PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Capsorin 25 mg soft capsules Capsorin 50 mg soft capsules Capsorin 100 mg soft capsules

Ciclosporin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if theirsigns of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Capsorin is and what it is used for

2.    What you need to know before you take Capsorin

3.    How to take Capsorin

4.    Possible side effects

5.    How to store Capsorin

6.    Contents of the pack and other information

1. What Capsorin is and what it is used for

What Capsorin is

The name of your medicine is Capsorin. 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 Capsorin is used for and how Capsorin works

•    If you have had an organ transplant, bone marrow and stem cell transplantation, the function of Capsorin is to control your body's immune system. Capsorin 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, Capsorin stops this immune reaction. Such diseases include eye problems which threaten your vision (endogenous uveitis, including Behget's uveitis), severe cases of certain skin diseases (atopic dermatitis, or eczema and psoriasis), severe rheumatoid arthritis and a kidney disease called nephrotic syndrome.

2. What you need to know before you take Capsorin

If you are taking Capsorin following a transplant it will only be prescribed for you by a doctor with experience in transplants and/or autoimmune diseases.

The advice in this leaflet may vary depending on whether you are taking the medicine for a transplant or for an autoimmune disease.

Follow all your doctor's instructions carefully. They may differ from the general information contained in this leaflet.

Do not take Capsorin:

•    if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6).

•    with products containing Hypericum perforatum (St. John's Wort).

•    with products containing dabigatran etexilate (used to avoid blood clots after surgery) orbosentan andaliskiren (used to reduce high blood pressure).

Do not take Capsorin and tell your doctor if the above applies to you. If you are not sure, talk to your doctor before taking Capsorin.

Warnings and precautions

Before and during treatment with Capsorin, tell your doctor straight away:

•    if you have any signs of infection, such as fever or a sore throat. Capsorin suppresses the immune system and may also affect your body's ability to fight against infection.

•    if you have liver problems.

•    if you have kidney problems. Your doctor will carry out regular blood tests and may change your dose if necessary.

•    If you develop high blood pressure. Your doctor will checkyour blood pressure regularly and may give you a medicine to lower blood pressure if necessary.

•    if you have low levels of magnesium in your body. Your doctor may give you magnesium supplements to take, especially just after your operation if you have had a transplant.

•    if you have high levels of potassium in your blood.

•    if you have gout.

•    ifyou need to have a vaccination.

If any of the above applies to you before or during treatment with Capsorin, tell your doctor straight away.

Sunlight and sun protection

Capsorin suppresses your immune system. This increases your risk of developing cancers, particularly of the skin and lymphoid system. You should limit your exposure to sunlight and UV light by:

•    Wearing appropriate protective clothing.

•    Often applying a sunscreen with a high protection factor.

Talk to your doctor before taking Capsorin:

•    ifyou have or have had alcohol-related problems.

•    ifyou have epilepsy.

•    ifyou have any liver problems.

•    ifyou are pregnant.

•    ifyou are breast-feeding.

•    if this medicine is being prescribed fora child.

If any of the above apply to you (or you are not sure), tell your doctor before taking Capsorin. This is because this medicine contains alcohol (see section below “Capsorin contains ethanol").

Monitoring during yourtreatment with Capsorin

Your doctor will check:

•    the levels of ciclosporin in your blood, especially if you have had a transplant,

•    your blood pressure before the start of your treatment and regularly during treatment,

•    how well your liverand kidneys are working,

•    yourblood lipids (fats).

Ifyou have any questions about how Capsorin works or why this medicine has been prescribed for you, askyourdoctor.

In addition if you are taking Capsorin for a non-transplant disease

(intermediary or posterior uveitis and Behget's uveitis, atopic dermatitis, severe rheumatoid arthritis or nephrotic syndrome), do not take Capsorin:

•    ifyou have kidney problems (exceptfor nephrotic syndrome).

•    ifyou have an infection which is not under control with medication.

•    ifyou haveanytypeofcancer.

•    if you have high blood pressure (hypertension) which is not under control with medication. If you get high blood pressure during treatment and it cannot be controlled, Capsorin should be stopped by your doctor.

Do not take Capsorin if any of the above applies to you. If you are not sure, talk to yourdoctor or pharmacist before taking Capsorin.

Ifyou are being treated for Behget's uveitis, yourdoctor will monitoryou particularly carefully ifyou have neurological symptoms (for example: increased forgetfulness, personality changes noticed over time, psychiatric or mood disorders, burning sensation in limbs, decreased sensation in limbs, tingling sensation in limbs, weakness of limbs, walking disturbances, headache with or without nausea and vomiting, vision disturbances including restricted movement of eyeball).

Your doctor will closely monitor you if you are elderly and are being treated for psoriasis or atopic dermatitis. Ifyou have been prescribed Capsorin to treat your psoriasis or atopic dermatitis, you must not be exposed to any UVB-rays or phototherapy during treatment.

Children and adolescents

Capsorin should not be given to children for a non-transplant disease, except for treatment of nephrotic syndrome.

Elderly population (65 years of age and older)

There is limited experience with Capsorin in elderly patients. Your doctor should monitor how well your kidneys work. If you are over 65 and have psoriasis or atopic dermatitis, you should only be treated with Capsorin if your condition is particularly severe.

Other medicines and Capsorin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular tell your doctor or pharmacist if you are taking any of the following medicines before or during Capsorin treatment:

•    Medicines that may affect your potassium levels. These include medicines which contain potassium, potassium supplements, water tablets (diuretics) called potassium-sparing diuretics and some medicines which lower your blood pressure.

•    Methotrexate. This is used to treat tumours, severe psoriasis and severe rheumatoid arthritis.

•    Medicines which may increase or decrease the level of ciclosporin (the active substance of Capsorin) in your blood. Your doctor might check the level of ciclosporin in your blood when starting or stopping treatment with other medicines.

. Medicines which may increase the level of ciclosporin in your blood include: antibiotics (such as erythromycin or azythromycin), anti-fungals (voriconazole, itraconazole), medicines used for heart problems or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to stop sickness), oral contraceptives, danazol (used to treat menstrual problems), medicines used to treat gout (allopurinol), cholic acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat leukaemia or tumours), colchicine, telaprevir(used to treat hepatitis C).

. Medicines which may decrease the level of ciclosporin in your blood include: barbiturates (used to help you to sleep), some anti-convulsant medicines (such as carbamazepine or phenytoine), octreotide (used to treat acromegaly or neuroendocrine tumours in the gut), anti-bacterial medicines used to treat tuberculosis, oriistat (used to help weight loss), herbal medicines containing St. John's wort, ticlopidine (used after a stroke), certain medicines which lower blood pressure (bosentan), and terbinafine (an anti-fungal medicine used to treat infections of the toes and nails).

•    Medicines which may affect your kidneys. These include: anti-bacterial medicines (gentamycin, tobramycin, ciprofloxacin), anti-fungal medicines which contain amphotericin B, medicines used for urinary tract infections which contain trimethoprim, medicines for cancer which contain melphalan, medicines used to lower the amount of acid in your stomach (acid secretion inhibitors of the H2-receptor antagonist type), tacrolimus, pain killers (nonsteroid anti-inflammatory medicines such as diclofenac), fibric acid medicines (used to lower the amount of fat in the blood).

•    Nifedipine. This is used to treat high blood pressure and heart pain. You might get swollen gums that might grow over your teeth if you are taking nifedipine during yourtreatment with ciclosporin.

•    Digoxin (used to treat heart problems), medicines which lower cholesterol (HMG-CoA reductase inhibitors also called statins), prednisolone, etoposide (used to treat cancer), repaglinide (oral anti-diabetic medicine), immunosuppressives (everolimus, sirolimus), ambrisentan and specific anticancer medicines called anthracyclines (such as doxorubicin).

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Capsorin.

Capsorin with food and drink

Do not take Capsorin with grapefruit or grapefruit juice. This is because these can affect how Capsorin works.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Your doctor will discuss with you the potential risks of taking Capsorin during pregnancy.

•    Tell your doctor if you are pregnant or intend to become pregnant. Experience with Capsorin in pregnancy is limited. In general, Capsorin 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 potential risks of taking it during pregnancy.

•    Tell your doctor if you are breast-feeding. Breast-feeding is not recommended during treatment with Capsorin. This is because ciclosporin, the active substance, passes into breast milk. This may affect your baby.

Driving and using machines

Capsorin contains alcohol. This may affect your ability to drive and use machines.

Capsorin contains macrogolglycerol hydroxystearate

•    Capsorin contains macrogolglycerol hydroxystearate, which may cause stomach upset and diarrhoea.

Capsorin contains ethanol

Capsorin contains approximately 12.7 vol. % ethanol (alcohol), which corresponds to up to 525mg per dose (maximum dose) used in transplant patients. This is equivalent to approximately 13 ml beer, or approximately 6 ml wine.

Alcohol may be harmful ifyou have alcohol-related problems, epilepsy, brain injury, liver problems or ifyou are pregnant or breast-feeding. It may also be harmful if this medicine is given to children.

3. Howto take Capsorin

Always take this medicine exactly as your doctor has told you. Check with your doctor ifyou are not sure.

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 Capsorin to take

Your doctor will work out the correct dose of Capsorin 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 afteryour 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 ifyou feel well.

If your doctor switches you from one oral formulation of ciclosporin to another

After you change from one oral formulation of ciclosporin to another:

•    Yourdoctorwill monitoryou more closelyforashorttime.

• You may have some side effects. If this happens, tell your doctor or pharmacist. Yourdose may need to be changed. Never change your dose yourself, unlessa doctor has told you to.

When to take Capsorin

Take Capsorin at the same time every day. This is very important ifyou have had a transplant.

How to take Capsorin

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 Capsorin

Your doctor will tell you how long you need to take Capsorin 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 Capsorin for as long as yourdoctor tells you.

If you have questions about how long to take Capsorin, talk to your doctor or your pharmacist.

Ifyou take more Capsorin than you should

Ifyou accidentally take too much of your medicine, tell your doctor immediately or go to your nearest emergency unit. You may need medical attention.

Ifyou forget to take Capsorin

•    If you forget to take a dose, take it as soon as you remember it. However, if it is almost time foryour next dose, skip the missed dose. Then go on as before.

•    Do not take a double dose to make up for a forgotten dose.

Ifyou stop taking Capsorin

Do not stop taking Capsorin unless yourdoctor tells you to.

Keep taking Capsorin even if you feel well. Stopping your treatment with Capsorin may increase the risk of yourtransplanted organ being rejected.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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.

•    Rash.

•    General swelling.

•    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 10in every 10,000 people.

•    Nerve problems with numbness ortingling 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 oranywhereinthebody.

•    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 100,000people.

•    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

Otherside 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/orthe 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.

If any of these affects you severely, tell your doctor.

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, Website: www.mhra.aov.uk/vellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. Howto store Capsorin

Keep out of the sight and reach of children.

This medicinal product does not require any special temperature storage conditions Store in the original package in orderto protect from light and moisture.

Leave your capsules in the foil. Only remove them when it is time to take your medicine.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

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.

Medicines should not be disposed of 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.

6. Contents of the pack and other information

4. 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.

•    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.

Otherside effects include:

Very common side effects: These side effects may affect more than 1 in 10 people.

•    Kidney problems.High blood pressure.

•    Headache.

•    Shaking ofyourbodywhichyou cannotcontrol.

•    Excessive growth of body and facial hair.

•    High level of lipids in yourblood.

If any of these affects you severely, tell yourdoctor.

Common side effects: These side effects may affect between 1 and 10in every 100 people.

•    Fits (seizures).

•    Liver problems.

•    High level of sugar in your blood.

•    Tiredness.

•    Loss of appetite.

•    Nausea (feeling sick), vomiting, abdominal pain, constipation, diarrhoea.

•    Excessive hairgrowth.

•    Acne, hotflushes.

•    Fever.

•    Low level of white blood cells.

•    Feeling numbortingling.

•    Pain in your muscles, muscle spasm.

•    Stomach ulcer.

•    Gum tissue overgrowing and covering yourteeth.

•    High level of uric acid or potassium in your blood, low levels of magnesium in yourblood.

If any of these affects you severely, tell yourdoctor.

What Capsorin contains

Capsorin 25 mg soft capsules

•    The active substance is ciclosporin. Each capsule contains 25 mg ciclosporin.

•    The other ingredients are: ethanol anhydrous, tocopherol acetate, dyethylene glycol monoethyl ether, oleoyl macrogolglycerides, macrogolglycerol hydroxystearate, gelatin, glycerol, propylene glycol, titanium dioxide (E171), iron oxide black (E172) purified water.

Capsorin 50 mg soft capsules

•    The active substance is ciclosporin. Each capsule contains 50 mg ciclosporin.

•    The other ingredients are: ethanol anhydrous, tocopherol acetate, dyethylene glycol monoethyl ether, oleoyl macrogolglycerides, macrogolglycerol hydroxystearate, gelatin, glycerol, propylene glycol, titanium dioxide (E171), purified water.

Capsorin 100 mg soft capsules

•    The active substance is ciclosporin. Each capsule contains 100 mg ciclosporin.

•    The other ingredients are: ethanol anhydrous, tocopherol acetate, dyethylene glycol monoethyl ether, oleoyl macrogolglycerides, macrogolglycerol hydroxystearate, gelatin, glycerol, propylene glycol, titanium dioxide (E171), iron oxide black (E172) purified water.

What Capsorin looks like and contents of the pack

Capsorin 25 mg soft capsules are grey.

Capsorin 50 mg soft capsules are white.

Capsorin 100 mg soft capsules are grey.

Capsorin is available in Aluminium/Aluminium blister packed in carton boxes of 10, 20,30,50 and 60 capsules.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Morningside Healthcare Ltd 115 Narborough Road, Leicester, LE3 0PA, UK

Manufacturers

Morningside Pharmaceuticals Limited 5 Pavilion Way, Castle Business Park Loughborough, Leicestershire, LE115GW, UK

Monteresearchs.r.l VialVNovembren.92 20021 Bollate (Ml), Italy

Medis International a.s„ production plant Bolatice

PrCimyslova 961/16

747 23 Bolatice, Czech republic

This leafletwas last revised in: 12/2013