NITROFURANTOIN 50MG TABLETS

Active substance: NITROFURANTOIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Furadantin® 50mg and 100mg Tablets
(Nitrofurantoin)
Read all of this leaflet carefully before you start using 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 becomes
serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Furadantin® Tablets are and what they are used for
2. Before you take Furadantin® Tablets
3. How to take Furadantin® Tablets
4. Possible side effects
5. How to store Furadantin® Tablets
6. Further information
1. WHAT FURADANTIN® TABLETS ARE AND WHAT THEY ARE USED FOR
Nitrofurantoin (the active substance in Furadantin® Tablets) is an antibiotic.
It is used to prevent and treat infections of the bladder, kidney and other parts of the urinary tract.
2. BEFORE YOU TAKE Furadantin® Tablets
DO NOT TAKE Furadantin® 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 ingredients of Furadantin® Tablets (listed in Section 6 at the end of
the leaflet) 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-6-phosphate 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- 6-phosphate dehydrogenase).
Tell your doctor if you are not sure about any of the above.
TAKE SPECIAL CARE with Furadantin® Tablets and speak to your doctor or
pharmacist before taking the 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 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 chance of developing a side effect which results in
damage to the nerves, causes altered sense of feeling, like pins and needles.
• you lack an enzyme (body chemical) called glucose-6-phosphate dehydrogenase, which causes
your red blood cells to be 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 Furadantin®
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.
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. If they are taken with
Furadantin® Tablets their effect or the effect of Furadantin® 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 acidic (e.g. potassium citrate mixture)
• Medicines for infections, known as quinolones
• Oral contraceptives “the pill”. You will need to use extra contraceptive precautions such as
using a condom, as antibiotics can make the contraceptive pill less effective
• 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.
Furadantin® Tablets may interfere with the results of some tests for glucose in the urine.
Taking Furadantin® Tablets with food and drink:
Furadantin® 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
Furadantin® 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:

Furadantin® Tablets may cause dizziness and drowsiness. You should not drive or operate
machinery if you are affected this way until such symptoms go away.
Important information about some of the ingredients in Furadantin® Tablets:
This medicine contains lactose and sucrose (sugars). 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 Furadantin® 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.
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 Furadantin® Tablets.
Medical Checks:
Your doctor will watch carefully for any effects on the liver, lungs, blood or nervous system.
Furadantin® Tablets may interfere with the results of some tests for glucose in the urine.
If you TAKE MORE Furadantin® Tablets than you should:
Consult your doctor or pharmacist immediately or go to the emergency department of the nearest
hospital. Always take any left over tablets with you, as well as the container and label, so that the
medical staff knows what you have taken.
If you FORGET TO TAKE Furadantin® 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 Furadantin® 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, Furadantin® Tablets can cause side effects, although not everybody gets
them. Most of them are mild and disappear when you stop taking Furadantin® 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 Furadantin® Tablets and
consult your doctor.
• Your lungs may react to Furadantin® 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 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 Furadantin® Tablets your urine may become dark yellow or brown
coloured. 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 infection by germs which are not sensitive to Furadantin® Tablets.
If any of the side effects become serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
Remember:
This medicine is only for you. Only a doctor can prescribe it for you. Never give this medicine to
someone else. It could harm them, even if their symptoms seem the same as yours.

5. HOW TO STORE Furadantin® Tablets
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package to protect from light and moisture..
Do not use Furadantin® Tablets after the expiry date which is stated on the carton (EXP). 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 dispose of medicines no longer required. These measures will help to protect the
environment.
6. FURTHER INFORMATION
What Furadantin® Tablets contains:
The active substance is Nitrofurantoin. Furadantin® Tablets are available in two strengths,
containing either 50 mg or 100 mg Nitrofurantoin.
The other ingredients are talc, maize starch, lactose, alginic acid, magnesium stearate and
purified water.
What Furadantin® Tablets looks like and contents of the pack:
Appearance: Both the 50mg and 100mg tablets are yellow and pentagonal. Each tablet has a
break line on one face and the tablet strength on the opposite face.
Packaging: The tablets are supplied to pharmacists in bottles of 100.
Marketing Authorisation Holder: Mercury Pharmaceuticals Limited, No.1 Croydon, 12-16
Addiscombe Road, Croydon CR0 0XT, UK
Manufacturer: Custom Pharmaceuticals Limited, Conway Street, Hove, East Sussex, BN3
3LW, UK
This leaflet was last revised in March 2012
Furadantin® is a registered trade mark of Mercury Pharma Group Limited.

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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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