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MACROBID 100MG CAPSULES

Active substance(s): NITROFURANTOIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

MacroBID 100mg Capsules
(nitrofurantoin)

The product is known by the name above but will be referred
to as MacroBID throughout the rest of this 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.

In this leaflet:
1.
2.
3.
4.
5.
6.

What MacroBID is and what it is used for
Before you take MacroBID
How to take MacroBID
Possible side effects
How to store MacroBID
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 (glucose-6phosphate 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.
Page 1 of 2

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.

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 you
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.
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.




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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via:
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 MacroBID
Keep out of the sight and reach of children.
Do not store above 25°C.
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.
Page 2 of 2

If your doctor tells you to stop taking MacroBID, please take
any unused capsules back to your pharmacist to be
destroyed. Only keep them if the doctor tells you to.
If the medicine becomes discoloured or show any signs of
deterioration, you should seek the advice of your doctor or
pharmacist.
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 MacroBID contains:

The active substance is 100mg nitrofurantoin.
Each prolonged-release capsule contains 100mg
nitrofurantoin (as monohydrate and anhydrous form).
The other ingredients are talc, corn starch, carbomer,
povidone, lactose, sucrose and magnesium stearate.
The capsule shell contains gelatin, sodium lauryl sulphate,
titanium dioxide (E171), quinoline yellow (E104) and
indigocarmine (E132).
The printing ink contains shellac, propylene glycol (E1520),
titanium dioxide (E171) and black iron oxide (E172).

What MacroBID looks like and contents of the pack:

MacroBID capsule has an opaque blue cap and opaque yellow
body printed in grey with GS on the cap and 100 on the body.
Your medicine is available in blister strips of 14 capsules.
Manufacturer:
Manufactured by: Custom Pharmaceuticals Limited,
Conway Street, Hove, East Sussex, BN3 3LW, UK.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0672

POM

Leaflet revision and issue date: 20.01.16
MacroBID® is the registered trademark of Mercury Pharma
Group Ltd.

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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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