Micophenolate mofetil Sandoz 250 mg kapsuvki tvarde

Leaflet attached to the packaging: patient information

Mycophenolate mofetil Sandoz 250 mg hard capsules

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 250 mg hard capsules are and what they are 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 are and what they are used for

used
Mycophenolate mofetil Sandoz 250 mg hard capsules contain mycophenolate mofetil. It belongs to the group of immunosuppressivemedicines. Mycophenolate mofetil Sandoz 250 mg hard capsules are used to prevent the body from rejecting a transplanted organ: kidney, heart, or liver.
Mycophenolate mofetil Sandoz 250 mg hard capsules are used in combination with other medicines: cyclosporine and corticosteroids.

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

hard
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) especially the effect 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 250 mg hard capsules

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 250 mg hard capsules, discuss the following with your doctor:
if the patient has symptoms of infection, such as fever, sore throat;
if the patient has unexpected bruising and/or bleeding;
if the patient has had gastrointestinal problems in the past, such as stomach ulcers;
if the patient plans to become pregnant or becomes pregnant while taking Mycophenolate mofetil Sandoz 250 mg hard capsules.
If any of the above points apply to the patient, consult a doctor or pharmacist before taking Mycophenolate mofetil Sandoz 250 mg hard capsules.

Sunlight effects

Mycophenolate mofetil Sandoz 250 mg hard capsules 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 that covers the head, neck, arms, and legs;
sunscreen with a high protection factor.

Mycophenolate Mofetil Sandoz 250 mg hard capsules and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription and herbal medicines. This is because Mycophenolate mofetil Sandoz 250 mg hard capsules and some other medicines may affect each other's action.
In particular, before starting to take this medicine, inform your doctor or pharmacist if you are 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 (used to treat conditions related to stomach acid, 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 you need to be vaccinated (with a live vaccine) while taking Mycophenolate mofetil Sandoz 250 mg hard capsules, consult your doctor or pharmacist first. The doctor will advise you on which vaccinations are suitable for you.
Do not donate blood while taking Mycophenolate mofetil Sandoz 250 mg hard capsules and for at least 6 weeks after stopping treatment. Men should not donate sperm while being treated and for 90 days after stopping treatment.

Mycophenolate Mofetil Sandoz 250 mg hard capsules with food and drink

Food and drink do not affect the 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 the patient is of childbearing age and may become pregnant, she must use effective contraception while taking Mycophenolate mofetil Sandoz 250 mg hard capsules. This applies to:
the period before starting treatment with Mycophenolate mofetil Sandoz 250 mg hard capsules;
the entire treatment period with Mycophenolate mofetil Sandoz 250 mg hard capsules;
6 weeks after stopping treatment with Mycophenolate mofetil Sandoz 250 mg hard capsules.
Discuss with your 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. Consult your doctor as soon as possible if you think your contraception may not be effective or if you have missed a contraceptive pill.
The patient is not able to become pregnant if she meets any of the following criteria:
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 specialist);
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 250 mg hard capsules

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 Mycophenolate mofetil Sandoz 250 mg hard capsules.
Plan to have a child and discuss with your 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 organ rejection if:
the patient plans to become pregnant;
the patient knows or suspects that she has not had a menstrual period, or her menstrual bleeding has been unusual, or she suspects she may be pregnant;
she has had unprotected sex.
If the patient becomes pregnant while taking Mycophenolate mofetil Sandoz 250 mg hard capsules, she should inform her doctor about the pregnancy as soon as possible, without stopping treatment until she visits her doctor.

Pregnancy

Mycophenolate frequently causes miscarriages (50%) and birth defects (23-27%) in the fetus. The 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 pregnancy test to rule out pregnancy before starting treatment.

Breastfeeding

Mothers 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 effect on the ability to drive and use tools or machines. If the patient feels drowsy, numbness, or confusion, they should tell their doctor or nurse and not drive or operate tools or machines until they feel better.

Mycophenolate Mofetil Sandoz 250 mg hard capsules contain sodium

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

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

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, 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 organ rejection.

Kidney transplant

Adults
The first dose is given within 3 days after transplantation.
The daily dose is 8 capsules (2 g of medicine), taken in two separate doses.
4 capsules are 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 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/m of the child's body surface area, taken twice a day.

Heart transplant

Adults
The first dose is given within 5 days after transplantation.
The daily dose is 12 capsules (3 g of medicine), taken in two separate doses.
6 capsules are taken in the morning and 6 capsules in the evening.
Children
There is no available data on the use of mycophenolate in children after heart transplantation.

Liver transplant

Adults
The first dose of mycophenolate is given orally after at least 4 days after transplantation and when the patient is able to take oral medicines.
The daily dose is 12 capsules (3 g of medicine), taken in two separate doses.
6 capsules are taken in the morning and 6 capsules in the evening.
Children
There is no available data on the use of mycophenolate in children after liver transplantation.

How to take the medicine

Swallow the capsules whole, with a glass of water.
Do not break or crush the capsules. Do not take capsules that have been broken, opened, or cracked.
Be careful not to get the powder from the capsule in your eyes or mouth.
If the powder gets into your eyes or mouth, rinse it with plenty of plain water.
Be careful not to get the powder from the capsule on your skin.
If the powder accidentally comes into contact with your skin, wash the affected area thoroughly with soap and water.

Taking a higher dose of Mycophenolate mofetil Sandoz 250 mg hard capsules than recommended

If you take more capsules than your doctor recommended or if someone else takes your medicine by mistake, go to your doctor or hospital immediately. Take the medicine packaging with you.

Missing a dose of Mycophenolate mofetil Sandoz 250 mg hard capsules

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 treatment with Mycophenolate mofetil Sandoz 250 mg hard capsules

Do not stop taking the medicine without your doctor's advice. Stopping treatment with mycophenolate may increase the risk of organ rejection.
If you have any further questions about taking 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.

If you notice any of the following serious side effects, contact your doctor immediately, as you may need urgent medical attention:

• symptoms 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 (anaphylaxis, angioedema).

Common disorders

The most common disorders include: diarrhea, decreased white or red blood cell count, infection, and vomiting. Your 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 weakens the body's defense system. This action prevents organ rejection. 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, intestines, lungs, and urinary system.

Lymphoma and skin cancer

In a very small number of patients treated with mycophenolate mofetil, lymphoma and skin cancer have developed, which can occur in patients taking this type of medicine (immunosuppressive).

Systemic side effects

The patient may experience systemic side effects. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling very 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 thickening, hair loss, rash, itching.
Urinary disorders, such as blood in the urine.
Gastrointestinal and mouth disorders, such as gum swelling and mouth ulcers;
pancreatitis, colon, or stomach inflammation;
gastrointestinal disorders, including bleeding;
liver 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 heart rate, vasodilation.
Respiratory disorders, such as pneumonia, bronchitis;
shortness of breath, cough, which may be caused by bronchiectasis (a condition where the airways are abnormally enlarged) or pulmonary fibrosis (scarring of the lungs). You should tell your doctor if you have persistent cough or shortness of breath;
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

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 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. This will help protect the environment.

6. Contents of the pack and other information

What Mycophenolate mofetil Sandoz 250 mg hard capsules contain

• The active substance is mycophenolate mofetil. Each capsule contains 250 mg of mycophenolate mofetil.
• The other ingredients are: cornstarch, 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 pack with PVC/PE/PVDC/Aluminum foil in a carton: 50 and 100 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
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

For more information about this medicine and its names in other European Economic Area countries, contact:

Sandoz Polska Sp. z o. o.
ul. Domaniewska 50 C
02-672 Warsaw
Tel. 22 209 70 00
Date of last revision of the leaflet:08/2021
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