Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking Mycobutin?
Mycobutin contains the active ingredient rifabutin. Mycobutin is taken in combination
with other medicines to treat mycobacterial infections e.g. tuberculosis (TB) or Mycobacteria
avium-intracellulare complex (MAC). It may also be taken to prevent infections in
patients with HIV disease. For more information, see Section
1. Why am I taking Mycobutin? in the full CMI.
2. What should I know before I take Mycobutin?
Do not take if you have ever had an allergic reaction to Mycobutin or any of the ingredients
listed at the end of the CMI. Talk to your doctor if you have any problems with your
liver or kidneys, any other medical conditions, take any other medicines, or are pregnant
or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I take Mycobutin? in the full CMI.
3. What if I am taking other medicines?
4. How do I take Mycobutin?
Mycobutin capsules should be swallowed whole once a day. They may be taken at any
time and do not need be taken with food. Follow the instructions provided by your
doctor. Do not stop taking Mycobutin unless your doctor tells you to, even if you
feel better. More instructions can be found in Section
4. How do I take Mycobutin? in the full CMI.
5. What should I know while taking Mycobutin?
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Things you should do
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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.
Remind any doctor or dentist you visit that you are taking Mycobutin.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Tell your doctor immediately if you have any pain, redness or blurry vision.
Tell your doctor immediately if you have a moderate or severe skin rash or blisters
often with flu-like symptoms
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Things you should not do
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Do not stop taking this medicine without advice from your doctor first.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Mycobutin
affects you.
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Drinking alcohol
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No information available.
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Looking after your medicine
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Store it in a cool dry place away from moisture, heat or sunlight.
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.
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6. Are there any side effects?
Side effects may include nausea and vomiting, pain in joints and muscles, red-orange
coloured urine and possibly discoloured skin or body secretions. More serious side
effects include allergic reactions (shortness of breath, chest pain or rashes that
may or may not be itchy, coughing and wheezing), diarrhoea, even after Mycobutin is
stopped, skin rash with flu like symptoms, eye pain, redness or, blurry vision, unexpected
bleeding or bruising and fever. For more information, including what to do if you
have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
Rifabutin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking Mycobutin. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking Mycobutin.
Where to find information in this leaflet:
1. Why am I taking Mycobutin?
Mycobutin contains the active ingredient rifabutin. Mycobutin is an antibiotic, an agent taken to kill certain types of bacteria, known
as mycobacteria.
Mycobutin is taken in combination with other medicines to treat mycobacterial infections
e.g. tuberculosis (TB) or Mycobacteria avium-intracellulare complex (MAC). It may
also be taken 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.
2. What should I know before I take Mycobutin?
Warnings
Do not take Mycobutin if:
1. You are allergic to rifabutin, other rifamycin antibiotics (e.g. rifampicin), or any
of the ingredients listed at the end of this leaflet.
2. Always check the ingredients to make sure you can take this medicine.
3. You are taking treatments that include ritonavir or prolonged-release rilpivirine
injections
4. The packaging is torn or shows signs of tampering
5. The expiry date printed on the pack has passed.
Do not give Mycobutin to children.
Check with your doctor if you:
have any other medical conditions
have or have had problems with your liver or kidneys
take any medicines for any other condition
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.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Oral contraceptives may be affected by Mycobutin. Discuss with your doctor about
using a different means of birth control during treatment with Mycobutin.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Mycobutin and affect how it works.
treatments for HIV, e.g. saquinavir, indinavir, ritonavir, amprenavir, fosamprenavir,
lopinavir, nevirapine, bictegravir, doravirine, rilpivirine, elvitegravir/cobicistat
anti-hepatitis C virus treatments, e.g. sofosbuvir
anti-tuberculosis treatments, e.g. bedaquiline
other antibiotics, e.g. clarithromycin, erythromycin, chloramphenicol, trimethoprim,
atovaquone
anti-fungal treatments, e.g. fluconazole, itraconazole, ketoconazole, posaconazole,
voriconazole
oral contraceptives, e.g. ethinylestradiol/norethisterone
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)
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Mycobutin.
4. How do I take Mycobutin?
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.
Follow the instructions provided by your doctor. They may differ from the information
contained in this leaflet.
Do not stop taking Mycobutin unless your doctor tells you to, even if you feel better.
You will usually need to take Mycobutin for a number of months.
If you do not complete the full course prescribed by your doctor, all of the bacteria
causing your infection may not be killed. The bacteria may then continue to grow and
multiply so that your infection may not clear completely, or it may return.
When to take Mycobutin
Mycobutin capsules should be swallowed whole once a day. They may be taken at any
time and may be taken with or without food.
If you forget to take Mycobutin
Mycobutin should be taken regularly around the same time each day.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you take too much Mycobutin
If you think that you have taken too much Mycobutin, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
An excessive dose may lead to severe side effects. You should inform your doctor
as soon as possible.
5. What should I know while taking Mycobutin?
Things you should 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.
Tell your doctor immediately if you have any pain, redness or blurry vision.
Tell your doctor immediately if you have a moderate or severe skin rash or blisters
often with flu-like symptoms
Remind any doctor or dentist you visit that you are taking Mycobutin.
Things you should not do
Do not stop this medicine without advice from your doctor first.
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.
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.
When taking Mycobutin, your urine (and possibly skin or body secretions) may become
a red-orange colour.
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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Mycobutin
affects you.
Drinking alcohol
No information available.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
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.
Do not take this medicine after the expiry date.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
Mycobutin, like all other medicines, may cause unwanted side effects. These are usually
mild and disappear when you have completed the course.
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.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Gastrointestinal symptoms:
nausea and vomiting
Aches and pains:
pain in joints and muscles
Other:
red-orange coloured urine or possibly discoloured skin and body secretions
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Skin symptoms:
jaundice (yellowing of the skin)
moderate or severe skin rash or blisters often with flu-like symptoms
Diarrhoea:
diarrhoea, especially if watery and severe, which may be bloody, particularly if occurs
several weeks after stopping Mycobutin.
Eye disorders:
redness, soreness of the eye, or blurry vision .
Signs of an allergic reaction or difficulty breathing, such as:
shortness of breath, chest pain or rashes that may or may not be itchy, coughing and
wheezing.
Symptoms related to anaemia (a red blood cell condition) and other blood conditions
tiredness or pale complexion
unexpected bleeding or bruising
Other:
fever
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
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. This should be monitored by your doctor through regular blood tests.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Mycobutin contains
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Active ingredient
(main ingredient)
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Each capsule contains 150 mg rifabutin as the active ingredient.
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Other ingredients
(inactive ingredients)
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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.
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Do not take this medicine if you are allergic to any of these ingredients.
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
AUST R 55038.
Who distributes Mycobutin
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in December 2023.
© Pfizer Australia Pty Ltd