Author: Unknown

WHAT YOU SHOULD KNOW ABOUT SANDIMMUN® (Cyclosporin) SOFT GELATIN CAPSULES
Please read this leaflet carefully before you start to take this medicine, even if you have taken SANDIMMUN® 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
SANDIMMUN® Soft Gelatin Capsules contain cyclosporin.
The capsules are available in 3 strengths. They contain either
•	25mg cyclosporin (Pale‑pink in colour)
•	50mg cyclosporin (Corn‑yellow in colour)
•	100mg cyclospmin (Dusky‑pink in colour)
All three capsule strengths contain the following inactive ingredients: Maize oil, titanium dioxide (E171), glycerol, sorbitol syrup gelatin and absolute ethanol.
The 25mg and 100mg capsules also contain iron oxide red (E172)
The 50mg capsules also contain iron oxide yellow (E172)
Packs contain 30 capsules.
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® Soft Gelatin Capsules
	are manufactured for: 	by: RP Scherer GmbH
	SANDOZ PHARMACEUTICALS	Gammelsbacher Strasse 2
	SANDOZ Pharmaceuticals (UK) Ltd	D‑69412 Eberbach
	Frimley Business Park	Germany
	Frimley Camberley
	Surrey GU16 5SG
WHY DOES YOUR DOCTOR WANT YOU TO USE SANDIMMUN® 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. 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 (atopic dermatitis) are thought to be caused by your immune system over‑reacting.
SANDIMMUN® may help to stop this by suppressing the 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® Soft Gelatin capsules 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 oi 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 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 if 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
•	anti‑inflammatory medicines (eg. 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 sun bed?
•	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?
continued

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 age transplantation and the lower doses are used once your transplanted organ or bane 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®, 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.

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

Remove the capsule from the foil
as shown in the picture

STORING YOUR MEDICINE
Leave your capsules in the foil. Only remove them when it is time to take your medicine
Store your capsules at room temperature (not exceeding 30 degrees centigrade).
Store your medicine in a safe place where children cannot reach it.
Your medicine could harm them.

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 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 Casually Department.

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.
DATE OF LAST REVISION: May t995
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 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.
25 mg SANDIMMUN® Soft Gelatin Capsules	PL 0101/0207
50 mg SANDIMMUN® Soft Gelatin Capsules 	PL 0101/0310
100 mg SANDIMMUN® Soft Gelatin Capsules	PL 0101/0208