WHAT YOU SHOULD KNOW ABOUT NEORAL® (CYCLOSPORIN) SOFT GELATIN CAPSULES

Please read this leaflet carefully before you start to take this medicine, even if you have taken NEORAL® Soft Gelatin Capsules 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.

WHAT'S IN YOUR MEDICINE

NEORAL® Soft Gelatin Capsules contain cyclosporin.

The capsules are available in 3 strengths They contain either

All three capsule strengths contain the following inactive ingredients: DL-a -tocopherol, absolute ethanol, propylene glycol, corn oil mono-di-triglycerides, polyoxyl 40 hydrogenated castor oil, titanium dioxide, glycerol 85% and gelatin. The 25mg and 100mg capsules also contain iron oxide black.

Packs contain 5 or 30 capsules.

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® Soft Gelatin Capsules

are manufactured by: Product Licence Holders:

R P Scherer GmbH SANDOZ PHARMACEUTICALS

Gammelsbacher Strasse 2 Frimley Business Park

D-69412 Eberbach Frimley, Camberley

Germany Surrey, GU16 5SG

WHY DOES YOUR DOCTOR WANT YOU TO USE NEORAL® SOFT GELATIN CAPSULES?

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. NEORAL® 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 overreacting. NEORAL® may help to stop this by suppressing the immune system, thereby improving your skin condition.

continued

If you have severe rheumatoid arthritis

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.

If you were previously taking SANDIMMUN® (cyclosporin) Soft Gelatin Capsules or Oral Solution

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 at 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 transfers 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.

BEFORE USING YOUR MEDICINE

Tell your doctor before you start taking NEORAL® Soft Gelatin Capsules it the answer to any 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 ot 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 ot potassium in your blood or that you have gout?

  • Do you have any skin conditions other than severe psoriasis or severe 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 it you are taking any of the following:
  • antibiotics or antifungal medicines for treatment of infection
  • oral contraceptive tablets
  • any medicines for heart problems or high blood pressure
  • anti-epileptic medicines
  • cholesterol lowering medicines
  • other immunosuppressive medicines (eg prednisolone)
  • sleeping tablets
  • potassium supplements
  • medicines to encourage urination

continued

 

 
  • anti-inflammatory medicines (i.e. NSAIDs) eg. 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 whiIst 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 sun bed?

  • Has the medicinc been prescribed for the treatment of eczema in sorneone who is less than 16 years of age?

  • Has the medicine been prescribed for the treatment of severe rheumatoid arthritis in someone who is Iess than 18 years of age?

TAKING YOUR MEDICINE

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 15mg/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 5mg/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 4mg/kg body weight per day.

Your doctor will tell you how much NEORAL® to take and how long you will need to take NEORAL®, depending on whether you are taking it 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.

Remove the capsule from the foil as shown in the picture.

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 for 1 hour before your dose as it may interfere with your medicine.

MISSED DOSE

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 go on as before.

OVERDOSE

If you accidentally take too much of your medicine, tell your doctor immediately, or go to your nearest Casualty Department.

continued

AFTER TAKING YOUR MEDICINE

Most people benefit from taking this medicine, but a few people can be upset by it. Once the ideal dose of NEORAL® has been established, the number of side-effects with NEORAL® is generally similar to that reported with SANDIMMUN® Soft Gelatin Capsules and Oral Solution.

The dose of this medicine needs to be carefully adjusted by your doctor. Too much can affect the kidneys. You will, therefore, have regular blood tests and visits to the hospital, particularly after transplantation. Your blood pressure will also be measured regularly. These visits will give you the chance to talk to your doctor about your treatment and mention any problems you are having.

If you develop a sore throat, any infections or begin to feel generally unwell see your doctor immediately.

Side-effects that have sometimes been reported in patients taking cyclosporin include shakiness of the hands, upset stomach or abdominal pain, swollen gums, increased growth of hair on the body or face, high blood pressure, liver problems, tiredness and sensations of heat in the hands and feet.

More rarely, headaches, skin rash, increased weight, fluid retention, confusion, feelings of numbness or tingling, muscle weakness or cramps, fits, gout, raised cholesterol levels, slight swelling of the breast tissue, changes in the menstrual period in women and tumours have also been reported.

In liver transplant patients vision and movement disturbances, and loss of concentration have also been reported as side-effects However, although these effects have been reported in patients taking cyclosporin, they may not have actually been due to the medicine. Tell your doctor or pharmacist if you suffer from any of these effects, or from any other side-effects not mentioned in this leaflet.

STORING YOUR MEDICINE

Leave your capsules in the foil. Only remove them when it is time to take your medicine. It is important not to store your capsules in a hot place (maximum temperature 25 degrees centigrade).

Store your medicine in a safe place where children cannot reach it. Your medicine could harm them.

Do not use this medicine after the expiry date shown on the carton/blister foil

If your doctor decides to stop your treatment, return any leftover medicine to the pharmacist. Only keep it if your doctor tells you to.

LEAFLET PRODUCED: February 1995

FURTHER INFORMATION

REMEMBER: This medicine is only for you. Only a doctor can prescribe it for you. Never give it to anyone else. It may harm them, even if their symptoms appear to be the same as yours. It you have any further questions about your medicine or are unsure about any at the advice in this leaflet, ask your doctor or pharmacist.

25mg NEORAL® Soft Gelatin Capsules: PL 0101/0387

50mg NEORAL® Soft Gelatin Capsules: PL 0101/0388

100mg NEORAL® Soft Gelatin Capsules: PL 0101/0389

NEORAL® and SANDIMMUN® are registered Trade Marks