Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I being given Rifadin?
Rifadin contains the active ingredient rifampicin. Rifadin is an antibiotic taken
with other medicines to treat tuberculosis and is taken to treat leprosy. It is also
taken to prevent meningococcal disease and infections caused by Haemophilus Influenza
Type B.
2. What should I know before I am given Rifadin?
Do not take Rifadin if you have ever had an allergic reaction to Rifadin or any of
the ingredients listed at the end of the CMI.
Do not take Rifadin if you have jaundice.
Do not take Rifadin if you are taking saquinavir or ritonavir. These are medicines
used to treat AIDS and HIV.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding or planning to breastfeed.
3. What if I am taking other medicines?
Some medicines may interfere with Rifadin and affect how it works.
4. How is Rifadin given?
Rifadin is diluted and given by intravenous infusion. Rifadin must only be given by
a doctor or nurse.
5. What should I know while being given Rifadin?
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Things you should do
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Remind any doctor, dentist, surgeon or pharmacist you visit that you are using Rifadin.
If you have to have any blood or urine tests tell your doctor you are being given
Rifadin.
If you are about to be started on a new medicine, including oral contraceptives, tell
your doctor you are taking Rifadin.
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Things you should not do
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Do not stop using this medicine suddenly.
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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 Rifadin
affects you.
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Looking after your medicine
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Rifadin is stored in the pharmacy or on the ward. The powder for IV infusion is kept
in a cool dry place where the temperature stays below 25°C.
Rifadin is used immediately after it has been made up into a solution.
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6. Are there any side effects?
Serious side effects include allergic reactions, interstitial lung disease (including
pneumonitis), severe bleeding or bruising, severe diarrhoea, severe stomach cramps,
worsening of tuberculosis symptoms typically associated with exaggerated inflammatory
symptoms including fever, swollen lymph nodes, breathlessness, cough and other symptoms
such as headache, loss of appetite and weight loss. Stop using Rifadin and immediately
contact a doctor if you experience any of the following symptoms such as nausea or
vomiting, fever, feeling tired, loss of appetite, dark-colored urine, light-colored
faeces, yellowing of the skin or white part of the eyes, itching, rash or upper stomach
pain. These symptoms may be signs of liver injury.
Active ingredient:
rifampicin (rif-am-pee-cin)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Rifadin. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Rifadin.
Where to find information in this leaflet:
1. Why am I being given Rifadin?
Rifadin contains the active ingredient rifampicin. Rifadin is an antibiotic which kills certain types of bacteria that can cause serious infections.
Rifadin is taken with other medicines to treat tuberculosis and is taken to treat
leprosy. Rifadin is also taken to prevent the following diseases:
Meningococcal disease that can cause meningitis.
Infections caused by the bacteria,
Haemophilus Influenzae
Type B. Despite the name, it is not related to influenza (‘the flu’). Symptoms of
this infection can include meningitis, pneumonia, or conjunctivitis.
2. What should I know before I am given Rifadin?
Warnings
Do not take Rifadin if:
you are allergic to rifampicin or other similar antibiotics such as rifabutin or rifaximin.
you are allergic to any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you are taking saquinavir/ritonavir. These medicines are used to treat acquired immune
deficiency syndrome (AIDS) and human immunodeficiency virus (HIV) infections.
you have jaundice (yellowing of the eyes and skin).
you are taking medicine called lurasidone (medicine for schizophrenia and bipolar
disorder), as rifampicin my reduce the blood levels of lurasidone.
you are breastfeeding or planning to breastfeed.
you have previously taken any rifampicin containing medicinal product and had liver
problems. If you are unsure talk to your doctor. Inflammation of the liver has been
reported in patients taking Rifadin with symptoms developing within a few days to
a few months following the start of treatment. Stop using Rifadin and contact a doctor
if you have symptoms of liver problems (see section
6. Are there any side effects?)
Check with your doctor if you:
have any problems with your liver including liver disease
have a problem with bleeding or a tendency to bruise easily
have diabetes
are taking other antibiotics
wear soft contact lenses. Urine, faeces, saliva, sputum, sweat, tears and teeth may
be coloured red-orange, yellow or brown by Rifadin. Soft contact lenses may be permanently
stained.
are taking any medicines for any other condition
are taking oral contraceptives. You should change to an alternative method of birth
control.
have any allergies to any other medicines or any other substances, such as foods,
preservatives or dyes.
have a history of lung inflammation (interstitial lung disease/pneumonitis)
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.
Rifadin should not be used while breastfeeding. Rifadin passes into breast milk and
there is a possibility your baby may be affected.
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 Rifadin and affect how it works.
Rifadin should not be taken with the following medicines:
the combination of saquinavir and ritonavir, antiviral agents used to treat acquired
immune deficiency syndrome (AIDS) and human immunodeficiency virus (HIV) infections
If you are taking dapsone (an antibiotic) with rifampicin, it may cause methemoglobinemia
(decrease in oxygen in your blood caused by changes in red blood cells).
If you are taking paracetamol and rifampicin, it can increase the risk of liver damage.
halothane, a general anaesthetic (a sleep inducing medicine)
medicines used to treat Hepatitis C (antiviral agents), such as daclatasvir, simeprevir,
sofosbuvir and telaprevir
Cephalosporin antibiotics, such as cefazolin used to treat infection
oral contraceptives
Rifadin and some medicines may interfere with each other and affect how they work,
such as:
atovaquone
isoniazid
p-aminosalicylic acid (PAS)
mifepristone
medicines for the treatment or prevention of breast cancer
medicines used to treat thyroid deficiency
medicines for nocturnal cramps
medicines for breathing difficulties
medicines to treat diabetes
medicines to treat nausea or vomiting
Heart or blood related
medicines that thin the blood, such as clopidogrel
medicines to lower cholesterol
medicines for treating heart problems
medicines for treating high blood pressure, such as enalapril
Infections or immune system-related
medicines to treat bacterial infections, such as antibiotics
medicines to treat fungal infections such as caspofungin, fluconazole, itraconazole
or ketoconazole
medicines to treat tuberculosis or leprosy
medicines for treating human immunodeficiency virus (HIV)
medicines to treat malaria
medicines to treat inflammatory conditions
medicines used to keep the body from rejecting transplanted organs
Mental health, brain or pain-related
medicines to treat mental illnesses, such as anxiety, depression, schizophrenia, or
bipolar disorder
medicines used to control or prevent seizures
medicines that can cause sedation
medicines for pain
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Rifadin.
4. How Rifadin is given
Rifadin is diluted and given by intravenous infusion.
Rifadin must only be given by a doctor or nurse.
Your doctor will decide what dose and for how long you will receive Rifadin.
5. What should I know while I am being given Rifadin?
Things you should do
You should see your doctor monthly for a check-up. Your doctor may order blood tests
from time-to-time. to check your progress or check for any side effects.
Continue taking Rifadin exactly as prescribed by your doctor.
If you have a blood test or urine test, tell your doctor you are taking Rifadin. Rifadin
may affect the results of some blood and urine tests.
If you are about to be started on a new medicine, including oral contraceptives, tell
your doctor that you are taking Rifadin.
If you are using oral contraception you should change to alternative methods of birth
control.
Call your doctor straight away if you:
develop new or sudden worsening of shortness of breath, possibly with a dry cough
or fever that is not responding to antibiotic treatment
These could be symptoms of lung inflammation (interstitial lung disease/pneumonitis)
and can lead to serious breathing problems due to collection of fluid in the lungs
and interfere with normal breathing which can lead to life threatening conditions.
become or intend to become pregnant
are breastfeeding or intend to breastfeed
are about to start taking any new medicine
Remind any doctor, surgeon, dentist or pharmacist you visit that you are being given
Rifadin.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Rifadin
affects you.
Rifadin may cause dizziness, drowsiness or other undesirable effects in some people.
After being given Rifadin
Rifadin is stored in the pharmacy or on the ward. The powder for IV infusion is stored
in a cool dry place where the temperature stays below 25°C.
When to discard your medicine (as relevant)
Rifadin is used immediately after it has been made up into a solution.
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.
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
Serious side effects
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Serious side effects
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What to do
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Liver-related:
nausea or vomiting, fever, feeling tired, loss of appetite, dark-colored urine, light-colored
faeces, yellowing of the skin or white part of the eyes, itching, rash or upper stomach
pain.
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Stop using Rifadin and immediately contact a doctor if you experience any of these
symptoms. These symptoms may be signs of liver injury.
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Skin-related:
severe red and/or itchy skin, blisters or pimples, bleeding, peeling or bruising of
the skin
Blood and lymph related:
blood in the urine or any other urination disturbances
severe bleeding or bruising more easily than normal
blood clots in small blood vessels (thrombotic microangiopathy). Symptoms may include
increased bruising, bleeding, fever, extreme weakness, headache, dizziness or light-headedness.
Your doctor may find changes in your blood and the function of your kidneys.
General:
itching, weakness, loss of appetite, nausea, vomiting, stomach or gut pain, yellowing
of the eyes or skin or dark urine
worsening of tuberculosis symptoms which are typically associated with exaggerated
inflammatory symptoms (reported between 2 weeks and as late as 18 months after the
initiation of anti-tuberculosis treatment). These symptoms include fever, swollen
lymph nodes, breathlessness and cough. Other symptoms include headache and gut symptoms
such as loss of appetite and weight loss.
fever, chills, headache or dizziness
bone pain.
new or sudden worsening of shortness of breath, possibly with a cough or fever (interstitial
lung disease/pneumonitis)
Liver-related:
inflammation of the liver as shown by yellowing of the skin and white part of eyes.
This may be associated with an increase in liver enzymes as shown through a blood
test.
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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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Allergy-related:
swelling of the face, lips, tongue or throat which may cause difficulty in breathing
or swallowing
Stomach or gut-related:
severe stomach cramps or gut cramps
watery and severe diarrhoea, which may also be bloody. Do not take any diarrhoea medicine
without first checking with your doctor.
fever, in combination with one or both above.
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Tell your doctor immediately if you notice any of these serious side effects, particularly
if they occur several weeks after stopping treatment with Rifadin.
These are rare but serious side effects. You may have a rare serious condition affecting
your bowel, which may need urgent medical attention.
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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.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects as follows:
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 Rifadin contains
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Active ingredient
(main ingredient)
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600 mg rifampicin per vial
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Other ingredients
(inactive ingredients)
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sodium formaldehyde sulfoxylate
sodium hydroxide
Diluent
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What Rifadin looks like
Rifadin is a red powder in a glass vial with sterile water for injections in a glass
vial as a solvent (Aust R 156919).
Who distributes Rifadin
Rifadin is distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Rifadin is distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
® Registered Trademark
This leaflet was prepared in August 2024.
rifadin-iv-ccdsv20-cmiv16-23aug24