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MAXTREX TABLETS 10.0MG

Active substance(s): METHOTREXATE / METHOTREXATE / METHOTREXATE

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Package leaflet: Information for the user

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

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. What

you need to know
before you take Maxtrex
Do not take Maxtrex Tablets if you:

• 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).

FPO

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.

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.

Other medicines and Maxtrex Tablets

Tell your doctor or pharmacist 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:
• 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).
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, breast-feeding and fertility

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.

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.

Maxtrex Tablets contains lactose

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.

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.

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

Standard Legend

110819-12
2016‑0004964/2

FPO

Maxtrex
10 mg Tablets
methotrexate
®

Regular check–ups

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

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 the use of this
medicine, ask your doctor or pharmacist.

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.

Other side-effects that may occur are:

FPO









Standard Legend




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.

6. Contents

of the pack and
other 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 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 06/2016
Ref: MX 12_0

FPO

• 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 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.
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.










Expand Transcript

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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