SANDIMMUN®
Cyclosporin
50mg / mL concentrate for intravenous infusion
What is in this leaflet
This leaflet answers some common questions about Sandimmun.
It does not contain all the available information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of
you taking Sandimmun against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Sandimmun is used for
Sandimmun is used for people who have had a kidney, heart, combined
heart-lung, liver or pancreas transplant, to prevent the body from rejecting the
new organ.
Sandimmun is also used for patients who have had a bone marrow transplant.
Sandimmun contains the active ingredient, cyclosporin. It belongs to a group
of medicines called immuno-suppressants. These medicines help to control your
body's immune system.
Ask your doctor if you have any questions about why this medicine has been
prescribed for you.
Your doctor may have prescribed it for another reason.
Sandimmun is only available with a doctor's prescription. It is not
addictive.
Before you have Sandimmun
When you must not have it
Do not have Sandimmun if you have ever had an allergic reaction to any of
the following:
- cyclosporin, the active ingredient in Sandimmun
- Cremophor® EL, an ingredient in Sandimmun concentrate for
intravenous infusion - any of the other ingredients of Sandimmun listed at the end of this
leaflet
Symptoms of an allergic reaction may include hives or an itchy skin rash,
swelling of the face, lips or tongue, faintness, wheezing or troubled breathing.
Do not have Sandimmun after the expiry date printed on the pack or if the
packaging is torn or shows signs of tampering.
In that case, return it to your pharmacist.
Before you start to have it
If you have been prescribed Sandimmun, tell your doctor if you also have
any of these health problems/medical conditions:
- high blood pressure that is not controlled
- any uncontrolled infection
- a poorly functioning immune system
- problems with your kidneys or liver
- severe heart, lung or blood vessel disease
- any type of cancer, including skin cancer
Your doctor may not want you to have Sandimmun or may want to take special
precautions if you have any of these conditions.
Tell your doctor if you are pregnant or intend to become pregnant.
Experience with Sandimmun in pregnancy is very limited. The use of
immunosuppressant medicines, including cyclosporin, during pregnancy has been
shown to increase the risk of problems in the mother and the unborn child. If it
is necessary for you to take this medicine, your doctor will discuss with you
the benefits and risks of taking it during pregnancy.
Tell your doctor if you are breast-feeding.
Breast-feeding is not recommended since cyclosporin, the active ingredient in
Sandimmun, passes into breast milk and may affect your baby.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that
you buy without a prescription from a pharmacy, supermarket or health food shop.
Many other medicines may be affected by Sandimmun or they may affect how well
Sandimmun works. This includes:
- a wide range of prescription medicines (please refer to full prescribing
information) - St John's wort, an ingredient in many medicines that you can buy without a
prescription from a pharmacy, health food shop or supermarket.
You may need to take different amounts of your medicines or you may need to
take different medicines.
Your doctor and pharmacist have more information on medicines to be careful
with or avoid while taking Sandimmun.
If you have not told your doctor about any of these things, tell him/her
before you have Sandimmun.
How Sandimmun is given
Follow all directions given to you by your doctor and pharmacist
carefully.
These instructions may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or
pharmacist for help.
Sandimmun is different from Neoral®
There is another medicine called Neoral which also contains cyclosporin.
However, there are important differences between these two medicines.
Because of these differences, you must not change from Sandimmun to Neoral
or from Neoral to Sandimmun unless it is under the strict supervision of your
doctor.
Do not take Sandimmun and Neoral at the same time.
How much is given
The dose of Sandimmun is worked out for each person. It will depend on how
much you weigh, what condition is being treated, how well Sandimmun works for
you, and whether you have any side effects from this medicine. Your dose may be
changed from time to time.
How it is given
Concentrate for intravenous infusion: Sandimmun can be given by
intravenous infusion (drip) for a short time after transplant surgery or in
other cases where the medicine cannot be taken by mouth. The dose is given in
hospital, usually over 2-6 hours.
When to take it
Solid organ transplantation
Patients in whom the use of Sandicmmun concentrate for infusion is indicated
should receive one-third of the recommended oral cyclosporine dose (See Neoral
data sheet) shortly after surgery.
Bone marrow transplantation
The recommended i.v. dose is 3 to 5mg/kg per day, starting on the day before
transplantation.
How long it is given
Keep having this medicine for as long as your doctor recommends.
The length of treatment will depend on what medical condition you have.
While you are taking Sandimmun
Things you must do
Make sure that you keep all of your doctor's appointments and have any
tests done that are ordered by your doctor.
Your doctor may ask you to have tests from time to time to check how well your
kidneys and liver are working. It may be necessary to measure the amount of
cyclosporin, as well as the levels of other chemicals (eg. potassium) in your
blood. Your blood pressure will also be checked regularly.
Avoid eating large amounts of foods that are high in potassium.
In some people having Sandimmun, the amount of potassium in the blood can
increase (called hyperkalaemia). The amount of potassium in the blood can also
be increased by eating certain foods. Your doctor can tell you which foods to
avoid.
If you become pregnant while having Sandimmun, tell your doctor.
Your doctor can discuss with you the risks of having it while you are pregnant
If you develop lumps anywhere in your body, or develop any moles, or you
notice changes in existing moles, tell your doctor.
This may be an early sign of a cancer. Immunosuppressant medicines, including
Sandimmun, may increase the risk of developing certain cancers, including skin
cancer and lymphoma (cancer of the lymphatic system).
If you go out in the sun, wear a hat, protective clothing and sunscreen.
This will help to prevent the development of skin cancer.
Take special care of your teeth and gums.
People taking immunosuppressant medicines are at a greater risk of getting
infections. Taking good care of your teeth and gums will help to prevent dental
and mouth infections.
If you are about to be started on any new medicine, remind your doctor and
pharmacist that you are having Sandimmun.
Tell any other doctor, dentist or pharmacist who treats you that you are
having Sandimmun.
Things you must not do
Do not have any vaccinations without first checking with your doctor.
Some vaccines may be less effective or they may cause unwanted side effects
while you are taking Sandimmun.
Do not give this medicine to anyone else even if their condition seems
similar to yours.
Do not take it to treat any other complaints unless your doctor tells you
to.
Things to be careful of
Be careful driving, operating machinery or doing jobs that require you to
be alert while you are having Sandimmun until you know how it affects you.
This medicine can cause tiredness, lack of energy or confusion in some people.
If you have any of these symptoms, do not drive or do anything else that could
be dangerous.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are having Sandimmun, even if you do not think it is connected with
the medicine.
All medicines can have side effects. Sometimes they are serious, but most of the
time they are not. You may need medical treatment if you get some of the side
effects. Your doctor may be able to relieve some of the side effects of
Sandimmun by lowering the dose.
If you are over 65 years old, you should be especially careful while
having this medicine. Report any side effects promptly to your doctor.
As people grow older, they are more likely to get side effects from medicines.
Do not be alarmed by this list of possible side effects. You may not
experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- tiredness, lack of energy
- excessive growth of body and facial hair
- thickened, swollen or bleeding gums
- stomach upset, including nausea (feeling sick), vomiting, loss of
appetite, diarrhoea, stomach cramps - tremor (shaking)
- headache
- weight loss or gain
- feeling depressed (sad)
- flushing of face, acne, darkening of skin
- painful menstrual periods or lack of periods
- increase in size of breasts in males
- muscle cramps, tenderness or weakness
- blocked or stuffy nose
The above side effects are not usually serious.
Tell your doctor immediately if you notice any of the following:
- fever (temperature above 37°C)
- constant "flu-like" symptoms such as chills, sore throat, aching joints,
swollen glands, or any other signs of infection - unusual bleeding or bruising
- signs of allergy such as rash, itching or hives on the skin; swelling of
the face, lips, tongue or other part of the body; shortness of breath,
wheezing or troubled breathing - new lumps or moles, or changes to existing moles, anywhere on the body
- swelling of the eyelids, hands or feet due to excess fluid
- change in the amount of urine passed or in the number of times you
urinate, pain on urinating, bloody or smelly urine - yellowing of the skin and/or eyes (jaundice) often accompanied by
generally feeling unwell (for example, tiredness, lack of energy, loss of
appetite, nausea and vomiting, pain in the abdomen) - severe pain or tenderness in the stomach or abdomen
- vomiting blood or material that looks like coffee grounds; black sticky
bowel motions or bloody diarrhoea - unusual tiredness or weakness, which may be accompanied by dizziness,
spots before the eyes, shortness of breath and pale skin - numbness or "pins and needles" in the hands and feet
- disturbance in brain function which may cause a variety of symptoms,
including confusion, disorientation, agitation, inability to sleep, decreased
responsiveness, weakness and incoordination in arms and legs, seizures (fits),
visual hallucinations (seeing things that are not there) or other problems
with vision - buzzing or ringing in the ears, difficulty hearing
The above are serious side effects that need medical attention.
Some side effects may not give you any symptoms and can only be found when
tests are done. Some of these side effects include:
- changes in kidney or liver function
- raised blood pressure
- an increase in the amount of potassium or cholesterol in the blood
- a decrease in the amount of magnesium in the blood
- n increase in the amount of uric acid in the blood, which can lead to gout
- an increase in blood sugar
Your doctor will make sure that tests are done regularly to watch for these
side effects.
Tell your doctor if you notice anything else that is making you feel
unwell.
Other side effects not listed here may happen in some people.
After using Sandimmun
Storage
Store the concentrate for i.v. infusion below 30°C. Once an ampoule is
opened, the contents should be used immediately. Diluted infusion solution must
be discarded after 24 hours.
Disposal
If your doctor tells you to stop having Sandimmun or it has passed its
expiry date, ask your pharmacist what to do with any medicine you have left
over.
Product description
What it looks like
Sandimmun concentrate for intravenous infusion is a clear liquid in 5 mL
glass ampoules; packs of 10.
Ingredients
Sandimmun concentrate for intravenous infusion: contains 50 mg cyclosporin
per mL of infusion solution. It also contains:
- polyoxyethylated castor oil (Cremophor® EL)
- ethanol (alcohol)
- macrogoglycerol ricinoleate