PFZ Methotrexate Tablet 2.5mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

METHOTREXATE

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

METHOTREXATE

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Excella GmbH

Risalah maklumat

Pfizer Confidential
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PFZ METHOTREXATE
® TABLET
Methotrexate (2.5 mg)
1
WHAT IS IN THIS LEAFLET
1.
What METHOTREXATE is
used for
2.
How METHOTREXATE works
3.
Before you use
METHOTREXATE
4.
How to use METHOTREXATE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
METHOTREXATE
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT METHOTREXATE IS USED
FOR
METHOTREXATE is used alone or
in combination with other anticancer
agents to treat various cancers.
METHOTREXATE is also indicated
in the symptomatic control of severe
psoriasis when other treatments are
not responsive.
HOW METHOTREXATE WORKS
METHOTREXATE works by
blocking an enzyme process in cells
that is required for cell growth.
This interferes with the growth of
some cells that are growing rapidly in
psoriasis and cancer.
BEFORE YOU USE METHOTREXATE
-
_When you must not use it _
_ _
Do not take METHOTREXATE:
-
if you are allergic to
METHOTREXATE or to any
other ingredients used in this
medicine
-
if you have severe kidney
problems
-
if you are breast feeding
Do not take METHOTREXATE for
treatment of psoriasis if
-
you consume excessive amounts
of alcohol
-
you have long term liver
problems
-
you have severely compromised
immune system
-
you have blood problems like
insufficient activity of bone
marrow and reduced number of
red or white blood cells or
platelets
-
pregnant or planning to become
pregnant
_Pregnancy and lactation _
Do not take METHOTREXATE if
you are pregnant, trying to get
pregnant or think you may be
pregnant. Pregnancy should be
avoided if either partner is receiving
METHOTREXATE.
METHOTREXATE can cause fetal
death, abortion or birth defects to
your baby. Before starting treatment,
your doctor will do a pregnancy test
and discuss the risks to fetus if you
become pregnant while using this
medicine.
METHOTREXATE passes into
breast milk. Do not take
METHOTREXATE if you are
breastfeeding.
Ask your doctor or pharmacist

Ciri produk

Pfizer confidential
CLD Title
: Methotrexate Tablet
CLD Date
: 21 May 2020
Country
: Malaysia
Reference Document
: CDS version 5 (16 February 2017)
Reason for change
: PfLEET 2020-0061147 (O) – To remove packager information
Pfizer confidential
1
METHOTREXATE
TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
PFZ Methotrexate Tablet 2.5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methotrexate Tablets contain 2.5 mg of Methotrexate
3.
PHARMACEUTICAL FORM
Round, convex, yellow in colour, approximately 6.35 ± 0.1 mm in
diameter, engraved with ‘2.5’ on one
side and scored in half on the other side and engraved with a block
letter ‘M’ above the score and ‘I’
below.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The following are representative indications. Locally approved
indications may differ.
Methotrexate is a cytotoxic drug used for antineoplastic chemotherapy
and in certain nonmalignant
conditions.
ANTI-NEOPLASTIC CHEMOTHERAPY
Methotrexate is indicated for the treatment of gestational
choriocarcinoma, and in patients with
chorioadenoma destruens and hydatidiform mole.
Methotrexate is indicated for the palliation of acute lymphocytic
leukemia. It is also indicated in the
treatment and prophylaxis of meningeal leukemia. Greatest effect has
been observed in palliation of
acute lymphoblastic (stem-cell) leukemias in children. In combination
with other anticancer drugs or
suitable agents Methotrexate may be used for induction of remission,
but it is most commonly used,
as described in the literature, in the maintenance of induced
remissions.
Methotrexate may be used alone or in combination with other anticancer
agents in the management
of breast cancer, epidermoid cancers of the head and neck, and lung
cancer, particularly squamous
cells and small cell types.
Methotrexate is also effective in the treatment of the advanced stages
(III and IV, Peters Staging
System) of lymphosarcoma, particularly in those cases in children; and
in advanced cases of mycosis
fungoides.
PSORIASIS CHEMOTHERAPY (SEE_ _SECTION 4