Label:patient information

CellCept 500mg powder for concentrate for solution for infusion

micofenolato mofetilo

Read this label carefully before starting to use 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 nurse.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

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:

•Kidney or liver.

CellCept must be used in combination with other medicines:

•Ciclosporin and corticosteroids

WARNING

Mycophenolate causes congenital malformations and spontaneous abortions. If you are a woman who can become pregnant, you must have a negative pregnancy test result 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 fully understand these instructions, please consult your doctor again before taking mycophenolate.

See more information 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, polisorbate 80, or any other component of this medication (including those listed in section 6).
• If you are a woman who can become pregnant and have not obtained a negative pregnancy test result 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 contraceptives (see Pregnancy, Contraception, 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 nurse before taking CellCept.

Warnings and Precautions

Consult your doctor or nurse 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 petechiae or bleeding.
• If you have or have had any gastrointestinal problems such as stomach ulcers.
• If you are planning to become pregnant or have become pregnant while taking CellCept.
• If you have a hereditary enzymatic deficiency such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome.

If you experience any of the above (or are unsure), consult your doctor or nurse 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 appropriate clothing that protects you and also covers your head, neck, arms, and legs.
• Using a high-protection sunscreen cream.

Children

Do not administer this medication to children, as the safety and efficacy of administration in pediatric patients have not been established.

Other medications and CellCept

Inform your doctor or nurse if you are using or have recently used any other medication. This includes over-the-counter medications, such as 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 nurse if you are taking any of the following medications before starting CellCept:

• Azathioprine or another immunosuppressive medication – administered after organ transplantation.
• Colestiramine – used to treat high cholesterol levels.
• Rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB).
• 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.

Vaccines

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

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 determine the most suitable contraceptive method 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 believe 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).
• You have had both ovaries and fallopian tubes removed by surgery (bilateral salpingo-oophorectomy).
• You have had your uterus removed by surgery (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 yet 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 treatment options with you 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 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 result 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 operating machinery

CellCept has a moderate effect on your ability to drive and operate machinery. If you feel drowsy, drowsy, or confused, speak with your doctor or nurse and do not drive or operate tools or machinery until you feel better.

CellCept contains polisorbate

This medication contains 25 mg of polisorbate 80 in each vial. Polisorbates can cause allergic reactions. Speak with your doctor if you have any known allergies.

CellCept contains sodium

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

CellCept is usually administered by a doctor or nurse in a hospital. It is administered as an intravenous infusion by drip.

Amount to Receive

The amount to receive 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 should be administered within 24 hours after the transplant surgery.
• The daily dose is 2 g of the medication administered in 2 separate doses.
• 1 g will be administered in the morning and 1 g at night.

Liver Transplant

Adults

• The first dose should be administered as soon as possible after the transplant surgery.
• The medication will be administered for at least 4 days.
• The recommended daily dose is 2 g of the medication administered in 2 separate doses.
• 1 g will be administered in the morning and 1 g at night.
• When able to swallow, the medication will be administered orally.

Medication Reconstitution

The medication is presented in powder form. This needs to be mixed with glucose before administration. Your doctor or nurse will reconstitute the medication and administer it. They will follow the instructions included in section 7 “Medication Reconstitution”.

If You Take More CellCept Than You Should

If you think you have received too much medication, consult your doctor or nurse immediately.

If You Forget to Take CellCept

If you forget to administer a dose of the medication, it will be administered as soon as possible. Your treatment will continue at the usual hours.

If You Interrupt Treatment with CellCept

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

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

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

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

• if you have signs 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 experiencing 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

Combating 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 who take 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 side 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 side effects may be:

Skin problemssuch as:

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

Urinary problemssuch as:

• blood in the urine.

Digestive system and mouth problemssuch as:

• swollen gums and mouth ulcers,
• pancreatitis, colitis, or gastritis,
• gastrointestinal disorders that include bleeding,
• hepatic disorders,
• diarrhea,constipation, nausea, indigestion, loss of appetite, flatulence.

Nervous system problemssuch as:

• feeling drowsy or numb,
• shaking, muscle spasms, convulsions,
• feeling anxious or depressed, mood or thought changes.

Cardiovascular and vascular problemssuch as:

• changes in blood pressure, blood clots, rapid heartbeat,
• dolor, redness, and swelling of blood vessels at the infusion site.

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.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect not listed in this prospectus.You can also report them directly through thenational reporting system included in theAppendix V. By reporting side 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 vial after EXP.
• Concentrate powder for infusion solution: do not store at a temperature above 86°F.
• Reconstituted and diluted solutions: store between 59°F and 86°F.
• Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

CellCept Composition

• The active ingredient is mycophenolate mofetil.
• Each vial contains 500 mg of mycophenolate mofetil.

The other components are: polisorbate 80, citric acid, hydrochloric acid, sodium chloride (see section 2 “CellCept contains sodium”).

Appearance of the product and contents of the pack

• CellCept is presented as a white to off-white powder in transparent type I glass vials of 20 ml with a grey butyl rubber stopper and an aluminium crimp cap with plastic capsules for easy opening.

• The reconstituted solution is slightly yellowish.
• It is available in packs of 4 vials.

7.Reconstitution of the medicinal product

Method of use and route of administration

CellCept 500 mg powder for concentrate for solution for infusion does not contain antibacterial preservatives; therefore, the 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 intravenous glucose solution 5%. A subsequent dilution with intravenous glucose solution 5% is required to achieve the final concentration of 6 mg/ml. This means that to prepare a dose of 1 g of mycophenolate mofetil, the contents of 2 vials reconstituted (approx. 2 x 15 ml) must be diluted subsequently in 140 ml of intravenous glucose solution 5%. If the infusion solution is not prepared immediately before administration, the start of administration of the infusion solution must be carried out within 3 hours following the reconstitution and dilution of the medicinal product.

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

• If this occurs, rinse your eyes with running water.

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

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

CellCept 500 mg powder for concentrate for solution for infusion must be administered as an intravenous infusion. The infusion rate must be controlled to cover a period of 2 hours of administration.

The intravenous solution of CellCept must never be administered by rapid intravenous injection or in a bolus.

Holder of the Marketing Authorization

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Responsible for manufacturing

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

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Last update of this leaflet

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