METHOTREXATE TABLET 2.5MG

Active substance: METHOTREXATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Methotrexate 2.5 mg Tablets
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Methotrexate is and what it is used for
2. Before you take Methotrexate Tablets
3. How to take Methotrexate Tablets
4. Possible side effects
5. How to store Methotrexate Tablets
6. Further information

1. WHAT METHOTREXATE IS AND WHAT IT IS USED FOR
Methotrexate is an anti-metabolite medicine (medicine which affects how the
body’s cells grow) and immunosuppressant (medicine which reduces the activity
of the immune system).
Methotrexate is used in large doses (on its own or in combination with other
medicines) to treat certain types of cancer such as leukaemia. In smaller doses
it can be used to treat severe psoriasis (a skin disease with thickened patches of
inflamed red skin, often covered by silvery scales) or rheumatoid arthritis, when
other treatments are not effective.

2. BEFORE YOU USE METHOTREXATE TABLETS
Your doctor may perform several tests such as blood tests, x-rays and physical
examinations before treatment with Methotrexate tablets is started, and at regular
intervals during treatment.

Do not take Methotrexate Tablets
• if you have shown signs of hypersensitivity (severe allergy) to methotrexate, or
any of the other ingredients (see section 6) in the past
• if you have significant kidney or liver problems
• if you have been told you have (or think you have) a blood disorder such as
low levels of white blood cells, red blood cells (anaemia) or platelets
• if you are pregnant or breast feeding
Tell your doctor if any of the above applies to you before this medicine is used.

Take special care with Methotrexate Tablets
• if you have a stomach ulcer or ulcerative colitis (inflammation and ulceration of
the gut)
• if you have an infection
• if you have mild kidney problems
• if you have a medical condition which causes a build up of fluid in the lining
of your lungs or in your abdomen (the fluid will need to be drained before
methotrexate treatment is started)
• if you are to have radiotherapy (risk of tissue and bone damage may be
increased)
• if you are to have any vaccinations
Tell your doctor if any of the above applies to you before this medicine is used.
Special care is also needed in children, the elderly and in those who are in poor
physical condition.

Taking/using other medicines
Special care is needed if you are taking/using other medicines as some could
interact with methotrexate, for example:
• non-steroidal anti-inflammatory medicines e.g. ibuprofen (medicines taken for
pain relief)
• aspirin or similar medicines (known as salicylates)
• medicines taken to help control rheumatism e.g. leflunomide, azathioprine and
sulphasalazine
• omeprazole (medicine used to stop the production of stomach acid)
• diuretics (water tablets)
• medicines used/taken for diabetes (including insulin and tablets)
• antibiotics such as penicillins, sulphonamides, co-trimoxazole, trimethoprim,
tetracycline, chloramphenicol and para-aminobenzoic acid
• phenytoin (medicine often used to treat epilepsy)
• vitamin supplements containing folic acid
• probenecid (medicine used to treat gout)
• nitrous oxide (used for general anaesthesia and pain relief)
• retinoids, such as acitretin (a medicine used to treat psoriasis) or isotretinoin
(used to treat severe acne)
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.

Taking Methotrexate Tablets and drinking alcohol
Alcohol increases the risk of liver damage with methotrexate and it should be
avoided during the full period of treatment.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding
before this medicine is used.
This medicine must not be used during pregnancy other than in the most
exceptional circumstances in the treatment of cancer; where the potential benefit
to the mother is considered to be greater than the risk to the unborn baby.
Mothers must not breast-feed whilst treatment with methotrexate in ongoing.
Due to the risk of birth defects, both men and women must avoid conception
during methotrexate treatment and for at least 6 months after treatment is
stopped.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Do not drive or use machines if you experience any side effect (e.g. dizziness,
drowsiness or blurred vision) which may lessen your ability to do so.

Important information about one of the ingredients of Methotrexate Tablets
These tablets contain lactose. If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO USE METHOTREXATE TABLETS
Always take these tablets exactly as your doctor has instructed you. You should
check with your doctor or pharmacist if you are unsure.
The tablets should be swallowed whole with a drink of water whilst sitting upright
or standing.
Q73283

110811-5

Component Specification

Requester

Item number:

Q73283

Request number:

AS1878

Country:

United Kingdom

Inventory code(s):

M8731A001

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q61943
Latest QP Release Date:

OI template:
Amalia version:
Mulgrave version:

OR004
3
N/A

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

140 x 480 mm
tablet bottle
Orion Pharma
N/A
Unknown
Yes
No

Pharma code:
Pharma code length:
Supplier Code:

1139 (1112221211)
18 mm
110811-5

Colours
Black:

Signed:
Date:

Version 1
Technician:
Date:

NC
12/Apr/12

Version 2
Technician:
Date:

KN
12/Apr/12

Version 3
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Date:

KN
13/Apr/12

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Dose
Rheumatoid arthritis:
Take methotrexate tablets once a week. The dose usually starts at 7.5 mg per
week but may rise to 20 mg per week.
Psoriasis:
Take methotrexate tablets once a week. The dose is usually between 10 to 25 mg
per week.
Cancer chemotherapy:
The dose will be calculated by your doctor and will depend on the type of cancer
being treated and your size. The tablets are normally taken daily for a number of
days followed by a rest period, after which treatment is started again.
Before treatment is started your doctor may carry out blood tests to check the
levels of cells in your blood, and also to check how well your kidneys and liver are
working. You may also have a chest X-ray. Further tests may also be done during
and after treatment. Do not miss appointments for blood tests.

If you take more Methotrexate Tablets than you should
See your doctor or go to a hospital Accident and Emergency (Casualty)
Department at once. Take your medicine container and show it to the doctor or
nurse who treats you.

If you forget to take Methotrexate Tablets
If you forget to take your tablet(s), do not take a double dose to make up for
forgotten tablets. Ask your doctor for advice.

4. POSSIBLE SIDE EFFECTS
Like all medicines, methotrexate can cause side effects, although not
everybody gets them. However, Methotrexate is a very toxic medicine and
some patients have died, or become very ill whilst being treated with it. During
treatment you should watch for any side effects and report them to your doctor.

If any of the following happen, tell your doctor immediately:
• severe allergic reaction - you may experience a sudden itchy rash (hives),
swelling of the hands, feet, ankles, face, lips, mouth or throat (which may
cause difficulty in swallowing or breathing), and you may feel you are going to
faint
• inflammation of the lung with breathlessness – you may develop a persistent
cough, experience pain or difficulty breathing, or become breathless
• symptoms of an infection e.g. fever, chills, achiness, sore throat
• unexpected bleeding e.g. bleeding gums, blood in the urine or in vomit, or the
appearance of unexpected bruises or broken blood vessels (broken veins)
• black tarry stools
• a sore mouth, particularly if you have a number of ulcers or blisters inside of
the mouth or on the tongue
• skin rashes or blistering to the surfaces of the eyes, nose, vagina or anus
(back passage)
• inflammation of the vagina
• diarrhoea
These are serious side effects. You may need urgent medical attention.

If any of the following happen, tell your doctor as soon as possible:




















fits
blurred vision
dizziness
difficulty with speech
muscle weakness
diabetes (you may feel the need to drink more than usual)
abnormally easily broken bones (osteoporosis)
vasculitis (pain or redness of the blood vessels)
itching or the appearance of lightened patches on the skin, bruises, boils and
increased sensitivity to sunlight
jaundice (yellowing of the skin)
pain in the stomach, loins or abdomen
cystitis (you may need to pass urine more often than usual, which may be
painful)
eye irritation
headaches
drowsiness
reduced appetite, feeling or being sick
irregular periods in women (periods may stop completely)
loss of libido/impotence
hair loss

Methotrexate may lead to problems with your blood, liver and kidneys. Your
doctor will take blood samples to check for these problems and may ask you to
have a small sample of your liver taken for testing (liver biopsy).
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.

Effects on fertility
Treatment with methotrexate may reduce fertility in men and women. Fertility is
thought to go back to normal after methotrexate treatment is stopped. Tell your
doctor if you have concerns.

5. HOW TO STORE METHOTREXATE TABLETS
Keep out of the reach and sight of children

Expiry
This medicine must not be used after the expiry date which is stated on the label
and carton after 'EXP'. Where only a month and year is stated, the expiry date
refers to the last day of that month.

Storage
There are no specific storage requirements.

Disposal
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6. FURTHER INFORMATION
What Methotrexate Tablets contain
The active substance is methotrexate. Each tablet contains 2.5 milligrams (mg) of
methotrexate.
The other ingredients are maize starch, lactose, pre-gelatinized starch,
polysorbate 80, microcrystalline cellulose and magnesium stearate.

What Methotrexate Tablets look like and contents of the pack
Methotrexate 2.5 mg Tablets are round, yellow and marked ‘M 2.5’ on one side.
Methotrexate 2.5 mg Tablets are supplied in plastic bottles containing 100 tablets.

Marketing authorisation holder and manufacturer
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire,
CV31 3RW, UK
This leaflet was last revised in April 2012.

Q73283

Component Specification

Requester

Item number:

Q73283

Request number:

AS1878

Country:

United Kingdom

Inventory code(s):

M8731A001

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q61943
Latest QP Release Date:

OI template:
Amalia version:
Mulgrave version:

OR004
3
N/A

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

140 x 480 mm
tablet bottle
Orion Pharma
N/A
Unknown
Yes
No

Pharma code:
Pharma code length:
Supplier Code:

1139 (1112221211)
18 mm
110811-5

Colours
Black:

Signed:
Date:

Version 1
Technician:
Date:

NC
12/Apr/12

Version 2
Technician:
Date:

KN
12/Apr/12

Version 3
Technician:
Date:

KN
13/Apr/12

Version 4
Technician:
Date:

XX
dd/mmm/yy

Version 5
Technician:
Date:

XX
dd/mmm/yy

Version 6
Technician:
Date:

XX
dd/mmm/yy

Version 7
Technician:
Date:

XX
dd/mmm/yy

Version 8
Technician:
Date:

XX
dd/mmm/yy

Version 9
Technician:
Date:

XX
dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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