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NEORAL ORAL SOLUTION

Active substance(s): CICLOSPORIN A / CYCLOSPORIN

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

Neoral® Oral Solution

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).

• 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:
Do not take Neoral and tell your doctor if the above applies to you. If you are not
• if you have kidney problems (except for nephrotic syndrome).
Read all of this leaflet carefully before you start taking this medicine because it
sure, talk to your doctor before taking Neoral.
if you have an infection which is not under control with medication.

contains important information for you.
Warnings and precautions
if you have any type of cancer.

– Keep this leaflet. You may need to read it again.
Before and during treatment with Neoral, tell your doctor straight away:
• if you have high blood pressure (hypertension) which is not under control with
– If you have any further questions, ask your doctor or pharmacist.
• if you have any signs of infection, such as fever or a sore throat. Neoral suppresses
medication. If you get high blood pressure during treatment and it cannot be
– This medicine has been prescribed for you only. Do not pass it on to others. It may
the immune system and may also affect your body’s ability to fight against infection.
controlled, Neoral should be stopped by your doctor.
harm them, even if their signs of illness are the same as yours.
• if you have liver problems.
Do
not take Neoral if any of the above applies to you. If you are not sure, talk to your
– If you get any side effects, talk to your doctor or pharmacist. This includes any
• if you have kidney problems. Your doctor will carry out regular blood tests and
doctor or pharmacist before taking Neoral.
possible side effects not listed in this leaflet.
may change your dose if necessary.
If you are being treated for Behçet`s uveitis, your doctor will monitor you particularly
What is in this leaflet
• if you develop high blood pressure. Your doctor will check your blood pressure
carefully if you have neurological symptoms (for example: increased forgetfulness,
1. What Neoral is and what it is used for
regularly and may give you a medicine to lower blood pressure if necessary.
personality changes noticed over time, psychiatric or mood disorders, burning
2. What you need to know before you take Neoral
• if you have low levels of magnesium in your body. Your doctor may give you
sensation in limbs, decreased sensation in limbs, tingling sensation in limbs,
3. How to take Neoral
magnesium supplements to take, especially just after your operation if you have
­weakness of limbs, walking disturbances, headache with or without nausea and
4. Possible side effects
had a transplant.
vomiting, vision disturbances including restricted movement of eyeball).
5. How to store Neoral
• if you have high levels of potassium in your blood.
6. Contents of the pack and other information
• if you have gout.
Your doctor will closely monitor you if you are elderly and are being treated for
• if you need to have a vaccination.
psoriasis or atopic dermatitis. If you have been prescribed Neoral to treat your
1. What Neoral is and what it is used for
If any of the above applies to you before or during treatment with Neoral, tell your
psoriasis or atopic dermatitis, you must not be exposed to any UVB-rays or
What Neoral is
doctor straight away.
­phototherapy during treatment.
The name of your medicine is Neoral. It contains the active substance ciclosporin.
Sunlight
and
sun
protection
This belongs to a group of medicines known as immunosuppressive agents. These
Children and adolescents
Neoral suppresses your immune system. This increases your risk of developing
medicines are used to lower the body’s immune reactions.
Neoral should not be given to children for a non-transplant disease, except for
cancers, particularly of the skin and lymphoid system. You should limit your
treatment of nephrotic syndrome.
What Neoral is used for and how Neoral works
­exposure to sunlight and UV light by:
• If you have had an organ transplant, bone marrow and stem cell transplantation, • Wearing appropriate protective clothing.
Elderly population (65 years of age and older)
the function of Neoral is to control your body’s immune system. Neoral prevents
There is limited experience with Neoral in elderly patients. Your doctor should
• Often applying a sunscreen with a high protection factor.
rejection of transplanted organs by blocking the development of certain cells
monitor how well your kidneys work. If you are over 65 and have psoriasis or atopic
Talk to your doctor before taking Neoral:
which would normally attack the transplanted tissue.
dermatitis, you should only be treated with Neoral if your condition is particularly
• if you have or have had alcohol-related problems.
• If you have an autoimmune disease, in which your body’s immune response
severe.
• if you have epilepsy.
attacks your body’s own cells, Neoral stops this immune reaction. Such diseases
Other medicines and Neoral
• if you have any liver problems.
include eye problems which threaten your vision (endogenous uveitis, including
Tell your doctor or pharmacist if you are taking, have recently taken or might take
if
you
are

pregnant.
Behçet’s uveitis), severe cases of certain skin diseases (atopic dermatitis, or
any other medicines.
• if you are breast-feeding.
eczema and psoriasis), severe rheumatoid arthritis and a kidney disease called

if
this
medicine
is
being
prescribed
for
a
child.
In particular tell your doctor or pharmacist if you are taking any of the following
nephrotic syndrome.
If any of the above apply to you (or you are not sure), tell your doctor before taking
medicines before or during Neoral treatment:
2. What you need to know before you take Neoral
Neoral. This is because this medicine contains alcohol (see section below “Neoral
• Medicines that may affect your potassium levels. These include medicines which
If you are taking Neoral following a transplant it will only be prescribed for you by a
contains ethanol”).
contain potassium, potassium supplements, water tablets (diuretics) called
doctor with experience in transplants and/or autoimmune diseases.
­potassium-sparing diuretics and some medicines which lower your blood pressure.
Monitoring during your treatment with Neoral
• Methotrexate. This is used to treat tumours, severe psoriasis and severe
The advice in this leaflet may vary depending on whether you are taking the mediYour doctor will check:
r­ heumatoid arthritis.
cine for a transplant or for an autoimmune disease.
• the levels of ciclosporin in your blood, especially if you have had a transplant,
ciclosporin

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• 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 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 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. Breast-feeding is not recommended
during treatment with Neoral. This is because ciclosporin, the active substance,
passes into breast milk. This may affect your baby.

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.
Driving and using machines
• In children:
Neoral contains alcohol. This may affect your ability to drive and use machines.
Nephrotic syndrome
– The total dose each day for children is usually 6 mg per kilogram body
Neoral contains ethanol
weight. This is divided in two doses. In patients with kidney problems, the
Neoral contains approximately 12.0 vol. % ethanol (alcohol), which corresponds to
first dose taken each day should not be more than 2.5 mg per kilogram body
up to 500 mg per dose used in transplant patients. This is equivalent to nearly 15 ml
weight.
beer or 5 ml wine per dose.
Follow your doctor’s instructions exactly and never change the dose yourself, even if
Alcohol may be harmful if you have alcohol-related problems, epilepsy, brain injury,
you feel well.
liver problems or if you are pregnant or breast-feeding. It may also be harmful if this
Switch from Sandimmun to Neoral
medicine is given to children.
You may have already been taking another medicine called Sandimmun Soft
Neoral contains castor oil
­Gelatin Capsules or Sandimmun Oral Solution. Your doctor may decide to change
Neoral contains castor oil, which may cause stomach discomfort and diarrhoea.
to this medicine, Neoral Oral Solution.
• These medicines all contain ciclosporin as the active ingredient.
3. How to take Neoral
• Neoral is a different, improved formulation of ciclosporin compared to
Always take this medicine exactly as your doctor has told you. Check with your
­Sandimmun. Ciclosporin is absorbed into your blood better with Neoral and
doctor if you are not sure.
absorption is less likely to be affected by taking the medicine with food. This
Do not take more than the recommended dose.
means that the levels of ciclosporin in your blood stay more constant with
The dose of this medicine will be carefully adjusted to your individual needs by your
­Neoral than with Sandimmun.
doctor. Too much of the medicine can affect your kidneys. You will have regular
If your doctor changes you from Sandimmun to Neoral:
blood tests and visits to the hospital, especially after a transplant. This will give you
• Do not go back to taking Sandimmun unless your doctor tells you to.
the chance to talk to your doctor about your treatment and talk about any problems • Following your transfer from Sandimmun to Neoral, your doctor will monitor you
you may be having.
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
How much Neoral to take
for your individual needs.
Your doctor will work out the correct dose of Neoral for you. This depends on your
You may have some side effects. If this happens, tell your doctor or pharmacist.

body weight and what you are taking the medicine for. Your doctor will also tell you
Your dose may need to be lowered. Never lower your dose yourself, unless a
how often to take your medicine.
doctor has told you to.
• In adults:
If your doctor switches you from one oral formulation of ciclosporin to another
Organ, bone marrow and stem cell transplantation
After you change from one oral formulation of ciclosporin to another:
– The total dose each day is usually between 2 mg and 15 mg per kilogram body
• Your doctor will monitor you more closely for a short time.
weight. This is divided in two doses.
• You may have some side effects. If this happens, tell your doctor or pharmacist.
– Usually, higher doses are used before and just after your transplant. Lower
Your dose may need to be changed. Never change your dose yourself, unless a
doses are used once your transplanted organ or bone marrow has stabilised.
doctor has told you to.
– Your doctor will adjust your dose to one that is ideal for you. To do this, your
When to take Neoral
doctor may need to do some blood tests.
Take Neoral at the same time every day. This is very important if you have had a
Endogenous uveitis
transplant.
– The total dose each day is usually between 5 mg and 7 mg per kilogram body
weight. This is divided in two doses.
How to take Neoral
Nephrotic syndrome
Your daily doses should always be taken in 2 divided doses.
– The total dose each day for adults is usually 5 mg per kilogram body weight.
– For initial use, follow steps 1 to 9.
This is divided in two doses. In patients with kidney problems, the first dose
– For subsequent use, follow steps 5 to 9.
taken each day should not be more than 2.5 mg per kilogram body weight.
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Starting a new bottle of Neoral Oral Solution
1.

2.

Lift the flap in the centre of the metal sealing ring.

Tear off the sealing ring completely.

Measuring your dose
5.

6.

Choose 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.

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.

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 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.

3.

Take off the black stopper and throw it away.

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

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
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.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4.

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

8.

Push the medicine out of the syringe into a small
glass containing liquid, preferably orange or apple
juice.
– Make sure that the syringe does not touch the
liquid in the glass.
– Stir and drink the whole contents of the glass
straight away.

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 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, 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 Neoral
• 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. Do not store below 20°C for more than 1 month.
This is because this product contains oils which can become solid at low temperatures.
• 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.
• 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 Neoral contains
• The active substance is ciclosporin. One ml oral solution contains 100 mg ciclosporin.
• The other ingredients are: DL-alpha-tocopherol, ethanol anhydrous, propylene
glycol, corn oil-mono-di-triglyceride, macrogolglycerol hydroxystearate (Ph.Eur.)/
polyoxyl 40 hydrogenated castor oil (USP).
What Neoral looks like and contents of the pack
Neoral comes in the form of an oral solution. It is a clear, faintly yellow-brownish
liquid.
It is available in a 50 ml glass bottle, with two syringes for measuring the dose.
• 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.
Neoral 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:
Neoral Oral Solution
This leaflet was last revised in January 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.
NEORAL is a registered trade mark.
Copyright Novartis Pharmaceuticals UK Limited.
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30.03.15 15:15

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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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