Methotrexate 2.5 mg Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Methotrexate

Disponible depuis:

Mercury Pharmaceuticals Ltd

Code ATC:

L04AX; L04AX03

DCI (Dénomination commune internationale):

Methotrexate

Dosage:

2.5 milligram(s)

forme pharmaceutique:

Tablet

Type d'ordonnance:

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

Domaine thérapeutique:

Other immunosuppressants; methotrexate

Statut de autorisation:

Marketed

Date de l'autorisation:

1983-05-23

Notice patient

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,
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 or
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Methotrexate 2.5 mg Tablets are and what they
are used for
2. What
you
need
to
know
before
you
take
Methotrexate 2.5 mg Tablets
3. How to take Methotrexate 2.5 mg Tablets
4. Possible side effects
5. How to store Methotrexate 2.5 mg Tablets
6. Contents of the pack and other information
1. WHAT METHOTREXATE 2.5 MG TABLETS ARE
AND WHAT THEY ARE USED FOR
Methotrexate 2.5 mg Tablets are one of a group of
medicines
called
antimetabolites
which
affect
cell
growth, including the growth of cancer cells.
Methotrexate can be used to treat severe cases of
psoriasis (a skin disease) and rheumatoid arthritis (a
disease of the joints). It is usually used for patients who
have tried other treatments but their illness has not
improved. It helps patients with psoriasis by killing the
cells in the skin which are growing too quickly. It is these
fast growing cells which cause the raised patches of
skin in psoriasis.
In the treatment of rheumatoid arthritis, methotrexate is
thought to stop or reduce inflammation in the joints by
altering the body’s defence mechanisms in the immune
system.
Methotrexate can also be used to treat several kinds of
cancer
when
it
and
can
be
given
alone
or
in
combination with other medicines. It is usually used in
much higher doses when it is used to treat cancer and
it will often be given as an injection rather than tablets.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
METHOTREXATE 2.5 MG TABLETS
DO NOT TAKE METHOTREXATE 2.5 MG TABLETS

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methotrexate 2.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains methotrexate sodium equivalent to 2.5 mg
methotrexate.
Excipient with known effect
Each tablet also contains 66.16 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Round, biconvex, yellow tablets, engraved with script ‘2.5’ on one
side, scored in half on the other side and engraved
with a block letter ‘M’ above the score and ‘1’ below;
approximately ¼ inch in diameter.
The scoreline is only to facilitate breaking of tablet for ease of
swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Methotrexate is indicated in the treatment of neoplastic disease, also
severe cases of psoriasis unresponsive to
conventional therapy.
The treatment of adults with severe, active, classical or definite
rheumatoid arthritis who are unresponsive or intolerant
to conventional therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and Children: Methotrexate has been used with beneficial
effects in a wide variety of neoplastic diseases, alone
and in combination with other cytotoxic agents, hormones, radiotherapy
or surgery. Dosage schedules therefore vary
considerably, depending on the clinical use, particularly when
intermittent high-dose regimes are followed by the
administration of calcium leucovorin (calcium folinate) to rescue
normal cells from toxic effects. Doses of
methotrexate should be reduced in cases of haematological deficiency
and hepatic or renal impairment.
Examples of doses of methotrexate that have been used for particular
indications are given below.
Leukaemia in Children: In acute lymphocytic leukaemia, remissions are
usually best induced with a combination of
corticosteroids and other cytotoxic agents.
Methotrexate 15 mg/m
2
, given orally once weekly, in combination with other drugs appears to
be the treatment of
choice for maintenan