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 treated with Pamisol?
Pamisol contains the active ingredient pamidronate disodium. Pamisol is used to treat
bone cancer, high blood calcium levels or a bone disease where bone breaks down excessively
and is incorrectly repaired by the body.
2. What should I know before treatment with Pamisol?
Pamisol should not be used if you have ever had an allergic reaction to pamidronate
disodium, any of the ingredients listed at the end of the CMI, other similar types
of medicine, or are pregnant or breastfeeding.
Talk to your doctor if you have any other medical conditions or take any other medicines.
3. What if I am taking other medicines?
Some medicines may interfere with Pamisol and affect how it works. Examples include
other bisphosphonates, medicines to slow down or prevent bone loss; calcitonin, a
medicine to reduce calcium in the blood; thalidomide, a medicine used to treat a number
of cancers; medicines that may have side effects on your kidneys.
4. How is Pamisol given?
Your doctor will give you Pamisol as a slow drip into a vein and decide how much you
will be given and for how long.
5. What should I know during treatment with Pamisol?
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Things you should do
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Tell or check with your doctor if you have kidney, heart or liver disease; thyroid
surgery; overactive parathyroid; calcium or vitamin D deficiency; pain, swelling or
numbness of the jaw, heavy jaw or loose teeth; low levels of red blood cells (anaemia),
white blood cells or platelets from blood tests; ear pain, discharge and/or ear infection;
thigh or groin pain.
Remind any doctor, surgeon, anaesthetist, pharmacist or dentist you visit that you
are being treated with Pamisol.
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Driving or using machines
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Pamisol may cause dizziness or drowsiness and may affect your ability to drive a car
or operate machinery.
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Drinking alcohol
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Drinking alcohol while you are being treated with Pamisol may cause dizziness to become
worse.
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Looking after your medicine
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The hospital will store and dispose of the medicine.
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6. Are there any side effects?
Possible side-effects include: seizures; signs of an allergic reaction (shortness
of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or
other parts of body, rash, itching, hives); light headedness, dizziness, faintness;
a tingling/burning sensation, numbness/cramps, twitching/muscle spasms; difficulty
urinating, blood in urine, vomiting, nausea; anaemia and/or other blood disorders,
or infection, bleeding and bruising more easily; irregular or changes to heart rhythm;
irritated, itchy, red or swollen eyes, sensitivity to light, blurred vision or pain
in the eye; pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth
or jaw, discharge, numbness or a feeling of heaviness in the jaw, loosening of a tooth,
infection; ear pain, discharge or ear infection; thigh or groin pain; pain/pressure
in the head with hearing or vision changes; breathlessness, swollen feet or lower
legs. 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):
pamidronate disodium (pa-mi-DROE-nate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Pamisol. 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 Pamisol.
Where to find information in this leaflet:
1. Why am I being treated with Pamisol?
Pamisol contains the active ingredient pamidronate disodium. Pamisol belongs to a group of medicine called bisphosphonates. Bisphosphonates bind
to bone and reduce the rate at which it is broken down. This helps strengthen bones
by preventing the loss of calcium and this reduces the high levels of calcium in the
blood..
In some cancers there can be an excessive breakdown of bone. As this happens, calcium
is lost from the bone and seeps into the blood, leading to higher than normal levels
of calcium in the blood. Pamisol is used to ease bone pain or to reduce high calcium
levels in the blood associated with some cancers.
In Paget's disease of bone, pamidronate disodium works on bones to make them stronger
and help prevent bone thickening
2. What should I know before treatment with Pamisol?
Warnings
You should not be given Pamisol if you:
are allergic to pamidronate disodium, or any of the ingredients listed at the end
of this leaflet.
are allergic to similar types of medicines that slow down or prevent bone loss.
are pregnant or breastfeeding.
Check with your doctor if you:
kidney disease.
heart disease.
liver disease.
thyroid surgery.
overactive parathyroid.
calcium deficiency or vitamin D deficiency
pain, swelling or numbness of the jaw or a heavy jaw feeling or loosening of a tooth
low levels of red blood cells (anaemia), white blood cells or platelets. Your doctor
may do tests to check for these problems.
ear pain, discharge and/or an ear infection
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.
You must not be given this medicine if you are pregnant or breastfeeding.
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 and Pamisol may interfere with each other. These include:
other bisphosphonates (such as risedronic acid or alendronic acid), medicines to
slow down or prevent bone loss.
calcitonin, medicine to reduce calcium in the blood.
thalidomide, medicine to treat a number of cancers.
medicines that may have side effects on your kidneys.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect
Pamisol
4. How is Pamisol given?
How much will be given
Pamisol is given as a slow drip into your vein. Your doctor will decide what dose
you will receive and for how long you will receive it. This depends on your condition
and other factors, such as your weight or if you have kidney problems.
If you are given too much Pamisol
As Pamisol is given to you under the supervision of your doctor, it is very unlikely
that you will receive too much. However, if you experience any severe side effects
after being given this medicine such as tingling or numbness of the hands or feet,
muscle cramps, dizziness or lightheadedness, tell your doctor or nurse immediately.
You may need urgent medical attention.
5. What should I know during treatment with Pamisol?
Things you should do
Tell your doctor immediately:
about any pain or unusual feeling in your teeth or gums or any dental infections.
about any ear pain, discharge or ear infection.
If you experience thigh or groin pain as this may indicate a type of fracture to your
leg.
Remind any doctor, pharmacist or dentist you visit that you are using Pamisol. It
is not advised to have invasive dental procedures while being treated with Pamisol.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
Take any vitamins or supplements your doctor has asked you to take while being treated
with Pamisol.
Have any tests that your doctor asks you to have while being treated with Pamisol
as these are important to monitor your health.
Things you should not do
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Pamisol
affects you.
This medicine may cause dizziness or drowsiness in some people. If you drink alcohol,
dizziness may be worse.
If you have any of these symptoms, do not drive, operate machinery or do anything
else that could be dangerous.
If you are given this medicine as an outpatient at hospital, you must not drive yourself
home from the hospital.
If dizziness or drowsiness occurs, it may last for up to 24 hours. It rarely lasts
for more than 24 hours.
Drinking alcohol
Drinking alcohol while you are being treated with this medicine may cause dizziness
to become worse.
Looking after your medicine
Pamisol is stored in a hospital which is responsible for storing and disposing of
any unused product correctly.
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.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Side effects
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Side effects
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What to do
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"flu-like" symptoms, fever, chills or shivering
generally feeling unwell
appearance of "cold sores", blisters around face, mouth or genital areas
tiredness, sleepiness or drowsiness
headache
agitation, confusion, seeing, feeling or hearings things that are not there, difficulty
sleeping
pain, redness or swelling at the injection site
rash, itching
bone, muscle or joint pain; general pain
upset stomach or pain, loss of appetite, nausea, vomiting, diarrhoea, constipation,
indigestion and/or changes in bowel habit.
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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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seizures (convulsions)
signs of an allergic reaction, such as 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
anaemia and/or blood disorders, which may cause tiredness, headaches, dizziness, shortness
of breath when exercising, looking pale; frequent infections such as fevers, severe
chills, sore throat or mouth ulcers; bleeding or bruising more easily than usual
irregular or changes to heart rhythm (fluttering or palpitations)
unusual light headedness, dizziness or faintness, tingling or burning sensation, numbness
or cramps, twitching or muscle spasms
swelling of the ankles, feet or lower legs
kidney problems with difficulty urinating, blood in urine, can be with drowsiness,
breathlessness, vomiting or nausea.
irritated, itchy, red or swollen eyes, sensitivity to light, blurred vision or pain
in the eye
pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth
or jaw, discharge, numbness or a feeling of heaviness in the jaw, loosening of a tooth,
or infection
ear pain, discharge, or ear infection
thigh or groin pain as this may indicate a type of fracture to your leg
a feeling of pressure in the head, which may be accompanied by headache, abnormal
sounds in ears, and/or visual changes.
heart problems which may cause breathlessness, particularly when lying down, swelling
of the feet or legs
Changes in liver function; reduced blood potassium, phosphorus, calcium and magnesium
levels; or elevated sodium and magnesium levels which will show up when you have 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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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/safety/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 Pamisol contains
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Active ingredient
(main ingredient)
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pamidronate disodium
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Other ingredients
(inactive ingredients)
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mannitol, phosphoric acid or sodium hydroxide.
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You should not be given this medicine if you are allergic to any of these ingredients.
Pamisol does not contain lactose, sucrose, gluten, tartrazine or other azo dyes.
What Pamisol looks like
Pamisol is a clear, colourless solution that will be diluted before use.
Australian Registration Number
Pamisol 15 mg /5 mL glass vial - AUST R 75106.
Pamisol 30 mg/10 mL glass vial - AUST R 75107.
Pamisol 60 mg /10 mL glass vial - AUST R 75108.
Pamisol 90 mg/10 mL glass vial - AUST R 75109.
Who distributes Pamisol
Pfizer Australia Pty Ltd
Sydney NSW.
Toll Free Number: 1800 675 229.
This leaflet was prepared in January 2025.