Methotrexate 2.5mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Methotrexate

Dostępny od:

Advanz Pharma

Kod ATC:

L04AX03

INN (International Nazwa):

Methotrexate

Dawkowanie:

2.5mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 10010300; GTIN: 5021691107828

Ulotka dla pacjenta

Package leaflet: Information for the patient
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, 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 2.5 mg Tablets are and what they are used for
2. What you need to know before you take Methotrexate 2.5 mg Tablets
3. How to take Methotrexate 2.5 mg Tablets
4. Possible side effects
5. How to store Methotrexate 2.5 mg Tablets
6. Contents of the pack and other information
1. What Methotrexate 2.5 mg Tablets are and what they are used for
Methotrexate 2.5 mg Tablets are one of a group of medicines called
antimetabolites which affect
cell growth, including the growth of cancer cells.
Methotrexate can be used to treat severe cases of psoriasis (a skin
disease) and rheumatoid
arthritis (a disease of the joints). It is usually used for patients
who have tried other treatments
but their illness has not improved. It helps patients with psoriasis
by killing the cells in the skin
which are growing too quickly. It is these fast growing cells which
cause the raised patches of
skin in psoriasis.
In the treatment of rheumatoid arthritis, methotrexate is thought to
stop or reduce inflammation
in the joints by altering the body's defence mechanism in the immune
system.
Methotrexate can also be used to treat several kinds of cancer, in
particular:

acute leukaemias

Non-Hodgkin’s lymphoma

soft tissue and bone sarcomas

solid tumours like breast, lung, head and neck, bladder, cervical,
ovarian and testicular
cancer.
Methotrexate can be given al

Charakterystyka produktu

OBJECT 1
METHOTREXATE 2.5 MG TABLETS
Summary of Product Characteristics Updated 23-Jan-2020 | ADVANZ Pharma
•
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
Each tablet contains methotrexate sodium equivalent to 2.5 mg of
methotrexate.
Excipient(s) with known effect
Lactose monohydrate- 66.166 mg per tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
Round, biconvex, yellow tablets, engraved with “2.5” on one side.
Scored in half on the other side and
engraved with 'M' above the score line and '1' below it.
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
Methotrexate is a folic acid antagonist and is classified as an
antimetabolite cytotoxic agent.
Methotrexate has been used to produce regression in a wide range of
neoplastic conditions including
acute le