MACRODANTIN 50MG CAPSULES HARD

Active substance: NITROFURANTOIN MACROCRYSTALS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Macrodantin® 50mg Capsules, Hard
(nitrofurantoin)
Your medicine is available using the name Macrodantin 50mg
Capsules, Hard but will be referred to as Macrodantin Capsules
throughout this leaflet. Other strength 100mg is also available.

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.
2.
3.
4.
5.
6.

What Macrodantin Capsules are and what they are used for
Before you take Macrodantin Capsules
How to take Macrodantin Capsules
Possible side effects
How to store Macrodantin Capsules
Further information

1. What Macrodantin Capsules are and what
they are used for
Nitrofurantoin (the active substance in Macrodantin 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 Macrodantin Capsules
DO NOT TAKE Macrodantin Capsules 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 Macrodantin 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-6phosphate 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 Macrodantin 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-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 Macrodantin 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 Macrodantin
Capsules their effect or the effect of Macrodantin 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.
Macrodantin Capsules may interfere with the results of some tests
for glucose in the urine.

Taking Macrodantin Capsules with food and drink:

Macrodantin 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 Macrodantin 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.
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Driving and using machines:

Macrodantin 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 in Macrodantin Capsules:

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 Macrodantin 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
Macrodantin Capsules.
Macrodantin Capsules 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.
Macrodantin Capsules may interfere with the results of some tests
for glucose in the urine.

If you TAKE MORE Macrodantin 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 TAKE Macrodantin 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 Macrodantin 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, Macrodantin Capsules can cause side effects,
although not everybody gets them. Most of them are mild and
disappear when you stop taking Macrodantin 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 Macrodantin Capsules and consult your
doctor.

Your lungs may react to Macrodantin 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 Macrodantin 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
Macrodantin Capsules.

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.
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 Macrodantin Capsules
Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Store in the original package in order to
protect from light and moisture.
Do not use Macrodantin Capsules after the expiry date which is
stated on the carton. The expiry date refers to the last day of that
month.
If your doctor decides to stop treatment, return any leftover
capsules to the pharmacist. Only keep them if the doctor tells you
to.
If your medicine appears to be discoloured or shows any other
signs of deterioration, please return to your pharmacist who will
advise you.
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 Macrodantin Capsules contain:
The active substance is nitrofurantoin.

Each hard gelatin capsule contains 50mg nitrofurantoin
(in macrocrystalline form).
The other ingredients are: talc, maize starch, lactose
monohydrate.
The capsule shell contains: gelatin, sodium lauryl sulphate,
quinoline yellow (E104) and titanium dioxide (E171).
The printing ink contains: shellac and black iron oxide (E172).

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What Macrodantin Capsules look like and contents
of the pack:

Macrodantin are hard gelatin capsules with an opaque yellow cap
and opaque white body, marked 'Eaton 008' in black ink on both
the cap and the body. The capsules contain a pale yellow powder.
Macrodantin Capsules are available in blister packs of 30 capsules.

Manufacturer

Manufactured by:
Lusomedicamenta S.A., Sociedade Tecnica Farmaceutica,
Estrada Consiglieri Pedroso 69B, Queluz de Baixo,
2730-055 Barcarena, Portugal.
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: 21828/0574

POM

Leaflet issue and revision date (Ref): 07.11.13
Macrodantin® is a registered trademark of Goldshield Group Plc.

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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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