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NEORAL25MG SOFT GELATIN CAPSULES

Active substance(s): CICLOSPORIN

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PATIENT INFORMATION LEAFLET

1815/ 1816/ 1817
22.10.15[11]

Neoral® 25mg Soft Gelatin Capsules
Neoral® 50mg Soft Gelatin Capsules
Neoral® 100mg Soft Gelatin Capsules
(ciclosporin)
This product will be called Neoral in this leaflet.
This product is also available in 10 mg strength.
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 Neoral is and what it is used for
2. What you need to know before you take Neoral
3. How to take Neoral
4. Possible side effects
5. How to store Neoral
6. Contents of the pack and other information
1. What Neoral is and what it is used for
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 Behcet’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 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.
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 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 these apply 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.
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 below “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.
Children and adolescents
Neoral 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 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.
Other medicines and Neoral
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 Neoral 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 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), antifungals (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 anticonvulsant 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 antidiabetic medicine), immunosuppressives (everolimus, sirolimus),
ambrisentan and specific anti-cancer medicines called anthracyclines
(such as doxorubicin).
If any of these apply 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.
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 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.
Neoral contains castor oil
Neoral contains castor oil, which may cause stomach discomfort and
diarrhoea.
3. How to take Neoral
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 Neoral to take
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 2 mg and 15 mg per
kilogram body weight. This is divided in two doses.
 Usually, higher doses are used before and just after your transplant.
Lower doses are used once your transplanted organ or bone marrow
has stabilised.
 Your doctor will adjust your dose to one that is ideal for you. To do
this, your doctor may need to do some blood tests.
Endogenous uveitis
 The total dose each day is usually between 5 mg and 7 mg per
kilogram body weight. This is divided in two doses.
Nephrotic syndrome
 The total dose each day for adults is usually 5 mg per kilogram body
weight. This is divided in two doses. In patients with kidney problems,
the first dose taken each day should not be more than 2.5 mg per
kilogram body weight.
Severe rheumatoid arthritis
 The total dose each day is usually between 3 mg per kilogram of your
body weight and 5 mg per kilogram body weight. This is divided in
two doses.
Psoriasis and atopic dermatitis
 The total dose each day is usually between 2.5 mg per kilogram of
your body weight and 5 mg per kilogram body weight. This is divided
in two doses.

 In children:

Nephrotic syndrome
 The total dose each day for children is usually 6 mg per kilogram
body weight. This is divided in two doses. In patients with kidney
problems, the first dose taken each day should not be more than 2.5
mg per kilogram body weight.
Follow your doctor’s instructions exactly and never change the dose
yourself, even if you feel well.
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
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 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
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. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Some side effects could be serious
Tell your doctor straight away if you notice any of the following serious
side effects:
 Like other medicines that act on the immune system, ciclosporin may
influence your body’s ability to fight against infection and may cause
tumours or other cancers, particularly of the skin. Signs of infection
might be fever or sore throat.
 Changes in your sight, loss of coordination, being clumsy, memory loss,
difficulty speaking or understanding what others say, and muscle
weakness. These might be signs of an infection of the brain called
progressive multifocal leukoencephalopathy.
 Brain problems with signs such as seizures, confusion, feeling
disorientated, being less responsive, personality changes, feeling
agitated, sleeplessness, changes to your sight, blindness, coma,
paralysis of part or all of the body, stiff neck, loss of coordination with or
without unusual speech or eye movements.
 Swelling at the back of the eye. This may be associated with blurred
vision. It may also affect your sight because of the higher pressure
inside your head (benign intracranial hypertension).
 Liver problems and damage with or without yellow skin and eyes,
nausea, loss of appetite and dark urine.
 Kidney problems which may greatly reduce the amount of urine you
produce.
 Low level of red blood cells or platelets. The signs include pale skin,
feeling tired, being breathless, having dark urine (this is a sign of the
breakdown of red blood cells), bruising or bleeding with no obvious
reasons, feeling confused, feeling disorientated, being less alert and
having kidney problems.
Other side effects include:
Very common side effects: These side effects may affect more than 1 in
10 people.
 Kidney problems.
 High blood pressure.
 Headache.
 Shaking of your body which you cannot control.
 Excessive growth of body and facial hair.
 High level of lipids in your blood.
If any of these affects you severely, tell your doctor.
Common side effects: These side effects may affect between 1 and 10
in every 100 people.
 Fits (seizures).
 Liver problems.
 High level of sugar in your blood.
 Tiredness.
 Loss of appetite.
 Nausea (feeling sick), vomiting, abdominal pain, constipation,
diarrhoea.
 Excessive hair growth.
 Acne, hot flushes.
 Fever.
 Low level of white blood cells.
 Feeling numb or tingling.
 Pain in your muscles, muscle spasm.
 Stomach ulcer.
 Gum tissue overgrowing and covering your teeth.
 High level of uric acid or potassium in your blood, low levels of
magnesium in your blood.
If any of these affects you severely, tell your doctor.
Uncommon side effects: These side effects may affect between 1 and
10 in every 1,000 people.
 Symptoms of brain disorders including sudden fits, mental confusion,
sleeplessness, disorientation, disturbance of vision, unconsciousness,
sense of weakness in the limbs, impaired movements.
 Rash.
 General swelling.
 Weight gain.
 Low level of red blood cells, low level of platelets in your blood which
could increase the risk of bleeding.
If any of these affects you severely, tell your doctor.
Rare side effects: These side effects may affect between 1 and 10 in
every 10,000 people.
 Nerve problems with numbness or tingling in fingers and toes.
 Inflammation of the pancreas with severe upper stomach pain.
 Muscle weakness, loss of muscle strength, pain in muscles of the legs
or hands or anywhere in the body.
 Destruction of red blood cells, involving kidney problems with symptoms
such as swelling of the face, stomach, hands and/or feet, decreased
urination, breathing difficulty, chest pain, fits, unconsciousness.
 Changes in menstrual cycle, breast enlargement in men.
If any of these affects you severely, tell your doctor.
Very rare side effects: These side effects may affect between 1 and 10
in every 100,000 people.
 Swelling at the back of the eye which may be associated with an
increase in pressure inside the head and eyesight disturbances.
If this affects you severely, tell your doctor.
Other side effects with frequency not known: Frequency cannot be
estimated from the available data.
 Serious liver problems both with and without yellowing of the eyes or
skin, nausea (feeling sick), loss of appetite, dark coloured urine,
swelling of the face, feet, hands and/or the whole body.
 Bleeding underneath the skin or purple skin patched, sudden bleeding
with no apparent cause.
 Migraine or severe headache often with feeling and being sick (nausea,
vomiting) and being sensitive to light.
 Pain in legs and feet.

If any of these affects you severely, tell your doctor.
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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
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 out of the reach and sight of children.
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.
Do not store above 25°C. Store in the original package.
Do not take Neoral Capsules after the expiry date which is printed on the
outside of the pack.
If your doctor tells you to stop taking the capsules, please take any
unused capsules back to your pharmacist to be destroyed. Do not throw
them away with your normal household water or waste. This will help to
protect the environment.
If your capsules become discoloured or shown any other signs of
deterioration please contact your doctor or pharmacist before taking your
medicine.
6. Contents of the pack and other information
The active ingredient in this medicine is ciclosporin.
Each Neoral soft gelatin capsules contain either 25mg, 50mg or 100mg
ciclosporin as the active ingredient.
Neoral Capsules contain the following inactive ingredients:
DL-alpha-tocopherol, absolute ethanol, propylene glycol, corn oil monodi-triglycerides, polyoxyl 40 hydrogenated castor oil, titanium dioxide
(E171), glycerol 85%, gelatin and red printing ink.
The 25mg and 100mg capsules also contain iron oxide black (E172).
Neoral 25mg Soft Gelatin Capsules are available as blue-grey coloured
soft gelatin capsules marked with the 'NVR' and '25mg'.
Neoral 50mg Soft Gelatin Capsules are available as yellow-white
coloured soft gelatin capsules marked with the 'NVR' and '50mg'.
Neoral 100mg Soft Gelatin Capsules are available as blue-grey coloured
soft gelatin capsules marked with the 'NVR' and '100mg'.
Neoral Capsules come in blister strip packs of 30 or 50 capsules.
Manufacturer and Product Licence Holder
Manufactured by Novartis Pharma Produktions GmbH, Oflinger Strasse
44, 79664 Wehr, Germany. Procured from within the EU by Product
Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow,
Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

POM

Neoral 25mg Soft Gelatin Capsules PL 20636/1815
Neoral 50mg Soft Gelatin Capsules PL 20636/1816
Neoral 100mg Soft Gelatin Capsules PL 20636/1817

Leaflet revision and issue date (Ref.) 22.10.15[11]
Neoral is a trademark of Novartis AG.

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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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