Mycophenolate mofetil AHCL

Package leaflet: Information for the user

Mycophenolate Mofetil AHCL 500 mg film-coated tablets

Equivalent medicine
Please read all of 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Mycophenolate Mofetil AHCL is and what it is used for
2. What you need to know before taking Mycophenolate Mofetil AHCL
3. How to take Mycophenolate Mofetil AHCL
4. Possible side effects
5. How to store Mycophenolate Mofetil AHCL
6. Contents of the pack and other information

1. What Micofenolato Mofetile AHCL is and what it is used for

Micofenolato Mofetile AHCL 500 mg film-coated tablets belong to a group of medicines called "immunosuppressants".
Micofenolato Mofetile AHCL is used to prevent rejection of transplanted kidney, heart, or liver. Micofenolato Mofetile AHCL must be administered in combination with other medicines, such as ciclosporina and corticosteroids.

2. What you should know before taking Mycophenolate Mofetil AHCL

WARNING
Mycophenolate causes birth defects and miscarriage. If you are a woman of childbearing potential,
you must provide a negative pregnancy test before starting treatment and must use the contraceptive
method advised by your doctor.
Your doctor will explain and provide you with written information, particularly regarding the effects of mycophenolate on unborn children. 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. See also further information in this section under "Warnings and precautions" and "Pregnancy and breastfeeding".
Do not take Mycophenolate Mofetil AHCL

• If you are allergic to mycophenolate mofetil, to mycophenolic acid, or to any of the other ingredients of this medicine (listed in section 6).
• If you are a woman of childbearing potential and have not provided a negative pregnancy test before the first prescription, because mycophenolate causes birth defects and miscarriage.
• If you are pregnant, planning a pregnancy, or think you may be pregnant.
• If you are not using an effective contraceptive method (see Pregnancy, contraception and breastfeeding).
• If you are breastfeeding. Do not take this medicine if any of the above conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking Mycophenolate Mofetil AHCL.

Warnings and precautions
Contact your doctor, pharmacist, or nurse immediately before starting treatment with
Mycofenolate Mofetil AHCL.

• If you are over 65 years of age, 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 have any unexplained bruising or bleeding.
• If you have ever had a gastrointestinal disorder, for example a stomach ulcer.
• If you are planning a pregnancy or become pregnant while you or your partner are being treated with mycophenolate mofetil tablets.
• If you have an inherited enzyme deficiency such as Lesch-Nyhan or Kelley-Seegmiller syndrome.

If any of the above apply to you (or if you are in doubt), contact your doctor immediately
before starting treatment with mycophenolate mofetil.
Effect of sunlight
Mycophenolate mofetil suppresses the body's immune system. As a result, there is an increased risk of skin cancer. Limit your exposure to sunlight and ultraviolet radiation by:

• Wearing protective clothing that covers your head, neck, arms, and legs.
• Using sunscreen with a high sun protection factor.

Children and adolescents
Paediatric population aged 2 to 18 years:
Mycofenolate Mofetil AHCL is used in children and adolescents (aged 2 to 18 years) to prevent rejection of a transplanted kidney.
Mycofenolate Mofetil AHCL must not be used in children and adolescents (aged 2 to 18 years) who have undergone heart or liver transplantation.
Mycofenolate Mofetil AHCL must not be used in children under 2 years of age, as, based on limited safety and efficacy data in this age group, dosage recommendations cannot be made.

Other medicines and Mycophenolate Mofetil AHCL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription such as herbal remedies, because mycophenolate mofetil may affect how other medicines work and other medicines may affect how mycophenolate mofetil works.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines before starting mycophenolate mofetil:

• Azathioprine or other medicines that suppress the immune system – administered after a transplant procedure.
• 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-related problems such as indigestion.
• Phosphate binders – used by people with chronic kidney failure to reduce the amount of phosphate absorbed into the blood.
• Antibiotics – used to treat bacterial infections.
• Isavuconazole – used to treat fungal infections.
• Telmisartan – used to treat high blood pressure.
• Aciclovir, valaciclovir, or ganciclovir.

Vaccines
If you need to receive a vaccination (a live vaccine) during treatment with Mycophenolate Mofetil AHCL, consult your doctor or pharmacist first. Your doctor will advise you on which vaccines you may receive.
You must not donate blood during treatment with Mycophenolate Mofetil AHCL and for at least 6 weeks after stopping treatment. Men must not donate sperm during treatment with Mycophenolate Mofetil AHCL and for at least 90 days after stopping treatment.

Mycofenolate Mofetil AHCL with food and drink
Taking food and drink does not affect treatment with Mycophenolate Mofetil AHCL.

Pregnancy, contraception and breastfeeding
Contraception in women taking Mycophenolate Mofetil AHCL
If you are a woman of childbearing potential, you must use an effective contraceptive method while taking Mycophenolate Mofetil AHCL. This includes:

• Before starting Mycophenolate Mofetil AHCL
• Throughout the entire treatment with Mycophenolate Mofetil AHCL
• For 6 weeks after stopping Mycophenolate Mofetil AHCL

Discuss with your doctor which contraceptive method is most suitable for you. This will depend on your individual situation. The use of two contraceptive methods is preferred to reduce the risk of unintended pregnancy. Contact your doctor as soon as possible if you think your contraception may not have been effective or if you have missed taking your contraceptive pill.

If you cannot become pregnant, one of the following conditions applies to you:

• You are post-menopausal, i.e. you are at least 50 years old and your last menstrual period was more than one year ago (if your menstrual cycles have stopped due to cancer therapy, you may still be able to become pregnant).
• Both fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy).
• Your womb (uterus) has been surgically removed (hysterectomy).
• Your ovaries no longer function (premature ovarian failure, confirmed by a gynaecological 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 started having menstrual periods.

Contraception in men treated with Mycophenolate Mofetil AHCL
Available evidence does not indicate an increased risk of birth defects or miscarriage if the father takes mycophenolate. However, a risk cannot be completely ruled out. As a precaution, it is recommended that you or your female partner use reliable contraceptive methods during treatment and for 90 days after stopping Mycophenolate Mofetil AHCL.
If you are planning to have a child, discuss potential risks and alternative therapies with your doctor.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine. Your doctor will explain the risks associated with pregnancy and the alternative treatments available 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 an effective contraceptive method. If you become pregnant during treatment with mycophenolate, you must inform your doctor immediately. However, continue taking Mycophenolate Mofetil AHCL until your doctor advises otherwise.

Pregnancy
Mycophenolate causes a very high rate of miscarriage (50%) and severe birth defects (23–27%) in the unborn child. Reported birth defects include abnormalities of the ears, eyes, face (cleft lip/palate), fingers, heart, oesophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g. spina bifida, where the bones of the spine are not properly formed). Your baby may be affected by one or more of these.
If you are a woman of childbearing potential, you must provide a negative pregnancy test before starting treatment and must follow your doctor's advice on contraception. Your doctor may require more than one test to ensure you are not pregnant before starting treatment.

Breastfeeding
Do not take Mycophenolate Mofetil AHCL if you are breastfeeding. This is because small amounts of the medicine may pass into breast milk.

Driving and using machines
Mycofenolate Mofetil AHCL has a moderate influence 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.

Mycofenolate Mofetil AHCL contains sodium: This medicine contains less than 1 mmol (23 mg) of sodium per dosage unit, i.e. essentially 'sodium-free'.

3. How to take Mycophenolate Mofetil AHCL

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

Dosage
The dose you take depends on the type of transplant you have received. The usual doses are described below. Treatment will continue as long as it is necessary to prevent rejection of the transplanted organ.

Kidney transplant
Adults

• The first dose should be given within 3 days after transplantation.
• The daily dose is 4 tablets (2 g of the medicine), taken in two divided doses.
• Take 2 tablets in the morning and 2 tablets in the evening.

Children (aged between 2 and 18 years)

• The dose administered varies depending on the child's size.
• Your 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 dose is 600 mg/m² taken twice daily.

Heart transplant
Adults

• The first dose should be given within 5 days after transplantation.
• The daily dose is 6 tablets (3 g of the medicine), taken in two divided doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

• There are no data available on the use of mycophenolate mofetil in children undergoing heart transplantation.

Liver transplant
Adults

• The first dose of oral mycophenolate mofetil will be administered at least 4 days after transplantation and when you are able to take oral medication.
• The total daily dose is 6 tablets (3 g of the medicine), taken in two divided doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

• There are no data available on the use of mycophenolate mofetil in children undergoing liver transplantation.

Method and route of administration:
Swallow the tablets with a glass of water. Do not break or crush the tablets.

If you take more Mycophenolate Mofetil AHCL than you should
If you take more Mycophenolate Mofetil AHCL than prescribed, or if someone else accidentally takes the tablets, contact your doctor immediately or go straight to hospital. Take the medicine pack with you.

If you forget to take Mycophenolate Mofetil AHCL
If you forget to take a dose at any time, take it as soon as you remember, then continue taking the medicine at your usual times. Do not take a double dose to make up for the forgotten dose.

If you stop taking Mycophenolate Mofetil AHCL
Do not stop treatment with Mycophenolate Mofetil AHCL 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, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you notice any of the following serious side effects – you may need
urgent medical treatment:
you have signs of infection, such as fever or sore throat

• you have any unexpected bruising or bleeding
• you develop a skin rash, swelling of the face, lips, tongue or throat, with breathing difficulties
  • you may be experiencing a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

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

• in blood cell counts or signs of infection.

Children may be more likely than adults to experience certain side effects. These include diarrhea, infections, lower white blood cell and lower red blood cell counts.
Fighting infections
Mycophenolate mofetil lowers the body's natural defences to prevent rejection of the transplanted organ. As a result, the body may be less able to fight infections effectively compared to normal. This means you may be more prone to infections, for example affecting the brain, skin, mouth, stomach and intestines, lungs, and urinary tract.
Lymphatic system and skin tumors
As with other drugs of this type (immunosuppressants), a very small number of patients treated with mycophenolate mofetil 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 tired, sleep disturbances, pain (in the stomach, chest, muscles or joints), headache, flu-like symptoms, and swelling.
Other possible 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:

• dizziness, drowsiness, or paresthesia (abnormal sensations like tingling or numbness)
• tremors, muscle spasms, seizures
• feelings of anxiety or depression, changes in mood or thinking.

Heart and blood vessel disorders such as:

• changes in blood pressure, rapid heartbeat, swelling around blood vessels.

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, bruising.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Micofenolato Mofetile AHCL

• Do not store above 25°C. Keep the blister in the outer packaging to protect the medicine from light.
• 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.". The expiry date refers to the last day of that month.
• Always return unused medicines to the pharmacist. Keep only upon the advice of your doctor.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Micofenolato Mofetile AHCL contains
The active substance is 500 mg of mycophenolate mofetil.
The other components are:
Tablet core: microcrystalline cellulose, povidone, hydroxypropylcellulose, sodium croscarmellose,
talc, magnesium stearate.
Tablet coating: hypromellose 6 cps, titanium dioxide (E171), macrogol 400, red iron oxide (E172), indigo carmine aluminium lake (E132), black iron oxide (E172), purified talc.

Description of the appearance of Micofenolato Mofetile AHCL and package contents:
Micofenolato Mofetile AHCL 500 mg tablets are lavender-coloured, film-coated, capsule-shaped, biconvex tablets, with "AHI" engraved on one side and "500" on the other.
Micofenolato Mofetile AHCL is available in blister packs containing 50, 150 or 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands

Manufacturers:
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Accord Healthcare Polska Sp. z o.o.,
ul. Lutomierska 50, 95-200 Pabianice,
Poland
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040 Spain
Accord Healthcare single member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009, Greece

This medicinal product is authorised in the European Economic Area countries under the following names:

| Member State | Name of the medicinal product | |------------------|-----------------------------------| | Austria | Mycophenolate Mofetil Accord 500mg Filmtabletten | | Belgium | Mycophenolate Mofetil Accord Healthcare 500mg comprimés pelliculés | | Cyprus | Mycophenolate Mofetil Accord 500 mg επικαλυμμένα με λεπτό υμένιο δισκία | | Denmark | Mycophenolate Mofetil Accord 500 mg Filmovertrukne tabletter | | Estonia | Mycophenolate Mofetil Accord 500mg õhukese polümeerikattega tabletid | | Finland | Mycophenolate Mofetil Accord 500mg Tabletti, kalvopäällysteinen / Filmdragerade tabletter | | France | Mycophenolate Mofetil Accord healthcare 500mg comprimé pelliculé | | Germany | Mycophenolate Mofetil Accord 500mg Filmtabletten | | Greece | Myfetil 500 mg επικαλυμμένα με λεπτό υμένιο δισκία | | Ireland | Mycophenolate Mofetil 500mg film-coated Tablets | | Italy | Micofenolato Mofetile AHCL 500 mg compresse rivestite con film | | Latvia | Mycophenolate Mofetil Accord 500mg apvalkotās tabletes | | Lithuania | Mycophenolate Mofetil Accord 500 mg plėvele dengtos tabletės | | Malta | Mycophenalate Mofetil 500mg | | Norway | Mycophenolate Mofetil Accord 500mg Tablett, filmdrasjert | | Poland | Mycofit, 500 mg, tabletki powlekane | | Portugal | Micofanolato de Mofetil Accord 500 mg comprimidos revestidos por película | | Spain | Micofenolato de mofetilo STADA 500 mg comprimidos recubiertos con película EFG | | Sweden | Mycophenolate Accord 500 mg Filmdragerade tabletter | | The Netherlands | Mycophenolaat Mofetil Accord 500mg Filmomhulde Tabletten | | United Kingdom | Mycophenolate Mofetil 500mg Film–coated Tablets |