Methotrexate 10 mg tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Methotrexate

थमां उपलब्ध:

Accord Healthcare Limited

ए.टी.सी कोड:

L01BA; L01BA01

INN (इंटरनेशनल नाम):

Methotrexate

डोज़:

10 milligram(s)

फार्मास्यूटिकल फॉर्म:

Tablet

प्रिस्क्रिप्शन प्रकार:

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

चिकित्सीय क्षेत्र:

Folic acid analogues; methotrexate

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2016-07-01

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE 10 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 or pharmacist.

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. 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 Tablets
3.
How to take Methotrexate Tablets
4.
Possible side effects
5.
How to store Methotrexate Tablets
6.
Contents of the pack and other information
1.
WHAT METHOTREXATE IS AND WHAT IT IS USED FOR
Methotrexate contains the active ingredient methotrexate. Methotrexate
is referred to as a cytotoxic
medicine. It is mostly commonly used to kill cells in tumours.
Methotrexate can also be used to treat severe, uncontrolled psoriasis.
It is usually used for patients
who have tried other treatments but their condition has not improved.
Methotrexate 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.
Methotrexate is used to treat a wide range of tumours, 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 alone or in combination with other
medicines.
You should consult your doctor if you are unsure why you have been
given Methotrexate 10mg
Tablets.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHOTREXATE TABLETS
DO NOT TAKE METHOTREXATE TABLETS IF YOU

are allergic to metho

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methotrexate 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg methotrexate.
Excipient(s) with known effect:
Each tablet contains 50 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellow coloured, capsule shaped, biconvex uncoated tablet with central
breakline on one side and plain on the other
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Methotrexate 10 mg tablet is
a folic acid antagonist and is classified as an antimetabolite
cytotoxic agent.
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.
used in the treatment of severe, uncontrolled psoriasis, which is not
responsive to other therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration: Oral
_DOSAGE FOR CANCER TREATMENT:_
A test dose of 5-10 mg parentally is recommended, one week prior to
therapy to detect idiosyncratic adverse events.
Single doses, not exceeding 30 mg/m
2
, on not more than 5 consecutive days. A rest period of at least two
weeks is
recommended between treatments, in order to allow the bone marrow to
return to normal.
Doses in excess of 100 mg are usually given parentally, when the
injectable preparation should be used. Doses in
excess of 70 mg/m
2
should not be administered without leucovorin rescue (folinic acid
rescue) or assay of serum
methotrexate levels 24-48 hours after dosing.
If methotrexate is administered in combination chemotherapy regimens,
the dosage should be reduced, taking into
consideration any overlapping toxicity of the other drug components.
_DOSAGE FOR PSORIASIS:_
For the treatment of severe psoriasis 10-25 mg orally, once a week, is
recommended. Dosage should be adjusted
according to the patient’s response and t