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MACROBID 100 MG PROLONGED-RELEASE CAPSULES

Active substance(s): NITROFURANTOIN

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500000/PL1a

®

MacroBID 100 mg prolonged-release capsules
(nitrofurantoin)
Patient Information Leaflet
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 become serious, or if you
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
The product is known by the name above but will be referred
to as MacroBID throughout the rest of this leaflet.
In this leaflet:
1. What MacroBID is and what it is used for
2. Before you take MacroBID
3. How to take MacroBID
4. Possible side effects
5. How to store MacroBID
6. Further information
1. WHAT MACROBID IS AND WHAT IT IS USED FOR
Nitrofurantoin (the active substance in MacroBID) 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 MACROBID
DO NOT TAKE MacroBID 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 MacroBID (see Section 6 below) 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)
• in patients with 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 (glucose6-phosphate dehydrogenase).
Tell your doctor if you are not sure about any of the above.
TAKE SPECIAL CARE with MacroBID 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); a
lack of vitamin B or abnormal levels of salts in your
blood (your doctor will be able to advise you).
The above conditions may increase the chance of developing
a side effect which causes damage to the nerves, altered
sense of feeling, like pins and needles.
• you lack an enzyme (body chemical) called glucose-6phosphate 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 MacroBID 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
• you have urine coloured yellow or brown.

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
MacroBID their effect or the effect of MacroBID may be
changed.
• Antacids for indigestion (e.g. magnesium trisilicate)
• Medicines for gout (e.g. probenecid or sulfinpyrazone)
• 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.
Taking MacroBID with food and drink:
MacroBID 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 MacroBID 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
with your doctor first.
Driving and using machines:
MacroBID 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
MacroBID:
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 MACROBID
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 and children over 12 years old:
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 bladder infections: One capsule twice
a day for seven days
• For prevention of bladder infections during surgery:
One capsule twice a day on the day of the operation
and three days thereafter.
MacroBID is not recommended for children under 12
years of age.
MacroBID should be taken with food or milk.
Medical Checks:
Your doctor will watch carefully for any effects on the liver,
lungs, blood or nervous system. MacroBID may interfere with
the results of some tests for glucose in the urine.
Continued overleaf

If you TAKE MORE MacroBID 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 know what you have taken.
If you FORGET TO TAKE MacroBID:
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 MacroBID:
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, MacroBID can cause side effects, although
not everybody gets them. Most of them are mild and
disappear when you stop taking MacroBID. If you experience
any of the side effects detailed below or any other side
effects, stop taking MacroBID and consult your doctor.
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.
Please note that while taking MacroBID your urine may
become coloured dark yellow or brown. This is quite normal
and not a reason to stop taking the medicine.
If you notice any of the following side effects consult your
doctor immediately:
• Your lungs may react to MacroBID. 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
• MacroBID may cause the liver to become inflamed,
producing jaundice (yellowing of the skin or whites of
the eyes).
Other side effects are:
• 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
• 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
• 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
• Raised pressure in the skull (causing severe
headaches)
• Urinary infection by germs which are not sensitive to
MacroBID.

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.
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 MACROBID
• Keep out of the sight and reach of children.
• Do not store above 30°C (aluminium/aluminium).
Do not store above 25°C (For PVC/polyethylene/
aclar/aluminium blisters).
• Store in the original package to protect from light and
moisture.
• Do not use MacroBID 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.
• If you notice any sign of discolouration or deterioration
of your medicine, please tell your pharmacist
immediately.
6. FURTHER INFORMATION
What MacroBID contains:
Each prolonged-release capsule contains 100 mg
nitrofurantoin (as monohydrate and anhydrous form).
The other ingredients are talc, corn starch, lactose, carbopol,
povidone, sugar, magnesium stearate and sodium lauryl
sulphate.
The capsule shell contains gelatin, quinoline yellow (E104),
titanium dioxide (E171) and indigo carmine.
The printing ink contains shellac, propylene glycol (E1520),
titanium dioxide (E171) black iron oxide (E172), ammonium
hydroxide (E527) and simethicone.
What MacroBID looks like and contents of the pack:
The 100 mg capsule has an opaque blue cap and opaque
yellow body and bears the monogram “GS 100”.
The capsules are available in blister strips of 14.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James' House, 8
Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Custom Pharmaceuticals Limited, Conway Street, Hove, East
Sussex, BN3 3LW, UK
®

MacroBID 100 mg prolonged-release capsules
PL No: 18067/0481

POM

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This leaflet was last revised on 12 August 2015.
®

MacroBID is the registered trademark of Mercury Pharma
Group Ltd.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

500000/PL1a

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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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