Please read this leaflet carefully before you start to take this medicine, even if you have taken NEORAL® Oral Solution before. You will notice that the advice contained in this leaflet may vary depending on whether you are receiving the drug for transplantation or taking it for your skin condition or as treatment for rheumatoid arthritis. If you have any questions or are unsure about anything, ask your doctor or pharmacist (chemist) for advice.

NEORAL® Oral Solution is a clear, faintly yellow to faintly brownish yellow liquid containing 100mg cyclosporin per ml.

It also contains the following inactive ingredients: DL-a -tocopherol, absolute ethanol, propylene glycol, corn oil-mono-di-triglycerides and polyoxyl 40 hydrogenated castor oil.

NEORAL® Oral Solution is available in 50ml bottles.

The name of your medicine is NEORAL® and it contains cyclosporin. It is one of a group of drugs known as immunosuppressive agents. These drugs are used to dampen down the body's immune reactions.

NEORAL® Oral Solution is manufactured by: Product Licence Holder:
SANDOZ PHARMA AG SANDOZ PHARMACEUTICALS
CH-4002 Frimley Business Park
Basle Frimley, Camberley
Switzerland Surrey, GU16 5SG

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. NEORAL® helps to stop this rejection response by blocking the development of special cells which would normally attack the transplanted tissue.

Some skin conditions, such as severe psoriasis or eczema (severe atopic dermatitis) are thought to be caused by your immune system over-reacting. NEORAL® may help to stop this by suppressing your immune system, thereby improving your skin condition.

It is thought that rheumatoid arthritis may be caused by inappropriate immune responses in your body. NEORAL® may help to stop this by suppressing your immune system, thereby improving your rheumatoid arthritis.

NEORAL® and SANDIMMUN® both contain cyclosporin as the active ingredient. However, NEORAL® is an improved formulation of cyclosporin and is, therefore, different to SANDIMMUN®.

Because of this difference, the absorption of cyclosporin into your blood should be much more reliable with NEORAL®. Absorption of cyclosporin with NEORAL® Soft Gelatin Capsules is much less likely to be affected by taking it with food, again resulting in more consistent levels of cyclosporin in your blood. This is thought to be of particular importance in the prevention of rejection following transplantation, especially in the longer term.

Because of the difference in absorption of cyclosporin, your doctor will probably want to monitor you more closely for a short period following transfer from SANDIMMUN® to NEORAL®, to make sure that you get the ideal dose for you. If your doctor transfers you from SANDIMMUN® to NEORAL®, you should not go back to taking SANDIMMUN® unless your doctor tells you to. If you were previously using SANDIMMUN® and your doctor has now transferred you to NEORAL®, any unused SANDIMMUN® that you have got left over should be returned to your pharmacist.

Tell your doctor before you start taking NEORAL® Oral Solution if the answer to any of the following questions is 'yes':

• Do you suspect that you have had an allergic reaction to, or been upset by any of the ingredients in NEORAL® (listed in 'What's in your medicine')?
• Do you have any kidney problems or have you had any disease which may have affected your kidneys?
• Do you have high blood pressure?
• Do you have an infection of any type?
• Have you been told that you have any kind of tumour?
• Do you have any liver problems or have you had any disease which may have affected your liver?
• Have you been told that you have high levels of potassium in your blood or that you have gout?
• Do you have any skin conditions other than severe psoriasis or eczema?
• Are you taking any other medicines (either bought or prescribed)? Some medicines can interfere with your treatment, so make sure to check with your doctor or pharmacist before taking any other medicines. In particular, tell your doctor if you are taking any of the following:
• antibiotics or antifungal medicines for treatment of infections
• oral contraceptive tablets
• any medicines for heart problems or high blood pressure
• anti-epileptic medicines
• cholesterol lowering medicines
• other immunosuppressive medicines (e.g. prednisolone)
• sleeping tablets
• potassium supplements
• medicines to encourage urination
• anti-inflammatory medicines (i.e. NSAIDs) e.g. diclofenac
• light treatment (PUVA or other UV treatment) for your skin condition
• colchicine
• Are you pregnant, or planning to become pregnant? If you do become pregnant whilst taking NEORAL®, tell your doctor.
• Are you breast feeding?
• Have you recently received any vaccinations or are you planning to have any vaccinations?
• Are you likely to be exposed to the sun a great deal without protecting your skin with a sun block cream?
• Do you regularly use a sunbed?
• Has the medicine been prescribed for the treatment of eczema in someone who is less than f 6 years of age?
• Has the medicine been prescribed for the treatment of severe rheumatoid arthritis in someone who is less than 18 years of age?

Your doctor will work out the correct dose of NEORAL® for you depending on your body weight and whether you are taking NEORAL® following a transplant or as a treatment for severe psoriasis, eczema or rheumatoid arthritis. Your doctor will also tell you how often to take your medicine.

If you have had an organ or bone marrow transplant the total dose is usually within the range of 2mg/kg body weight per day and 15 mg/kg body weight per day. Generally, the higher doses are used just after transplantation and the 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, he may need to do some blood tests.

For the treatment of severe psoriasis and eczema the total dose is usually within the range of 2.5mg/kg body weight per day and 5.0mg/kg body weight per day.

For the treatment of severe rheumatoid arthritis, the total daily dose is usually within the range of 2.5mg/kg body weight per day and 4.0mg/kg body weight per day.

Your doctor will tell you how much NEORAL® to take and how long you will need to take NEORAL® for, depending on whether you are taking NEORAL® following transplantation, or for the treatment of a severe skin condition, or rheumatoid arthritis. For the treatment of severe eczema, treatment usually lasts for 8 weeks.

Follow your doctor's instructions exactly and never change the dose yourself, however well you feel.

Do not stop taking your medicine unless your doctor tells you to, however well you feel.

Ask your doctor or pharmacist if you are unsure about how much medicine to take or when to take it.

Your pack of NEORAL® contains a bottle of medicine, a cap, an oral syringe and a tube with attached white stopper.

7. If any large bubbles appear slowly press plunger all the way down and then draw the medicine up again to the dosage level prescribed. The presence of a few tiny bubbles is not important and will not affect the dose in any way.

Hold the syringe above the orange or apple juice and press the plunger.

Stir well and drink at once.

8. Do not wash the syringe. After use, wipe the outside with a clean tissue and return syringe to its cover. Dispose of the tissue carefully.

The white stopper and tube should remain in the bottle.

The next time you use your medicine start at Point 5.

For improved taste, the solution can be diluted with orange juice or squash or apple juice. However, it may also be taken with water if preferred. Grapefruit juice should not 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.