500 mg film-coated tablets
mycophenolate mofetil
What Mycophenolate mofetil Sandoz is and what it is used for
Mycophenolate mofetil Sandoz contains mycophenolate mofetil. It belongs to a group of medicines called “immunosuppressants”.
Mycophenolate mofetil Sandoz is used to preventing the body from rejecting a transplanted organ:
- Kidney, heart or liver.
Mycophenolate mofetil Sandoz should be used with other medicines:
- Ciclosporin and corticosteroids .
Mycophenolate mofetil contained in Mycophenolate mofetil Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Mycophenolate mofetil Sandoz
WARNING
Mycophenolate causes congenital developmental disorders and miscarriages. If you are a woman and may become pregnant, you must show a negative pregnancy test before starting treatment. In addition, you must follow your doctor’s instructions on contraception.
Your doctor will talk to you and give you written information, especially about the effects mycophenolate has on the fetus. Read the information carefully and follow the instructions.
If you do not understand all the instructions, ask your doctor to explain them again before taking mycophenolate. See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.
Do not take Mycophenolate mofetil Sandoz :
- if you are allergic to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of this medicine (listed in section 6)
- if you are a woman and may become pregnant and have not taken a negative pregnancy test before receiving your first prescription, as mycophenolate causes birth defects and miscarriages
- if you are pregnant, planning to become pregnant or think you may be pregnant
- if you are not using effective contraception (see Pregnancy, contraception and breastfeeding)
- if you are breast-feeding.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Mycophenolate mofetil Sandoz.
Warnings and cautions
Talk to your doctor immediately before using Mycophenolate mofetil Sandoz:
- if you have signs of infection , e.g. fever or sore throat
- if you have any unexpected bruising and / or bleeding
- if you have or have had problems in the gastrointestinal tract, e.g. gastric ulcer
- if you are planning to become pregnant or become pregnant while you or your partner are using Mycophenolate mofetil Sandoz.
If any of the above applies to you (or you are not sure), talk to your doctor immediately before taking Mycophenolate mofetil Sandoz.
Effect of sunlight
Mycophenolate mofetil Sandoz reduces the body’s immune system. A consequence of this is an increased risk of skin cancer. Limit the amount of sunlight and UV radiation you are exposed to by:
- Wear protective clothing that also covers the head, neck, arms and legs
- use sunscreen with a high protection factor.
Other medicines and Mycophenolate mofetil Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter medicines, including herbal preparations. This is because Mycophenolate mofetil Sandoz can affect the way some other medicines work. Other medicines may also affect the way Mycophenolate mofetil Sandoz works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines before starting Mycophenolate mofetil Sandoz:
- azathioprine or other drugs that weaken the immune system – given after an organ transplant
- Cholestyramine – used in the treatment of high cholesterol
- rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB)
- antacids or proton pump inhibitors – used for stomach acid problems such as indigestion
- phosphate-binding drug – used in chronic kidney failure to reduce the amount of phosphate absorbed into the blood
- antibiotics – used to treat bacterial infections
- isavuconazole – used to treat fungal infections
- telmisartan – used to treat high blood pressure .
Vaccines
If you need to be vaccinated (with live vaccine) while taking Mycophenolate mofetil Sandoz, talk to your doctor or pharmacist first. Your doctor will advise you on which vaccines you can get.
You must not donate blood during treatment with Mycophenolate mofetil Sandoz and for at least 6 weeks after stopping treatment. Men should not donate semen during treatment with Mycophenolate mofetil Sandoz and for at least 90 days after stopping treatment.
Mycophenolate mofetil Sandoz with food and drink
Consumption of food and drink does not affect treatment with Mycophenolate mofetil Sandoz.
Pregnancy, contraception and breastfeeding
Use of contraceptives in women taking Mycophenolate mofetil Sandoz
If you are a woman and could become pregnant, you must use an effective method of contraception with Mycophenolate mofetil Sandoz. This applies:
- before starting treatment with Mycophenolate mofetil Sandoz
- throughout treatment with Mycophenolate mofetil Sandoz
- for six weeks after stopping treatment with Mycophenolate mofetil Sandoz.
Talk to your doctor about the most suitable contraceptives for you. It depends on your situation. Two forms of contraception are preferred as it reduces the risk of accidental pregnancy. Contact your doctor immediately if you think your contraceptive has not worked or if you have forgotten to take your contraceptive pill.
Women who meet any of the following criteria cannot become pregnant:
- if you have passed menopause, ie. is at least 50 years old and has had your last period more than a year ago (if your period has stopped due to treatment for cancer, there is still a chance that you may become pregnant)
- if your fallopian tubes and both ovaries have been removed (bilateral salpingo -oophorectomy )
- if your uterus has been operated on ( hysterectomy )
- if your ovaries have stopped working (premature menopause determined by a gynecologist)
- if you have been born with any of the following rare conditions that lead to inability to conceive: XY genotype, Turner syndrome , or congenital absence of uterus
- if you are a child or teenager who has not yet had your period.
Use of contraceptives in men taking Mycophenolate mofetil Sandoz
Available data do not indicate an increased risk of birth defects or miscarriage if the father takes mycophenolate. However, the risk can not be completely ruled out. As a precautionary measure, it is recommended that you or your female partner use reliable contraception during treatment and for a further 90 days after stopping Mycophenolate mofetil Sandoz.
If you are planning to have a baby, talk to your doctor about the potential risks and alternative treatments.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about the risks of pregnancy and alternative treatments you can take to prevent rejection of your transplanted organ if:
- you are planning to get pregnant
- you have missed or think you have missed a period, if you have unusual menstrual bleeding or if you think you are pregnant
- you have sex without using a safe method of contraception.
If you become pregnant during treatment with mycophenolate, you must inform your doctor immediately. However, continue to take Mycophenolate mofetil Sandoz until you see your doctor.
Pregnancy
Mycophenolate causes a very high frequency of miscarriages (50%) and severe birth defects (23–27%) in the unborn baby. Fetal injuries that have been reported are malformations of the ears, eyes, and face (cleft lip/palate), fingers, heart, esophagus (the tube that connects the pharynx to the stomach), and the kidneys and the nervous system (eg spinal hernia, where the vertebrae in the spine do not are properly developed). Your child may have one or more of these birth defects.
If you are a woman and could become pregnant, you must perform a negative pregnancy test before starting treatment and follow your doctor’s instructions on contraception. Your doctor may ask you to do more than one test to make sure you are not pregnant before starting treatment.
Breast-feeding
Do not take Mycophenolate mofetil Sandoz if you are breastfeeding. This is because small amounts of the drug can pass into breast milk.
Driving and using machines
Mycophenolate mofetil Sandoz has a moderate effect on your ability to drive or use tools or machines. If you feel drowsy, numb, or confused, talk to your doctor or nurse and do not drive or use any tools or machines until you feel better.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Mycophenolate mofetil Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose unit, ie essentially ‘sodium-free’.
How to take Mycophenolate mofetil Sandoz
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How much to take
The amount you should take depends on the type of transplant you have received. The usual dose is shown below. Treatment should continue for as long as you need 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 the medicine) divided into 2 separate doses .
- Take 2 tablets in the morning and 2 tablets in the evening.
Children (2-18 years):
- The dose one is given varies depending on the size of the child.
- Your doctor will determine the most appropriate dose based on your child’s height and weight (body area – measured as square meters or m 2 ). The recommended dose is 600 mg / m 2 twice daily.
Special patient groups
Older
The recommended dose for elderly patients is 1 g twice daily for kidney transplantation and 1.5 g twice daily for heart or liver transplantation.
Heart transplant
Adults
- The first dose is given within 5 days after transplantation.
- The daily dose is 6 tablets (3 g of the medicine) divided into 2 separate doses .
- Take 3 tablets in the morning and 3 tablets in the evening.
Children
There is no information on the use of Mycophenolate mofetil Sandoz in children with a heart transplant.
Liver transplantation
Adults
- The first dose of oral mycophenolate mofetil is given at the earliest 4 days after transplantation when you are able to swallow medicines.
- The daily dose is 6 tablets (3 g of the medicine) divided into 2 separate doses .
- Take 3 tablets in the morning and 3 tablets in the evening.
Children
There is no information on the use of Mycophenolate mofetil Sandoz in children with a liver transplant.
Taking the medicine
- Swallow your tablets whole along with a glass of water.
- Do not break or crush them.
If you take more Mycophenolate mofetil Sandoz than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Also, do this if someone else accidentally took your medicine. Bring the medicine pack.
If you forget to take Mycophenolate mofetil Sandoz
If you forget to take this medicine at any time, take your dose as soon as you remember. Then continue to take the medicine at the usual times. Do not take a double dose to make up for a forgotten dose.
If you stop taking Mycophenolate mofetil Sandoz
Do not stop taking Mycophenolate mofetil Sandoz unless your doctor tells you to. If you stop the treatment, the risk of rejection of the transplanted organ may increase.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Talk to a doctor immediately if you notice any of the following serious side effects – you may need urgent medical attention:
- you have signs of infection such as fever or sore throat
- you get unexpected bruising or bleeding
- you get a rash, swelling of the face, lips, tongue or pharynx with difficulty breathing – you may have a severe allergic reaction to the medicine (such as anaphylaxis , angioedema ).
Common side effects are
Some of the most common side effects are diarrhea, fewer white or red blood cells, infection, and vomiting. Your doctor will regularly take blood samples to check for changes in:
- the number of blood cells or signs of infection .
Children may get some side effects more easily than adults. This applies to e.g. diarrhea, infection, decrease in the number of white and red blood cells.
- Fight your infection
- Mycophenolate mofetil Sandoz reduces your body’s defenses. This prevents you from rejecting the graft . As a result, your body will not be as good at fighting infection as you used to be. This means that you can get more infection than normal. It includes infection in your brain, skin, mouth, stomach and intestines, lungs and urinary tract.
- Cancer of the lymph nodes and skin
- As may occur in patients taking this type of medicine (immunosuppressive agents), a very small number of Mycophenolate mofetil Sandoz patients have developed cancer of the lymph tissue and skin.
- General adverse effects
- You can get general side effects that affect your entire body. It includes severe allergic reactions (such as anaphylaxis , angioedema ), fever, feeling very tired, sleep disturbances, pain (such as in the stomach, chest, joints and muscles), headaches, flu symptoms and swelling.
- Other side effects may include:
- Skin side effects such as:
- acne , cold sores, shingles , skin growth, hair loss, rash, itching .
- Urinary tract side effects such as:
- blood in urine.
- Side effects are in the gastrointestinal tract and mouth such as:
- swelling of the gums and cold sores
- inflammation of the pancreas, colon or stomach
- intestinal diseases including bleeding
- liver disease
- diarrhea, constipation, nausea, indigestion, loss of appetite, gas tension.
- Side effects are in the central and peripheral nervous system such as:
- feeling of dizziness, drowsiness or numbness
- tremors, muscle twitching, seizures
- feeling anxious or depressed, changes in mood or thinking.
- Side effects in the heart and blood vessels such as:
- altered blood pressure , increasing heart rate, dilation of blood vessels.
- Lung side effects such as:
- pneumonia , tracheitis
- shortness of breath, cough which may be due to bronchiectasis (a condition in which the airways are abnormally dilated) or pulmonary fibrosis (scarring of the lungs). Tell your doctor if you develop persistent cough or shortness of breath.
- fluid in lungs or chest cavity
- problems with the sinuses.
- Other side effects are such as:
- weight loss, gout , high blood sugar, bleeding, bruising.
How to store Mycophenolate mofetil Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister, or label after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is mycophenolate mofetil. Each film-coated tablet contains 500 mg of mycophenolate mofetil.
- Other ingredients are:Core:Microcrystalline cellulose, povidone, talc, magnesium stearate, croscarmellose sodium.
Film coating:Hypromellose, hydroxypropylcellulose, titanium dioxide (E171), macrogol (400), black iron oxide (E172), red iron oxide (E172).
What the medicine looks like and contents of the pack
Mycophenolate mofetil Sandoz film-coated tablets are lavender-colored, film-coated, biconvex tablets that are smooth on both sides.
PVC / PE / PVDC / Alu-blister
Pack sizes: 50, 100, 120, 150, 180 or 250 film-coated tablets.
HDPE Jar
Pack sizes: 50 or 150 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany
or
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia
or
Lek Pharmaceuticals dd, Trimlini 2D, 9220 Lendeva, Slovenia
or
LEK SA, ul. Domaniewska 50 c, 02-672 Warsaw, Poland