Methotrexate 2.5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

METHOTREXATE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

L04AX03

INN (International Name):

METHOTREXATE 2.5 mg

Pharmaceutical form:

TABLET

Composition:

METHOTREXATE 2.5 mg

Prescription type:

POM

Therapeutic area:

IMMUNOSUPPRESSANTS

Authorization status:

Withdrawn

Authorization date:

2017-08-11

Patient Information leaflet

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE 2.5 MG TABLETS
methotrexate
“TAKE METHOTREXATE TABLET ONCE A WEEK”
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 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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Methotrexate Tablets are and what they are 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 TABLETS ARE AND WHAT THEY ARE USED FOR
Methotrexate Tablets contain the active ingredient methotrexate.
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 adults,
•
severe psoriasis, especially plaque-type, in patients who have tried
other treatments but their
illness has not improved,
•
active psoriatic arthritis, in adult patients
acute lymphoblastic leukaemia (ALL) in adults, adolescents and
children aged 3 years and over
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 TABLETS
DO NOT TAKE METHOTREXATE TABLETS IF YOU
-
if you are allergic to methotrexate or any of the other ingredients of
this medicine (listed
in section 6)
-
if you have a severe kidney impairment (or your doctor classes the
impairment as severe)
-
if you have a liver impai

Summary of Product characteristics

Page 1 of 17
1.
NAME OF THE MEDICINAL PRODUCT
Methotrexate 2.5 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg methotrexate.
Excipient with known effect:
Each tablet contains 12.5 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Methotrexate 2.5 mg: Yellow, circular, biconvex uncoated tablets with
4.50 ± 0.20mm in diameter
plain on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Methotrexate tablet is indicated in the treatment of:
•
Active rheumatoid arthritis in adult patients.
•
Severe forms of psoriasis vulgaris, particularly of the plaque type,
which cannot be sufficiently
treated with conventional therapy and active psoriatic arthritis in
adults
•
Maintenance therapy in acute lymphoblastic leukaemia (ALL) in adults,
adolescents and
children aged 3 years and over.
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.
Posology
Rheumatological and dermatological diseases
IMPORTANT WARNING WITH REFERENCE TO THE DOSING OF METHOTREXATE
TABLETS:
In the treatment of Rheumatological and dermatological diseases,
Methotrexate Tablets
MUST BE TAKEN
ONCE A WEEK.
Dosage errors in the use of Methotrexate Tablets (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.
Page 2 of 17
Methotrexate is given once weekly.
It must be explicitly pointed out to the patient that methotrexate is
taken
ONLY ONCE A WEEK
.
The prescriber should specify the day of intake on the prescription.
The dose and duration of treatment are determined individually on the
basis of the patient's clinical
picture and the tolerability of methotrexate. Treatment of active
rheumatoid arthr