Leaflet MICOFENOLAT MOFETIL STADA 250mg capsules


Indicated for: prevention of transplant rejection

Route of administration: oral

Substance: mycophenolate mofetil (immunosuppressant)

ATC: L04AA06 (Antineoplastic and immunomodulating agents | Immunosuppressants | Selective immunosuppressants)

Precautions:
Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Avoid live vaccines
Avoid live vaccines

Avoid live vaccines during treatment if contraindicated.

Immunosuppression / infection risk
Immunosuppression / infection risk

This medicine may increase the risk of infections.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis
Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Teratogenic / fetal risk
Teratogenic / fetal risk

This medicine may affect fetal development.

Mycophenolate is an immunosuppressive medication used to prevent organ rejection in transplant recipients, such as kidney, liver, or heart transplants. It is often used in combination with other immunosuppressive drugs, such as cyclosporine and corticosteroids. Mycophenolate works by inhibiting the proliferation of T and B lymphocytes, thereby reducing the immune response against the transplanted organ.

Mycophenolate is available as mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), both of which are taken orally, usually twice daily, as directed by a doctor. The exact dosage depends on the type of transplant and the patient’s condition.

Common side effects include nausea, diarrhea, vomiting, abdominal pain, and infections, as the medication suppresses the immune system. Other side effects may include anemia, leukopenia (low white blood cell count), and an increased risk of severe or opportunistic infections.

Mycophenolate is contraindicated in pregnant women, as it can cause severe birth defects. Women of childbearing age must use effective contraception during treatment and for several weeks after stopping the medication. Regular monitoring is essential to detect potential side effects and adjust the dosage if necessary.

General data about MICOFENOLAT MOFETIL STADA 250mg

  • Substance: mycophenolate mofetil
  • Date of last drug list: 01-03-2022
  • Commercial code: W56643001
  • Concentration: 250mg
  • Pharmaceutical form: capsules
  • Quantity: 100
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: APOTEX NEDERLAND B.V. - OLANDA
  • Holder: STADA HEMOFARM S.R.L. - ROMANIA
  • Number: 7888/2015/02
  • Shelf life: 3 years

Concentrations available for mycophenolate mofetil

  • 1mg/5ml
  • 250mg
  • 500mg