Methotrexate 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methotrexate

Available from:

Wockhardt UK Ltd

ATC code:

L04AX03

INN (International Name):

Methotrexate

Dosage:

2.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010300; GTIN: 5012727904467 5012727904962

Patient Information leaflet

METHOTREXATE 2.5MG TABLETS
(methotrexate sodium)
PATIENT INFORMATION LEAFLET
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, 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 2.5mg Tablets are and what they are used for
2. What you need to know before you take Methotrexate 2.5mg Tablets
3. How to take Methotrexate 2.5mg Tablets
4. Possible side effects
5. How to store Methotrexate 2.5mg Tablets
6. Contents of the pack and other information
1. WHAT METHOTREXATE 2.5MG 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
mechanism in the immune system.
Methotrexate can also be used to treat several kinds of cancer, in
particular:
•
acute leukaemias
•
Non-Hodgkin’s lymphoma
•
soft tissue and bone sarcomas
•
solid tumours like breast, lung, head and neck, bladder, cervical,
ovarian and testicular cancer.
Methotrexate can be given alon

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 of
methotrexate.
Excipient(s) with known effect
Lactose monohydrate- 66.166 mg per tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Round, biconvex, yellow tablets, engraved with “2.5” on one side.
Scored in
half on the other side and engraved with ‘M’ above the score line
and ‘1’
below it.
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Methotrexate is a folic acid antagonist and is classified as an
antimetabolite
cytotoxic agent.
Methotrexate has been used to produce regression in a wide range of
neoplastic conditions including acute leukaemias, non-Hodgkin's
lymphoma,
soft-tissue and osteogenic sarcomas, and solid tumours particularly
breast,
lung, head and neck, bladder, cervical, ovarian, and testicular
carcinoma.
The treatment of neoplastic disease. Methotrexate has also been used
in the
treatment of severe cases of uncontrolled psoriasis, unresponsive to
conventional therapy.
It is also used in 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
Methotrexate should only be prescribed by physicians with expertise in
the use
of methotrexate and a full understanding of the risks of methotrexate
therapy.
ADULTS AND CHILDREN:
Methotrexate
may
be
given
by
oral,
intramuscular,
intravenous
(bolus
injection or infusion), intrathecal and intra-arterial routes of
administration.
Dosages are based on the patient’s body weight or surface area
except in the
case
of
intrathecal
administration
when
a
maximum
dose
of
15
mg
is
recommended. Doses should be reduced in cases of haematological
deficiency
and hepatic or renal impairment. Larger doses (greater than 10