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Active substance(s): METHOTREXATE

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Methotrexate 10mg tablets

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
- if you have significant kidney disease
(your doctor decides the severity of your
- 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
- 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
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, breast-feeding 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
- certain antibiotics (such as penicillins,
sulfonamides, trimethoprim/
sulfamethoxazole, tetracycline and
- agents that may be harmful to kidneys
and liver [e.g. sulfasalazine and
leflunomide (medicines for rheumatic
diseases), vitamin A and its derivatives,
- anticancer agents (e.g. cisplatin,
- phenytoin (medicine often used to treat

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
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.
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
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
- 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
If you take (or someone else has
taken) more of the medicine than you
should, a physician or nearest hospital
casualty department must be contacted
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.

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Myriad Pro / 9 pt

Your doctor will be able to explain how
Methotrexate Tablets might help in your
particular condition.

Pregnancy, breast-feeding and fertility
Do not use Methotrexate during
pregnancy or if you are trying to become
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 ”).

1/1 black

Methotrexate is used to treat:
- active rheumatoid arthritis in adult
- 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.

Taija Oksanen
Orion Oyj

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

Methotrexate with food, drink and
Alcohol should be avoided during
methotrexate therapy.

Pharmacode: 788

1. What Methotrexate is and what it is
used for

Tell your physician about use of
Methotrexate during your next visits.

140 x 480
140 x 240

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, 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
What is in this leaflet:
1. What Methotrexate is and what it is
used for
2. What you need to know before you take
3. How to take Methotrexate
4. Possible side effects
5. How to store Methotrexate
6. Contents of the pack and other

- aspirin or similar medicines (known as
- 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
- 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).

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
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
• 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
• 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.

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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
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
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
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
and the outer carton. The expiry date refers
to the last day of that month.
Keep the tablet container 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
What Methotrexate contains
- The active substance is methotrexate,
each tablet contains 10 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, convex, capsule-shaped,
scored and engraved with M 10 on one side,
length 8 mm, breadth 4.5 mm. The tablet
can be divided into equal halves.
Pack sizes 10, 16, 24, 25, 30 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FIN-02200 Espoo
Orion Corporation, Orion Pharma
Orionintie 1
FIN-02200 Espoo
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Czech Republic
MTX-Orion 10 mg
France Imeth
The information leaflet was last
revised in:
January 2015

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