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DEXIMUNE 25MG CAPSULES

Active substance: CICLOSPORIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Deximune® 25 mg soft capsules
Deximune® 50 mg soft capsules
Deximune® 100 mg soft capsules
(Ciclosporin)
Read all of this leaflet carefully before you start
taking this 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
symptoms 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.

In addition if you are taking Deximune for a nontransplant disease (atopic dermatitis, severe rheumatoid
arthritis or nephrotic syndrome), do not take Deximune if
you:
• have kidney problems (except for nephrotic syndrome)
• have an infection which is not under control with
medication
• have any type of cancer
• 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,
Deximune should be stopped by your doctor.

What is in this leaflet:
1. What Deximune is and what it is used for
2. What you need to know before you take Deximune
3. How to take Deximune
4. Possible side effects
5. How to store Deximune
6. Contents of the pack and other information

Do not take Deximune if any of the above applies to you. If
you are not sure, talk to your doctor or pharmacist before
taking Deximune.

1. What Deximune is and what it is used for
What Deximune is
The name of your medicine is Deximune. 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 is Deximune used for
• If you have had an organ transplant, bone
marrow and stem cell transplantation, the
function of Deximune is to control your body’s
immune system. Deximune 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,
Deximune stops this immune reaction. Such diseases
include , 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 Deximune
If you are taking Deximune 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 Deximune:
- 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 Deximune and tell your doctor if the above
applies to you. If you are not sure, talk to your doctor before
taking Deximune.
Warnings and precautions
Before and during treatment with Deximune, tell your
doctor straight away if you:
• have any signs of infection, such as fever or a sore throat.
Deximune suppresses the immune system and may also
affect your body’s ability to fight against infection
• have liver problems
• have kidney problems. Your doctor will carry out regular
blood tests and may change your dose if necessary
• develop high blood pressure. Your doctor will check
your blood pressure regularly and may give you a
medicine to lower blood pressure if necessary
• 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
• have high levels of potassium in your blood
• have gout
• need to have a vaccination.
If any of the above applies to you before or during
treatment with Deximune, tell your doctor straight
away.
Sunlight and sun protection
Deximune 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 Deximune if:
• you have or have had alcohol-related problems
• you have epilepsy
• you have any liver problems
• you are pregnant
• you are breast-feeding
• 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 Deximune. This is because this
medicine contains an ingredient which is broken down
into alcohol (see section below “Deximune contains ethyl
lactate”).
Monitoring during your treatment with Deximune
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 Deximune works or
why this medicine has been prescribed for you, ask your
doctor.

Your doctor will closely monitor you if you are
elderly and are being treated for psoriasis or atopic
dermatitis. If you have been prescribed Deximune to
treat your psoriasis or atopic dermatitis, you must not
be exposed to any UVB-rays or phototherapy during
treatment.
Children and adolescents
Deximune should not be given to children for a nontransplant disease, except for treatment of nephrotic
syndrome.
Elderly population (65 years of age and older)
There is limited experience with Deximune 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
Deximune if your condition is particularly severe.
Other medicines and Deximune
Tell your doctor or pharmacist if you are taking any of the
following medicines before or during Deximune treatment.
- Medicines 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.
- 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 Deximune) 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), 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).
- 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 (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
Deximune.
Deximune with food and drink
Do not take Deximune with grapefruit or grapefruit
juice. This is because these can affect how Deximune
works. Deximune Capsules can be taken with or without
food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine. Your doctor will discuss with you the potential
risks of taking Deximune during pregnancy.
• Tell your doctor if you are pregnant or intend to
become pregnant. Experience with Deximune in
pregnancy is limited. In general, Deximune 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. Breastfeeding is not recommended during treatment with
Deximune. This is because ciclosporin, the active
substance, passes into breast milk. This may affect your
baby.
Driving and using machines
Deximune contains ethyl lactate, which is hydrolysed to
alcohol and lactic acid in the gastrointestinal tract. This may
affect your ability to drive and use machines.
Deximune contains ethyl lactate
Deximune contains ethyl lactate that changes into ethanol
(alcohol) and lactic acid in your stomach. The maximum

daily dose of Deximune (5 soft capsules Deximune 100mg,
or 11 soft capsules Deximune 50mg or 21 soft capsules
Deximune 25mg) would result in approximately 680mg of
ethanol, equivalent to 15ml (nearly three teaspoons) of
beer or approximately one teaspoon (6ml) of wine.
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.
Deximune contains lecithin (soya)
Deximune contains lecithin from soya. If you are allergic to
peanut or soya, do not use this medicine.
Deximune contains macrogolglycerol hydroxystearate
Deximune contains macrogolglycerol hydroxystearate. It
may cause stomach upset and diarrhoea.
3. How to take Deximune
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 Deximune to take
Your doctor will work out the correct dose of
Deximune 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 and bone marrow 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.
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 Deximune
Take Deximune at the same time every day. This is very
important if you have had a transplant.
How to take Deximune
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 Deximune
Your doctor will tell you how long you need to take
Deximune for. This depends on whether you are taking
it after a transplant or for the treatment of a severe
skin condition, rheumatoid arthritis or nephrotic
syndrome. For severe atopic dermatitis, the treatment
usually lasts for 8 weeks.
Keep taking Deximune for as long as your doctor tells
you.
If you have questions about how long to take
Deximune, talk to your doctor or your pharmacist.
If you take more Deximune 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 Deximune
• 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 Deximune
Do not stop taking Deximune unless your doctor tells you
to.
Keep taking Deximune even if you feel well. Stopping your
treatment with Deximune 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.

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 (fits),
confusion, feeling disorientated, being less responsive,
personality changes, feeling agitated, sleeplessness,
changes to your sight, blindness, coma, unconsciousness,
paralysis of part or all of the body, sense of weakness
in the limbs, impaired movements, 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 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.
• 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, breathing difficulties, having dark
urine (this is a sign of the breakdown of red blood cells),
bruising or bleeding with no obvious reasons, bleeding
underneath the skin or purple skin patched, feeling
confused, feeling disorientated, being less alert and
having kidney problems, swelling of the face, stomach,
hands and/or feet, decrease urination, chest pain,
fits, unconsciousness.
• High blood pressure
• High level of potassium in your blood
Other side effects include:
Very common side-effects: These side effects may
affect more than 1 in 10 people.
• Headache.
• Shaking of your body which you cannot control.
• Excessive growth of body and facial hair.
• High level of lipids in your blood.
Common side-effects: These side effects may
affect between 1 in 10 and 1 in 100 people.
• High level of sugar in your blood.
• Tiredness.
• Vomiting, abdominal pain, constipation, diarrhoea.
• Acne, hot flushes.
• 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 in your blood, low levels of
magnesium in your blood.
Uncommon side effects: These side effects may affect
between 1 and 10 in every 1,000 people.
• Rash.
• Weight gain.
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.
• Loss of muscle strength.
• Changes in menstrual cycle, breast enlargement in men.
Other side effects with frequency not known: Frequency
cannot be estimated from the available data.
• Migraine or severe headache.
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.
5. How to store Deximune
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is
stated on the package.
• Do not store your capsules in a hot place (maximum
temperature 25°C). Do not refrigerate and/or freeze
• Leave your capsules in the foil. Only remove them when it
is time to take your medicine.
• When a blister is opened, a characteristic smell is
noticeable. This is normal and does not mean that there
is anything wrong with the capsules.
• 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 further information
What Deximune contains
Deximune soft capsules are available in 3 strengths
containing 25mg, 50mg or 100mg of the active
substance, ciclosporin.
All capsule strengths contain the following other
ingredients: polysorbate 20, sorbitan oleate,
lecithin from soya, triglyceride, macrogolglycerol
hydroxystearate, ethyl lactate.
Ingredients of the capsule shell: gelatin, glycerol,
ferric oxide black (E172), titanium dioxide (E171).
What Deximune looks like and contents of the
pack
Deximune 25 mg soft capsules are grey, soft gelatin
capsules with a “DX 25 mg” imprint. Deximune 50 mg soft
capsules are grey, soft gelatin capsules with a “DX 50 mg”
imprint. Deximune 100 mg soft capsules are grey, soft
gelatin capsules with a “DX 100 mg” imprint. There are 30,
50 or 60 capsules in a pack.
Not all pack sizes may be available.
Marketing Authorization Holder and Manufacturer
Dexcel®- Pharma Ltd., 7 Sopwith Way, Drayton Fields,
Daventry, Northamptonshire NN11 8PB, England.
This leaflet was revised in February 2014.
Deximune is a registered Trade Mark.

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

1213720115 / V1016

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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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