possible side effects
5. How to store Aratoin Tablets
6. Contents of the pack and other information

1. What Aratoin Tablets are and what
they are used for
Nitrofurantoin (the active ingredient) is an
antibiotic.
It is used to prevent and treat infections of
the bladder, kidney and other parts of the
urinary tract.

2. What you need to know before you
take Aratoin Tablets
Do not take Aratoin Tablets and talk to
your doctor if:

you are allergic (causing itching,
reddening of the skin or difficulty in
breathing) to nitrofurantoin or any of
the other ingredients (listed in
Section 6 at the end of the leaflet) or
other medicines containing
nitrofurantoin.

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 have porphyria (blood disorder)

you have G6PD (glucose-6phosphate dehydrogenase)
deficiency

in infants under three months of age

you are breast feeding a baby with
suspected or known deficiency in an
enzyme called G6PD (glucose-6phosphate-dehydrogenase.
Tell your doctor if you are not sure about
any of the above.
Warnings and precautions:
Talk to your doctor or pharmacist before
taking Aratoin tablets if:

you have diabetes

you are suffering from any illness
causing severe weakness

you have anaemia (a decrease in
red blood cells causing pale skin,
weakness and breathlessness) or a
lack of vitamin B (particularly folate)
or abnormal levels of salts in your
blood (your doctor will be able to
advise you)

you have a history of allergic
reactions.
The above conditions may increase the
chances of developing a side effect which
results in damage to the nerves, causes
altered sense of feeling and pins and
needles.








you lack of an enzyme (body
chemical) called glucose-6phosphate dehydrogenase which
causes your red blood cells to
become more easily damaged (this
is more common in black people and
people of Mediterranean, Middle
Eastern or Asian origin. Your doctor
will know)
you have any disease of the lungs,
liver or nervous system. If you need
to take Aratoin Tablets for a number
of months, your doctor may want to
regularly check how your lungs and
liver are working
you have false positive results on
testing your urine for glucose
your urine is dark yellow or brown
coloured.

Children
Do not give Aratoin Tablets to infants
under 3 months of age.
Other medicines and Aratoin Tablets
Please tell your doctor or pharmacist if
you are taking, have recently taken or
might take any other medicines. If they are
taken with Aratoin Tablets their effect or
the effect of Aratoin Tablets may be
changed.
• Antacids for indigestion (e.g.
magnesium trisilicate)
• Medicines for gout (e.g. probenecid
or sulfinpyrazone)
• Medicines which slow the passage
of food through the stomach (e.g.
atropine, hyoscine)
• Medicines for raised pressure in the
eye (glaucoma) such as carbonic
• anhydrase inhibitors (e.g.
acetazolamide)
• Medicines which make the urine less
acid (e.g. potassium citrate mixture)
• Medicines for infections, known as
quinolones
• Typhoid vaccine, which is given for
the prevention of typhoid.
If you are in doubt about any of these
medicines ask your doctor or pharmacist.
Nitrofurantoin may interfere with the
results of some tests for glucose in the
urine.
Aratoin Tablets with food and drink
Aratoin tablets should be taken at meal
times with food or milk. This will help to
avoid stomach upset and also to help the
absorption.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine. As far as is
known Aratoin Tablets may be used in
pregnancy. However, it should not be
used during labour or delivery because
there is a possibility that use at this stage
may affect the baby. If you want to breast
feed, please consult your doctor first.
Driving and using machines
Aratoin Tablets may cause dizziness and
drowsiness. You should not drive or
operate machinery if you are affected this
way until such symptoms go away.
Aratoin Tablets contain lactose
This medicine contains lactose. If you
have been told by your doctor that you are
intolerant to some sugars and have to
avoid them, contact your doctor before
taking this medicine.

3. How to take Aratoin Tablets
Follow your doctor’s instructions exactly and
complete the course of treatment even if
you feel better. You should check with your
doctor or pharmacist if you are not sure.
Do not forget to take your medicine.
Tablets should be swallowed whole.

Adults:
The normal dosage depends on the type of
infection you have and instructions should be
written on the label provided by the
pharmacist. Consult your pharmacist or
doctor if these instructions are not clear. The
usual doses are:
• For treatment of infections: Either one
50mg tablet or one 100mg tablet four
times a day for seven days.
• For prevention of further infections:
Either one 50mg tablet or one 100mg
tablet at bedtime.
• For prevention of infections during surgery:
One 50mg tablet four times a day on the
day of the operation and three days
thereafter.
Use in Children:
Children over three months of age:
The dose depends on the weight of the child
and will be provided by your doctor. Follow
your doctor’s instructions exactly.
Children below 3 months of age should
not take Aratoin Tablets
Medical checks
Your doctor will watch carefully for any
effects on the liver, lungs, blood or nervous
system. Aratoin Tablets may interfere with
the results of some tests for glucose in the
urine.
If you TAKE MORE Aratoin Tablets than
you should
Consult your doctor or pharmacist
immediately or go to the emergency
department of the nearest hospital. Always
take any leftover tablets with you, as well as
the container and label, so that the medical
staff know what you have taken.
If you FORGET TO TAKE Aratoin Tablets
Do not worry. If you remember later on that
day, take that day’s dose as usual. If you
miss a whole day’s dose take the normal
dose on the next day. Do not take a double
dose to make up for a forgotten tablet. If you
are not sure ask your doctor or pharmacist.
If you STOP TAKING Aratoin Tablets
Your doctor will tell you how long to take the
treatment. Do not stop earlier than you are
told, even if you feel better.
If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Aratoin Tablets can cause
side effects, although not everybody gets
them. Most of them are mild and disappear
when you stop taking Aratoin Tablets.
All medicines can cause allergic reactions
although serious allergic reactions are rare. If
you notice any sudden wheeziness, difficulty
in breathing, swelling of the eyelids, face or
lips, rash or itching (especially affecting your
whole body) STOP TAKING your medicine
and go to a doctor immediately. If you
experience any of the side effects detailed
below stop taking Aratoin Tablets and
consult your doctor.
• Your lungs may react to Aratoin Tablets.
This may develop quickly, within a week
of starting treatment or very slowly,
especially in elderly patients. This may
produce fever, chills, cough and
shortness of breath.
• Jaundice (inflammation of the liver
causing yellowing of the skin or whites of
the eyes).
• The nerves outside of the spinal cord
may be affected causing changes to the
sense of feeling and the use of muscles.
In addition headache, extreme changes
of mood or mental state, confusion,
weakness, blurred vision may occur.
These effects may be severe and in
some instances permanent.
• Raised pressure in the skull (causing
severe headaches).
Please note that while taking Aratoin Tablets
your urine may become coloured dark yellow
or brown. This is quite normal and not a
reason to stop taking the medicine.

Other side effects include:
• Feeling sick (nausea) and headache
• Loose stools
• Loss of appetite, stomach ache and
being sick (vomiting)
• Dizziness, drowsiness
• Blood cells have been affected in some
patients. This may result in bruising,
delayed clotting of the blood, sore throat,
fever, anaemia and a susceptibility to
colds or persistent cold
• A variety of skin rashes or reactions
have occurred in some patients. These
may appear as flaking skin, a red rash or
fever accompanied by rapid heart rate
and severe rash with blistering. Other
reactions may include inflammation of
salivary glands (causing facial pains),
inflammation of the pancreas gland
(causing severe abdominal pain) and
joint pains
• Short-term hair loss
• Urinary infections by germs that are not
sensitive to Aratoin Tablets.
Reporting of side effects
If you get any side effects, talk toyour doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme, website:
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.

5. How to store Aratoin Tablets
Keep out of the sight and reach of
children. Do not store above 25˚C.
Do not open the container until you are ready
to begin taking the course of treatment.
Do not use after the expiry date which is
stated on the bottle/label after ‘Exp
(MM/YY)’. The expiry date refers to the last
day of that month. Medicines should not be
disposed of via wastewater or household
waste. Ask your pharmacist how to throw
away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other
information
What Aratoin Tablets contain
The active substance (which makes the
medicine work) is Nitrofurantoin. Each tablet
contains either 50mg or 100mg of
nitrofurantoin. The other ingredients are:
lactose, maize starch, pregelatinised maize
starch, sodium starch glycollate and
magnesium stearate.
What Aratoin Tablets look like and
contents of the pack
Aratoin Tablets are flat, round bevelled,
yellow scored tablets. Both 50 mg and
100 mg strengths are available
in containers and blister packs of 28, 30, 50,
56, 60, 84, 100, 250, 500 and 1,000 tablets.
Marketing Authorisation Holder and
Manufacturer
Aratoin 50mg Tablets PL 08553/0087
Aratoin 100mg Tablets PL 08553/0088
Dr Reddy’s Laboratories (UK) Ltd,
6 Riverview Road, Beverley, HU17 0LD
Leaflet last revised: April 2016
© Dr. Reddy’s Laboratories (UK) Ltd

Expand view ⇕

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.

Hide