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CICLOSPORIN 100 MG SOFT GELATIN CAPSULES

Active substance(s): CICLOSPORIN

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Neoral® 100 mg Soft Gelatin Capsules

tingling sensation in limbs, weakness of limbs, walking disturbances, headache with or without
nausea and vomiting, vision disturbances including restricted movement of eyeball).

(ciclosporin)
Patient Information Leaflet

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.

This product will be called Neoral Capsules or Neoral in this leaflet.

Children and adolescents

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

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)

-

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.
2.
3.
4.
5.
6.

What Neoral Capsules are and what they are used for
What you need to know before you take Neoral Capsules
How to take Neoral Capsules
Possible side effects
How to store Neoral Capsules
Contents of the pack and other information

1. What Neoral Capsules are and what they are 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.

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 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.

2. What you need to know before you take Neoral Capsules
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:
-

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.

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.
• 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.

Talk to your doctor before taking Neoral:

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.
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,
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).
- 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).
• 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 antiinflammatory 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.

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

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

3. How to take Neoral Capsules

• 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”).

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.

Monitoring during your treatment with Neoral

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.

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.
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,

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.

How much Neoral to take

• 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.

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.

Psoriasis and atopic dermatitis

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

-

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.

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.
• 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.

Switch from Sandimmun to Neoral

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

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.





-

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.

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.

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

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

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.
• 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.

How to take Neoral

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

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

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

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.

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.

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.

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.

5. How to store Neoral Capsules
Keep out of the sight and reach 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 25°C.
Protect from Moisture.
Store in original package.
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.

Keep taking Neoral even if you feel well. Stopping your treatment with Neoral may increase the risk
of your transplanted organ being rejected.

This will help to protect the environment.

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

If your medicine gets discoloured or shows any other signs of deterioration, seek the advice of your
pharmacist.

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
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.
• 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.

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.
• 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.

6. Contents of the pack and other information
Each soft capsule contains 100 mg ciclosporin.
Capsule content: alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oil-mono-ditriglycerides, macrogolglycerol hydroxystearate / polyoxyl hydrogenated castor oil.
Capsule shell: black iron oxide (E 172), titanium dioxide (E 171), glycerol 85%, propylene glycol,
gelatin.
Imprint: carmine (E 120).
100 mg capsule are blue-grey, oblong soft gelatin capsules marked 'NVR 100 mg' in purple ink.
They are available in strengths of 25mg, 50mg and 100mg capsules in packs of 5, 30 or 50
capsules in blister.
Manufactured by: Novartis s.r.o., Na Pankraci 1724/129, 140 00 Prague 4, Czech Republic
Procured from within the EU & repackaged by Product Licence holder:
Kosei Pharma UK Ltd, 956 Buckingham Avenue, Slough Trading Estate, SL1 4NL, UK

Neoral® 100 mg Soft gelatin Capsules,
PL: 39352/0107
Neoral® is a registered trademark of Novartis AG Corporation.
Leaflet date: 18.09.2015

POM

Ciclosporin 100 mg Soft Gelatin Capsules

Children and adolescents

Patient Information Leaflet

Ciclosporin should not be given to children for a non-transplant disease, except for treatment of
nephrotic syndrome.

This product will be called Ciclosporin Capsules or Ciclosporin in this leaflet.

Elderly population (65 years of age and older)

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

There is limited experience with Ciclosporin 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 Ciclosporin if your condition is particularly severe.

-

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.
2.
3.
4.
5.
6.

What Ciclosporin Capsules are and what they are used for
What you need to know before you take Ciclosporin Capsules
How to take Ciclosporin Capsules
Possible side effects
How to store Ciclosporin Capsules
Contents of the pack and other information

1. What Ciclosporin Capsules are and what they are used for
What Ciclosporin is
The name of your medicine is Ciclosporin. 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.

What Ciclosporin is used for and how Ciclosporin works




If you have had an organ transplant, bone marrow and stem cell transplantation, the
function of Ciclosporin is to control your body’s immune system. Ciclosporin 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, Ciclosporin 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.

2. What you need to know before you take Ciclosporin Capsules
If you are taking Ciclosporin 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 Ciclosporin:
-

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 Ciclosporin and tell your doctor if the above applies to you. If you are not sure, talk to
your doctor before taking Ciclosporin.

Warnings and precautions
Before and during treatment with Ciclosporin, tell your doctor straight away:


if you have any signs of infection, such as fever or a sore throat. Ciclosporin 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.
• if you have gout.
• if you need to have a vaccination.
If any of these applies to you before or during treatment with Ciclosporin, tell your doctor straight
away.

Sunlight and sun protection
Ciclosporin 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.

Talk to your doctor before taking Ciclosporin:
• 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 Ciclosporin. This
is because this medicine contains alcohol (see section below “Ciclosporin contains ethanol”).

Monitoring during your treatment with Ciclosporin
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 Ciclosporin works or why this medicine has been prescribed
for you, ask your doctor.
In addition if you are taking Ciclosporin for a non-transplant disease (intermediary or posterior
uveitis and Behçet’s uveitis, atopic dermatitis, severe rheumatoid arthritis or nephrotic syndrome),
do not take Ciclosporin:
• 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, Ciclosporin should be
stopped by your doctor.
Do not take Ciclosporin if any of the above applies to you. If you are not sure, talk to your doctor or
pharmacist before taking Ciclosporin.
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 Ciclosporin to treat your psoriasis or atopic dermatitis, you
must not be exposed to any UVB-rays or phototherapy during treatment.

Other medicines and Ciclosporin
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 Ciclosporin 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
Ciclosporin) 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,
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).
- 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).
• 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 antiinflammatory 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 these applies to you (or you are not sure), talk to your doctor or pharmacist before taking
Ciclosporin.

Ciclosporin with food and drink
Do not take Ciclosporin with grapefruit or grapefruit juice. This is because these can affect how
Ciclosporin works.

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 Ciclosporin during pregnancy.
• Tell your doctor if you are pregnant or intend to become pregnant. Experience with
Ciclosporin in pregnancy is limited. In general, Ciclosporin 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 Ciclosporin. This is because ciclosporin, the active substance, passes into breast
milk. This may affect your baby.

Driving and using machines
Ciclosporin contains alcohol. This may affect your ability to drive and use machines.

Ciclosporin contains ethanol
Ciclosporin 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 problems
or if you are pregnant or breast-feeding. It may also be harmful if this medicine is given to children.

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

3. How to take Ciclosporin Capsules
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.

How much Ciclosporin to take
Your doctor will work out the correct dose of Ciclosporin 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.

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.

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.

Switch from Sandimmun to Ciclosporin
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, Ciclosporin Soft
Gelatin Capsules.
• These medicines all contain ciclosporin as the active ingredient.
• Ciclosporin is a different, improved formulation of ciclosporin compared to Sandimmun.
Ciclosporin is absorbed into your blood better with Ciclosporin 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 Ciclosporin than with Sandimmun.
If your doctor changes you from Sandimmun to Ciclosporin:
• Do not go back to taking Sandimmun unless your doctor tells you to.
• Following your transfer from Sandimmun to Ciclosporin, 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.

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

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

How long to take Ciclosporin
Your doctor will tell you how long you need to take Ciclosporin 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 Ciclosporin for as long as your doctor tells you.
If you have questions about how long to take Ciclosporin, talk to your doctor or your pharmacist.

If you take more Ciclosporin 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.

If you forget to take Ciclosporin
• 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 Ciclosporin
Do not stop taking Ciclosporin unless your doctor tells you to.
Keep taking Ciclosporin even if you feel well. Stopping your treatment with Ciclosporin 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.

4. Possible side effects

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.

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.
• 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.
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.

5. How to store Ciclosporin Capsules
Keep out of the sight and reach 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 25°C.
Protect from Moisture.
Store in original package.
Do not take Ciclosporin 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.
If your medicine gets discoloured or shows any other signs of deterioration, seek the advice of your
pharmacist.

6. Contents of the pack and other information
Each soft capsule contains 100 mg ciclosporin.

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

Capsule content: alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oil-mono-ditriglycerides, macrogolglycerol hydroxystearate / polyoxyl hydrogenated castor oil.

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

Capsule shell: black iron oxide (E 172), titanium dioxide (E 171), glycerol 85%, propylene glycol,
gelatin.










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.
• 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.

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.
• 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.

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,
disorientation, 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.

Imprint: carmine (E 120).
100 mg capsule are blue-grey, oblong soft gelatin capsules marked 'NVR 100 mg' in purple ink.
They are available in strengths of 25mg, 50mg and 100mg capsules in packs of 5, 30 or 50
capsules in blister.
Manufactured by: Novartis s.r.o., Na Pankraci 1724/129, 140 00 Prague 4, Czech Republic
Procured from within the EU & repackaged by Product Licence holder:
Kosei Pharma UK Ltd, 956 Buckingham Avenue, Slough Trading Estate, SL1 4NL, UK

Ciclosporin 100 mg Soft gelatin Capsules,
PL: 39352/0107
Leaflet date: 18.09.2015

POM

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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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