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MAXTREX TABLETS 10.0MG

Active substance(s): METHOTREXATE

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Package leaflet: Information for the user

Maxtrex
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
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.

What is in this leaflet

1. What Maxtrex Tablets are and what they are
used for
2. What you need to know before you take Maxtrex
3. How to take Maxtrex
4. Possible side effects
5. How to store Maxtrex
6. Contents of the pack and other information

This includes the following medicines, as the effect
of Maxtex Tablets may be altered when they are
taken at the same time:
• vaccinations
• aspirin, ibuprofen, indometacin (NSAID’s,
non-steroidal anti-inflammatory drugs), which
are used for pain or inflammation
• antibiotics (used to treat bacterial infections
e.g. chloramphenicol, penicillin, sulphonamides,
co-trimoxazole, trimethoprim, ciprofloxacin and
tetracyclines)
• thiazides (a group of diuretics for fluid retention
e.g. bendroflumethiazide)
• hypoglycaemics (used for lowering blood sugar
levels e.g. metformin)
• p-aminobenzoic acid, acitretin (used to treat
psoriasis or skin disorders)
• diphenylhydantoins, phenytoin (used to treat
epilepsy)
• probenicid, sulfinpyrazone (used to treat gout)
• vitamin preparations containing folic acid or
similar products
• nitrous oxide (a gas used in general anaesthesia)
• levetiracetam (a medicine used to treat seizures
in epilepsy).
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.

1. What Maxtrex Tablets are
and what they are used for

Taking Maxtrex Tablets with food and
drink

Maxtrex Tablets contain the active ingredient
methotrexate. Methotrexate is referred to as a
cytotoxic, most commonly used to kill cells in
tumours.

Pregnancy, breast-feeding and fertility

Alcohol should be avoided while receiving
methotrexate.

Maxtrex Tablets can also be used to treat severe,
uncontrolled psoriasis. It is usually used for patients
who have tried other treatments but their condition
has not improved.
Methotrexate 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.
Maxtrex is used to treat a wide range of tumours, 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.

If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Methotrexate can cause birth defects, harm unborn
babies or cause miscarriages and so it is very
important that it is not given to pregnant patients
or patients planning to become pregnant. It may
also affect women’s periods; they may become
less frequent or stop completely. Methotrexate can
affect sperm and egg production with the potential
to cause birth defects. You and your partner should
avoid conception (becoming pregnant or fathering
children) for at least three months after your
treatment with methotrexate has stopped.
You should not take Maxtrex Tablets if you are
breast-feeding.

Maxtrex can be given alone or in combination with
other medicines.

Driving and using machines

Maxtrex Tablets may cause some side effects which
could affect your ability to drive or use machinery
for example drowsiness, loss of co-ordination or
blurred vision. If you experience these symptoms,
do not drive or use any tools or machinery. The full
list of side effects are listed in Section 4.

You should consult your doctor if you are unsure
why you have been given Maxtrex 10mg Tablets.

2. What you need to know
before you take Maxtrex

Maxtrex Tablets contains lactose

Do not take Maxtrex Tablets if you:

Lactose is a type of sugar. If you have been told that
you have an intolerance to some sugars, contact
your doctor before taking this medicine.

• are allergic to methotrexate, or any of the other
ingredients of this medicine (listed in section 6).
• are pregnant, trying to become pregnant or
breast-feeding. Methotrexate may harm your
baby (see section on Pregnancy). You and your
partner should avoid conception (becoming
pregnant or fathering children) for at least three
months after your treatment with methotrexate
has stopped.
• have severe liver problems (including fibrosis,
cirrhosis and recent or active hepatitis).
• have severe kidney problems, including
conditions requiring kidney dialysis.
• have any serious blood problems including
serious anaemia and clotting problems.
• have a medical condition or are receiving
medication which lowers your resistance to
infection.
• are taking antibiotics which prevent the
production of folic acid (vitamin B9) such as
co-trimoxazole, which are used to treat bacterial
infections.
• have an active infectious disease (e.g. fever,
chills, joint pain).

3. How to take Maxtrex
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The usual dose is:

Dosage for psoriasis:
Adults

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.

Elderly:

No dosage adjustment required.

Children:

Not recommended for use in children.

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

• Your doctor should give you a test dose of 5 to
10mg by injection one week before starting
treatment.
• The doctor will calculate the dosage required
from your body surface area (m2), and the dose is
expressed as mg/m2.
• Maxtrex Tablets are usually given as single doses,
not exceeding 30mg/m2, for up to five days.
• A rest period of at least two weeks is advised
between treatments, to allow recovery from any
side effects.

Warnings and precautions

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 illness,
• 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.

• Doses in excess of 100mg are usually given by
injection by your doctor or physician.
• Doses of more than 70mg/m2 should not be
administered without calcium folinate rescue or
blood levels of methotrexate being checked 24 to
48 hours after taking your medicine.
• These doses may be reduced if you are receiving
other medication. Your doctor will decide
the correct dose for you, if you want more
information you should ask your doctor.
If you have the impression that the effect of Maxtrex
Tablets is too strong or too weak, talk to your doctor
or pharmacist.

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.

Always take Maxtrex Tablets exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are still not sure.

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.

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.

Other medicines and Maxtrex Tablets

Tell your doctor or pharmacist if you are taking, have
recently taken, or might take any other medicines.

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

2017-0013096A

Date: 21 Dec 2017 Time: 20:15
New Component Nº 2017-0013096A
OLD Component Nº N/A

Packaging Site Orion Corporation
Barcode Nº N/A
Smallest

BODY TEXT Size 8.3 pt

Dimensions 140 x 480 mm
Notes N/A
PAR Number PAR-2017-0013096

Market United Kingdom
Proof Nº 01
Component Leaflet
Pharma Code FPO
Drawing Nº N/A

Colours
Printing

Non-Printing

Black

Profile

6. Contents of the pack and
other information

If you forget to take Maxtrex Tablets

If you forget to take a dose, take it as soon as you
remember if this is within two days. However, if
you have missed a dose by more than two days,
please contact your doctor for advice. Do not take
a double dose to make up for a missed dose.

What Maxtrex Tablets contains
Each tablet contains 10mg of the active ingredient
methotrexate.

If you stop taking Maxtrex Tablets

The other ingredients are maize starch,
lactose, pregelatinised starch, polysorbate 80,
microcrystalline cellulose, magnesium stearate and
purified water.

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.

What Maxtrex Tablets looks like and
contents of the pack

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Maxtrex 10mg Tablets are yellow, elongated like
a capsule and is scored and marked ‘M10’ on the
same side of the tablet.

4. Possible side effects
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 becoming breathless, methotrexate can
cause diseases of the lung 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.
• Loss of coordination, loss of ability to
speak or understand speech, weakness and
inability to move one side of the body or the
whole body, convulsions or fits.
• Swelling of the hands, ankles or feet
(which may be a sign of kidney damage).
• Yellowing of the skin and whites of the eye
(a sign of liver damage).
• 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.

The tablet has a deeper scoreline to help it to break
more easily.
Maxtrex Tablets are available in plastic bottles
containing 100 tablets.

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

Manufacturer

Orion Corporation,
Orion Pharma
Orionintie 1
FI-02200
Espoo
Finland

Company Contact address:

For further information please contact Medical
Information at Pfizer Limited on 01304 616161.
This leaflet was last revised in 10/2017
Ref: MX 13_1

Other side-effects that may occur are:















































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 diabetes
Inability to move
Inability to move in one half of the body
Dizziness
Headaches, Blurred vision
Loss of ability to speak or understand speech
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)
Loss of interest in, or inability to have sex
Stomach pains and soreness of the mouth,
throat and lips
Inflamed blood vessels
Feeling sick, being sick and/or diarrhoea,
decreased absorption from intestines
Irritation or swelling of the vaginal tissues
Vaginal ulcers
Pain or difficulty in passing urine
The need to pass urine more often than usual
Joint and muscle pain
Chills and fever
Changes in skin colouration
Hair loss
Red spots on the skin, skin lesions, acne, boils
Flaking skin, redness
Itchiness and rash
Sensitivity to light
Eye irritation
Tiredness
General feeling of illness
Other metabolic changes

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.

5. How to store Maxtrex
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stamped on the carton and label. The
expiry date refers to the last day of that month.
Do not throw medicines via wastewater or
household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

Date: 21 Dec 2017 Time: 20:15
New Component Nº 2017-0013096A
OLD Component Nº N/A

Packaging Site Orion Corporation
Barcode Nº N/A
Smallest

BODY TEXT Size 8.3 pt

Dimensions 140 x 480 mm
Notes N/A
PAR Number PAR-2017-0013096

Market United Kingdom
Proof Nº 01
Component Leaflet
Pharma Code FPO
Drawing Nº N/A

Colours
Printing

Non-Printing

Black

Profile

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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