NITROFURANTOIN 50 MG CAPSULES

Active substance: NITROFURANTOIN MACROCRYSTALS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nitrofurantoin 50mg and 100mg Capsules
Nitrofurantoin

Read all of this leaflet carefully before you start using this medicine.
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Keep this leaflet. You may need to read it again.

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If you have any further questions, ask your doctor or pharmacist.

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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.

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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 Capsules are and what they are used for
2. Before you take Nitrofurantoin Capsules
3. How to take Nitrofurantoin Capsules
4. Possible side effects
5. How to store Nitrofurantoin Capsules
6. Further 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.

2.

BEFORE YOU TAKE NITROFURANTOIN CAPSULES

Do not take Nitrofurantoin Capsules if:
 you are allergic (causing itching, reddening of the skin or difficulty in breathing) to
nitrofurantoin or any of the ingredients of Nitrofurantoin Capsules (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 suffer from a blood disorder called porphyria.
• you are deficient in an enzyme called G6PD (glucose-6-phosphate dehydrogenase).
• 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 Nitrofurantoin Capsules and speak to your doctor or
pharmacist before taking the capsules 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, 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
Nitrofurantoin Capsules for a number of months, your doctor may want to regularly
check how your lungs and liver are working.

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
Nitrofurantoin Capsules their effect or the effect of Nitrofurantoin Capsules 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 contraceptive “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.
Nitrofurantoin Capsules may interfere with the results of some tests for glucose in the
urine.

Taking Nitrofurantoin Capsules with food and drink
Nitrofurantoin Capsules 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 it is
known Nitrofurantoin Capsules 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
Nitrofurantoin Capsules 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 of Nitrofurantoin Capsules

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 NITROFURANTOIN CAPSULES

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.
Capsules 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 capsule or one 100mg capsule four times a
day for seven days.
• For prevention of further infections: Either one 50mg capsule or one 100mg capsule at
bedtime.

• For prevention of infections during surgery: One 50mg capsule four times a day on the
day of the operation and three days thereafter.
Children and infants 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 Nitrofurantoin Capsules.

Medical Checks:

Your doctor will watch carefully for any effects on the liver, lungs, blood or nervous
system.
Nitrofurantoin Capsules may interfere with the results of some tests for glucose in the
urine.

If you take more Nitrofurantoin Capsules than you should

Consult your doctor or pharmacist immediately or go to the emergency department of the
nearest hospital. Always take any left over capsules with you, as well as the container and
label, so that the medical staff knows what you have taken.

If you forget to more Nitrofurantoin Capsules
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 capsule. If you are not sure ask your doctor or pharmacist.

If you stop taking Nitrofurantoin Capsules

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, Nitrofurantoin Capsules can cause side effects, although not
everybody gets them. Most of them are mild and disappear when you stop taking
Nitrofurantoin Capsules.

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 Nitrofurantoin
Capsules and consult your doctor.
• Your lungs may react to Nitrofurantoin Capsules. 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 Nitrofurantoin Capsules 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 (causing severe abdominal pain) and joint pains.
• Short-term hair loss.
• Urinary infection by germs which are not sensitive to Nitrofurantoin Capsules.

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.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: 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 NITROFURANTOIN CAPSULES

Keep out of the reach and sight of children.
Store in the original container in order to protect from light.

Do not use Nitrofurantoin Capsules after the expiry date which is stated on the carton.
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 Nitrofurantoin Capsules contain

The active substance is Nitrofurantoin. Nitrofurantoin Capsules are available in two
strengths, containing either 50mg or 100mg Nitrofurantoin.

The other ingredients are lactose monohydrate, maize starch, purified talc, gelatin,
sodium lauryl sulphate, iron oxide yellow (E172), titanium dioxide (E171).

What Nitrofurantoin Capsules look like and contents of the pack
Nitrofurantoin 50mg Capsules are yellow coloured free flowing granules filled in hard
gelatine capsule with white body printed with “50” in black and yellow cap printed with
“NTF” in black.

Nitrofurantoin 100mg Capsules are 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.

They are available in blister packs of 10, 14, 15, 20, 28, 30 and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester
LE3 0PA
UK

Manufacturer
Morningside Pharmaceuticals Ltd
Pavillion Way
Loughborough
LE11 5GW
UK
This leaflet was last revised in October 2013

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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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