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NEORAL 100MG SOFT GELATIN CAPSULES

Active substance(s): CICLOSPORIN / CICLOSPORIN A / CICLOSPORINE / CYCLOSPORIN

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PATIENT INFORMATION LEAFLET

NEORAL® 100MG SOFT GELATIN CAPSULES
(ciclosporin)
Your medicine is available using the name Neoral 100mg Soft
Gelatin Capsules, but will be referred to as Neoral throughout this
leaflet.

What you need to know about Neoral

Your doctor has decided that you need this medicine to help treat
your condition.

Please read this leaflet carefully before you
start to take your medicine. It contains
important information.

Keep the leaflet in a safe place because you may want to read it
again.
If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to
someone else. It may not be the right medicine for them even if
their symptoms seem to be the same as yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Neoral is and what it is used for
Things to consider before you start to take Neoral
How to take Neoral
Possible side effects
How to store Neoral
Further information

1. What Neoral is and what it is used for
Neoral is available in four different strengths containing 10, 25, 50
or 100mg of the active ingredient, ciclosporin. Ciclosporin is one of
a group of drugs known as immunosuppressive agents. These drugs
are used to dampen down the body’s immune reactions.
Neoral can be used to treat a number of different conditions as
follows:

After an organ (e.g. kidney, liver, etc.) or bone marrow
transplant

Although you may have had a series of tests before your organ or
bone marrow transplant to ensure that the match between your
body and the transplanted organ or bone marrow is as close as
possible, the donor tissue will still not be identical to your tissue. As
a result, your body's immune system will try to reject the donor
tissue. Neoral helps to stop this rejection response by blocking the
development of special cells which would normally attack the
transplanted tissue.

If you have severe psoriasis or atopic dermatitis (eczema)
These serious skin conditions are thought to be caused by your
immune system over-reacting. Neoral may help to stop this by
suppressing the immune system.

If you have severe rheumatoid arthritis or nephrotic
syndrome

It is thought that rheumatoid arthritis and some forms of nephrotic
syndrome may be caused by inappropriate immune responses in
your body. Neoral may help to stop this by suppressing your
immune system.

2. Things to consider before you start to take
Neoral
Some people MUST NOT take Neoral. Talk to your
doctor if:
ƒ

ƒ
ƒ
ƒ
ƒ

ƒ

ƒ

You think you may be allergic to ciclosporin, or to any of the
other ingredients of Neoral. (These are listed at the end of the
leaflet).
You are taking a drug called tacrolimus.
You are taking a drug called rosuvastatin.
You are breast-feeding.

People with psoriasis or atopic dermatitis MUST NOT be
treated with Neoral if they have kidney problems, if they
have uncontrolled high blood pressure or infections, or if they
have any cancer except skin cancer.
People with rheumatoid arthritis MUST NOT be treated
with Neoral if they are under 18 years old, or if they have
kidney problems, uncontrolled high blood pressure, infections,
or any type of cancer.
People with nephrotic syndrome MUST NOT be treated
with Neoral if they have uncontrolled high blood pressure or
infections, or if they have any type of cancer.

You should also ask yourself these questions before taking
Neoral. If the answer to any of these questions is YES,
discuss your treatment with your doctor or pharmacist
because Neoral might not be the right medicine for you.
ƒ
Have you been told that you have high levels of potassium in
your blood? Are you taking potassium supplements or is your
diet particularly rich in potassium? (Fruit and vegetables are
rich sources of potassium.)
ƒ
Do you have gout or other conditions caused by high levels of
uric acid in your blood?
ƒ
Are you worried about any unusual spots, moles or warts on
your skin?
ƒ
Are you out in the sun a lot, or do you use a sun bed?
ƒ
Do you have any skin infections, including herpes (cold
sores)?
ƒ
Are you pregnant?

Other special warnings
ƒ

ƒ

ƒ

Are you taking other medicines?

Ciclosporin interacts with a large number of other medicines
and this can interfere with your treatment. Tell your doctor or
pharmacist if you are taking any of the following:
ƒ
Medicines to treat heart problems or high blood pressure
such as bosentan, diltiazem, nicardipine, verapamil and
aliskiren.
ƒ
Drugs containing potassium (your doctor will know which
these are).
ƒ
Medicines called NSAIDs used to treat pain and
inflammation. (Some of these can be bought over-thecounter).
ƒ
Medicines to treat infections including antibiotics
(especially erythromycin and clarithromycin) and
antifungal medicines (especially terbinafine and
voriconazole).
ƒ
Oral contraceptives.
ƒ
Medicines for epilepsy.
ƒ
Cholesterol lowering medicines (including statins).
ƒ
Sleeping tablets.
ƒ
Potassium supplements.
ƒ
Diuretics or “water tablets” that affect the amount of
urine you produce and might also affect the level of
potassium in your blood.
ƒ
Danazol (used to treat menstrual disorders,
endometriosis or breast problems).
ƒ
St John's Wort: The herbal remedy St John's Wort
(Hypericum perforatum) should not be taken at the same
time as this medicine. If you are already taking St John's
Wort consult your doctor before stopping the St John's
Wort preparation.
ƒ
Octreotide (known as Sandostatin®).
ƒ
Medicines to treat tuberculosis.
ƒ
Medicines to treat gout.
ƒ
Metoclopramide (used to stop sickness).
ƒ
Melphalan (used to treat lymphomas or tumours).
ƒ
Imatinib (used to treat leukaemia or tumours).
ƒ
Orlistat (used to help weight loss).
ƒ
Ticlopidine (used after a stroke).
ƒ
Corticosteroids (used to treat conditions such as asthma,
allergic conditions, inflammatory conditions including
inflammatory bowel disease, adrenocortical insufficiency and
rheumatic disease).
ƒ
Ursodeoxycholic acid (used to treat gallstones).
ƒ
Protease inhibitors (used to treat Human Immunodeficiency
Virus (HIV)).
ƒ
Tacrolimus, sirolimus and everolimus (other
immunosuppressants).
ƒ
Methotrexate (used to treat tumours, severe psoriasis and
rheumatoid arthritis).
ƒ
Etoposide (used to treat cancer).
ƒ
Repaglinide (used to treat diabetes).
ƒ
Medicines to treat stomach ulcers.
Always tell your doctor or pharmacist about all the medicines you
are taking. This means medicines you have bought yourself as well
as medicines on prescription from your doctor.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or intend to become pregnant.
Experience with Neoral in pregnancy is limited. In general, Neoral
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 risks of taking it during pregnancy.
Tell your doctor if you are breast-feeding. Breast-feeding is not
recommended during treatment with Neoral since ciclosporin, the
active ingredient in Neoral, passes into breast milk and may affect
your baby.

Will there be any problems with driving or using
machinery?

No problems have been reported. However, Neoral does contain a
small amount of alcohol. See the section below containing
information on some of the ingredients of Neoral.

Page 1 of 2

ƒ

ƒ

ƒ
ƒ
ƒ
ƒ

ƒ

The dose of this medicine needs to be carefully adjusted by
your doctor. You will, therefore, have regular blood tests and
visits to the hospital. This will give you the chance to talk to
your doctor about your treatment and mention any problems
you are having.
Ciclosporin can affect how the liver and kidneys work. It can
also affect blood pressure, and the composition of the blood.
Your doctor will want to perform tests from time to time while
you are being treated with Neoral.
Because ciclosporin dampens down the immune system you
are more prone to catch infections and they can become very
serious. If you experience vision changes, loss of
coordination, clumsiness, memory loss, difficulty speaking or
understanding what others say, and muscle weakness, these
can be the signs and symptoms of an infection of the brain
called progressive multifocal leukoencephalopathy. Contact
your doctor as soon as you feel unwell.
There have been very rare reports of people developing a
condition called Benign Intracranial Hypertension when they
are being treated with ciclosporin. Tell your doctor as soon as
possible if you start to feel nauseous, develop tinnitus (ringing
in your ears), or get pains in your head, neck or back, or
problems with your sight, balance or memory.
Before giving you Neoral to treat psoriasis, the doctor will
examine you to make sure that you do not have any skin
cancers or pre-cancers.
You must not have light treatment (PUVA or other UV
treatment) for psoriasis while you are taking Neoral.
Do not go out into the sun too much without protecting your
skin.
You must not eat grapefruit or drink grapefruit juice in the
hour before you take the capsules.
If you have recently had a vaccination or are planning to have
any vaccinations make sure the doctor or nurse knows you
are taking Neoral.
You must visit the dentist regularly while you are taking
Neoral to make sure that your gums remain healthy.

Important information about some of the ingredients
of Neoral

Neoral contains:
ƒ
Polyoxyl 40 hydrogenated castor oil which may cause stomach
upsets and diarrhoea.
ƒ
11.8% ethanol (alcohol). A 500mg dose of Neoral contains
500mg of ethanol equivalent to nearly three teaspoons of
beer or one teaspoon of wine. This may be harmful if you are
suffering from alcoholism and should be taken into account if
you are pregnant or breast-feeding, or if you have liver
disease or epilepsy, or if this medicine is being given to a
child.

3. How to take Neoral
Your doctor will work out the correct dose of Neoral for you
depending on your body weight and your condition. Your doctor will
also tell you how often to take your medicine. Always follow his/her
instructions carefully. The dose will be on the pharmacist’s label.
Check the label carefully. If you are not sure, ask your doctor or
pharmacist. Do not change the dose however well you feel. Keep
taking your medicine for as long as you have been told, unless you
have any problems. In that case, check with your doctor.
Swallow the capsule whole with a mouthful of water. You may drink
more water afterwards. You are usually advised to take Neoral
twice a day.
If you have had an organ or bone marrow transplant the total
dose is usually within the range of 2 to 15mg/kg body weight per
day. Generally, higher doses are used just after your transplant
operation and 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 he may need to do some blood
tests.
For the treatment of severe psoriasis and eczema the total
dose is usually within the range of 2.5 to 5mg/kg body weight per
day.
For the treatment of severe rheumatoid arthritis the total
dose is usually within the range of 2.5 to 4mg/kg body weight per
day.
For the treatment of nephrotic syndrome the total dose is
usually within the range of 2.5 to 5mg/kg body weight per day in
adults and 2.5 to 6mg/kg body weight per day in children.

Has your treatment been switched from other
ciclosporin brands to Neoral?

The absorption of ciclosporin into the blood stream will vary from
brand to brand. Consistent blood levels of ciclosporin are thought to
be particularly important in the prevention of rejection following
transplantation, especially in the longer term.
Because of the difference in absorption of ciclosporin, your doctor
will probably want to monitor you more closely for a short period if
you change to Neoral, to make sure that you get the ideal dose for
you. If your doctor transfers you to Neoral, you should not go back
to another ciclosporin brand unless your doctor tells you to.

What if you forget to take a dose?

If you forget to take a dose, take another one as soon as you
remember, unless it is almost time for your next dose. Then go on
as before.

What if you take too many capsules?

5. How to store Neoral
ƒ
ƒ

ƒ
ƒ

ƒ

ƒ

Do not store above 25°C.
Leave your capsules in the foil. Only remove them when it is
time to take your medicine. You will notice that they have a
strong and distinctive smell.
Store your medicine in a safe place out of the reach and sight
of children. It could harm them.
Do not use this medicine after the expiry date shown on the
carton/blister foil. the expiry date refers to the last day of
each month.
If your medicine appears to be discoloured or shows any other
signs of deterioration, please return it to your pharmacist who
will advise you.
If your doctor decides to stop your treatment, return any
leftover medicine to the pharmacist. Only keep it if your
doctor tells you to. Do not throw it away with your normal
household water or waste. This will help to protect the
environment.

If you accidentally take too much of your medicine, tell your doctor
immediately, or go to your nearest casualty department.

6. Further information

4. Possible side effects

What Neoral contains

Most people who are prescribed Neoral benefit. Like all medicines
though, it can sometimes cause side effects in some people.
If you develop a sore throat, any infections, or begin to feel
generally unwell, see your doctor immediately.

The following side effects have been reported:
More than 10% of people have experienced:

Kidney problems, high blood pressure, headache including
migraine, tremor, increased levels of lipids (for example
cholesterol) in the blood, chest infections, urinary infections and
infection with CMV (cytomegalovirus).

Up to 1 in 10 people have experienced:

Numbness or tingling, loss of appetite, feeling or being sick,
stomach pain, diarrhoea, swollen gums, liver disorders, high level
of uric acid or potassium in the blood, low levels of magnesium in
the blood, muscle pain or cramp, increased hair growth on the
body, tiredness, herpes infection, candida infection, blood
poisoning, skin disorders and cancers and over production of white
blood cells.

Up to 1 in 100 people have experienced:

Seizures, confusion, disorientation, decreased responsiveness,
agitation, sleeplessness, visual disturbances, blindness, coma,
partial paralysis, loss of co-ordination, changes in blood (for
example anaemia), allergic rash, water retention which may cause
swelling and weight increase.

Up to 1 in 1,000 people have experienced:

Each capsule contains 100mg ciclosporin.
The capsules contain the following inactive ingredients:
DL-α-tocopherol, absolute ethanol, propylene glycol, corn oil
mono-di-triglycerides, polyoxyl 40 hydrogenated castor oil,
titanium dioxide (E171), glycerol 85%, gelatine, red printing ink
and black iron oxide (E172).

What Neoral looks like and contents of the pack

Neoral are blue-grey capsules marked with ‘NVR’ and ‘100 mg’.
Packs contain 30 or 50 capsules.

Manufacturer

Neoral is manufactured by: R.P. Scherer GmbH, Eberbach,
Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0027

POM

Leaflet revision and issue date (Ref): 01.06.12
Neoral® and Sandostatin® are registered trademarks of
Novartis AG.
To request a copy of this leaflet in Braille, large print or audio
please call 01302 365000 and ask for the Regulatory Department.

Problems with the nerves that control muscles, inflammation of the
pancreas, high levels of glucose in the blood, muscle weakness,
wasting of muscles, destruction of red blood cells which may be
associated with kidney problems, changes in the menstrual cycle in
women and slight enlarging of the breasts in men.

Up to 1 in 10,000 people have experienced:

Swelling at the back of the eye which may be associated with an
increase in pressure inside the head (benign intracranial
hypertension) and visual disturbances.
Like other medicines that dampen down the immune system,
ciclosporin may cause tumours or other malignancies, particularly
of the skin. It may also make you more likely to get infections
which may be serious. If you experience vision changes, loss of
coordination, clumsiness, memory loss, difficulty speaking or
understanding what others say, and muscle weakness, these can be
the signs and symptoms of an infection of the brain called
progressive multifocal leukoencephalopathy.
A few people have had serious liver problems that have happened
both with and without yellowing of the eyes or skin.
Tell your doctor or pharmacist if you suffer from any of these
effects, or from any other side effects not mentioned in this leaflet.

Page 2 of 2

PATIENT INFORMATION LEAFLET

NEORAL® 100MG SOFT GELATIN CAPSULES
(ciclosporin)
Your medicine is available using the name Neoral 100mg Soft
Gelatin Capsules, but will be referred to as Neoral throughout this
leaflet.

What you need to know about Neoral

Your doctor has decided that you need this medicine to help treat
your condition.

Please read this leaflet carefully before you
start to take your medicine. It contains
important information.

Keep the leaflet in a safe place because you may want to read it
again.
If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to
someone else. It may not be the right medicine for them even if
their symptoms seem to be the same as yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Neoral is and what it is used for
Things to consider before you start to take Neoral
How to take Neoral
Possible side effects
How to store Neoral
Further information

1. What Neoral is and what it is used for
Neoral is available in four different strengths containing 10, 25, 50
or 100mg of the active ingredient, ciclosporin. Ciclosporin is one of
a group of drugs known as immunosuppressive agents. These drugs
are used to dampen down the body’s immune reactions.
Neoral can be used to treat a number of different conditions as
follows:

After an organ (e.g. kidney, liver, etc.) or bone marrow
transplant

Although you may have had a series of tests before your organ or
bone marrow transplant to ensure that the match between your
body and the transplanted organ or bone marrow is as close as
possible, the donor tissue will still not be identical to your tissue. As
a result, your body's immune system will try to reject the donor
tissue. Neoral helps to stop this rejection response by blocking the
development of special cells which would normally attack the
transplanted tissue.

If you have severe psoriasis or atopic dermatitis (eczema)
These serious skin conditions are thought to be caused by your
immune system over-reacting. Neoral may help to stop this by
suppressing the immune system.

If you have severe rheumatoid arthritis or nephrotic
syndrome

It is thought that rheumatoid arthritis and some forms of nephrotic
syndrome may be caused by inappropriate immune responses in
your body. Neoral may help to stop this by suppressing your
immune system.

2. Things to consider before you start to take
Neoral
Some people MUST NOT take Neoral. Talk to your
doctor if:
ƒ

ƒ
ƒ
ƒ
ƒ

ƒ

ƒ

You think you may be allergic to ciclosporin, or to any of the
other ingredients of Neoral. (These are listed at the end of the
leaflet).
You are taking a drug called tacrolimus.
You are taking a drug called rosuvastatin.
You are breast-feeding.

People with psoriasis or atopic dermatitis MUST NOT be
treated with Neoral if they have kidney problems, if they
have uncontrolled high blood pressure or infections, or if they
have any cancer except skin cancer.
People with rheumatoid arthritis MUST NOT be treated
with Neoral if they are under 18 years old, or if they have
kidney problems, uncontrolled high blood pressure, infections,
or any type of cancer.
People with nephrotic syndrome MUST NOT be treated
with Neoral if they have uncontrolled high blood pressure or
infections, or if they have any type of cancer.

You should also ask yourself these questions before taking
Neoral. If the answer to any of these questions is YES,
discuss your treatment with your doctor or pharmacist
because Neoral might not be the right medicine for you.
ƒ
Have you been told that you have high levels of potassium in
your blood? Are you taking potassium supplements or is your
diet particularly rich in potassium? (Fruit and vegetables are
rich sources of potassium.)
ƒ
Do you have gout or other conditions caused by high levels of
uric acid in your blood?
ƒ
Are you worried about any unusual spots, moles or warts on
your skin?
ƒ
Are you out in the sun a lot, or do you use a sun bed?
ƒ
Do you have any skin infections, including herpes (cold
sores)?
ƒ
Are you pregnant?

Other special warnings
ƒ

ƒ

ƒ

Are you taking other medicines?

Ciclosporin interacts with a large number of other medicines
and this can interfere with your treatment. Tell your doctor or
pharmacist if you are taking any of the following:
ƒ
Medicines to treat heart problems or high blood pressure
such as bosentan, diltiazem, nicardipine, verapamil and
aliskiren.
ƒ
Drugs containing potassium (your doctor will know which
these are).
ƒ
Medicines called NSAIDs used to treat pain and
inflammation. (Some of these can be bought over-thecounter).
ƒ
Medicines to treat infections including antibiotics
(especially erythromycin and clarithromycin) and
antifungal medicines (especially terbinafine and
voriconazole).
ƒ
Oral contraceptives.
ƒ
Medicines for epilepsy.
ƒ
Cholesterol lowering medicines (including statins).
ƒ
Sleeping tablets.
ƒ
Potassium supplements.
ƒ
Diuretics or “water tablets” that affect the amount of
urine you produce and might also affect the level of
potassium in your blood.
ƒ
Danazol (used to treat menstrual disorders,
endometriosis or breast problems).
ƒ
St John's Wort: The herbal remedy St John's Wort
(Hypericum perforatum) should not be taken at the same
time as this medicine. If you are already taking St John's
Wort consult your doctor before stopping the St John's
Wort preparation.
ƒ
Octreotide (known as Sandostatin®).
ƒ
Medicines to treat tuberculosis.
ƒ
Medicines to treat gout.
ƒ
Metoclopramide (used to stop sickness).
ƒ
Melphalan (used to treat lymphomas or tumours).
ƒ
Imatinib (used to treat leukaemia or tumours).
ƒ
Orlistat (used to help weight loss).
ƒ
Ticlopidine (used after a stroke).
ƒ
Corticosteroids (used to treat conditions such as asthma,
allergic conditions, inflammatory conditions including
inflammatory bowel disease, adrenocortical insufficiency and
rheumatic disease).
ƒ
Ursodeoxycholic acid (used to treat gallstones).
ƒ
Protease inhibitors (used to treat Human Immunodeficiency
Virus (HIV)).
ƒ
Tacrolimus, sirolimus and everolimus (other
immunosuppressants).
ƒ
Methotrexate (used to treat tumours, severe psoriasis and
rheumatoid arthritis).
ƒ
Etoposide (used to treat cancer).
ƒ
Repaglinide (used to treat diabetes).
ƒ
Medicines to treat stomach ulcers.
Always tell your doctor or pharmacist about all the medicines you
are taking. This means medicines you have bought yourself as well
as medicines on prescription from your doctor.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or intend to become pregnant.
Experience with Neoral in pregnancy is limited. In general, Neoral
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 risks of taking it during pregnancy.
Tell your doctor if you are breast-feeding. Breast-feeding is not
recommended during treatment with Neoral since ciclosporin, the
active ingredient in Neoral, passes into breast milk and may affect
your baby.

Will there be any problems with driving or using
machinery?

No problems have been reported. However, Neoral does contain a
small amount of alcohol. See the section below containing
information on some of the ingredients of Neoral.

Page 1 of 2

ƒ

ƒ

ƒ
ƒ
ƒ
ƒ

ƒ

The dose of this medicine needs to be carefully adjusted by
your doctor. You will, therefore, have regular blood tests and
visits to the hospital. This will give you the chance to talk to
your doctor about your treatment and mention any problems
you are having.
Ciclosporin can affect how the liver and kidneys work. It can
also affect blood pressure, and the composition of the blood.
Your doctor will want to perform tests from time to time while
you are being treated with Neoral.
Because ciclosporin dampens down the immune system you
are more prone to catch infections and they can become very
serious. If you experience vision changes, loss of
coordination, clumsiness, memory loss, difficulty speaking or
understanding what others say, and muscle weakness, these
can be the signs and symptoms of an infection of the brain
called progressive multifocal leukoencephalopathy. Contact
your doctor as soon as you feel unwell.
There have been very rare reports of people developing a
condition called Benign Intracranial Hypertension when they
are being treated with ciclosporin. Tell your doctor as soon as
possible if you start to feel nauseous, develop tinnitus (ringing
in your ears), or get pains in your head, neck or back, or
problems with your sight, balance or memory.
Before giving you Neoral to treat psoriasis, the doctor will
examine you to make sure that you do not have any skin
cancers or pre-cancers.
You must not have light treatment (PUVA or other UV
treatment) for psoriasis while you are taking Neoral.
Do not go out into the sun too much without protecting your
skin.
You must not eat grapefruit or drink grapefruit juice in the
hour before you take the capsules.
If you have recently had a vaccination or are planning to have
any vaccinations make sure the doctor or nurse knows you
are taking Neoral.
You must visit the dentist regularly while you are taking
Neoral to make sure that your gums remain healthy.

Important information about some of the ingredients
of Neoral

Neoral contains:
ƒ
Polyoxyl 40 hydrogenated castor oil which may cause stomach
upsets and diarrhoea.
ƒ
11.8% ethanol (alcohol). A 500mg dose of Neoral contains
500mg of ethanol equivalent to nearly three teaspoons of
beer or one teaspoon of wine. This may be harmful if you are
suffering from alcoholism and should be taken into account if
you are pregnant or breast-feeding, or if you have liver
disease or epilepsy, or if this medicine is being given to a
child.

3. How to take Neoral
Your doctor will work out the correct dose of Neoral for you
depending on your body weight and your condition. Your doctor will
also tell you how often to take your medicine. Always follow his/her
instructions carefully. The dose will be on the pharmacist’s label.
Check the label carefully. If you are not sure, ask your doctor or
pharmacist. Do not change the dose however well you feel. Keep
taking your medicine for as long as you have been told, unless you
have any problems. In that case, check with your doctor.
Swallow the capsule whole with a mouthful of water. You may drink
more water afterwards. You are usually advised to take Neoral
twice a day.
If you have had an organ or bone marrow transplant the total
dose is usually within the range of 2 to 15mg/kg body weight per
day. Generally, higher doses are used just after your transplant
operation and 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 he may need to do some blood
tests.
For the treatment of severe psoriasis and eczema the total
dose is usually within the range of 2.5 to 5mg/kg body weight per
day.
For the treatment of severe rheumatoid arthritis the total
dose is usually within the range of 2.5 to 4mg/kg body weight per
day.
For the treatment of nephrotic syndrome the total dose is
usually within the range of 2.5 to 5mg/kg body weight per day in
adults and 2.5 to 6mg/kg body weight per day in children.

Has your treatment been switched from other
ciclosporin brands to Neoral?

The absorption of ciclosporin into the blood stream will vary from
brand to brand. Consistent blood levels of ciclosporin are thought to
be particularly important in the prevention of rejection following
transplantation, especially in the longer term.
Because of the difference in absorption of ciclosporin, your doctor
will probably want to monitor you more closely for a short period if
you change to Neoral, to make sure that you get the ideal dose for
you. If your doctor transfers you to Neoral, you should not go back
to another ciclosporin brand unless your doctor tells you to.

What if you forget to take a dose?

If you forget to take a dose, take another one as soon as you
remember, unless it is almost time for your next dose. Then go on
as before.

What if you take too many capsules?

5. How to store Neoral
ƒ
ƒ

ƒ
ƒ

ƒ

ƒ

Do not store above 25°C.
Leave your capsules in the foil. Only remove them when it is
time to take your medicine. You will notice that they have a
strong and distinctive smell.
Store your medicine in a safe place out of the reach and sight
of children. It could harm them.
Do not use this medicine after the expiry date shown on the
carton/blister foil. The expiry date refers to the last day of the
month.
If your medicine appears to be discoloured or shows any other
signs of deterioration, please return it to your pharmacist who
will advise you.
If your doctor decides to stop your treatment, return any
leftover medicine to the pharmacist. Only keep it if your
doctor tells you to. Do not throw it away with your normal
household water or waste. This will help to protect the
environment.

If you accidentally take too much of your medicine, tell your doctor
immediately, or go to your nearest casualty department.

6. Further information

4. Possible side effects

What Neoral contains

Most people who are prescribed Neoral benefit. Like all medicines
though, it can sometimes cause side effects in some people.
If you develop a sore throat, any infections, or begin to feel
generally unwell, see your doctor immediately.

The following side effects have been reported:
More than 10% of people have experienced:

Kidney problems, high blood pressure, headache including
migraine, tremor, increased levels of lipids (for example
cholesterol) in the blood, chest infections, urinary infections and
infection with CMV (cytomegalovirus).

Up to 1 in 10 people have experienced:

Numbness or tingling, loss of appetite, feeling or being sick,
stomach pain, diarrhoea, swollen gums, liver disorders, high level
of uric acid or potassium in the blood, low levels of magnesium in
the blood, muscle pain or cramp, increased hair growth on the
body, tiredness, herpes infection, candida infection, blood
poisoning, skin disorders and cancers and over production of white
blood cells.

Up to 1 in 100 people have experienced:

Seizures, confusion, disorientation, decreased responsiveness,
agitation, sleeplessness, visual disturbances, blindness, coma,
partial paralysis, loss of co-ordination, changes in blood (for
example anaemia), allergic rash, water retention which may cause
swelling and weight increase.

Up to 1 in 1,000 people have experienced:

Problems with the nerves that control muscles, inflammation of the
pancreas, high levels of glucose in the blood, muscle weakness,
wasting of muscles, destruction of red blood cells which may be
associated with kidney problems, changes in the menstrual cycle in
women and slight enlarging of the breasts in men.

Each capsule contains 100mg ciclosporin.
The capsules contain the following inactive ingredients:
DL-α-tocopherol, absolute ethanol, propylene glycol, corn oil
mono-di-triglycerides, polyoxyl 40 hydrogenated castor oil,
titanium dioxide (E171), glycerol 85%, gelatin, red printing ink
and black iron oxide (E172).

What Neoral looks like and contents of the pack

Neoral are blue-grey capsules marked with the Sandoz logo and
'100mg'.
Packs contain 30 or 50 capsules.

Manufacturer

Neoral is manufactured by: R.P. Scherer GmbH, Eberbach,
Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0027

POM

Leaflet revision and issue date (Ref): 01.06.12
Neoral® and Sandostatin® are registered trademarks of
Novartis AG.
To request a copy of this leaflet in Braille, large print or audio
please call 01302 365000 and ask for the Regulatory Department.

Up to 1 in 10,000 people have experienced:

Swelling at the back of the eye which may be associated with an
increase in pressure inside the head (benign intracranial
hypertension) and visual disturbances.
Like other medicines that dampen down the immune system,
ciclosporin may cause tumours or other malignancies, particularly
of the skin. It may also make you more likely to get infections
which may be serious. If you experience vision changes, loss of
coordination, clumsiness, memory loss, difficulty speaking or
understanding what others say, and muscle weakness, these can be
the signs and symptoms of an infection of the brain called
progressive multifocal leukoencephalopathy.
A few people have had serious liver problems that have happened
both with and without yellowing of the eyes or skin.
Tell your doctor or pharmacist if you suffer from any of these
effects, or from any other side effects not mentioned in this leaflet.

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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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