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METHOTREXATE 25 MG/ML SOLUTION FOR INJECTION

Active substance(s): METHOTREXATE

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METHOTREXATE 25 mg/ml
SOLUTION FOR INJECTION

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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

It is especially important to tell your doctor if you are
using:
• other treatments for rheumatoid arthritis or psoriasis
such as leflunomide, sulfasalazine (also used for
ulcerative colitis), acetylsalicylic acid, phenylbutazone,
or amidopyrine
• alcohol (should be avoided)
• live vaccinations
• azathioprine (used to prevent rejection after an organ
transplantation)
• retinoids (used to treat skin disorders)
• anticonvulsant drugs (used to prevent fits)
• cancer treatments
IN THIS LEAFLET:
• barbiturates (sleeping injection)
1. What Methotrexate 25 mg/ml solution for injection is • tranquillisers
• oral contraceptives
and what it is given for
• probenecid (used to treat gout)
2. Before you receive Methotrexate 25 mg/ml solution
• antibiotics
for injection
3. How Methotrexate 25 mg/ml solution for injection is • pyrimethamine (used to prevent and treat malaria)
• vitamin preparations, which contain folic acid
given
• proton-pump inhibitors (used to treat severe heartburn
4. Possible side effects
or ulcers)
5. How to store Methotrexate 25 mg/ml solution for
• theophylline (used to treat asthma).
injection
6. Further information
Using Methotrexate with food and drink
During treatment with this medicine you should avoid
WHAT
METHOTREXATE
25
mg/ml
1 SOLUTION FOR INJECTION IS AND WHAT any alcohol consumption as well as excessive
consumption of coffee, caffeine-containing beverages, or
IT IS GIVEN FOR
black tea. Also make sure you drink plenty of liquids
during treatment with Methotrexate because dehydration
Methotrexate is a drug with the following
(reduction in body water) can increase the toxicity of
properties:
Methotrexate.
• it interferes with the growth of certain cells in the body
that reproduce quickly (anti-tumour agent)
Pregnancy, breast-feeding and male fertility
• it reduces undesired reactions of the body’s own
Pregnancy
defence mechanism (immunosuppressant), and
Do not use Methotrexate during pregnancy or if you are
• it has anti-inflammatory effects.
trying to become pregnant. Methotrexate can cause birth
Read all of this leaflet carefully before you start using
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 gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

Methotrexate is given for the treatment of:
• active rheumatoid arthritis (RA) in adult patients where
treatment with disease modifying antirheumatic drugs
(DMARDs) is indicated
• polyarthritic forms (when five or more joints are
involved) of severe, active juvenile idiopathic arthritis
(JIA) when the response to so-called non-steroidal
anti-inflammatory drugs (NSAIDs) has been inadequate
• severe forms of psoriasis, which cannot be sufficiently
treated with conventional therapy such as phototherapy,
PUVA, and retinoids, and severe psoriasis affecting the
joints (psoriatic arthritis).

2

BEFORE YOU RECEIVE METHOTREXATE
25 mg/ml SOLUTION FOR INJECTION

Do not use Methotrexate if you
• are allergic (hypersensitive) to the active substance
methotrexate, or any of the other ingredients of
Methotrexate 25 mg/ml solution for injection
• have significant kidney disease (your doctor decides
the severity of your disease)
• have significant liver disease (your doctor decides the
severity of your disease)
• have disorders of the blood-forming system
• have increased alcohol consumption
• have an impaired immune system
• have severe or existing infections
• have gastrointestinal ulcers
• are pregnant or breast-feeding (see section “Pregnancy,
breast-feeding and male fertility”).
You should not be given live vaccines during treatment
with Methotrexate.
Take special care with Methotrexate
• if you have diabetes mellitus treated with insulin
• if you have inactive, prolonged infections (e.g.
tuberculosis, hepatitis B or C, shingles [herpes zoster])
• if you have or have had any liver or kidney disease
• if you have problems with your lung function
• if you are severely overweight
• if you have abnormal accumulation of liquid in the
abdomen, in the cavity between the lungs and chest
wall (ascites, pleural effusions)
• if you are dehydrated or suffer from conditions leading
to dehydration (vomiting, diarrhoea, stomatitis).

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
“Do not use 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 your doctor, who may refer
you for specialist advice, before the planned start of
treatment, because methotrexate may be genotoxic,
which means that the medicine may harm your unborn
baby.
Breast-feeding
Do not breast-feed during treatment, because
methotrexate passes into breast milk. If your attending
doctor considers treatment with methotrexate as
absolutely necessary during the lactation period, you
must stop breast-feeding (see also section “Do not use
Methotrexate”).
Male fertility
Methotrexate may be genotoxic. This means that the
medicine may cause genetic mutation.
Methotrexate can affect sperm 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.
Driving and using machines
Tiredness and dizziness can occur during treatment. If
affected, you should not drive or operate machinery.

Important information about some of the ingredients of
Methotrexate 25 mg/ml solution for injection
This medicinal product contains less than 1 mmol sodium
(23 mg) per pre-filled syringe, i.e. essentially ‘sodiumIf you experienced problems with your skin after radiation free’.
therapy (radiation induced dermatitis) and sun-burn,
these conditions can reappear under methotrexate
TO USE METHOTREXATE 25 mg/ml
3 HOW
therapy (recall-reaction).
SOLUTION FOR INJECTION
Use in children, adolescents and elderly
Dosage instructions depend on patients body weight.
Use in children below 3 years of age is not recommended
due to the insufficient experience in this age group.
Children and the elderly should be kept under particularly
close medical surveillance during treatment with
Methotrexate, in order to identify possible side effects as
early as possible.
Dosage for elderly patients should be relatively low due
to age-related reduced liver and kidney function and low
folate reserves.
Special precautionary measures during treatment of
Methotrexate:
Methotrexate should only be prescribed by doctors with
sufficient experience in the Methotrexate treatment of
the disease concerned.

This medicine should only be prescribed by physicians,
who are familiar with the various characteristics of the
medicinal product and its mode of action.
Important warning concerning methotrexate dosage
For the treatment of rheumatic diseases or diseases
of the skin, you must only use Methotrexate 25 mg/ml
Solution for Injection once weekly.
Faulty dosing may lead to serious side effects including
fatal courses. Please read section “3. How to use
Methotrexate 25 mg/ml Solution for Injection” of this
package leaflet very carefully.
Always use Methotrexate exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are unsure.
The usual dosage is:

Dosage in patients with rheumatoid arthritis
The recommended starting dose for methotrexate is
7.5 mg once a week. Methotrexate is given in a single
application as injection under the skin or into a muscle
(see section “Method and duration of administration”).
In case of inadequate action and if tolerated well,
Methotrexate doses may be gradually increased by
2.5 mg per week. The mean weekly dose is
Skin changes caused by psoriasis can worsen during
15 - 20 mg. Generally, a weekly dose of 20 mg
treatment with Methotrexate if exposure to UV irradiation Methotrexate should not be exceeded. Upon achieving
occurs at the same time.
the desired therapeutic results, the dose should be
reduced gradually to the lowest possible effective
Recommended examinations:
maintenance dose.
Even if Methotrexate is administered at low doses, severe
side effects can occur. In order to diagnose them early,
Dosage in children and adolescents with
regular monitoring by the doctor at short-term intervals is polyarthritic forms of juvenile idiopathic arthritis
necessary.
The recommended dose is 10-15 mg/m² body surface
Before treatment is started your doctor may carry out
area per week. In cases with inadequate response, the
blood tests, and also check how well your kidneys and
weekly dosage may be increased up to 20 mg/m² body
liver are working. You may also have a chest X-ray.
surface area/week. However, regular check-ups should
Further tests may also be done during and after
be done more often.
treatment. Do not miss appointments for blood tests.
Use in children below 3 years of age is not
If the results of any of these tests are abnormal,
recommended due to the insufficient experience in this
treatment will only be resumed when all readings are
age group.
back to normal.
Methotrexate temporarily affects sperm and egg
production. You and your partner must 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 male fertility”).

Using other medicines
Please tell your doctor or pharmacist if you are taking,
have recently taken or want to start taking any other
medicines, including medicines obtained without a

Dosage in adult patients with psoriasis or psoriatic
arthritis
Recommended initial dose (for an average body weight
of 70 kg):

It is recommended to administer a single test dose of
5 - 10 mg, in order to assess possibly damaging effects.
This dose can be administered subcutaneously (under the
skin) or intramuscularly (into a muscle).
If, one week later, no blood count changes are observed,
therapy is continued with a dose of approximately
7.5 mg. The dose may be gradually increased until ideal
therapeutic results are obtained. Generally, a weekly dose
of 30 mg should not be exceeded.
Upon achieving the desired therapeutic results, the dose
should be weekly reduced to the lowest possible effective
maintenance dose for the individual patient.

rheumatic nodules (lumps of tissues), shingles, painful
psoriasis, joint or muscle pain, brittle bones, inflammation
and ulcers in the bladder (possibly with blood in the
urine), painful urination, severe allergic reactions,
inflammation and ulcers of the vagina.

Rare (affects 1 to 10 users in 10,000):
Inflammation of the lining of the heart, fluid around the
heart, severe visual disturbance, mood alterations, low
blood pressure, blood clots, sore throat, interruption of
breathing, asthma, inflammation of the digestive tract,
bloody stools, inflamed gums, abnormal digestion,
changed colour of nails, acne, red or purple spots, bone
fracture, kidney failure, little or no urine production,
Patients with kidney disorders
Patients with a kidney disorder may need a reduced dose. waste products in the blood, decreased number of red
blood cells.
Method and duration of administration
Very rare (affects less than 1 user in 10,000) and
For subcutaneous and intramuscular use.
frequency not known:
Infections, liver disorders, low level of antibodies, severe
Any unused solution should be discarded (see also
failure of the bone marrow (can be detected by a test
section “How to store Methotrexate 25 mg/ml Solution
carried out by a doctor), swollen glands, sleeplessness,
for Injection”).
pain, muscle weakness, pins and needles, breathing
disorders, changes in sense of taste (metallic taste),
The duration of treatment is determined by the treating
inflammation of the lining of the brain causing paralysis
physician. Methotrexate is injected once weekly. It is
or vomiting, red eyes, damage to the retina of the eye,
recommended to specify a certain day of the week as
fluid on the lungs, vomiting blood, cold sores, protein in
“day for injection”.
Methotrexate is given as injection under the skin or into a the urine (can be detected by a test carried out by a
doctor), loss of sex drive, problems having an erection,
muscle.
infection around a fingernail, severe complication of the
digestive tract, boils, small blood vessels in the skin,
Treatment of rheumatoid arthritis, juvenile idiopathic
fungal infections, damage to the blood vessels of the
arthritis, psoriasis vulgaris and psoriatic arthritis with
skin, lumps in the armpit or groin, slow wound healing,
Methotrexate is a long-term treatment.
low sperm production, abnormal periods, vaginal
discharge, infertility.
Rheumatoid arthritis
Generally, improvement of the symptoms can be
expected after 4 - 8 weeks of treatment. Symptoms may Other:
After injection into a muscle, there may be a burning
return after Methotrexate treatment is stopped.
sensation or damage at the injection site. After injection
Severe types of psoriasis vulgaris and psoriatic arthritis under the skin there may be a mild skin reaction.
(psoriasis arthropathica)
If any of the side effects gets serious, or if you notice any
Generally, response to treatment can be expected after
side effects not listed in this leaflet, please tell your doctor
2 - 6 weeks. Depending on symptoms severity and on
or pharmacist.
laboratory parameters, the therapy is then continued or
discontinued.
At the start of your therapy, Methotrexate may be
injected by a doctor. However, your doctor may decide
that it is right for you to learn how to inject Methotrexate
yourself. You will receive appropriate training for you to
do this. Under no circumstances should you attempt to
inject yourself unless you have been trained to do so.
If you use more Methotrexate than you should
Do not change the dosage by yourself.
Use Methotrexate according to the doctor’s orders or
according to the dosage directions stated in this package
leaflet. If you use more of this medicine than you should,
a physician or nearest hospital casualty department must
be contacted immediately.

5

HOW TO STORE METHOTREXATE
25 mg/ml SOLUTION FOR INJECTION

Keep out of the reach and sight of children.
Do not use Methotrexate 25 mg/ml Solution for Injection
after the expiry date which is stated on the label of the
pre-filled syringe and the carton after “EXP.” The expiry
date refers to the last day of that month.
Keep the pre-filled syringes in the outer carton in order to
protect from light.
Do not store above 25°C.
Do not refrigerate or freeze.
Do not use Methotrexate 25 mg/ml Solution for Injection
if you notice the solution is not clear and free of particles
or if the container is damaged.

An overdose of methotrexate can lead to severe toxic
reactions. Overdose symptoms may include easy bruising
or bleeding, unusual weakness, mouth sores, nausea,
This medicinal product must not be mixed with other
vomiting, black or bloody stools, coughing up blood or
medicinal products.
vomit that looks like coffee grounds, and decreased
The product has to be used immediately after opening.
urinating (see also section ”Possible side effects”).
For single use only. Any unused solution should be
Take your medicine package with you if you go to a
discarded.
doctor or hospital. The antidote in case of an overdose is This medicine and its packaging should not be disposed
calcium folinate.
of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines and packaging
If you forget to use Methotrexate 25 mg/ml Solution for no longer required. These measures will help to protect
Injection
the environment.
Do not take a double dose to make up for forgotten
individual doses, but continue taking the ordered dose.
6 FURTHER INFORMATION
Ask your doctor for advice.
What Methotrexate 25 mg/ml Soltuion for Injection
If you stop taking Methotrexate 25 mg/ml Solution for
contains
Injection
You should not interrupt or discontinue your treatment
The active substance is methotrexate.
with Methotrexate, unless you have discussed this with
1 ml of solution for injection contains 25 mg
your doctor. If you suspect severe side effects, contact
methotrexate.
your doctor immediately for advice.
1 pre-filled syringe with 0.3 ml contains 7.5 mg
If you have any further questions on the use of this
methotrexate.
product, ask your doctor or pharmacist.
1 pre-filled syringe with 0.4 ml contains 10 mg
methotrexate.
1 pre-filled syringe with 0.6 ml contains 15 mg
4 POSSIBLE SIDE EFFECTS
methotrexate.
Like all medicines, Methotrexate can cause side effects,
1 pre-filled syringe with 0.8 ml contains 20 mg
although not everybody gets them.
methotrexate.
Tell your doctor straight away if you get any sudden
1 pre-filled syringe with 1.0 ml contains 25 mg
wheeziness; difficulty in breathing; swelling of the
methotrexate.
eyelids, face or lips; rash or itching (especially affecting
your whole body).
The other ingredients are: sodium chloride, sodium
hydroxide (for pH adjustment) and water for injections.
Serious side effects
What Methotrexate 25 mg/ml Solution for Injection
If you develop any of the following side effects, contact
looks like and contents of the pack
your doctor immediately:
Methotrexate 25 mg/ml Solution for Injection is a clear,
• lung complaints (symptoms may be general illness; dry, yellowish solution for injection available in pre-filled
irritating cough; shortness of breath, breathlessness at syringes with attached needle.
rest, chest pain, or fever)
• severe peeling or blistering of the skin
Each box contains 1, 4, 5, 6 or 10 pre-filled syringe(s)
• unusual bleeding (including vomiting blood) or
with (each) 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml or 1.0 ml
bruising
solution for injection.
• severe diarrhoea
Not all pack sizes may be marketed.
• ulcers in mouth
• blistering of mucous membranes
Marketing Authorisation Holder
• black or tarry stools
TEVA UK Limited, Eastbourne, BN22 9AG.
• blood in the urine or stools
United Kingdom.
• tiny red spots on the skin
• fever
Manufacturer
• yellowing of the skin (jaundice)
Merckle GmbH, Ludwig-Merckle Str. 3, 89143
• tenderness in the upper right area of your abdomen
Blaubeuren-Weiler, Germany.
• pain or difficulty in passing urine
• thirst and/or frequent urination
This leaflet was last revised in June 2011.
• fits (convulsions)
• loss of consciousness
PL 00289/1692
• blurred or decreased vision
The following side effects have also been reported:
Very common (affects more than 1 user in 10):
Inflammation of the mouth, indigestion, loss of appetite,
nausea (feeling sick), vomiting, tummy pain, inflammation
and ulcers in the mouth and throat, and increase in liver
enzymes (can be detected by a test carried out by a
doctor).
Common (affects 1 to 10 users in 100):
Changes in the number of blood cells and platelets (can
be detected by a test carried out by a doctor), headache,
tiredness, sleepiness, diarrhoea, measles-like rash (alone),
redness, and itching.
Uncommon (affects 1 to 10 users in 1,000):
Spinning sensation, confusion, depression, fits, lung
damage, ulcers and bleeding in the digestive tract, liver
disorders (can be detected by a test carried out by a
doctor), diabetes, decreased blood protein (can be
detected by a test carried out by a doctor), nettle rash
(alone), light sensitivity, brown skin, hair loss, increase of

50210-B


PRESCRIBER INFORMATION LEAFLET
The following information is intended for medical or
healthcare professionals only:
PREPARATION GUIDE FOR:
Methotrexate 25 mg/ml solution for injection
Pre-filled syringe
Methotrexate 25 mg/ml solution for injection for the
therapy of rheumatic or skin diseases must only be used
once weekly.

Handling and disposal must be consistent with that of
other cytotoxic preparations in accordance with local
requirements. Pregnant health care professionals should
not handle and/or administer Methotrexate 25 mg/ml
Solution for Injection.
Any contact of methotrexate with skin and mucosa is to
be avoided! In case of contamination, the affected parts
are to be rinsed immediately with plenty of water.
For single use only. Any unused solution should be
discarded.
Any unused product or waste material should be disposed
of in accordance with local requirements for cytotoxic
agents.

Please refer to Summary of Product Characteristics for full
prescribing and other information.

Incompatibilities
In the absence of compatibility studies, this medicinal
product must not be mixed with other medicinal products.

Instructions for use and handling and disposal
The solution is to be visually inspected prior to use. Only
clear solutions practically free from particles should be
used.

Special precautions for storage
Keep the pre-filled syringes in the outer carton in order to
protect from light.
Do not store above 25°C.
Do not refrigerate or freeze.

Step-by-step instructions for subcutaneous injection:
Setting up for an injection:
• Open the box on a flat surface. Read the package
leaflet carefully.
• Take one pre-filled syringe out of the box without
shaking it.
• Visually inspect the solution in the syringe.
• Choose an injection site. Wipe the injection site with an
alcohol pad, using a circular motion. Do not touch this
area before injection. You will be instructed in detail by
your doctor.
Injecting the solution:
• Remove the needle cover by firmly pulling it straight off
the syringe. Be careful not to bend or twist the cover
during removal to avoid damage to the needle.
• When you remove the needle cover, there may be a
drop of liquid at the end of the needle. This is normal.
Do not touch the needle or allow it to touch any
surface. Do not touch or bump the plunger to avoid loss
of fluid.
• With two fingers, form a skin fold and puncture it
almost vertically. With a quick, short motion, push the

needle completely into the skin fold. There is no need to
aspirate prior to injection.
• Push the plunger down and inject the fluid at a slow,
steady rate.
End of injection:
• Remove the needle. Be careful to keep it at the same
angle as inserted.
• Dab the injection site with a swab. Do not rub as this
will cause irritation at the injection site.
• To avoid any injuries, carefully put the needle cover
back on the needle by gently pressing it into place.

50210-B

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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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