Methotrexate 2.5mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Methotrexate

Saatavilla:

Morningside Healthcare Ltd

ATC-koodi:

L04AX03

INN (Kansainvälinen yleisnimi):

Methotrexate

Annos:

2.5mg

Lääkemuoto:

Oral tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 10010300; GTIN: 5055132712791 5055132712722

Pakkausseloste

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
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 your partner should avoid
conception (becoming
pregnant or fathering children) for at least 6 months after your
treatment with methotrexate has
stopped.
•
have severe liver problems, including fibrosis, cirrhosis and recent
or active hepatitis.
•
have severe

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Methotrexate 2.5 mg 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 toxic effects. If, one week later, appropriate
laboratory tests are
normal, tr