CELLCEPT 1 g/5 ml POWDER FOR ORAL SUSPENSION

Introduction

Package Leaflet:information for the patient

CellCept 1g/5ml powder for oral suspension

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 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.

Contents of the pack and other information:

1. What is CellCept and what is it used for
2. What you need to know before you take CellCept
3. How to take CellCept
4. Possible side effects
5. Storing CellCept
6. Contents of the pack and further information
7. Reconstitution of the medicinal product

1. What is CellCept and what is it used for

CellCept contains mycophenolate mofetil:

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

CellCept is used to prevent your body from rejecting a transplanted organ (kidney, heart or liver) in adults and children:

• Kidney, heart or liver.

CellCept should be used together with other medicines:

• Ciclosporin and corticosteroids.

2. What you need to know before you take CellCept

WARNING

Mycophenolate causes birth defects and miscarriages. If you are a woman who can become pregnant, you must have a negative pregnancy test before starting treatment and must follow the advice on contraception given by your doctor.

Your doctor will explain and give you written information, particularly on the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions.

If you do not understand these instructions completely, please consult your doctor again so that they can explain them to you before you take mycophenolate.

See more information below in this section, under the headings “Warnings and precautions” and “Pregnancy and breast-feeding”.

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 who can become pregnant and have not had a negative pregnancy test before the first prescription, as mycophenolate may cause birth defects and miscarriages
• If you are pregnant or plan to become pregnant or think you may be pregnant
• If you are not using effective contraception (see Contraception, pregnancy and breastfeeding).
• If you are breast-feeding.

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking CellCept.

Warnings and precautions

Consult your doctor before starting treatment with CellCept:

• If you are over 65 years old, as you may have a higher risk of developing side effects such as certain viral infections, gastrointestinal bleeding and pulmonary oedema compared to younger patients
• If you have any signs of infection such as fever or sore throat
• If you have unexpected bruising or bleeding
• If you have or have had any problems with your digestive system such as stomach ulcers
• If you have a rare metabolic disorder called phenylketonuria of familial development
• If you plan to become pregnant or become pregnant while you or your partner are taking CellCept
• If you have an inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome

If any of the above applies to you (or you are not sure), consult your doctor immediately before starting treatment with CellCept.

Effect of sunlight

CellCept reduces your body's defenses. For this reason, there is a higher risk of skin cancer. Limit the amount of sunlight and UV light you absorb by:

• wearing protective clothing that covers your head, neck, arms and legs
• using a sunscreen with a high protection factor

Children

Children, especially those under 6 years of age, are more likely than adults to have certain side effects, including diarrhea, vomiting, infections, low red blood cell count and low white blood cell count, and the possibility of lymphoma or skin cancer.

Do not give this medicine to children under 1 year of age, as safety and efficacy data in this age group are limited and no dosage recommendations can be made.

If you are not sure about something related to your child's treatment, talk to your doctor or pharmacist before taking it.

Other medicines and CellCept

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, such as herbal medicines. This is because CellCept may affect how other medicines work. Other medicines may also affect how CellCept works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines before starting CellCept:

• azathioprine or another medicine that suppresses the immune system – which was given to you after the transplant operation.
• cholestyramine – used to treat high cholesterol levels
• rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB)
• antacids, or proton pump inhibitors – used for stomach acid problems such as indigestion
• phosphate binders – used in patients with chronic kidney failure to reduce phosphate absorption in 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 be vaccinated (live organism vaccine) during treatment with CellCept, consult your doctor or pharmacist first. Your doctor will advise you on which vaccines you can have.

Do not donate blood during treatment with CellCept and for at least 6 weeks after stopping treatment. Men should not donate semen during treatment with CellCept and for at least 90 days after stopping treatment.

Taking CellCept with food and drinks

Taking food and drinks has no effect on your treatment with CellCept.

Contraception in women taking CellCept

If you are a woman who can become pregnant, you must use an effective method of contraception. This includes:

• Before starting CellCept
• During all treatment with CellCept
• Until 6 weeks after stopping CellCept.

Consult your doctor to see which contraceptive method is most suitable for you. This will depend on your personal situation. It is recommended to use two contraceptive methods as this will reduce the risk of unintended pregnancy. Consult your doctor as soon as possible if you think your contraceptive method may not have been effective or if you have forgotten to take the contraceptive pill.

You cannot become pregnant if your situation is one of the following:

• You are post-menopausal, i.e. you are at least 50 years old and your last period was more than a year ago (if your periods have stopped due to cancer treatment, you may still be able to become pregnant)
• Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-oophorectomy)
• Your uterus has been removed by surgery (hysterectomy)
• Your ovaries do not work (premature ovarian failure confirmed by a specialist gynecologist)
• You were born with one of the following rare conditions that make pregnancy impossible: XY genotype, Turner syndrome or uterine agenesis
• You are a girl or adolescent who has not started having periods.

Contraception in men taking CellCept

Available evidence does not indicate an increased risk of birth defects or miscarriage if the father takes mycophenolate. However, the risk cannot be completely excluded. As a precaution, it is recommended that you or your female partner use a reliable method of contraception during treatment and for up to 90 days after stopping CellCept.

If you are planning to have a child, consult your doctor about potential risks and alternative treatments.

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. Your doctor will discuss the risks and alternative treatments that you can take to prevent organ rejection if:

• You plan to become pregnant
• You have missed a period or have unusual menstrual bleeding or suspect you may be pregnant
• You have had unprotected sex.

If you become pregnant during treatment with mycophenolate, inform your doctor immediately. However, continue taking CellCept until you see your doctor.

Pregnancy

Mycophenolate causes a very high frequency of miscarriages (50%) and severe harm to the unborn baby (23-27%). Among the birth defects reported are ear, eye, facial (cleft lip and palate), finger, heart, esophagus (tube connecting the throat to the stomach), kidney and nervous system (e.g. spina bifida (where the bones of the spine do not develop properly)) abnormalities. Your baby may be affected by one or more of these.

If you are a woman who can become pregnant, you must have a negative pregnancy test before starting treatment and must follow the advice on contraception given by your doctor. Your doctor may request more than one pregnancy test to ensure you are not pregnant before starting treatment.

Breast-feeding

Do not take CellCept if you are breast-feeding. This is because small amounts of the medicine may pass into breast milk.

Driving and using machines

The influence of CellCept on the ability to drive and use machines is moderate. If you feel drowsy, dazed or confused, talk to your doctor or nurse and do not drive or use tools or machines until you feel better.

Important information about some of the ingredients of CellCept

• CellCept contains aspartame. If you have a rare problem with your metabolism called “phenylketonuria”, consult your doctor before taking this medicine.
• CellCept contains sorbitol (a type of sugar). If your doctor has told you that you cannot tolerate or digest certain sugars, consult with your doctor before taking this medicine.

CellCept contains methyl parahydroxybenzoate

This medicine contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).

CellCept contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to take CellCept

Follow exactly the instructions for administration of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Amount to be taken

The amount to be taken depends on the type of transplant you have. The usual doses are shown below. Treatment will continue until it is necessary to prevent organ rejection.

Kidney transplant

Adults

• The first dose should be given within 3 days after the transplant operation.
• The daily dose is 10 ml of suspension (2 g of the medicine), given in 2 divided doses.
• Take 5 ml of suspension in the morning and another 5 ml of suspension in the evening.

Children (between 1 and 18 years)

• The dose varies depending on the child's height.
• Your doctor will decide which dose is most suitable for your child, taking into account the child's height and weight (body surface area measured in square meters “m2”). The recommended starting dose is 600 mg/m2, given twice daily. The recommended maintenance dose is 600 mg/m2 twice daily (maximum total daily dose of 2 g or 10 ml of oral suspension). The dose should be individualized based on clinical evaluation by the doctor.

Heart transplant

Adults

• The first dose should be given within 5 days after the transplant operation.
• The daily dose is 15 ml of suspension (3 g of the medicine), given in 2 divided doses.
• Take 7.5 ml of suspension in the morning and another 7.5 ml of suspension in the evening.

Children (between 1 and 18 years)

• The dose varies depending on the child's height.
• Your child's doctor will decide which dose is most suitable for your child, taking into account the child's height and weight (body surface area measured in square meters “m2”). The recommended starting dose is 600 mg/m2, given twice daily. The dose should be individualized based on clinical evaluation by the doctor. If well tolerated, the dose may be increased to 900 mg/m2 twice daily if necessary (maximum total daily dose of 3 g or 15 ml of oral suspension).

Liver transplant

Adults

• The first dose should be given at least 4 days after the transplant operation and when you are able to take the oral medicine.
• The daily dose is 15 ml of suspension (3 g of the medicine), given in 2 divided doses.
• Take 7.5 ml of suspension in the morning and another 7.5 ml of suspension in the evening.

Children (between 1 and 18 years)

• The dose varies depending on the child's height.
• Your child's doctor will decide which dose is most suitable for your child, taking into account the child's height and weight (body surface area measured in square meters “m2”). The recommended starting dose is 600 mg/m2, given twice daily. The dose should be individualized based on clinical evaluation by the doctor. If well tolerated, the dose may be increased to 900 mg/m2 twice daily if necessary (maximum total daily dose of 3 g or 15 ml of oral suspension).

Reconstitution of the medicinal product

The medicine is presented as a powder. This needs to be mixed with purified water before administration. Your pharmacist will normally reconstitute the medicine for you. If you need to do it yourself, follow the instructions included in section 7 “Reconstitution of the medicinal product”.

Taking this medicine

To measure the dose, you need to use the dispenser and adapter of the bottle, which are included in the packaging. Try not to inhale the dry powder. Also, try not to let it come into contact with your skin, the inside of your mouth or nose. Be careful not to let the reconstituted medicine get into your eyes.

• If this happens, rinse them with plenty of running water. Be careful not to let the reconstituted medicine come into contact with your skin.
• If this happens, wash the area with plenty of water and soap.

1. Before each use, shake the closed bottle well for about 5 seconds.
2. Remove the child-resistant cap.
3. Place the dispenser in the adapter of the bottle and push the plunger completely to the end of the dispenser.
4. Then insert the end of the dispenser firmly into the opening of the adapter of the bottle.
5. Turn the whole unit (bottle and dispenser - see drawing below) upside down.

1. Slowly pull out the plunger.

Pull out the plunger until you have the amount of medicine you want to extract with the dispenser.

1. Turn the whole unit (bottle and dispenser) right side up.

Holding the body of the dispenser, slowly separate the dispenser from the adapter of the bottle.

The adapter of the bottle should remain in the bottle.

Put the dispenser directly into your mouth and swallow the medicine.

Do not mix the medicine with any liquid while swallowing.

Close the bottle with the child-resistant cap after each use.

1. Immediately after administration - disassemble the dispenser and rinse it under running water. Let it air dry before the next use.

Do notboil the oral dispenser. Do notuse wipes that contain solvents to clean. Do notuse

cloths or wipes to dry.

Contact your doctor, pharmacist or nurse if both dispensers are lost or damaged, and they will inform you on how to continue taking your medicine.

If you take more CellCept than you should

If you take more CellCept than you should, consult your doctor or go to the hospital immediately. Do this also if someone accidentally takes your medicine. Take the medicine packaging with you.

If you forget to take CellCept

If you ever forget to take the medicine, take it as soon as you remember. Then continue taking it at the usual times. Do not take a double dose to make up for forgotten doses.

If you stop taking CellCept

Do not stop taking CellCept unless your doctor tells you to. If you stop treatment, you may increase the risk of organ rejection.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Consult your doctor immediately if you notice any of the following serious adverse effects, as you may need urgent medical treatment:

Common Problems

Some of the most common problems are diarrhea, decrease in the number of white or red blood cells in the blood, infection, and vomiting. Your doctor will perform regular blood tests to monitor any changes in:

• the number of blood cells or signs of infection

Fighting Infections

Treatment with CellCept reduces the body's defenses. This is to prevent transplant rejection. For this reason, the body cannot fight infections as effectively as under normal conditions. This means you may contract more infections than usual. These include infections that affect the brain, skin, mouth, stomach, and intestines, lungs, and urinary system.

Skin and Lymph Cancer

As with patients taking this type of medicine (immunosuppressants), a very small number of patients treated with CellCept have developed cancer of lymphoid tissues and skin.

General Undesired Effects

General adverse effects that affect your entire body may occur. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling very tired, difficulty sleeping, pain (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, and swelling.

Other undesired adverse effects may be:

Skin Problemssuch as:

• acne, cold sores, shingles, skin growth, hair loss, skin rash, itching

Urinary Problemssuch as:

• blood in the urine

Problems with the Digestive System and Mouthsuch as:

• swollen gums and mouth ulcers
• inflammation of the pancreas, colon, or stomach
• gastrointestinal disorders that include bleeding
• liver disorders
• diarrhea, constipation, feeling unwell (nausea), indigestion, loss of appetite, flatulence

Nervous System Problemssuch as:

• feeling dizzy, drowsy, or numb
• tremors, muscle spasms, convulsions
• feeling anxious or depressed, mood or thought changes

Cardiac and Blood Vessel Problemssuch as:

• changes in blood pressure, rapid heartbeat, and dilation of blood vessels

Lung Problemssuch as:

• pneumonia, bronchitis
• breathing difficulties, cough, which may be due to bronchiectasis (a condition in which the airways are abnormally dilated) or pulmonary fibrosis (scarring of the lungs). Consult your doctor if you develop persistent cough or shortness of breath
• fluid in the lungs or inside the chest
• problems with the nasal sinuses

Other Problemssuch as:

• weight loss, gout, high blood sugar levels, bleeding, bruising

Additional Adverse Reactions in Children and Adolescents

Children, especially those under 6 years of age, are more likely than adults to have certain adverse reactions, including diarrhea, vomiting, infections, fewer red and white blood cells in the blood, and the possibility of lymphoma or skin cancer.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CellCept

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date that appears on the packaging and on the bottle after EXP.
• The validity period of the reconstituted suspension is 2 months. Do not use the suspension after this expiration date.
• Oral powder for suspension: Do not store above 30°C.
• Reconstituted suspension: Do not store above 30°C.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of CellCept

• The active ingredient is mycophenolate mofetil.
• Each bottle contains 35 g of mycophenolate mofetil.
• The other ingredients are sorbitol, anhydrous colloidal silica, sodium citrate, soy lecithin, fruit flavor mixture, xanthan gum, aspartame* (E951), methyl parahydroxybenzoate (E218), anhydrous citric acid. Please also consult section 2 "Important information about some of the ingredients of CellCept" and "CellCept contains sodium".

*contains an amount of phenylalanine equivalent to 2.78 mg/5 ml of suspension.

Appearance of the Product and Package Contents

• Each 110 g bottle of oral powder for suspension contains 35 g of mycophenolate mofetil. It must be reconstituted with 94 ml of purified water. After reconstitution, the volume of the suspension is 175 ml, providing a useful volume of 160-165 ml. Each 5 ml of reconstituted suspension contains 1 g of mycophenolate mofetil.
• Also included are a bottle adapter and 2 oral dispensers.

1. Reconstitution of the medicine

Your pharmacist will normally reconstitute the medicine. If you need to do it yourself, follow the instructions described below:

Try not to inhale the dry powder. Also, try not to let it come into contact with your skin, mouth, or nose.

Be careful not to let the reconstituted medicine get into your eyes.

• If this happens, rinse them with plenty of running water.

Be careful not to let the reconstituted medicine come into contact with your skin.

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

1. Gently tap the closed bottle several times to loosen the powder.
2. Measure 94 ml of purified water in a measuring cup.
3. Add approximately half of the total amount of purified water to the bottle.

• Then shake the closed bottle well for about 1 minute.

1. Add the rest of the water.

• And shake the closed bottle well for another minute.

1. Remove the child-resistant cap and attach the adapter to the neck of the bottle.
2. Then close the bottle tightly with the child-resistant cap.

• This will ensure the correct placement of the adapter on the bottle and the state of the child-resistant cap.

1. Write the expiration date of the reconstituted suspension on the label of the bottle.

• The validity period of the reconstituted suspension is 2 months.

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet

Detailed information about this medicine is available on the European Medicines Agency website http://www.ema.europa.eu