Methotrexate 10mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Methotrexate

MAH:

DE Pharmaceuticals

ATC_code:

L04AX03

INN:

Methotrexate

dosage:

10mg

pharmaceutical_form:

Oral tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 10010300

PIL

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, 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-feeding

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Methotrexate 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Methotrexate 10 mg tablet
Each tablet contains methotrexate 10mg
_Excipients with known effects _
Each tablet contains 50 mg lactose (as lactose monohydrate)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Methotrexate 10 mg tablet
Yellow coloured, capsule shaped, biconvex uncoated tablet with length
of 10.00
mm ± 0.20 mm and breadth 5.00 mm ± 0.20 mm, with central breakline
on one
side and plain on other side.
The breakline is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Active rheumatoid arthritis in adult patients.
•
Severe recalcitrant disabling psoriasis, which is not adequately
responsive
to other forms of therapy such as phototherapy, PUVA, and retinoids,
and
severe psoriatic arthritis in adult patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
IMPORTANT WARNING ABOUT THE DOSAGE OF METHOTREXATE TABLETS
(METHOTREXATE):
In the treatment of rheumatic diseases or diseases of the skin
requiring dosing once a week,
Methotrexate tablets (methotrexate) MUST ONLY BE TAKEN ONCE A WEEK.
Dosage errors in the use of
Methotrexate tablets (methotrexate) can result in serious adverse
reactions, including death. Please
read this section of the summary of product characteristics very
carefully.
Methotrexate should only be prescribed by physicians with expertise in
the use of methotrexate and a f
understanding of the risks of methotrexate therapy. Methotrexate is
given once weekly.
It must be explicitly pointed out to the patient that methotrexate is
applied ONLY ONCE A WEEK.
The prescriber should specify the day of intake on the prescription.
The prescriber should ensure that patients or their carers will be
able to comply with the once wee
regimen.
Rheumatoid arthritis
The usual dose is 7.5 - 15 mg once weekly. The schedule may be
adjusted gradually to achiev