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SANDIMMUN ORAL SOLUTION

Active substance(s): CICLOSPORIN

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Package leaflet: Information for the patient

Sandimmun® Oral Solution
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 you take Sandimmun
3. How to take Sandimmun
4. Possible side effects
5. How to store Sandimmun
6. Contents of the pack and other information

1. What Sandimmun is and what it is used for
What Sandimmun is
The name of your medicine is Sandimmun. It contains the active substance ciclosporin.
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 Sandimmun works
• If you have had an organ transplant, bone marrow and stem cell transplantation, the
function of Sandimmun is to control your body’s immune system. Sandimmun
prevents rejection of transplanted organs by blocking the development of certain cells
which would normally attack the transplanted tissue.
• If you have an autoimmune disease, in which your body’s immune response attacks
your body’s own cells, Sandimmun stops this immune reaction. Such diseases
include eye problems which threaten your vision (endogenous uveitis, including
Behçet’s uveitis), severe cases of certain skin diseases (atopic dermatitis, or eczema
and psoriasis), severe rheumatoid arthritis and a kidney disease called nephrotic
syndrome.

2. What you need to know before you take Sandimmun
If you are taking Sandimmun following a transplant it will only be prescribed for you by
a doctor with experience in transplants and/or autoimmune diseases.
The advice in this leaflet may vary depending on whether you are taking the medicine
for a transplant or for an autoimmune disease.

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Follow all your doctor’s instructions carefully. They may differ from the general
information contained in this leaflet.
Do not take Sandimmun:
–– if you are allergic to ciclosporin or any of the other ingredients of this medicine
(listed in section 6).
–– 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 take Sandimmun and tell your doctor if the above applies to you. If you are not
sure, talk to your doctor before taking Sandimmun.
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 operation if you have had
a transplant.
• 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 apply to you (or you are not sure), tell your doctor before taking
Sandimmun. This is because this medicine contains alcohol (see section below
“Sandimmun contains 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.
In addition if you are taking Sandimmun for a non-transplant disease (intermediary or
posterior uveitis and Behçet’s uveitis, atopic dermatitis, severe rheumatoid arthritis or
nephrotic syndrome), do not take Sandimmun:
• if you have kidney problems (except for nephrotic syndrome).
• if you have an infection which is not under control with medication.
• if you have any type of cancer.
• if you have high blood pressure (hypertension) which is not under control with
medication. If you get high blood pressure during treatment and it cannot be
controlled, Sandimmun should be stopped by your doctor.
Do not take Sandimmun if any of the above applies to you. If you are not sure, talk to
your doctor or pharmacist before taking Sandimmun.
If you are being treated for Behçet`s uveitis, your doctor will monitor you particularly
carefully if you have neurological symptoms (for example: increased forgetfulness,
personality changes noticed over time, psychiatric or mood disorders, burning sensation
in limbs, decreased sensation in limbs, tingling sensation in limbs, weakness of limbs,
walking disturbances, headache with or without nausea and vomiting, vision
disturbances including restricted movement of eyeball).
Your doctor will closely monitor you if you are elderly and are being treated for psoriasis
or atopic dermatitis. If you have been prescribed Sandimmun to treat your psoriasis or
atopic dermatitis, you must not be exposed to any UVB-rays or phototherapy during
treatment.
Children and adolescents
Sandimmun should not be given to children for a non-transplant disease, except for
treatment of nephrotic syndrome.
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. If you are over 65 and have psoriasis or atopic
dermatitis, you should only be treated with Sandimmun if your condition is particularly
severe.
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
potassium-sparing 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
neuroendocrine 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 (oral anti-diabetic medicine), immunosuppressives (everolimus,
sirolimus), ambrisentan and specific anti-cancer medicines called anthracyclines
(such as doxorubicin).
If any of the above applies 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 ethanol
Sandimmun contains approximately 12.0 vol. % ethanol (alcohol), which corresponds to
up to 500 mg per dose used in transplant patients. This is equivalent to nearly 15 ml
beer or 5 ml wine per dose.
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 to take Sandimmun
Always take this medicine exactly as your doctor has told you. Check with your doctor if
you are not sure.
Do not take more than the recommended dose.
The dose of this medicine will be carefully adjusted to your individual needs by your
doctor. Too much of the medicine can affect your kidneys. You will have regular blood
tests and visits to the hospital, especially after a transplant. This will give you the
chance to talk to your doctor about your treatment and talk about any problems you
may be having.
How much Sandimmun to take
Your doctor will work out the correct dose of Sandimmun for you. This depends on your
body weight and what you are taking the medicine for. Your doctor will also tell you how
often to take your medicine.
• In adults:
Organ, bone marrow and stem cell transplantation
– The total dose each day is usually between 2 mg and 15 mg per kilogram body
weight. This is divided in 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.
Endogenous uveitis
– The total dose each day is usually between 5 mg and 7 mg per kilogram body
weight. This is divided in two doses.
Nephrotic syndrome
– The total dose each day for adults is usually 5 mg per kilogram body weight. This is
divided in two doses. In patients with kidney problems, the first dose taken each
day should not be more than 2.5 mg per kilogram body weight.
Severe rheumatoid arthritis
– The total dose each day is usually between 3 mg per kilogram of your body weight
and 5 mg per kilogram body weight. This is divided in two doses.
Psoriasis and atopic dermatitis
– The total dose each day is usually between 2.5 mg per kilogram of your body weight
and 5 mg per kilogram body weight. This is divided in two doses.
• In children:
Nephrotic syndrome
– The total dose each day for children is usually 6 mg per kilogram body weight. This
is divided in two doses. In patients with kidney problems, the first dose taken each
day should not be more than 2.5 mg per kilogram body weight.
Follow your doctor’s instructions exactly and never change the dose yourself, even if you
feel well.
If your doctor switches you from one oral formulation of ciclosporin to another
After you change from one oral formulation of ciclosporin to another:
• Your doctor will monitor you more closely for a short time.
• You may have some side effects. If this happens, tell your doctor or pharmacist. Your
dose may need to be changed. Never change your dose yourself, unless a doctor has
told you to.
When to take Sandimmun
Take Sandimmun at the same time every day. This is very important if you have had a
transplant.
How to take Sandimmun
Your daily doses should always be taken in 2 divided doses.
–– For initial use, follow steps 1 to 9.
–– For subsequent use, follow steps 5 to 9.

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Starting a new bottle of Sandimmun oral solution
1. Lift the flap in the centre of the metal sealing ring.

2. Tear off the sealing ring completely.

3. Take off the black stopper and throw it away.

4. Push the tube unit with the white stopper firmly into the neck of
the bottle.

7. Push down and pull up the plunger a few times.
– This will get rid of any large air bubbles. It does not matter if
there are a few tiny bubbles in the syringe. This will not affect
the dose in any way.
Ensure that the correct amount of medicine is in the syringe.
Then, take the syringe out of the bottle
8. P
 ush the medicine out of the syringe into a small glass
(not plastic) containing liquids, preferably cold chocolate drink,
milk, fruit juice or cola
– Make sure that the syringe does not touch the liquid in the glass.
– Stir and drink the whole contents of the glass straight away.

9. After use, wipe the syringe on the outside only with a dry tissue.
– Then, put the syringe back in its cover.
– Leave the white stopper and tube in the bottle.
– Close the bottle with the cap provided.

How long to take Sandimmun
Your doctor will tell you how long you need to take Sandimmun for. This depends on
whether you are taking it after a transplant or for the treatment of a severe skin
condition, rheumatoid arthritis, uveitis or nephrotic syndrome. For severe rash, the
treatment usually lasts for 8 weeks.
Keep taking Sandimmun for as long as your doctor tells you.
If you have questions about how long to take Sandimmun, talk to your doctor or your
pharmacist.

Measuring your dose
5. C
 hoose the syringe depending on how much medicine you need
to measure:
– For 1 ml or less of medicine, use the 1 ml syringe.
– For more than 1 ml of medicine, use the 4 ml syringe.
Push the nozzle of the syringe into the white stopper.

6. Pull up the plunger until you have drawn up the correct
amount of medicine.
– The lower part of the plunger ring needs to be in front of the
mark on the syringe which shows the amount of medicine.

If you take more Sandimmun than you should
If you accidentally take too much of your medicine, tell your doctor immediately or go
to your nearest hospital emergency unit. You may need medical attention.
If you forget to take Sandimmun
• If you forget to take a dose, take it as soon as you remember it. However, if it is
almost time for your next dose, skip the missed dose. Then go on as before.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Sandimmun
Do not stop taking Sandimmun unless your doctor tells you to.
Keep taking Sandimmun even if you feel well. Stopping your treatment with Sandimmun
may increase the risk of your transplanted organ being rejected.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

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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:
• 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 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, breast 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.
• Do not use this medicine after the expiry date which is stated on the package.
• Store at room temperature (15°C to 30°C).
• Do not store in the refrigerator.
• If the medicine is put in the refrigerator by mistake, let it reach room temperature
before using it again. Flakes or small bits (sediments) in the medicine do not affect
how the medicine works or how safe it is to use. The dose can still be measured
correctly with the syringe.
• The content of the bottle is stable for 2 months after opening. After 2 months, you
should use a new bottle.
• Use immediately after dilution
• Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help to protect the environment.

• The 1 ml syringe is used to measure doses of 1 ml or smaller. Each mark on the
syringe is 0.05 ml. This contains 5 mg of ciclosporin.
• The 4 ml syringe is used to measure doses bigger than 1 ml and up to 4 ml. Each
mark on the syringe is 0.1 ml. This contains 10 mg of ciclosporin.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Novartis Pharmaceuticals UK Limited, Frimley
Business Park, Frimley, Camberley, Surrey GU16 7SR, England.
Sandimmun Oral Solution is 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 Oral Solution.
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.

6. Contents of the pack and other information
What Sandimmun contains
• The active substance is ciclosporin. One ml oral solution contains 100 mg
ciclosporin.
• The other ingredients are ethanol anhydrous, maize oil interesterified, maize oil
refined.
What Sandimmun looks like and contents of the pack
Sandimmun comes in the form of an oral solution. It is a clear, yellow to yellowbrownish liquid with a small amount of very fine sediment.
It is available in a 50 ml glass bottle, with two syringes for measuring the dose.

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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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