Methotrexate 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methotrexate

Available from:

Kent Pharma (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

Patient Information leaflet

_S1336 LEAFLET Methotrexate 20200211 _

muscle pain, joint pain

weakening or softening of bones

an increase in rheumatic nodules

loss of interest in, or inability to have sex

menstrual disorders

impotence.
_ _
VERY RARE: MAY AFFECT UP TO 1 IN 10,000 PEOPLE

immune disorder

fatigue

irritation

difficulty with speech

blurred vision

eye infection

chest pain or tightness of chest, with difficulty in breathing

lung infection

vomiting blood

small bruises on the skin caused by blood leaking from
broken blood vessels

boils

vasculitis (pain or redness of the blood vessels)

dilatation of small blood vessels causing focal red lesions

low sperm count

abnormally high levels of nitrogen-containing compounds in
the blood

pain or difficulty in passing urine

blood in urine

elevation of urea and/or creatinine in the blood

infertility

enlargement of breasts in men

vaginal bleeding

dry cough

lymphoproliferative disorders (excessive growth of white
blood cells).
NOT KNOWN: FREQUENCY CANNOT BE ESTIMATED FROM THE AVAILABLE
DATA

severe reduction in blood cells which can cause weakness,
bruising or make infections more likely

high amount of white blood cell

mood alteration

loss of intellectual functions such as thinking, reasoning

drowsiness

general feeling of illness

other metabolic changes

fits (seizures)

deficiency of blood supply to the heart muscle

fluid in lung

syndrome consisting of pleuritic pain and pleural thickening
has been reported following high doses

pain and inflammation of the body's mucous membrane

inflammation of vagina

increased risk of toxic reaction

bone damage in the jaw (secondary to excessive growth of
white blood cells)

bleeding from the lungs*.
*(has been reported for methotrexate used in patients with
underlying rheumatologic disease).
In a small number of patients methotrexate may cause serious side
effects and on rare occasions, death

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