Brand Name Choices
No generic medication is available for Neoral Suspension (Cyclosporine)
What Neoral Suspension is and what it is used for
What Neoral is
The name of your medicine is Neoral. It contains the active substance ciclosporin. This belongs to a
group of medicines known as immunosuppressive agents. These medicines are used to lower the
body’s immune reactions. What Neoral is used for and how Neoral works
• If you have had an organ transplant, bone marrow and stem cell transplantation, the function of Neoral is to control your body’s immune system. Neoral prevents rejection of transplanted organs by blocking the development of certain cells which would normally attack the transplanted tissue.
• If you have an autoimmune disease, in which your body’s immune response attacks your body’s own cells, Neoral stops this immune reaction. Such diseases include eye problems which threaten your vision (endogenous uveitis, including Behçet's uveitis), severe cases of certain skin diseases (atopic dermatitis, or eczema and psoriasis), severe rheumatoid arthritis and a kidney disease called nephrotic syndrome.
How to take Neoral Suspension
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not
Do not take more than the recommended dose.
The dose of this medicine will be carefully adjusted to your individual needs by your doctor. Too
much of the medicine can affect your kidneys. You will have regular blood tests and visits to the
hospital, especially after a transplant. This will give you the chance to talk to your doctor about your
treatment and talk about any problems you may be having.
How much Neoral to take
Your doctor will work out the correct dose of Neoral for you. This depends on your body weight and
what you are taking the medicine for. Your doctor will also tell you how often to take your medicine.
• In adults: Organ, bone marrow and stem cell transplantation
•The total dose each day is usually between 2 mg and 15 mg per kilogram body weight. This is divided in two doses.
•Usually, higher doses are used before and just after your transplant. Lower doses are used once your transplanted organ or bone marrow has stabilised.
•Your doctor will adjust your dose to one that is ideal for you. To do this, your doctor may need to do some blood tests. Endogenous uveitis
•The total dose each day is usually between 5 mg and 7 mg per kilogram body weight. This is divided in two doses. Nephrotic syndrome
•The total dose each day for adults is usually 5 mg per kilogram body weight. This is divided in two doses. In patients with kidney problems, the first dose taken each day should not be more than 2.5 mg per kilogram body weight. Severe rheumatoid arthritis
•The total dose each day is usually between 3 mg per kilogram of your body weight and 5 mg per kilogram body weight. This is divided in two doses. Psoriasis and atopic dermatitis
•The total dose each day is usually between 2.5 mg per kilogram of your body weight and 5 mg per kilogram body weight. This is divided in two doses.
• In children: Nephrotic syndrome
•The total dose each day for children is usually 6 mg per kilogram body weight. This is divided in two doses. In patients with kidney problems, the first dose taken each day should not be more than 2.5 mg per kilogram body weight. Follow your doctor's instructions exactly and never change the dose yourself, even if you feel well. Switch from Sandimmun to Neoral You may have already been taking another medicine called Sandimmun Soft Gelatin Capsules or Sandimmun Oral Solution. Your doctor may decide to change to this medicine, Neoral Soft Gelatin Capsules.
• These medicines all contain ciclosporin as the active ingredient.
• Neoral is a different, improved formulation of ciclosporin compared to Sandimmun. Ciclosporin is absorbed into your blood better with Neoral and absorption is less likely to be affected by taking the medicine with food. This means that the levels of ciclosporin in your blood stay more constant with Neoral than with Sandimmun. If your doctor changes you from Sandimmun to Neoral:
• Do not go back to taking Sandimmun unless your doctor tells you to.
• Following your transfer from Sandimmun to Neoral, your doctor will monitor you more closely for a short time. This is because of the change in how ciclosporin is absorbed into your blood. Your doctor will make sure that you get the right dose for your individual needs. 6
• You may have some side effects. If this happens, tell your doctor or pharmacist. Your dose may need to be lowered. Never lower your dose yourself, unless a doctor has told you to. If your doctor switches you from one oral formulation of ciclosporin to another After you change from one oral formulation of ciclosporin to another:
• Your doctor will monitor you more closely for a short time.
• You may have some side effects. If this happens, tell your doctor or pharmacist. Your dose may need to be changed. Never change your dose yourself, unless a doctor has told you to. When to take Neoral Take Neoral at the same time every day. This is very important if you have had a transplant. How to take Neoral Your daily doses should always be taken in 2 divided doses. Remove the capsules from the blister. Swallow the capsules whole with water. How long to take Neoral Your doctor will tell you how long you need to take Neoral for. This depends on whether you are taking it after a transplant or for the treatment of a severe skin condition, rheumatoid arthritis, uveitis or nephrotic syndrome. For severe rash, the treatment usually lasts for 8 weeks. Keep taking Neoral for as long as your doctor tells you. If you have questions about how long to take Neoral, talk to your doctor or your pharmacist. If you take more Neoral than you should If you accidentally take too much of your medicine, tell your doctor immediately or go to your nearest hospital emergency unit. You may need medical attention. If you forget to take Neoral
• If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose. Then go on as before.
• Do not take a double dose to make up for a forgotten dose. If you stop taking Neoral Do not stop taking Neoral unless your doctor tells you to. Keep taking Neoral even if you feel well. Stopping your treatment with Neoral may increase the risk of your transplanted organ being rejected. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects could be serious
Tell your doctor straight away if you notice any of the following serious side effects:
• Like other medicines that act on the immune system, ciclosporin may influence your body’s ability to fight against infection and may cause tumours or other cancers, particularly of the skin. Signs of infection might be fever or sore throat. 7
• Changes in your sight, loss of coordination, being clumsy, memory loss, difficulty speaking or understanding what others say, and muscle weakness. These might be signs of an infection of the brain called progressive multifocal leukoencephalopathy.
• Brain problems with signs such as seizures, confusion, feeling disorientated, being less responsive, personality changes, feeling agitated, sleeplessness, changes to your sight, blindness, coma, paralysis of part or all of the body, stiff neck, loss of coordination with or without unusual speech or eye movements.
• Swelling at the back of the eye. This may be associated with blurred vision. It may also affect your sight because of the higher pressure inside your head (benign intracranial hypertension).
• Liver problems and damage with or without yellow skin and eyes, nausea, loss of appetite and dark urine.
• Kidney problems which may greatly reduce the amount of urine you produce.
• Low level of red blood cells or platelets. The signs include pale skin, feeling tired, being breathless, having dark urine (this is a sign of the breakdown of red blood cells), bruising or bleeding with no obvious reasons, feeling confused, feeling disorientated, being less alert and having kidney problems.
Other side effects include:
Very common side effects: These side effects may affect more than 1 in 10 people.
• Kidney problems.
• High blood pressure.
• Shaking of your body which you cannot control.
• Excessive growth of body and facial hair.
• High level of lipids in your blood. If any of these affects you severely, tell your doctor.
Common side effects: These side effects may affect between 1 and 10 in every 100 people.
• Fits (seizures).
• Liver problems.
• High level of sugar in your blood.
• Loss of appetite.
• Nausea (feeling sick), vomiting, abdominal pain, constipation, diarrhoea.
• Excessive hair growth.
• Acne, hot flushes.
• Low level of white blood cells.
• Feeling numb or tingling.
• Pain in your muscles, muscle spasm.
• Stomach ulcer.
• Gum tissue overgrowing and covering your teeth.
• High level of uric acid or patassium in your blood, low levels of magnesium in your blood. If any of these affects you severely, tell your doctor.
Uncommon side effects: These side effects may affect between 1 and 10 in every 1,000 people.
• Symptoms of brain disorders including sudden fits, mental confusion, sleeplessness, disorientation, disturbance of vision, unconsciousness, sense of weakness in the limbs, impaired movements.
• General swelling. 8
• Weight gain.
• Low level of red blood cells, low level of platelets in your blood which could increase the risk of bleeding. If any of these affects you severely, tell your doctor.
Rare side effects: These side effects may affect between 1 and 10 in every 10,000 people.
• Nerve problems with numbness or tingling in fingers and toes.
• Inflammation of the pancreas with severe upper stomach pain.
• Muscle weakness, loss of muscle strength, pain in muscles of the legs or hands or anywhere in the body.
• Destruction of red blood cells, involving kidney problems with symptoms such as swelling of the face, stomach, hands and/or feet, decreased urination, breathing difficulty, chest pain, fits, unconsciousness.
• Changes in menstrual cycle, breast enlargement in men. If any of these affects you severely, tell your doctor.
Very rare side effects: These side effects may affect between 1 and 10 in every 100,000 people.
• Swelling at the back of the eye which may be associated with an increase in pressure inside the head and eyesight disturbances. If this affects you severely, tell your doctor.
Other side effects with frequency not known: Frequency cannot be estimated from the available data.
• Serious liver problems both with and without yellowing of the eyes or skin, nausea (feeling sick), loss of appetite, dark coloured urine, swelling of the face, feet, hands and/or the whole body.
• Bleeding underneath the skin or purple skin patched, sudden bleeding with no apparent cause.
• Migraine or severe headache often with feeling and being sick (nausea, vomiting) and being sensitive to light.
• Pain in legs and feet If any of these affects you severely, tell your doctor. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Additional side effects in children and adolescents There are no additional side effects to be expected in children and adolescents compared to adults.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Neoral Suspension
Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the package.
• Do not store your capsules in a hot place (maximum temperature 25°C).
• Leave your capsules in the foil. Only remove them when it is time to take your medicine.
• When a blister is opened, a characteristic smell is noticeable. This is normal and does not mean that there is anything wrong with the capsules. 9
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
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