WHAT YOU SHOULD KNOW ABOUT
SANDIMMUN® (Cyclosporin) ORAL SOLUTION

Please read this leaflet carefully before you start to take this medicine, even if you have taken SANDIMMUN® 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.

WHAT'S IN YOUR MEDICINE

SANDIMMUN® Oral Solution is a yellow or brownish-yellow, oily liquid, containing 100mg cyclosporin per ml.

It also contains the followings inactive ingredients: absolute ethanol and maize oil.

SANDIMMUN® Oral Solution is available in 50ml bottles.

The name of your medicine is SANDIMMUN® 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.

SANDIMMUN® Oral Solution is manufactured

for: SANDOZ PHARMACEUTICALS by: SANDOZ PHARMA AG

SANDOZ Pharmaceuticals (UK) Ltd CH-4002

Frimley Business Park Baste

Frimley, Camberley Switzerland

Surrey, GU16 5SG

WHY DOES YOUR DOCTOR WANT YOU
TO USE SANDIMMUN® ORAL SOLUTION

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. SANDIMMUN® 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 (severe atopic dermatitis) are thought to be caused by your immune system over-reacting. SANDIMMUN® may help to stop this by suppressing your immune system, thereby improving your skin condition.

If you have severe rheumatoid arthritis

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

 

BEFORE USING YOUR MEDICINE

Tell your doctor before you start taking SANDIMMUN® 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 SANDIMMUN® (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 (e.g. diclofenac)
  • light treatment for a skin condition
  • colchicine

  • Are you pregnant, or planning to become pregnant? If you do become pregnant whilst taking SANDIMMUN®, 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 16 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?

TAKING YOUR MEDICINE

Your doctor will work out the correct dose of SANDIMMUN® for you depending on your body weight and whether you are taking SANDIMMUN® 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 SANDIMMUN® to take and how long you will need to take SANDIMMUN® for, depending on whether you are taking SANDIMMUN® 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.

continued

 

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.

When you open your medicine for the first time follow the instructions below:-

1. Raise flap in centre of metal sealing ring.

2. Tear off sealing ring completely.

3. Remove black rubber stopper from bottle and dispose of carefully.

4. Take tube with attached white stopper from case and insert into bottle, pushing stopper firmly into the neck.

5. Pour about 50ml (1/2 cup) of cold milk into a clean glass or cup. The cup should not be made of plastic. Do not use hot milk. Insert nozzle of syringe into stopper.

6. Draw up the plunger until the medicine rises up the syringe to the dosage level prescribed by your doctor.

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.

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

Stir well and drink at once.

Do not leave the mixture to stand.

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

The white stopper and tube should remain in the bottle.

Close bottle with cap provided.

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

You can mix your medicine with cold milk flavoured with drinking chocolate or milkshake.

SANDIMMUN® mixes best with milk, but fruit juices, cola or cordial can be used instead. Grapefruit juice should not be used. In addition, do not eat grape fruit or drink grapefruit juice for 1 hour before taking your dose as it may interfere with your medicine. If you have previously been taking your medication with grapefruit juice, consult your doctor.

 

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.

AFTER TAKING YOUR MEDICINE

Most people benefit from taking this medicine, but a few people can be upset by it.

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 SANDIMMUN® include shakiness of the hands, upset stomach or abdominal pain, altered bowel habit, 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 SANDIMMUN®, 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

Store your SANDIMMUN® Oral Solution at room temperature (not exceeding 30 degrees centigrade).

Do not store your SANDIMMUN® Oral Solution in the fridge.

If you store your SANDIMMUN® Oral Solution at temperatures lower than 10 degrees centigrade, fine particles may appear in it. If this happens, SANDIMMUN® should NOT be used even if the particles seem to disappear once the SANDIMMUN® warm up to room temperature again.

Do not use the medicine more than 2 months after opening the bottle.

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 bottle label.

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: January 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.

If you have any further questions about your medicine or are unsure about any of the advice in this leaflet, ask your doctor or pharmacist.

SANDIMMUN® Oral Solution: PL 0101/0390

SANDIMMUN® are registered Trade Marks