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NEORAL SOFT GELATIN CAPSULES 50MG

Active substance(s): CICLOSPORIN / CICLOSPORIN A

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1378520

Neoral

®

1378520 GB

Soft Gelatin Capsules

(ciclosporin)

Patient Information Leaflet
01/04/2015 12:39

Neoral

®

Soft Gelatin Capsules

(ciclosporin)

Patient Information Leaflet

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Package leaflet: Information for the patient

Neoral® Soft Gelatin Capsules 10 mg
Neoral ® Soft Gelatin Capsules 25 mg
Neoral® Soft Gelatin Capsules 50 mg
Neoral® Soft Gelatin Capsules 100 mg
ciclosporin
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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
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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
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.

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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 t­ ransplanted 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.

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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.

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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.

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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.
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• 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.

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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”).

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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.

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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.
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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.

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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.

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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), anti-fungals (voriconazole, itraconazole), medicines used for
heart problems or high blood pressure (diltiazem, nicardipine, verapamil, a
­ miodarone),
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­ etoclopramide (used to stop sickness), oral contraceptives, danazol (used to treat menstrual
m
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).
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• 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.

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• Digoxin (used to treat heart problems), medicines which lower cholesterol (HMG-CoA r­ eductase
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.

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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 t­ reatment
with Neoral. This is because ciclosporin, the active substance, passes into breast milk. This may
affect your baby.

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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 p
­ roblems 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.

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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.

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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.
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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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 r­ esponsive,
personality changes, feeling agitated, sleeplessness, changes to your sight, b
­ lindness, coma,
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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 b
­ reathless,
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.

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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.

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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.
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• 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.

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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, d
­ isorientation,
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.

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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.

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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.

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• 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.

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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.

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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.
Do not store your capsules in a hot place (maximum temperature 25°C).
Leave your capsules in the foil. Only remove them when it is time to take your medicine.
When a blister is opened, a characteristic smell is noticeable. This is normal and does not mean that
there is anything wrong with the capsules.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.

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6. Contents of the pack and other information
What Neoral contains
Neoral Soft Gelatin Capsules 10mg
• The active substance is ciclosporin. Each capsule contains 10 mg ciclosporin.
• The other ingredients are:
Capsule contents: alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oil-mono˚ di-triglycerides, macrogolglycerol hydroxystearate /polyoxyl 40 hydrogenated castor oil.
Capsule shell: Titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin.
˚
Imprint: carminic acid (E 120).

˚

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Neoral Soft Gelatin Capsules 25mg
• The active substance is ciclosporin. Each capsule contains 25 mg ciclosporin.
• The other ingredients are:
Capsule contents: alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oil-mono˚ di-triglycerides, macrogolglycerol hydroxystearate / polyoxyl 40 hydrogenated castor oil.
Capsule shell: Black iron oxide (E172), titanium dioxide (E171), glycerol 85%, propylene glycol,
˚ gelatin.
Imprint: carminic acid (E 120).

˚

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Neoral Soft Gelatin Capsules 50mg
• The active substance is ciclosporin. Each capsule contains 50 mg ciclosporin.
• The other ingredients are:
Capsule content: alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oil-mono˚ di-triglycerides, macrogolglycerol hydroxystearate / polyoxyl 40 hydrogenated castor oil.
Capsule shell: Titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin.
˚
Imprint: carminic acid (E 120).

˚

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Neoral Soft Gelatin Capsules 100mg
• The active substance is ciclosporin. Each capsule contains 100 mg of the active substance
ciclosporin.
• The other ingredients are:
Capsule contents: alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oil-mono˚ di-triglycerides, macrogolglycerol hydroxystearate / polyoxyl 40 hydrogenated castor oil.
Capsule shell: Black iron oxide (E172), titanium dioxide (E171), glycerol 85%, propylene glycol,
˚ gelatin.
Imprint: carminic acid (E 120).

˚

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What Neoral looks like and contents of the pack
Neoral Soft Gelatin Capsules 10mg are yellow to white oval, and marked with “NVR 10” in red.
Neoral Soft Gelatin Capsules 25 mg are blue to grey oval and marked with “NVR 25mg” in red.
Neoral Soft Gelatin Capsules 50 mg are yellow to white oblong and marked with “NVR 50mg” in red.
Neoral Soft Gelatin Capsules 100 mg are blue to grey oblong and marked with “NVR 100mg” in red.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Novartis Pharmaceuticals UK Limited, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, England.

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Neoral Capsules are manufactured by Novartis Pharmaceuticals UK Limited, Wimblehurst Road,
Horsham, West Sussex, RH12 5AB and Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR,
England.
This medicinal product is authorised in the Member States of the EEA under the following
names:
Neoral Soft Gelatin Capsules 10 mg
Neoral Soft Gelatin Capsules 25 mg
Neoral Soft Gelatin Capsules 50 mg
Neoral Soft Gelatin Capsules 100 mg
This leaflet was last revised in - January 2015

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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.

1378520 GB

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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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