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 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. For more information, see Section
1. Why am I taking Rifadin? in the full CMI.
2. What should I know before I take 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.
For more information, see Section
2. What should I know before I take Rifadin? in the full CMI.
3. What if I am taking other medicines?
4. How do I take Rifadin?
Follow the instructions provided when Rifadin was prescribed, including the number
of days it should be taken.
More instructions can be found in Section
4. How do I take Rifadin? in the full CMI.
5. What should I know while taking 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 taking Rifadin.
You should see your doctor monthly for a check-up.
Continue taking Rifadin exactly as prescribed by your doctor.
If you have a blood or urine test, tell your doctor you are taking 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 taking this medicine because you feel better.
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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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Store below 25°C.
Store Rifadin in a cool dry place away from moisture, heat or sunlight.
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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.
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: rifampicin (rif-am-pee-cin)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking 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 taking Rifadin.
Where to find information in this leaflet:
1. Why am I taking 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 take 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 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 other medical conditions
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:
antacids
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 or fungal infections, such as antibiotics 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 or depression
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 do I take Rifadin?
How much to take
Follow the instructions provided when Rifadin was prescribed, including the number
of days it should be taken.
Swallow Rifadin capsules whole with a glass of water.
If you need to take an antacid, take it at least 1 hour after your dose of Rifadin.
When to take Rifadin
Rifadin capsules or syrup should be taken on an empty stomach at least 30 minutes
before or 2 hours after a meal.
If you forget to take Rifadin
Rifadin should be taken regularly at the same time each day. If you miss your dose
at the usual time, take the dose as soon as you remember, and then resume taking Rifadin
as directed.
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 are unsure about taking the next dose, speak to your doctor or pharmacist.
If you take too much Rifadin
If you think that you have taken too much Rifadin, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26 in Australia), or (by calling 0800 764 766 in New Zealand) 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.
If you take too much Rifadin you may experience nausea, vomiting, stomach pain, itching,
headache, tiredness, dizziness, swelling, fast or uneven heartbeat or other problems
with heartbeating.
5. What should I know while taking 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 using Rifadin.
Things you should not do
Do not stop taking this medicine because you feel better. If you do not complete the
full treatment your infection may not completely clear or may return.
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.
Looking after your medicine
Store below 25°C
Follow the instructions in the carton on how to take care of your medicine properly.
Store Rifadin 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
do not store it in the car or on window sills.
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.
Do not take this medicine after the expiry date.
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
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Less serious side effects
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What to do
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Central nervous system-related:
drowsiness
fatigue
difficulty in concentrating
confusion
mental problems
General:
problems with your period
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.
Skin or eye-related:
yellow discolouration of skin or eyes
conjunctivitis
problems with your eyesight
Thrush-related:
white, furry, sore tongue and mouth. These are signs of oral thrush.
sore and itchy vagina with or without discharge. These are signs of vaginal thrush.
Muscle or nerve-related:
poor coordination
muscle weakness
pain in the fingers or toes
numbness
Stomach or gut-related:
heartburn
loss of appetite
nausea
vomiting
upset stomach
gut discomfort
wind
cramps
diarrhoea. Do not take any diarrhoea medicine without first checking with your doctor.
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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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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.
Allergy-related:
swelling of the face, lips, tongue or throat which may cause difficulty in breathing
or swallowing
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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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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: Australia: 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 Rifadin capsules contains
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Active ingredient
(main ingredient)
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150 mg or 300 mg of rifampicin per capsule
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Other ingredients
(inactive ingredients)
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maize starch
magnesium stearate
The capsule shell also contains:
titanium dioxide
erythrosine
indigo carmine
gelatin
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Potential allergens
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sulfur dioxide
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What Rifadin syrup contains
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Active ingredient
(main ingredient)
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100 mg of rifampicin per 5 mL of syrup
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Other ingredients
(inactive ingredients)
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agar
sucrose
methyl hydroxybenzoate
propyl hydroxybenzoate
potassium sorbate
saccharin
sodium metabisulfite
polysorbate 80
Raspberry Aroma 15 D 90
diethanolamine
purified water
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Potential allergens
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methyl hydroxybenzoate
propyl hydroxybenzoate
potassium sorbate
sodium metabisulfite
saccharin
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Do not take this medicine if you are allergic to any of these ingredients.
Diabetics should note that Rifadin syrup contains 2 g of sugar per 5 mL of syrup.
Rifadin preparations do not contain azo dyes.
What Rifadin looks like
Rifadin 150 mg capsules have a blue cap and red body each marked “R-150”. They come
in packs of 100 capsules (Aust R 233442).
Rifadin 300 mg capsules are opaque red and marked “R-300”. They come in packs of 100
capsules (Aust R 233443).
Rifadin 100 mg per 5 mL syrup is a red liquid supplied in 60 mL bottles (Aust R 10113).
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 January 2024.
rifadin-ccdsv18-cmiv16-15jan24