Package leaflet: Information for the patient

CellCept 250 mg hard capsules

mycophenolate mofetil
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What CellCept is and what it is used for
What you need to know before taking CellCept
How to take CellCept
Possible side effects
How to store CellCept
Contents of the pack and other information

1. What CellCept is and what it is used for

CellCept contains mycophenolate mofetil.

This belongs to a group of medicines called "immunosuppressants". CellCept is used in adults and children to prevent the body from rejecting a transplanted organ.
Kidney, heart, or liver. CellCept must be used in combination with other medicines:
cyclosporine and corticosteroids.

2. What you should know before taking CellCept

WARNING
Mycophenolate causes birth defects and miscarriage. If you are a woman of childbearing potential,
you must have a negative pregnancy test before starting treatment and follow your doctor’s
advice regarding contraception.
Your doctor will discuss this with you and provide written information, particularly about the effects of
mycophenolate on the unborn child. Read this information carefully and follow the instructions.
If you do not fully understand these instructions, ask your doctor to explain them again before taking
mycophenolate. Also read the information within this section under “Warnings and precautions” and “Pregnancy and breastfeeding”.
Do not take CellCept:

if you are allergic to mycophenolate mofetil, mycophenolic acid, or any of the other ingredients of this medicine (listed in section 6)
if you are a woman of childbearing potential and have not had a negative pregnancy test before the first prescription, because mycophenolate causes birth defects and miscarriage
if you are pregnant, suspect you may be pregnant, or are planning a pregnancy
if you are not using an effective contraceptive method (see Contraception, pregnancy, and breastfeeding)
if you are breastfeeding.

Do not take this medicine if any of the above conditions apply to you. If you have any
doubts, speak with your doctor or pharmacist before taking CellCept.
Warnings and precautions
Tell your doctor immediately before starting treatment with CellCept:

if you are over 65 years old, as you may have an increased risk of developing adverse events such as certain viral infections, gastrointestinal bleeding, and pulmonary edema compared to younger patients
if you have signs of infection such as fever or sore throat
if you experience unexpected bruising or bleeding
if you have ever had a digestive disorder, for example a stomach ulcer
if you are planning a pregnancy or if you become pregnant while you or your partner are being treated with CellCept
if you have a hereditary enzyme deficiency such as Lesch-Nyhan or Kelley-Seegmiller syndrome.

If any of the above conditions apply to you (or if you have any doubts), inform your
doctor immediately before starting treatment with CellCept.
Effects of sunlight
CellCept lowers the body's defenses, increasing the risk of skin cancer. Limit your exposure to sunlight and UV rays by:

wearing protective clothing covering your head, neck, arms, and legs
using sunscreen products with high sun protection factor.

Children
Children, especially those under 6 years of age, may be more likely than adults to experience certain side effects, including diarrhea, vomiting, infections, reduced red and white blood cells in the blood, and possibly lymphoma or skin cancer.
The capsules are suitable only for children able to swallow solid medicines without risk of choking. The medicine must therefore be administered only as prescribed by the doctor.
If you have any doubts about your child’s treatment, consult your doctor or pharmacist before use.
Other medicines and CellCept
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, such as herbal remedies. CellCept may affect the action of other medicines. Other medicines may also affect the action of CellCept.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines before taking CellCept:

azathioprine or other medicines that suppress the immune system, prescribed after an organ transplant
cholestyramine – used to treat high cholesterol
rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB)
antacids or proton pump inhibitors – used for stomach acidity problems such as indigestion
phosphate binders – used in patients with chronic kidney failure to reduce phosphate absorbed into the blood
antibiotics – used to treat bacterial infections
isavuconazole – used to treat fungal infections
telmisartan – used to treat high blood pressure.

Vaccines
If you need to receive a vaccination (live vaccine) during treatment with CellCept, inform your doctor or pharmacist first. Your doctor will advise you which vaccine is appropriate for you.
You must not donate blood during treatment with CellCept and for at least 6 weeks after stopping treatment. Men must not donate sperm during treatment with CellCept and for at least 90 days after stopping treatment.
CellCept with food and drink
Eating and drinking have no effect on treatment with CellCept.
Contraception in women taking CellCept
If you are a woman of childbearing potential, you must use an effective contraceptive method while taking CellCept. This means:

before starting CellCept
throughout the entire treatment with CellCept
for 6 weeks after stopping treatment with CellCept. Talk to your doctor about the most suitable contraceptive method for you. This will depend on your individual situation. Using two contraceptive methods is preferable to reduce the risk of unintended pregnancy. Contact your doctor as soon as possible if you think your contraceptive method may not have been effective or if you missed taking your oral contraceptive pill.

You cannot become pregnant if any of the following conditions apply to you:

you are postmenopausal, i.e., you are at least 50 years old and your last menstrual period was more than one year ago (if your menstrual cycle has stopped due to cancer treatment, you may still be able to become pregnant).
your Fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy).
your uterus has been surgically removed (hysterectomy).
your ovaries no longer function (premature ovarian failure, confirmed by a gynecological specialist).
you were born with one of the following rare conditions that make pregnancy impossible: XY genotype, Turner syndrome, or uterine agenesis.
you are a child or adolescent who has not yet had her first menstrual period.

Contraception in men taking CellCept
Although available clinical data do not indicate an increased risk of birth defects or miscarriage when the father takes mycophenolate, this risk cannot be completely ruled out.
As a precaution, you and your partner are therefore advised to use a reliable contraceptive method during treatment and for 90 days after stopping treatment with CellCept.
If you are planning a pregnancy, talk to your doctor about potential risks and alternative treatments.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will discuss with you the risks of pregnancy and alternative treatments you may consider to prevent organ transplant rejection if:

you are planning a pregnancy
you miss or think you may have missed a menstrual period, have unusual menstrual bleeding, or suspect you are pregnant
you have had sexual intercourse without using effective contraceptive methods.

If you become pregnant during treatment with mycophenolate, you must inform your doctor immediately. In any case, continue taking CellCept until you see your doctor.
Pregnancy
Mycophenolate very frequently causes miscarriage (50%) and serious birth defects (23–27%) in the unborn child. Reported birth defects include abnormalities of the ears, eyes, face (cleft lip/palate), fingers, heart, esophagus (the tube connecting the throat and stomach), kidneys, and nervous system (e.g., spina bifida [where the bones of the spine are not fully developed]). The baby may have one or more of these defects.
If you are a woman of childbearing potential, you must have a negative pregnancy test before starting treatment and follow your doctor’s advice regarding contraception. Your doctor may require more than one test to ensure you are not pregnant before starting treatment.
Breastfeeding
Do not take CellCept if you are breastfeeding. Small amounts of the medicine may pass into breast milk.
Driving and using machines
CellCept has a moderate effect on the ability to drive vehicles or operate tools or machinery. If you feel drowsy, dazed, or confused, consult your doctor or nurse and do not drive or operate tools or machinery until you feel better.
CellCept contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially ‘sodium-free’.

3. How to take CellCept

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

How much to take
The dose you need depends on the type of transplant you have received. The usual doses are indicated below. Treatment will continue as long as you need to prevent rejection of the transplanted organ.

Kidney transplant
Adults

The first dose is administered within 3 days after transplantation surgery.
The daily dose is 8 capsules (2 g of medicine), divided into two separate doses.
Take 4 capsules in the morning and 4 capsules in the evening.

Children

Capsules are suitable only for children able to swallow solid medicines without risk of choking. The medicine must therefore be administered only as prescribed by the doctor. If you have any doubts, consult your doctor or pharmacist before use.
The dose to be administered will depend on the child's body surface area.
The child’s doctor will determine the most appropriate dose based on the child’s height and weight (body surface area – measured in square meters or “m²”). The recommended initial dose is 600 mg/m² administered twice daily. The recommended maintenance dose remains 600 mg/m² twice daily (maximum total daily dose of 2 g). The dose should be individualized based on clinical assessment.

Heart transplant
Adults

The first dose is administered within 5 days after transplantation surgery.
The daily dose is 12 capsules (3 g of medicine), divided into two doses.
Take 6 capsules in the morning and 6 capsules in the evening.

Children

Capsules are suitable only for children able to swallow solid medicines without risk of choking. The medicine must therefore be administered only as prescribed by the doctor. If you have any doubts, consult your doctor or pharmacist before use.
The dose to be administered will depend on the child's body surface area.
The child’s doctor will determine the most appropriate dose based on the child’s height and weight (body surface area – measured in square meters or “m²”). The recommended initial dose is 600 mg/m² administered twice daily. The dose should be individualized based on the doctor’s clinical assessment. If well tolerated, the dose may be increased to 900 mg/m² administered twice daily, as needed (maximum total daily dose of 3 g).

Liver transplant
Adults

The first dose of oral CellCept will be administered at least 4 days after transplantation surgery and when you are able to swallow oral medication.
The daily dose is 12 capsules (3 g of medicine), divided into two separate doses.
Take 6 capsules in the morning and 6 capsules in the evening.

Children

Capsules are suitable only for children able to swallow solid medicines without risk of choking. The medicine must therefore be administered only as prescribed by the doctor. If you have any doubts, consult your doctor or pharmacist before use.
The dose to be administered will depend on the child's body surface area.
The child’s doctor will determine the most appropriate dose based on the child’s height and weight (body surface area – measured in square meters or “m²”). The recommended initial dose is 600 mg/m² administered twice daily. The dose should be individualized based on the doctor’s clinical assessment. If well tolerated, the dose may be increased to 900 mg/m² administered twice daily, as needed (maximum total daily dose of 3 g).

Taking the medicine
Swallow the capsules whole with a glass of water.

Do not break or crush the capsules.
Do not take broken or opened capsules.

Be careful to avoid contact between the powder leaking from damaged capsules and your eyes or mouth.

If this occurs, rinse thoroughly with plenty of running water.

Be careful to avoid contact between the powder leaking from damaged capsules and your skin.

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

If you take more CellCept than you should
If you take more CellCept than prescribed, inform a doctor or go to hospital immediately. Do the same if someone else accidentally takes the medicine. Take the medicine pack with you.

If you forget to take CellCept
If you forget to take your dose, take it as soon as you remember, then continue taking it as usual. Do not take a double dose to make up for the forgotten dose.

If you stop taking CellCept
Do not stop taking CellCept unless instructed by your doctor. Stopping treatment may increase the risk of rejection of the transplanted organ.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, CellCept can cause side effects, although not everyone gets them.
Talk to a doctor immediately if you notice any of the following serious side effects;
you may need urgent medical treatment:

signs of infection such as fever or sore throat
unexpected bruising or bleeding
rash, itching, hives, shortness of breath or difficulty breathing, wheezing or cough, mental confusion, dizziness, altered consciousness, hypotension, with or without mild generalized itching, skin redness and swelling of the face/throat (symptoms of a severe allergic reaction)

Common problems
Some of the more common problems are diarrhoea, decreased white or red blood cells in the blood, infections and vomiting. Your doctor will perform regular blood tests to check for any changes:

in blood cell counts or signs of infection.

Fighting infections
CellCept lowers the body's defences to prevent transplant rejection. As a result, the body will not be able to fight infections effectively as it normally would. This means you may get infections more often, for example infections affecting the brain, skin, mouth, stomach and intestines, lungs and urinary tract.
Lymphatic system and skin tumours
As can occur with other drugs of this type (immunosuppressants), a very small number of patients taking CellCept have developed tumours of the lymphatic system and skin.
General side effects
You may experience side effects affecting the body in general. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling of fatigue, sleep disturbances, pain (in stomach, chest, muscles or joints), headache, flu-like symptoms and swelling.
Other side effects may include:
Skin disorders such as:

acne, cold sores, shingles, skin thickening, hair loss, rash and itching.

Urinary system disorders such as:

presence of blood in the urine.

Digestive system and mouth disorders such as:

swollen gums and mouth ulcers
inflammation of the pancreas, colon or stomach
gastrointestinal disorders including bleeding
liver disorder
diarrhoea, constipation, malaise (nausea), indigestion, loss of appetite and flatulence.

Nervous system disorders such as:

dizziness, drowsiness or paraesthesia
tremors, muscle spasms, seizures
feelings of anxiety or depression, changes in mood and thinking.

Heart and blood vessel disorders such as:

changes in blood pressure, increased heart rate and blood vessel dilation.

Lung disorders such as:

pneumonia, bronchitis
shortness of breath, cough, which may be caused by bronchiectasis (a condition in which the airways of the lungs are abnormally widened) or pulmonary fibrosis (scarring of lung tissue). Consult your doctor if you have a persistent cough or shortness of breath
fluid accumulation in the lungs or chest
sinusitis.

Other disorders such as:

weight loss, gout, high blood sugar, bleeding and bruising.

Additional side effects in children and adolescents
Children, especially those under 6 years of age, may be more likely than adults to experience certain side effects, including diarrhoea, vomiting, infections, reduced red and white blood cells in the blood and, possibly, lymphatic system or skin cancer.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store CellCept

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp.
Do not store above 25 °C.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CellCept contains

The active substance is mycophenolate mofetil. Each capsule contains 250 mg of mycophenolate mofetil.
The other components are:
- CellCept capsules: pregelatinized maize starch, cross-linked sodium carboxymethylcellulose, polyvinylpyrrolidone (K-90), magnesium stearate (see section 2, “CellCept contains sodium”);
- capsule shell: gelatin, indigotine (E132), yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), potassium hydroxide, shellac gum.

Description of the appearance of CellCept and package contents

CellCept capsules are oblong-shaped, with one end blue and the other brown. "CellCept 250" is printed in black on the top part, and the name "Roche" is printed in black on the bottom part.
Available in packs of 100 or 300 capsules (both in 10-capsule blisters) or in a multiple pack containing 300 capsules (3 packs of 100). Not all pack sizes may be marketed.

Marketing Authorization Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Manufacturer
Roche Pharma AG, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany.

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799

България Luxembourg/Luxemburg
Рош България ЕООД (Voir/siehe Belgique/Belgien)
Тел: +359 2 818 44 44

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 - 1 279 4500

Danmark Malta
Roche Pharmaceuticals A/S (See Ireland)
Tlf: +45 - 36 39 99 99

Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050

Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00

Ελλάδα Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Τηλ: +30 210 61 66 100 Tel: +43 (0) 1 27739

España Polska
Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88

France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0) 1 47 61 40 00 Tel: +351 - 21 425 70 00

Hrvatska România
Roche d.o.o. Roche România S.R.L.
Tel: + 385 1 47 22 333 Tel: +40 21 206 47 01

Ireland Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Tel: +353 (0) 1 469 0700 Tel: +386 - 1 360 26 00

Ísland Slovenská republika
Roche Pharmaceuticals A/S Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000

Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500

Kύπρος Sverige
Γ.Α.Σταμάτης & Σια Λτδ. Roche AB
Τηλ: +357 - 22 76 62 76 Tel: +46 (0) 8 726 1200

Latvija United Kingdom (Northern Ireland)
Roche Latvija SIA Roche Products (Ireland) Ltd.
Tel: +371 - 6 7039831 Tel: +44 (0) 1707 366000

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

Package leaflet: information for the user

CellCept 500 mg powder for concentrate for solution for infusion

mycophenolate mofetil
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

What CellCept is and what it is used for
What you need to know before using CellCept
How to use CellCept
Possible side effects
How to store CellCept
Contents of the pack and other information
Reconstitution of the medicine

1. What CellCept is and what it is used for

CellCept contains mycophenolate mofetil.

This belongs to a group of medicines called "immunosuppressants". CellCept is used to prevent the body from rejecting a transplanted organ.
Kidney or liver. CellCept must be used in combination with other medicines:
cyclosporine and corticosteroids.

2. What you should know before using CellCept

WARNING
Mycophenolate causes birth defects and miscarriage. If you are a woman of childbearing potential,
you must have a negative pregnancy test before starting treatment and follow your doctor’s
advice regarding contraception.
Your doctor will discuss this with you and provide written information, particularly on the effects of
mycophenolate on the unborn child. Read this information carefully and follow the instructions.
If you do not fully understand these instructions, ask your doctor to explain them again before
taking mycophenolate. Also read the information in this section under “Warnings and precautions” and “Pregnancy and breastfeeding”.
Do not use CellCept:

if you are allergic to mycophenolate mofetil, mycophenolic acid, polysorbate 80, or any of the other ingredients of this medicine (listed in section 6)
if you are a woman of childbearing potential and have not had a negative pregnancy test before the first prescription, as mycophenolate causes birth defects and miscarriage
if you are pregnant, suspect you may be pregnant, or are planning a pregnancy
if you are not using an effective contraceptive method (see Pregnancy, contraception and breastfeeding)
if you are breastfeeding. Do not use this medicine if any of the above conditions apply to you. If you have any doubts, speak with your doctor or nurse before using CellCept.

Warnings and precautions
Inform your doctor or nurse immediately before starting treatment with CellCept:

if you are over 65 years of age, as you may have an increased risk of adverse events such as certain viral infections, gastrointestinal bleeding, and pulmonary edema compared to younger patients
if you have signs of infection such as fever or sore throat
if you experience unexpected bruising or bleeding
if you have suffered from a digestive disorder, for example a gastric ulcer
if you are planning a pregnancy or become pregnant while you or your partner are being treated with CellCept
if you have a hereditary enzyme deficiency such as Lesch-Nyhan or Kelley-Seegmiller syndrome

If any of the above conditions apply to you (or if you have any doubts), inform your doctor or nurse immediately before starting treatment with CellCept.
Effects of sunlight
CellCept lowers the body's natural defences, increasing the risk of skin cancer. Limit exposure to sunlight and UV rays by:

wearing protective clothing that covers your head, neck, arms, and legs
using sunscreen products with high sun protection factor.

Children
Do not administer this medicine to children, as the safety and efficacy of infusions have not been established in paediatric patients.
Other medicines and CellCept
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, such as herbal remedies.
CellCept may alter the activity of other medicines. Other medicines may also interact with CellCept.
In particular, inform your doctor or nurse if you are taking any of the following medicines before using CellCept:

azathioprine or other medicines that suppress the immune system, prescribed after an organ transplant
cholestyramine, used to treat high cholesterol
rifampicin, an antibiotic used to prevent and treat infections such as tuberculosis (TB)
phosphate binders, used in patients with chronic kidney failure to reduce phosphate absorption into the blood
antibiotics, used to treat bacterial infections
isavuconazole, used to treat fungal infections
telmisartan, used to treat hypertension.

Vaccines
If you need to receive a vaccination (live vaccine) during treatment with CellCept, inform your doctor or pharmacist first. Your doctor will advise you which vaccine is appropriate for you.
You must not donate blood during treatment with CellCept and for at least 6 weeks after stopping treatment. Men must not donate sperm during treatment with CellCept and for at least 90 days after stopping treatment.
Contraception in women using CellCept
If you are a woman of childbearing potential, you must use an effective contraceptive method while taking CellCept. This means:

before starting CellCept
throughout the entire treatment with CellCept
for 6 weeks after stopping treatment with CellCept. Discuss with your doctor which contraceptive method is most suitable for you. This will depend on your individual situation. Using two contraceptive methods is preferable to reduce the risk of unintended pregnancy. Contact your doctor as soon as possible if you think your contraceptive method may not have been effective or if you forgot to take your oral contraceptive pill.

You cannot become pregnant if any of the following conditions apply to you:

you are postmenopausal, i.e. you are at least 50 years old and your last menstrual period was more than one year ago (if your menstrual period stopped due to cancer treatment, you may still be able to become pregnant)
both your fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy)
your uterus has been surgically removed (hysterectomy)
your ovaries no longer function (premature ovarian failure, confirmed by a gynaecology specialist)
you were born with one of the following rare conditions that make pregnancy impossible: XY genotype, Turner syndrome, or uterine agenesis
you are a child or adolescent who has not yet had her first menstrual period.

Contraception in men taking CellCept
Although available clinical data do not indicate an increased risk of birth defects or miscarriage when the father takes mycophenolate, this risk cannot be completely ruled out. As a precaution, you and your partner are therefore advised to use a reliable contraceptive method during treatment and for 90 days after stopping therapy with CellCept.
If you are planning a pregnancy, talk to your doctor about potential risks and alternative treatments.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine. Your doctor will discuss with you the risks associated with pregnancy and alternative treatments you may undergo to prevent organ transplant rejection if:

you are planning a pregnancy
you miss or think you may have missed a menstrual period, have unusual menstrual bleeding, or suspect a pregnancy
you have had sexual intercourse without using effective contraceptive methods. If you become pregnant during treatment with mycophenolate, you must inform your doctor immediately. In any case, continue taking CellCept until you see your doctor.

Pregnancy
Mycophenolate very frequently causes miscarriage (50%) and serious birth defects (23–27%) in the unborn child. Reported birth defects include abnormalities of the ears, eyes, face (cleft lip/palate), finger development, heart, oesophagus (the tube connecting the throat and stomach), kidneys, and nervous system (e.g. spina bifida [where the bones of the spine are not fully developed]). The baby may have one or more of these defects.
If you are a woman of childbearing potential, you must have a negative pregnancy test before starting treatment and follow your doctor’s advice regarding contraception. Your doctor may require more than one test to ensure you are not pregnant before starting treatment.
Breastfeeding
Do not use CellCept if you are breastfeeding. Small amounts of the medicine may pass into breast milk.
Driving and using machines
CellCept has a moderate effect on the ability to drive and use machines. If you feel drowsy, dizzy, or confused, consult your doctor or nurse and do not drive or operate tools or machinery until you feel better.
CellCept contains polysorbate
This medicine contains 25 mg of polysorbate 80 in each vial. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.
CellCept contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to use CellCept

CellCept is generally administered by a doctor or nurse in a hospital setting via slow intravenous infusion.
How much to use
The amount you should receive depends on the type of transplant you have had. Usual doses are indicated below. Treatment will continue for as long as needed to prevent rejection of the transplanted organ.
Kidney transplant
Adults

The first dose is administered within 24 hours after transplantation surgery.
The daily dose is 2 g of medicine given in two separate doses.
You will receive 1 g in the morning and 1 g in the evening.

Liver transplant
Adults

The first dose is administered as soon as possible after transplantation surgery.
You will receive the medicine for at least 4 days.
The daily dose is 2 g of medicine given in two separate doses.
You will receive 1 g in the morning and 1 g in the evening.
As soon as you are able to swallow, you will be switched to oral administration of the medicine.

Reconstitution of the medicine
The medicine is in powder form. It must be mixed with glucose prior to administration. The doctor or nurse will reconstitute the medicine and administer it according to the instructions in section 7 “Reconstitution of the medicine”.
If you use more CellCept than you should
If you think you have been given too much CellCept, speak to your doctor or nurse immediately.
If you forget a dose of CellCept
If a dose of CellCept is missed, it should be administered as soon as possible. Then continue treatment as usual.
If you stop using CellCept
Do not stop using CellCept unless instructed by your doctor. Stopping treatment may increase the risk of rejection of the transplanted organ.
If you have any questions about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, CellCept can cause side effects, although not everyone gets them.
Talk to a doctor or nurse immediately if you notice any of the following serious side effects – you may need urgent medical treatment:

signs of infection such as fever or sore throat
unexpected bruising or bleeding
rash, itching, hives, shortness of breath or difficulty breathing, wheezing or cough, mental confusion, dizziness, altered state of consciousness, hypotension, with or without mild generalized itching, skin redness and swelling of the face/throat (symptoms of a severe allergic reaction)

Common problems
Some of the more common side effects include diarrhea, reduced white or red blood cells in the blood, infections, and vomiting. Your doctor will carry out regular blood tests to check for any changes:

in blood cell counts or signs of infection.

Fighting infections
CellCept lowers the body's defences to prevent transplant rejection. As a result, the body may not be able to fight infections effectively as it normally would. This means you may get infections more often, such as in the brain, skin, mouth, stomach and intestines, lungs, or urinary system.
Lymphatic system and skin tumors
As with other drugs of this type (immunosuppressants), a very small number of patients taking CellCept have developed tumors of the lymphatic system and skin.
General side effects
You may experience side effects affecting the body in general. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling of fatigue, sleep disturbances, pain (in the stomach, chest, muscles or joints), headache, flu-like symptoms, and swelling.
Other side effects may include:
Skin disorders such as:

acne, cold sores, skin thickening, shingles (herpes zoster), hair loss, skin rashes, and itching.

Urinary system disorders such as:

blood in the urine.
Digestive and mouth disorders such as:
swollen gums and mouth ulcers
inflammation of the pancreas, colon, or stomach
gastrointestinal disorders including bleeding
liver disorders
diarrhea, constipation, feeling unwell (nausea), indigestion, loss of appetite, and flatulence.

Nervous system disorders such as:

drowsiness or paraesthesia
tremors, muscle spasms, seizures
feelings of anxiety or depression, mood or thought disturbances.

Heart and blood vessel disorders such as:

changes in blood pressure, blood clots, rapid heartbeat
pain, redness, and swelling at the site of the blood vessel where the infusion was administered.

Lung disorders such as:

pneumonia, bronchitis
shortness of breath, cough, which may be caused by bronchiectasis (a condition in which the airways of the lungs are abnormally widened) or pulmonary fibrosis (scarring of lung tissue). Consult your doctor if you have a persistent cough or shortness of breath
fluid accumulation in the lungs or chest
sinusitis.

Other disorders such as:

weight loss, gout, high blood sugar (hyperglycemia), bleeding, bruising.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store CellCept

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the vials after Exp.
Powder for concentrate for solution for infusion: do not store above 30 °C.
Reconstituted solution and diluted solution: store between 15 °C and 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CellCept contains

The active substance is mycophenolate mofetil. Each vial contains 500 mg of mycophenolate mofetil.
The other ingredients are: polysorbate 80, citric acid, hydrochloric acid, sodium chloride (see section 2, “CellCept contains sodium”).

Description of the appearance of CellCept and package contents

CellCept is supplied as a white to off-white powder in 20 mL clear type I glass vials with a grey butyl rubber stopper, an aluminium seal and a plastic flip-off cap.
The reconstituted solution is slightly yellow.
It is available in packs containing 4 vials each.

7. Reconstitution of the medicinal product

Method and route of administration
CellCept 500 mg powder for concentrate for solution for infusion contains no antibacterial preservative; therefore, reconstitution and dilution of the product must be carried out under aseptic conditions.
The contents of each vial of CellCept 500 mg powder for concentrate for solution for infusion must be reconstituted with 14 mL of 5% glucose solution for intravenous infusion.
Further dilution with 5% glucose solution for intravenous infusion is required to achieve a final concentration of 6 mg/mL. This means that the contents of 2 reconstituted vials (approximately 15 mL x 2), corresponding to a dose of 1 gram of mycophenolate mofetil, must be further diluted with 140 mL of 5% glucose solution for intravenous infusion. If the infusion solution is not prepared immediately prior to administration, the infusion must be started within 3 hours after reconstitution and dilution of the medicinal product.
Take care to avoid contact between the prepared solutions and the eyes.

In such a case, rinse eyes thoroughly with running water.

Take care to avoid contact of the prepared solutions with the skin.

In such a case, wash the area thoroughly with water and soap.

CellCept 500 mg powder for concentrate for solution for infusion must be administered by intravenous infusion (i.v.). The infusion rate must be controlled so that administration of the medicinal product is completed over a period of 2 hours.
CellCept intravenous solution must never be administered by rapid intravenous injection or bolus injection.

Marketing Authorization Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Manufacturer
Roche Pharma AG, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany.

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799

България Luxembourg/Luxemburg
Рош България ЕООД (See Belgique/Belgien)
Тел: +359 2 818 44 44

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 1 279 4500