Methotrexate 2.5mg tablets

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

METHOTREXATE

Saatavilla:

Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom

ATC-koodi:

L04AX03

INN (Kansainvälinen yleisnimi):

METHOTREXATE 2.5 mg

Lääkemuoto:

TABLET

Koostumus:

METHOTREXATE 2.5 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

IMMUNOSUPPRESSANTS

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2015-01-12

Pakkausseloste

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE 2.5 MG TABLETS
METHOTREXATE 10 MG TABLETS
methotrexate
▼DO NOT EXCEED THE WEEKLY DOSE OF THIS MEDICINE DUE TO TOXICITY
HAZARDS.
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, 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 Tablets are and what they are 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 TABLETS ARE AND WHAT THEY ARE USED FOR
Methotrexate Tablets contain the active ingredient methotrexate.
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, in patients who have tried
other treatments but their
illness has not improved,
-
severe psoriatic arthritis.
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 TABLETS
DO NOT TAKE METHOTREXATE TABLETS:

if you are allergic (hypersensitive) to methotrexate, or any of the
other ingredients of this medicine
(listed in section 6);

if you are pregnant or breast-feeding (see section “Pregnancy,
breast-feeding and fertility”);

if you have significant liver disease (your doctor decides

Valmisteyhteenveto

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Methotrexate 2.5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.5 mg tablet: each tablet contain methotrexate 2.5mg
Excipients with known effects
Each 2.5 mg tablet contain 12.50 mg lactose (as lactose monohydrate)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
2.5 mg tablet: yellow, circular, biconvex uncoated tablets with
dimension of 4.50 mm ± 0.20 mm
plain on both sides
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Active rheumatoid arthritis in adult patients.

Severe forms of psoriasis vulgaris, particularly of the plaque type,
which cannot be sufficiently
treated with conventional therapy such as phototherapy, PUVA, and
retinoids, and severe
psoriatic arthritis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
Rheumatoid arthritis
The usual dose is 7.5 - 15 mg once weekly. The planned weekly dose may
be administered in three
divided doses over 36 hours. The schedule may be adjusted gradually to
achieve an optimal response
but should not exceed a total weekly dose of 20 mg. Thereafter the
dose should be reduced to the
lowest possible effective dose which in most cases is achieved within
6 weeks.
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 7.5–15 mg taken once weekly. The
planned weekly dose administered as
three divided doses over 24 hours. As necessary, the total weekly dose
can be increased up to 25 mg.
Page 2 of 13
Thereafter the dose should be reduced to the lowest effective dose
according to therapeutic response
which in most cases is achieved within 4 to 8 weeks.
The