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METHOTREXATE ORION 2.5 MG TABLETS

Active substance(s): METHOTREXATE DISODIUM

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Package leaflet:
Information for the user
Methotrexate Orion
2.5 and 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, pharmacist or nurse.
–– 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, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Methotrexate Orion is and what it is
used for
2. What you need to know before you take
Methotrexate Orion
3. How to take Methotrexate Orion
4. Possible side effects
5. How to store Methotrexate Orion
6. Contents of the pack and other information
1. What Methotrexate Orion is and what it
is used for
The active substance of Methotrexate Orion
tablets, methotrexate, is a substance with the
following properties:
–– it interferes with the growth of certain cells
in the body that reproduce quickly and
hence slows down the growth of tumour
cells
–– it reduces the activity of the immune system (the body’s own defence mechanism)
–– it has anti-inflammatory effects.
Methotrexate is used to treat:
–– active rheumatoid arthritis in adult patients
–– severe recalcitrant disabling psoriasis, which
is not adequately responsive to other forms
of therapy such as phototherapy, PUVA and
retinoids
–– severe psoriatic arthritis in adult patients
–– maintenance therapy in acute lymphoblastic leukaemia.
Your doctor will be able to explain how
Methotrexate Orion tablets might help you in
your particular condition.
2. What you need to know before you take
Methotrexate Orion
Do not take Methotrexate Orion:
–– if you are allergic (hypersensitive) to
methotrexate, or any of the other ingredients of this medicine (listed in section 6)
–– if you are pregnant or breast-feeding (see
section “Pregnancy, breast-feeding and
fertility”)
–– 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 have severe acute or chronic infections or immunodeficiency syndrome
–– if you suffer from alcoholism.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Methotrexate Orion if you suffer from
or have suffered in the past from any of the
following conditions:
–– have or have had any liver or kidney disease
–– are using any medicines or vitamin
products (see section “Other medicines
and Methotrexate Tablets”)
–– have ulcerations in your stomach or bowel
(peptic ulcer or ulcerative colitis)
–– are in poor general condition
–– have received any vaccinations recently or
are you due to have any
–– have any symptoms or signs of infection
–– diabetes mellitus treated with insulin.
Methotrexate temporarily affects sperm and
egg production. You and your partner should
avoid conception (becoming pregnant or
fathering children) if currently receiving
Methotrexate Orion and for at least six months
after your treatment with methotrexate has
stopped. See 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.
If you take Methotrexate Orion for psoriasis or
reumatoid arthritis, make sure you take a single
dose once per week or divide this dose and
take it in 3 doses weekly at 12 hours’ interval. If
you mistakenly take Methotrexate Orion more
than once a week serious adverse effects may
occur. In case of doubts regarding the dosage
please consult your doctor, pharmacist or
nurse.
Children, adolescents and elderly
Children, adolescents and the elderly
should be kept under particularly close
medical surveillance during treatment with
Methotrexate Orion, in order to identify
possible side effects as early as possible.
Use in children below 3 years of age is
not recommended due to the insufficient
experience in this age group.
Other medicines and Methotrexate Orion
Other concomitant medication may affect
the efficacy and safety of this medicine.
Methotrexate Orion may also affect the
efficacy and safety of other medications.

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. Remember to tell your doctor about
your treatment with Methotrexate Orion, 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, ciprofloxacin, cefalotin,
trimethoprim/sulfamethoxazole,
tetracycline and chloramphenicol)
–– agents that may be harmful to kidneys, liver or blood [e.g. sulfasalazine, azathioprine
and leflunomide (medicines for rheumatic
diseases), vitamin A and its derivatives, alcohol]
–– other antirheumatic medicinal products
(e.g. gold compounds, penicillamine,
hydroxychloroquine, ciclosporin)
–– anticancer agents (e.g. mercaptopurine
and 5-fluorouracil)
–– anticonvulsant medicines (e.g. phenytoin
and carbamazepine)
–– aspirin or similar medicines (known as
salicylates)
–– non-steroidal anti-inflammatory medicines (medicines taken for pain relief ) e.g.
ibuprofen and pyrazoles
–– omeprazole or pantoprazole (medicine
used to stop the production of stomach
acid)
–– diuretics (water tablets)
–– probenecid (medicine used to treat gout)
–– folic acid (vitamin preparation)
–– theophylline (medicine used to treat
respiratory diseases)
–– vitamin preparations or other products
containing folic acid.
Methotrexate Orion with food, drink and
alcohol
Alcohol as well as large amounts of coffee,
caffeine-containing soft drinks and black tea
should be avoided during treatment with
Methotrexate Orion.
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.
Pregnancy
Do not use Methotrexate Orion 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 section “Warnings and
precautions”).
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 Orion 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 section “Warnings and precautions”).
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
You can feel fatigue and dizziness during
Methotrexate Orion treatment. Do not drive or
use machines if you have such symptoms.
Methotrexate Orion 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 Orion
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
–– Take Methotrexate Orion 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
You will usually take your tablets once a
week on the same day each week. The
dose will normally be between 7.5 and
15 mg. The weekly dose may be administered

in three divided doses during 24 hours (at
12 hours’ interval).
Dosage for treatment of tumours
The doctor will calculate the dosage required
from your body surface. Your doctor will
decide the correct dose for you. If you want
more information you should ask your doctor.
Special populations
Usually reduced dose according to doctor´s
prescription is used for elderly patients and
for patients with renal or hepatic impairment.
See also section 2. “Do not take Methotrexate
Orion”.
Use in children and adolescents
For children and adolescents with maintenance therapy in acute lymphoblastic leukaemia the doctor will calculate the dose individually, depending on the body surface.
Safe handling of Methotrexate Orion
tablets
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.
If you take more Methotrexate Orion than
you should
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 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 “Possible side effects”.
Take your medicine package with you if you go
to a doctor or hospital. If you used too much
methotrexate you will receive calcium folinate
to lessen the side effects of methotrexate.
If you forget to take Methotrexate Orion
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 for a
forgotten dose.
Make sure before your holiday or trip that you
have enough of your medicine.
If you stop taking Methotrexate Orion
Do not stop taking Methotrexate Orion unless
your doctor tells you to. Should you need to
stop taking Methotrexate Orion, 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, pharmacist or
nurse.
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.
If you notice any of the following, please
contact your doctor immediately:
–– unusual bleeding (including vomiting
blood) or bruising
–– severe diarrhoea
–– ulcers in mouth
–– an allergic reaction such as skin rash or
swelling of your lips or tongue
–– fever
–– yellowing of the skin (jaundice)
–– pain or difficulty in passing urine
–– thirst and/or frequent urination
–– chest pain
–– a dry cough and/or pain or difficulty in
breathing or shortness of breath
–– blurred or decreased vision.
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.
Common (may affect up to 1 in 10 people)
–– leukopenia (decrease number of white
blood cells)*
–– nausea
–– vomiting
–– diarrhoea
–– unusual fatigue
–– headache
–– dizziness
–– loss of appetite
–– erythematous rashes
–– stomatitis (soreness of the mouth and lips)
–– increase of liver transaminases (enzymes)*
–– decreased resistance to infections
–– tingling or numbness in the hands or feet
–– alopecia.
Uncommon (may affect up to 1 in 100 people)
–– bone marrow depression manifested by
thrombocytopenia and other abnormalities developing in the blood*
–– formation of excess fibrous connective
tissue in an organ (fibrosis)
–– inflammation of the lungs, which can
cause shortness of breath and difficulty
breathing
–– itchy skin
–– anemia
–– nosebleed
–– skin condition that causes painful blisters
and sores of the skin and mucous membranes, especially in the mouth (Stevens-Johnson syndrome)
–– serious illness with blistering of the skin
(toxic epidermal necrolysis)
–– anaphylactic reactions
–– kidney dysfunction

–– a cancer of the lymph nodes (or tissues)
–– vaginal ulceration.
* Only detected by your doctor.
Rare (may affect up to 1 in 1,000 people)
–– depression
–– confusion
–– hemiparesis (impairment of motor function affecting only one side of the body)
–– diabetes mellitus
–– hypotension
–– thromboembolism
–– dyspnoea
–– gastrointestinal ulceration and bleeding
–– liver damage (hepatic toxicity, periportal
fibrosis, hepatic cirrhosis, acute hepatitis)
–– skin reactions (acne, skin depigmentation,
urticaria, photosensitivity, erythema multiforme, burning in skin psoriatic lesions,
skin ulcers)
–– herpes zoster
–– decreased bone mineral density a type of
bone disease (osteoporosis)
–– increase in rheumatic nodules
–– pain in joint or muscles
–– menstrual disorders
–– impotence
–– decrease of libido
–– fatal whole-body inflammation (sepsis).
Very rare (may affect up to 1 in 10,000 people)
–– immune deficiency (hypogammaglobulinaemia)
–– irritation
–– difficulty in speaking (dysarthria)
–– sleepiness, tiredness (lethargy)
–– visual disturbance
–– redness and irritation of the thin membrane that covers the eye (conjunctivitis)
–– fluid in the sac around the heart. May
cause cardiac tamponade which is a life
threatening condition where the heart
is unable to pump correctly due to the
external pressure. May require medical
intervention to drain the fluid and remove
the pressure
–– inflammation of blood vessels, often with
skin rash (vasculitis)
–– infection of lungs
–– dry cough
–– loss of sex drive
–– low sperm count
–– vaginal bleeding.
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 Orion
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 bottle, blister or the
outer carton. The expiry date refers to the last
day of that month.
This medicinal product does not require any
special temperature storage conditions. Keep
the tablet container or blisters in the outer
carton, in order to protect from light.
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 Orion contains
–– The active substance is methotrexate.
Each tablet contains 2.5 mg or 10 mg
methotrexate (as methotrexate disodium).
–– The other ingredients are lactose
monohydrate, microcrystalline cellulose
and magnesium stearate.
What Methotrexate Orion looks like and
contents of the pack
Methotrexate Orion 2.5 mg tablets: Yellow,
round, uncoated, flat tablet, scored and
engraved with ORN 57 on one side, diameter
6 mm. The score line is only to facilitate
breaking for ease of swallowing and not to
divide into equal doses.
Methotrexate Orion 10 mg tablets: Yellow,
round, uncoated, flat tablet, scored and
engraved with ORN 59 on one side, diameter
10.5 mm. The tablet can be divided into equal
doses.
Pack sizes:
Bottle with child-resistance closure
2.5 mg: 10, 12, 24, 28, 30, 50 and 100 tablets.
10 mg: 10, 15, 25, 50 and 100 tablets.
Blister pack
2.5 mg: 24, 50 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1, FI-02200 Espoo, Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1, FI-02200 Espoo, Finland
This leaflet was last revised:
22.06.2016
XXXXX-XX

Package leaflet:
Information for the user
Methotrexate Orion
2.5 and 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, pharmacist or nurse.
–– 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, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Methotrexate Orion is and what it
is used for
2. What you need to know before you take
Methotrexate Orion
3. How to take Methotrexate Orion
4. Possible side effects
5. How to store Methotrexate Orion
6. Contents of the pack and other information
1. What Methotrexate Orion is and
what it is used for
The active substance of Methotrexate Orion
tablets, methotrexate, is a substance with
the following properties:
–– it interferes with the growth of certain
cells in the body that reproduce quickly
and hence slows down the growth of
tumour cells
–– it reduces the activity of the immune
system (the body’s own defence mechanism)
–– it has anti-inflammatory effects.
Methotrexate is used to treat:
–– active rheumatoid arthritis in adult
patients
–– severe recalcitrant disabling psoriasis,
which is not adequately responsive to
other forms of therapy such as phototherapy, PUVA and retinoids
–– severe psoriatic arthritis in adult patients
–– maintenance therapy in acute lymphoblastic leukaemia.
Your doctor will be able to explain how
Methotrexate Orion tablets might help you
in your particular condition.
2. What you need to know before you
take Methotrexate Orion
Do not take Methotrexate Orion:
–– if you are allergic (hypersensitive) to
methotrexate, or any of the other ingredients of this medicine (listed in section
6)
–– if you are pregnant or breast-feeding
(see section “Pregnancy, breast-feeding
and fertility”)
–– 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 have severe acute or chronic
infections or immunodeficiency syndrome
–– if you suffer from alcoholism.
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before taking Methotrexate Orion if you
suffer from or have suffered in the past from
any of the following conditions:
–– have or have had any liver or kidney
disease
–– are using any medicines or vitamin
products (see section “Other medicines
and Methotrexate Tablets”)
–– have ulcerations in your stomach or
bowel (peptic ulcer or ulcerative colitis)
–– are in poor general condition
–– have received any vaccinations recently
or are you due to have any
–– have any symptoms or signs of infection
–– diabetes mellitus treated with insulin.
Methotrexate temporarily affects sperm
and egg production. You and your partner
should avoid conception (becoming
pregnant or fathering children) if currently
receiving Methotrexate Orion and for at
least six months after your treatment with
methotrexate has stopped. See 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.
If you take Methotrexate Orion for psoriasis
or reumatoid arthritis, make sure you take
a single dose once per week or divide
this dose and take it in 3 doses weekly at
12 hours’ interval. If you mistakenly take
Methotrexate Orion more than once a week
serious adverse effects may occur. In case
of doubts regarding the dosage please
consult your doctor, pharmacist or nurse.
Children, adolescents and elderly
Children, adolescents and the elderly
should be kept under particularly close
medical surveillance during treatment with
Methotrexate Orion, in order to identify
possible side effects as early as possible.
Use in children below 3 years of age is
not recommended due to the insufficient
experience in this age group.
Other medicines and Methotrexate
Orion
Other concomitant medication may affect
the efficacy and safety of this medicine.
Methotrexate Orion may also affect the
efficacy and safety of other medications.
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines. Remember to tell
your doctor about your treatment with
Methotrexate Orion, 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, ciprofloxacin, cefalotin,
tr i metho pr im /sulf am et hox azo le,
tetracycline and chloramphenicol)
–– agents that may be harmful to kidneys,
liver or blood [e.g. sulfasalazine, azathioprine and leflunomide (medicines for
rheumatic diseases), vitamin A and its
derivatives, alcohol]
–– other antirheumatic medicinal products
(e.g. gold compounds, penicillamine,
hydroxychloroquine, ciclosporin)
–– anticancer agents (e.g. mercaptopurine
and 5-fluorouracil)
–– anticonvulsant medicines (e.g. phenytoin and carbamazepine)
–– aspirin or similar medicines (known as
salicylates)
–– non-steroidal anti-inflammatory medicines (medicines taken for pain relief )
e.g. ibuprofen and pyrazoles
–– omeprazole or pantoprazole (medicine
used to stop the production of stomach
acid)
–– diuretics (water tablets)
–– probenecid (medicine used to treat
gout)
–– folic acid (vitamin preparation)
–– theophylline (medicine used to treat
respiratory diseases)
–– vitamin preparations or other products
containing folic acid.
Methotrexate Orion with food, drink and
alcohol
Alcohol as well as large amounts of coffee,
caffeine-containing soft drinks and black
tea should be avoided during treatment
with Methotrexate Orion.
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.
Pregnancy
Do not use Methotrexate Orion 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 section “Warnings
and precautions”).
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 Orion 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 section
“Warnings and precautions”).
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
You can feel fatigue and dizziness during
Methotrexate Orion treatment. Do not drive
or use machines if you have such symptoms.
Methotrexate Orion 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 Orion
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
–– Take Methotrexate Orion 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
You will usually take your tablets once a
week on the same day each week. The
dose will normally be between 7.5 and
15 mg. The weekly dose may be administered
in three divided doses during 24 hours (at
12 hours’ interval).
Dosage for treatment of tumours
The doctor will calculate the dosage
required from your body surface. Your
doctor will decide the correct dose for you.
If you want more information you should
ask your doctor.
Special populations
Usually reduced dose according to doctor´s
prescription is used for elderly patients
and for patients with renal or hepatic
XXXXX-XX

impairment. See also section 2. “Do not take
Methotrexate Orion”.
Use in children and adolescents
For children and adolescents with maintenance therapy in acute lymphoblastic leukaemia the doctor will calculate the dose
individually, depending on the body surface.
Safe handling of Methotrexate Orion
tablets
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.
If you take more Methotrexate Orion
than you should
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 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
“Possible side effects”.
Take your medicine package with you if
you go to a doctor or hospital. If you used
too much methotrexate you will receive
calcium folinate to lessen the side effects of
methotrexate.
If you forget to take Methotrexate Orion
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 for a forgotten dose.
Make sure before your holiday or trip that
you have enough of your medicine.
If you stop taking Methotrexate Orion
Do not stop taking Methotrexate Orion
unless your doctor tells you to. Should you
need to stop taking Methotrexate Orion,
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,
pharmacist or nurse.
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.
If you notice any of the following, please
contact your doctor immediately:
–– unusual bleeding (including vomiting
blood) or bruising
–– severe diarrhoea
–– ulcers in mouth
–– an allergic reaction such as skin rash or
swelling of your lips or tongue
–– fever
–– yellowing of the skin (jaundice)
–– pain or difficulty in passing urine
–– thirst and/or frequent urination
–– chest pain
–– a dry cough and/or pain or difficulty in
breathing or shortness of breath
–– blurred or decreased vision.
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.
Common (may affect up to 1 in 10 people)
–– leukopenia (decrease number of white
blood cells)*
–– nausea
–– vomiting
–– diarrhoea
–– unusual fatigue
–– headache
–– dizziness
–– loss of appetite
–– erythematous rashes
–– stomatitis (soreness of the mouth and
lips)
–– increase of liver transaminases (enzymes)*
–– decreased resistance to infections
–– tingling or numbness in the hands or
feet
–– alopecia.
Uncommon (may affect up to 1 in 100
people)
–– bone marrow depression manifested
by thrombocytopenia and other abnormalities developing in the blood*
–– formation of excess fibrous connective
tissue in an organ (fibrosis)
–– inflammation of the lungs, which can
cause shortness of breath and difficulty
breathing
–– itchy skin
–– anemia
–– nosebleed
–– skin condition that causes painful
blisters and sores of the skin and mucous membranes, especially in the
mouth (Stevens-Johnson syndrome)
–– serious illness with blistering of the skin
(toxic epidermal necrolysis)
–– anaphylactic reactions
–– kidney dysfunction
–– a cancer of the lymph nodes (or tissues)
–– vaginal ulceration.
* Only detected by your doctor.
Rare (may affect up to 1 in 1,000 people)
–– depression
–– confusion
–– hemiparesis (impairment of motor
function affecting only one side of the
body)
–– diabetes mellitus
–– hypotension
–– thromboembolism
–– dyspnoea
–– gastrointestinal ulceration and bleeding
–– liver damage (hepatic toxicity, periportal fibrosis, hepatic cirrhosis, acute hepatitis)
–– skin reactions (acne, skin depigmentation, urticaria, photosensitivity, erythe-

ma multiforme, burning in skin psoriatic
lesions, skin ulcers)
–– herpes zoster
–– decreased bone mineral density a type
of bone disease (osteoporosis)
–– increase in rheumatic nodules
–– pain in joint or muscles
–– menstrual disorders
–– impotence
–– decrease of libido
–– fatal whole-body inflammation (sepsis).
Very rare (may affect up to 1 in 10,000
people)
–– immune deficiency (hypogammaglobulinaemia)
–– irritation
–– difficulty in speaking (dysarthria)
–– sleepiness, tiredness (lethargy)
–– visual disturbance
–– redness and irritation of the thin membrane that covers the eye (conjunctivitis)
–– fluid in the sac around the heart. May
cause cardiac tamponade which is a
life threatening condition where the
heart is unable to pump correctly due
to the external pressure. May require
medical intervention to drain the fluid
and remove the pressure
–– inflammation of blood vessels, often
with skin rash (vasculitis)
–– infection of lungs
–– dry cough
–– loss of sex drive
–– low sperm count
–– vaginal bleeding.
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 Orion
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 bottle, blister or
the outer carton. The expiry date refers to
the last day of that month.
This medicinal product does not require
any special temperature storage conditions.
Keep the tablet container or blisters in the
outer carton, in order to protect from light.
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 Orion contains
–– The active substance is methotrexate.
Each tablet contains 2.5 mg or 10 mg
methotrexate (as methotrexate disodium).
–– The other ingredients are lactose
monohydrate, microcrystalline cellulose
and magnesium stearate.
What Methotrexate Orion looks like and
contents of the pack
Methotrexate Orion 2.5 mg tablets: Yellow,
round, uncoated, flat tablet, scored and
engraved with ORN 57 on one side,
diameter 6 mm. The score line is only to
facilitate breaking for ease of swallowing
and not to divide into equal doses.
Methotrexate Orion 10 mg tablets: Yellow,
round, uncoated, flat tablet, scored and
engraved with ORN 59 on one side, diameter
10.5 mm. The tablet can be divided into
equal doses.
Pack sizes:
Bottle with child-resistance closure
2.5 mg: 10, 12, 24, 28, 30, 50 and 100 tablets.
10 mg: 10, 15, 25, 50 and 100 tablets.
Blister pack
2.5 mg: 24, 50 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
This leaflet was last revised:
22.06.2016

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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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