Label:information for the patient

CellCept 1g/5ml oral powder for suspension

micofenolato mofetilo

Read this label carefully before starting to take this medication, as it contains important information for you.

•Keep this label, as you may need to read it again.

•If you have any questions, consult your doctor or pharmacist.

•This medication has been prescribed only for you, and you should not give it to others

although they may have the same symptoms as you, as it may harm them.

•If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed

in this label. See section 4.

1.What is CellCept and how is it used

2.What you need to know before starting to take CellCept

3.How to take CellCept

4.Adverse effects

5.Storage of CellCept

6.Contents of the package and additional information

7.Reconstitution of the medication

CellCept contains mycophenolate mofetil:

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

CellCept is used to prevent the body from rejecting a transplanted organ in adults and children:

•Kidney, heart, or liver.

CellCept must be used in combination with other medicines:

•Ciclosporin andcorticosteroids.

WARNING

Mycophenolate causes congenital malformations and spontaneous abortions. If you are a woman who can become pregnant, you must have a negative pregnancy test before starting treatment and follow the contraceptive advice provided by your doctor.

Your doctor will explain and provide written information, particularly about 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 before taking mycophenolate.

See more information below in this section, under the headings “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 components of this medication (including those in section 6)

•If you are a woman who can become pregnant and have not obtained a negative pregnancy test before the first prescription, as mycophenolate may cause congenital malformations and spontaneous abortions

•If you are pregnant or intend to become pregnant or believe you may be pregnant

•If you are not using effective contraception (see Contraception, Pregnancy, and Breastfeeding)

•If you are breastfeeding.

Do not take this medication if you experience any of the above. If you are unsure, 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 adverse reactions such as certain viral infections, gastrointestinal bleeding, and pulmonary edema compared to younger patients

•If you have any signs of infection such as fever or sore throat

•If you experience unexpected cardinals or bleeding

•If you have or have had any digestive system problems such as stomach ulcers

•If you have a rare metabolic disorder called familial phenylketonuria

•If you plan to become pregnant or have become pregnant while taking CellCept

•If you have an inherited enzyme deficiency such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome

If you experience any of the above (or are unsure), consult your doctor immediately before starting treatment with CellCept.

Effect of sunlight

CellCept reduces your body's defenses. Therefore, there is a higher risk of developing 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 high-protection sunscreen cream

Children

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

Do not administer this medication to children under 1 year of age, as the safety and efficacy data for this age group are limited, and no dosage recommendations can be made.

If you are unsure about anything related to your child's treatment, speak with your doctor or pharmacist before taking it.

Other medications and CellCept

Inform your doctor or pharmacist if you are using or have recently used any other medication. This includes over-the-counter medications and herbal remedies. This is because CellCept may affect how other medications work. Other medications may also affect how CellCept works.

Specifically, inform your doctor or pharmacist if you are taking any of the following medications before starting CellCept:

•Azathioprine or another immunosuppressive medication – administered after transplant surgery

•Colestiramine – used to treat high cholesterol

•Rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB)

•Antacids or proton pump inhibitors – used to treat stomach acid problems such as indigestion

•Phosphate binders – used in patients with chronic kidney disease 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

Vaccinations

If you need to receive a vaccine (live organism vaccine) during treatment with CellCept, consult your doctor or pharmacist first. Your doctor will advise you on the vaccines you can receive.

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

CellCept with food and drinks

The consumption of 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 contraceptive method. This includes:

•Before starting to take CellCept

•During the entire treatment with CellCept

•For at least 6 weeks after stopping CellCept.

Consult your doctor to see which contraceptive method is most suitable for you. This will depend on your individual 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 case is one of the following:

•You are postmenopausal, i.e., you are at least 50 years old and your last period occurred more than a year ago (if your periods have stopped due to cancer treatment, there is still a possibility that you may become pregnant)

•Your fallopian tubes and ovaries have been surgically removed (bilateral salpingo-oophorectomy)

•Your uterus has been surgically removed (hysterectomy)

•Your ovaries do not function (premature ovarian failure confirmed by a specialist gynecologist)

•You were born with one of the following rare diseases that make pregnancy impossible: XY genotype, Turner syndrome, or uterine agenesis

•You are a girl or adolescent who has not started menstruating.

Contraception in men taking CellCept

The available evidence does not indicate a higher risk of malformations or spontaneous abortion if the father takes mycophenolate. However, the risk cannot be completely ruled out. As a precaution, it is recommended that you or your female partner use a reliable contraceptive method during treatment and for at least 90 days after stopping CellCept.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or believe you may be pregnant, consult your doctor or pharmacist before using this medication. Your doctor will discuss the risks and alternative treatments you can take to prevent rejection of the transplanted organ if:

•You intend to become pregnant

•You have missed or suspect you may have missed a period or have unusual menstrual bleeding

•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 spontaneous abortions (50%) and severe damage to the unborn baby (23-27%). Among the malformations that have been reported are ear, eye, facial (cleft lip and palate), finger development, heart, esophagus (tube connecting the throat to the stomach), kidney, and nervous system (e.g., spina bifida) 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 follow the contraceptive advice provided by your doctor. Your doctor may request multiple pregnancy tests to ensure you are not pregnant before starting treatment.

Breastfeeding

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

Driving and using machines

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

Important information about some of the components of CellCept

•CellCept contains aspartame. If you have a rare metabolic disorder called “phenylketonuria”, consult your doctor before starting this medication.

•CellCept contains sorbitol (a type of sugar). If your doctor has told you that you cannot tolerate or digest certain sugars, consult your doctor before taking this medication.

CellCept contains parahydroxybenzoic acid methyl ester

This medication contains parahydroxybenzoic acid methyl ester (E218) which may cause allergic reactions (possibly delayed).

CellCept contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Amount to take

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

Kidney transplant

Adults

•The first dose must be administered within 3 days after the transplant surgery.

•The daily dose is 10ml of suspension (2g of the medication), administered in 2 separate doses.

•Take 5ml of suspension in the morning and another 5ml of suspension at night.

Children (between 1 and 18 years)

•The dose varies depending on the child's height.

•Your child's doctor will decide on the most suitable dose taking into account the child's height and weight (body surface area measured in square meters "m2”). The recommended starting dose is 600mg/m2, administered twice a day. The maintenance dose recommended is maintained at 600 mg/m2twice a day (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 must be administered within 5 days after the transplant surgery.

•The daily dose is 15ml of suspension (3g of the medication), administered in 2 separate doses.

•Take 7.5ml of suspension in the morning and another 7.5ml of suspension at night.

Children (between 1 and 18 years)

• The dose varies depending on the child's height.

•Your child's doctor will decide on the most suitable dose taking into account the child's height and weight (body surface area measured in square meters "m2”). The recommended starting dose is 600mg/m2, administered twice a day. The dose should be individualized based on clinical evaluation by the doctor. If well tolerated, the dose can be increased to 900mg/m2twice a day if necessary (maximum total daily dose of 3g or 15ml of oral suspension).

Liver transplant

Adults

•The first dose must be administered at least 4 days after the transplant surgery and when able to take oral medication.

•The daily dose is 15ml of suspension (3g of the medication), administered in 2 separate doses.

•Take 7.5ml of suspension in the morning and another 7.5ml of suspension at night.

Children (between 1 and 18 years)

• The dose varies depending on the child's height.

•Your child's doctor will decide on the most suitable dose taking into account the child's height and weight (body surface area measured in square meters "m2”). The recommended starting dose is 600mg/m2, administered twice a day. The dose should be individualized based on clinical evaluation by the doctor. If well tolerated, the dose can be increased to 900mg/m2twice a day if necessary (maximum total daily dose of 3g or 15ml of oral suspension).

Reconstitution of the medication

The medication is presented in powder form. This needs to be mixed with purified water before being administered. Your pharmacist will normally reconstitute the medication. If you need to do it yourself, follow the instructions included in section 7 "Reconstitution of the medication".

Take this medication

To measure the dose, you need to use the dispenser and the adapter from the bottle that come in the package. 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 medication get into your eyes.

•If this happens, rinse them with plenty of running water. Be careful not to let the reconstituted medication 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 closure.

3.Place the dispenser in the adapter of the bottle and push the plunger all the way 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.Put the entire unit (bottle and dispenser - see below drawing) upside down.

6.Slowly pull out the plunger.

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

7.Put the entire unit right side up.

Hold 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 medication.

Do not mix the medication with any liquid while swallowing.

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

8.Immediately after administration - disassemble the dispenser and rinse it under running water. Dry it before the next use.

Do notboil the oral dispenser.Do notuse cleaning wipes that contain solvents.Do notuse

cloths or cleaning 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 medication.

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 medication. Bring the medication package with you.

If you forget to take CellCept

If you ever forget to take the medication, take it as soon as you remember. Then continue taking it at the usual times.Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with CellCept

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

•if you have symptoms of infection such as fever or sore throat

•if you develop petechiae or unexpected bleeding

•if you have a rash, facial swelling, lip, tongue, or throat swelling with difficulty breathing. You may be having a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

Common problems

Some of the most common problems are diarrhea, decreased white blood cell or red blood cell count 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

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

Skin and lymphatic cancer

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

Unwanted general effects

You may experience general unwanted effects that affect your entire body. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling extremely tired, difficulty sleeping, pains (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, and swelling.

Other unwanted effects may be:

Skin problemssuch as:

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

Urinary problemssuch as:

•blood in the urine.

Digestive system and mouth problemssuch as:

•swollen gums and mouth ulcers,

•pancreatitis, colon, or stomach inflammation,

•gastrointestinal disorders that include bleeding,

•liver disorders,

•diarrhea,constipation, nausea, indigestion, loss of appetite, flatulence.

Nervous system problemssuch as:

•dizziness, somnolence, or numbness,

•shaking, muscle spasms, convulsions,

•feeling anxious or depressed, mood or thought changes.

Cardiovascular and vascular problemssuch as:

•changes in blood pressure, rapid heartbeat, and blood vessel dilation.

Pulmonary problemssuch as:

•pneumonia, bronchitis,

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

•fluid in the lungs or chest cavity,

•nasal sinus problems.

Other problemssuch as:

•weight loss, gout, high blood sugar levels, bleeding, petechiae.

Additional adverse reactions in children and adolescents

Children, especially those under 6 years of age, are more prone to some adverse reactions, including diarrhea, vomiting, infections, decreased white blood cell or red blood cell count in the blood, and possibility of lymphoma or skin cancer.

Reporting adverse effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect that does not appear in this prospectus.You can also report them directly through thenational reporting system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

•Keep this medication out of the sight and reach of children.

•Do not use this medication after the expiration date that appears on the packaging and on the bottle after EXP.

•The shelf life of the reconstituted suspension is two months. Do not use the suspension once this expiration date has passed.

•Oral suspension powder: Do not store at a temperature above 86°F (30°C).

•Reconstituted suspension: Do not store at a temperature above 86°F (30°C).

•Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment.

CellCept Composition

•The active ingredient is mycophenolate mofetil.

•Each bottle contains 35g of mycophenolate mofetil.

•The other components are sorbitol, colloidal anhydrous silica, sodium citrate, soy lecithin, fruit flavor mix, xanthan gum, aspartame* (E951), methyl parahydroxybenzoate (E218), anhydrous citric acid. Please also refer to section 2 “Important information about some of the components of CellCept” and “CellCept contains sodium”.

*contains a quantity of phenylalanine equivalent to 2.78mg/5ml of suspension.

Product Appearance and Packaging Contents

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

•Also included are a bottle adapter and 2 oral dispensers.

7.Reconstitution of the Medicinal Product

Your pharmacist will normally reconstitute the medicinal product. 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, the inside of your mouth or nose.

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

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

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

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

1Tap the closed bottle gently several times to loosen the powder.

2.Measure 94ml of purified water in a measuring cylinder.

3.Add approximately half the total amount of purified water to the bottle.

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

4.Add the rest of the water.

•And shake the closed bottle well for another minute.

5.Remove the child-resistant closure and attach the bottle adapter to the neck of the bottle.

6.Then close the bottle hermetically with the child-resistant closure.

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

7.Write the date of expiry of the reconstituted suspension on the label of the bottle.

•The shelf life of the reconstituted suspension is 2 months.

Marketing Authorization Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Responsible Person

Roche Pharma AG,Emil-Barell-Strasse1, 79639 Grenzach-Wyhlen, Germany

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

Last Update of this Leaflet

The detailed information about this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu