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NEORAL 10MG SOFT GELATIN CAPSULES

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S291 LEAFLET Neoral Capsules 20120920

PACKAGE LEAFLET: INFORMATION FOR THE USER

NEORAL 10mg SOFT GELATIN CAPSULES
(ciclosporin)
The name of your medicine is Neoral 10mg Soft Gelatin Capsules
but will be referred to as Neoral Capsules throughout the following
leaflet.

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).

What you need to know about Neoral Capsules



Your doctor has decided that you need this medicine to help treat
your condition.

Medicines called NSAIDs used to treat pain and inflammation.
(Some of these can be bought over-the-counter).



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.

Medicines to treat infections including antibiotics (especially
erythromycin and clarithromycin) and antifungal medicines
(especially terbinafine and voriconazole).

Information for other strengths of Neoral Capsules also may be
present in this leaflet.



Oral contraceptives.

If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.



Medicines for epilepsy.



Cholesterol lowering medicines (including statins).

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.



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.

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.

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 Capsules.
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.

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?

®

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 500 mg dose of Neoral Capsules
contains 500 mg 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.

5. HOW TO STORE NEORAL CAPSULES


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Neoral should not be stored above 25°C. It should be stored in
the aluminium blister. Only remove the capsules from the blister
when it is time to take them.



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



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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.

6. FURTHER INFORMATION
What Neoral Capsules contains


Each soft gelatin capsule contains 10mg of the active
ingredient, ciclosporin.



The capsules also contain DL--tocopherol, absolute ethanol,
propylene glycol, corn oil mono-di-triglycerides, polyoxyl 40
hydrogenated castor oil, red printing ink, gelatin, titanium
dioxide and glycerol.

What Neoral Capsules look like and contents of the pack
Neoral Capsules are cream and marked “NVR” and “10”.
Neoral Capsules are available as blister packs of 30, 50 or 60
capsules.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Novartis Farma S.p.A., Torre
Annunziata, Naples, Italy.
POM

PL No: 19488/0291
th

Leaflet revision date: 20 September 2012
Neoral is a registered trade mark of Novartis AG, Switzerland.
S291 LEAFLET Neoral Capsules 20120920

Expand Transcript

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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