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CAPIMUNE 100 MG SOFT CAPSULES

Active substance(s): CICLOSPORIN / 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 you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

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

• 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.

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.

Other medicines and Capimune soft capsules

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

In particular tell your doctor or pharmacist if you are taking
any of the following medicines before or during Capimune
soft capsules treatment:

2. What you need to know before you take
Capimune Soft 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

Talk to your doctor or pharmacist before and while
taking Capimune Soft Capsules• 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).

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.

• M
 edicines that may affect your potassium levels. These
include medicines which contain potassium, potassium
supplements, water tablets (diuretics) called potassiumsparing diuretics and some medicines which lower your
blood pressure.
• M
 ethotrexate. This is used to treat tumours, severe
psoriasis and severe rheumatoid arthritis.
• M
 edicines 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.
• M
 edicines 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).
• M
 edicines 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), antibacterial 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).
 edicines which may affect your kidneys. These include:
• M
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).
 ifedipine. This is used to treat high blood pressure and
• N
heart pain. You might get swollen gums that might grow
over your teeth if you are taking nifedipine during your
treatment with ciclosporin.
• D
 igoxin (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 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 work.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine

Pregnancy

• T
 ell 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.

Breast-feeding

• T
 ell your doctor if you are breast-feeding. Breastfeeding 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 contain 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.

784401

530

Description Ciclosporin 25 mg,50 mg,100 mg 50,60,100,10,20,30
Component Type LeafletInsert
Affiliate Item Code 784401
Superceded Affiliate Item Code 379679
TrackWise PR No. 784401
MA No. 04569/0939 - 0941
Packing Site/Printer NA
Supplier Code 084773

Pharma Code 530
SAP No. NA
Vendor Job No. 270377
Trackwise Proof No. 3
Glams Proof No. NA
Client Market United Kingdom
Keyline/Drawing No. NA
Barcode Info NA

Date: 21 Mar 2016
No. of colours
Colours

1

Time: 17:19
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 180 x 590 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

3. How to take Capimune Soft Capsules
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist 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.

• Adults:
Organ, bone marrow and stem cell transplantation:
• T he 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

• T he total dose each day is usually between 5 mg and
7 mg per kilogram body weight. This is divided in
two doses.

Nephrotic syndrome

• T he 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

• T he 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

• T he 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.

Children and adolescents
Nephrotic syndrome

• T he 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

• I f 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:
Very common (may affect more than 1 in 10 people):
• Kidney problems which may greatly reduce the amount
of urine you produce
Uncommon (may affect up to 1 in 100 people):
• 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.
Rare (may affect up to 1 in 1,000 people):
• 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.

against infection and may cause tumours or other
cancers, particularly of the skin. Signs of infection might
be fever or sore throat.
• C
 hanges 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.
Other possible side effects include:
Very common (may affect more than 1 in 10 people):
• Kidney problems.
• H
 igh blood pressure.
• Headache.
• S haking of your body which you cannot control.
• E xcessive growth of body and facial hair.
• H
 igh level of lipids in your blood.
Common (may affect up to 1 in 10 people):
• Fits (seizures).
• Liver problems.
• H
 igh level of sugar in your blood.
• Tiredness.
• L oss of appetite.
 ausea (feeling sick), vomiting, abdominal pain,
• N
constipation, diarrhoea.
• E xcessive hair growth.
• Acne,
• Hot flushes.
• Fever.
• L ow level of white blood cells.
• F eeling numb or tingling.
• P
 ain in your muscles, muscle spasm.
• Stomach ulcer.
 um tissue overgrowing and covering your teeth.
• G
• H
 igh level of uric acid or potassium in your blood.
Uncommon (may affect up to 1 in 100 people):
• S ymptoms 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.
• L ow level of red blood cells, low level of platelets in your
blood which could increase the risk of bleeding.
Rare (may affect up to 1 in 1000 people):
• N
 erve problems with numbness or tingling in fingers
and toes.
• I nflammation of the pancreas with severe upper
stomach pain.
• M
 uscle weakness, loss of muscle strength, pain in
muscles of the legs or hands or anywhere in the body.
• D
 estruction 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.
• C
 hanges in menstrual cycle, breast enlargement in men.
Very rare (may affect up to 1 in 10,000 people):
• S welling at the back of the eye which may be associated
with an increase in pressure inside the head and eyesight
disturbances.
Not known (frequency cannot be estimated from the
available data):
• S erious 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. Pain in the legs which may
include a condition called calcineurin-induced pain
syndrome (CIPS).
• B
 leeding underneath the skin or purple skin patched,
sudden bleeding with no apparent cause.
• M
 igraine or severe headache often with feeling and
being sick (nausea, vomiting) and being sensitive
to light.
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 this medicine after the expiry date, which is
stated on the label after EXP. 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
protect the environment.

6. Content of the pack and other information
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) (25mg and 100mg), Purified water.

What Capimune soft gel capsules looks like and
contents of the pack

Capimune soft gel capsules is available in three strengths:
25mg which are grey in colour, 50mg which are white in
colour and 100mg which are grey in colour
Pack size: The soft capsules are available in aluminiumaluminium blister of:
10, 20, 30, 50, 60 & 100 capsules. Not all pack sizes may
be marketed

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13
Ireland
Generics (UK) Ltd, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
This leaflet was last revised in 12/2015

Very rare (may affect up to 1 in 10,000 people):
• 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).

Description Ciclosporin 25 mg,50 mg,100 mg 50,60,100,10,20,30
Component Type LeafletInsert
Affiliate Item Code 784401
Superceded Affiliate Item Code 379679
TrackWise PR No. 784401
MA No. 04569/0939 - 0941
Packing Site/Printer NA
Supplier Code 084773

Pharma Code 530
SAP No. NA
Vendor Job No. 270377
Trackwise Proof No. 3
Glams Proof No. NA
Client Market United Kingdom
Keyline/Drawing No. NA
Barcode Info NA

084773 / LAETUS-530

Not known (frequency cannot be estimated from the
available data):
• Liver problems and damage with or without yellow skin
and eyes, nausea, loss of appetite and dark urine.
• Like other medicines that act on the immune system,
ciclosporin may influence your body’s ability to fight

Date: 21 Mar 2016
No. of colours
Colours

1

Time: 17:19
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 180 x 590 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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