Mycophenolate mofetil sandoz 250 mg hard capsules

Package leaflet: Information for the patient

Mycophenolate mofetil Sandoz 250 mg hard capsules
Mycophenolas mofetil
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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Mycophenolate mofetil Sandoz 250 mg hard capsules is and what it is used for
2. Important information before taking Mycophenolate mofetil Sandoz 250 mg hard capsules
3. How to take Mycophenolate mofetil Sandoz 250 mg hard capsules
4. Possible side effects
5. How to store Mycophenolate mofetil Sandoz 250 mg hard capsules
6. Contents of the pack and other information

1. What Mycophenolate mofetil Sandoz 250 mg hard capsules is and what it is used for

Mycophenolate mofetil Sandoz 250 mg hard capsules contains mycophenolate mofetil. It belongs to a group of medicines called immunosuppressants. Mycophenolate mofetil Sandoz 250 mg hard capsules is used to prevent rejection of a transplanted organ (kidney, heart or liver) by the patient's body.
Mycophenolate mofetil Sandoz 250 mg hard capsules is taken together with other medicines: cyclosporine and corticosteroids.

2. Important information before taking Mycophenolate mofetil Sandoz 250 mg hard capsules

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 risks of mycophenolate on the unborn child. Please read carefully the information provided by your doctor and follow the instructions.
If you do not fully understand the instructions, 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 take Mycophenolate mofetil Sandoz 250 mg hard capsules
Do not take this medicine if:

• you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid, or to 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 result before receiving the first prescription, because mycophenolate causes birth defects and miscarriage;
• you are pregnant or planning a pregnancy, or suspect you may be pregnant;
• you are a woman 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 Mycophenolate mofetil Sandoz 250 mg hard capsules, talk to your doctor immediately if:

• you have signs of infection, such as fever, sore throat;
• you have unexpected bruising and/or bleeding;
• you have ever had gastrointestinal problems, such as stomach ulcers;
• you are planning a pregnancy or become pregnant while you or your partner are taking Mycophenolate mofetil Sandoz 250 mg hard capsules.

If any of the above apply to you, consult your doctor or pharmacist before taking Mycophenolate mofetil Sandoz 250 mg hard capsules.

Effect of sunlight
Mycophenolate mofetil Sandoz 250 mg hard capsules weakens the body's natural defences, 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 250 mg hard capsules and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription and herbal medicines. This is because Mycophenolate mofetil Sandoz 250 mg hard capsules and certain other medicines may affect each other.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines before starting this medicine:

• azathioprine or other medicines that suppress the immune system (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);
• medicines that neutralize stomach acid or proton pump inhibitors (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 250 mg hard capsules, consult your doctor or pharmacist first. Your doctor will advise you on which vaccinations are appropriate for you.
You must not donate blood while taking Mycophenolate mofetil Sandoz 250 mg hard capsules and for at least 6 weeks after stopping the medicine. Men should not donate sperm during treatment and for at least 3 months after stopping the medicine.

Mycophenolate mofetil Sandoz 250 mg hard capsules with food and drink
Food and drink do not affect treatment with Mycophenolate mofetil Sandoz 250 mg hard capsules.

Pregnancy, contraception and breastfeeding

Contraception in women taking Mycophenolate mofetil Sandoz 250 mg hard capsules
If you are a woman of childbearing potential and could become pregnant, you must use an effective method of contraception during treatment with Mycophenolate mofetil Sandoz 250 mg hard capsules. This applies to the period:

• before starting Mycophenolate mofetil Sandoz 250 mg hard capsules;
• throughout the entire treatment period with Mycophenolate mofetil Sandoz 250 mg hard capsules;
• for 6 months after stopping Mycophenolate mofetil Sandoz 250 mg hard capsules.

Talk to your doctor about the most appropriate method of contraception. The choice will depend on your individual situation. 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 contraception may not be effective or if you missed a contraceptive pill.

You are considered unable to become pregnant if any of the following apply:

• you are postmenopausal, i.e. over 50 years old and have not had a menstrual period for over a year (if menstruation stopped due to cancer treatment, pregnancy is still possible);
• you have had surgery to remove both fallopian tubes and both ovaries (bilateral salpingo-oophorectomy);
• you have had a hysterectomy (surgical removal of the uterus);
• your ovaries have stopped working (premature ovarian failure confirmed by a gynaecologist 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 250 mg hard capsules
Available data do not indicate an increased risk of miscarriage or birth defects in children fathered by men 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 Mycophenolate mofetil Sandoz 250 mg hard capsules.
If you are planning a pregnancy, talk to your doctor about the risks and alternative treatments.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, 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 250 mg hard capsules, inform your doctor about the pregnancy as soon as possible, without stopping treatment until you see your doctor.

Pregnancy
Mycophenolate very frequently causes miscarriage (50%) and 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 spinal bones are not properly formed). The 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 on 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 250 mg hard capsules, as small amounts of the medicine may pass into breast milk.

Driving and using machines
Mycophenolate mofetil has a moderate influence on the ability to drive and use machines. If you feel drowsy, dizzy or confused, tell your doctor or nurse and do not drive or operate tools or machinery until you feel better.

Mycophenolate mofetil Sandoz 250 mg hard capsules contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to take Mycophenolate mofetil Sandoz 250 mg hard capsules

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
How much medicine should be taken
The dose of the medicine depends on the type of transplant the patient has received. The usual doses
are given 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 should be given within 3 days after transplantation.
The daily dose is 8 capsules (2 g of medicine), taken in two separate doses.
4 capsules should be taken in the morning and 4 capsules in the evening.
Children and adolescents (aged 2 to 18 years)
The dose will vary depending on the child's size.
The 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.
Heart transplant
Adults
The first dose should be given within 5 days after transplantation.
The daily dose is 12 capsules (3 g of medicine), taken in two separate doses.
6 capsules should be taken in the morning and 6 capsules in the evening.
Children
There are no available data on the use of mycophenolate in children after heart transplantation.
Liver transplant
Adults
The first oral dose of mycophenolate should be given at least 4 days after transplantation and when the patient is able to take oral medication.
The daily dose is 12 capsules (3 g of medicine), taken in two separate doses.
6 capsules should be taken in the morning and 6 capsules in the evening.
Children
There are no available data on the use of mycophenolate in children after liver transplantation.
How to take the medicine
The capsules should be swallowed whole with a glass of water.
Do not break or crush the capsules. Do not take capsules that have been cracked, opened or broken.
Take care to avoid contact of the capsule powder with the eyes or mouth.
If the powder gets into the eyes or mouth, rinse thoroughly with plenty of clean, plain water.
Take care to avoid contact of the capsule powder with the skin.
If accidental contact with the skin occurs, wash off any traces of powder from the skin thoroughly with soap and water.
Taking more than the recommended dose of Mycophenolate mofetil Sandoz 250 mg hard capsules
If you take more capsules than prescribed by your doctor, or if the medicine is accidentally taken
by someone else, seek medical advice immediately or go directly to a hospital.
Take the medicine packaging with you.
Missing a dose of Mycophenolate mofetil Sandoz 250 mg hard capsules
If you forget to take your medicine, take the missed dose as soon as you remember.
Take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
Stopping Mycophenolate mofetil Sandoz 250 mg hard capsules
Do not stop taking this medicine without consulting your doctor. Stopping treatment with mycophenolate
may increase the risk of rejection of the transplanted organ.
If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, 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 commonly observed disorders include: diarrhoea, decreased number of white or
red blood cells, infection and vomiting. Your doctor will regularly order blood tests to
monitor any changes:
blood cell counts or signs of infection.
The likelihood of certain adverse reactions occurring in children is higher than
in adults. These include diarrhoea, infections, decreased number of white blood cells and decreased
number of red blood cells.
Fighting infections
Mycophenolate mofetil weakens the body's immune system. This effect helps prevent transplant rejection. However, as a result, the body is less able to fight infections as effectively as under normal conditions. This means there is an increased risk of infections, which may occur more frequently than usual. Such infections may affect the brain, skin, mouth, stomach and intestines, lungs and urinary system.
Lymphoid tissue and skin tumours
In a very small number of patients treated with mycophenolate mofetil, lymphoid tissue and skin tumours have developed, which may occur in patients taking this type of medicine (immunosuppressive).
Systemic adverse reactions
Systemic adverse reactions may occur in patients. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling of extreme 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, shingles, skin hypertrophy, hair loss, rash, itching.
Urinary system disorders, such as
presence of blood in urine.
Gastrointestinal and oral disorders, such as
gum swelling and oral ulceration;
pancreatitis, colitis or gastritis;
gastrointestinal disorders, including bleeding,
liver disorders;
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;
dyspnoea, cough, which may be caused by bronchiectasis (a condition in which the airways are abnormally widened) or pulmonary fibrosis (scarring of the lungs). Inform your doctor if the patient develops a persistent cough or shortness of breath.
fluid in the lungs or around 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 Reactions of Medicinal Products 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 250 mg hard capsules

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Mycophenolate mofetil Sandoz 250 mg hard capsules contains

• The active substance is mycophenolate mofetil. Each capsule contains 250 mg of mycophenolate mofetil.
• The other ingredients are: pregelatinized starch, sodium croscarmellose, povidone, magnesium stearate, gelatin, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), indigo carmine (E 132).

What Mycophenolate mofetil Sandoz 250 mg hard capsules look like and contents of the pack
Hard gelatin capsules (size 1) with a blue, opaque cap and an orange, opaque body.
Blister packs made of PVC/PE/PVDC/Aluminium in cardboard packaging: 50 and 100 capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Tel. +48 22 209 70 00

Manufacturers
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Trade names in other European Economic Area (EEA) countries
Czech Republic: MYCOPHENOLAT MOFETIL SANDOZ 250 mg
Spain: Micofenolato de mofetilo Sandoz 250 mg cápsulas duras EFG
Ireland: Mycolat 250 mg hard capsules
Northern Ireland: Mycophenolate mofetil Sandoz 250 mg capsules, hard
Germany: Mycophenolat - 1 A Pharma 250 mg Hartkapseln
Poland: Mycophenolate mofetil Sandoz 250 mg kapsułki twarde