Methotrexate 10mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Methotrexate

Tersedia dari:

Orion Pharma (UK) Ltd

Kode ATC:

L04AX03

INN (Nama Internasional):

Methotrexate

Dosis:

10mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 10010300; GTIN: 6432100013781 6432100058362

Selebaran informasi

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

Karakteristik produk

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