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CICLOSPORIN

Brand Name(s) : Neoral, Sandimmune
Warnings
Uses
Side Effects
Precautions
Interactions
Overdose

CICLOSPORIN WARNINGS

Ciclosporin should be used with caution by:

  • People who have had a previous injection or infusion containing polyethoxylated castor oil
  • People with allergies
  • People with high levels of potassium in their blood
  • People taking potassium supplements
  • People on a diet rich in potassium (fruit and vegetables are rich sources of potassium)
  • People with gout
  • People with other conditions caused by high levels of uric acid in their blood
  • People with any unusual spots, moles or warts on their skin
  • People who are out in the sun a lot, or using a sun bed
  • People with any skin infections, including herpes (cold sores)
  • Pregnant women

Other special warnings

  • The dose of this medicine needs to be carefully adjusted by your doctor. You will therefore have regular blood tests and visits to the hospital. This will give you the chance to talk to your doctor about your treatment and mention any problems you are having.
  • 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 suppresses the immune system you are more prone to catch infections and they can become very serious. 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.
  • Before giving you ciclosporin to treat psoriasis, the doctor will examine you to make sure that you do not have any skin cancers or pre-cancers.
  • 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 ciclosporin.
  • You must visit the dentist regularly while you are being treated with ciclosporin to make sure that your gums remain healthy.

It should not be used in:

  • allergies to ciclosporin, or to any of the other ingredients
  • taking a drug called tacrolimus
  • taking a drug called rosuvastatin
  • breastfeeding

In addition:

People with psoriasis or atopic dermatitis must not be treated with ciclosporin if they have:

  • kidney problems
  • uncontrolled high blood pressure
  • uncontrolled infections
  • any cancer except skin cancer

People with rheumatoid arthritis must not be treated with ciclosporin if they have:

  • kidney problems
  • uncontrolled high blood pressure
  • uncontrolled infections
  • any type of cancer

People with nephrotic syndrome must not be treated with ciclosporin if they have:

Also see list of precautions and interactions

STORAGE

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

CICLOSPORIN USES

What is it used for?

  • Ciclosporin is used to decrease the body's immune reaction by blocking the development of special cells.
  • It is a calcineurin inhibitor, sometimes known as an immunosuppressive agent.
  • It is used to prevent rejection after a kidney, liver, heart, heart/lung, lung, pancreas or bone marrow transplant. It is also used to stop the immune system over-reacting in skin conditions, such as severe psoriasis or atopic dermatitis (eczema), and to suppress inappropriate immune responses in your body, such as those seen in severe rheumatoid arthritis or nephrotic syndrome (a condition associated with a type of kidney damage).
  • In general this drug is used to suppress the immune system to prevent rejection of organs after transplant and in conditions where the immune system is causing illnesses.

Listed below are the typical uses of ciclosporin.

  • Organ transplantation:
    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. Ciclosporin helps to stop this rejection response by blocking the development of special cells which would normally attack the transplanted tissue. Ciclosporin also works in the prevention of a condition called graft-versus-host disease (GVHD), in which transplanted bone marrow cells attack the person's own body tissues.
  • Non-transplantation uses:
    • If you have severe psoriasis or atopic dermatitis (eczema). These serious skin conditions are thought to be caused by the immune system over-reacting. Ciclosporin may help to stop this by suppressing the immune system.
    • If you have severe rheumatoid arthritis or nephrotic syndrome (a condition associated with a type of kidney damage). It is thought that rheumatoid arthritis and some forms of nephrotic syndrome may be caused by inappropriate immune responses in the body. Ciclosporin may help to stop this by suppressing your immune system.

On occasion your doctor may prescribe this medicine to treat a condition not on the above list.

HOW TO USE/TAKE

How often do I take it?

  • Your doctor will tell you how much to take and how long to take it for, depending on the reason you have been prescribed ciclosporin. Always follow your doctor’s instructions carefully and check the pharmacy label on your medicine carefully.
  • Taking the tablets:
    Take this medication by mouth usually twice a day, exactly as directed by your doctor.
  • The absorption of ciclosporin varies from one preparation to another, so it is important you stay on the same brand the doctor has prescribed for you. If your doctor transfers you to another ciclosporin preparation, they will probably want to monitor you more closely for a short period.
  • Use this medication for as long as your doctor tells you in order to get the most benefit from it.
  • Remember to use it at the same time each day - unless specifically told not to by your doctor.
  • Certain medical conditions may require different dosage instructions as directed by your doctor.

What dose?

  • Dosage is based on your weight, age, gender, medical condition, response to therapy, and use of certain interacting medicines.

Do I need to avoid anything?

  • No problems with driving or operating machinery have been reported. However, ciclosporin capsules do contain a small amount of alcohol.
  • You must not have light treatment (PUVA or other UV treatment) for psoriasis while you are taking ciclosporin.
  • Do not go out into the sun too much without protecting your skin.
  • You must not eat a fatty meal or grapefruit or drink grapefruit juice in the hour before you take the medication.
  • If you have recently had a vaccination or are planning to have any vaccinations make sure the doctor or nurse knows you are taking ciclosporin.
  • You must visit the dentist regularly while you are taking ciclosporin to make sure that your gums remain healthy.
  • Consult your doctor or pharmacist for more details.

When can I stop?

  • It is important to continue taking this medication even if you feel well, unless your doctor tells you to stop.

CICLOSPORIN SIDE EFFECTS

  • Kidney problems
  • high blood pressure
  • headache
  • tremor
  • increased levels of lipids (for example cholesterol) in the blood
  • chest infections
  • urinary infections
  • infection with CMV (cytomegalovirus)
  • numbness or tingling
  • loss of appetite
  • feeling or being sick
  • stomachpain
  • diarrhoea
  • swollengums
  • 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
  • tiredness
  • herpes infection
  • candida infection
  • blood poisoning
  • skin disorders
  • skin cancers
  • over production of white blood cells.

See patient information leaflet enclosed with your medication for details of other less common side effects.

If any of these persist or you consider them severe then inform your doctor or pharmacist.

Tell your doctor immediately if you develop any of the following symptoms:

  • a sore throat, any infections, or begin to feel generally unwell

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

The Yellow Card Scheme allows you to report suspected side effects from any type of medicine (which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the medicines safety watchdog called the Medicines and Healthcare products Regulatory agency (MHRA). Please report any suspected side effect on the Yellow Card Scheme website.

CICLOSPORIN PRECAUTIONS

Before taking ciclosporin, tell your doctor or pharmacist if you are allergic to it; or to other immunosuppressive agents; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist in case of:

  • allergies to ciclosporin, or to any of the other ingredients
  • taking a drug called tacrolimus
  • taking a drug called rosuvastatin
  • breastfeeding
  • kidney problems
  • uncontrolled high blood pressure
  • uncontrolled infections
  • any cancer (except skin cancer - patients with psoriasis only)
  • under 18 years old (patients with rheumatoid arthritis only)

Before using this medication tell your doctor or pharmacist your medical history, especially any of the following:

  • If you have had a previous injection or infusion containing polyethoxylated castor oil
  • If you have multiple allergies
  • If you have high levels of potassium in your blood
  • If you are taking potassium supplements
  • If you have a diet rich in potassium (fruit and vegetables are rich sources of potassium)
  • If you suffer with gout
  • If you have other conditions caused by high levels of uric acid in your blood
  • If you have any unusual spots, moles or warts on your skin
  • If you are out in the sun a lot, or using a sun bed
  • If you have any skin infections, including herpes (cold sores)
  • If you are pregnant

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. 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.

Before giving you ciclosporin to treat psoriasis, the doctor will examine you to make sure that you do not have any skin cancers or pre-cancers.

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 ciclosporin.

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

Before having surgery, tell your doctor or dentist that you are taking this medication.

Does alcohol intake affect this drug?

  • Alcohol intake is not known to affect ciclosporin. However your medication may contain alcohol. 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.

The elderly: ciclosporin can be used in the elderly, but kidney function should be monitored.

Pregnancy and breastfeeding - please ensure you read the detailed information below

PREGNANCY

The safety of ciclosporin has not been established during pregnancy. It should only be used if the potential benefit justifies the potential risk.
Ask your doctor or pharmacist if you have any doubts or questions about this.

It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

BREAST FEEDING

Ciclosporin is not safe to take if you are breastfeeding. You should not breast-feed if you are taking ciclosporin, as ciclosporin passes into breast milk.

It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

CICLOSPORIN INTERACTIONS

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious, possibly fatal interactions may occur:

  • tacrolimus,
  • rosuvastatin.

If you are currently using any such medicine, tell your doctor or pharmacist before starting ciclosporin.

Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:

  • 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).

This information does not contain all possible interactions. Therefore, before using ciclosporin, tell your doctor or pharmacist of all the products you use.

CICLOSPORIN OVERDOSE

The effects of overdose with ciclosporin are not known.

If you think you, or someone you care for, might have accidentally taken more than the recommended dose of ciclosporin or intentional overdose is suspected, contact your local hospital, GP or if in England call 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.

MISSED DOSE

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

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Source: Selected from data included with permission and copyrighted by Boots UK Limited or TicTac Communications Ltd. This copyrighted material is sourced from a licensed data provider and is not for distribution, except as may be authorised by the applicable terms of use.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgement of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse events, nor should it be construed to indicate that use of a particular medicine is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any medicine, changing any diet, or discontinuing any course of treatment.

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