Methotrexate 2.5mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Methotrexate

Dostupné z:

Orion Pharma (UK) Ltd

ATC kód:

L04AX03

INN (Medzinárodný Name):

Methotrexate

Dávkovanie:

2.5mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 10010300; GTIN: 6432100013750 6432100013798 6432100013767 6432100023841 6432100058379 6432100058386

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE 2.5 MG TABLETS
methotrexate
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 is and what it is used for
2.
What you need to know before you take Methotrexate
3.
How to take Methotrexate
4.
Possible side effects
5.
How to store Methotrexate
6.
Contents of the pack and other information
1.
WHAT METHOTREXATE IS AND WHAT IT IS 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 in adult patients
-
severe resistant disabling psoriasis,which is not adequately
responsive to other forms of therapy such
as phototherapy, PUVA, and retinoids
-
severe psoriatic arthritis in adult patients
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
DO NOT TAKE METHOTREXATE IF:
-
you have significant liver disease (your doctor decides the severity
of your disease)
-
you have significant kidney disease (your doctor decides the severity
of your disease)
-
you have or have had a bone marrow disease or serious blood disorders.
-
you are allergic to methotrexate or any of the other ingredients of
this medicine (listed in section 6)
-
you are pregnant or breast-feeding (see also section “Pregnancy,
breast-feedin

Súhrn charakteristických

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