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MAXTREX TABLETS 10.0MG

Active substance(s): METHOTREXATE

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Package leaflet: Information for the user
®

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 get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:

1. What Maxtrex Tablets are and what
they are used for
2. Before you take Maxtrex
3. How to take Maxtrex
4. Possible side effects
5. How to store Maxtrex
6. Further information

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

Maxtrex Tablets contain the active ingredient
methotrexate. Methotrexate is referred to as a
cytotoxic, most commonly used to kill cells in tumours.
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.
Maxtrex can be given alone or in combination with
other medicines.
You should consult your doctor if you are unsure why
you have been given Maxtrex 10mg Tablets.

2. Before you take Maxtrex
Do not take Maxtrex Tablets if you:

• are allergic (hypersensitive) to methotrexate, or
any of the other ingredients of Maxtrex 10mg
Tablets, refer to 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).

Take special care with Maxtrex Tablets

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.

Taking other medicines

Some medicines can affect the way Maxtrex Tablets
work, or Maxtrex Tablets can reduce the effectiveness
of other medicines taken at the same time.
These include:
• vaccinations
• aspirin, ibuprofen, indometacin (NSAID’s, nonsteroidal 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).
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.

Taking Maxtrex Tablets with food and drink

Alcohol should be avoided while receiving methotrexate.

Pregnancy

If you think you might be pregnant, or are planning
to get pregnant, tell your doctor before you take
Maxtrex Tablets.
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.

Breast-feeding

You should not take Maxtrex Tablets if you are
breast-feeding.
Ask your doctor or pharmacist for advice before
taking any medicine.

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.

Important information about some of the
ingredients of Maxtrex Tablets

Maxtrex Tablets contains lactose, a type of sugar. If
you have been told that you have an intolerance to
some sugars, contact your doctor before taking this
medicinal product.
You will find more about MAXTREX on
the back of this leaflet

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221

Medicines are not always suitable for everyone. Tell
your doctor before you take Maxtrex Tablets if you
suffer from or have suffered in the past from any of
the following conditions:
• 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,

Regular check–ups

2014-0020249/1

221

methotrexate

FPO

Maxtrex 10 mg Tablets

• 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).

3. How to take Maxtrex

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.
• 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 leucovorin rescue (folinic
acid 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.
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.

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.

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.

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 how to take this
product, ask your doctor or pharmacist.

4. Possible side effects

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221

Like all medicines, Maxtrex Tablets 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
inflammation of the 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.

Other side effects that may occur are:

• drowsiness
• confusion
• dizziness
• weakening or softening of bones
• stomach pains
• reduced resistance to infection
• joint and muscle pain, chills and fever
• headaches, blurred vision
• mood swings
• tingly sensations in the head
• tiredness
• general feeling of illness
• flaking skin, redness
• itchiness and rash
• sensitivity to light
• inflamed skin (rash) triggered by sunlight
• changes in skin colour
• hair loss
• red spots on the skin, skin lesions, acne, boils
• skin ulcers and breakdown of inflamed areas in
patients with psoriasis
• soreness of the mouth, throat and lips
• black or tarry stools, diarrhoea
• feeling sick and vomiting with anorexia
• increased risk of diabetes
• low levels of white and red blood cells and cells
that clot blood
• pain or difficulty passing urine or increased need
to pass urine, blood in the urine
• loss of interest in, or inability to have sex
• irritation or swelling of the vaginal tissues,
vaginal ulcers
• reduced ability to become pregnant or for a man
to father children
• eye irritation
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.

5. How to store Maxtrex

Keep out of the reach and sight of children.
Do not use Maxtrex Tablets after the expiry date
which is stamped on the carton and label. The expiry
date refers to the last day of that month.
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 Maxtrex Tablets contains

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

PFIZER Limited, Ramsgate Road, Sandwich,
Kent CT13 9NJ, United Kingdom.

Manufacturer

Orion Corporation, Farmos, PO Box 425,
SF 20101, Turku, Finland.

Company Contact address

If you have any comments on the way this leaflet is
written, please contact Medical Information at Pfizer
Limited in Walton Oaks, Tadworth, Surrey.
Tel: 01304 616161.
This leaflet was last revised in 09/2014.
Ref: MX 9_0

221

Dosage for psoriasis:

• 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.

FPO

Always take Maxtrex Tablets exactly as your doctor
has instructed you. You should check with your
doctor or pharmacist if you are unsure.
The usual dose is:

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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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