Methotrexate 2.5mg Tablets

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

METHOTREXATE

זמין מ:

Accord Healthcare Limited

קוד ATC:

L04AX03

INN (שם בינלאומי):

METHOTREXATE

טופס פרצבטיות:

TABLET

הרכב:

METHOTREXATE 2.5 mg

סוג מרשם:

POM

איזור תרפויטי:

IMMUNOSUPPRESSANTS

מצב אישור:

Authorised

עלון מידע

Page 1 of 8
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

are allergic to methotrexate or any of the other ingredients of this
medicine (listed in section 6);

are pregnant or breast-feeding (see section “Pregnancy,
breast-feeding and fertility”).

have significant liver

מאפייני מוצר

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
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
IMPORTANT WARNING WITH REFERENCE TO THE DOSING OF METHOTREXATE:
METHOTREXATE MUST ONLY BE TAKEN ONCE WEEKLY.
INCORRECT DOSING OF METHOTREXATE MAY LEAD TO SERIOUS ADVERSE EFFECTS
INCLUDING FATAL OUTCOMES.
PLEASE READ THIS PARAGRAPH OF THE SMPC VERY CAREFULLY.
Methotrexate should only be prescribed by physicians with experience
in the various properties of the
medicinal product and its mode of action. Methotrexate is given once
weekly.
It must be explicitly pointed out to the patient that methotrexate is
taken
ONLY ONCE A WEEK
.
It is recommended to specify a certain day of the weeks as “the day
for taking methotrexate” on the
prescription.
Posology
Page 2 of 14
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 25 mg.
After the therapeutically desired
result is achieved the dose should be reduced to the lowest possible
effective dose which in most cases
is achieved within 6 weeks.
Psoriasis and psoriatic arthritis:
Before startin