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CAPSORIN 100 MG/ML ORAL SOLUTION

Active substance(s): CICLOSPORIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Capsorin 100 mg/ml Oral Solution
Ciclosporin
treatment of epilepsy); nafcillin, rifampicin, griseofulvin, sulphadiazine,
Read all of this leaflet carefully, before you start taking the medicine.
! Keep this leaflet. You may need to read it again.
trimethoprim and sulfadimidine i.v. (antibiotic); octreotide (medicine that
! If you have any further questions, please ask your doctor or pharmacist.
restricts the release of certain hormones); probucol (for treatment of high
! This medicine has been prescribed for you. Do not pass it on to others. It
cholesterol); orlistat (for treatment of obesity); troglitazone (for treatment of
type II-diabetes); ticlopidine (for inhibition of blood clotting), metamizole
may harm them, even if their symptoms are the same as yours.
! If any of the side effects gets serious, or if you notice any side effects not
(analgesic), Hypericum perforatum (St. John's Wort).
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Capsorin is and what it is used for
2. Before you take Capsorin
3. How to take Capsorin
4. Possible side effects
5. How to store Capsorin
6. Further information
1. WHAT CAPSORIN IS AND WHAT IT IS USED FOR
Capsorin is an immunosuppressant. It suppresses the immune system and
reduces inflammation.
Ciclosporin is used to prevent rejection of newly transplanted organs or
bone marrow transplants. Capsorin is also used for treatment of severe
psoriasis, kidney disease (nephrotic syndrome), severe arthritis and severe
eczema (atopic dermatitis).

The following medicines increase the effect of Capsorin:
Macrolide antibiotics e.g. erythromycin, doxycycline, josamycin,
roxithromycin, pristinamycin and clarithromycin (antibiotics); ketoconazole,
fluconazole, itraconazole (anti-fungal); diltiazem, nicardipine, verapamil
(for high blood pressure and heart disease); metoclopramide (for treatment
of nausea); oral contraceptives; danazol (for a condition related to painful
periods); bromocriptine (for treatment of infertility and Parkinson's disease)
methylprednisolone in high doses (anti-inflammatory); allopurinol (for
treatment of arthritis); amiodarone, propafenone (for treatment of heart
arrhythmia); cimetidine, ranitidine (reduces the amount of acid in the
stomach); chloroquine (anti-malarial), protease inhibitors (used to treat HIV
infection).
Capsorin may increase the effect of the following medicines:
Diclofenac (for rheumatic pain); digoxin (for treatment of heart arrhythmia);
colchicine (for treatment of arthritis); lovastatin, pravastatin, simvastatin,
atorvastatin (for treatment of high cholesterol); prednisolone; nifedipine (for
high blood pressure and heart disease).

2. BEFORE YOU TAKE CAPSORIN
Do not take Capsorin:
! if you are allergic (hypersensitive) to ciclosporin or any of the other
ingredients of Capsorin (listed in 'FURTHER INFORMATION')
! if you are taking this medicine for psoriasis or other severe skin
complaints, or for rheumatoid arthritis, and have any kidney problems. If
you are taking this medicine for nephrotic syndrome you should
continue with your treatment as your doctor will be monitoring your
kidney function carefully
! if you have kidney disorders other than nephrotic syndrome
! if you have psoriasis and are receiving PUVA, UVB, coal tar, radiation
therapy or other immunosuppressants
! if you have uncontrolled high blood pressure
! if you have any uncontrolled infections
! if you have been told that you have any kind of tumour
! if you are taking products/herbal medicines which contain Hypericum
perforatum (St. John's Wort)
! if you have rheumatoid arthritis and are under 18 years of age
! if you are taking tacrolimus
! if you are taking rosuvastatin
! if you are breast-feeding
Take special care with Capsorin:
Tell your doctor if any of the following applies to you:
! if you are treated with other immunosuppressants (e.g. methotrexate)
! if your diet contains a large amount of potassium or you receive
medicine that contains potassium (ask your doctor)
! if you are suffering from a low amount of magnesium in the blood
! if you are suffering from an excess amount of uric acid in the blood (e.g. if
you have a kidney disease or a certain kind of arthritis)
! if you are suffering from an excess amount of lipids in the blood
! if you have poor kidney and/or liver function
! if you have high blood pressure or are being treated for high blood
pressure (with potassium sparing diuretics, ACE-inhibitors, angiotensin
II receptor antagonists)
Capsorin should only be prescribed by physicians specialising in organ
transplantation, dermatology (skin diseases), nephrology (kidney diseases)
or rheumatology.
Patients treated with Capsorin should avoid excessive unprotected sun
exposure.
Patients treated with Capsorin should have their blood pressure and kidney
function monitored regularly. Regular blood samples should be taken to
monitor the concentration of ciclosporin and lipids in the blood and liver
function.
Blood concentrations of ciclosporin should also be monitored if you are
taking certain other drugs or when treatment with the other drug is
discontinued.
Please inform your doctor if you suffer from an acute infection not treated
with any medicine.
Routine dental check-ups are recommended.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
The following medicines reduce the effect of Capsorin:
Barbiturates, carbamazepine, phenytoin, phenobarbital, primidone (for

Other medicines that may interact with Capsorin: aminoglycosides (such as
gentamicin and tobramycin), ciprofloxacin, vancomycin (antibiotic);
amphotericin B (anti-fungal); sulfamethoxazole (for urinary infection); nonsteroidal anti-inflammatory drugs (for rheumatic pain); melphalane
(cytostatic); tacrolimus and sirolimus (immunosuppressant).
Vaccines may be less effective during treatment with Capsorin.
Taking Capsorin with food and drink
Capsorin can be taken with or without food.
Grapefruit juice should be avoided because it may increase the effect of
Capsorin.

!
!

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
If you are pregnant, planning to become pregnant or get pregnant whilst
taking Capsorin you should inform your doctor immediately. Capsorin
should not be taken during pregnancy unless your doctor has discussed it
with you.
Breast-feeding
Capsorin should not be used when breast-feeding.
Driving and using machines
Capsorin does not affect the ability to drive or use machines. However
Capsorin contains ethanol; if affected you should not drive or use machines.
Important information about some of the ingredients of Capsorin
Capsorin contains 12.7 vol% ethanol (alcohol), i.e. up to 525mg per dose,
equivalent to 13 ml beer or 6 ml wine per dose. This may be harmful if you
are suffering from alcoholism and should be taken into account in you are
pregnant or breast-feeding, if you have liver disease or epilepsy or if this
medicine is being given to a child.
3. HOW TO TAKE CAPSORIN
Always take Capsorin exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
The daily dose of Capsorin should always be divided in 2 doses and taken in
the morning and in the evening.

February 2015

Ciclosporina Generis

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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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