Mycophenolate mofetil sandoz 500 mg coated tablets

Package leaflet: Information for the patient

Mycophenolate mofetil Sandoz 500 mg film-coated tablets
Mycophenolas mofetil
Please read this entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Mycophenolate mofetil Sandoz 500 mg film-coated tablets are and what they are used for

Mycophenolate mofetil Sandoz 500 mg film-coated tablets contain mycophenolate mofetil. It belongs to a group of medicines called immunosuppressants. Mycophenolate mofetil Sandoz 500 mg film-coated tablets are used to prevent rejection of a transplanted organ (kidney, heart, or liver) by the patient's body.
Mycophenolate mofetil Sandoz 500 mg film-coated tablets should be taken together with other medicines: cyclosporine and corticosteroids.

2. Important information before taking Mycophenolate mofetil Sandoz 500 mg film-coated tablets

WARNING
Mycophenolate causes birth defects and miscarriage. Women of childbearing potential must have a negative pregnancy test before starting treatment and must follow medical advice regarding contraception.
Your doctor will discuss with you (and provide written information) about the specific effects of mycophenolate on the unborn child.
Please read the information provided by your doctor carefully and follow the instructions.
If any part of the instructions is not fully understood, please ask your doctor for clarification before taking mycophenolate. You should also read the further information provided in the sections "Warnings and precautions" and "Pregnancy, contraception and breastfeeding".

When not to use Mycophenolate mofetil Sandoz 500 mg film-coated tablets
Do not take this medicine if:

• you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid, or any of the other ingredients of this medicine (listed in section 6);
• you are a woman who could become pregnant and have not had a negative pregnancy test before receiving the first prescription for this medicine, as mycophenolate causes birth defects and miscarriage;
• you are pregnant or planning to become pregnant, or suspect you may be pregnant;
• you are not using effective contraception (see "Pregnancy, contraception and breastfeeding");
• you are breastfeeding.

If any of the above apply to you, do not take this medicine. If in doubt, consult your doctor or pharmacist before taking the medicine.

Warnings and precautions
Before starting treatment with Mycophenolate mofetil Sandoz 500 mg film-coated tablets, consult your doctor immediately if:

• you have any signs of infection, such as fever or sore throat;
• you experience unexpected bruising or bleeding;
• you have had previous gastrointestinal problems, such as stomach ulcers;
• you are planning a pregnancy, or if you or your partner become pregnant while taking Mycophenolate mofetil Sandoz 500 mg film-coated tablets.

If any of the above apply to you (or if you are unsure), consult your doctor before taking Mycophenolate mofetil Sandoz 500 mg film-coated tablets.

Exposure to sunlight
Mycophenolate mofetil Sandoz 500 mg film-coated tablets weaken the body's immune defenses, increasing the risk of skin cancer. You should limit exposure to sunlight and ultraviolet (UV) radiation by:

• wearing protective clothing that covers the head, neck, arms, and legs;
• using sunscreen with a high sun protection factor.

Mycophenolate mofetil Sandoz 500 mg film-coated tablets and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines and herbal remedies. This is because Mycophenolate mofetil Sandoz 500 mg film-coated tablets and certain other medicines may interact with each other. In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• azathioprine or other immunosuppressive medicines (given to transplant patients);
• cholestyramine (a medicine used to treat high blood cholesterol levels);
• rifampicin (an antibiotic used to prevent and treat infections such as tuberculosis);
• antacids or proton pump inhibitors (medicines used to treat conditions related to stomach acid secretion, e.g. indigestion);
• 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 you need to be vaccinated (with a live vaccine) while taking Mycophenolate mofetil Sandoz 500 mg film-coated tablets, consult your doctor or pharmacist first. Your doctor will advise you on which vaccinations are appropriate.
You must not donate blood while taking Mycophenolate mofetil Sandoz 500 mg film-coated tablets and for at least 6 weeks after stopping the medicine. Men should not donate semen during treatment and for 3 months after stopping the medicine.

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

Pregnancy, contraception and breastfeeding

Contraception in women taking Mycophenolate mofetil Sandoz 500 mg film-coated tablets
If you are of childbearing age and could become pregnant, you must use an effective method of contraception during treatment with Mycophenolate mofetil Sandoz 500 mg film-coated tablets. This applies to the following periods:

• before starting treatment with Mycophenolate mofetil Sandoz 500 mg film-coated tablets;
• during the entire course of therapy with Mycophenolate mofetil Sandoz 500 mg film-coated tablets;
• for 6 months after stopping treatment with Mycophenolate mofetil Sandoz 500 mg film-coated tablets.

Discuss with your doctor the most appropriate method of contraception. The choice will depend on your individual circumstances. It is best to use two methods of contraception, as this reduces the risk of unintended pregnancy. You should contact your doctor as soon as possible if you think your contraception may not be effective or if you have missed taking a contraceptive pill.

You are not able to become pregnant if any of the following criteria apply to you:

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

Contraception in men taking Mycophenolate mofetil Sandoz 500 mg film-coated tablets
Available data do not indicate an increased risk of miscarriage or birth defects in children when the father is taking mycophenolate. However, this risk cannot be completely ruled out. As a precaution, it is recommended that you or your partner use effective contraception during treatment and for 3 months after stopping treatment.
If you are planning a pregnancy, discuss the risks and alternative treatments with your doctor.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss with you the risks associated with pregnancy and alternative treatments that can be used to prevent rejection of the transplanted organ if:

• you are planning a pregnancy;
• you know or suspect you have missed a period, your menstrual bleeding has been unusual, or you suspect you may be pregnant;
• you have had sexual intercourse without effective contraceptive protection.

If you become pregnant while taking Mycophenolate mofetil Sandoz 500 mg film-coated tablets, inform your doctor as soon as possible, but do not stop treatment until you have seen your doctor.

Pregnancy
Mycophenolate very frequently causes miscarriages (50%) and birth defects (23–27%) in the unborn child. Reported birth defects include abnormalities of the ears, eyes, face (cleft lip/palate), finger development, heart, oesophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g. spina bifida, where the spinal bones are not properly formed). A child may have more than one birth defect.
Women of childbearing potential must have a negative pregnancy test before starting treatment and must follow their doctor's advice regarding contraception. Your doctor may consider it necessary to perform more than one pregnancy test to exclude pregnancy before starting treatment.

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

Driving and operating machinery
Mycophenolate mofetil has a moderate effect on the ability to drive and operate tools or machines. If you experience drowsiness, dizziness, or confusion, inform your doctor or nurse and do not drive or operate tools or machines until you feel better.

Mycophenolate mofetil Sandoz 500 mg film-coated tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Mycophenolate mofetil Sandoz 500 mg film-coated tablets

Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

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

Kidney transplantation
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.
Take 2 tablets in the morning and 2 tablets in the evening.

Children and adolescents (aged 2 to 18 years)
The dose will vary depending on the child's size.
Your doctor will decide the most appropriate dose based on the child's height and body weight [body surface area (expressed in square meters, m²)].
The recommended dose is 600 mg/m² of body surface area, taken twice daily.

Use in special patient groups
Elderly patients
The recommended dose of 1 g twice daily for kidney transplant recipients and 1.5 g twice daily for heart or liver transplant recipients is appropriate for elderly patients.

Heart transplantation
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.
Take 3 tablets in the morning and 3 tablets in the evening.

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

Liver transplantation
Adults
The first oral dose of mycophenolate mofetil is given at least 4 days after transplantation and when the patient is able to take oral medication.
The daily dose is 6 tablets (3 g of medicine), taken in two separate doses.
Take 3 tablets in the morning and 3 tablets in the evening.

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

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

If you take more Mycophenolate mofetil Sandoz 500 mg film-coated tablets than prescribed
If you take more tablets than prescribed by your doctor or if the medicine is accidentally taken by someone else, seek medical advice immediately or go directly to hospital.
Take the medicine pack with you.

If you forget to take Mycophenolate mofetil Sandoz 500 mg film-coated tablets
If you forget to take a dose, take it as soon as you remember. Take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping Mycophenolate mofetil Sandoz 500 mg film-coated tablets
Do not stop taking this medicine without your 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, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur, contact your doctor immediately,
as urgent treatment may be required:
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. anaphylactic reaction, angioedema)
Common disorders
The most frequently occurring disorders include: diarrhoea, reduced number of white or
red blood cells, infection, and vomiting. Your doctor will regularly order blood tests to
monitor for any changes in blood cell counts or signs of infection.
The likelihood of certain adverse reactions occurring is higher in children than in adults.
These include diarrhoea, infections, reduced white blood cell count, and reduced red blood cell count.
Fighting infections
The medicine Mycophenolate mofetil Sandoz 500 mg tablets, film-coated weakens the body's immune system.
This effect helps prevent transplant rejection. However, as a result, the body is less able to
fight infections effectively than under normal conditions. This means there is an increased risk
of infections occurring more frequently than usual. These include infections of the brain, skin,
mouth, stomach and intestines, lungs, and urinary tract.
Lymphoid tissue and skin tumours
As with other medicines of this type (which suppress immune system function),
a very small number of patients taking Mycophenolate mofetil Sandoz 500 mg tablets, film-coated
have developed tumours of lymphoid tissue and skin.
Systemic adverse reactions
Systemic adverse reactions (affecting the entire patient's body) may occur.
These include severe allergic reactions (such as anaphylaxis, angioedema), fever,
a strong feeling of fatigue, sleep disturbances, pain (e.g. stomach, chest, joints, or muscles),
headache, flu-like symptoms, and oedema.
Other adverse reactions:
Skin disorders, such as:
acne, herpes simplex, shingles, skin changes, hair loss, rash, itching
Urinary tract disorders, such as:
presence of blood in urine
Gastrointestinal and oral disorders, such as:
swelling of the gums and oral ulceration
pancreatitis, colitis, or gastritis
gastrointestinal disorders, including bleeding,
liver function abnormalities
diarrhoea, constipation, nausea, dyspepsia, loss of appetite, bloating
Nervous system disorders, such as:
dizziness, drowsiness or numbness
tremor, muscle cramps, seizures
anxiety or depression, mood changes or cognitive disturbances
Cardiac and vascular disorders, such as:
changes in blood pressure, increased heart rate, vasodilation
Respiratory system disorders, such as:
pneumonia, bronchitis
shortness of breath, cough (which may be due to bronchiectasis – a condition in which the airways are abnormally widened) or pulmonary fibrosis (scarring of the lungs). If you experience persistent cough or shortness of breath, inform your doctor.
fluid in the lungs or within the chest cavity
sinus disorders
Other disorders, such as:
weight loss, gout, high blood sugar levels, bleeding, bruising
Reporting adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Mycophenolate mofetil Sandoz 500 mg tablets

Keep this 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 following EXP. The expiry date refers to the last day of the specified month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Mycophenolate mofetil Sandoz 500 mg film-coated tablets contain

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

What Mycophenolate mofetil Sandoz 500 mg film-coated tablets look like and contents of the pack
Packaging
Lavender-coloured film-coated tablets are biconvex, smooth on both sides.
Blister packs made of PVC/PE/PVDC/Aluminium in a cardboard box contain 50 film-coated tablets.
HDPE bottle with PP cap, in a cardboard box, contains 50 or 150 film-coated tablets.
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
tel. +48 22 209 70 00
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-791 Warsaw, Poland
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
Austria Mycophenolat Mofetil Sandoz 500 mg - Filmtabletten
Belgium Mycophenolat Mofetil Sandoz 500 mg filmomhulde tabletten
Czech Republic MYCOPHENOLAT MOFETIL SANDOZ 500 mg
Denmark Mycophenolatemofetil "Sandoz"
Finland Mycophenolate mofetil Sandoz 500 mg kalvopäällysteiset tabletit
France MYCOPHENOLATE MOFETIL SANDOZ 500 mg, comprimé pelliculé
Iceland Mycophenolate mofetil Sandoz 500 mg filmuhúðaðar töflur.
Italy MICOFENOLATO MOFETILE SANDOZ
Netherlands Mycofenolaat mofetil Sandoz 500 mg, filmomhulde tabletten
Poland Mycophenolate mofetil Sandoz 500 mg film-coated tablets
Romania MICOFENOLAT MOFETIL SANDOZ 500 mg comprimate filmate
Slovakia Mykofenolát mofetil Sandoz 500 mg filmom obalené tablety
Spain Micofenolato de mofetilo Sandoz 500 mg comprimidos recubiertos con película
EFG
Sweden Mycophenolate mofetil Sandoz 500 mg filmdragerade tabletter.
Ireland Mycophenolate mofetil Sandoz 500 mg Film-coated Tablets
Northern