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MYCOBUTIN

Active substance(s): RIFABUTIN

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Package Leaflet:
Information for the user

Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
• Keep this leaflet. You may need
to read it again.
• If you have any further questions,
ask your doctor, pharmacist or
nurse.
• This medicine has been
prescribed for you only. Do not
pass it on to others. It may harm
them, even if their signs of illness
are the same as yours.
• If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Mycobutin is and what it is
used for
2. What you need to know before
you take Mycobutin
3. How to take Mycobutin
4. Possible side effects
5. How to store Mycobutin

6. Contents of the pack and other
information

you are unsure why you have been
given Mycobutin.

1. What Mycobutin is and
what it is used for

2. What you need to know
before you take Mycobutin

Mycobutin contains the active
substance rifabutin, which is
an antibiotic. It is used to treat
infections caused by germs
(bacteria) called mycobacteria.
These are bacteria which cannot
be destroyed with usual antibiotics.
• One of the most common
mycobacterial infections is
Mycobacterium tuberculosis.
Mycobutin can be used
in combination with other
antibiotics for the treatment of
tuberculosis of the lung.
• Mycobutin can also
be used to treat other
mycobacterial infections such
as Mycobacterium avium
intracellulare (MAI, also known as
MAC) or Mycobacterium xenopi.
• People who are unable to fight
infection (such as those with HIV)
are more likely to be infected
with mycobacteria; especially
MAC. Mycobutin can be given
(on its own) to people with HIV
disease when the number of CD4
cells (part of the immune system)
falls below 75 per microlitre of
blood. This will help to stop them
from developing MAC infections.
You should consult your doctor if

Do not take Mycobutin:
• if you are allergic (hypersensitive)
to rifabutin or other drugs to
treat tuberculosis or any of the
other ingredients of this medicine
(listed in section 6)
• if you are pregnant or breastfeeding
• if the medicine has been
prescribed for a child under 12
years
Warnings and precautions
Talk to your doctor, pharmacist or
nurse before taking Mycobutin.
Medicines are not always suitable
for everyone. Your doctor needs to
know before you take Mycobutin if
you suffer from or have suffered in
the past from problems with your
liver or kidneys.
It is common for Mycobutin to
colour your urine (water) red/
orange, you may also experience
colouring of the skin and other
body fluids. These are nothing to
worry about. It can also colour soft
contact lenses.
Your doctor will carry out tests
to check that you do not have
active tuberculosis or another
mycobacterial disease. You may

also have regular eye examinations
if you are taking Mycobutin
with other medicines to treat an
infection.
You may need to take Mycobutin
for the rest of your life, to prevent
you from getting MAC infection.
Other medicines and Mycobutin
Tell your doctor or pharmacist if
you are taking, have recently taken
or might take any other medicines.
This includes medicines that you
have bought for yourself.
Some medicines can affect the way
Mycobutin works, or Mycobutin
itself can reduce the effectiveness
of other medicines taken at the
same time. You should therefore
inform your doctor if you are taking
any of the following medicines:
• medicines to treat diabetes
• painkillers (e.g. aspirin)
• narcotics (including methadone)
• anticoagulants (blood thinners)
such as warfarin
• corticosteroids (to treat
inflammation or allergy) such as
prednisolone
• ciclosporin or tacrolimus (to
suppress the immune system )
• quinidine or digitalis (but not
digoxin) (for heart conditions)
• dapsone (to treat skin infections
or pneumonia)
• phenytoin (to treat epilepsy)
• anti-fungals (especially
fluconazole, itraconazole,

posaconazole, voriconazole,
ketoconazole or miconazole)
• anti-virals (especially indinavir,
saquinavir, ritonavir or
amprenavir, fosamprenavir/
ritonavir, lopinavir/ritonavir,
tipranavir/ritonavir)
• clarithromycin (an antibiotic).
When taking Mycobutin, oral
contraceptives (the pill) may not
prevent pregnancy. You are advised
to use other forms of birth control.
Pregnancy, breast-feeding and
fertility
You should not take Mycobutin if
you are pregnant or breast-feeding.
If you think you may be pregnant or
planning to have a baby, ask your
doctor or pharmacist for advice
before taking this medicine.
Driving and using machines
Mycobutin is not expected to affect
your ability to drive or use any tools
or machinery.

3. How to take Mycobutin
Always take this medicine exactly
as your doctor or pharmacist has
told you. Check with your doctor or
pharmacist if you are not sure.
The capsules should be taken by
mouth, once a day.
Mycobutin is usually given in
combination with other antibiotics

4205738.05.8

for treating mycobacterial
infections. The number of capsules
depends upon the condition you
are being treated for.
Mycobutin can be taken before or
after food and drinks.
The usual doses are:
Tuberculosis:
1 to 3 capsules once a day
Treatment of other mycobacterial
infections:
3 to 4 capsules once a day, though
your doctor may prescribe a lower
dose if you are taking certain other
drugs
When used to prevent MAI/MAC
Infection:
2 capsules once a day
If you are taking Mycobutin to
treat an infection you may not feel
better for 2 to 3 weeks. You should
continue taking your capsules
unless your doctor tells you
otherwise.
If you take more Mycobutin than
you should
If you accidentally take too much
Mycobutin contact your doctor at
once or go to the nearest hospital
casualty department. Always take
the labelled medicine package
with you, whether there are any
Mycobutin capsules left or not.
If you forget to take Mycobutin
If you forget to take a dose, take it
as soon as you remember unless it

is time for your next dose. Do not
take a double dose to make up
for a forgotten dose.
If you stop taking Mycobutin
Do not stop taking Mycobutin
unless your doctor tells you to as
your infection could return.
If you have any further questions
on how to take Mycobutin, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine
can cause side effects, although
not everybody gets them.
Tell your doctor immediately if
you experience any of the following
serious symptoms after taking this
medicine.
• Sudden wheeziness, difficulty
in breathing, pain in the chest,
swelling of eyelids, face or
lips, rash or itching (especially
affecting the whole body).
• Diarrhoea, stomach pain, blood
in stool and/or increase in body
temperature may occur during, or
after completing treatment with
antibiotics and could be a sign of
serious bowel inflammation.
• Anaphylactic shock, as seen
with other antibiotics of the same
class.
• Frequent and/or severe
infections, mouth and/or throat
ulcers, unusual or unexplained

bruising or bleeding, small (pinpoint) red spots on the skin and/
or in the mouth, unusually pale
skin, feeling weak (symptoms of
blood disorders).
Other side effects
Common side effects (may affect
up to 1 in 10 people)
• nausea (feeling sick)
• fever/high temperature
• skin rash
• muscle pain
Uncommon side effects (may affect
up to 1 in 100 people)
• pain or redness in the eye,
cloudiness or loss of vision
• yellowing of the skin and eyes,
itchy skin, dark urine (symptoms
of jaundice)
• vomiting (being sick)
• aching joints
• skin discolouration
Additional side effects have also
been reported including flu-like
symptoms, chest pressure or
pain with shortness of breath,
inflammation of the liver (hepatitis)
and haemolysis (loss of red blood
cells), the frequency is unknown.
Your doctor will need to take
regular blood tests while you are
on Mycobutin as it may affect the
level of white and red blood cells,
platelets (which help the blood clot)
and substances produced by the
liver known as enzymes. This will
make sure your blood and liver are

working properly.
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 Mycobutin
Keep this medicine out of the sight
and reach of children.
Store below 25oC.
Do not use this medicine after the
expiry date which is stated on the
blister and carton after EXP. The
expiry date refers to the last day of
that month.
Do not throw away any medicines
via wastewater or household
waste. Ask your pharmacist how
to throw away medicines you no
longer use. These measures will
help protect the environment.

6. Contents of the pack and
other information
What Mycobutin contains
Each Mycobutin capsule contains
150mg of the active ingredient
rifabutin.
The other ingredients are

microcrystalline cellulose, sodium
lauryl sulphate, magnesium
stearate, gelatin and silica gel.
What Mycobutin looks like and
contents of the pack
Mycobutin capsules are opaque,
red-brown hard gelatin capsules
presented in blister packs of 30
capsules.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Company Contact Address:
For further information on your
medicine contact Medical
Information at Pfizer Limited,
Walton Oaks, Dorking Road
Tadworth, Surrey, KT20 7NS. Tel:
01304 616161.
Manufacturer
Pfizer Italia S.r.l.
Marino del Tronto
Ascoli Piceno
Italy.
This leaflet was last revised in:
03/2015
Ref: MY 8_0

4205738.05.8

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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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