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Sandimmun (Ciclosporin)

What Sandimmun is and what it’s used for

Sandimmun is a clear, brown/yellow oily liquid containing 50 mg/ml of the active ingredient, ciclosporin.  It is used to prepare a solution which is administered by intravenous infusion. Ciclosporin is one of a group of drugs known as immunosuppressive agents. These drugs are used to dampen down the body’s immune reactions.

Sandimmun can be used to prevent rejection after a kidney, liver, heart, heart/lung, lung, pancreas or bone marrow transplant.

Although you may have had 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 is 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.

Things to consider before you have Sandimmun

Some people must not have Sandimmun. Talk to your doctor if:

  • you think you may be allergic to ciclosporin, or to any of the other ingredients of Sandimmun.  (These are listed at the end of the leaflet.)
  • You are taking a drug called tacrolimus.
  • You are taking a drug called rosuvastatin.
  • You are breastfeeding.

You should also ask yourself these questions before having Sandimmun. If the answer to any of these questions is YES, discuss your treatment with the doctor or nurse because Sandimmun might not be the right medicine for you.

  • Have you previously had an injection or infusion containing polyethoxylated castor oil (see Important information about some of the ingredients of Sandimmun, below)?
  • Are you allergic to many things?
  • Have you been told that you have high levels of potassium in your blood? Are you taking potassium supplements or is your diet particularly rich in potassium?  (Fruit and vegetables are rich sources of potassium.)
  • Do you have gout or other conditions caused by high levels of uric acid in your blood?
  • Are you worried about any unusual spots, moles or warts on your skin?
  • Are you out in the sun a lot, or do you use a sun bed?
  • Do you have any skin infections, including herpes (cold sores)?
  • Are you pregnant?
  • Are you taking other medicines?

Ciclosporin interacts with a large number of other medicines and this can interfere with your treatment. Tell your doctor or nurse if you are taking any of the following:

  • Medicines to treat heart problems or high blood pressure such as bosentan, diltiazem, nicardipine and verapamil.
  • Drugs containing potassium (your doctor will know which these are).
  • Medicines called NSAIDs used to treat pain and inflammation.  (Some of these can be bought over-the-counter).
  • Medicines to treat infections including antibiotics (especially erythromycin and clarithromycin) and antifungal medicines (especially terbinafine and voriconazole).
  • Oral contraceptives.
  • Medicines for epilepsy.
  • Cholesterol lowering medicines (including statins).
  • Sleeping tablets.
  • Potassium supplements.
  • Diuretics or “water tablets” that affect the amount of urine you produce and might also affect the level of potassium in your blood.
  • Danazol (used to treat menstrual disorders, endometriosis or breast problems).
  • St John’s Wort: The herbal remedy St John’s Wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you are already taking St John’s Wort consult your doctor before stopping the St John’s Wort preparation.
  • Octreotide (known as Sandostatin®).
  • Medicines to treat tuberculosis.
  • Medicines to treat gout.
  • Metoclopramide (used to stop sickness).
  • Melphalan (used to treat lymphomas or tumours).
  • Imatinib (used to treat leukaemia or tumours).
  • Orlistat (used to help weight loss).
  • Ticlopidine (used after a stroke).
  • Corticosteroids (used to treat conditions such as asthma, allergic conditions, inflammatory conditions including inflammatory bowel disease, adrenocortical insufficiency and rheumatic disease).
  • Ursodeoxycholic acid (used to treat gallstones).
  • Protease inhibitors (used to treat Human Immunodeficiency Virus (HIV)).
  • Tacrolimus, sirolimus and everolimus (other immunosuppressants).
  • Methotrexate (used to treat tumours, severe psoriasis and rheumatoid arthritis).
  • Etoposide (used to treat cancer).
  • Repaglinide (used to treat diabetes).

Always tell your doctor or pharmacist about all the medicines you are taking.  This means medicines you have bought yourself as well as medicines on prescription from your doctor.

Will there be any problems with driving or using machinery?

Not applicable.

Other special warnings

Ciclosporin can affect how the liver and kidneys work. It can also affect blood pressure, and the composition of the blood.  Your doctor will monitor you closely while you are being treated.

Because ciclosporin dampens down the immune system you are more prone to catch infections and they can become very serious. If you experience vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and muscle weakness, these can be the signs and symptoms of an infection of the brain called progressive multifocal leukoencephalopathy. Make sure your doctor or nurse knows if you are feeling unwell.

There have been very rare reports of people developing a condition called Benign Intracranial Hypertension when they are being treated with ciclosporin. Tell your doctor as soon as possible if you start to feel nauseous, develop tinnitus (ringing in your ears), or get pains in your head, neck or back, or problems with your sight, balance or memory.

You must not eat a fatty meal or grapefruit, or drink grapefruit juice, before your infusion.

If you have recently had a vaccination or are planning to have any vaccinations make sure the doctor or nurse knows you are being treated with Sandimmun.

You must visit the dentist regularly while you are being treated with Sandimmun to make sure that your gums remain healthy.

Important information about some of the ingredients of Sandimmun

Sandimmun contains:

Polyethoxylated castor oil which may cause severe allergic reactions.

34.4% ethanol (alcohol). A lOOmg dose of Sandimmun contains 556 mg of ethanol equivalent to nearly three teaspoons of beer or one teaspoon of wine. This may be harmful if you are suffering from alcoholism and should be taken into account if you are pregnant or breast feeding, have liver disease, epilepsy or if this medicine is being given to a child.

Administering Sandimmun

Your doctor will work out the correct dose of Sandimmun for you depending on your body weight and your condition.

The usual dose is from 3 to 5 mg/kg body weight per day starting on the day before your transplant operation and continuing for up to two weeks after the operation. You will be started on oral ciclosporin (capsules or liquid) as soon as possible after the operation.

You will be given Sandimmun by slow intravenous infusion over a period of 2 to 6 hours. Sandimmun will be diluted with normal saline or 5% glucose before use.

If you think you have been given too much tell the doctor or nurse as soon as possible.

Possible side effects

Most people who are treated with Sandimmun benefit. Like all medicines though, it can sometimes cause side effects in some people.

If you develop a sore throat, any infections, or begin to feel generally unwell, tell the doctor or nurse immediately.

The following side effects have been reported:More than 10% of people have experienced:

Kidney problems, high blood pressure, headache, tremor and increased levels of lipids (for example cholesterol) in the blood.

Up to 1 in 10 people have experienced:

Numbness or tingling, loss of appetite, feeling or being sick, stomach pain, diarrhoea, swollen gums, liver problems, high level of uric acid or potassium in the blood, low levels of magnesium in the blood, muscle pain or cramp, increased hair growth on the body and tiredness.

Up to 1 in 100 people have experienced:

Seizures, confusion, disorientation, decreased responsiveness, agitation, sleeplessness, visual disturbances, blindness, coma, partial paralysis, loss of co-ordination, changes in blood (for example anaemia), allergic rash, water retention which may cause swelling and weight increase.

Up to 1 in 1,000 people have experienced:

Problems with the nerves that control muscles, inflammation of the pancreas, high levels of glucose in the blood, muscle weakness, wasting of muscles, destruction of red blood cells which may be associated with kidney problems, changes in the menstrual cycle in women and slight enlarging of the breasts in men.

Up to 1 in 10,000 people have experienced:

Swelling at the back of the eye which may be associated with an increase in pressure inside the head (benign intracranial hypertension) and visual disturbances.

Like other medicines that dampen down the immune system, ciclosporin may cause tumours or other malignancies, particularly of the skin. It may also make you more likely to get infections which may be serious. If you experience vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and muscle weakness, these can be the signs and symptoms of an infection of the brain called progressive multifocal leukoencephalopathy.

Tell your doctor or pharmacist if you suffer from any of these effects, or from any other side effects not mentioned in this leaflet.

How to store Sandimmun

Keep out of the reach and sight of children.

Store below 30°C.

Do not use Sandimmun after the expiry date which is printed on the outside of the pack.

Further information

Sandimmun Concentrate for Solution for Infusion is a clear, brown-yellow, oily liquid containing 50 mg ciclosporin per ml. It also contains the inactive ingredients absolute ethanol and polyethoxylated castor oil.

Sandimmun Concentrate for Solution for Infusion is available in 1 ml and 5 ml ampoules. Some of these pack sizes may not be marketed.

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