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NEORAL 100 MG CAPSULES

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Patient Information Leaflet
Neoral® 100 mg Capsules
(ciclosporin)
This name of the product is Neoral® 100 mg capsules but will be known as
Neoral Capsules throughout this leaflet. Other strengths are available.
What you need to know about Neoral Capsules
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to take your
medicine. It contains important information.
Keep the leaflet in a safe place because you may want to read it again.
If you have any other questions, or if there is something you don’t
understand, please ask yourdoctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else. It
may not be the right medicine for them even if their symptoms seem to be
the same as yours.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Neoral Capsules are and what they are used for
2. Things to consider before you start to take Neoral Capsules
3. How to take Neoral Capsules
4. Possible side effects
5. How to store Neoral Capsules
6. Further information

1. What Neoral capsules are and what are they used for
Neoral Capsules are available in four different strengths containing 10, 25,
50 or 100 mg of the active ingredient, ciclosporin. Ciclosporin is one of a
group of drugs known as immunosuppressive agents. These drugs are used
to dampen down the body's immune reactions.
Neoral Capsules can be used to treat a number of different conditions as
follows:
After an organ (e.g. kidney, liver, etc.) or bone marrow transplant
Although you may have had a series of tests before your organ or bone
marrow transplant to ensure that the match between your body and the
transplanted organ or bone marrow is as close as possible, the donor tissue
will still not be identical to your tissue. As a result, your body's immune
system will try to reject the donor tissue. Neoral Capsules help to stop this
rejection response by blocking the development of special cells which would
normally attack
the transplanted tissue.
If you have severe psoriasis or atopic dermatitis (eczema)
These serious skin conditions are thought to be caused by your immune
system over-reacting. Neoral Capsules may help to stop this by suppressing
the immune system.
If you have severe rheumatoid arthritis or nephrotic syndrome
It is thought that rheumatoid arthritis and some forms of nephrotic syndrome
may be caused by inappropriate immune responses in your body. Neoral
Capsules may help to stop this by suppressing your immune system.

2. Things to consider before you start to take Neoral
Capsules
Some people MUST NOT take Neoral Capsules.
Talk to your doctor if:
• You think you may be allergic to ciclosporin, or to any of the other
ingredients of Neoral Capsules. (These are listed at the end of the leaflet.)
• You are taking a drug called tacrolimus.
• You are taking a drug called rosuvastatin.
• You are breastfeeding.
• People with psoriasis or atopic dermatitis MUST NOT be treated with
Neoral Capsules if they have kidney problems, if they have uncontrolled
high blood pressure or infections, or if they have any cancer except skin
cancer.
• People with rheumatoid arthritis MUST NOT be treated with Neoral
Capsules if they are under 18 years old, or if they have kidney problems,
uncontrolled high blood pressure, infections, or any type of cancer.
• People with nephrotic syndrome MUST NOT be treated with Neoral
Capsules if they have uncontrolled high blood pressure or infections, or if
they have any type of cancer.
You should also ask yourself these questions before taking Neoral
Capsules. If the answer to any of these questions is YES, discuss your
treatment with your doctor or pharmacist because Neoral Capsules
might not be the right medicine for you.
• Have you been told that you have high levels of potassium in your blood?
Are you taking potassium supplements or is your diet particularly rich in
potassium? (Fruit and vegetables are rich sources of potassium.)
• Do you have gout or other conditions caused by high levels of uric acid in
your blood?
• Are you worried about any unusual spots, moles or warts on your skin?
• Are you out in the sun a lot, or do you use a sun bed?
• Do you have any skin infections, including herpes (cold sores)?
• Are you pregnant?

Are you taking other medicines?
Ciclosporin interacts with a large number of other medicines and this can
interfere with your treatment. Tell your doctor or pharmacist if you are taking
any of the following:
• Medicines to treat heart problems or high blood pressure such as
bosentan, diltiazem, nicardipine, verapamil and aliskiren.
• Drugs containing potassium (your doctor will know which these are).
• Medicines called NSAIDs used to treat pain and inflammation. (Some of
these can be bought over-the-counter).
• Medicines to treat infections including antibiotics (especially erythromycin
and clarithromycin) and antifungal medicines (especially terbinafine and
voriconazole).
• Oral contraceptives.
• Medicines for epilepsy.
• Cholesterol lowering medicines (including statins).
• Sleeping tablets.
• Potassium supplements.
• Diuretics or “water tablets” that affect the amount of urine you produce
and might also affect the level of potassium in your blood.
• Danazol (used to treat menstrual disorders, endometriosis or breast
problems).
• St John’s Wort: The herbal remedy St John’s Wort (Hypericum
perforatum) should not be taken at the same time as this medicine. If you
are already taking St John’s Wort consult your doctor before stopping the
St John’s Wort preparation.
• Octreotide (known as Sandostatin®).
• Medicines to treat tuberculosis.
• Medicines to treat gout.
• Metoclopramide (used to stop sickness).
• Melphalan (used to treat lymphomas or tumours).
• Imatinib (used to treat leukaemia or tumours).
• Orlistat (used to help weight loss).
• Ticlopidine (used after a stroke).
• Corticosteroids (used to treat conditions such as asthma, allergic
conditions, inflammatory conditions including inflammatory bowel disease,
adrenocortical insufficiency and rheumatic disease).
• Ursodeoxycholic acid (used to treat gallstones).
• Protease inhibitors (used to treat Human Immunodeficiency Virus (HIV)).
• Tacrolimus, sirolimus and everolimus (other immunosuppressants).
• Methotrexate (used to treat tumours, severe psoriasis and rheumatoid
arthritis).
• Etoposide (used to treat cancer).
• Repaglinide (used to treat diabetes).
• Medicines to treat stomach ulcers.
Always tell your doctor or pharmacist about all the medicines you are taking.
This means medicines you have bought yourself as well as medicines on
prescription from your doctor.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or intend to become pregnant.
Experience with Neoral Capsules in pregnancy is limited. In general, Neoral
Capsules 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 risks of
taking it during pregnancy.
Tell your doctor if you are breast-feeding. Breast-feeding is not
recommended during treatment with Neoral Capsules since ciclosporin, the
active ingredient in Neoral Capsules, passes into breast milk and may affect
your baby.
Will there be any problems with driving or using machinery?
No problems have been reported. However, Neoral Capsules do contain a
small amount of alcohol. See the section below containing information on
some of the ingredients of Neoral.
Other special warnings
• The dose of this medicine needs to be carefully adjusted by your doctor.
You will, therefore, have regular blood tests and visits to the hospital. This
will give you the chance to talk to your doctor about your treatment and
mention any problems you are having.
• Ciclosporin can affect how the liver and kidneys work. It can also affect
blood pressure, and the composition of the blood. Your doctor will want to
perform tests from time to time while you are being treated with Neoral
Capsules.
• Because ciclosporin dampens down the immune system you are more
prone to catch infections and they can become very serious. If you
experience vision changes, loss of coordination, clumsiness, memory
loss, difficulty speaking or understanding what others say, and muscle
weakness, these can be the signs and symptoms of an infection of the
brain called progressive multifocal leukoencephalopathy. Contact your
doctor as soon as you feel unwell.
• There have been very rare reports of people developing a condition called
Benign Intracranial Hypertension when they are being treated with
ciclosporin. Tell your doctor as soon as possible if you start to feel
nauseous, develop tinnitus (ringing in your ears), or get pains in your
head, neck or back, or problems with your sight, balance or memory.
• Before giving you Neoral Capsules to treat psoriasis, the doctor will
examine you to make sure that you do not have any skin cancers or precancers.
• You must not have light treatment (PUVA or other UV treatment) for
psoriasis while you are taking Neoral Capsules.
• Do not go out into the sun too much without protecting your skin.
• You must not eat grapefruit or drink grapefruit juice in the hour before you
take the capsules.
• If you have recently had a vaccination or are planning to have any
vaccinations make sure the doctor or nurse knows you are taking Neoral
Capsules.
• You must visit the dentist regularly while you are taking Neoral Capsules
to make sure that your gums remain healthy.

Important information about some of the ingredients of Neoral
Capsules
Neoral Capsules contain:
• Polyoxyl 40 hydrogenated castor oil which may cause stomach upsets
and diarrhoea.
• 11.8% ethanol (alcohol). A 500mg dose of Neoral Capsules contains
500mg of ethanol equivalent to nearly three teaspoons of beer or one
teaspoon of wine. This may be harmful if you are suffering from
alcoholism and should be taken into account if you are pregnant or breast
feeding, or if you have liver disease or epilepsy, or if this medicine is being
given to a child.

3. How to take Neoral Capsules
Your doctor will work out the correct dose of Neoral Capsules for you
depending on your body weight and your condition. Your doctor will also tell
you how often to take your medicine. Always follow his/her instructions
carefully. The dose will be on the pharmacist’s label. Check the label
carefully. If you are not sure, ask your doctor or pharmacist. Do not change
the dose however well you feel. Keep taking your medicine for as long as
you have been told, unless you have any problems. In that case, check with
your doctor.
Swallow the capsule whole with a mouthful of water. You may drink more
water afterwards.
You are usually advised to take Neoral Capsules twice a day.
If you have had an organ or bone marrow transplant the total dose is
usually within the range of 2 to 15 mg/kg body weight per day. Generally,
higher doses are used just after your transplant operation and 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 he may
need to do some blood tests.
For the treatment of severe psoriasis and eczema the total dose is
usually within the range of 2.5 to 5 mg/kg body weight per day.
For the treatment of severe rheumatoid arthritis the total dose is usually
within the range of 2.5 to 4 mg/kg body weight per day.
For the treatment of nephrotic syndrome the total dose is usually within
the range of 2.5 to 5 mg/kg body weight per day in adults and 2.5 to 6 mg/kg
body weight per day in children.
Has your treatment been switched from other ciclosporin brands to
Neoral?
The absorption of ciclosporin into the blood stream will vary from brand to
brand. Consistent blood levels of ciclosporin are thought to be particularly
important in the prevention of rejection following transplantation, especially
in the longer term.
Because of the difference in absorption of ciclosporin, your doctor will
probably want to monitor you more closely for a short period if you change
to Neoral, to make sure that you get the ideal dose for you. If your doctor
transfers you to Neoral, you should not go back to another ciclosporin brand
unless your doctor tells you to.
What if you forget to take a dose?
If you forget to take a dose, take another one as soon as you remember,
unless it is almost time for your next dose. Then go on as before.
What if you take too many capsules?
If you accidentally take too much of your medicine, tell your doctor
immediately, or go to your nearest casualty department.

4. Possible side effects
Most people who are prescribed Neoral Capsules benefit. Like all medicines
though, it can sometimes cause side effects in some people.
If you develop a sore throat, any infections, or begin to feel generally
unwell, see your doctor immediately.
The following side effects have been reported:
More than 10% of people have experienced:
Kidney problems, high blood pressure, headache including migraine,
tremor, increased levels of lipids (for example cholesterol) in the blood,
chest infections, urinary infections and infection with CMV
(cytomegalovirus).
Up to 1 in 10 people have experienced:
Numbness or tingling, loss of appetite, feeling or being sick, stomach pain,
diarrhoea, swollen gums, liver disorders, high level of uric acid or potassium
in the blood, low levels of magnesium in the blood, muscle pain or cramp,
increased hair growth on the body, tiredness, herpes infection, candida
infection, blood poisoning, skin disorders and cancers and over production
of white blood cells.
Up to 1 in 100 people have experienced:
Seizures, confusion, disorientation, decreased responsiveness, agitation,
sleeplessness, visual disturbances, blindness, coma, partial paralysis, loss
of co-ordination, changes in blood (for example anaemia), allergic rash,
water retention which may cause swelling and weight increase.
Up to 1 in 1,000 people have experienced:
Problems with the nerves that control muscles, inflammation of the
pancreas, high levels of glucose in the blood, muscle weakness, wasting of
muscles, destruction of red blood cells which may be associated with kidney
problems, changes in the menstrual cycle in women and slight enlarging of
the breasts in men.

Up to 1 in 10,000 people have experienced:
Swelling at the back of the eye which may be associated with an increase in
pressure inside the head (benign intracranial hypertension) and visual
disturbances.
Like other medicines that dampen down the immune system, ciclosporin
may cause tumours or other malignancies, particularly of the skin. It may
also make you more likely to get infections which may be serious. If you
experience vision changes, loss of coordination, clumsiness, memory loss,
difficulty speaking or understanding what others say, and muscle weakness,
these can be the signs and symptoms of an infection of the brain called
progressive multifocal leukoencephalopathy. A few people have had serious
liver problems that have happened both with and without yellowing of the
eyes or skin.
Tell your doctor or pharmacist if you suffer from any of these effects, or from
any other side effects not mentioned in this leaflet.

5. How to store Neoral Capsules
Keep out of the sight and reach of children.
Store in original package. 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 25oC
Protect from moisture
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.

6. Further information
The soft gelatin capsules contain 100mg of the active ingredient,
ciclosporin. Also contains the following inactive ingredients: DL-αtocopherol, absolute ethanol, propylene glycol, corn oil mono-ditriglycerides, polyoxyl 40 hydrogenated castor oil, titanium dioxide, glycerol
85%, gelatin and black iron oxide (E172). The ink contains carminic acid,
aluminium chloride, sodium hydroxide and hydroxypropylmethylcellulose.
100mg capsules are blue-grey, oblong soft gelatin capsules marked 'NVR
100mg' in purple ink.
Marketed in packs of 30.
Procured within the EU by the Product Licence holder: PilsCo Ltd, 9-15
Springburn Place, East Kilbride, G74 5NU
Neoral 100 mg Capsules PL 39467/0060
Repackaged by TBC

POM

Manufactured by Novartis s.r.o, Gemini, Building B,
Na Pankraci 1724/129, CZ-140 00 Praha 4, Czech Republic
Repackaged by TBC
This leaflet was revised in 13/11/2012.
NEORAL® is a registered trade mark 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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