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NEORAL 25 MG CAPSULES

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Patient Information Leaflet
Neoral® 25 mg Capsules
(ciclosporin)
This name of the product is Neoral® 25 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 your doctor 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 they are 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 pre-cancers.
• 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 coordination, 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 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. It is
important not to store your capsules in a hot place. Do not store above 25oC
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 capsules contain 25 mg of the active ingredient, ciclosporin. Also contain
the following inactive ingredients: DL-α-tocopherol, absolute ethanol,
propylene glycol, corn oil mono-di-triglycerides, polyoxyl 40 hydrogenated
castor oil, titanium dioxide (E171), glycerol 85%, gelatin, carminic acid,
aluminium chloride, sodium hydroxide, hydroxypropylmethylcellulose.
25 mg capsules are blue-grey, oblong soft gelatin capsules marked 'NVR 25mg'
in red ink and plain on the reverse
Marketed in blister packs of 30.
Procured within the EU by the Product Licence holder: PilsCo Ltd, 9-15
Springburn Place, East Kilbride, G74 5NU
POM
Neoral 25 mg Capsules PL 39467/0070
Manufactured by Novartis Pharma GmbH, Roonstrasse 25, D-90429
Nuremburg, Germany
Repackaged by TBC
This leaflet was revised in 11/01/2013.
NEORAL is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited

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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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