Capsorin 100 Mg/Ml Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully, before you start taking the medicine.
• Keep this leaflet. You may need to read it again.
• Ifyou have any further questions, pleaseaskyourdoctororpharmacist.
• This medicine has been prescribed for you. Do not pass it on toothers. It 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 listed in this leaflet, please tell your doctor or pharmacist.
treatment of epilepsy); nafcillin, rifampicin, griseofulvin, sulphadiazine, trimethoprim and sulfadimidine i.v. (antibiotic); octreotide (medicine that restricts the release of certain hormones); probucol (for treatment of high cholesterol); orlistat (for treatment of obesity); troglitazone (for treatment of type ll-diabetes); ticlopidine (for inhibition of blood clotting), metamizole (analgesic), Hypericum perforatum (St. John's Wort).
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.
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).
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).
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
• ifyou have kidney disorders other than nephrotic syndrome
• if you have psoriasis and are receiving PUVA, UVB, coal tar, radiation therapy or other immunosuppressants
• ifyou have uncontrolled high blood pressure
• ifyou have any uncontrolled infections
• ifyou 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)
• ifyou have rheumatoid arthritis and are under 18 years of age
• ifyou are taking tacrolimus
• ifyou are taking rosuvastatin
• ifyou are breast-feeding
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).
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.
Take special care with Capsorin:
Tell your doctor if any of the following applies to you:
• ifyou 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)
• ifyou are suffering from a low amount of magnesium in the blood
• ifyou 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)
• ifyou are suffering from an excess amount of lipids in the blood
• ifyou havepoorkidneyand/orliverfunction
• 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
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 perdose, 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 ifyou are not sure.
The daily dose of Capsorin should always be divided in 2 doses and taken in the morning and in the evening.
1) Raise flap on top of the metallic sealing ring
2) Tearoff sealing ring completely
3) Remove rubber stopper from bottle and dispose of it carefully
4) Insert the tube with attached white stopper into the bottle, and press until the stopper is firmly into the neck of the bottle
5) Insert the nozzle of syringe (doser) into the white stopper
6) Draw up the plunger until the medicine rises up the syringe to the dosage level prescribed by your doctor
7) If any larger bubbles of air appear in the syringe, push the plunger all the way down and aspirate the solution with various times to force the bubbles out. After the large bubbles are gone, measure the prescribed solution volume again. The presence of a few tiny bubbles will not affect the dosing in anyway
8) After use, clean the exterior of the syringe with a clean dry tissue and return to its protective cover. The white stopper and tube should remain permanently in the bottle. Close bottle with the screw-top
Next use: The next time you use your medicine, start at Point 5
Capsorin Oral Solution can be taken with water. For improved taste, the solution can be diluted with orange juice or squash or apple juice. Grapefruit juice should never be used. In addition, do not eat grapefruit or drink grapefruit juice for 1 hour before taking your dose as it may interfere with your medicine.
Individual dosage. It is important to follow the doctor's prescription very carefully.
Bone marrow transplantation:
Individual dosage. It is important to follow the doctor's prescription very carefully.
Nephrotic syndrome (kidney disease):
Initially the recommended oral dose is 5 mg per kg body weight daily divided in 2 doses for adults and 6 mg per kg body weight daily for children. The ciclosporin concentration should be monitored regularly. In patients with reduced kidney function the initial dose should not exceed 2.5 mg per kg body weight daily.
Initially the recommended dose is 2.5-5 mg per kg body weight daily divided in 2 doses. To achieve full therapeutic effect it may be necessary to treat with Capsorin for up to 12 weeks.
The recommended oral initial dose is 2.5 mg per kg body weight daily divided in 2 doses. After 1 month, the daily dose can gradually be increased to a maximum of 5 mg per kg body weight. In maintenance treatment the dose is individually adjusted to the lowest clinically effective level.
The treatment of this condition is individually adjusted, since the disease varies greatly. The recommended dose is 2.5-5 mg per kg body weight per day divided in 2 oral doses.
No special adjustment of the dose is necessary. Ask your doctor.
There is limited experience in children. However, ciclosporin has been used at the recommended dose for children from 1 year of age without special problems.
If you take more Capsorin than you should
Contact your doctor or casualty department immediately.
If you forget to take Capsorin
Take another one as soon as you remember, unless it is almost time for your next dose. Then go on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Capsorin
Keep taking Capsorin while your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Capsorin can cause side effects, although not everybody gets them.
Very common (affects more than 1 user in 10)
Increased lipid in the blood (for example cholesterol), tremor headache, high blood pressure, kidney problems.
Common (affects 1 to 10 users in 100)
Increased uric acid in the blood, increased potassium in the blood, decreased magnesium in the blood, tingling, pricking, or numbness of the skin (paresthesia), loss of appetite, nausea, vomiting, stomach pain, diarrhoea, swollen gums, liver problems, increased hair growth, muscle cramps or pain, tiredness.
Uncommon (affects 1 to 10 users in 1,000)
Anaemia, reduced platelet count, signs of neurological disorder (e.g. convulsion, confusion, feeling disorientated, decreased reactivity, agitation, sleeplessness, blurred vision, blindness, partial muscle paralysis, muscle incoordination, coma), rash, water retention, weight gain, development of malignant tumours.
Rare (affects 1 to 10 users in 10,000)
Anaemia in the small blood vessels, haemolytic uraemic syndrome (acute kidney failure and anaemia), menstrual disturbances, enlargement of the male breast, increased blood glucose, progressive muscle weakness, pancreatitis, muscle weakness or stiffness or spasm.
Very rare (affects less than 1 user in 10,000)
Swelling of the optic nerve with possible visual impairment in cases of benign intracranial hypertension (increased pressure in the brain).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
5. HOWTO STORE CAPSORIN
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Capsorin 100 mg/ml oral solution after the expiry date which is stated on the label, after EXP. The expiry date refers to the last day of that month.
The oral solution should be used within 2 months, after the bottle has been opened.
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 Capsorin contains
• The active substance is ciclosporin. Each ml of oral solution contains 100 mg of ciclosporin.
• The other ingredients are Ethanol anhydrous, Tocopherol acetate, Dyethylene glycol monoethyl ether, Oleoyl macrogolglycerides, Oleoyl macrogolglycerides.
What Capsorin looks like and contents of the pack:
Capsorin 100 mg/ml oral solution is a clear and transparent solution, packed in amber glass bottles with plastic cover and aluminium cap. It comes with a disperser set for adult and anotherfor children.
Capsorin 100 mg/ml oral solution is available in a pack size of 1 bottle of 50 ml.
Marketing Authorisation Holder
Morningside Healthcare Ltd 115 Narborough Road Leicester, LE3 0PA UK
Site responsible for batch release
Sofarimex Industria Quimica e Farmaceutica, S.A Av. das Industrias
Alto de Colaride, Agualva, 2735-213 Cacem Portugal
Viale Vittorio Veneto 4, Milan
revised in February 2015
This medicinal product is authorised in the Member States of the EEA under the following names:
Ciclosporin Alkaloid 100 mg/ml oral solution Ciklosporin Alkaloid-INT 100 mg/ml peroralna raztopina Ciclosporina Germed 100 mg/ml solucion oral EFG Capsorin 100 mg/ml oral solution