Methotrexate 10mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Methotrexate

MAH:

Wockhardt UK Ltd

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; GTIN: 5012727904474

PIL

METHOTREXATE 10MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is known by the above name but will be referred to as
Methotrexate throughout this leaflet.
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,
- severe psoriasis, especially plaque-type,
- psoriatic arthritis in adult patients who have tried other
treatments but their
illness has not improved.
Your doctor will be able to explain how Methotrexate 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).
- if you have significant kidney disease (your doctor decides the
severity of
your disease).
- if you have or have had a bone marrow disease or serious blood
disorders.
- if you are allergic (hypersensitive) to methotrexate or any of the
other
ingredients of Methotrexate tablets.
- if
you
are
pregnant
or
breast-feeding
(see
also
section
“Pregnancy,
breastfeeding and fertility”).
- if you have severe acute or chronic infections or immunodeficiency
syndrome.
- if you suffer from alcoholism.
WARNINGS AND PRECAUTIONS
Please tell your doctor or pharmacist if any of the following
conditions concern
or have concerned you:
- Diabetes mellitus treated with insulin.
- You have received any vaccinations recently or are you due to have
any
- You are using any other medicines or vitamin products (Please see
section
“Other medicines and Methotrexate”)
- You have infection

SPC

PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
Methotrexate 10 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methotrexate 10 mg per tablet.
Excipient with known effect:
Each tablet contains 38.5mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet for oral administration.
Scored yellow capsule shaped tablets marked ‘M10’ on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Severe forms of psoriasis vulgaris, particularly of the plaque type,
which cannot be sufficiently treated with conventional therapy such as
phototherapy and PUVA, and severe psoriatic arthritis.
•
Active rheumatoid arthritis in adult patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Methotrexate should only be prescribed by physicians with expertise in
the use
of methotrexate and a full understanding of the risks of methotrexate
therapy.
The prescriber should ensure that patients or their carers will be
able to comply
with the once weekly regimen.
IMPORTANT WARNING ABOUT THE DOSAGE OF METHOTREXATE
In the treatment of, psoriasis and rheumatoid arthritis Methotrexate
MUST ONLY
BE USED ONCE A WEEK. Dosage errors in the use of Methotrexate can
result in
serious adverse reactions, including death. Please read this section
of the
summary of product characteristics very carefully.
This medicine should be taken once a week.
Do not exceed the weekly dose of this medicine due to toxicity hazards
in psoriasis and
rheumatoid arthritis.
The prescriber may specify the day of intake on the prescription.
PSORIASIS
Before starting treatment it is advisable to give the patient a test
dose of 2.5-5.0 mg to
exclude unexpected toxic effects. If, one week later, appropriate
laboratory tests are
normal, treatment may be initiated.
The usual dose is 5-25 mg taken once weekly, starting with a low dose
and
increasing as necessary.
The prescriber should specify the day of intake on the prescription.
The patient should be fully informed of the risks involved and the
clinician
should pay par