DEXIMUNE 25MG CAPSULES

Active substance: CICLOSPORIN

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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Deximune 25 mg soft capsules
Deximune 50 mg soft capsules
Deximune 100 mg soft capsules
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(Ciclosporin)
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms
are the same as yours.
- If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor.
In this leaflet:
1. What Deximune is and what it is used for
2. Before you take Deximune
3. How to take Deximune
4. Possible side effects
5. How to store Deximune
6. Further information
1. WHAT Deximune IS AND WHAT IT IS USED FOR
Deximune contains the active substance ciclosporin. It is one of a group of medicines known as immunosuppressive
agents. These medicines are used to reduce the activity of the patient’s immune system and, so, the risk of organ
rejection.
If you have received an organ or bone marrow transplant
Although you may have undergone a series of tests before your organ or bone marrow transplant to ensure that the
match between your body and the transplanted organ or bone marrow was as close as possible, the donor tissue will
still not be identical to your tissue. As a result, your body's immune system will try to reject the donor tissue. Deximune
helps to stop this rejection response by blocking the development of special cells which would normally
attack the transplanted tissue.
If you have a severe skin complaint
Some skin conditions, such as severe psoriasis or eczema (atopic dermatitis) are thought to be caused by your immune
system over-reacting. If other medicines have not worked or are not suitable, Deximune may help to stop this by
suppressing the immune system, thereby improving your skin condition.
If you have severe rheumatoid arthritis or nephrotic syndrome
It is thought that rheumatoid arthritis and some forms of nephrotic syndrome (a kidney condition that causes them
to leak large amounts of protein) may be caused by inappropriate immune responses in your body. If other medicines
have not worked or are not suitable, Deximune may help to counter these by suppressing your immune system, thereby
improving your rheumatoid arthritis or nephrotic syndrome.
2. BEFORE YOU TAKE Deximune
Do not take Deximune:
- if you are allergic (hypersensitive) to ciclosporin or any of the other ingredients of Deximune (see section 6).
- if you have psoriasis or eczema (atopic dermatitis) you must not take Deximune if you also have kidney problems,
uncontrolled high blood pressure, uncontrolled infections, or any type of cancer except for skin cancer.
- if you have rheumatoid arthritis you must not take Deximune if you also have kidney problems, uncontrolled high
blood pressure, uncontrolled infections, have any type of cancer or if you are under 18 years of age.
- if you have nephrotic syndrome (a kidney condition that causes them to leak large amounts of protein) you must
not take Deximune if you also have uncontrolled high blood pressure, uncontrolled infections, or have any type of
cancer.
- if you are taking medicine to reduce the activity of the immune system and lower the risk of organ rejection (tacrolimus).
- if you are taking medicine used to treat high cholesterol and to prevent cardiovascular disease (rosuvastatin).
- if you are breast-feeding.
- if you are taking herbal medicines containing St. John’s Wort.
Take special care with Deximune:
You should contact your doctor if you:
- have any liver problems or you have had any disease which may have affected your liver
- have high levels of potassium in your blood, are taking potassium supplements, are taking medicine that increase
the level of potassium in your blood, or your diet is particularly rich in potassium
- have gout (recurrent attacks of acute inflammatory arthritis) or any skin conditions (such as cold sores), other than
severe psoriasis or severe eczema
- recently received vaccinations or you plan to have any vaccinations
- are likely to be exposed to the sun a great deal without protecting your skin with a sun block cream, if you regularly
use a sun bed or are receiving light treatment (PUVA or other UV treatment) for a skin condition, you are at increased
risk of developing skin cancer
- are under 16 years of age and Deximune has been prescribed for the treatment of psoriasis, atopic dermatitis (longlasting, chronic skin inflammation) or rheumatoid arthritis
- are or suspect you might be pregnant
Important
- Deximune can cause kidney problems. Your doctor will carry out regular blood tests and may adjust your dose if
necessary, particularly if you are elderly or have kidney problems.
- Deximune may increase your blood pressure. Your doctor will check your blood pressure regularly and may give you
appropriate medicine to decrease it if necessary.
- if you take Deximune for a long period of time or with other medications that reduce the activity of your immune
system, you are at increased risk of developing skin, blood and solid organ cancers.
- if you take Deximune for a long period of time or with other medications that reduce the activity of your immune
system, you are at increased risk of infections that may become very serious or cause death.
- Deximune may increase the level of fatty substances (including cholesterol) in your blood.
- Deximune can cause liver problems especially in people with more than one medical condition.
- While taking Deximune you should not receive ultraviolet B irradiation or PUVA photochemotherapy for psoriasis.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained
without a prescription. Some medications can interfere with your treatment, so make sure you check with your doctor
or pharmacist before taking any other medicine.
Do not take Deximune:
- If you are taking a medicine to reduce the activity of the immune system and lower the risk of organ rejection
(tacrolimun)
- If you are taking a medicine used to treat high cholesterol and to prevent cardiovascular disease (rosuvastatin)
- If you are taking herbal medicines containing St. John’s Wort
Also, tell your doctor if you are taking any of the following:
- antibiotics (especially erythromycin, azithromycin, clarithromycin, gentamycin, tobramycin, amphotericin B,
ciprofloxacin, vancomycin, trimethoprim)
- antifungal medicines for treatment of infection (especially terbinafine, voriconazole, itraconazole, fluconazole,
ketoconazole)
- oral contraceptives
- any medicines for heart problems or high blood pressure (e.g. bosentan, diltiazem, nicardipine, lercanidipine,
digoxin, aliskiren and verapamil)
- anti-epileptic medicines (e.g. carbamazepine, oxcarbazepine, phenytoin)
- cholesterol-lowering medicines (including statins)
- oral anti-diabetic (repaglinide)
- other immunosuppressives (e.g. prednisolone, sirolimus and everolimus)
- barbiturates (used to help you sleep)
- medicines containing potassium or potassium supplements
- medicines that increase the potassium levels in your blood, e.g. angiotensin converting enzyme inhibitors and
angiotensin II receptor antagonists (used to treat high blood pressure)
- diuretics or ‘water tablets’ (used to affect the amount of urine you produce)
- anti-inflammatory medicines (i.e. NSAIDs) e.g. diclofenac, including medicines used to treat rheumatoid
arthritis, osteoarthritis, ankylosing spondylitis (inflammatory arthritis affecting the spine and pelvis), gout, period
pains and muscle disorders
- light treatment (PUVA or other UV treatment) for your skin condition
- medicine used to treat menstrual disorders, endometriosis or breast problems (danazol)
- a hormone medicine that is used to treat some types of tumours (octreotide)
- medicines to treat tuberculosis
- medicines to treat gout (e.g. allopurinol, colchicine)
- medicine used to stop sickness (metoclopramide)
- medicine used to treat lymphomas or tumours (melphalan)
- medicine used to help with weight loss (orlistat)
- medicines used to treat conditions such as asthma, allergic conditions, inflammatory conditions
including inflammatory bowel disease, adrenocortical insufficiency and rheumatic disease (corticosteroids)
- medicine used after a stroke (ticlopidine)
- medicine used to treat gallstones (ursodeoxycholic acid)
- medicine used to treat tumours, severe psoriasis and rheumatoid arthritis (methotrexate)
- medicine used to treat cancer (etoposide)
- medicine used to treat leukaemia or tumours (imatinib)
- medicine used to treat heart problems (digoxin)
- medicine used to treat human immunodeficiency virus (HIV) (protease inhibitors)
- medicines used to reduce the amount of acid in your stomach (e.g. cimetidine, ranitidine)
- medicine used to treat high blood pressure and heart pain (nifedipine) - if you take nifedipine and ciclosporin
together you might get swollen gums that spread over your teeth.
Tell your doctor if you have recently had a vaccination or are planning to have any vaccinations.
If you take certain medicines while taking Deximune, your doctor will regularly check for kidney problems and for any
potential side effects, and will adjust your dose if necessary. If you have received an organ transplant, your doctor
will check the levels of Deximune in your blood and adjust your dose if necessary.
Taking Deximune with food and drink
Do not eat grapefruit or drink grapefruit juice 1 hour before taking your dose as it may interfere with your medicine.
Deximune Capsules can be taken with or without food.

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Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or planning to become pregnant, tell your doctor before you start taking Deximune.
If you do become pregnant while taking Deximune, tell your doctor. Deximune increases the risk of pre-eclampsia
(high blood pressure and swelling in the feet and legs), premature births, and decreased birth weights. If you are taking
Deximune, you should not breast-feed.
Driving and using machines
This medicine may make you feel confused, disoriented or cause visual disturbances. Use caution when driving or
operating machinery as your ability to drive or operate machines can be impaired. If you have any doubts, talk to your
doctor or pharmacist.
Important information about some of the ingredients of Deximune
This medicine contains macrogolglycerol hydroxystearate. It may cause stomach upset and diarrhoea.
This medicine contains lecithin from soya. If you are allergic to peanut or soya, do not use this medicine.
It also contains the ingredient 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. This may be harmful if you are suffering from alcoholism and
should be taken into account if you are pregnant or breast feeding, you have liver disease or epilepsy, or if this medicine
is being given to a child.
3. HOW TO TAKE Deximune
Depending on your body weight and whether you are taking Deximune following transplantation or for the treatment
of a severe skin condition, rheumatoid arthritis, or nephrotic syndrome, your doctor will determine the correct dose
of Deximune for you, how often to take your medicine, and for how long you need to take it.
Place the capsule in your mouth. Take a mouthful of water, then swallow the capsule whole. You may drink more water
afterwards.
Do not eat grapefruit or drink grapefruit juice 1 hour before taking your dose as it may interfere with your medicine.
Dosage:
If you have had an organ or bone marrow transplant the total dose is usually within the range of 2-15 mg/kg body
weight per day. Generally, higher doses are used just after transplantation and lower doses are used once your
transplanted organ or bone marrow is working properly with no signs of rejection.
Your doctor will adjust your dose to one that is ideal for you. To do this he may need to do some blood tests and monitor
kidney function.
For the treatment of severe psoriasis and eczema the total dose is usually within the range of 2.5-5 mg/kg body
weight per day.
For the treatment of severe rheumatoid arthritis the total daily dose is usually within the range of 2.5-4 mg/kg body
weight per day.
For the treatment of nephrotic syndrome the total daily dose is usually within the range of 2.5-5 mg/kg body weight
per day in adults and 2.5-6 mg/kg body weight per day in children.
Ask your doctor or pharmacist if you are unsure about how much medicine to take or when to take it.
You should not be transferred to or from other Ciclosporin medicinal products without being closely monitored by your
physician.
Use in children
Although transplant recipients as young as 3 months have received Deximune at the recommended dosage and
showed no particular problems, at higher doses children showed fluid retention, convulsions, and increased blood
pressure. Follow your doctor’s instructions before administering Deximune to children.
If you take more Deximune than you should
IMMEDIATELY contact your doctor, the hospital, or pharmacist if you have taken more Deximune than your doctor
has prescribed. Symptoms of overdose include: increased blood pressure, convulsions.
If you forget to take Deximune
If you forget to take a dose, take another one as soon as you remember, unless it is almost time for your next dose.
Then continue as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Deximune
Always follow your doctor’s instructions exactly. Never change the dose yourself or stop taking the medicine even if
you start feeling well.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, Deximune can have side-effects, although not everybody experiences them.
The dose of this medicine needs to be carefully adjusted by your doctor. You will, therefore, have to have
regular blood tests and make regular visits to the hospital, particularly after transplantation.
If you develop a sore throat, any infections or begin to feel generally unwell, see your doctor immediately.
This may include symptoms such as having difficulty breathing, dizziness, rapid or irregular heartbeat, itching
or swelling in the face, eyelids, lips, tongue, throat, hands, and feet. If you experience any of these symptoms
or if you notice any changes to your skin, for example if you develop a rash, lesion or skin growth, see your
doctor immediately.
Very common side-effects (affecting more than 1 in 10 people) include:
• kidney dysfunction
• high blood pressure (hypertension), increased level of fats (hyperlipidaemia) or increased level of cholesterol
(hypercholesterolaemia) in the blood
• headache including migraine
• tremor
• chest infection, upper and lower respiratory tract infection – bronchitis
• urinary infections and infection with CMV (cytomegalovirus [type of herpes virus])
Common side-effects (affecting between 1 in 10 and 1 in 100 people) include:
• numbness or tingling of the body
• loss of appetite (anorexia), nausea, stomach pain, diarrhoea, swollen gums
• liver dysfunction, high level of uric acid or potassium in the blood, low levels of magnesium in the blood, blood
poisoning
• muscle pain or cramps
• tiredness
• herpes infection, candida infection (fungal infection), sepsis (inflammation of the body due to infection)
• increased hair growth on the body, skin disorders and cancers, blood disorders resulting from the
over-production of white blood cells, including cancer of the white blood cells
Uncommon side-effects (affecting between 1 in 100 and 1 in 1,000 people) include:
• seizures, confusion, disorientation, decreased responsiveness, agitation, sleeplessness, coma
• visual disturbances, blindness
• partial paralysis, loss of co-ordination
• changes in blood (for example anaemia), reduction in blood platelets which increases the risk of bleeding
and bruising
• allergic rash
• water retention which may cause swelling, weight increase
• benign skin growths, skin cancer and solid organ cancers
Rare side-effects (affecting between 1 in 1,000 and 1 in 10,000 people) include:
• problems with the nerves that control muscles
• inflammation of the pancreas
• muscle weakness, wasting of muscles
• destruction of red blood cells which may be associated with kidney problems, high levels of glucose in the blood
• changes in the menstrual cycle in women and slight swelling of breast tissue in men and women
Very rare side-effects (affecting less than 1 in 10,000 people) include:
• swelling at the back of the eye which may be associated with an increase in pressure inside the head
(benign intracranial hypertension) and visual disturbances
Other side-effects (it is not know how many people may be affected) include:
• there have been reports of harmless breast lumps in patients who have received a kidney transplant.
• serious liver problems that have happened both with and without yellowing of the eyes or skin.
Due to higher initial doses and longer maintenance therapy required after transplantation, side-effects are more
frequent and usually more severe in transplant patients than in patients treated for other indications.
Tell your doctor or pharmacist if you suffer from any of these side-effects, or if you notice any side-effects
not listed in this leaflet.
5. HOW TO STORE Deximune
Keep out of the reach and sight of children.
Leave capsules in the foil and only remove them when it is time to take your medicine.
When a packaged blister is opened, a characteristic smell is noticeable. This is normal and does not mean that there
is anything wrong with the capsule.
Do not store above 25˚C and do not refrigerate and/or freeze.
Do not use after the expiry date stated on the carton/blister foil. The expiry date refers to the last day of that month.
If your doctor decides to stop your treatment, return any leftover medicine to the pharmacist. Only keep your medicine
if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect the environment.
6. 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, 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 marketed.
Marketing Authorization Holder and Manufacturer
Dexcel ®- Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire NN11 8PB, England.
This leaflet was revised in July 2012.
Deximune is a registered Trade Mark.

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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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