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NEORAL 50MG SOFT GELATIN CAPSULES

Active substance(s): CICLOSPORIN / CICLOSPORIN A

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

6. Contents of the pack and other information





The active substance in Neoral is ciclosporin. Each Soft Gelatin
Capsule contains 50mg of active substance ciclosporin.



The other ingredients are: DL-α tocopherol, ethanol absolute,
propylene glycol, corn oil mono-di-triglycerides, polyoxyl 40
hydrogenated castor oil. Capsule shell: glycerol 85%, gelatin,
titanium dioxide (E171).

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.

What Neoral Capsules look like and contents of the pack



Low level of red blood cells, low level of platelets in your blood
which could increase the risk of bleeding.

Neoral Soft Gelatin Capsules are Cream and marked ‘NVR 50mg’
in purple.

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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

What Neoral Capsules contains



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

S1144 LEAFLET Neoral 20150910

NEORAL® 50mg SOFT GELATIN CAPSULES
(ciclosporin)

Information for other strengths of Neoral Capsules also may be
present in this leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.



Pain in legs and feet

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.



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 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 get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.



if you have gout.



if you need to have a vaccination.

Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, Middlesex, HA0 1DX.
Manufacturer
This product is manufactured by Novartis Pharma GmbH,
Roonstrasse 25, D-90429 Nuremberg, Germany.
POM

PLPI 19488/1144

What is in this leaflet
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 doctor straight away.

2. What you need to know before you take Neoral

Sunlight and sun protection

3. How to take Neoral

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:

4. Possible side effects

S1144 LEAFLET Neoral 20150910

Migraine or severe headache often with feeling and being sick
(nausea, vomiting) and being sensitive to light.









if you have kidney problems. Your doctor will carry out regular
blood tests and may change your dose if necessary.

Product Licence holder

6. Contents of the pack and other information

Bleeding underneath the skin or purple skin patched, sudden
bleeding with no apparent cause.



If you have any further questions, ask your doctor or
pharmacist.

5. How to store Neoral



if you have liver problems.



Neoral is a registered trade mark of Novartis AG, Switzerland.

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.



Neoral Capsules are available as blister packs of 30 and 50
capsules.

Leaflet revision date: 10 September 2015



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.

Keep this leaflet. You may need to read it again.

Very rare side effects: These side effects may affect between 1
and 10 in every 100,000 people.

Other side effects with frequency not known: Frequency cannot
be estimated from the available data.



Your medicine is known as Neoral 50mg Soft Gelatin Capsules but
will be referred to as Neoral Capsules or Neoral in this leaflet.

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

If this affects you severely, tell your doctor.

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



Changes in menstrual cycle, breast enlargement in men.

Swelling at the back of the eye which may be associated with
an increase in pressure inside the head and eyesight
disturbances.

Warnings and precautions

1. What Neoral is and what it is used for



Wearing appropriate protective clothing.



Often applying a sunscreen with a high protection factor.

Talk to your doctor before taking Neoral:

What Neoral is



if you have or have had alcohol-related problems.

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.



if you have epilepsy.



if you have any liver problems.



if you are pregnant.

What Neoral is used for and how Neoral works



if you are breast-feeding.



if this medicine is being prescribed for a child.





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.

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.

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).

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 at: www.mhra.gov.uk/yellowcard. By reporting side effects,
you can help provide more information on the safety of this
medicine.

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:

5. How to store Neoral capsules





if you are allergic to ciclosporin or any of the other ingredients
of this medicine (listed in section 6).

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.





Do not store above 25°C. Store in the original package.

with products containing Hypericum perforatum (St John´s
Wort).



Do not use after the expiry date printed on the carton or blister
label.



If your doctor tells you to stop taking the capsules, please take
them back to the pharmacist for safe disposal. Only keep the
capsules if your doctor tells you to.



If the capsules become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Do not throw them away with your normal household water or
waste. This will help to protect the environment.



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.

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.

Neoral with food and drink

Psoriasis and atopic dermatitis

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



Pregnancy and breast-feeding
Children and adolescents
Neoral should not be given to children for a non-transplant disease,
except for treatment of nephrotic syndrome.





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.

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 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.



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.

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









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 antifungal medicine used to treat infections of the toes and
nails).

Medicines which may affect your kidneys. These include: antibacterial 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.

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.

Neoral contains ethanol

Methotrexate. This is used to treat tumours, severe psoriasis
and severe rheumatoid arthritis.

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).



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



In children:



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.



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.

After you change from one oral formulation of ciclosporin to
another:

Do not take more than the recommended dose.



Your doctor will monitor you more closely for a short time.

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.



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.

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.



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.



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.

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



Headache.



Shaking of your body which you cannot control.

How to take Neoral



Excessive growth of body and facial hair.

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



High level of lipids in your blood.

How long to take Neoral

Common side effects: These side effects may affect between 1
and 10 in every 100 people.

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.

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



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.

 Do not take a double dose to make up for a forgotten dose.
If you stop taking Neoral



Stomach ulcer.



Gum tissue overgrowing and covering your teeth.

Do not stop taking Neoral unless your doctor tells you to.



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 accidentally take too much of your medicine, tell your doctor
immediately or go to your nearest hospital emergency unit. You
may need medical attention.

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

Tell your doctor straight away if you notice any of the following
serious side effects:







Some side effects could be serious



If you take more Neoral than you should

Nephrotic syndrome

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

When to take Neoral

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.

4. Possible side effects

If your doctor changes you from Sandimmun to Neoral:

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

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

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

Nephrotic syndrome

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.

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 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.

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 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.

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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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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