Leaflet ERLOTINIB ACTAVIS 100mg film-coated tablets


Indicated for: non-small cell lung cancer; pancreatic cancer

Route of administration: oral

Substance: erlotinib (tyrosine kinase inhibitor)

ATC: L01EB02 (Antineoplastic and immunomodulating agents | Protein kinase inhibitors | Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

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 grapefruit
Avoid grapefruit

Avoid grapefruit and grapefruit juice.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

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.

Cardiac risk / QT prolongation / arrhythmias
Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

Erlotinib is a medication used in the treatment of certain types of lung cancer and advanced pancreatic cancer. It works by blocking a protein involved in the growth and multiplication of cancer cells, thus helping to slow disease progression.

Erlotinib is administered orally as tablets, once daily, according to the oncologist's instructions. The dose may be adjusted depending on the patient's response to treatment and any side effects.

Side effects may include skin rashes, diarrhea, nausea, fatigue, or, rarely, liver dysfunction and severe allergic reactions. Medical monitoring is necessary throughout the treatment.

Erlotinib is an effective option for patients with advanced lung or pancreatic cancer, offering the chance to prolong survival and improve quality of life.

General data about ERLOTINIB ACTAVIS 100mg

  • Substance: erlotinib
  • Date of last drug list: 01-08-2019
  • Commercial code: W65985001
  • Concentration: 100mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 30
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: S.C. SINDAN-PHARMA S.R.L. - ROMANIA
  • Holder: ACTAVIS GROUP PTC EHF. - ISLANDA
  • Number: 11700/2019/01
  • Shelf life: 30 months

Concentrations available for erlotinib

  • 100mg
  • 150mg
  • 25mg
  • 50mg