ADMINISTRATION ONLY ONCE A WEEK Measures for preventing accidental overdoses resulting from daily administration
Methotrexate preparations authorised for use in rheumatoid arthritis and psoriasis
Methotrexat Farmos tablets: 2.5 mg and 10 mg (pack of 100 tablets)
Methotrexat Pfizer tablets: 2.5 mg (pack of 100 tablets)
Methotrexat Sandoz tablets: 5 mg (pack of 20 tablets) and 10 mg (pack of 10 tablets)
Metoject prefilled syringes
Methrexx prefilled syringes
Methotrexat Farmos, solution for parenteral administration
Methotrexat Pfizer, solution for parenteral administration
Methotrexat Sandoz, concentrate for solution for infusion
Methotrexat Teva, solution for parenteral administration
Methotrexat Proreo, solution for parenteral administration (only for the indication of psoriasis)
The six marketing authorisation holders Curatis AG, Gebro Pharma AG, Orion Pharma AG, Pfizer AG, Sandoz Pharmaceuticals AG and Teva AG in cooperation with Swissmedic would like to inform you about jointly devised measures for preventing accidental overdoses as a result of daily instead of once weekly administration of low-dose methotrexate:
1. Patient Card
The Patient Card is intended to be issued to the patient by the doctor/pharmacist, who enters the specified day of the week for administration and the methotrexate preparation. The card provides information on correct administration, possible symptoms of an overdose and the steps to be taken in this situation. The patients should carry the card with them and present it to doctors and medical personnel, particularly on admission to a hospital department or care institution or in the event of a change in the caregivers.
2. Sticker/fixed overprint on the pack (German and French)
The following “Boxed Warning” has been affixed to the outer packages as a sticker or fixed overprint: For rheumatoid arthritis and psoriasis, take/administer only once a week. The pack also has space for the dispensing outlet to enter the specified day of the week for administration.
3. Boxed warning on the SPC and patient information leaflets
Notice highlighted prominently in colour and framed in a box in the “Dosage and administration” section stating that the medicinal product may be taken/administered only once a week for non-oncological indications and requesting the prescriber to note the day of the week for administration on the prescription.
Please find detailed information and the patient card in the pdf-documents on the right.