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METHOTREXATE 2.5 MG TABLETS

Active substance: METHOTREXATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Methotrexate 2.5 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, pharmacist or nurse.
–– 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 you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet.
What is in this leaflet:
1. What Methotrexate is and what it is used for
2. What you need to know before you take
Methotrexate
3. How to take Methotrexate
4. Possible side effects
5. How to store Methotrexate
6. Contents of the pack and other information
1. What Methotrexate is and what it is
used for
The active substance of Methotrexate tablets,
methotrexate, is an antimetabolite and
immunosuppressant (medicine which affects
the reproduction of the body’s cells and
reduces the activity of the immune system).
Methotrexate is used to treat:
–– active rheumatoid arthritis in adult patients,
–– severe resistant disabling psoriasis,which is
not adequately responsive to other forms
of therapy such as phototherapy, PUVA, and
retinoids,
–– severe psoriatic arthritis in adult patients.
Your doctor will be able to explain how
Methotrexate tablets might help in your
particular condition.
2. What you need to know before you
take Methotrexate
Do not take Methotrexate:
–– if you have significant liver disease (your
doctor decides the severity of your disease).
–– if you have significant kidney disease (your
doctor decides the severity of your disease).
–– if you have or have had a bone marrow
disease or serious blood disorders.
–– if you are allergic (hypersensitive)
to methotrexate or any of the other
ingredients of Methotrexate tablets.
–– if you are pregnant or breast-feeding (see
also section “Pregnancy, breast-feeding and
fertility”).
–– if you have severe acute or chronic
infections or immunodeficiency syndrome.
–– if you suffer from alcoholism.
Warnings and precautions
Please tell your doctor or pharmacist if any
of the following conditions concern or have
concerned you:
–– Diabetes mellitus treated with insulin.
–– You have received any vaccinations recently
or are you due to have any
–– You are using any other medicines or
vitamin products (Please see section “Other
medicines and Methotrexate”)
–– You have infections
–– You have ulcerations in your stomach or
bowel (peptic ulcer or ulcerative colitis)
–– You are in poor general condition
–– You have or have had any liver or kidney
disease.
Methotrexate temporarily affects sperm and
egg production. You and your partner should
avoid conception (becoming pregnant or
fathering children) if currently receiving
methotrexate and for at least six months
after your treatment with methotrexate has
stopped. See also section “Pregnancy, breastfeeding and fertility”.
Before treatment is started your doctor may
carry out blood tests, 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.
Other medicines and Methotrexate
Other concomitant medication may affect
the efficacy and safety of this medicine.
Methotrexate may also affect the efficacy and
safety of other medications.
Please tell your doctor or pharmacist if you
are taking, have recently taken or might take
any other medicines, including medicines
obtained without a prescription and herbal
or natural medicinal products. Remember to
tell your doctor about your treatment with
Methotrexate, if you are prescribed another
medicine while the treatment is still ongoing. It
is especially important to tell your doctor if you
are using:
–– certain antibiotics (such as penicillins,
sulfonamides, trimethoprim/
sulfamethoxazole, tetracycline and
chloramphenicol);
–– agents that may be harmful to kidneys and
liver [e.g. sulfasalazine and leflunomide
(medicines for rheumatic diseases), vitamin

A and its derivatives, alcohol];
–– anticancer agents (e.g. cisplatin,
mercaptopurine);
–– phenytoin (medicine often used to treat
epilepsy);
–– aspirin or similar medicines (known as
salicylates);
–– non-steroidal anti-inflammatory medicines
(medicines taken for pain relief ) e.g.
ibuprofen and pyrazoles;
–– medicines taken to help control
rheumatism e.g. azathioprine;
–– omeprazole or pantoprazole (medicine
used to stop the production of stomach
acid);
–– diuretics, triamterene (water tablets);
–– probenecid (medicine used to treat gout);
–– folic acid (vitamin preparation);
–– theophylline (medicine used to treat
respiratory diseases);
–– cyclosporine (an agent that can suppress or
prevent the immune response).
Tell your physician about use of Methotrexate
during your next visits.
Methotrexate with food, drink and alcohol
Alcohol should be avoided during
methotrexate therapy.
Pregnancy, breast-feeding and fertility
Pregnancy
Do not use Methotrexate during pregnancy
or if you are trying to become pregnant.
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. Therefore, in women of
child-bearing age any possibility of pregnancy
must be excluded with appropriate
measures, e.g. a pregnancy test, before
starting treatment. You must avoid becoming
pregnant whilst taking methotrexate and
for at least 6 months after treatment is
stopped. Therefore you must ensure reliable
contraception during this whole period
(see also section “Take special care with
Methotrexate”).
If you do become pregnant during treatment,
you should be offered advice regarding the
risk of harmful effects on the child through
treatment.
If you wish to become pregnant you should
consult a genetic information centre before
the planned start of treatment, because
methotrexate may be genotoxic, which
means that the medicine may cause genetic
mutation.
Breast-feeding
Do not breastfeed during treatment, because
methotrexate passes into breast milk. If your
attending doctor considers treatment with
methotrexate absolutely necessary during the
lactation period, you must stop breast-feeding.
Fertility
Male fertility
Methotrexate may be genotoxic. This means
that the medicine may cause genetic mutation.
Methotrexate can affect sperm and egg
production with the potential to cause birth
defects. Therefore, you must avoid fathering a
child whilst taking methotrexate and for at least 6
months after treatment is stopped.
Since treatment with methotrexate may lead to
infertility, it might be advisable for male patients
to look into the possibility of sperm preservation
before starting treatment (see also section “Take
special care with Methotrexate”).
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
You can feel fatigue and dizziness during
Methotrexate treatment. Do not drive or use
machines if you have such symptoms.
Methotrexate contains lactose
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 medicinal product.
3. How to take Methotrexate
Always take Methotrexate exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
–– Take Methotrexate once a week.
–– Patients with rheumatoid arthritis or
psoriasis will usually take their tablets orally
once a week on the same day each week.
–– Do not take tablets more often than your
doctor has told you to.
–– Daily administration can lead to serious
toxic effects, including death.Take the
tablets with a glass of water whilst sitting
upright or standing.
Dosage for rheumatoid arthritis, psoriasis and
severe psoriatic arthritis:
The recommended dose is 7.5 - 15 mg orally,
once weekly.
This should be adjusted according to your
response to treatment and side effects. Your
doctor may also instruct you to take the
weekly dose in three divided doses over 24 or
36 hours
If you take more Methotrexate than you
should
If you take (or someone else has taken)
more of the medicine than you should, a
physician or nearest hospital casualty
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department must be contacted immediately.
An overdose of methotrexate can lead to
severe toxic reactions, including death.
Overdose symptoms may include easy bruising
or bleeding, unusual weakness, mouth sores,
nausea, vomiting, black or bloody stools,
coughing up blood or vomit that looks like
coffee grounds, and decreased urinating. See
also section 4.
Take your medicine package with you if you
go to a doctor or hospital.
If you forget to take Methotrexate
Take the forgotten dose 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 a
forgotten dose.
Make sure before your holiday or trip that you
have enough of your medicine.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them. In
general, the incidence and severity of adverse
reactions of methotrexate are related to dose
and frequency of administration. Most adverse
reactions are reversible if detected early.
Most of the effects listed below will only be
seen in patients who are receiving high doses
of methotrexate to treat cancer. They are not
seen as often and are not as severe at the
doses used in the treatment of psoriasis or
rheumatoid arthritis.
Serious side effects
Contact your doctor or hospital emergency
department immediately if you have any of the
following symptoms:
• A cough producing a thick mucus, difficulty
breathing, fever or shortness of breath.
You may be suffering from pneumonitis,
pulmonary fibrosis or pneumonia. (Common:
may affect up to 1 in 10 people)
• Tightness in your chest, difficulty breathing,
swelling of the face, throat or hands, feeling
dizzy or faint. These could be signs of a severe
allergic reaction. (Uncommon: may affect up
to 1 in 100 people)
• Severe skin reactions, including peeling and
blistering of the skin, mouth, eyes and
genitals and numerous pus filled spots
with a fever. You could be suffering from
Stevens-Johnson syndrome or toxic epidermal necrolysis. (Uncommon: may affect up
to 1 in 100 people)
• Fever and deterioration of your general
condition, or fever with local infections
such as in the throat or mouth. You may
have a reduced number of white blood cells
(possibly due to bone marrow depression)
and your resistance to infection may be
decreased. (Uncommon: may affect up to 1
in 100 people)
• Loss of appetite, nausea, itchy skin, yellowing
of the skin or eyes, fever, swollen or tender
stomach. You may be suffering from
inflammation or damage of the liver. (Rare:
may affect up to 1 in 1,000 people)
• Vomiting blood, passing black tar-like stools
and pain in the stomach. You may have a
stomach ulcer or bleeding. (Rare: may
affect up to 1 in 1,000 people)
• Cramping pain, heavy ache or swelling in
the leg, redness, breathlessness, chest pain
or sudden collapse. You may have a blood
clot. (Rare: may affect up to 1 in 1,000
people)
• Blood in the urine, more or less frequent
urination or difficulty urinating, itching,
fever, tenderness of the stomach or pain in
the back or side. You may be suffering from
kidney damage. (Very rare: may affect up
to 1 in 10,000 people)
• A high temperature, chills and shivering, a
fast heartbeat, rapid breathing, confusion or
dizziness. You may have sepsis as the result
of an infection. (Not known: frequency cannot be estimated from the available data)
Common side effects (may affect up to 1 in
10 people):
Nausea, vomiting, diarrhoea, exhaustion,
tiredness, headache, dizziness, loss of
appetite, rash or large red spots on the skin,
hair loss, inflamed or sore mouth and lips, an
increase in liver enzymes.
Uncommon side effects (may affect up to 1 in
100 people):
Reduced blood clotting, changes to your
blood count, anaemia, nosebleed, itching,
vaginal ulcers, swelling of the lymph nodes.
Rare side-effects (may affect up to 1 in 1,000
people):
Depression, confusion, weakness on one side
of the body, diabetes , low blood pressure,
shortness of breath, inflamed gums, sore
throat, acne, whitening of the skin, raised
itchy rash, sensitivity to light, burning in
psoriatic lesions on the skin, skin ulcers,
appearance of local tissue lumps, shingles or
painful skin rash, osteoporosis, pain in joints
or muscles, menstrual disorders, difficulty
having an erection, reduced sex drive.
Very rare side-effects (may affect up to 1 in
10,000 people):
Reduced levels of antibodies, feeling irritable,

difficulty speaking or communicating, lack
of energy, blurred vision, eye infection,
fluid or swelling around the heart or lungs,
inflammation of blood vessels, chronic
obstructive lung disease, dry cough, vomiting
of blood, boils, blood like bruises or small
blood vessels on the surface of the skin, painful
urination, bladder inflammation, fertility
problems, low sperm count, infertility, vaginal
bleeding, enlargement of male breast tissue.
The following have also been reported but
the frequency is not known:
Abnormally low number of blood cells, sepsis
resulting in death, miscarriage, foetal damages,
increased risk of toxic reactions during
radiotherapy, increase in the number of white
blood cells and inflammation of the lung tissue.
Scaly, red skin patches associated with psoriasis
may get worse when exposed to sources of
ultraviolet light, such as the sun, and taking
Methotrexate.
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any side
effects not listed in this leaflet. Please note, some
of these side effects may only be detectable by
your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the national
reporting system, see below. By reporting side
effects you can help provide more information
on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
5. How to store Methotrexate
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the tablet container/blister
and the outer carton. The expiry date refers to
the last day of that month.
Keep the tablet container/blister in the outer
carton, in order to protect from light.
Proper procedures for safe handling of
cytotoxic agents should be administered.
Disposable gloves should be used when
handling methotrexate tablets. Pregnant
women should avoid handling methotrexate
tablets, if possible.
Any unused medicinal product or waste
material should be disposed of in accordance
with local requirements for cytotoxic agents.
Do not throw away any 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 Methotrexate contains
–– The active substance is methotrexate, each
tablet contains 2.5 mg.
–– The other ingredients are: Lactose
monohydrate, maize starch, starch,
pregelatinised (potato starch), polysorbate
80, cellulose, microcrystalline and
magnesium stearate.
What Methotrexate looks like and contents
of the pack
Tablet: Yellow, round, convex, engraved with
M 2.5 on one side, diameter 6 mm.
Methotrexate tablets are supplied in HDPE
containers of 12, 16, 24, 28, 30 and 100 tablets.
Methotrexate tablets are supplied in blister
packs containing 24 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1, FIN-02200 Espoo, Finland
Manufacturer
Orion Corporation, Orion Pharma
Orionintie 1 , FIN-02200 Espoo Finland
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Czech Republic
Trexan
Latvia
Lithuania
Slovakia
Sweden

Methotrexate Orion

Germany

MTX-Orion 2,5 mg
Tabletten
Methotrexate

Ireland
UK
France

Imeth

The information leaflet was last revised in:
January 2015

HPW :722814 GB2

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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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