Methotrexate Morningside 2.5mg Tablets

Nazione: Malta

Lingua: inglese

Fonte: Malta Medicines Authority

Principio attivo:

METHOTREXATE

Commercializzato da:

Aspire Pharma (Malta) Limited Trident Park, Notabile Gardens No. 2, Level 3, Mdina Road Central Business District Birkirkara CBD2010 , Malta

Codice ATC:

L04AX03

INN (Nome Internazionale):

METHOTREXATE 2.5 mg

Forma farmaceutica:

TABLET

Composizione:

METHOTREXATE 2.5 mg

Tipo di ricetta:

POM

Area terapeutica:

IMMUNOSUPPRESSANTS

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2019-08-08

Foglio illustrativo

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
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, includ

Scheda tecnica

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, t