Methotrexate Orion 10 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Methotrexate

Available from:

Orion Corporation

ATC code:

L01BA; L01BA01; L04AX; L04AX03

INN (International Name):

Methotrexate

Dosage:

10 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

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

Therapeutic area:

Folic acid analogues; methotrexate; Other immunosuppressants; methotrexate

Authorization status:

Marketed

Authorization date:

2016-10-21

Patient Information leaflet

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,

Summary of Product characteristics

Health Products Regulatory Authority
26 April 2023
CRN00DFH3
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methotrexate Orion 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains methotrexate disodium equivalent to 10 mg
methotrexate (anhydrous).
Excipient with known effect: 311.2 mg lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellow, capsule-shaped, convex, uncoated tablet, engraved with ORN 59
on one side and score on other side, length of 14 mm
and width of 6 mm.
The tablet can be divided 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 ONCE A WEEK.
The pr