Methofill 10 mg solution for injection in pre-filled injector

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Methotrexate

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

L01BA; L01BA01

INN (International Name):

Methotrexate

Dosage:

10 milligram(s)

Pharmaceutical form:

Solution for injection in pre-filled injector

Therapeutic area:

Folic acid analogues; methotrexate

Authorization status:

Marketed

Authorization date:

2017-08-04

Patient Information leaflet

SE/H/1431/001-011/IA/045, ver 001, Sep 2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOFILL 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR
METHOFILL 10 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR
METHOFILL 12.5 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR
METHOFILL 15 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR
METHOFILL 17.5 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR
METHOFILL 20 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR
METHOFILL 22.5 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR
METHOFILL 25 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR
METHOFILL 27.5 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR
METHOFILL 30 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR
methotrexate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Methofill is and what it is used for
2.
What you need to know before you use Methofill
3.
How to use Methofill
4.
Possible side effects
5.
How to store Methofill
6.
Contents of the pack and other information
1.
WHAT METHOFILL IS AND WHAT IT IS USED FOR
Methofill contains methotrexate as active substance
Methotrexate is a substance with following properties:
•
it interferes with the growth of certain cells in the body that
reproduce quickly
•
it reduces the activity of the immune system (the body’s own defence
mechanism)
•
it has anti-inflammatory effects
Methofill is indicated for the treatment of
•
Rheumatoid arthritis (RA) in adult patients-
(RA)
is a chronic disease, characterised by
inflammation

Summary of Product characteristics

Health Products Regulatory Authority
11 May 2023
CRN00DGL4
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methofill 10 mg solution for injection in pre-filled injector
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pre-filled injector with 0.20 ml solution contains 10 mg
methotrexate
Excipient with known effect:
Each pre-filled injector contains <1 mmol sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in pre-filled injector.
Clear, yellow to brown solution.
pH: Between 7.0 to 9.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Methotrexate is indicated for the treatment of
- active rheumatoid arthritis in adult patients,
- polyarthritic forms of severe, active juvenile idiopathic arthritis,
when the response to nonsteroidal anti-inflammatory drugs
(NSAIDs) has been inadequate,
- severe recalcitrant disabling psoriasis, which is not adequately
responsive to other forms of therapy such as phototherapy,
PUVA, and retinoids, and severe psoriatic arthritis in adult patients.
- mild to moderate Crohn’s disease either alone or in combination
with corticosteroids in adult patients refractory or
intolerant to thiopurines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Methotrexate should only be prescribed by physicians, who are familiar
with the various characteristics of the medicinal
product and its mode of action. If considered appropriate, the
treating physician can, in selected cases, delegate subcutaneous
administration to the patient. Patients must be educated to use the
proper injection technique. The first injection of
methotrexate should be performed under direct medical supervision.
Methotrexate is injected ONCE WEEKLY
The patient must be explicitly informed about the fact that
methotrexate is administered ONCE A WEEK ONLY. It is advisable to
determine an appropriate fixed day of the week for the injection.
Methotrexate elimination is reduced in patients with a third
distribution space (ascites, pleural effusions). Such patien