Methotrexate Orion 2.5 mg tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Methotrexate

Disponibil de la:

Orion Corporation

Codul ATC:

L01BA; L01BA01; L04AX; L04AX03

INN (nume internaţional):

Methotrexate

Dozare:

2.5 milligram(s)

Forma farmaceutică:

Tablet

Tip de prescriptie medicala:

Product subject to prescription which may not be renewed (A)

Zonă Terapeutică:

Folic acid analogues; methotrexate; Other immunosuppressants; methotrexate

Statutul autorizaţiei:

Marketed

Data de autorizare:

2016-10-21

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE ORION 2.5 AND 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 Orion is and what it is used for
2.
What you need to know before you take Methotrexate Orion
3.
How to take Methotrexate Orion
4.
Possible side effects
5.
How to store Methotrexate Orion
6.
Contents of the pack and other information
1.
WHAT METHOTREXATE ORION IS AND WHAT IT IS USED FOR
The active substance of Methotrexate Orion tablets, methotrexate, is a
substance with the following
properties:
-
it suppresses the growth of certain cells in the body that reproduce
quickly
-
it reduces the activity of the immune system (the body’s own defence
mechanism).
Methotrexate is used to treat:
-
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 in adult patients
-
severe psoriatic arthritis in adult patients
-
maintenance treatment of acute lymphoblastic leukaemia (ALL) in
adults, adolescents and children aged
3 years and over.
Your doctor will be able to explain how Methotrexate Orion tablets
might help you in your particular
condition.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHOTREXATE ORION
DO NOT TAKE METHOTREXATE ORION:
-
if you are allergic (hypersensitive) to methotrexate, or any of the
other ingredients of this medicine
(listed in section 6)
-
if you are breast-feeding and additionally,

Caracteristicilor produsului

Health Products Regulatory Authority
26 April 2023
CRN00DFH3
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methotrexate Orion 2.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains methotrexate disodium equivalent to 2.5 mg
methotrexate (anhydrous).
Excipient with known effect: 77.8 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellow, round, uncoated, flat tablet, scored and engraved with ORN 57
on one side, diameter 6 mm. The score line is only to
facilitate breaking for ease of swallowing and not to divide into
equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

_Antirheumatic:_ Active rheumatoid arthritis in adult patients

_Antipsoriatic:_ 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

_Cytostatic_: Maintenance treatment of acute lymphoblastic leukaemia
(ALL) in adults, adolescents and children aged
3 years and over.
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.
IMPORTANT WARNING WITH REFERENCE TO THE DOSING OF METHOTREXATE ORION
(METHOTREXATE): In the treatment of rheumatic
diseases, psoriasis or severe psoriatic arthritis, Methotrexate Orion
(methotrexate) MUST ONLY BE TAKEN ONCE A WEEK. Dosage
errors in the use of Methotrexate Orion (methotrexate) can result in
serious adverse reactions, including death. Please read this
section of the summary of product characteristics very carefully.
The prescriber should ensure that patients or their carers will be
able to comply with the once weekly regimen.
It must be explicitly pointed out to the patient that for the therapy
of rheumatic diseases, psoriasis or severe psoriatic arthritis
methotrexate is administered ONLY O