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SANDIMMUN SOFT GELATIN CAPSULES 50MG

Active substance(s): CICLOSPORIN

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Package leaflet: Information for the patient

Sandimmun®
Soft Gelatin Capsules
25 mg
Sandimmun®
Soft Gelatin Capsules
50 mg
Sandimmun®
Soft Gelatin Capsules
100 mg
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
r­ eactions.
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.
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
p
­ erforatum (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.

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• 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.

If you are being treated for Behçet`s uveitis,
your doctor will monitor you particularly
carefully if you have neurological s­ ymptoms
(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).

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 (hyper­
tension) 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.

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 (HMGCoA 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 p
­ regnancy.
• 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 c
­ orresponds 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.

Sandimmun contains sorbitol
If you have an intolerance to some sugars,
inform your doctor before taking this ­medicine.
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.
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– 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.

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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.
Remove the capsules from the blister.
Swallow the capsules whole with water.
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 s­ evere rash, the treatment
usually lasts for 8 weeks.

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.

Keep taking Sandimmun for as long as your
doctor tells you.

4. Possible side effects

If you have questions about how long to take
Sandimmun, talk to your doctor or your
pharmacist.

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

Some side effects could be serious
If you take more Sandimmun than you
Tell your doctor straight away if you notice
should
any of the following serious side effects:
If you accidentally take too much of your
Like other medicines that act on the

medicine, tell your doctor immediately or go
immune system, ciclosporin may influence
to your nearest hospital emergency unit. You
your body’s ability to fight against infection
may need medical attention.
and may cause tumours or other cancers,
If you forget to take Sandimmun
particularly of the skin. Signs of infection
might be fever or sore throat.
• If you forget to take a dose, take it as soon
as you remember it. However, if it is almost • Changes in your sight, loss of coordination,
time for your next dose, skip the missed
being clumsy, memory loss, difficulty
dose. Then go on as before.
speaking or understanding what others say,
and muscle weakness. These might be signs
• Do not take a double dose to make up for a
forgotten dose.
of an infection of the brain called ­progressive
multifocal leukoencephalopathy.
If you stop taking Sandimmun
Brain problems with signs such as seizures,

Do not stop taking Sandimmun unless your
confusion, feeling disorientated, being less
doctor tells you to.
responsive, personality changes, feeling
agitated, sleeplessness, changes to your
Keep taking Sandimmun even if you feel well.
Stopping your treatment with Sandimmun
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 patassium 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, s­ leeplessness,
disorientation, disturbance of vision,

­ nconsciousness, sense of w
u
­ eakness 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.
Do not store your capsules in a hot
place (maximum temperature 30°C).
Leave your capsules in the foil. Only
­remove them when it is time to take
your medicine.
When a blister is opened, a characteristic
smell is noticeable. This is normal and does
not mean that there is anything wrong with
the capsules.
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.
6. Contents of the pack and other information
What Sandimmun contains
Sandimmun Soft Gelatin Capsules 25 mg
• The active substance is ciclosporin. Each
capsule contains 25 mg ciclosporin.
• The other ingredients are:
° Capsule contents: ethanol anhydrous,
maize oil interesterified, maize oil refined.
° Capsule shell: Iron oxide red (E172),
titanium dioxide (E 171), glycerol 85%,
sorbitol syrup special, gelatin.
Sandimmun Soft Gelatin Capsules 50 mg
• The active substance is ciclosporin. Each
capsule contains 50 mg ciclosporin.
• The other ingredients are:
° Capsule contents: ethanol anhydrous,
maize oil interesterified, maize oil
refined.
° Capsule shell: Iron oxide yellow (E172),
titanium dioxide (E171), glycerol 85%,
sorbitol syrup special, gelatin.
Sandimmun Soft Gelatin Capsules 100 mg
• The active substance is ciclosporin. Each
capsule contains 100 mg ciclosporin.
• The other ingredients are:
° Capsule content: ethanol anhydrous,
maize oil interesterified, maize oil
refined.



° Capsule shell: Iron oxide red (E172),

titanium dioxide (E 171), glycerol 85%,
sorbitol syrup special, gelatin.

What Sandimmun looks like and contents of
the pack
Sandimmun 25 mg soft capsules are pink and
oval.
Sandimmun 50 mg soft capsules are corn
­yellow and oblong.
Sandimmun 100 mg soft capsules are dusty
rose and oblong.

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.

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.
Sandimmun Capsules are manufactured by
Novartis Pharmaceuticals UK Limited,
­Wimblehurst Road, Horsham, West ­Sussex,
RH12 5AB and 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 Soft Gelatin Capsules 25 mg
Sandimmun Soft Gelatin Capsules 50 mg
Sandimmun Soft Gelatin Capsules 100 mg

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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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