Package leaflet: Information for the patient

Capimune 25 mg Soft Capsules Capimune 50 mg Soft Capsules Capimune 100 mg, Soft Capsules

(ciclosporin)

Read all of this leaflet carefully, before you start

taking the 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 their sign 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. See section 4.

What is in this leaflet

1.    What Capimune soft gel capsules are and what they are used for

2.    What you need to know before you take Capimune soft gel capsules

3.    How to take Capimune soft gel capsules

4.    Possible side effects

5.    How to store Capimune soft gel capsules

6.    Contents of the pack and other information

1.    What Capimune soft gel capsules are and what they are used for

What Capimune soft gel capsules are

The name of your medicine is Capimune soft gel capsules. 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 Capimune soft gel capsules are used for and how Capimune soft gel capsules work

•    If you have had an organ transplant, bone marrow and stem cell transplantation, the function of Capimune soft gel capsules is to control your body's immune system. Capimune soft capsules 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, Capimune soft gel capsules 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

2.    What you need to know before you take Capimune Soft Capsules

If you are taking Capimune soft gel capsules 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 Capimune soft gel capsules:

•    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) or bosentan and aliskiren (used to reduce high blood pressure).

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

Warnings and precautions Talk to your doctor or pharmacist before and while taking Capimune Soft Capsules^ if you have any signs of infection, such as fever or a sore throat. Capimune soft capsules 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 check your 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.

•    if you need to have a vaccination.

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

Sunlight and sun protection

Capimune soft gel capsules 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 Capimune soft capsules:

•    if you have or have had alcohol-related problems.

•    if you have epilepsy.

•    if you have any liver problems.

•    if you are pregnant.

•    if you are breast-feeding.

•    if this medicine is being prescribed for a child.

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

Monitoring during your treatment with Capimune soft capsules

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 liver and kidneys are working,

•    your blood lipids (fats).

If you have any questions about how Capimune soft capsules works or why this medicine has been prescribed for you, ask your doctor.

In addition if you are taking Capimune soft capsules for a non-transplant disease (intermediary or posterior uveitis and Behget's uveitis, atopic dermatitis, severe rheumatoid arthritis or nephrotic syndrome), do not take Capimune soft capsules:

•    if you have kidney problems (except for nephrotic syndrome).

784401

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

•    if you have any type of cancer.

•    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, Capimune soft capsules should be stopped by your doctor.

Do not take Capimune soft capsules if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Capimune soft capsules.

If you are being treated for Behget's uveitis, your doctor will monitor you particularly carefully if you 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.

If you have been prescribed Capimune soft capsules to treat your psoriasis or atopic dermatitis, you must not be exposed to any UVB-rays or phototherapy during treatment.

Children and adolescents

Capimune soft capsules 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 Capimune soft capsules 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 Capimune soft capsules if your condition is particularly severe.

Other medicines and Capimune soft capsules

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

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 Capimune soft capsules treatment:

•    Medicines that may affect your potassium levels. These include medicines which contain potassium, potassium supplements, water tablets (diuretics) called potassiumsparing 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 Capimune soft capsules) 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), antibacterial medicines used to treat tuberculosis, orlistat (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 (non-steroid 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 your treatment 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 anti-cancer 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 Capimune soft capsules.

Capimune soft gel capsules with food and drink

Do not take Capimune soft capsules with grapefruit or grapefruit juice. This is because these can affect how Capimune soft capsules work.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

Pregnancy

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

Breast-feeding

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

Driving and using machines

Capimune soft capsules contains alcohol. This may affect your ability to drive and use machines.

Capimune soft capsules contains ethanol

Capimune soft capsules contain approximately 12.0 vol.

% ethanol (alcohol), which corresponds to up to 500 mg per dose used in transplant patients. This is equivalent to nearly 15 ml beer or 5 ml wine per dose.

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

530

3.    How to take Capimune Soft Capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you 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 Capimune soft capsules to take

Your doctor will work out the correct dose of Capimune soft capsules 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.

•    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.

Children and adolescents

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.

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 Capimune soft capsules

Take Capimune soft capsules at the same time every day. This is very important if you have had a transplant.

How to take Capimune soft capsules

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 Capimune soft capsules

Your doctor will tell you how long you need to take Capimune soft capsules 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 Capimune soft capsules for as long as your doctor tells you.

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

If you take more Capimune soft gel capsules 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 Capimune soft gel capsules

•    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 Capimune soft capsules

Do not stop taking Capimune soft capsules unless your doctor tells you to.

Keep taking Capimune soft capsules even if you feel well. Stopping your treatment with Capimune soft capsules 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.

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:

Very common (may affect more than 1 in 10 people):

•    Kidney problems which may greatly reduce the amount of urine you produce

Uncommon (may affect up to 1 in 100 people):

•    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.

Rare (may affect up to 1 in 1,000 people):

•    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.

Very rare (may affect up to 1 in 10,000 people):

•    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).

Not known (frequency cannot be estimated from the available data):

•    Liver problems and damage with or without yellow skin and eyes, nausea, loss of appetite and dark urine.

•    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.

Other possible side effects include:

Very common (may affect more than 1 in 10 people):

•    Kidney problems.

•    High blood pressure.

•    Headache.

•    Shaking of your body which you cannot control.

•    Excessive growth of body and facial hair.

•    High level of lipids in your blood.

Common (may affect up to 1 in 10 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 hair growth.

•    Acne,

•    Hot flushes.

•    Fever.

•    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 potassium in your blood.

Uncommon (may affect up to 1 in 100 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.

Rare (may affect up to 1 in 1000 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.

Very rare (may affect up to 1 in 10,000 people):

•    Swelling at the back of the eye which may be associated with an increase in pressure inside the head and eyesight disturbances.

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. Pain in the legs which may include a condition called calcineurin-induced pain syndrome (CIPS).

•    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 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 at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Capimune soft gel capsules

Keep this medicine out of the sight and reach of children.

There are no special storage precautions for Capimune soft gel capsules

Store in the original package.

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

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 protect the environment.

6.    Content of the pack and other information

What Capimune soft gel capsules contain

The active substance is ciclosporin 25 mg, 50 mg or 100 mg.

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) (25mg and 100mg), Purified water.

What Capimune soft gel capsules looks like and contents of the pack

Capimune soft gel capsules is available in three strengths: 25mg which are grey in colour, 50mg which are white in colour and 100mg which are grey in colour

Pack size: The soft capsules are available in aluminium-aluminium blister of:

10, 20, 30, 50, 60 & 100 capsules. Not all pack sizes may be marketed

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13

Ireland

Generics (UK) Ltd, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

This leaflet was last revised in 12/2015

O

co

to

CO

<

_l

CO

h-

f-

v1/May 2015