Methotrexate 2.5mg tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Methotrexate

Verfügbar ab:

Morningside Healthcare Ltd

ATC-Code:

L04AX; L04AX03

INN (Internationale Bezeichnung):

Methotrexate

Dosierung:

2.5 milligram(s)

Darreichungsform:

Tablet

Verschreibungstyp:

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

Therapiebereich:

Other immunosuppressants; methotrexate

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2012-02-24

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER METHOTREXATE 2.5MG TABLETS
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 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 on 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
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,

severe psoriasis, especially plaque-type,

psoriatic arthritis in adult patients who have tried other treatments
but their illness
has not improved.
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
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 section 6).

are pregnant, trying to become pregnant or breast-feeding.
Methotrexate may harm
your baby (see section on Pregnancy). You and

Fachinformation

Health Products Regulatory Authority
02 December 2020
CRN009YFY
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methotrexate 2.5mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg of methotrexate.
Excipients: 11.88 mg lactose (as lactose monohydrate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellow, circular, biconvex, uncoated tablets plain on both sides,
4.50mm in diameter.
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, PUVA, and retinoids, 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
risk of methotrexate therapy.
The prescriber should ensure that patients or their carers will be
able to comply with the once weekly regimen. For doses not
realisable/practicable with this strength another strength of this
medicinal product is available.
IMPORTANT WARNING ABOUT THE DOSAGE OF METHOTREXATE:
In the treatment of rheumatoid arthritis and psoriasis, 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 specify the day of intake on the prescription.
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 patient a test
dose of 2.5–5.0 mg to exclude unexpected t