PACKAGE LEAFLET: INFORMATION FOR THE USER

Emulsoforal 10 mg, 25 mg, 50 mg, 100 mg Capsules, soft

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 their signs 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 Emulsoforal is and what it is used for

2.    What you need to know before you take Emulsoforal

3.    How to take Emulsoforal

4.    Possible side effects

5.    How to store Emulsoforal

6.    Contents of the pack and other information

1.    WHAT EMULSOFORAL IS AND WHAT IT IS USED FOR

What Emulsoforal is

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

•    If you have had an organ transplant, bone marrow and stem cell transplantation, the function of Emulsoforal is to control your body’s immune system. Emulsoforal 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, Emulsoforal stops this immune reaction. Such diseases include eye problems which threaten your vision (endogenous uveitis, including Behcet'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 EMULSOFORAL

If you are taking Emulsoforal 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 Emulsoforal

-    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 Johns 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 Emulsoforal and tell your doctor if the above applies to you. If you are not sure, talk to your doctor before taking [invented name].

Warnings and precautions

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

•    if you have any signs of infection, such as fever or a sore throat. Emulsoforal 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 Emulsoforal, tell your doctor straight away.

Sunlight and sun protection

Emulsoforal 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 Emulsoforal,:

• 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 Emulsoforal,. This is because this medicine contains alcohol (see section below “Emulsoforal,contains ethanol”).

Monitoring during your treatment with Emulsoforal,

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 Emulsoforal, works or why this medicine has been prescribed for you, ask your doctor.

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

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

• 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, Emulsoforal should be stopped by your doctor.

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

If you are being treated for Behcet'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 Emulsoforal to treat your psoriasis or atopic dermatitis, you must not be exposed to any UVB-rays or phototherapy during treatment.

Children and adolescents

Emulsoforal 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 Emulsoforal 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 Emulsoforal if your condition is particularly severe.

Other medicines and Emulsoforal

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

Emulsoforal 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 Emulsoforal) 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, 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 antidiabetic 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

Emulsoforal.

Emulsoforal with food and drink

Do not take Emulsoforal with grapefruit or grapefruit juice. This is because these can affect how Emulsoforal works.Pregnancy and breast-feeding

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

• Tell your doctor if you are pregnant or intend to become pregnant. Experience with Emulsoforal in

pregnancy is limited. In general, Emulsoforal 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 Emulsoforal This is because ciclosporin, the active substance, passes into breast milk. This may affect your baby.

Driving and using machines

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

Emulsoforal contains ethanol.

Emulsoforal contains approximately 14.7 % ethanol (alcohol), which corresponds up to 797.5 mg per dose used in transplant patients, This is equivalent 20 ml of beer or about 8 mlof 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..

Emulsoforal contains macrogolglycerol hydroxystearate

Emulsoforal contains macrogolglycerol hydroxystearate, which may cause stomach discomfort and diarrhoea.

Emulsoforal contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE EMULSOFORAL

Always take this medicine exactly as your doctor has told you. Check with your doctor 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 Emulsoforal to take

Your doctor will work out the correct dose of Emulsoforal 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 bodyweight .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.

Psoriasisand atopic dermatitis

•    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 oral ciclosporin to oral microemulsified ciclosporin

You may have already been taking another oral ciclosporin. Your doctor may decide to change to this medicine, Emulsoforal

•    These medicines all contain ciclosporin as the active ingredient.

•    Emulsoforal is a different, improved formulation of ciclosporin. Ciclosporin is absorbed into your blood better with Emulsoforal 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 Emulsoforal

If your doctor changes you from oral ciclosporin to oral microemulsified ciclosporin:

•    Do not go back to taking your previous medicine unless your doctor tells you to.

•    Following your transfer, 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.

•    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 Emulsoforal

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

How to take Emulsoforal

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 Emulsoforal

Your doctor will tell you how long you need to take Emulsoforal 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 Emulsoforal for as long as your doctor tells you.

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

If you take more Emulsoforal than you should

If you accidentally take too much of your medicine, talk to your doctor mmediately. or go to your nearest hospital emergency unit. You may need medical attention...

If you forget to take Emulsoforal

•    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 Emulsoforal

Do not stop taking Emulsoforal unless your doctor tells you to.

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

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.

Other side effects include:

Very common side effects: These side effects 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.

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 peopleFits (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 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

•    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 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 ot the back 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.

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, pharmacist or nurse. 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 EMULSOFORAL

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 carton box and blister after EXP. The expiry date refers to the last day of that month.

Store below 30°C. Do not freeze. Store in the original package in order to protect from light and moisture.

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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Emulsoforal contains

-    The active substance is ciclosporin.

Each soft capsule contains 10 mg ciclosporin.

Each soft capsule contains 25 mg ciclosporin.

Each soft capsule contains 50 mg ciclosporin.

Each soft capsule contains 100 mg ciclosporin.

-    The other ingredients in the capsule fill are macrogolglycerol hydroxystearate, glycerol monolinoleate, diethylene glycol monoethyl ether, anhydrous ethanol and D,L-a-tocopherol.

-    The other ingredients in the capsule shell are:

-    10 mg

gelatin, glycerol 85%, non-crystallizing sorbitol 70% (E420), glycine, titanium dioxide (E171) and paraffin, light liquid.

25 mg & 50 mg

gelatin, glycerol 85%, non-crystallizing sorbitol 70% (E420), glycine, titanium dioxide (E171), iron oxide yellow (E172) and paraffin, light liquid.

100 mg

gelatin, glycerol 85%, non-crystallizing sorbitol 70% (E420), glycine, titanium dioxide (E171), iron oxide brown (E172) and paraffin, light liquid.

What Emulsoforal looks like and contents of the pack

Emulsoforal 10 mg soft capsules are opaque white to off-white soft gelatin capsules containing colourless to slightly yellowish oily liquid. Approximate size of 9.0 x 5.5 mm.

Emulsoforal 25 mg soft capsules are opaque yellow soft gelatin capsules containing colourless to slightly yellowish oily liquid, with printing the IVAX “hourglass” logo “25”. Approximate size of 12.2 x 7.6 mm.

Emulsoforal 50 mg soft capsules are opaque ochre-yellow soft gelatin capsules containing colourless to slightly yellowish oily liquid, with printing the IVAX “hourglass” logo “50”. Approximate size of 20.7 x 7.8 mm.

Emulsoforal 100 mg soft capsules are opaque brown soft gelatin capsules containing colourless to slightly yellowish oily liquid, with printing the IVAX “hourglass” logo “100”. Approximate size of 24.7 x 9.9 mm.

The capsules are available in pack sizes of 20, 30, 50, 50x1, 60, 90 and 100 in OPA/Alu/PVC - Aluminium blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Teva UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer

Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, 74770 Opava-Komarov, Czech Republic *OR

TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom *OR

Teva Operations Poland Sp. z.o.o, ul. Mogilska 80. 31-546, Krakow, Poland This leaflet was last revised in 07/2016.

* Only the actual site of batch release will appear on the printed version of the leaflet