Leaflet METHOFILL 2.5mg tablets


Indicated for: cancer; autoimmune inflammatory diseases

Route of administration: oral

Substance: methotrexate (antimetabolite antineoplastic)

ATC: L04AX03 (Antineoplastic and immunomodulating agents | Immunosuppressants | Other immunosuppressants)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling
Cytotoxic / special handling

Handle with special care.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding
Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

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.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

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.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions
Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Teratogenic / fetal risk
Teratogenic / fetal risk

This medicine may affect fetal development.

Methotrexate is a medication used to treat various conditions, including autoimmune diseases and certain types of cancer. It is commonly prescribed for rheumatoid arthritis, severe psoriasis, psoriatic arthritis, and other chronic inflammatory diseases. It is also used in chemotherapy to treat leukemia, lymphomas, and other cancers.

Methotrexate works by inhibiting an enzyme called dihydrofolate reductase, which is essential for DNA synthesis and cell division. In autoimmune diseases, this mechanism helps reduce inflammation and immune system activity, while in cancer, it slows the growth of tumor cells.

Side effects may include nausea, vomiting, fatigue, mouth ulcers, hair loss, and a decrease in blood cell counts. In rare cases, more serious reactions can occur, such as liver damage, lung problems, or bone marrow suppression. It is crucial to take methotrexate as prescribed by a doctor, with regular blood tests to monitor for potential complications.

General data about METHOFILL 2.5mg

  • Substance: methotrexate
  • Date of last drug list: 01-07-2020
  • Commercial code: W64134008
  • Concentration: 2.5mg
  • Pharmaceutical form: tablets
  • Quantity: 30
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: ACCORD HEALTHCARE LIMITED - MAREA BRITANIE
  • Holder: ACCORD HEALTHCARE POLSKA SP. Z O.O. - POLONIA
  • Number: 10342/2017/01
  • Shelf life: 2 years

Concentrations available for methotrexate

  • 100mg/ml
  • 10mg
  • 10mg/ml
  • 12.5mg
  • 12.5mg/ml
  • 15mg
  • 15mg/ml
  • 17.5mg
  • 17.5mg/ml
  • 2.5mg
  • 2.5mg/ml
  • 20mg
  • 20mg/ml
  • 22.5mg
  • 22.5mg/ml
  • 25mg
  • 25mg/ml
  • 27.5mg
  • 27.5mg/ml
  • 2mg/ml
  • 30mg
  • 30mg/ml
  • 50mg
  • 50mg/ml
  • 5mg
  • 5mg/ml
  • 7.5mg
  • 7.5mg/ml