Mycophenolate mofetil accord

Package leaflet: Information for the user

Mykofenolan mofetylu Accord, 500 mg,
powder for concentrate for solution for infusion
Mycophenolas Mofetil
Please read all of 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 further questions, ask your doctor or nurse.
• This medicine has been prescribed for a specific patient. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of the leaflet:

1. What Mykofenolan mofetylu Accord is and what it is used for
2. Important information before taking Mykofenolan mofetylu Accord
3. How to take Mykofenolan mofetylu Accord
4. Possible side effects
5. How to store Mykofenolan mofetylu Accord
6. Contents of the pack and other information

1. What Mykofenolan mofetylu Accord is and what it is used for

Mykofenolan mofetylu Accord contains mycophenolate mofetil.

• It belongs to a group of medicines called "immunosuppressants".

Mykofenolan mofetylu Accord is used to prevent rejection of a transplanted organ:

• Kidney or liver

Mykofenolan mofetylu Accord should be used together with other medicines:

• Cyclosporine
• Corticosteroids

2. Important information before taking Mykofenolan mofetylu Accord

WARNING
Mycophenolate causes birth defects and miscarriages. If the patient is a woman of childbearing age who may become pregnant, she must present a negative pregnancy test result before starting treatment and must follow the contraception recommendations provided by the physician.
The doctor will discuss the therapy with the patient and provide written information, particularly regarding the effects of mycophenolate on the unborn child. Please read this information carefully and follow the instructions.
If the patient does not fully understand these instructions, she should consult the doctor for further explanation before taking mycophenolate. Also, please review the additional information provided in this section under "Warnings and precautions" and "Pregnancy and breastfeeding".

When not to use Mykofenolan mofetylu Accord

• if the patient is allergic to mycophenolic acid, mycophenolate mofetil, Polysorbate 80, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is a woman of childbearing potential and has not provided a pregnancy test result excluding pregnancy before the first prescription of the medicine, because mycophenolate causes birth defects and miscarriages;
• during pregnancy, planned pregnancy, or suspected pregnancy;
• if effective contraception is not being used (see Pregnancy, contraception and breastfeeding);
• if the patient is breastfeeding;

Do not use this medicine if any of the above points apply to the patient.
If in doubt, consult a doctor or pharmacist before taking Mykofenolan mofetylu Accord.

Warnings and precautions
Before starting treatment with Mykofenolan mofetylu Accord, discuss with your doctor or nurse if:

• the patient is over 65 years of age, as they may be at increased risk of adverse effects such as certain viral infections, gastrointestinal bleeding, and pulmonary oedema compared to younger patients;
• symptoms of infection occur (such as fever or sore throat);
• unexpected bruising or bleeding occurs;
• the patient has ever had or currently has gastrointestinal disorders, such as peptic ulcer disease;
• the patient plans to become pregnant or becomes pregnant while she or her partner is taking Mykofenolan mofetylu Accord;
• the patient has an inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

If any of the above situations apply to the patient (or if the patient is uncertain), speak with the doctor before starting treatment with Mykofenolan mofetylu Accord.

Sunlight exposure
Mykofenolan mofetylu Accord weakens the body's immune defences. Therefore, there is an increased risk of skin cancer. Exposure to sunlight and ultraviolet (UV) radiation should be limited. This can be achieved by:

• wearing protective clothing covering the head, neck, arms, and legs;
• using high-protection sunscreens.

Children
This medicine should not be given to children, as based on limited safety and efficacy data in this age group, dosing recommendations cannot be established.

Mykofenolan mofetylu Accord and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, including over-the-counter medicines and herbal remedies. Mykofenolan mofetylu Accord may affect the action of certain medicines, and some medicines may affect the action of Mykofenolan mofetylu Accord.

In particular, inform your doctor or nurse if you are taking any of the following medicines before starting Mykofenolan mofetylu Accord:

• azathioprine or other immunosuppressive medicines used after transplantation;
• cholestyramine, used to treat high cholesterol levels;
• rifampicin, an antibiotic used to prevent or 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 high blood pressure;
• acyclovir, ganciclovir, or valganciclovir, used to treat and prevent viral infections.

Vaccinations
If vaccination (with a live vaccine) is required while taking Mykofenolan mofetylu Accord, consult your doctor or pharmacist first. The doctor will advise which vaccine should be administered.
The patient must not donate blood during treatment with Mykofenolan mofetylu Accord and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with Mykofenolan mofetylu Accord and for at least 90 days after stopping treatment.

Pregnancy, contraception and breastfeeding
Contraception in women taking Mykofenolan mofetylu Accord
If the patient is a woman of childbearing age who may become pregnant, she must use an effective method of contraception during treatment with Mykofenolan mofetylu Accord. This applies to the periods:

• before starting treatment with Mykofenolan mofetylu Accord;
• throughout the entire treatment period with Mykofenolan mofetylu Accord;
• for 6 weeks after stopping treatment with Mykofenolan mofetylu Accord.

Discuss with your doctor the most appropriate method of contraception. The choice will depend on the individual patient's situation. It is best for the patient to use two methods of contraception, as this reduces the risk of unintended pregnancy. Contact your doctor immediately if you think contraception may not be effective or if you missed taking a contraceptive pill.

A woman is considered not able to become pregnant if any of the following criteria apply:

• She is postmenopausal, i.e. over 50 years old and has not menstruated for more than one year (if menstruation has stopped due to cancer treatment, pregnancy is still possible);
• She has undergone surgery to remove both fallopian tubes and both ovaries (bilateral salpingo-oophorectomy);
• She has undergone hysterectomy (removal of the uterus);
• Her ovaries have ceased functioning (premature ovarian failure confirmed by a specialist gynaecologist);
• She was born with one of the following rare conditions resulting in infertility: XY genotype, Turner syndrome, or uterine agenesis;
• She is a child or adolescent who has not yet started menstruating.

Contraception in men taking Mykofenolan mofetylu Accord
Available data do not indicate an increased risk of miscarriage or congenital malformations in children fathered by men taking mycophenolate. However, this risk cannot be completely ruled out. As a precautionary measure, it is recommended that the patient or his partner use effective contraception during treatment and for 90 days after stopping Mykofenolan mofetylu Accord.
If planning a pregnancy, discuss risks and alternative treatment options with your doctor.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine. The doctor will inform the patient about the risks associated with pregnancy and alternative treatments available to prevent rejection of the transplanted organ if:

• the patient plans to become pregnant;
• the patient misses a menstrual period or experiences unusual bleeding, or suspects she is pregnant;
• the patient had unprotected intercourse.

Inform the doctor immediately if pregnancy occurs during treatment with mycophenolate. However, continue taking Mykofenolan mofetylu Accord until you consult your doctor.

Pregnancy
Mycophenolate very frequently causes miscarriages (50%) and severe congenital malformations in the unborn child (23–27%). Reported birth defects include abnormalities of the ears, eyes, face (cleft lip/palate), limb developmental defects, heart, oesophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g. spina bifida (abnormally formed spinal bones)). A child born to a woman treated with mycophenolate may have one or more of these anomalies.

If the patient is of childbearing age, she must provide a negative pregnancy test result before starting treatment and must follow the doctor's contraception recommendations. The doctor may request more than one test before starting treatment to confirm that the patient is not pregnant.

Breastfeeding
Do not use Mykofenolan mofetylu Accord while breastfeeding, as small amounts of the medicine may pass into breast milk.

Driving and using machines
Mykofenolan mofetylu Accord has a moderate influence on the ability to drive and use tools or operate machinery. If the patient experiences drowsiness, dizziness, or confusion, inform the doctor or nurse and do not drive or operate tools or machinery until well-being improves.

Mykofenolan mofetylu Accord contains Polysorbate 80
This medicine contains 25 mg of Polysorbate 80 per vial. Polysorbates may cause allergic reactions. Inform your doctor about any known allergies.

Mykofenolan mofetylu Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning it is essentially "sodium-free".

3. How to take Mykofenolan mofetylu Accord

Mykofenolan mofetylu Accord is administered in hospital by a doctor or nurse.
The medicine is given as a slow intravenous infusion.

What dose to take
The dose depends on the type of organ transplanted. The usual doses are listed below. Treatment will continue as long as immunosuppression is needed to prevent rejection of the transplanted organ.

Kidney transplantation
Adults:

• The first dose is administered within 24 hours after transplantation.
• The daily dose is 2 g of the medicine, given in two separate doses.
• Take 1 g in the morning and 1 g in the evening.

Liver transplantation
Adults:

• The first dose is administered as soon as possible after transplantation.
• The patient will receive the medicine for at least 4 days.
• The daily dose is 2 g of the medicine, given in two separate doses.
• Take 1 g in the morning and 1 g in the evening.
• When the patient is able to swallow, the medicine will be administered orally.

Preparation of the medicine
The medicine is supplied as a powder. Before use, it must be mixed with glucose solution.
The doctor or nurse will prepare and administer the medicine according to the instructions in section 7 "Preparation of the medicine".

Taking more than the recommended dose of Mykofenolan mofetylu Accord
If the patient feels that too high a dose has been administered, contact the doctor or nurse immediately.

Missing a dose of Mykofenolan mofetylu Accord
If a dose of Mykofenolan mofetylu Accord is missed, the next dose will be given as soon as possible. Treatment will then continue as usual.

Stopping treatment with Mykofenolan mofetylu Accord
Do not stop taking Mykofenolan mofetylu Accord unless instructed by the doctor. Stopping treatment may increase the risk of rejection of the transplanted organ by the body.

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

4. Possible side effects

Like all medicines, Mykofenolan mofetylu Accord may cause side effects, although not everybody gets them.
Immediately inform your doctor or nurse if any of the following serious side effects occur – the patient may require urgent treatment:

• signs of infection such as fever or sore throat,
• unexplained bruising or bleeding,
• rash, swelling of the face, lips, tongue or throat, difficulty breathing – these may indicate a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

Commonly occurring disorders
The most frequently occurring disorders include: diarrhoea, decreased number of white or red blood cells in the blood, infections and vomiting. Your doctor will regularly order blood tests to monitor for any changes in:

• blood cell counts or signs of infection.

Fighting infections
Mykofenolan mofetylu Accord weakens the body's immune system. This action helps prevent transplant rejection. However, as a result, the body will not fight infections as effectively as usual. This means that patients may be more likely than usual to develop infectious diseases. These include infections of the brain, skin, mouth, stomach and intestines, lungs and urinary tract.

Malignant lymphatic and skin tumours
A very small number of patients treated with Mykofenolan mofetylu Accord have developed malignant lymphatic and skin tumours, which may occur in patients taking this type of medicine (immunosuppressive).

General systemic side effects
Patients may experience general systemic side effects, including severe hypersensitivity reactions (such as anaphylaxis, angioedema), fever, feeling of fatigue, sleep disturbances, pain (such as stomach pain, chest pain, joint or muscle pain, headache), flu-like symptoms, oedema.

Other possible side effects may include:

Skin disorders such as:

• acne, herpes simplex, shingles, skin hypertrophy, hair loss, rash, itching.

Urinary system disorders such as:

• presence of blood in urine.

Gastrointestinal and oral disorders such as:

• swollen and ulcerated gums, mouth ulcers,
• pancreatitis, colitis, gastritis,
• gastrointestinal disorders including bleeding,
• liver disorders,
• diarrhoea, constipation, nausea, indigestion, loss of appetite, bloating.

Nervous system disorders such as:

• drowsiness or numbness,
• tremor, muscle spasms, convulsions,
• anxiety or depression, thinking or mood disturbances.

Cardiovascular disorders such as:

• changes in blood pressure, blood clots, rapid heartbeat,
• pain, redness and swelling of blood vessels affected by infection.

Lung disorders such as:

• pneumonia, bronchitis,
• shortness of breath, cough, which may be caused by bronchiectasis (a condition in which the bronchi are abnormally widened) or pulmonary fibrosis (scarring of the lungs). If persistent cough or shortness of breath occurs, contact your doctor.
• fluid in the lungs or chest cavity,
• sinus problems.

Other disorders such as:

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

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products at the following address:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of the medicine.
Side effects can also be reported to the marketing authorisation holder.

5. How to store Mykofenolan mofetylu Accord

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and vial with the symbol EXP. The expiry date refers to the last day of the stated month.
• Powder for solution for concentrate for infusion: do not store above 30°C.
• Reconstituted and diluted medicine: chemical and physical stability has been demonstrated for at least 24 hours at temperatures from 20°C to 30°C. From a microbiological standpoint, the solution should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions and duration.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Mykofenolan mofetylu Accord contains

• The active substance is mycophenolate mofetil.
• The other components are: polysorbate 80, anhydrous citric acid, hydrochloric acid, sodium chloride, sodium hydroxide (for pH adjustment).

What Mykofenolan mofetylu Accord looks like and contents of the pack
Mykofenolan mofetylu Accord is supplied in 20 ml vials made of type I glass, closed with a bromobutyl rubber stopper and an aluminium flip-off cap.
Mykofenolan mofetylu Accord is available in packs containing 1 or 4 vials.
Not all pack sizes may be marketed.

7. Preparation of the medicine for administration
Method and route of administration
Mykofenolan mofetylu Accord does not contain antibacterial preservatives; therefore, reconstitution and dilution must be carried out under aseptic conditions.
The contents of each vial of Mykofenolan mofetylu Accord should be reconstituted with 14 ml of 5% glucose infusion solution. Further dilution in 5% glucose solution is required to achieve a final concentration of 6 mg/ml. This means that to prepare a dose of 1 g of mycophenolate mofetil, the reconstituted contents of two vials (approximately 2 x 15 ml) should be diluted in 140 ml of 5% glucose infusion solution. If the infusion solution is not prepared immediately before use, the infusion must be started no later than within 24 hours after reconstitution and preparation of the infusion solution.
Care must be taken to avoid contact of the prepared medicine with the eyes.

• If this occurs, rinse the conjunctivae thoroughly with plenty of water.

Care must be taken to avoid contact of the prepared medicine with the skin.

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

Mykofenolan mofetylu Accord must be administered as an intravenous infusion (IV). The infusion rate should be controlled so that the infusion lasts 2 hours.
Mykofenolan mofetylu Accord in the form of a solution for intravenous administration must never be given rapidly or as a bolus injection.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Tąśmowa 7 Street
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer / Importer
Accord Healthcare Polska Sp. z o.o.
Lutomierska 50 Street
85-200 Pabianice
Accord Healthcare Single Member S.A.
64th Km National Road Athens, Lamia,
32009, Schimatari
Greece

This medicinal product is authorised in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

| Country | Name of the medicinal product | |-------------|-----------------------------------| | Austria | Mycophenolatmofetil Accord 500 mg Pulver zur Herstellung eines Infusionslösungskonzentrats | | Belgium | Mycophenolate mofetil Accord Healthcare 500 mg poeder voor concentraat voor oplossing voor infusie / poudre pour solution à diluer pour perfusion / Powder for concentrate for solution for infusion | | Denmark | Mycophenolatmofetil Accord 500 mg pulver til koncentrat til infusionsvæske, opløsning | | France | Mycophénolate mofétil Accord 500 mg poudre pour solution à diluer pour perfusion | | Spain | Micofenolato de mofetilo Accord 500 mg polvo para concentrado para solución para perfusión EFG | | Netherlands | Mycofenolaatmofetil Accord 500 mg poeder voor concentraat voor oplossing voor infusie | | Malta | Mycophenolate mofetil 500 mg Powder for concentrate for solution for infusion | | Germany | Mycophenolatmofetil Accord 500 mg Pulver zur Herstellung eines Infusionslösungskonzentrats | | Norway | Mykofenolatmofetil Accord | | Poland | Mykofenolan mofetylu Accord | | Portugal | Micofenolato de mofetil Accord 500 mg pó para concentrado para solução para perfusão | | Sweden | Mykofenolatmofetil Accord 500 mg pulver till koncentrat till infusionsvätska, lösning | | Hungary | Mikofenolát-mofetil Accord 500 mg por oldatos infúzióhoz való koncentrátumhoz | | United Kingdom (Northern Ireland) | Mycophenolate mofetil 500 mg Powder for concentrate for solution for infusion |