Methotrexate 2.5 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:

2.5 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:

Authorised

प्राधिकरण की तारीख:

2016-07-01

सूचना पत्रक

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 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 be used to treat rheumatoid arthritis. It is usually
used for patients who have tried
other treatments but their illness has not improved. In the treatment
of rheumatoid arthritis,
methotrexate is thought to stop or reduce inflammation by altering the
body’s defences.
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.
Methotrexa

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methotrexate 2.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg methotrexate.
Excipient(s) with known effect:
Each tablet contains 12.5 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellow, circular, biconvex uncoated tablets plain on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Methotrexate 2.5 mg tablet is
a folic acid antagonist and is classified as an antimetabolite
cytotoxic agent.
used in the treatment of adults with severe, active, classical or
definite rheumatoid arthritis who are unresponsive
or intolerant to conventional therapy.
used in the treatment of severe, uncontrolled psoriasis, which is not
responsive to other therapy.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration: Oral
_Dosage and Administration with reference to Rheumatoid arthritis and
Psoriasis_
1.1.Dosage for Rheumatoid arthritis
ADULTS:
In adults with severe, active, classical or definite rheumatoid
arthritis who are unresponsive or intolerant to
conventional therapy, methotrexate should be taken as 7.5 mg orally
once a week. The prescriber may specify the day
of intake on the prescription.
ELDERLY:
Methotrexate should be used with extreme caution in elderly patients,
a reduction in dosage should be considered.
CHILDREN:
Safety and effectiveness in children have not been established, other
than in cancer chemotherapy.
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