Generic Name: CICLOSPORIN

Active Ingredient: CICLOSPORIN

CICLOSPORIN TABLET  25mg, 50mg, 100mg.

Indication and usage:

• 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.

Warnings!

• 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 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.
• 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, any 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.
• 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:

• Children.
• 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.

Side effects:

• Shaking, usually of the hands (tremor).
• Headache.
• 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.

Dose:
The recommended starting dose is 2.5mg/kg/day in two divided doses for the first six weeks. The starting dose may be reduced to 1.0 mg/kg if required. If the clinical effect is insufficient, the dose may then be gradually increased until clinically effective, toxicity occurs, or a maximum dose of 4mg/kg/day is reached.

STORAGE: Store below 25°C-30°C depending on the formulation.  

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