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CAPIMUNE 50 MG SOFT CAPSULES

Active substance(s): CICLOSPORIN

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Capimune 25 mg soft capsules
Capimune 50 mg soft capsules
Capimune 100 mg, soft capsules
(ciclosporin)
Read all of this leaflet carefully, before you start taking the medicine because it
contains important information for you.
• 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 sign of illness are the same as yours.
• If any of the side effects, gets serious, talk your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Capimune soft gel capsules are and what they are used for
2. What you need to know before you take Capimune soft gel capsules
3. How to take Capimune soft gel capsules
4. Possible side effects
5. How to store Capimune soft gel capsules
6. Contents of the pack and other information
1. WHAT CAPIMUNE SOFT GEL CAPSULES ARE AND WHAT THEY ARE USED FOR
What Capimune soft gel capsules are
The name of your medicine is Capimune soft gel capsules. 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 Capimune soft gel capsules are used for and how Capimune soft gel
capsules work
• If you have had an organ transplant, bone marrow and stem cell transplantation, the
function of Capimune soft gel capsules is to control your body’s immune system.
Capimune soft capsules 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, Capimune soft gel capsules 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
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPIMUNE SOFT GEL CAPSULES
If you are taking Capimune soft gel capsules 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 Capimune soft gel capsules:
• 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 Capimune soft capsules and tell your doctor if the above applies to you.
If you are not sure, talk to your doctor before taking Capimune soft capsules.
Warnings and precautions
Before and during treatment with Capimune soft capsules, tell your doctor
straight away:
• if you have any signs of infection, such as fever or a sore throat. Capimune soft
capsules 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 Capimune soft
capsules, tell your doctor straight away.
Sunlight and sun protection
Capimune soft gel capsules 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 Capimune soft 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
Capimune soft capsules. This is because this medicine contains alcohol (see section
below “Capimune soft capsules contains ethanol”).
Monitoring during your treatment with Capimune soft capsules
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 Capimune soft capsules works or why this
medicine has been prescribed for you, ask your doctor.

In addition if you are taking Capimune soft capsules for a non-transplant disease
(intermediary or posterior uveitis and Behçet's uveitis, atopic dermatitis, severe
rheumatoid arthritis or nephrotic syndrome), do not take Capimune soft capsules:
• 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, Capimune soft capsules should be stopped by your doctor.
Do not take Capimune soft capsules if any of the above applies to you. If you are not
sure, talk to your doctor or pharmacist before taking Capimune soft capsules.
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 Capimune soft capsules to
treat your psoriasis or atopic dermatitis, you must not be exposed to any UVB-rays or
phototherapy during treatment.
Children and adolescents
Capimune soft capsules 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)
There is limited experience with Capimune soft capsules 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 Capimune soft capsules
if your condition is particularly severe.
Other medicines and Capimune soft capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
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 Capimune soft capsules 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 Capimune soft capsules) 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 anti-inflammatory medicines such
as diclofenac), fibric acid medicines (used to lower the amount of fat in the blood).
• Nifedipine. This is used to treat high blood pressure and heart pain. You might get
swollen gums that might grow over your teeth if you are taking nifedipine during
your treatment with ciclosporin.
• Digoxin (used to treat heart problems), medicines which lower cholesterol (HMGCoA 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 Capimune soft capsules.
Capimune soft gel capsules with food and drink
Do not take Capimune soft capsules with grapefruit or grapefruit juice. This is because
these can affect how Capimune soft capsules works.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before this any medicine. This is because
these can affect how Capimune soft capsules works.
• Tell your doctor if you are pregnant or intend to become pregnant. Experience
with Capimune soft capsules in pregnancy is limited. In general, Capimune soft
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 potential risks of taking
it during pregnancy.
• Tell your doctor if you are breast-feeding. Breast-feeding is not recommended
during treatment with Capimune soft capsules. This is because ciclosporin, the active
substance, passes into breast milk. This may affect your baby.
Driving and using machines
Capimune soft capsules contains alcohol. This may affect your ability to drive and
use machines.
Capimune soft capsules contains ethanol
Capimune soft capsules 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.

3. HOW TO TAKE CAPIMUNE SOFT GEL 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 Capimune soft capsules to take
Your doctor will work out the correct dose of Capimune soft capsules 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.
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 Capimune soft capsules
Take Capimune soft capsules at the same time every day. This is very important if you
have had a transplant.
How to take Capimune soft capsules
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 Capimune soft capsules
Your doctor will tell you how long you need to take Capimune soft capsules 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 Capimune soft capsules for as long as your doctor tells you.
If you have questions about how long to take Capimune soft capsules, talk to your
doctor or your pharmacist.
If you take more Capimune soft gel capsules 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 Capimune soft gel capsules
• 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 Capimune soft capsules
Do not stop taking Capimune soft capsules unless your doctor tells you to.
Keep taking Capimune soft capsules even if you feel well. Stopping your treatment with
Capimune soft capsules 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
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: 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: may affect up to 1 in 10 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 potassium in your blood,
If any of these affects you severely, tell your doctor.
Uncommon: may affect up to 1 in 100 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.
Rare: may affect up to 1 in 1000 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: may affect up to 1 in 10,000 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.
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 CAPIMUNE SOFT GEL CAPSULES
Keep this medicine out of the sight and reach of children.
There are no special storage precautions for Capimune soft gel capsules
Store in the original package.
Do not use Capimune soft gel capsules after the expiry date, which is stated on the
label. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
to protect the environment.
6. CONTENTS OF THE PACK AND OTHERINFORMATION
What Capimune soft gel capsules contain
The active substance is ciclosporin 25 mg, 50 mg or 100 mg.
The other ingredients are Ethanol anhydrous, Tocopherol acetate, Dyethylene glycol
monoethyl ether, Oleoyl macrogolglycerides, Macrogolglycerol Hydroxystearate,
Gelatin, Glycerol, Propylene glycol, Titanium dioxide (E171), Iron oxide black (E172)
(25 mg and 100 mg), Purified water.
What Capimune soft gel capsules looks like and contents of the pack
Capimune soft gel capsules is available in three strengths:
25 mg which are grey in colour, 50 mg which are white in colour and 100 mg which are
grey in colour
Pack size: The soft capsules are available in aluminium-aluminium blister of:
10, 20, 30, 50, 60 & 100 capsules. Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Mylan, Potters Bar, Hertfordshire, EN6 1TL
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan UK, Potters Bar, Hertfordshire, EN6 1TL
This leaflet was last revised
in 02/2014

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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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