Patient Information Leaflet Neoral® 50 mg Capsules (ciclosporin)

This name of the product is Neoral® 50 mg capsules but will be known as Neoral Capsules throughout this leaflet. Other strengths are available.

What you need to know about Neoral Capsules

Your doctor has decided that you need this medicine to help treat your condition.

Please read this leaflet carefully before you start to take your medicine. It contains important information.

Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don't understand, please ask yourdoctor or pharmacist.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Neoral Capsules are and what they are used for

2.    Things to consider before you start to take Neoral Capsules

3.    How to take Neoral Capsules

4.    Possible side effects

5.    How to store Neoral Capsules

6.    Further information

1.    What Neoral capsules are and what are they used for

Neoral Capsules are available in four different strengths containing 10, 25, 50 or 50 mg of the active ingredient, ciclosporin. Ciclosporin is one of a group of drugs known as immunosuppressive agents. These drugs are used to dampen down the body's immune reactions.

Neoral Capsules can be used to treat a number of different conditions as follows:

After an organ (e.g. kidney, liver, etc.) 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. Neoral Capsules help to stop this rejection response by blocking the development of special cells which would normally attack the transplanted tissue.

If you have severe psoriasis or atopic dermatitis (eczema)

These serious skin conditions are thought to be caused by your immune system over-reacting. Neoral Capsules may help to stop this by suppressing the immune system.

If you have severe rheumatoid arthritis or nephrotic syndrome It is thought that rheumatoid arthritis and some forms of nephrotic syndrome may be caused by inappropriate immune responses in your body. Neoral Capsules may help to stop this by suppressing your immune system.

2.    Things to consider before you start to take Neoral Capsules

Some people MUST NOT take Neoral Capsules.

Talk to your doctor if:

•    You think you may be allergic to ciclosporin, or to any of the other ingredients of Neoral Capsules. (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.

•    People with psoriasis or atopic dermatitis MUST NOT be treated with Neoral Capsules if they have kidney problems, if they have uncontrolled high blood pressure or infections, or if they have any cancer except skin cancer.

•    People with rheumatoid arthritis MUST NOT be treated with Neoral Capsules if they are under 18 years old, or if they have kidney problems, uncontrolled high blood pressure, infections, or any type of cancer.

•    People with nephrotic syndrome MUST NOT be treated with Neoral Capsules if they have uncontrolled high blood pressure or infections, or if they have any type of cancer.

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

•    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 pharmacist if you are taking any of the following:

•    Medicines to treat heart problems or high blood pressure such as bosentan, diltiazem, nicardipine, verapamil and aliskiren.

•    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).

•    Medicines to treat stomach ulcers.

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.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or intend to become pregnant. Experience with Neoral Capsules in pregnancy is limited. In general, Neoral Capsules should not be taken during pregnancy. If it is necessary for you to take this medicine, your doctor will discuss with you the benefits and risks of taking it during pregnancy.

Tell your doctor if you are breast-feeding. Breast-feeding is not recommended during treatment with Neoral Capsules since ciclosporin, the active ingredient in Neoral Capsules, passes into breast milk and may affect your baby.

Will there be any problems with driving or using machinery?

No problems have been reported. However, Neoral Capsules do contain a small amount of alcohol. See the section below containing information on some of the ingredients of Neoral.

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 want to perform tests from time to time while you are being treated with Neoral Capsules.

•    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. Contact your doctor as soon as you feel 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 Neoral Capsules to treat psoriasis, the doctor will examine you to make sure that you do not have any skin cancers or precancers.

•    You must not have light treatment (PUVA or other UV treatment) for psoriasis while you are taking Neoral Capsules.

•    Do not go out into the sun too much without protecting your skin.

•    You must not eat grapefruit or drink grapefruit juice in the hour before you take the capsules.

•    If you have recently had a vaccination or are planning to have any vaccinations make sure the doctor or nurse knows you are taking Neoral Capsules.

•    You must visit the dentist regularly while you are taking Neoral Capsules to make sure that your gums remain healthy.

Important information about some of the ingredients of Neoral Capsules

Neoral Capsules contain:

•    Polyoxyl 40 hydrogenated castor oil which may cause stomach upsets and diarrhoea.

•    11.8% ethanol (alcohol). A 500mg dose of Neoral Capsules contains 500mg 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, or if you have liver disease or epilepsy, or if this medicine is being given to a child.

3.    How to take Neoral Capsules

Your doctor will work out the correct dose of Neoral Capsules for you depending on your body weight and your condition. Your doctor will also tell you how often to take your medicine. Always follow his/her instructions carefully. The dose will be on the pharmacist's label. Check the label carefully. If you are not sure, ask your doctor or pharmacist. Do not change the dose however well you feel. Keep taking your medicine for as long as you have been told, unless you have any problems. In that case, check with your doctor.

Swallow the capsule whole with a mouthful of water. You may drink more water afterwards.

You are usually advised to take Neoral Capsules twice a day.

If you have had an organ or bone marrow transplant the total dose is usually within the range of 2 to 15 mg/kg body weight per day. Generally, higher doses are used just after your transplant operation and 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 he may need to do some blood tests.

For the treatment of severe psoriasis and eczema the total dose is usually within the range of 2.5 to 5 mg/kg body weight per day.

For the treatment of severe rheumatoid arthritis the total dose is usually within the range of 2.5 to 4 mg/kg body weight per day.

For the treatment of nephrotic syndrome the total dose is usually within the range of 2.5 to 5 mg/kg body weight per day in adults and 2.5 to 6 mg/kg body weight per day in children.

Has your treatment been switched from other ciclosporin brands to Neoral?

The absorption of ciclosporin into the blood stream will vary from brand to brand. Consistent blood levels of ciclosporin are thought to be particularly important in the prevention of rejection following transplantation, especially in the longer term.

Because of the difference in absorption of ciclosporin, your doctor will probably want to monitor you more closely for a short period if you change to Neoral, to make sure that you get the ideal dose for you. If your doctor transfers you to Neoral, you should not go back to another ciclosporin brand unless your doctor tells you to.

What if you forget to take a dose?

If you forget to take a dose, take another one as soon as you remember, unless it is almost time for your next dose. Then go on as before.

What if you take too many capsules?

If you accidentally take too much of your medicine, tell your doctor immediately, or go to your nearest casualty department.

4.    Possible side effects

Most people who are prescribed Neoral Capsules 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, see your doctor immediately.

The following side effects have been reported:

More than 10% of people have experienced:

Kidney problems, high blood pressure, headache including migraine, tremor, increased levels of lipids (for example cholesterol) in the blood, chest infections, urinary infections and infection with CMV (cytomegalovirus).

Up to 1 in 10 people have experienced:

Numbness or tingling, loss of appetite, feeling or being sick, stomach pain, diarrhoea, swollen gums, liver disorders, 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 and cancers and over production of white blood cells.

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. A few people have had serious liver problems that have happened both with and without yellowing of the eyes or skin.

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

5.    How to store Neoral Capsules

Keep out of the sight and reach of children.

Store in original package. Only remove them when it is time to take your medicine. You will notice that they have a strong and distinctive smell.

Do not store above 25^oC Protect from moisture

Do not take Neoral Capsules after the expiry date which is printed on the outside of the pack. If your doctor tells you to stop taking the capsules, please take any unused capsules back to your pharmacist to be destroyed. Do not throw them away with your normal household water or waste. This will help to protect the environment.

6.    Further information

The soft gelatin capsules contain 50mg of the active ingredient, ciclosporin. Also contain the following inactive ingredients: DL-a-tocopherol, absolute ethanol, propylene glycol, corn oil mono-di- triglycerides, polyoxyl 40 hydrogenated castor oil, titanium dioxide, glycerol 85% and gelatin. The ink contains carminic acid, aluminium chloride, sodium hydroxide and hydroxypropylmethylcellulose.

50mg capsules are yellow-white, oblong soft gelatin capsules marked 'NVR 50mg' in purple ink.

Marketed in packs of 30.

Procured within the EU by the Product Licence holder: PilsCo Ltd, 9-15 Springburn Place, East Kilbride, G74 5NU Neoral 50 mg Capsules PL 39467/0058

Repackaged by TBC    POM

Manufactured by Novartis s.r.o, Gemini, Building B,

Na Pankraci 1724/129, CZ-140 00 Praha 4, Czech Republic Repackaged by TBC

This leaflet was revised in 08/11/2012.

NEORAL® is a registered trade mark of Novartis AG