Rifabutin
Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully before taking Mycobutin. This leaflet answers
some common questions about Mycobutin. It does not contain all the available information
and it does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
Mycobutin against the expected benefits it will have for you.
Ask your doctor if you have any concerns about taking this medicine.
Keep this leaflet with your medicine.
You may need to read it again.
What Mycobutin is used for
Mycobutin contains the active ingredient, rifabutin. It is an antibiotic, an agent
used to kill certain types of germs, known as mycobacteria.
Mycobutin is used in combination with other medicines to treat mycobacterial infections
e.g. tuberculosis (TB) or Mycobacteria avium-intracellulare complex (MAC). It may
also be used to prevent infections in patients with HIV disease.
Your doctor, however, may prescribe Mycobutin for another purpose. Ask your doctor
if you have any questions about why Mycobutin has been prescribed for you.
Mycobutin can only be obtained on prescription from a doctor.
Before taking Mycobutin
Some information is provided below. However, always talk to your doctor if you have
concerns or questions about your treatment.
When you must not take it
Do not take Mycobutin and talk to your doctor or pharmacist if:
you are allergic to rifabutin or other rifamycin antibiotics (e.g. rifampicin)
you are allergic to any of the other ingredients listed at the end of this leaflet
the packaging is torn or shows signs of tampering
Do not take Mycobutin capsules after the expiry date printed on the pack has passed.
Do not give Mycobutin to children.
Before you take Mycobutin
You should tell your doctor if you:
have or have had problems with your liver or kidneys
are or may become pregnant during the time in which you are taking Mycobutin.
are breastfeeding or intend to breast-feed
Your doctor may need to adjust your dose or your treatment in these situations.
When taking Mycobutin, your urine (and possibly skin or body secretions) may become
a red-orange colour. Contact lenses, especially soft contact lenses, may be permanently
stained.
Tell your doctor if you are taking any other medicines, including medicines that you
buy without a prescription from a pharmacy, supermarket or health food shop.
In particular, tell your doctor if you are taking:
treatments for HIV, e.g. saquinavir, indinavir, ritonavir, amprenavir, fosamprenavir,
lopinavir, nevirapine, bictegravir, doravirine, rilpivirine
other antibiotics, e.g. clarithromycin, erythromycin, chloramphenicol, trimethoprim,
atovaquone
anti-fungal treatments, e.g. fluconazole, itraconazole, ketoconazole, posaconazole,
voriconazole
oral contraceptives
oestrogens, e.g. in hormone replacement therapy (HRT)
heart medicines
medicines taken orally for diabetes
epilepsy medicines, e.g. phenytoin
sedatives, sleeping pills or medicines to treat anxiety
corticosteroids (used to treat inflammatory diseases, such as skin disorders, asthma
or rheumatoid arthritis, or as replacement therapy in adrenal disorders)
tacrolimus (used to prevent organ transplant rejection)
methadone or other opiates, such as morphine (used for severe pain or to treat drug
dependence)
cisapride (used to treat heartburn or stomach ulcers)
warfarin (used after a heart attack or to treat blood clotting disorders)
Ask your doctor or other health care professional if you are not sure about this list
of medicines.
It is very important that your doctor knows all the medicines you are taking. The
dose of Mycobutin or the other medicine may need to be adjusted.
How to take Mycobutin
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
Mycobutin capsules should be swallowed whole once a day. They may be taken at any
time and need not be taken with food.
How much to take
The dose of Mycobutin depends on the infection for which you are being treated and
the other medicines you are taking. The usual dose of Mycobutin will be 2 to 4 capsules
per day (1-2 capsules per day for newly diagnosed pulmonary tuberculosis patients),
but this may not always apply. Your doctor will decide your dose.
How long to take it
Continue taking Mycobutin until your doctor tells you to stop. You will usually need
to take Mycobutin for a number of months.
Do not stop taking Mycobutin unless your doctor tells you to, even if you feel better.
If you do not complete the full course prescribed by your doctor, all of the germs
causing your infection may not be killed. These germs may continue to grow and multiply
so that your infection may not clear completely or it may return.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to. Otherwise, take it as soon as you remember, and then
go back to taking Mycobutin as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much (overdose)
Immediately telephone your doctor or pharmacist or Poisons Information Centre (telephone
13 11 26), or go to Accident and Emergency at your nearest hospital if you think that
you or anyone else may have taken too much Mycobutin.
Do this even if there are no signs of discomfort or poisoning. You may need urgent
medical attention. Keep telephone numbers for these places handy.
An excessive dose may lead to severe side effects. You should inform your doctor
as soon as possible.
While taking Mycobutin
Things you must do
Keep all appointments with your doctor and always discuss any problems you may be
experiencing during your course of treatment with him/her.
Mycobutin may affect the liver or reduce the body's ability to make red or white blood
cells or platelets. Regular blood tests may be required.
As part of your treatment, you may be given other medicines including other antibiotics.
It is important to keep taking these medicines as well as Mycobutin unless you are
told otherwise by your doctor or pharmacist.
Tell your doctor immediately if you become pregnant while you are taking Mycobutin.
If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this
even if it occurs several weeks after Mycobutin has been stopped.
Diarrhoea may mean you have a serious condition affecting your bowel.
Do not take any diarrhoea medicine without first checking with your doctor.
Mycobutin has been prescribed for you by your doctor. Do not give it to anyone else,
even if they seem to have the same condition as you.
Tell all doctors, dentists and pharmacists who are treating you that you are taking
Mycobutin.
Things you must not do
Whilst you are taking Mycobutin, do not start taking any other medicines, prescription
or not, without first telling your doctor or pharmacist.
Things to be careful of
Oral contraceptives may be affected by Mycobutin. Discuss with your doctor about
using a different means of birth control during treatment with Mycobutin.
Contact lenses may be permanently stained. Therefore, it is better not to wear contact
lenses, particularly soft contact lenses, during a treatment course of Mycobutin.
Side effects
Mycobutin, like all other medicines, may cause unwanted side effects. These are usually
mild and disappear when you have completed the course.
Tell your doctor or pharmacist as soon as possible if you do not feel well after taking
Mycobutin.
You may need medical treatment if you get certain side effects.
Mycobutin is generally given together with other medications, so it is not always
easy to identify which medicine may be causing the side effects that you may experience.
Common side effects reported are:
nausea or vomiting
jaundice (yellowing of the skin)
pain in joints and muscles
skin rash
fever
Less common side effects are:
allergic reactions causing problems with breathing, or shock
skin discolouration
Mycobutin, particularly when used with some other medicines, has been associated with
mild to severe inner eye inflammation (uveitis). Tell your doctor as soon as possible
if you get red sore eyes after taking Mycobutin.
Mycobutin can also cause changes in the levels of certain chemicals in your blood
and can also increase or decrease the levels of red or white cells or platelets in
your blood.
Tell your doctor if you have signs of anaemia (tiredness or pale complexion) or unexpected
bleeding or bruising.
Tell your doctor immediately or go to the nearest hospital if you experience diarrhoea
during your treatment with Mycobutin.
Tell your doctor immediately or go to the nearest hospital if you have moderate or
severe skin rash or blisters often with flu-like symptoms.
Other side effects not listed above may happen in some people.
Tell your doctor as soon as possible if you experience any side effects, including
any effects not listed above.
After taking Mycobutin
Tell your doctor immediately if you notice watery and severe diarrhoea which may be
bloody, particularly if they occur several weeks after stopping Mycobutin.
These are rare but serious side effects. You may need urgent medical attention. Mycobutin
can cause certain bacteria (that are normally harmless and present in the bowel) to
multiply
Storage
Keep your capsules in their original packaging, including outer carton, until it is
time to take them.
If you take the medicine out of the pack, it may not keep well.
Keep Mycobutin in a cool dry place where the temperature stays below 25°C.
Do not store Mycobutin or any other medicines in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep Mycobutin where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Disposal
If your doctor tells you to stop taking Mycobutin or the medicine has passed its expiry
date, ask your pharmacist what to do with any that is left over.
Product Description
What Mycobutin looks like
Mycobutin capsules are opaque and red-brown in colour with the words "Pharmacia &
Upjohn" and "Mycobutin" printed on them in white ink. They are supplied in blister
packs of 30 capsules
Identification
Mycobutin can be identified by an Australian Register Number which is found on the
carton:
AUST R 55038.
Ingredients
Each capsule contains 150 mg rifabutin as the active ingredient. Other ingredients
(mainly as filling agents) are:
microcrystalline cellulose
sodium lauryl sulfate
magnesium stearate
silicon dioxide
gelatin
The colorants in the capsule are
red iron oxide
titanium dioxide
White printing ink is used on the capsules.
Supplier
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au
This leaflet was revised in July 2021.
© Pfizer Australia Pty Ltd