Methotrexate 2.5mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Methotrexate

Disponible des:

Cipla EU Ltd

Codi ATC:

L04AX03

Designació comuna internacional (DCI):

Methotrexate

Dosis:

2.5mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 10010300; GTIN: 8901117248366 8901117079892

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE 2.5 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 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 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 TABLETS
DO NOT TAKE METHOTREXATE TABLETS:

if you are allergic 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 the
severity of your disease);

if you have significant kidney disease (

Fitxa tècnica

OBJECT 1
METHOTREXATE 2.5 MG TABLETS
Summary of Product Characteristics Updated 07-Oct-2020 | Cipla EU Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Methotrexate 2.5 mg Tablets
2. Qualitative and quantitative composition
Methotrexate 2.5 mg tablet
Each tablet contains methotrexate 2.5 mg.
Excipient with known effect
Each tablet contains 12.50 mg lactose (as lactose monohydrate).
Each tablet contains 0.076 mg sodium
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
Methotrexate 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 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
IMPORTAN