2. What should I know before I use Sandimmun?
Do not use if you have ever had an allergic reaction to Sandimmun 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.
For more information, see Section
2. What should I know before I use Sandimmun? in the full CMI.
3. What if I am taking other medicines?
4. How do I use Sandimmun?
Sandimmun will be given to you in hospital, usually over 2 to 6 hours.
5. What should I know while using Sandimmun?
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Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using Sandimmun.
If you develop any lumps anywhere on/in your body, or develop any moles, or you notice
changes in existing moles, tell your doctor immediately.
Limit your exposure to sunlight and UV light.
Avoid taking this medicine with grapefruit, grapefruit juice or a fatty meal.
Avoid eating large amounts of foods that are high in potassium content.
Take special care of your teeth and gums and see your dentist regularly.
|
|
Things you should not do
|
Do not have any vaccinations without first consulting with your doctor.
Do not stop treatment unless your doctor tells you to.
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|
Driving or using machines
|
Sandimmun may make you feel sleepy, dizzy, have blurred vision or headaches. Take
care driving until you know how it affects you.
|
|
Drinking alcohol
|
Your doctor may ask you to limit your alcohol intake.
|
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Looking after your medicine
|
Sandimmun is usually stored at the hospital or pharmacy.
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6. Are there any side effects?
Sandimmun may increase your risk of infections, cause headache, tiredness, tremors,
burning sensation in the hands or feet, excess hair growth, vomiting, feeling sick,
swollen or puffy gums, allergic reactions such as hives, rash, itchy skin.
Active ingredient(s):
ciclosporin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Sandimmun. 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 Sandimmun.
Where to find information in this leaflet:
1. Why am I using Sandimmun?
Sandimmun contains the active ingredient
ciclosporin
. Sandimmun belongs to group of medicines known as immunosuppressive agents. These
medicines help to control your body's immune system.
Sandimmun is used for people who have had a kidney, liver or heart transplant, to
prevent the body from rejecting a new organ. It does this by blocking the development of special cells which would normally attack
the transplanted tissue.
It is also used to treat other conditions which are thought to be caused by a problem
with your immune system:
Nephrotic syndrome (a kidney disease)
Severe active rheumatoid arthritis (a disease affecting the joints with pain and swelling)
Severe psoriasis (a skin disease with thickened patches of red skin, often with silvery
scales)
Severe atopic dermatitis (a skin allergy causing dry itchy and inflamed skin).
2. What should I know before I use Sandimmun?
Warnings
Do not use Sandimmun if:
you are allergic to ciclosporin, polyoxyethylated castor oil (Cremophor® EL, present
in the infusion) or any of the ingredients listed at the end of this leaflet.
Symptoms of allergic reactions may include flushing of face or area between neck and
abdomen, shortness of breath or difficulty in breathing, coughing up blood, , wheezing,
blood pressure changes and fast heartbeat.
Your doctor may discontinue the infusion if you develop allergic reactions.
Always check the ingredients to make sure you can use this medicine.
Do not use Sandimmun if you are taking it for non-transplant related conditions and
you have:
uncontrolled high blood pressure
any uncontrolled infection.
Use in children
Do not give Sandimmun to patients under 16 years of age to treat severe rheumatoid
arthritis, psoriasis or atopic dermatitis. However, it can be used in children younger
than 16 years of age who have had an organ transplant or who have a kidney disease
(nephrotic syndrome).
Check with your doctor if you have:
Kidney problems - Sandimmun should not be taken by some patients with impaired kidney
function.
Any type of cancer or conditions that may develop into cancer.
Vaccinations planned as these may be less effective during treatment with Sandimmun.
Use of live attenuated vaccines should be avoided.
Liver problems
Severe heart, lung or blood vessel disease.
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.
There is an increased risk of problems in the mother and unborn child with the use
of Sandimmun or any immuno-suppressive therapy in general.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Breast-feeding is not recommended if you are on treatment with Sandimmun. Ciclosporin,
the main ingredient of the medicine, passes into the breast milk and can cause serious
problems for the baby.
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 Sandimmun and affect how it works. Let your doctor
know if you are using any of the following drugs:
Methotrexate, a medicine used to treat rheumatoid arthritis
Antibiotics, medicines used to treat infections, e.g. erythromycin, clarithromycin,
azithromycin, rifampicin, ciprofloxacin, trimethoprim, gentamicin, tobramycin, vancomycin
Antifungal medicines, e.g. fluconazole, ketoconazole, itraconazole, voriconazole,
amphotericin B
Tacrolimus, everolimus, sirolimus, mycophenolate sodium, other medicines which are
used to suppress the immune system
Diuretics (water tablets), a medicine that increases your amount of urine passed
Heart or blood pressure medicines, e.g. lercanidipine, nifedipine, amlodipine, verapamil,
diltiazem, nicardipine
Digoxin, a medicine used to treat heart failure
Statins, medicines used to treat high cholesterol, e.g. simvastatin, atorvastatin,
pravastatin
Fenofibrate, a medicine used to treat high cholesterol
Certain medicines used to prevent fits or seizures e.g. carbamazepine, phenytoin
Methylprednisolone, a medicine used to treat inflammatory diseases such as arthritis,
asthma, colitis
Colchicine, a medicine used to treat gout
NSAIDs (non-steroid anti-inflammatory drugs), used to treat pain e.g. diclofenac,
naproxen, indomethacin
Recombinant human erythropoietin (rhEPO), a medicine used to treat specific types
of anaemia
Repaglinide, a medicine used to treat diabetes
Cannabidiol (medicinal cannabis)
Certain medicines used to decrease the amount of acid in your stomach, e.g. cimetidine,
ranitidine
Some oral contraceptives medicines, e.g. levonorgestrel and norethisterone
Etoposide, imatinib, doxorubicin, medicines used to treat certain cancers
Octreotide, a medicine used to treat a condition called acromegaly, and certain types
of cancer
Metoclopramide, a medicine used to treat nausea and vomiting
Orlistat, a medicine used to help with weight loss
St John's wort, a herbal supplement used to treat conditions such as depression.
Consult your doctor or pharmacist if you are taking any other medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Sandimmun.
4. How do I use Sandimmun?
Sandimmun will be prepared and given to you by a doctor or nurse.
If you have any questions about how Sandimmun is given, ask the doctor or nurse who
is giving you the infusion.
How much to take
Your doctor will determine the correct dose for you. It will depend on how much you
weigh, what condition you are taking it for, how well Sandimmun works for you, and
whether you have any side effects from this medicine.
Your doctor may adjust your dose based on your response to medicine.
When will I be given Sandimmun
Sandimmun will be given to you in hospital, usually over 2 to 6 hours.
The usual dose starts on the day before your transplant operation and continues for
up to two weeks after the operation.
For non-transplant patients who cannot swallow capsules, your doctor will tell you
how often an injection is needed.
How the infusion is given:
The IV infusion will be prepared and given to you in hospital. The infusion is given
directly into your vein.
If you forget to take Sandimmun
It is important that you receive all your infusions. Let your doctor know as soon
as possible if you think you have missed an infusion.
If you are given too much Sandimmun
If you think that you have been given too much Sandimmun, you may need urgent medical
attention.
You should immediately:
tell the nurse giving you the infusion, 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 Sandimmun?
Things you should do
Keep all your medical appointments.
Your doctor will do routine tests to monitor your blood levels, to check how well
your kidneys and liver are working, and to decide if your dose needs to be changed.
Limit your exposure to sunlight and UV light.
If you go out in the sun, wear a hat, appropriate protective clothing and use sunscreen
with a high protection factor.
This will help prevent the risk of developing skin cancer.
Avoid eating large amounts of foods that are high in potassium content.
Taking Sandimmun can increase the amount of potassium in your blood. Too much potassium
will cause unwanted side effects. Check with your doctor or pharmacist if you are
not sure what foods contain high amounts of potassium.
Avoid taking this medicine with grapefruit, grapefruit juice or a fatty meal as it
may cause unwanted side effects.
Take special care of your teeth and gums and see your dentist regularly.
Sandimmun may increase your risk of gum disease.
Call your doctor straight away if you:
develop any lumps anywhere on/in your body, or develop any moles, or you notice changes
in existing moles.
become pregnant while having Sandimmun
experience any symptoms of infection (e.g. fever, sore throat).
Remind any doctor, dentist or pharmacist you visit that you are using Sandimmun.
Things you should not do
Do not stop treatment unless your doctor or healthcare professional tells you.
Do not have any vaccinations without first consulting with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Sandimmun
affects you.
Sandimmun may make you feel sleepy, dizzy, have blurred vision or headaches.
If your child is on Sandimmun, check how the medicine affects them before they ride
a bike or do activities that need coordination and concentration.
Drinking alcohol
Tell your doctor if you drink alcohol.
Drinking alcohol while on treatment with Sandimmun may lead to unwanted effects. Your
doctor may ask you to limit your alcohol intake.
Looking after your medicine
Sandimmun will be stored at the hospital or pharmacy.
If you need to collect the medicine from a pharmacy, store and transport below 30°C.
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 it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
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
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Less serious side effects
|
What to do
|
|
General problems:
Fever
Swelling in the hands or feet
Feeling more tired than normal
Headache
Dizziness
Confusion
Feeling of tingling, numbness
Burning sensation in hands and feet (usually during the first week of treatment)
Tremor, shakiness
Gastrointestinal problems:
Loss of appetite
Swelling of the gums
Feeling sick, vomiting
Diarrhoea
Pain or discomfort in the tummy
Skin problems:
Excessive growth of body and facial hair, particularly in women
Acne
Skin rash
Flushing of the face
Reproductive system issues:
Painful or no menstrual periods
Increased breast size in males
Muscle problems:
Muscle cramps
Pain or tenderness in the muscles
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Sudden swelling of the face, lips, tongue, or throat; difficulty breathing; rash or
hives; feeling faint or dizzy
High fever, chills, feeling very unwell, confusion, rapid heartbeat, trouble breathing
Unusual bruising or bleeding, frequent infections (fever, chills, sore throat), extreme
tiredness or weakness
Severe headache, sudden confusion, trouble seeing, hallucinations, difficulty speaking,
seizures
Severe stomach pain, swelling of the abdomen, vomiting blood, black or bloody stools,
yellowing of the skin or eyes
Yellowing of the skin or eyes, dark urine, severe tiredness, pain in the upper right
side of the abdomen
Muscle cramps, weakness, confusion, irregular heartbeat, fainting, seizures
Aching muscles, muscle tenderness or weakness, not caused by exercise
Little or no urine, bloody or smelly urine
New lumps or moles, or changes to existing moles
|
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.
|
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.
Some side effects may not give you any symptoms and can only be found when tests are
done.
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 Sandimmun contains
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Active ingredient
(main ingredient)
|
ciclosporin
|
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Other ingredients
(inactive ingredients)
|
castor oil – (Cremophor® EL) 65 %
ethanol 26 % w/v
|
|
Potential allergens
|
Contains ethanol
|
Do not take this medicine if you are allergic to any of these ingredients.
What Sandimmun looks like
250 mg/5 mL: Clear brown-yellow, oily solution. Supplied in packs of 10 x 5 mL ampoules.
50 mg/1 mL: Clear brown-yellow, oily solution. Supplied in packs of 10 x 1 mL ampoules.
Australian Registration Numbers:
Sandimmun 50mg/1mL ampoule AUST R 13370
Sandimmun 250mg/5mL ampoule AUST R 47290
Who distributes Sandimmun
Sandimmun is supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone: 1 800 671 203
®= Registered Trademark
This leaflet was prepared in December 2025.
Internal Document Code: sim210324c_v2 based on PI 210324i