250 mg mycophenolate mofetil capsules
Mycophenolic acid
What CellCept is and what it is used for
The full name of your medicine is CellCept 250 mg capsules.
- This leaflet uses the shorter name CellCept.
CellCept contains mycophenolate mofetil.
- It belongs to a group of medicines called “immunosuppressants”.
CellCept is used to prevent the body from rejecting a transplanted organ.
- Kidney, heart, or liver.
CellCept should be used with other medicines:
- Ciclosporin and corticosteroids .
2. What you need to know before you take CellCept
WARNING
Mycophenolate causes birth defects and miscarriages. If you are a woman and could become pregnant, you must show a negative pregnancy test before starting treatment and you must follow your doctor’s instructions on contraception.
Your doctor will talk to you and give you written information, in particular about the effects mycophenolate has on the fetus. Read the information carefully and follow the instructions. If you do not fully understand these 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 CellCept:
- If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid, or any of the other ingredients of this medicine (listed in section 6).
- If you are a woman and could become pregnant and have not performed a negative pregnancy test before receiving your first prescription, 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 CellCept.
Warnings and cautions
Tell your doctor immediately before starting treatment with CellCept:
- If you have signs of infection such as fever or sore throat
- If you have any unexpected bruising or bleeding
- If you have or have had digestive problems such as a stomach ulcer
- If you are planning to become pregnant or become pregnant while you or your partner are using CellCept.
If any of the above apply to you (or you are not sure), talk to your doctor immediately before starting treatment with CellCept.
Effect of sunlight
CellCept reduces the body’s defenses. A consequence of this is an increased risk of skin cancer. Limit the amount of sun and UV light you are exposed to. Do this by:
- Wear protective clothing that also covers your head, neck, arms, and legs
- use a sunscreen with a high protection factor.
Other medicines and CellCept
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
This includes over-the-counter medicines, such as herbal medicines. This is because CellCept can affect the way some other medicines work. Other medicines may also affect the way CellCept works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before starting CellCept:
- azathioprine or other medicines that weaken your immune system – given after a transplant operation
- 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 digestive problems
- phosphate-binding drug – used by people with 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 vaccines) while you are taking CellCept, talk to your doctor or pharmacist first. Your doctor must then advise you on which vaccines you can get.
You must not donate blood during treatment with CellCept and for at least 6 weeks after stopping treatment. Men are not allowed to donate semen during treatment with CellCept and for at least 90 days after stopping treatment.
CellCept with food and drink
Intake of food and drink has no effect on treatment with CellCept.
Pregnancy, contraception and breastfeeding
Use of contraceptives in women taking CellCept
If you are a woman and could become pregnant, you must use an effective method of contraception with CellCept. It includes:
- Before you start taking CellCept
- Throughout treatment with CellCept
- For 6 weeks after stopping treatment with CellCept.
Talk to your doctor about the most suitable contraceptives for you. It depends on your own 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 yourcontraceptive pill.
Women who meet any of the following criteria cannot become pregnant:
- You have passed menopause, ie at least 50 years old and your last period was more than a year ago (if your period has stopped due to treatment for cancer, there is a chance that you may become pregnant)
- Your fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy )
- Your uterus has had surgery ( hysterectomy )
- Your ovaries have stopped working (premature menopause determined by a gynecologist)
- You have been born with any of the following conditions that are rare and that lead to the inability to conceive: XY genotype, Turner syndrome or congenital absence of uterus
- You are a child or teenager who has not yet had your period.
Use of contraceptives in men taking CellCept
Available data do not indicate an increased risk of birth defects or miscarriages if the father takes mycophenolate. However, the risk cannot 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 CellCept.
If you are planning to have a baby, talk to your doctor about the potential risks and alternative treatments.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 what options you can take to prevent your transplanted organ from being rejected if:
- You are planning to get pregnant.
- You have skipped or think you have skipped 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, keep taking CellCept until you see him or her.
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 include malformations of the ears, eyes, face (cleft lip/palate), malformations in the development of the fingers, heart, esophagus (the tube that connects the pharynx to the stomach), kidneys, and nervous system (such as spinal hernias). 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 you must follow your doctor’s instructions on contraception. Your doctor may require more than one test to make sure you are not pregnant before starting treatment.
Breast-feeding
Do not take CellCept if you are breast-feeding. This is because small amounts of the drug can pass into breast milk.
Driving and using machines
CellCept 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.
This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.
3. How to take CellCept
Always take CellCept 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 transplant
Adults
- The first dose is given within 3 days after transplantation.
- The daily dose is 8 capsules (2 g of the medicine) taken as 2 separate doses.
- Take 4 capsules in the morning and 4 capsules in the evening.
Children (2 to 18 years)
- The dose one is given may vary 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.
Heart transplant
Adults
- The first dose is given within 5 days after transplantation.
- The daily dose is 12 capsules (3 g of the medicine) taken as 2 separate doses.
- Take 6 capsules in the morning and 6 capsules in the evening.
Children
- There is no information on the use of CellCept in children with a heart transplant.
Liver transplant
Adults
- You will receive the first dose of oral CellCept at the earliest 4 days after the transplant and when you are able to swallow the medicine.
- The daily dose is 12 capsules (3 g of the medicine) taken as 2 separate doses.
- Take 6 capsules in the morning and 6 capsules in the evening.
Children
- There is no information on the use of CellCept in children with a liver transplant.
Taking the medicine
Swallow your capsules whole along with a glass of water
- Do not break or crush them.
- Do not take capsules that are open or split.
Be careful not to let any powder from a broken capsule get into your eyes or mouth.
- If this happens, rinse thoroughly with plain water.
Be careful not to let powder from a broken capsule get on the skin.
- If this happens, wash the area thoroughly with soap and water.
If you take more CellCept than you should
If you take more CellCept than you should, talk to a doctor or see a hospital immediately. Also do this if someone else accidentally takes your medicine. Bring the medicine pack.
If you forget to take CellCept
If you forget to take this medicine at any time, take your dose as soon as you remember. Then continue to take it at the usual times. Do not take a double dose to make up for a forgotten dose .
If you stop taking CellCept
Do not stop taking CellCept unless your doctor tells you to. If you stop the treatment, the risk of the transplanted organ being rejected may increase.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, CellCept can cause side effects, although not everybody gets them.
Tell 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 throat with difficulty breathing – you may have had 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 cell s or signs of infection s
Children may possibly get some side effects more easily than adults. It includes diarrhea, infection, reduction of white and red blood cell counts.
Fight your infection
CellCept 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 the 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 CellCept patients have developed cancer of the lymph tissue and skin.
General adverse effects
You can get general side effects that affect your entire body. These include severe allergic reactions (such as anaphylaxis, angioedema ), fever, feeling very tired, sleep disturbances, pain (such as in the abdomen, chest, joints, and muscles, and pain associated with urination), headache, 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 the lungs or chest cavity
- problems with the sinuses.
Other side effects are such as:
- weight loss, gout , high blood sugar, bleeding, bruising.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store CellCept
- 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 after EXP.
- Do not store above 25 ° C.
- Store in the original package. Moisture sensitive.
- 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.
6. Contents of the packaging and other information
Content declaration
- The active substance is mycophenolate mofetil.
- Other ingredients are:
- CellCept capsules: pregelatinized maize starch, croscarmellose sodium, polyvidone (K-90), magnesium stearate
- capsule shell: gelatin, indigo carmine (E132), yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), potassium hydroxide, shellac.
What the medicine looks like and contents of the pack
- CellCept capsules are oblong, one part is blue and the other part is brown. They are marked with “CellCept 250” in black on one half of the capsule and “Roche” in black on the other.
- They are available in cartons of 100 or 300 capsules (both with blister cards of 10 capsules) or as a multipack containing 300 (3 packs of 100) capsules.
Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer responsible for release batch:
Roche Pharma AG, Emil-Barell-Str. 1, D-79639 Grenzach-Wyhlen, Germany.
Contact the representative of the marketing authorization holder to find out more about this medicine:
Finland / Finland
Roche Oy
Puh / Tel: +358 (0) 10 554 500