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SANDIMMUN CONCENTRATE FOR SOLUTION FOR INFUSION 50MG/ML

Active substance(s): CICLOSPORIN

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1. What Sandimmun is and what it is used for
Package leaflet: Information for the patient

Sandimmun®
Concentrate for Solution for Infusion
50 mg/ml
ciclosporin

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
––Keep this leaflet. You may need to read it again.
––If you have any further questions, ask your doctor or
pharmacist.
––This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
––If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
What is in this leaflet
1. What Sandimmun is and what it is used for
2. What you need to know before Sandimmun is used
3. How Sandimmun is used
4. Possible side effects
5. How to store Sandimmun
6. Contents of the pack and other information

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What Sandimmun is
The name of your medicine is Sandimmun. It contains the
active substance ciclosporin. The concentrate is used to
prepare a solution which is administered by intravenous
infusion. This belongs to a group of medicines known as
immunosuppressive agents. These medicines are used to
lower the body’s immune reactions.
What Sandimmun is used for and how it works
Sandimmun is used to control the body’s immune system
following an organ transplant, including bone marrow and
stem cell transplantation. It prevents rejection of transplanted
organs by blocking the development of certain cells which
would normally attack the transplanted tissue.

2. What you need to know before Sandimmun is used
Sandimmun will only be prescribed for you by a doctor with
experience in transplants.
Follow all your doctor’s instructions carefully. They may differ
from the general information contained in this leaflet.
Do not use Sandimmun:
––if you are allergic to ciclosporin or any of the other
ingredients of this medicine (listed in section 6; also see
section “Sandimmun contains castor oil and ethanol”).
––with products containing Hypericum perforatum
(St John´s Wort).
––with products containing dabigatran etexilate (used to
avoid blood clots after surgery) or bosentan and aliskiren
(used to reduce high blood pressure).
Do not use Sandimmum and tell your doctor if the above
applies to you. If you are not sure, talk to your doctor or
pharmacist before taking Sandimmum.

Warnings and precautions
Before and during treatment with Sandimmun,
tell your doctor straight away:
• if you have any signs of infection, such as fever or a sore
throat. Sandimmun suppresses the immune system and
may also affect your body’s ability to fight against
infection.
• if you have liver problems.
• if you have kidney problems. Your doctor will carry out
regular blood tests and may change your dose if
necessary.
• if you develop high blood pressure. Your doctor will check
your blood pressure regularly and may give you a medicine
to lower blood pressure if necessary.
• if you have low levels of magnesium in your body. Your
doctor may give you magnesium supplements to take,
especially just after your transplant operation.
• if you have high levels of potassium in your blood.
• if you have gout.
• if you need to have a vaccination.
If any of the above applies to you before or during treatment
with Sandimmun, tell your doctor straight away.
Sunlight and sun protection
Sandimmun suppresses your immune system. This increases
your risk of developing cancers, particularly of the skin and
lymphoid system. You should limit your exposure to sunlight
and UV light by:
• Wearing appropriate protective clothing.
• Often applying a sunscreen with a high protection factor.
Talk to your doctor before taking Sandimmun:
• if you have or have had alcohol related problems.
• if you have epilepsy.

• if you have any liver problems.
• if you are pregnant.
• if you are breast-feeding.
• if this medicine is being prescribed for a child.

If any of the above applies to you (or you are not sure), tell
your doctor before taking Sandimmun. This is because this
medicine contains alcohol (see section below “Sandimmun
conatins castor oil and ethanol”).
Monitoring during your treatment with Sandimmun
Your doctor will check:
• the levels of ciclosporin in your blood, especially if you
have had a transplant,
• your blood pressure before the start of your treatment
and regularly during treatment,
• how well your liver and kidneys are working,
• your blood lipids (fats).
If you have any questions about how Sandimmun works or
why this medicine has been prescribed for you, ask your
doctor.
Children and adolescents
There is limited experience with Sandimmun in children.
Elderly population (65 years of age and older)
There is limited experience with Sandimmun in elderly
patients. Your doctor should monitor how well your
kidneys work.
Other medicines and Sandimmun
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking
any of the following medicines before or during Sandimmun
treatment:

• Medicines that may affect your potassium levels. These

include medicines which contain potassium, potassium
supplements, water tablets (diuretics) called potassiumsparing diuretics, and some medicines which lower your
blood pressure.
• Methotrexate. This is used to treat tumours,
severe psoriasis and severe rheumatoid arthritis.
• Medicines which may increase or decrease the level of
ciclosporin (the active substance of Sandimmun) in your
blood. Your doctor might check the level of ciclosporin in
your blood when starting or stopping treatment with other
medicines.
––Medicines which may increase the level of ciclosporin in
your blood include: antibiotics (such as erythromycin or
azythromycin), anti-fungals (voriconazole, itraconazole),
medicines used for heart problems or high blood
pressure (diltiazem, nicardipine, verapamil,
amiodarone), metoclopramide (used to stop sickness),
oral contraceptives, danazol (used to treat menstrual
problems), medicines used to treat gout (allopurinol),
cholic acid and derivatives (used to treat gallstones),
protease inhibitors used to treat HIV, imatinib (used to
treat leukaemia or tumours), colchicine, telaprevir (used
to treat hepatitis C).
––Medicines which may decrease the level of ciclosporin
in your blood include: barbiturates (used to help you to
sleep), some anti-convulsant medicines (such as
carbamazepine or phenytoine), octreotide (used to
treat acromegaly or neuroendorcrine tumours in the
gut), anti-bacterial medicines used to treat
tuberculosis, orlistat (used to help weight loss), herbal
medicines containing St. John’s wort, ticlopidine
(used after a stroke), certain medicines which lower

blood pressure (bosentan), and terbinafine
(an anti-fungal medicine used to treat infections of the
toes and nails).
• Medicines which may affect your kidneys. These include:
anti-bacterial medicines (gentamycin, tobramycin,
ciprofloxacin), anti-fungal medicines which contain
amphotericin B, medicines used for urinary tract
infections which contain trimethoprim, medicines for
cancer which contain melphalan, medicines used to lower
the amount of acid in your stomach (acid secretion
inhibitors of the H2-receptor antagonist type), tacrolimus,
pain killers (non-steroid anti-inflammatory medicines
such as diclofenac), fibric acid medicines (used to lower
the amount of fat in the blood).
• Nifedipine. This is used to treat high blood pressure and
heart pain. You might get swollen gums that might grow
over your teeth if you are taking nifedipine during your
treatment with ciclosporin.
• Digoxin (used to treat heart problems), medicines which
lower cholesterol (HMG-CoA reductase inhibitors also
called statins), prednisolone, etoposide (used to treat
cancer), repaglinide (an anti-diabetic medicine),
immunosuppressives (everolimus, sirolimus), ambrisentan
and specific anti-cancer medicines called anthracyclines
(such as doxorubicin).
If any of the above apply to you (or you are not sure), talk to
your doctor or pharmacist before taking Sandimmun.
Sandimmun with food and drink
Do not take Sandimmun with grapefruit or grapefruit juice.
This is because these can affect how Sandimmun works.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking this
medicine. Your doctor will discuss with you the potential
risks of taking Sandimmun during pregnancy.
• Tell your doctor if you are pregnant or intend to
become pregnant. Experience with Sandimmun in
pregnancy is limited. In general, Sandimmun should not be
taken during pregnancy. If it is necessary for you to take
this medicine, your doctor will discuss with you the
benefits and potential risks of taking it during pregnancy.
• Tell your doctor if you are breast-feeding.
Breast-feeding is not recommended during treatment with
Sandimmun. This is because ciclosporin, the active
substance, passes into breast milk. This may affect
your baby.
Driving and using machines
Sandimmun contains alcohol. This may affect your ability
to drive and use machines.
Sandimmun contains castor oil and ethanol
Sandimmun concentrate for solution for infusion contains
castor oil which may cause severe allergic reactions.
Sandimmun concentrate for solution for infusion contains
approximately 34.4 v/v ethanol (alcohol). A 100 mg dose of
Sandimmun contains 556 mg ethanol. This is equivalent to
nearly 15 ml beer or 5 ml wine.
Alcohol may be harmful if you have alcohol-related problems,
epilepsy, brain injury, liver problems or if you are pregnant or
breast-feeding. It may also be harmful if this medicine is
given to children.

3. How Sandimmun is used

Carefully follow all the instructions given to you by your
doctor. Check with your doctor if you are not sure.
How much Sandimmun you will be given
Your doctor will work out the correct dose of Sandimmun
for you. This depends on your body weight and what you
are being given the medicine for.
• The total dose each day is usually between 3 to 5 mg per
kilogram of your weight. This is divided into two doses.
• Usually, higher doses are used before and just after your
transplant. Lower doses are used once your transplanted
organ or bone marrow has stabilised.
• Your doctor will adjust your dose to one that is ideal for
you. To do this, your doctor may need to do some blood
tests.
How Sandimmun will be used
The medicine will be diluted before use 1:20 to 1:100 with
saline or 5% glucose and then given to you by slow infusion
over approximately 2 to 6 hours. Diluted medicine must be
thrown away after 24 hours.
How long Sandimmun will be used
You will be switched to ciclosporin in the form of capsules
or oral solution (both of which are taken by mouth) as soon
as possible.
If you have been given more Sandimmun than you should
Too much of the medicine can affect your kidneys. You will
have regular blood tests and visits to the hospital. This will
give you the chance to talk to your doctor about your
treatment and talk about any problems you may be having.
If you think you have been given too much Sandimmun,
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If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Some side effects could be serious.
Tell your doctor straight away if you notice any of the
following serious side effects:
• Signs of anaphylactoid reactions appeared following
intravenous administration of Sandimmun. These reactions
can consist of flushing of the face and upper chest, fluid in
the lungs, shortness of breath, wheezing, blood pressure
changes (you may feel you are going to faint) and
accelerated heartbeat (tachycardia).
• Like other medicines that act on the immune system,
ciclosporin may influence your body’s ability to fight
against infection and may cause tumours or other cancers,
particularly of the skin. Signs of infection might be fever
or sore throat.
• Changes in your sight, loss of coordination, being clumsy,
memory loss, difficulty speaking or understanding what
others say, and muscle weakness. These might be signs of
an infection of the brain called progressive multifocal
leukoencephalopathy.
• Brain problems with signs such as seizures, confusion,
feeling disorientated, being less responsive, personality
changes, feeling agitated, sleeplessness, changes to your
sight, blindness, coma, paralysis of part or all of the body,
stiff neck, loss of coordination with or without unusual
speech or eye movements.
• Swelling at the back of the eye. This may be associated
with blurred vision. It may also affect your sight because of

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the higher pressure inside your head (benign intracranial
hypertension).
• Liver problems and damage with or without yellow skin
and eyes, nausea, loss of appetite and dark urine.
• Kidney problems, which may greatly reduce the amount of
urine you produce.
• Low level of red blood cells or platelets. The signs include
pale skin, feeling tired, being breathless, having dark urine
(this is a sign of the breakdown of red blood cells), bruising
or bleeding with no obvious reasons, feeling confused,
feeling disorientated, being less alert and having kidney
problems.
Other side effects include:
Very common side effects: These side effects may affect
more than 1 in 10 people.
• Kidney problems.
• High blood pressure.
• Headache.
• Shaking of your body which you cannot control.
• Excessive growth of body and facial hair.
• High level of lipids in your blood.
If any of these affects you severely, tell your doctor.
Common side effects: These side effects may affect
between 1 and 10 in every 100 people.
• Fits (seizures).
• Liver problems.
• High level of sugar in your blood.
• Tiredness,
• Loss of appetite.
• Nausea (feeling sick), vomiting, abdominal pain,
constipation, diarrhoea.

• Excessive hair growth.
• Acne, hot flushes.
• Fever.
• Low level of white blood cells.
• Feeling numb or tingling.
• Pain in your muscles, muscle spasm.
• Stomach ulcer.
• Gum tissue overgrowing and covering your teeth.
• High level of uric acid or potassium in your blood,

low levels of magnesium in your blood.
If any of these affects you severely, tell your doctor.
Uncommon side effects: These side effects may affect
between 1 and 10 in every 1,000 people.
• Symptoms of brain disorders including sudden fits, mental
confusion, sleeplessness, disorientation, disturbance of
vision, unconsciousness, sense of weakness in the limbs,
impaired movements.
• Rash.
• General swelling.
• Weight gain.
• Low level of red blood cells, low level of platelets in your
blood which could increase the risk of bleeding.
If any of these affects you severely, tell your doctor.
Rare side effects: These side effects may affect between
1 and 10 in every 10,000 people.
• Nerve problems with numbness or tingling in fingers
and toes.
• Inflammation of the pancreas with severe upper
stomach pain.
• Muscle weakness, loss of muscle strength, pain in
muscles of the legs or hands or anywhere in the body.

• Destruction of red blood cells, involving kidney problems

with symptoms such as swelling of the face, stomach,
hands and/or feet, decreased urination, breathing
difficulty,  chest pain, fits, unconsciousness.
• Changes in menstrual cycle, enlargement in men.
If any of these affects you severely, tell your doctor.

Very rare side effects: These side effects may affect
between 1 and 10 in every 100,000 people.
• Swelling at the back of the eye which may be associated
with an increase in pressure inside the head and eyesight
disturbances.
If this affects you severely, tell your doctor.
Other side effects with frequency not known: Frequency
cannot be estimated from the available data.
• Serious liver problems both with and without yellowing
of the eyes or skin, nausea (feeling sick), loss of appetite,
dark coloured urine, swelling of the face, feet, hands
and/or the whole body.
• Bleeding underneath the skin or purple skin patched,
sudden bleeding with no apparent cause.
• Migraine or severe headache often with feeling and being
sick (nausea, vomiting) and being sensitive to light.
• Pain in legs and feet
If any of these affects you severely, tell your doctor.
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet.
Additional side effects in children and adolescents
There are no additional side effects to be expected in children
and adolescents compared to adults.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme (www.mhra.gov.uk/yellowcard). By reporting
side effects you can help provide more information on the
safety of this medicine.

5. How to store Sandimmun

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any special temperature
storage conditions.

• Store in the original package.
• Once an ampoule has been opened, the contents should be
used immediately.
• Following dilution, the solution should be used immediately
and discarded after 24 hours.
• Do not use this medicine after the expiry date which is
stated on the package.
• Do not throw away any medicines via wastewater or
household waste. These measures will help to protect
the environment.

6. Contents of the pack and other information
What Sandimmun contains
• The active substance is ciclosporin. One ml of the
concentrate for solution for infusion contains 50 mg
ciclosporin.
• The other ingredients are: ethanol anhydrous, castor oil
polyoxyl.
What Sandimmun looks like and contents of the pack
Sandimmun concentrate for solution for infusion is supplied
in ampoules containing 1 ml or 5 ml concentrate. The

concentrate is a clear brown/yellow oily liquid. It is used by
your doctor or nurse to prepare a solution which will be given
to you by slow intravenous infusion.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Novartis
Pharmaceuticals UK Limited, Frimley Business Park, Frimley,
Camberley, Surrey GU16 7SR, England.
Manufactured by Novartis Pharmaceuticals UK Limited,
Wimblehurst Road, Horsham, West Sussex RH12 5AB, and
Novartis Pharmaceuticals UK Limited, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, England.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Sandimmun® Concentrate for Solution for Infusion 50 mg / ml.
This leaflet was last revised in August 2015
If you would like any more information, or would like
the leaflet in a different format, please contact Medical
Information at Novartis Pharmaceuticals UK Ltd,
telephone number 01276 698370.
SANDIMMUN is a registered trade mark.
Copyright Novartis Pharmaceuticals UK Limited.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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