Methotrexate 2.5mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Methotrexate

Available from:

Orion Corporation

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:

2008-10-03

Patient Information leaflet

1
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, 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
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
3.
How to take Methotrexate
4.
Possible side effects
5.
How to store Methotrexate
6.
Contents of the pack and other information
1.
WHAT METHOTREXATE IS AND WHAT IT IS USED FOR
The active substance of Methotrexate tablets, methotrexate, is an
antimetabolite and
immunosuppressant (medicine which affects the reproduction of the
body's cells and reduces the
activity of the immune system).
Methotrexate is used to treat:
-
active rheumatoid arthritis in adult patients
-
severe resistant disabling psoriasis, which is not adequately
responsive to other forms of therapy
such as phototherapy, PUVA, and retinoids
-
severe psoriatic arthritis in adult patients.
Your doctor will be able to explain how Methotrexate tablets might
help in your particular condition.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHOTREXATE
DO NOT TAKE METHOTREXATE IF:
-
you have significant liver disease (your doctor decides the severity
of your disease)
-
you have significant kidney disease (your doctor decides the severity
of your disease)
-
you have or have had a bone marrow disease or serious blood disorders
-
you are allergic to methotrexate or any of the other ingredients of
this medicine (listed in section
6)
-
you are pregnant or breast-feeding (see also section “Pregnancy,
breast-feedi

Summary of Product characteristics

Health Products Regulatory Authority
23 September 2020
CRN009WQN
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methotrexate 2.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 2.5 mg methotrexate.
Excipients with known effect: 39.9 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellow, round, convex, uncoated tablet engraved with M 2.5 on one
side, diameter 6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Active rheumatoid arthritis in adult patients.

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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Rheumatoid arthritis and psoriasis
Methotrexate should only be prescribed by physicians with expertise in
the use of methotrexate and a full understanding of the
risks of methotrexate therapy.
​
IMPORTANT WARNING ABOUT THE DOSAGE OF METHOTREXATE
IN THE TREATMENT OF RHEUMATIC DISEASES, PSORIASIS OR PSORIATIC
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.
The prescriber should ensure that patients or their carers will be
able to comply with the once weekly regimen.
The prescriber should specify the day of intake on the prescription.
For doses not realisable/practicable with this strength, another
strength of this medicinal product is available.
Rheumatoid arthritis
The usual dose is 7.5 – 15 mg once weekly. The schedule may be
adjusted gradually to achieve an optimal response but should
not exceed a total weekly dose of 20 mg. Thereafter the dose should be
reduced to the lowest possible effective dose which in
most cases is achieved within 6 weeks.
Psoriasis
Before starting treatment it is advisable to give the patien