Package leaflet: Information for the user

Mycophenolate mofetil 500 mg powder for concentrate for solution for infusion

mycophenolate mofetil

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 nurse.

•    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.

What is in this leaflet:

1.    What Mycophenolate mofetil for infusion is and what it is used for

2.    What you need to know before you take Mycophenolate mofetil for infusion

3.    How to take Mycophenolate mofetil for infusion

4.    Possible side effects

5.    How to store Mycophenolate mofetil for infusion

6.    Contents of the pack and other information

7.    Making up the medicine

1. What Mycophenolate mofetil for infusion is and what it is used for

The full name of your medicine is Mycophenolate mofetil 500 mg powder for concentrate for solution for infusion

•    In this leaflet the shorter name Mycophenolate mofetil for infusion is used.

Mycophenolate mofetil for infusion contains mycophenolate mofetil.

•    This belongs to a group of medicines called “immunosuppressants”.

Mycophenolate mofetil for infusion is used to prevent your body rejecting a transplanted organ.

•    A kidney or liver.

Mycophenolate mofetil for infusion should be used together with other medicines:

•    ciclosporin

•    corticosteroids.

2. What you need to know before you take Mycophenolate mofetil for infusion

Do not have Mycophenolate mofetil for infusion if:

•    you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid, polysorbate 80 or any of the other ingredients of Mycophenolate mofetil for infusion (listed in Section 6)

•    you are pregnant or breast-feeding.

Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before having Mycophenolate mofetil for infusion.

Warnings and precautions

Talk to your doctor or nurse straight away before having Mycophenolate mofetil for infusion if:

•    you have a sign of infection such as a fever or sore throat

•    you have any unexpected bruising or bleeding

•    you have ever had a problem with your digestive system such as a stomach ulcer

•    you are planning to become pregnant or if you get pregnant while taking Mycophenolate mofetil for infusion.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse straight away before having Mycophenolate mofetil for infusion.

The effect of sunlight

Mycophenolate mofetil for infusion reduces your body's defences. As a result, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Do this by:

•    wearing protective clothing which also covers your head, neck, arms and legs

•    using a sunscreen with a high protection factor.

Other medicines and Mycophenolate mofetil for infusion

Please tell your doctor or nurse if you are taking or have recently taken, any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Mycophenolate mofetil for infusion can affect the way some other medicines work. Also other medicines can affect the way Mycophenolate mofetil for infusion works.

In particular, tell your doctor or nurse if you are taking any of the following medicines before you start Mycophenolate mofetil for infusion:

•    azathioprine or other medicines which suppress your immune system - given after a transplant operation

•    cholestyramine - used to treat high cholesterol

•    rifampicin - an antibiotic used to prevent and treat infections such as tuberculosis (TB)

•    phosphate binders - used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood.

Vaccines

If you need to have a vaccine (a live vaccine) while having Mycophenolate mofetil for infusion, talk to your doctor or pharmacist first. Your doctor will have to advise you on what vaccines you can have.

Pregnancy, contraception and breast-feeding

Pregnancy

•    If you are pregnant, do not take Mycophenolate mofetil for infusion. This is because Mycophenolate mofetil for infusion may cause miscarriage or damage to your unborn baby (affecting development of ears for example).

•    In certain situations, you and your doctor may decide that the benefits of having Mycophenolate mofetil for infusion for your health are more important than the possible risks to your unborn baby.

•    If you plan to become pregnant, talk to your doctor first. Your doctor will talk to you about other medicines you can take to prevent rejection of your transplant organ.

•    If you think you may be pregnant tell your doctor or nurse straight away.

•    However, keep having Mycophenolate mofetil for infusion until you see him or her.

If you are able to become pregnant, you must have a pregnancy test before you start Mycophenolate mofetil for infusion. You can only start Mycophenolate mofetil for infusion if the test is negative.

You are a woman who is not capable of

becoming pregnant if any of the following applies

to you:

•    you are post-menopausal, i.e. at least 50 years old and your last period was more than a year ago (if your periods have stopped because you have had treatment for cancer, then there is still a chance you could become pregnant)

•    your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-oophorectomy)

•    your womb (uterus) has been removed by surgery (hysterectomy)

•    your ovaries no longer work (premature ovarian failure, which has been confirmed by a specialist gynaecologist)

•    you were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner's syndrome or uterine agenesis

•    you are a child or teenager who has not started having periods.

Contraception

You must always use an effective method of contraception with Mycophenolate mofetil for infusion. This includes:

•    before you start having Mycophenolate mofetil for infusion

•    during your entire treatment with Mycophenolate mofetil for infusion

•    for 6 weeks after you stop having Mycophenolate mofetil for infusion.

Talk to your doctor about the most suitable contraception for you. This will depend on your individual situation.

Breast-feeding

Do not have Mycophenolate mofetil for infusion if you are breast-feeding. This is because small amounts of the medicine can pass into the mother's milk.

Driving and using machines

Mycophenolate mofetil for infusion is not likely to affect you being able to drive or use any tools or machines.

3. How to take Mycophenolate mofetil for infusion

Mycophenolate mofetil for infusion is usually given by a doctor or nurse in hospital. It is given as a slow drip (infusion) into a vein.

How much to take

The amount you take depends on the type of transplant you have had. The usual doses are shown below. Treatment will continue for as long as you need to prevent you from rejecting your transplant organ.

Kidney transplant Adults

•    The first dose is given within 24 hours of the transplant operation.

•    The daily dose is 2 g of the medicine taken as 2 separate doses.

•    This will be given as 1 g in the morning and then 1 g in the evening.

Liver transplant

Adults

•    The first dose is given to you as soon as possible after the transplant operation.

•    You will have the medicine for at least 4 days.

•    The daily dose is 2 g of the medicine taken as 2 separate doses.

•    This will be given as 1 g in the morning and then 1 g in the evening.

•    When you are able to swallow, you will be given this medicine by mouth.

Making up the medicine

The medicine comes as a powder. This needs mixing with glucose before using. Your doctor or nurse will make up the medicine and give it to you. They will follow the instructions under Section 7 “Making up the medicine”.

If you have more Mycophenolate mofetil for infusion than you should

If you think that you have had too much medicine, talk to your doctor or nurse straight away.

If you forget to take Mycophenolate mofetil for infusion

If a dose of Mycophenolate mofetil for infusion is missed, this will be given to you as soon as possible. Your treatment will then continue at the normal times.

If you stop taking Mycophenolate mofetil for infusion

Do not stop having Mycophenolate mofetil for infusion unless your doctor tells you to. If you stop your treatment you may increase the chance of rejection of your transplant organ.

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

4. Possible side effects

Like all medicines, Mycophenolate mofetil for infusion can cause side effects, although not everybody gets them.

Talk to a doctor or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment:

•    you have a sign of infection such as a fever or sore throat

•    you have any unexpected bruising or bleeding

•    you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing - you may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema).

Usual problems

Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection and vomiting. Your doctor will do regular blood tests to check for any changes in:

•    the number of your blood cells

•    the amount in your blood of things like sugar, fat or cholesterol.

Fighting infections

Mycophenolate mofetil for infusion reduces your body's defences. This is to stop you rejecting your transplant. As a result, your body will not be as good as normal at fighting infections. This means you may catch more infections than usual. This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary system.

Lymph and skin cancer

As can happen in patients having this type of medicine (immune-suppressants), a very small number of Mycophenolate mofetil for infusion patients have developed cancer of the lymphoid tissues and skin.

General unwanted effects

You may get general side effects affecting your body as a whole. These include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such as stomach, chest, joint or muscle, pain on passing urine), headache, flu symptoms and swelling.

Other unwanted effects may include:

Skin problems such as:

•    acne, cold sores, shingles, hair loss, rash, itching.

Urinary problems such as:

•    kidney problems or the urgent need to pass water (urine).

Digestive system and mouth problems such as:

•    swelling of the gums and mouth ulcers

•    inflammation of the pancreas, colon or stomach

•    gut problems including bleeding, liver problems

•    constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.

Nervous system problems such as:

•    feeling drowsy or numb

•    tremor, muscle spasms, convulsions

•    feeling depressed, changes in your mood or thoughts.

Heart and blood vessel problems such as:

•    change in blood pressure, blood clots, unusual heartbeat

•    pain, redness and swelling of the blood vessels where you had the infusion.

Lung problems such as:

•    pneumonia, bronchitis

•    shortness of breath, cough which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Talk to your doctor if you develop a persistent cough or breathlessness

•    fluid on the lungs or inside the chest

•    sinus problems.

Other problems such as:

•    weight loss, high blood sugar, bleeding, bruising.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the the national reporting system (see contact details below).

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Malta

ADR Reporting

Website:www.medicinesauthority.gov.mt/adrportal

5. How to store Mycophenolate mofetil for infusion

•    Keep out of the sight and reach of children.

•    Do not use after the expiry date stated on the carton and vial label (EXP).

•    Powder for concentrate for solution for infusion: do not store above 30°C.

•    Reconstitution and dilution: After reconstitution and dilution, chemical and physical in-use stability of solution for infusion has been demonstrated for 24 hours at 20 to 30 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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7. Making up the medicine_

Method and route of administration

Mycophenolate mofetil for infusion does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.

The content of Mycophenolate mofetil for infusion vials must be reconstituted with 14 ml of glucose intravenous infusion 5 % each. A further dilution with glucose intravenous infusion 5 % is required to a final concentration of 6 mg/ml. This means that to prepare a 1 g dose of mycophenolate mofetil the content of 2 reconstituted vials (approx. 2 x 15 ml) must be further diluted into 140 ml glucose intravenous infusion 5 % solution. If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 24 hours from reconstitution and dilution of the medicinal product.

Take care not to let the made-up medicine get into your eyes.

• If this happens, rinse your eyes with plain water.

Take care not to let the made-up medicine get on your skin.

• If this happens, wash the area thoroughly with soap and water.

Mycophenolate mofetil for infusion must be given as intravenous (IV) infusion. The infusion flow rate should be controlled to equate a 2 hour period of administration.

Mycophenolate mofetil for infusion IV solution should never be administered by rapid or bolus intravenous injection.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow,

Middlesex, HA1 4HF, United Kingdom

Manufacturer

Accord Healthcare Limited

Ground Floor, Sage House, 319 Pinner Road,

North Harrow, Middlesex, HA1 4HF,

United Kingdom

Wessling Hungary Kft.

Foti ut 56., Budapest, 1047, Hungary

This medicinal product is authorised in the Member States of the EEA under the following names:

Proposed Name

Mycophenolatmofetil Accord 500 mg Pulver zur Herstellung eines

Infusionslosungskonzentrats Mycophenolate mofetil Accord Healthcare 500 mg poeder voor concentraat voor oplossing voor infusie / poudre pour solution a diluer pour perfusion / Pulver fur ein Konzentrat zur Herstellung einer Infusionslosung Mycophenolatmofetil Accord 500 mg Pulver zur Herstellung eines

Infusionslosungskonzentrats Mycophenolatmofetil Accord 500 mg pulver til koncentrat til infusionsv^ske, oplosning Micofenolato de mofetilo Accord 500 mg polvo para concentrado para solucion para perfusion EFG Mycophenolate mofetil Accord 500 mg poudre pour solution a diluer pour perfusion Mikofenolat-mofetil Accord 500 mg por oldatos infuziohoz valo koncentratumhoz Mycophenolate mofetil 500 mg Powder for concentrate for solution for infusion Mycofenolaat mofetil Accord 500 mg poeder voor concentraat voor oplossing voor infusie

Mykofenolatmofetil Accord Mykofenolan mofetylu Accord Micofenolato de mofetil Accord 500 mg po para concentrado para solugao para perfusao Mykofenolatmofetil Accord 500 mg pulver till koncentrat till infusionsvatska, losning Mycophenolate mofetil 500 mg Powder for concentrate for solution for infusion

This leaflet was last revised in 02/2015.

6. Contents of the pack and other information

What Mycophenolate mofetil for infusion contains

•    The active substance is mycophenolate mofetil.

•    The other ingredients are: polysorbate 80, citric acid, hydrochloric acid, sodium chloride and sodium hydroxide (for pH-adjustment).

What Mycophenolate mofetil for infusion looks like and contents of the pack

•    Mycophenolate mofetil for infusion is provided in a 20 ml type I clear glass vial with a grey butyl rubber stopper and aluminium flip off seal.

•    It is available in packs of either 4 vials or 1 vial.