Methotrexate 10mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Methotrexate

Disponibil de la:

A A H Pharmaceuticals Ltd

Codul ATC:

L04AX03

INN (nume internaţional):

Methotrexate

Dozare:

10mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 10010300; GTIN: 5025903092834

Prospect

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

Caracteristicilor produsului

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