Micophenolate mofetil Sandoz 500 mg tabletki povlekane

Leaflet attached to the packaging: patient information

Mycophenolate mofetil Sandoz 500 mg coated tablets

Mycophenolate mofetil

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What Mycophenolate mofetil Sandoz 500 mg coated tablets are and what they are used for
• 2. Important information before taking Mycophenolate mofetil Sandoz 500 mg coated tablets
• 3. How to take Mycophenolate mofetil Sandoz 500 mg coated tablets
• 4. Possible side effects
• 5. How to store Mycophenolate mofetil Sandoz 500 mg coated tablets
• 6. Contents of the packaging and other information

1. What Mycophenolate Mofetil Sandoz 500 mg coated tablets are and what they are used for

What they are used for
Mycophenolate mofetil Sandoz 500 mg coated tablets contain mycophenolate mofetil. It belongs to a group of medicines called immunosuppressants. Mycophenolate mofetil Sandoz 500 mg coated tablets are used to prevent the body from rejecting a transplanted organ: kidney, heart, or liver.
Mycophenolate mofetil Sandoz 500 mg coated tablets should be used in combination with other medicines: cyclosporine and corticosteroids.

2. Important information before taking Mycophenolate Mofetil Sandoz 500 mg coated tablets

Important information
WARNING
Mycophenolate can cause birth defects and miscarriage. Women of childbearing age must have a negative pregnancy test before starting treatment and follow the doctor's instructions for contraception.
The doctor will discuss with the patients (and provide written information) the effects of mycophenolate on the fetus.
Read the information provided by the doctor carefully and follow the instructions.
If the instructions are not fully understood, ask the doctor for explanations before taking mycophenolate. Also, read the additional information provided in the "Warnings and precautions" and "Pregnancy, contraception, and breastfeeding" sections.

When not to take Mycophenolate mofetil Sandoz 500 mg coated tablets

if the patient is allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid, or any of the other ingredients of this medicine (listed in section 6);
if the patient may become pregnant and has not had a negative pregnancy test before receiving the first prescription for this medicine, as mycophenolate can cause birth defects and miscarriage;
if the patient is pregnant or plans to become pregnant or suspects she may be pregnant;
if the patient is not using effective contraception (see "Pregnancy, contraception, and breastfeeding");
if the patient is breastfeeding.
If any of the above points apply to the patient, do not take this medicine. In case of doubt, consult a doctor or pharmacist before taking the medicine.

Warnings and precautions

Before starting to take Mycophenolate mofetil Sandoz 500 mg coated tablets, the patient should immediately discuss with their doctor if they have any signs of infection, such as fever or sore throat;
if they have unexpected bruising or bleeding;
if they have had any problems with their digestive system, such as stomach ulcers;
if the patient plans to become pregnant or becomes pregnant while taking Mycophenolate mofetil Sandoz 500 mg coated tablets;
If any of the above points apply to the patient (or the patient is unsure), consult a doctor before taking Mycophenolate mofetil Sandoz 500 mg coated tablets.

Sunlight effects

Mycophenolate mofetil Sandoz 500 mg coated tablets weaken the body's defense mechanisms, which increases the risk of skin cancer. Limit exposure to sunlight and ultraviolet (UV) radiation by using:
protective clothing covering the head, neck, arms, and legs
sunscreen with a high protection factor.

Mycophenolate Mofetil Sandoz 500 mg coated tablets and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take, including those obtained without a prescription and herbal medicines. This is because Mycophenolate mofetil Sandoz 500 mg coated tablets and some other medicines may affect each other's action. In particular, before starting treatment with this medicine, inform the doctor or pharmacist if the patient is taking any of the following medicines:
azathioprine or other medicines that suppress the immune system (given to patients after transplantation),
cholestyramine (a medicine used to treat high cholesterol levels in the blood),
rifampicin (an antibiotic used to prevent and treat infections such as tuberculosis),
antacids or proton pump inhibitors (medicines used to treat stomach acid-related diseases, such as heartburn),
phosphate binders (used in patients with chronic kidney failure to reduce phosphate absorption),
antibiotics (medicines used to treat bacterial infections),
isavuconazole (a medicine used to treat fungal infections),
telmisartan (a medicine used to treat high blood pressure).

Vaccinations

If the patient needs to be vaccinated (with a live vaccine) while taking Mycophenolate mofetil Sandoz 500 mg coated tablets, they should consult their doctor or pharmacist first. The doctor will advise the patient on which vaccinations are suitable for them.
Do not donate blood while taking Mycophenolate mofetil Sandoz 500 mg coated tablets and for at least 6 weeks after stopping treatment. Men should not donate sperm while taking the medicine and for 90 days after stopping treatment.

Mycophenolate Mofetil Sandoz 500 mg coated tablets with food and drink

Food and drink do not affect treatment with Mycophenolate mofetil Sandoz 500 mg coated tablets.

Pregnancy, contraception, and breastfeeding

Contraception in women taking Mycophenolate mofetil Sandoz 500 mg coated tablets

If the patient is of childbearing age and may become pregnant, she must use effective contraception while taking Mycophenolate mofetil Sandoz 500 mg coated tablets. This applies to:
the period before starting treatment with Mycophenolate mofetil Sandoz 500 mg coated tablets;
the entire treatment period with Mycophenolate mofetil Sandoz 500 mg coated tablets;
6 weeks after stopping treatment with Mycophenolate mofetil Sandoz 500 mg coated tablets.
Discuss with the doctor the most suitable method of contraception. The choice will depend on the individual situation of the patient. It is recommended that the patient uses two methods of contraception, as this will reduce the risk of unintended pregnancy. Contact the doctor as soon as possible if the patient thinks that contraception may not be effective or if the patient has missed a contraceptive pill.
The patient is not able to become pregnant if any of the following criteria apply:
she is postmenopausal, i.e., over 50 years old and has not had a menstrual period for over a year (if menstrual periods have stopped due to cancer treatment, there is still a possibility of becoming pregnant);
she has had her fallopian tubes and both ovaries removed (bilateral salpingo-oophorectomy);
she has had her uterus removed (hysterectomy);
her ovaries have stopped working (premature ovarian failure confirmed by a gynecologist);
she was born with one of the following rare disorders that result 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 Mycophenolate mofetil Sandoz 500 mg coated tablets

Available data do not indicate an increased risk of miscarriage or birth defects in the child if the father is taking mycophenolate. However, this risk cannot be completely ruled out. As a precaution, it is recommended that the patient or his partner use effective contraception during treatment and for 90 days after stopping treatment.
If planning a child, discuss with the doctor the risk and other treatment options.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine. The doctor will discuss with the patient the risk associated with pregnancy and alternative treatments that can be used to prevent rejection of the transplanted organ, if:
the patient plans to become pregnant
the patient knows or suspects that she has not had a menstrual period, has had unusual menstrual bleeding, or suspects she may be pregnant
has had unprotected sex.
If the patient becomes pregnant while taking Mycophenolate mofetil Sandoz 500 mg coated tablets, she should inform her doctor about the pregnancy as soon as possible, without stopping treatment until she has seen her doctor.

Pregnancy

Mycophenolate frequently causes miscarriages (50%) and birth defects (23-27%) in the fetus. Reported birth defects include ear, eye, facial (cleft lip/palate), finger, heart, esophagus (the part connecting the throat to the stomach), kidney, and nervous system (e.g., spina bifida, where the spine bones are not properly formed) abnormalities. The child may have more than one abnormality.
Women of childbearing age must have a negative pregnancy test before starting treatment and follow the doctor's instructions for contraception. The doctor may consider it necessary to perform more than one test to rule out pregnancy before starting treatment with this medicine.

Breastfeeding

Mothers who are breastfeeding should not take Mycophenolate mofetil Sandoz 500 mg coated tablets, as small amounts of the medicine may pass into breast milk.

Driving and using machines

Mycophenolate mofetil has a moderate effect on the ability to drive and use machines. If the patient feels drowsy, numb, or confused, they should tell their doctor or nurse and not drive or operate tools or machines until they feel better.

Mycophenolate Mofetil Sandoz 500 mg coated tablets contain sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to take Mycophenolate Mofetil Sandoz 500 mg coated tablets

Always take this medicine exactly as the doctor has told you. If you are not sure, ask your doctor or pharmacist.

How much to take

The dose of the medicine depends on the type of transplant the patient has received. The usual doses are shown below. Treatment will continue for as long as it is necessary to suppress the immune system to prevent rejection of the transplanted organ.

Kidney transplant

Adults
The first dose is given within 3 days after transplantation.
The daily dose is 4 tablets (2 g of medicine), taken in two separate doses.
2 tablets are taken in the morning and 2 tablets in the evening.
Children and adolescents (aged 2 to 18 years)
The dose will vary depending on the size of the child.
The doctor will decide the most suitable dose based on the child's height and weight [body surface area (expressed in square meters, m)].
The recommended dose is 600 mg/m² of body surface area of the child, taken twice a day.

Heart transplant

Adults
The first dose is given within 5 days after transplantation.
The daily dose is 6 tablets (3 g of medicine), taken in two separate doses.
3 tablets are taken in the morning and 3 tablets in the evening.
Children
There is no available data on the use of mycophenolate mofetil in children after heart transplantation.

Liver transplant

Adults
The first dose of mycophenolate mofetil is given orally at least 4 days after transplantation and when the patient is able to take oral medicines.
The daily dose is 6 tablets (3 g of medicine), taken in two separate doses.
3 tablets are taken in the morning and 3 tablets in the evening.
Children
There is no available data on the use of mycophenolate mofetil in children after liver transplantation.
Use in special patient groups
Elderly patients
The recommended dose of 1 g twice daily for patients after kidney transplantation and 1.5 g twice daily for patients after heart or liver transplantation is suitable for elderly patients.

How to take the medicine

Swallow the tablets whole, with a glass of water.
Do not break or crush the tablets.

Taking more than the prescribed dose of Mycophenolate mofetil Sandoz 500 mg coated tablets

If the patient takes more tablets than prescribed by the doctor or if the medicine is accidentally taken by another person, they should immediately contact a doctor or go to the hospital.
Take the medicine packaging with them.

Missing a dose of Mycophenolate mofetil Sandoz 500 mg coated tablets

If the patient forgets to take a dose, they should take it as soon as possible. The next dose should be taken at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Mycophenolate mofetil Sandoz 500 mg coated tablets

Do not stop taking the medicine without the doctor's advice. Stopping treatment with mycophenolate mofetil may increase the risk of rejection of the transplanted organ.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In case of any of the following serious side effects, contact a doctor immediately, as urgent treatment may be needed:

signs of infection, such as fever or sore throat
unusual bruising or bleeding
rash, swelling of the face, lips, tongue, or throat with difficulty breathing – this may be a severe allergic reaction to the medicine (i.e., anaphylaxis, angioedema)

Common disorders

The most common disorders include: diarrhea, decreased white or red blood cell count, infection, and vomiting. The doctor will regularly order blood tests to check for any changes:
in blood cell count or signs of infection.
The risk of some side effects is higher in children than in adults. These include diarrhea, infections, decreased white blood cell count, and decreased red blood cell count.

Fighting infections

Mycophenolate mofetil Sandoz 500 mg coated tablets weaken the body's defense system. This action prevents the rejection of the transplant. As a result, the body is not able to fight infections as effectively as it normally would. This means a higher risk of infections than usual. These include infections of the brain, skin, mouth, stomach and intestines, lungs, and urinary system.

Lymphoma and skin cancer

As with medicines of this type (immunosuppressants), a very small number of patients taking Mycophenolate mofetil Sandoz 500 mg coated tablets have developed lymphoma and skin cancer.

Systemic side effects

Systemic side effects (affecting the whole body) are possible. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling extremely tired, sleep disturbances, pain (e.g., stomach, chest, joint, or muscle), headache, flu-like symptoms, and swelling.
Other side effects:
Skin disorders, such as:
acne, herpes, shingles, skin changes, hair loss, rash, itching
Urinary disorders, such as:
blood in the urine
Gastrointestinal and mouth disorders, such as:
gum hypertrophy and oral ulcers
pancreatitis, colitis, or gastritis
gastrointestinal disorders, including bleeding,
liver function disorders
diarrhea, constipation, nausea, indigestion, loss of appetite, bloating
Nervous system disorders, such as:
dizziness, drowsiness, or numbness
tremors, muscle spasms, seizures
anxiety or depression, mood changes, or thinking disorders
Heart and blood vessel disorders, such as:
changes in blood pressure, rapid heartbeat, vasodilation
Respiratory disorders, such as:
pneumonia, bronchitis
shortness of breath, cough (which may be caused by bronchiectasis – a condition in which the airways are abnormally widened) or pulmonary fibrosis (scarring of the lungs). If you have a persistent cough or shortness of breath, tell your doctor.
fluid in the lungs or around the chest
sinus disorders
Other disorders, such as:
weight loss, gout, high blood sugar, bleeding, bruising

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Mycophenolate Mofetil Sandoz 500 mg coated tablets

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or label after EXP. The expiry date refers to the last day of the month stated.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Mycophenolate mofetil Sandoz 500 mg coated tablets contain

• The active substance is mycophenolate mofetil. Each coated tablet contains 500 mg of mycophenolate mofetil.
• The other ingredients are: microcrystalline cellulose, povidone, talc, magnesium stearate, sodium croscarmellose. Coating: Opadry 20B50135: hypromellose, hydroxypropylcellulose, titanium dioxide (E171), macrogol 400; iron oxide black (E172), iron oxide red (E172).

What Mycophenolate mofetil Sandoz 500 mg coated tablets look like and contents of the pack

The tablets are lavender-colored, biconvex, and smooth on both sides.
Blisters of PVC/PE/PVDC/Aluminum in a cardboard box contain 50 coated tablets.
An HDPE bottle with a PP cap in a cardboard box contains 50 or 150 coated tablets.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek S.A.
Domaniewska 50 C
02-791 Warsaw
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia

To obtain more detailed information on this medicine and its names in other European Economic Area countries, contact:

Sandoz Polska Sp. z o.o.
Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:10/2021
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