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 using BONDRONAT?
BONDRONAT contains the active ingredient ibandronic acid. In patients with breast
cancer, BONDRONAT is used to slow down the attachment, spread and growth of cancer
cells within the bone, known as metastatic bone disease. BONDRONAT injection can also
be used to lower very high levels of calcium in the blood. High levels of calcium
can occur in the presence of a tumour. This is known as hypercalcaemia of malignancy.
2. What should I know before I take or receive BONDRONAT?
Do not use if you have ever had an allergic reaction to BONDRONAT or any of the ingredients
listed at the end of the CMI.
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.
3. What if I am taking other medicines?
Some medicines may interfere with BONDRONAT and affect how it works.
4. How do I use BONDRONAT?
The recommended dose of BONDRONAT tablets is one 50 mg tablet once daily.
Your doctor will decide what dose of BONDRONAT injection you will receive, depending
on your condition. BONDRONAT is added to an infusion bag and given as a 'drip' into
a vein, usually over a period of 1-2 hours.
5. What should I know while using BONDRONAT?
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Things you should do
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Remind any doctor, dentist, nurse or pharmacist you visit that you are using BONDRONAT.
Be sure to brush and floss your teeth daily, and have regular dental check-ups with
your dentist.
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Things you should not do
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Do not stop taking BONDRONAT or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
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Driving or using machines
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Be careful before you drive or operate any machines or tools until you know how BONDRONAT
affects you.
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Looking after your medicine
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Keep the blister pack in a cool dry place where the temperature stays below 30°C.
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6. Are there any side effects?
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. The most common side effects are a rise in body temperature or feeling
hot, fever, chills, headache, sweating, bone or muscle pain, similar to the flu, muscle
aches, diarrhoea, indigestion, vomiting, abdominal pain, dizziness, and nausea.
Serious side effects include difficulty breathing, chest tightness or wheezing, severe
lightheadedness, severe skin rash, itching, hives, swelling of the face, lips, mouth
and severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
Active ingredient(s):
ibandronic acid
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using BONDRONAT. 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 BONDRONAT.
Where to find information in this leaflet:
1. Why am I using BONDRONAT?
BONDRONAT contains the active ingredient ibandronic acid. BONDRONAT belongs to a group of medicines called bisphophonates.
In patients with breast cancer, BONDRONAT is used to slow down the attachment, spread
and growth of cancer cells within the bone, known as metastatic bone disease.
BONDRONAT works by stopping the breakdown of bone.
BONDRONAT injection can also be used to lower very high levels of calcium in the blood.
High levels of calcium can occur in the presence of a tumour. This is known as hypercalcaemia
of malignancy.
Your doctor may have prescribed BONDRONAT for another purpose.
Ask your doctor if you have any questions why BONDRONAT has been prescribed for you.
BONDRONAT is not addictive.
This medicine is available only with a doctor's prescription.
2. What should I know before I take or receive BONDRONAT?
Warnings
Do not use BONDRONAT if:
you are allergic to ibandronic acid, or to any other biphosphonate medicine or any
of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Always check the ingredients to make sure you can use this medicine.
you have low levels of calcium in your blood (called hypocalcaemia)
you have certain disorders of the food-pipe (also called oesophagus) including those
that cause difficulty swallowing
you are unable to stand or sit up straight for at least 30 minutes
the package is torn or shows signs of tampering
the expiry date (EXP) printed on the pack has passed. If you take this medicine after
the expiry date has passed, it may not work as well.
Do not give BONDRONAT to a child. Safety and effectiveness in children have not been established.
If you are not sure if you should be receiving BONDRONAT, talk to your doctor.
Check with your doctor if you:
have any other medical conditions, especially the following:
poor kidney function
disturbances of bone and mineral metabolism
poor dental health, such as bleeding gums
heartburn
swallowing or digestive problems, such as ulcers
take any medicines for any other condition
are allergic to any other medicines, foods, dyes or preservatives
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.
BONDRONAT is not recommended to be used during pregnancy. Your doctor will discuss
the risks and benefits of using BONDRONAT if you are pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known whether BONDRONAT passes into breast milk.
3. What if I am taking other medicines?
Tell your doctor, nurse 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 BONDRONAT and affect how it works.
These medicines include:
aminoglycoside medicines, used to treat severe infections, as both agents can lower
blood calcium levels
non-steroidal anti-inflammatory drugs (also known as NSAIDs), these may cause irritation
to the stomach when given with BONDRONAT tablets
calcium supplements, medicines used to treat low calcium levels
antacids, medicines used to treat indigestion and heartburn
These medicines may be affected by BONDRONAT, or may affect how well it works. You
may need to receive different amounts of your medicine, or you may need to take different
medicines. Your doctor will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect BONDRONAT.
Ask your doctor or pharmacist if you are not sure about this list of medicines.
4. How do I use BONDRONAT?
How much to take - BONDRONAT tablets
Take BONDRONAT tablets exactly as your doctor has prescribed.
The recommended dose of BONDRONAT is one 50 mg tablet once daily. If you have a reduced
kidney function, your doctor may decide to lower your dose.
Follow the instructions provided and use BONDRONAT until your doctor tells you to
stop.
When to take BONDRONAT tablets
BONDRONAT tablets should be taken at least 30 minutes before the first food, drink
(other than plain water) or any other medicine of the day. Food and medicines can interfere with the absorption of BONDRONAT tablets.
Your doctor will decide how long you should take BONDRONAT depending on your response
to the medicine and the state of your disease.
If you are at low risk of broken bones, your doctor may put you on a break from BONDRONAT
after 3 to 5 years.
How to take BONDRONAT tablets
Swallow tablets whole with a plain glass of water.
Mineral water and other drinks such as juices, coffee and tea will affect how well
BONDRONAT tablets work in your body.
Do not chew or suck on the tablet. Mouth ulcers may occur if the tablet is chewed or sucked.
Do not lie down for at least 30 minutes after taking BONDRONAT tablets.
It is important to remain standing or sitting in an upright position after taking
your tablet. This will help make sure the tablet reaches your stomach quickly and
avoids irritating your food-pipe (oesophagus).
If you forget to take BONDRONAT tablets
BONDRONAT should be used regularly at the same time each day. If you miss your dose
at the usual time, do not take more tablets on the same day. Return to taking one
tablet per day the following day.
How BONDRONAT injection is given
BONDRONAT injection is usually given in a hospital setting.
Your doctor will decide what dose of BONDRONAT injection you will receive, depending
on your condition.
BONDRONAT injection is prepared by a healthcare professional. It is added to an infusion
bag and given as a 'drip' into a vein, usually over a period of 1-2 hours.
How long to receive BONDRONAT injection
For the treatment of hypercalcaemia, only a single dose of BONDRONAT injection is
normally required. However, some patients may require a second dose.
For the treatment of metastatic bone disease, BONDRONAT infusion is repeated every
4 weeks.
Your doctor will decide how long you should receive BONDRONAT depending on your response
to the medicine and the state of your disease.
If you take or receive too much BONDRONAT
If you think that you have used too much BONDRONAT, 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.
5. What should I know while using BONDRONAT?
Things you should do
Tell all doctors, dentists, nurses and pharmacists who are treating you that you are
receiving BONDRONAT.
Tell your doctor immediately if you experience allergic reactions such as chest tightness,
wheezing, severe dizziness or lightheadedness, swelling of the lips or skin rash during
or after receiving BONDRONAT.
Tell your doctor if you become pregnant while receiving BONDRONAT
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment
unnecessarily.
Tell your doctor that you are receiving BONDRONAT if you are going to have any laboratory
tests.
Be sure to brush and floss your teeth daily, and have regular dental check-ups with
your dentist.
If you develop pain in your mouth, teeth or jaw, or have bleeding gums, or have an
unusual feeling in your teeth or gums, tell your doctor and dentist immediately.
If you develop any thigh, hip or groin pain, tell your doctor immediately.
Be sure to keep all of your appointments with your doctor so that your progress can
be checked.
BONDRONAT may cause jaw-bone problems in some people. Jaw-bone problems may include
infection, and delayed healing after teeth are pulled out or other dental work that
involves drilling into the jaw.
Things you should not do
Do not stop taking BONDRONAT or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give BONDRONAT to anyone else even if they have the same condition as you.
Do not use BONDRONAT to treat other complaints unless your doctor tells you to.
Do not take any other medicines whether they require a prescription or not without
first telling your doctor or consulting a pharmacist.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BONDRONAT
affects you.
The effect of BONDRONAT on the ability to drive or use machinery has not been studied.
However BONDRONAT is not expected to affective your ability to drive a car or operate
machinery.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the packaging they will not keep well.
Keep the blister pack in a cool dry place where the temperature stays below 30°C.
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.
Heat and dampness can destroy some medicines.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking BONDRONAT tablets, or the tablets have passed
their expiry date, ask your pharmacist what to do with any tablets that are left over.
Do not use 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
Serious side effects
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 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 BONDRONAT injection solution contains
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Active ingredient
(main ingredient)
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ibandronic acid
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Other ingredients
(inactive ingredients)
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sodium chloride
glacial acetic acid
water for injections
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Potential allergens
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N/A
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What BONDRONAT tablets contain
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Active ingredient
(main ingredient)
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ibandronic acid
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Other ingredients
(inactive ingredients)
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lactose monohydrate
microcrystalline cellulose
povidone
crospovidone
stearic acid
colloidal anhydrous silica
hypromellose
titanium dioxide
purified talc
macrogol 6000
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Potential allergens
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lactose
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Do not take this medicine if you are allergic to any of these ingredients.
BONDRONAT injection and tablets do not contain sucrose, gluten, tartrazine or any
other azo dyes.
What BONDRONAT looks like
BONDRONAT injection is a clear to colourless solution, which is mixed with a sterile
infusion solution before being administered as "a drip" (AUST R 98008).
BONDRONAT 50 mg tablets are white to off-white oblong tablet, with "L2" engraved on
one side and "IT" engraved on the other side (AUST R 119673).
Who distributes BONDRONAT
Sponsor:
Atnahs Pharma Australia Pty Ltd
Level 10 / 10 Shelley Street
Sydney, NSW, 2000
Australia
Distributor:
Clinect Pty Ltd
120 - 132 Atlantic Drive
Keysborough, VIC, 3173
Australia
Customer enquiries: 1800 899 005
Please check with your pharmacist for the latest Consumer Medicine Information.
This leaflet was prepared in February 2023.