Skip to Content

NEORAL 100MG SOFT GELATIN CAPSULES

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT

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. Other strengths, 10mg, 25mg & 50mg are also
available.

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.
2.
3.
4.
5.
6.

What Neoral is and what it is used for
What you need to know before you take Neoral
How to take Neoral
Possible side effects
How to store Neoral
Contents of the pack and other information

1. What Neoral is and what it is used for
What Neoral is

The name of your medicine is Neoral. 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 Neoral is used for and how Neoral works




If you have had an organ transplant, bone marrow
and stem cell transplantation, the function of Neoral
is to control your body’s immune system. Neoral
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,
Neoral 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.

Talk to your doctor before taking Neoral:


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 Neoral. This is because this
medicine contains alcohol (see section “Neoral contains
ethanol”).

Monitoring during your treatment with Neoral

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 Neoral works or why
this medicine has been prescribed for you, ask your doctor.
In addition if you are taking Neoral for a
non-transplant disease (intermediary or posterior uveitis
and Behçet's uveitis, atopic dermatitis, severe rheumatoid
arthritis or nephrotic syndrome), do not take Neoral:

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,
Neoral should be stopped by your doctor.
Do not take Neoral if any of the above applies to you. If you
are not sure, talk to your doctor or pharmacist before taking
Neoral.
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 Neoral to treat your psoriasis or atopic
dermatitis, you must not be exposed to any UVB-rays or
phototherapy during treatment.

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 Neoral.


Neoral with food and drink

Do not take Neoral with grapefruit or grapefruit juice. This is
because these can affect how Neoral 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 Neoral during pregnancy.

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 potential risks of taking it during
pregnancy.

Tell your doctor if you are breast-feeding. Breastfeeding is not recommended during treatment with
Neoral. This is because ciclosporin, the active substance,
passes into breast milk. This may affect your baby.

Driving and using machines

Neoral contains alcohol. This may affect your ability to drive
and use machines.

Neoral contains ethanol

Neoral contains approximately 12.0 vol.% ethanol (alcohol),
which corresponds to up to 500mg per dose used in
transplant patients. This is equivalent to nearly 15ml beer or
5ml 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.

Neoral contains polyoxyl 40 hydrogenated castor oil

Neoral contains polyoxyl 40 hydrogenated castor oil, which
may cause stomach discomfort and diarrhoea.

3. How to take Neoral

Children and adolescents

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.

Elderly population (65 years of age and older)

There is limited experience with Neoral 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 Neoral if your condition is
particularly severe.

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.

The advice in this leaflet may vary depending on whether you
are taking the medicine for a transplant or for an autoimmune
disease.

Other medicines and Neoral

How much Neoral to take

Follow all your doctor’s instructions carefully. They may differ
from the general information contained in this leaflet.

In particular tell your doctor or pharmacist if you are taking
any of the following medicines before or during Neoral
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 Neoral) 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 azithromycin), 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 phenytoin),
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).

2. What you need to know before you take
Neoral
If you are taking Neoral following a transplant it will only be
prescribed for you by a doctor with experience in transplants
and/or autoimmune diseases.

Do not take Neoral:

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 Neoral and tell your doctor if the above applies
to you. If you are not sure, talk to your doctor before taking
Neoral.


Warnings and precautions
Before and during treatment with Neoral, tell your
doctor straight away:

if you have any signs of infection, such as fever or a
sore throat. Neoral 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 Neoral, tell your doctor straight away.


Sunlight and sun protection

Neoral 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.

Neoral should not be given to children for a non-transplant
disease, except for treatment of nephrotic syndrome.

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

Page 1 of 2

Your doctor will work out the correct dose of Neoral 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 2mg
and 15mg 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 5mg
and 7mg per kilogram body weight. This is divided
in two doses.

Nephrotic syndrome


The total dose each day for adults is usually 5mg
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
2.5mg per kilogram body weight.

Severe rheumatoid arthritis


The total dose each day is usually between 3mg
per kilogram of your body weight and 5mg per
kilogram body weight. This is divided in two doses.

Psoriasis and atopic dermatitis




The total dose each day is usually between 2.5mg
per kilogram of your body weight and 5mg per
kilogram body weight. This is divided in two doses.

In children:
Nephrotic syndrome

The total dose each day for children is usually 6mg
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
2.5mg per kilogram body weight.
Follow your doctor's instructions exactly and never change
the dose yourself, even if you feel well.


Switch from Sandimmun to Neoral

You may have already been taking another medicine called
Sandimmun Soft Gelatin Capsules or Sandimmun Oral
Solution. Your doctor may decide to change to this medicine,
Neoral Soft Gelatin Capsules.

These medicines all contain ciclosporin as the active
ingredient.

Neoral is a different, improved formulation of ciclosporin
compared to Sandimmun. Ciclosporin is absorbed into
your blood better with Neoral and absorption is less
likely to be affected by taking the medicine with food.
This means that the levels of ciclosporin in your blood
stay more constant with Neoral than with Sandimmun.
If your doctor changes you from Sandimmun to Neoral:

Do not go back to taking Sandimmun unless your doctor
tells you to.

Following your transfer from Sandimmun to Neoral, your
doctor will monitor you more closely for a short time.
This is because of the change in how ciclosporin is
absorbed into your blood. Your doctor will make sure
that you get the right dose for your individual needs.

You may have some side effects. If this happens, tell
your doctor or pharmacist. Your dose may need to be
lowered. Never lower your dose yourself, unless a doctor
has told you to.

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 Neoral

Take Neoral at the same time every day. This is very
important if you have had a transplant.

How to take Neoral

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.















If

Uncommon side effects: These side effects may affect
between 1 and 10 in every 1,000 people.







Your daily doses should always be taken in 2 divided doses.
Remove the capsules from the blister. Swallow the capsules
whole with water.

If

How long to take Neoral



Your doctor will tell you how long you need to take Neoral 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 Neoral for as long as your doctor tells you.
If you have questions about how long to take Neoral, talk to
your doctor or your pharmacist.

If you take more Neoral 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 Neoral




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 Neoral

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:












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.

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.
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.





If

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.
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.


Do not stop taking Neoral unless your doctor tells you to.
Keep taking Neoral even if you feel well. Stopping your
treatment with Neoral may increase the risk of your
transplanted organ being rejected.

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.
any of these affects you severely, tell your doctor.





If

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.
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 Neoral










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.

Page 2 of 2

6. Contents of the pack and other
information
What Neoral contains

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 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): 09.09.16
Neoral® and Sandostatin® are registered trademarks of
Novartis AG.

Other Formats

To listen to or request a copy of this leaflet in Braille, large
print or audio please call: 01302 365000 and ask for the
Regulatory Department.
Please be ready to give the following information:
Product name:
Neoral 100mg Soft Gelatin
Capsules
Reference number:
08929/0027

Expand Transcript

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.

Hide