Methotrexate 2.5mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Methotrexate

Available from:

Pfizer Healthcare Ireland

ATC code:

L04AX; L04AX03

INN (International Name):

Methotrexate

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other immunosuppressants; methotrexate

Authorization status:

Not marketed

Authorization date:

1986-05-22

Patient Information leaflet

Page 1 of 9
2023-0083369
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE 2.5 MG TABLETS
Methotrexate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
•
If you get any side effects talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet.
•
THIS MEDICINE SHOULD ONLY BE TAKEN ONCE A WEEK.
•
DO NOT EXCEED THE WEEKLY DOSE AS INCORRECT DOSING MAY LEAD TO SERIOUS
TOXIC
EFFECTS, INCLUDING DEATH
WHAT IS IN THIS LEAFLET
:
1.
What Methotrexate is and what it is used for
2.
What you need to know before you take Methotrexate Tablets
3.
How to take Methotrexate Tablets
4.
Possible side effects
5.
How to store Methotrexate Tablets
6.
Contents of the pack and other information
1.
WHAT METHOTREXATE IS AND WHAT IT IS USED FOR
Methotrexate is an anti-metabolite medicine (medicine which affects
how the body’s cells
grow) and immunosuppressant (medicine which reduces the activity of
the immune system).
Methotrexate is used to treat severe psoriasis (a skin disease with
thickened patches of
inflamed red skin, often covered by silvery scales) when other
treatments are not effective,
severe arthritis due to psoriasis, and rheumatoid arthritis (a disease
that causes inflammation
of the joints).
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHOTREXATE TABLETS
Your doctor may perform several tests such as blood tests, x-rays and
physical examinations
before treatment with Methotrexate tablets is started, and at regular
intervals during treatment.
DO NOT TAKE METHOTREXATE TABLETS IF YOU
•
are allergic to methotrexate or any of the other ingredients of this
medicine (listed in

Summary of Product characteristics

Health Products Regulatory Authority
26 June 2023
CRN00DG5G
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methotrexate 2.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Methotrexate 2.5mg.
Excipients: also includes 41.8mg lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A round, convex yellow tablet with a diameter of 6mm marked ‘M2.5’
on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Active rheumatoid arthritis in adult patients.

Severe forms of psoriasis vulgaris, particularly of the plaque type,
which cannot be sufficiently treated with
conventional therapy such as phototherapy and PUVA, and severe
psoriatic arthritis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Methotrexate should only be prescribed by physicians with expertise in
the use of methotrexate and a full understanding of the
risks of methotrexate therapy.
The prescriber should ensure that patients or their carers will be
able to comply with the once weekly regimen.
​
IMPORTANT WARNING ABOUT THE DOSAGE OF METHOTREXATE:
In the treatment of psoriasis and rheumatoid arthritis, methotrexate
MUST ONLY BE TAKEN ONCE A WEEK. Dosage errors in the
use of methotrexate can result in serious adverse reactions, including
death. Please read this section of the summary of
product characteristics very carefully.
Posology
For doses not realisable/practicable with this strength, another
strength of this medicinal product is available.
It is recommended to specify a certain day of the week as "the day for
taking Methotrexate" on the prescription
This medicine should be taken once a week. Do not exceed the weekly
dose of this medicine due to toxicity hazards in
psoriasis and rheumatoid arthritis. The prescriber should specify the
day of intake on the prescription.
_Rheumatoid arthritis_
_ _
ADULTS
The usual dose is 7.5 – 15 mg once weekly. The schedule may be
adjusted gradually to achieve an optimal response but shoul