How does it work?
Neoral capsules and oral solution contain the active ingredient ciclosporin (previously spelt cyclosporin in the UK), which is a type of medicine called an immunosuppressant. It works by dampening down the body's immune system.
Ciclosporin suppresses the immune system by preventing white blood cells called T lymphocytes from producing substances called lymphokines. Lymphokines normally stimulate the growth of T and B lymphocytes, which are white blood cells responsible for regulating and triggering immune responses. They provide defence against infection and foreign cells.
By preventing the production of lymphokines, ciclosporin suppresses the action of T and B lymphocytes. This prevents certain immune responses from occurring the immune system is suppressed.
If you have received an organ or bone marrow transplant, the donor cells, although matched as close as possible to yours, will not be identical. As a result, your immune system will try to reject the transplanted tissue. Ciclosporin prevents this by suppressing the activity of the cells in your immune system that would normally attack the transplanted tissue.
The skin conditions psoriasis and dermatitis are also affected by the immune system. It is thought that T cells over-react to a stimulus in these conditions, causing the scaling and inflammation of the skin. Ciclosporin can be used in severely disabling and resistant forms of these conditions to suppress the action of the T cells and therefore improve the scaling of the skin.
Rheumatoid arthritis, and a syndrome involving the kidneys called nephrotic syndrome, are also treated with ciclosporin in certain cases. These conditions are thought to be caused by inappropriate activity of the immune system towards the bodys own cells. T cells are involved in producing inflammation as part of their immune function. Suppressing their action can help to reduce the inflammation in the joints seen in arthritis and the inflammation in the kidneys seen in the nephrotic syndrome.
What is it used for?
- Prevention of organ or tissue rejection following kidney, liver, heart, lung, combined heart-lung, pancreas or bone marrow transplants.
- Treatment of transplant rejection in people previously receiving other immunosuppressants.
- Prevention and treatment of graft-versus-host disease, where the cells from transplanted bone marrow tissue attack the cells of the transplant recipient.
- A syndrome caused by kidney inflammation, characterised by a large amount of protein in the urine, swelling, weight gain and high blood pressure (nephrotic syndrome).
- Short-term treatment (eight weeks) of severe atopic dermatitis (eczema) for which conventional treatments are ineffective or inappropriate.
- Severe psoriasis for which conventional treatment is ineffective or inappropriate.
- Severe rheumatoid arthritis for which conventional disease-modifying antirheumatic drugs (DMARDs) are ineffective or inappropriate.
How do I take it?
- Neoral capsules should be swallowed whole with a mouthful of water.
- Neoral oral solution doses should be diluted before taking, either with water, or alternatively with orange juice/squash or apple juice to improve the taste. Stir the mixture well and drink at once. Neoral oral solution should never be diluted with grapefruit juice.
- You should not eat grapefruit or drink grapefruit juice in the hour before taking your dose of Neoral capsules or Neoral oral solution, as this can increase the amount of medicine that is absorbed into the bloodstream.
- The measuring device for Neoral oral solution should not be allowed to come into contact with the liquid you use to dilute your dose. The measuring device should not be rinsed with water, alcohol or any other liquid. If it is necessary to clean it, the outside should be wiped with a dry tissue.
- This medicine increases your susceptibility to infections because the suppressed immune system is less able to fight them. For this reason, consult your doctor immediately if you develop a sore throat, high temperature, any other signs of infections, or begin to feel generally unwell.
- People having long-term or intense immunosuppressive treatment are at increased risk of developing lymphomas and other cancers, particularly skin cancer. To reduce the risk of skin cancer you should minimise your exposure to strong sunlight and UV light by wearing protective clothing and using a sunscreen with a high protection factor.You should avoid sun beds and excessive unprotected sun exposure. Discuss this with your doctor.
- This medicine can cause the amount of potassium in your bloodstream to increase. For this reason you should avoid consuming large amounts of foods that have a high potassium content, for example dried fruit, bananas, tomatoes and 'low sodium' salt, while you are taking the medicine. You should also avoid potassium supplements and certain other medicines - see the end of this factsheet for more details.
- You will need to have regular blood tests to monitor your kidney and liver function and the level of potassium and lipids in your blood while you are taking this medicine.
- If you are taking this medicine for psoriasis or dermatitis you should not receive light treatment, such as PUVA, or other UV light treatment, while taking this medicine.
- Your blood pressure should be regularly monitored while you are taking this medicine. If your blood pressure rises too high you may be prescribed a medicine to lower it.
Use with caution in
- Elderly people.
- Decreased kidney function.
- People with a high level of uric acid in their blood (hyperuricaemia).
- Dermatitis patients with skin infections.
- Dermatitis and psoriasis patients with malignant (cancerous) or pre-malignant skin conditions.
Not to be used in
- Nephrotic syndrome patients with uncontrolled high blood pressure, uncontrolled infections, or any kind of malignancy (cancer).
- Psoriasis and dermatitis patients with abnormal kidney function, uncontrolled high blood pressure, uncontrolled infections or any kind of malignancy (except of the skin).
- Rheumatoid arthritis patients under 18 years of age.
- Rheumatoid arthritis patients with abnormal kidney function, uncontrolled high blood pressure, uncontrolled infections, or any kind of malignancy.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor. Seek medical advice from your doctor.
- This medicine passes into breast milk and women taking this medicine should therefore not breastfeed. Seek medical advice from your doctor.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
Very common (affect more than 1 in 10 people)
- Shaking, usually of the hands (tremor).
- Increase in the level of fats eg cholesterol in the blood (hyperlipidaemia).
- High blood pressure (hypertension).
- Decreased kidney function.
- Infections of the lungs and airways or urinary tract.
Common (affect between 1 in 10 and 1 in 100 people)
- Pins and needles (paraesthesia).
- Loss of appetite.
- Disturbances of the gut such as nausea, vomiting, diarrhoea or abdominal pain.
- Swollen gums.
- Increased level of potassium in the blood (hyperkalaemia).
- Increased level of uric acid in the blood (hyperuricaemia), which can cause kidney problems and gout.
- Decreased level of magnesium in the blood.
- Disturbances of liver function.
- Increased body hair.
- Muscle cramps or aches.
- Herpes or thrush infections.
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Fluid retention (oedema).
- Weight gain.
- Decreased numbers of red blood cells (anaemia) or platelets (thrombocytopenia) in the blood.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.
The immunosuppressant tacrolimus must not be taken in combination with this medicine.
The following medicines may decrease the level of ciclosporin in the blood and could make it less effective, so if you are prescribed any of these medicines your doctor may need to increase your ciclosporin dose:
- barbiturates, eg phenobarbital, amobarbital
- bosentan (in addition ciclosporin increases the blood level of bosentan; these medicines should not be used together)
- the herbal remedy St John's wort (Hypericum perforatum). You should not take St John's wort if you are taking ciclosporin.
The following medicines may increase the level of ciclosporin in the blood and so could increase the risk of side effects. Your doctor may need to perform extra monitoring or lower your ciclosporin dose if you are prescribed any of these:
- azole antifungals such as ketoconazole, fluconazole, itraconazole, miconazole, posaconazole, voriconazole
- calcium channel blockers such as diltiazem, nicardipine, verapamil or lercanidipine (ciclosporin also increases lercanidipine levels and this combination is not recommended)
- macrolide-type antibiotics, eg erythromycin, clarithromycin
- methylprednisolone (high-dose)
- oral contraceptives
- protease inhibitors for HIV infection, eg ritonavir, amprenavir, saquinavir
- ursodeoxycholic acid.
If any of the following medicines are taken in combination with ciclosporin there may be an increased risk of side effects on the kidneys. If you are prescribed any of these while taking ciclosporin your doctor may want to monitor your kidney function more frequently:
- aminoglycoside-type antibiotics, eg gentamicin, tobramycin
- amphotericin B
- fibrates such as fenofibrate, bezafibrate
- non-steroidal anti-inflammatory drugs (NSAIDs), eg ibuprofen, diclofenac, naproxen, sulindac
- quinolone-type antibiotics, eg ciprofloxacin
- sulphonamides, eg sulfamethoxazole
Ciclosporin may increase the blood level of the following medicines. As this could increase the risk of their side effects, your doctor may need to perform extra monitoring or reduce the dose of these medicines if they are used in combination with ciclosporin:
There may be an increased risk of side effects on the muscles, eg muscle pain, weakness or inflammation, if ciclosporin is taken in combination with statins used to lower cholesterol levels, eg atorvastatin, simvastatin, pravastatin. Ciclosporin should not be used in combination with rosuvastatin or simvastatin.
There may be an increased risk of swollen gums (a side effect called gingival hyperplasia), if this medicine is taken in combination with nifedipine.
There is a greater risk of the level of potassium in your blood rising too high if any of the following are taken in combination with ciclosporin:
- ACE inhibitors, eg enalapril, captopril
- angiotensin II receptor antagonists, eg losartan, valsartan
- potassium-containing salt substitutes, eg Lo-Salt
- potassium salts, eg potassium citrate for treating cystitis
- potassium-sparing diuretics, eg spironolactone, amiloride, triamterene
- potassium supplements.
Vaccines may be less effective in people taking ciclosporin. This is because ciclosporin suppresses the immune system and prevents the body forming adequate antibodies. Live vaccines should be avoided because they may cause infection. Live vaccines include the following: oral polio; rubella; measles, mumps and rubella (MMR); BCG; yellow fever and oral typhoid vaccines.
If you are taking this medicine for psoriasis or dermatitis you should not receive light treatment such as PUVA, or other UV light treatment, while taking this medicine.
Other medicines containing the same active ingredient