Mycophenolic acid Tillymed: detailed information

Package leaflet: Information for the patient

Mycophenolic Acid Tillomed 180 mg and 360 mg gastro-resistant tablets

Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Mycophenolic Acid Tillomed is and what it is used for
What you need to know before taking Mycophenolic Acid Tillomed
How to take Mycophenolic Acid Tillomed
Possible side effects
How to store Mycophenolic Acid Tillomed
Contents of the pack and other information

1. What Acido Micofenolico Tillomed is and what it is used for

This medicinal product contains a substance called mycophenolic acid. It belongs to
a group of medicines known as immunosuppressants.
This medicine is used to prevent rejection of the transplanted kidney by the immune system. It is used in combination with other medicinal products containing cyclosporine and
corticosteroids.

2. What you need to know before taking Mycophenolic Acid Tillomed

WARNING
Mycophenolate causes birth defects and miscarriages. If you are a woman of childbearing age,
you must provide a negative pregnancy test before starting treatment and must follow the
contraception advice provided by your doctor.
Your doctor will speak with you 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 the instructions, ask your doctor to explain them again before
taking mycophenolate. You may find further information in this section under
“Warnings and precautions” and “Pregnancy and breastfeeding”.
Do not take Mycophenolic Acid Tillomed:

if you are allergic (hypersensitive) to mycophenolic acid, sodium mycophenolate, mycophenolate mofetil, or to any of the other components of this medicine (listed in section 6).
if you are a woman of childbearing age and have not provided a negative pregnancy test before the first prescription, as mycophenolate causes congenital malformations 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 Contraception in women and men).
if you are breastfeeding (see also “Pregnancy and breastfeeding”). If this applies to you, inform your doctor without taking Mycophenolic Acid Tillomed.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.

if you have or have ever had severe digestive disorders, such as gastric ulcer.
if you have a rare inherited deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase (HGPRT), such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

You should also be aware that:

this medicine reduces the skin’s natural protection from sunlight. This increases the risk of skin cancer. You should limit exposure to sunlight and ultraviolet (UV) rays by protecting exposed skin areas as much as possible and regularly applying high-protection sunscreen. Ask your doctor for advice on how to protect yourself from the sun.
if you have previously had hepatitis B or C, this medicine may increase the risk of reactivation of these diseases. Your doctor may perform blood tests and monitor symptoms of these diseases. If you experience any symptoms (yellowing of the skin or eyes, nausea, loss of appetite, dark urine), inform your doctor immediately.
if you develop a persistent cough or shortness of breath, especially while taking other immunosuppressants, you must inform your doctor immediately.
your doctor may request periodic checks of antibody levels in your blood during treatment with sodium mycophenolate, particularly if infections recur, especially if you are also being treated with other immunosuppressants, and will inform you whether you can continue taking this medicine.
if you show signs of infection (such as fever or sore throat) or experience unexpected bruising or bleeding, you must inform your doctor immediately.
your doctor may request periodic monitoring of white blood cell counts during treatment with this medicine and will inform you whether you can continue taking it.
the active substance, mycophenolic acid, is different from that of other medicines with a similar name, such as mycophenolate mofetil. You must not switch from one medicine to another unless instructed by your doctor.
the use of this medicine during pregnancy may be harmful to the fetus (see also “Pregnancy and breastfeeding”) and may increase the risk of pregnancy loss (miscarriage).

Other medicines and Mycophenolic Acid Tillomed
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those without a prescription.
In particular, you must inform your doctor if you are taking any of the following
medicines:

other immunosuppressive medicines such as azathioprine or tacrolimus.
medicines used to treat high cholesterol levels in the blood, such as colestyramine.
activated charcoal used to treat digestive disorders such as diarrhoea, stomach upset, and flatulence.
antacids containing magnesium and aluminium.
medicines used to treat viral infections such as aciclovir or ganciclovir.

You should also inform your doctor if you intend to receive any vaccinations.
You must not donate blood during treatment with this medicine and for at least 6
weeks after stopping treatment. Men must not donate sperm during treatment with this
product and for at least 90 days after stopping treatment.
Mycophenolic Acid Tillomed with food and drinks
This medicine may be taken with or without food. You should choose whether to take the
tablets with or without food and then continue taking them the same way every day.
This way, you ensure that you absorb the same amount of medicine each day.
Elderly
Elderly people (aged 65 years or older) may take this medicine without the need to adjust the
recommended usual dose.
Children and adolescents
Due to lack of data, the use of this medicine is not recommended in children and
adolescents.
Pregnancy, contraception and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are
breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will
discuss the risks associated with pregnancy and alternative therapies you may take 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 sexual intercourse without using an effective contraceptive method. If you become pregnant during treatment with mycophenolate, inform your doctor immediately. In any case, continue taking mycophenolate until you have seen your doctor.

Pregnancy
Mycophenolate causes a very high rate of miscarriages (50%) and serious birth defects (23%-27%) in newborns. Reported birth defects include abnormalities of the ears, eyes, face (cleft lip/palate), finger development, heart, oesophagus (the tract connecting the throat to the stomach), kidneys, and the nervous system (e.g. spina bifida (where the spinal bones are not properly developed)). One or more of these may affect your baby.
If you are a woman of childbearing age, you must provide a negative pregnancy test before starting
treatment and must follow the contraception advice provided by your doctor. Your doctor may
request more than one test to confirm that you are not pregnant before starting
treatment.
Breastfeeding
Do not take this medicine if you are breastfeeding. This is because small amounts of
the medicine may pass into breast milk.
Contraception in women taking Mycophenolic Acid Tillomed
If you are a woman of childbearing age, you must use an effective method of contraception with this
medicine. This includes:

before starting treatment with Mycophenolic Acid Tillomed
throughout the entire treatment with Mycophenolic Acid Tillomed
for 6 weeks after stopping treatment with Mycophenolic Acid Tillomed. Discuss with your doctor which contraceptive method is most suitable for you. This will depend on your personal situation. The use of two contraceptive methods is preferred, as this reduces the risk of unintended pregnancy. Contact your doctor as soon as possible if you think your contraceptive method may not be effective or if you have forgotten to take your contraceptive pill.

If any of the following conditions apply to you, you may be considered not fertile:

you are postmenopausal, i.e. you are at least 50 years old and your last menstrual period occurred more than one year ago (if menstruation has stopped due to cancer treatment, there is still a possibility you could become pregnant)
you have had both Fallopian tubes and both ovaries surgically removed (bilateral salpingo-oophorectomy)
you have had your uterus surgically removed (hysterectomy)
your ovaries are no longer functioning (confirmed premature ovarian failure by a gynaecology 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 had her first menstrual period.

Contraception in men taking Mycophenolic Acid Tillomed
Available evidence does not indicate an increased risk of malformations or miscarriage if the father is taking 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 therapy with this medicine.
If you are planning a pregnancy, discuss potential risks with your doctor.
Driving and using machines
This medicine is not known to affect the ability to drive or use machinery.
Mycophenolic Acid Tillomed contains sodium
Mycophenolic Acid Tillomed 180 mg
This medicine contains 13 mg of sodium (a main component of table salt) per tablet. This corresponds to 0.65% of the maximum daily dietary intake recommended for an adult.
Mycophenolic Acid Tillomed 360 mg
This medicine contains 26 mg of sodium (a main component of table salt) per tablet. This corresponds to 1.3% of the maximum daily dietary intake recommended for an adult.
Mycophenolic Acid Tillomed contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.

3. How to take Mycophenolic Acid Tillomed

Always take this medicine exactly as instructed by your doctor or pharmacist.
This medicine will only be prescribed to you by a doctor experienced in the treatment of transplant patients.
If you have any doubts, consult your doctor or pharmacist.

Recommended dose
180 mg
The recommended daily dose of Mycophenolic Acid Tillomed is 1440 mg (8 tablets of Mycophenolic Acid Tillomed 180 mg). These are taken as two separate doses of 720 mg each (4 tablets of Mycophenolic Acid Tillomed 180 mg).

360 mg
The recommended daily dose of Mycophenolic Acid Tillomed is 1440 mg (4 tablets of Mycophenolic Acid Tillomed 360 mg). These are taken as two separate doses of 720 mg each (2 tablets of Mycophenolic Acid Tillomed 360 mg).

Take the tablets in the morning and in the evening.
The first 720 mg dose will be administered within 72 hours after transplantation.

If you have severe kidney problems
The daily dose must not exceed 1440 mg (8 tablets of Mycophenolic Acid 180 mg; 4 tablets of Mycophenolic Acid Tillomed 360 mg).

How to take Mycophenolic Acid Tillomed
Swallow the tablets whole with a glass of water.
Do not break or crush the tablets.
Do not take any broken or divided tablets.

Treatment will continue for as long as immunosuppression is needed to prevent rejection of the transplanted organ.

If you take more Mycophenolic Acid Tillomed than you should
If you take more Mycophenolic Acid Tillomed than prescribed, or if someone else has taken your tablets, contact your doctor or go to hospital immediately. Medical treatment may be necessary. Bring the tablets with you and show them to your doctor or hospital staff. If you have run out of tablets, bring the empty packaging.

If you forget to take Mycophenolic Acid Tillomed
If you forget to take a dose of Mycophenolic Acid Tillomed, take it as soon as you remember, unless it is almost time for your next dose. In that case, take the next dose at your usual time.

If you stop taking Mycophenolic Acid Tillomed
Do not stop taking Mycophenolic Acid Tillomed unless instructed by your doctor. Stopping treatment with this medicine may increase the risk of rejection of the transplanted kidney.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Elderly patients may experience more side effects due to a reduced immune defence.
Immunosuppressants, including mycophenolate sodium, reduce your body's defence mechanisms to prevent rejection of your transplanted organ. As a result, your body will not be able to defend itself against infections as it normally would. Therefore, while taking this medicine, you may get more infections than usual, such as infections of the brain, skin, mouth, stomach and intestine, lungs, and urinary tract.
You will be regularly monitored by your doctor with blood tests to check for changes in blood cell counts or levels of substances carried in the blood, such as sugar, fats, and cholesterol.

Some side effects can be serious:

signs of infection including fever, chills, sweating, feeling tired, drowsiness, or lack of energy. While taking this medicine, you may get viral, bacterial, and fungal infections more often than usual. These infections may affect various parts of the body but most commonly the kidneys, bladder, and upper and/or lower airways.
vomiting blood, dark or bloody stools, gastric or intestinal ulcer.
swelling of the glands, development of new skin growths, increase in size of existing growths, or changes in existing growths. As may occur in patients treated with immunosuppressants, a very small number of patients receiving mycophenolate sodium have developed skin cancer or lymph node tumours.

If you experience any of the above side effects after taking this medicine, contact your doctor immediately.

Other side effects may include:

Very common: may affect more than 1 in 10 people

low levels of white blood cells
low levels of calcium in the blood (hypocalcaemia)
low levels of potassium in the blood (hypokalaemia)
high levels of uric acid in the blood (hyperuricaemia)
high blood pressure (hypertension)
anxiety
diarrhoea
joint pain (arthralgia)

Common: may affect up to 1 in 10 people

low levels of red blood cells which may cause tiredness, shortness of breath, and paleness (anaemia)
low levels of platelets in the blood which may cause unexpected bleeding and bruising (thrombocytopenia)
high levels of potassium in the blood (hyperkalaemia)
low levels of magnesium in the blood (hypomagnesaemia)
dizziness
headache
cough
low blood pressure (hypotension)
shortness of breath (dyspnoea)
abdominal or stomach pain, inflammation of the stomach lining, abdominal swelling, constipation, indigestion, flatulence, loose stools, nausea, vomiting
fatigue, fever
abnormal results in liver and kidney function tests
respiratory infections
acne
weakness (asthenia)
muscle pain (myalgia)
swelling of the hands, ankles, or feet (peripheral oedema)
itching

Uncommon: may affect up to 1 in 100 people

fast (tachycardia) or irregular heartbeat (ventricular extrasystoles), fluid in the lungs (pulmonary oedema)
fluid-filled skin sac (cyst) containing lymph (lymphocele)
tremor, difficulty sleeping
redness and swelling of the eyes (conjunctivitis), blurred vision
wheezing
belching, difficulty breathing, intestinal blockage (ileus), ulceration of the lips, heartburn, change in tongue colour, dry mouth, inflammation of the gums, inflammation of the pancreas causing severe pain in the upper stomach (pancreatitis), blockage of the salivary glands, inflammation of the inner abdominal wall (peritonitis)
bone, blood, and skin infections
blood in the urine, kidney damage, pain and difficulty urinating
hair loss, bruising
joint inflammation (arthritis), back pain, muscle cramps
loss of appetite, increased levels of lipids (hyperlipidaemia), sugar (diabetes), cholesterol (hypercholesterolaemia), or decreased levels of phosphate in the blood (hypophosphataemia)
flu-like symptoms (such as tiredness, chills, sore throat, joint or muscle pain), swelling of ankles and feet, pain, stiffness, thirst, or weakness
unusual dreams, feeling of disappointment
inability to achieve or maintain an erection
cough, difficulty breathing, painful breathing (possible symptoms of interstitial lung disease)

Not known: frequency cannot be estimated from the available data

skin rash
fever, sore throat, frequent infections (possible symptoms of lack of white blood cells in the blood) (agranulocytosis)

Other side effects reported with medicines similar to Mycophenolic Acid Tillomed
Additional side effects have been reported with the group of medicines to which mycophenolate sodium belongs:

inflammation of the colon (large intestine)
inflammation of the stomach lining caused by cytomegalovirus
formation of a lesion in the intestinal wall causing severe abdominal pain with possible bleeding, gastric or duodenal ulcer
low levels of white blood cells specifically or of all blood cells, severe infections such as inflammation of the heart and heart valves and of the membranes lining the brain and spinal cord, shortness of breath, cough which may be caused by bronchiectasis (a condition in which the airways of the lungs are abnormally widened) and other less common bacterial infections that usually cause serious lung disorders (tuberculosis and infections from atypical mycobacteria). Contact your doctor if you have a persistent cough or shortness of breath.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 Mycophenolic Acid Tillomed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of the month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
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 Acido Micofenolico Tillomed contains

The active substance is mycophenolic acid. Each gastro-resistant tablet contains 180 mg or 360 mg of mycophenolic acid (as sodium mycophenolate).
The other components are:
Tablet core
Maize starch
Povidone
Crospovidone
Lactose monohydrate
Colloidal anhydrous silica
Magnesium stearate

Tablet coating
Hypromellose phthalate
Titanium dioxide (E171)
Yellow iron oxide (E172)
Indigo carmine (E132) (only for 180 mg tablets)
Red iron oxide (E172) (only for 360 mg tablets)
Hypromellose (E464)
Macrogol
Printing ink
Shellac (20% esterified)
Black iron oxide (E172)
Propylene glycol (E1520)

Description of the appearance of Acido Micofenolico Tillomed and package contents

The 180 mg gastro-resistant tablets are enteric-coated, lime-green in colour, round, with bevelled edges, marked “HP 544” on one side and smooth on the other.

The 360 mg gastro-resistant tablets are enteric-coated, light red-orange in colour, oval-shaped, marked “HP 545” on one side and smooth on the other.

The 180 mg gastro-resistant tablets are available in packages containing 50x1, 100x1, 120x1 or 250x1 gastro-resistant tablets in perforated unit-dose blisters made of OPA/Alu/PVC.

The 360 mg gastro-resistant tablets are available in packages containing 50x1, 100x1, 120x1 or 250x1 gastro-resistant tablets in perforated unit-dose blisters made of OPA/Alu/PVC.

It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Tillomed Italia S.r.l.
Viale Giulio Richard 1, Torre A
20143 Milano, Italy

Manufacturer
Tillomed Malta Ltd.
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN3000, Malta
SGS Pharma Magyarorszag Kft.
Derkovits Gyula Utca 53,
Budapest XIX, 1193, Hungary

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark Mycophenolsyre Tillomed, enterotabletter 180 mg
Mycophenolsyre Tillomed, enterotabletter 360 mg
France ACIDE MYCOPHENOLIQUE TILLOMED 180 mg, comprimé gastro-résistant
ACIDE MYCOPHENOLIQUE TILLOMED 360 mg, comprimé gastro-résistant
Germany Mycophenolic acid Tillomed 180 mg and 360 mg magensaftresistente Tabletten
Hungary Mikofenolsav Tillomed 180 mg gyomornedv-ellenálló tabletta
Mikofenolsav Tillomed 360 mg gyomornedv-ellenálló tabletta
Italy Acido Micofenolico Tillomed
Portugal Ácido Micofenólico Tillomed
Spain Ácido Micofenólico Tillomed 180 mg comprimidos gastrorresistentes EFG
Ácido Micofenólico Tillomed 360 mg comprimidos gastrorresistentes EFG