The most serious risk associated with CellCept is the possible development of cancer, particularly lymphoma and skin cancer. The most common side effects with CellCept used in combination with ciclosporin and corticosteroids seen in more than 1 patient in 10 are sepsis blood infection , gastrointestinal candidiasis a fungal infection of the stomach or gut , urinary tract infection infection of the structures that carry urine , herpes simplex a viral infection that causes cold sores , herpes zoster a viral infection that causes chickenpox and shingles , leucopenia low white blood cell counts , thrombocytopenia low blood platelet counts , anaemia low red blood cell counts , vomiting, abdominal tummy pain, diarrhoea and nausea feeling sick.
For the full list of side effects reported with CellCept, see the Package Leaflet. CellCept should not be used in people who may be hypersensitive allergic to mycophenolate mofetil or mycophenolic acid. It should not be used in women are breast-feeding. CellCept treatment is not recommended for use in pregnant women, and should only be started in women after a negative pregnancy test and if effective contraception is used before, during and for six weeks after CellCept treatment.
The Committee recommended that CellCept be given marketing authorisation. A kidney, heart or liver. CellCept should be used together with other medicines: If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor.
Your doctor will speak to you and give you written information, particularly on the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions. If you do not fully understand these instructions, please ask your doctor to explain them again before you take 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 in this medicine listed in Section 6 If you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage.
If you are pregnant or planning to become pregnant or think you may be pregnant If you are not using effective contraception see Pregnancy, contraception and breast-feeding. If you are breast-feeding. Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking CellCept. Warnings and precautions Talk to your doctor straight away before taking CellCept: If you have a sign of infection such as a fever or sore throat If you have any unexpected bruising or bleeding If you have ever had a problem with your digestive system such as a stomach ulcer If you are planning to become pregnant or if you get pregnant while taking CellCept If any of the above apply to you or you are not sure , talk to your doctor straight away before taking CellCept.
The effect of sunlight CellCept reduces your body's defences. As a result, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Other medicines and CellCept Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
This includes medicines obtained without a prescription, including herbal medicines. This is because CellCept can affect the way some other medicines work. Also other medicines can affect the way CellCept works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start CellCept: Your doctor will have to advise you on what vaccines you can have.
You must not donate blood during treatment with CellCept and for at least 6 weeks after stopping treatment. Mycophenolate Mofetil mg may increase your risk of getting a rare but very serious possibly fatal brain infection progressive multifocal leukoencephalopathy-PML. Get medical help right away if you have any of these side effects: A very serious allergic reaction to Mycophenolate Mofetil mg is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: This is not a complete list of possible side effects.
If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at Click here to view a more detailed list of Mycophenolate Mofetil side effects. If you miss a dose of Mycophenolate Mofetil mg, take it as soon as you remember.
If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions.
Do not start, stop, or change the dosage of any medicines without your doctor's approval. Additionally, this product is sealed under vacuum and should retain a vacuum throughout its shelf life. If a lack of vacuum in the vial is noted while adding diluent, the vial should not be used. CellCept Intravenous infusion solution must be prepared in two steps: A detailed description of the preparation is given below: Step 1 a Two 2 vials of CellCept Intravenous are used for preparing each 1 g dose, whereas three 3 vials are needed for each 1.
Discard the vials if particulate matter or discoloration is observed. Step 2 a To prepare a 1 g dose, further dilute the contents of the two reconstituted vials approx. To prepare a 1. The final concentration of both solutions is 6 mg mycophenolate mofetil per mL. In immunosuppressed patients, physicians should consider PML in the differential diagnosis in patients reporting neurological symptoms and consultation with a neurologist should be considered as clinically indicated.
Therapeutic approaches to limiting CMV disease exist and should be routinely provided. Patient monitoring may help detect patients at risk for CMV disease. The development of neutropenia may be related to CellCept itself, concomitant medications, viral infections, or some combination of these causes.
Neutropenia has been observed most frequently in the period from 31 to days posttransplant in patients treated for prevention of renal, cardiac, and hepatic rejection. Patients receiving CellCept should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
The mechanism for mycophenolate mofetil induced PRCA is unknown; the relative contribution of other immunosuppressants and their combinations in an immunosuppression regimen are also unknown. In transplant patients, however, reduced immunosuppression may place the graft at risk.
Females of reproductive potential include girls who have entered puberty and all women who have a uterus and have not passed through menopause. Menopause is the permanent end of menstruation and fertility. Menopause should be clinically confirmed by a patient's healthcare practitioner. Some commonly used diagnostic criteria include 1 12 months of spontaneous amenorrhea not amenorrhea induced by a medical condition or medical therapy or 2 postsurgical from a bilateral oophorectomy.
Another pregnancy test with the same sensitivity should be done 8 to 10 days later. Repeat pregnancy tests should be performed during routine follow-up visits.
Results of all pregnancy tests should be discussed with the patient.
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© Copyright 2017 Cellcept 250mg capsules *** Inactive ingredients in CellCept mg capsules include croscarmellose sodium, magnesium stearate, povidone (K) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide..