Active substance: METHOTREXATE

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Package leaflet: Information for the user

Regular Check–ups


Whilst being treated with this medicine your
doctor will want to monitor your progress on
a weekly basis until your therapy is stable.
Thereafter, you will be monitored every 2 to
3 months, whilst taking the medicine.
These checks may include taking blood and
urine samples to check your blood cells and
to make sure that your liver and kidneys are
working properly. It is important that you do not
miss any blood tests.
There may also be a chest x-ray and a physical
examination to check for swelling of your lymph
nodes (glands in your neck, armpits and groin).
Any unusual swellings should also be reported
to your doctor.


2.5mg Tablets


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
• 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 or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.

Other medicines and Maxtrex Tablets

Talk to your doctor or pharmacist before
taking Maxtrex Tablets if you have any of
the following conditions. This will help them
decide if Maxtrex Tablets are suitable for you:
• have any mild or moderate kidney disease
• have any blood disorders or anaemia
• have diarrhoea
• have gastro-intestinal (digestive) problems,
• have or have ever suffered from mental
• received or you are receiving radiotherapy
(x-ray treatment)
• have received any vaccinations recently or
you are due to have any, as methotrexate
can reduce their effect
• have any symptoms or signs of infection
• have excess fluid, between the lungs and
chest wall or abdominal swelling (ascites),
• develop a persistent cough or develop
shortness of breath as it may be associated
with serious lung disease.


You will usually take your tablets once a week on
the same day each week. The dose will normally
be between 7.5 and 20mg. However, this may
be changed depending upon your response to


Elderly patients may need smaller doses of


Not recommended for use in children.

Dosage for psoriasis:

For severe psoriasis, the usual dose is 10 to
25mg by mouth, once a week on the same day
each week. This should be adjusted according
to your response to treatment and side effects.


No dosage adjustment required.


Not recommended for use in children.

You will find more about MAXTREX on the
back of this leaflet.


Warnings and precautions


Tell your doctor or pharmacists if you are
taking, have recently taken, or might take any
other medicines. This includes the following
medicines, as the effect of Maxtex Tablets may
be altered when they are taken at the same time:
What is in this leaflet
• vaccinations
1.  hat Maxtrex Tablets are and what they • aspirin, ibuprofen, indometacin (NSAID’s,
non-steroidal anti-inflammatory drugs)
are used for
which are used for pain or inflammation
2.  hat you need to know before you take
• antibiotics (used to treat bacterial
Maxtrex Tablets
infections e.g. chloramphenicol,
3.  ow to take Maxtrex Tablets
penicillin, sulphonamides, co-trimoxazole,
4. Possible side effects
trimethoprim, ciprofloxacin and
5. How to store Maxtrex Tablets
6.  ontents of the pack and other information
• thiazides (a group of diuretics used
1. What Maxtrex Tablets for the treatment of fluid retention
e.g. bendroflumethiazide)
are and what they are • hypoglycaemics (used for lowering blood
sugar levels e.g. metformin)
used for
Maxtrex Tablets contain the active ingredient • p-aminobenzoic acid, acitretin (used to treat
psoriasis or skin disorders)
methotrexate. Methotrexate is referred to as a
cytotoxic medicine. It is most commonly used • diphenylhydantoins, phenytoin (used to
treat epilepsy)
to kill cells in tumours.
• probenicid, sulfinapyrazone (used to treat
Maxtrex Tablets can be used to treat rheumatoid
arthritis. It is usually used for patients who have
tried other treatments but their illness has not • vitamin preparations containing folic acid
or similar products
improved. In the treatment of rheumatoid
arthritis, methotrexate is thought to stop or • nitrous oxide (a gas used in general
reduce inflammation by altering the body’s
Please tell your doctor or pharmacist if you
Maxtrex Tablets can also be used to treat severe, are taking or have recently taken any other
uncontrolled psoriasis. It is usually used for medicines, including medicines obtained without
patients who have tried other treatments but a prescription.
their condition has not improved.
Taking Maxtrex Tablets with food and
Methotrexate helps patients with psoriasis by drink
killing the cells in the skin, which are growing Alcohol should be avoided while receiving
too quickly. It is these fast growing cells, which methotrexate.
cause the raised patches of skin in psoriasis.
Pregnancy, breast-feeding and
Maxtrex is used to treat a wide range of tumours, fertility
in particular:
If you are pregnant or breast-feeding, think you
• acute leukaemias,
may be pregnant or are planning to have a baby,
• Non-Hodgkin’s lymphoma,
ask your doctor or pharmacist for advice before
taking this medicine.
• soft tissue and bone sarcomas,
• solid tumours like breast, lung, head Methotrexate can cause birth defects, harm
and neck, bladder, cervical, ovarian and unborn babies or cause miscarriages and
testicular cancer.
so it is very important that it is not given to
Maxtrex can be given alone or in combination pregnant patients or patients planning to
become pregnant. It may also affect women’s
with other medicines.
You should consult your doctor if you are unsure periods; they may become less frequent or stop
why you have been given Maxtrex 2.5mg Tablets. completely. Methotrexate can affect sperm and
egg production with the potential to cause birth
defects. You and your partner
2. What you need to know conception (becoming pregnantshould avoid
or fathering
before you take Maxtrex children) for at least three months after your
treatment with methotrexate has stopped.
You should not take Maxtrex Tablets if you are
Do not take Maxtrex Tablets if you:
• are allergic to methotrexate, or any of the
other ingredients of this medicine (listed in Driving and using machines
Maxtrex Tablets may cause some side effects
section 6).
• are pregnant, trying to become pregnant which could affect your ability to drive or use
or breast-feeding. Methotrexate may harm machinery for example drowsiness, loss of
your baby (see section on Pregnancy). You co-ordination or blurred vision. If you experience
and your partner should avoid conception these symptoms, do not drive or use any tools
(becoming pregnant or fathering children) or machinery. The full list of side effects are
for at least three months after your listed in Section 4.
treatment with methotrexate has stopped. Maxtrex Tablets contains lactose
• have severe liver problems, including Lactose is a type of sugar. If you have been told
fibrosis, cirrhosis and recent or active that you have an intolerance to some sugars,
contact your doctor before taking this medicine.
• have severe kidney problems, including
conditions requiring kidney dialysis.
3. How to take Maxtrex
• have any serious blood problems including
severe anaemia and clotting problems.
• have a medical condition or are receiving Always take this medicine exactly as your
medication which lowers your resistance doctor or pharmacist has told you. Check with
to infection.
your doctor or pharmacist if you are not sure.
• are taking antibiotics which prevent the
Alcohol should be avoided while receiving
production of folic acid (vitamin B9) such
as co-trimoxazole, which are used to treat
The usual dose is:
bacterial infections.
• have an active infectious disease (e.g. fever, Dosage for rheumatoid arthritis:
chills, joint pain).

Dosage for treatment of cancer:
Adults, the Elderly and Children

• Loss of interest in, or inability to have sex
• Stomach pains and soreness of the mouth,
throat and lips
• Your doctor should give you a test dose of
5 to 10mg by injection one week before • Inflamed blood vessels
• Feeling sick, being sick and/or diarrhoea,
starting treatment.
decreased absorption from intestines
• The doctor will calculate the dosage
required from your body surface area (m2), • Irritation or swelling of the vaginal tissues
• Vaginal ulcers
and the dose expressed as mg/m2.
• Pain or difficulty in passing urine
• Maxtrex Tablets are usually given as single • The need to pass urine more often than
doses, not exceeding 30mg/m , for up to
five days.
• Joint and muscle pain
• A rest period of at least two weeks is • Chills and fever
advised between treatments, to allow • Changes in skin colouration
recovery from any side effects.
• Hair loss
• Doses in excess of 100mg are usually given • Red spots on the skin, skin lesions, acne,
by injection by your doctor or physician.
• Doses of more than 70mg/m2 should not • Flaking skin, redness
be administered without calcium folinate • Itchiness and rash
rescue or blood levels of methotrexate • Sensitivity to light
being checked 24 to 48 hours after taking • Eye irritation
your medicine.
• Tiredness
• These doses may be reduced if you are • General feeling of illness
receiving other medication. Your doctor • Other metabolic changes
will decide the correct dose for you, if you Reporting of side effects
want more information you should ask If you get any side effects, talk to your doctor
your doctor.
or pharmacist. This includes any possible side
If you have the impression that the effect of effects not listed in this leaflet.
Maxtrex Tablets is too strong or too weak, talk You can also report side effects directly via the
to your doctor or pharmacist.
Yellow Card Scheme at:
Always take Maxtrex Tablets exactly as your By reporting
doctor has told you. You should check with your side effects you can help provide more
information on the safety of this medicine.
doctor or pharmacist if you are still not sure.

If you take more Maxtrex Tablets than
you should

If you accidentally take too many Maxtrex
Tablets contact your doctor at once or go to
the nearest hospital casualty department.
Always take the labelled medicine package
with you, whether there are any Maxtrex
Tablets left or not.
Inappropriate intake resulting in overdose can
sometimes lead to death.

5. How to store Maxtrex

Keep this medicine out of the sight and reach
of children.
Keep the blister in the outer carton in order to
protect from light.
Do not use this medicine after the expiry date
which is stamped on the carton and label. The
If you forget to take Maxtrex Tablets expiry date refers to the last day of that month.
If you forget to take a dose, take it as soon Do not throw away any medicines via
as you remember if this is within two days. wastewater or household waste. Ask your
However, if you have missed a dose by more pharmacist how to throw away medicines you
than two days, please contact your doctor for no longer use. These measures will help protect
advice. Do not take a double dose to make the environment.
up for a missed dose.



If you stop taking Maxtrex Tablets

Do not stop taking Maxtrex Tablets unless your
doctor tells you to. Should you need to stop
taking Maxtrex Tablets, your doctor will have
decided which is the best method for you.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects

• Drowsiness
• Convulsions
• Loss of coordination
• Confusion
• Liver damage (seen as yellowing of the skin
and whites of the eye)
• Kidney damage
• Low levels of white and red blood cells and
cells that clot blood
• Infection, reduced resistance to infection
• Abnormal red blood cell function
• May encourage the development of
• Inability to move
• Inability to move in one half of the body
• Dizziness
• Headaches, Blurred vision
• Loss of ability to speak or understand
• Slow thought process
• Mood alteration
• Black or tarry stools
• Skin ulcers and erosions of inflamed areas,
in psoriasis patients
• Damaged skin becomes inflamed on
re-exposure to radiation and sunlight
• Reduced ability to become pregnant and
reduced ability to father children
• Blood in the urine
• Raised liver enzymes
• Weakening or softening of bones
• Unusual sensations in the head
• Anorexia (eating disorders)

Each tablet contains 2.5mg of the active
ingredient methotrexate.
The other ingredients are maize starch,
lactose, pregelatinised starch, polysorbate 80,
microcrystalline cellulose, magnesium stearate
and purified water.

What Maxtrex Tablets looks like and
contents of the pack
Maxtrex 2.5mg Tablets are yellow, round in
shape and have ‘M2.5’ written on one side of
the tablets.
Maxtrex Tablets are available in plastic bottles
containing 100 tablets.
Maxtrex Tablets are also available in packs
containing 2 blisters with 12 tablets in each
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Kent, CT13 9NJ
United Kingdom

Orion Corporation
PO Box 425 
SF 20101 

Company Contact address:

For further information please contact
Medical Information at Pfizer Limited on
01304 616161.
This leaflet was last revised in 06/2014
Ref: MX 9_0



Other side effects that may occur are:

What Maxtrex Tablets contains


Like all medicines, this medicine can
cause side effects, although not everybody
gets them.
Tell your doctor immediately if you experience
any of the following symptoms after taking this
medicine. Although they are very rare, these
symptoms can be serious.
• Severe skin rash that causes blistering,
(this can affect the mouth and tongue).
These may be signs of a condition known
as Stevens Johnson Syndrome. Your doctor
will stop your treatment in these cases.
• Persistent cough, pain or difficulty
breathing or become breathless;
methotrexate can cause diseases of the
lungs e.g. fluid in lungs.
• Skin rash and fever with swollen glands,
particularly in the first two months of
treatment, as these may be signs of a
hypersensitivity reaction.
• Sore throat, fever, chills or achiness;
methotrexate can make you more likely to
catch infections.
• Severe allergic reaction (anaphylactic
reaction) – although very rare you may
experience a sudden itchy skin rash (hives),
swelling of the hands, feet, ankles, face,
lips, mouth or throat (which may cause
difficulty in swallowing or breathing),
wheeze, and you may feel you are going
to faint. If this happens you should seek
medical attention immediately.

6. Contents of the pack
and other information

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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.