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METHOTREXATE STRIDES 25 MG/ML SOLUTION FOR INJECTION/INFUSION

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Package leaflet: information for the patient

Methotrexate 25 mg/ml
solution for injection/infusion
methotrexate
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet
1. What Methotrexate 25 mg/ml solution for injection/infusion is and what it
is used for
2. What you need to know before you use Methotrexate 25 mg/ml solution for
injection/infusion
3. How to use Methotrexate 25 mg/ml solution for injection/infusion
4. Possible side effects
5. How to store Methotrexate 25 mg/ml solution for injection/infusion
6. Contents of the pack and other information
1. What Methotrexate 25 mg/ml solution for injection/infusion is and
what it is used for
Methotrexate is a substance with the following properties:
- it interferes with the growth of tumour cells in the body that reproduce
quickly (anti-tumour agent)
- it reduces undesired reactions of the body’s own defence mechanism
(immunosuppressant), and
- it has anti-inflammatory effects.
Methotrexate is used to treat cancer, such as:
• lymphatic leukaemia (disease of the blood or bone marrow with increased

Warnings and precautions

Methotrexate 25 mg/ml solution for injection/infusion with food, drink and

The following information

Take special care with Methotrexate 25 mg/ml solution for injection/infusion if
you:
• have diabetes mellitus treated with insulin
• have inactive, prolonged infections (e.g. tuberculosis, hepatitis B or C,
shingles (herpes zoster))
• have problems with your lung function
• have/had any liver or kidney disease
• experience any sign or symptoms suggestive of infection, e.g. fever
• have abnormal accumulation of liquid in the abdomen or in the cavity
between the lungs and chest wall (ascites, pleural effusions)
• are dehydrated or suffer from conditions leading to dehydration (vomiting,
diarrhoea, stomatitis).
Inform your doctor in case any of the above applies to you.
You should avoid solarium and direct sun light during treatment, as the skin is
more sensitive.
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. 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 fertility”.
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.
Even if Methotrexate 25 mg/ml solution for injection/infusion is administered
at low dosage, severe side effects can occur. In order to diagnose them early,
regular monitoring by the doctor at short-term intervals is necessary.
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 the results of any of these tests are abnormal, treatment will only be resumed
when all readings are back to normal.

alcohol

is intended for medical or

During Methotrexate 25 mg/ml solution for injection/infusion treatment, you
should avoid any alcohol consumption as well as excessive consumption of
coffee, caffeine-containing beverages or black tea. Also make sure you drink
plenty of liquids during treatment with Methotrexate 25 mg/ml solution for
injection/infusion, because dehydration (reduction in body water) can increase
the toxicity of Methotrexate 25 mg/ml solution for injection/infusion.

healthcare professionals only

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 for advice before taking this medicine.
You must not use Methotrexate 25 mg/ml solution for injection/infusion
during pregnancy. Men and women should use an effective method of birth
control during treatment and during a further six months after treatment with
Methotrexate 25 mg/ml solution for injection/infusion has been discontinued.
In women of child-bearing age, any existing pregnancy must be excluded with
certainty by taking appropriate measures e.g. pregnancy test, prior to therapy.
As methotrexate can be genotoxic, all women who wish to become pregnant
are advised to consult a genetic counselling centre, if possible already
prior to therapy, and men should seek advice about the possibility of sperm
preservation before starting therapy, see also section “Take special care with
Methotrexate 25 mg/ml solution for injection/infusion”.

free medium such as glucose

Breast-feeding
Methotrexate passes into breast milk. Breast-feeding should be stopped prior
to and during treatment with Methotrexate 25 mg/ml solution for injection/
infusion.

designed to protect personnel

mg/ml solution for injection/infusion.

Other medicines and Methotrexate 25 mg/ml solution for injection/
infusion
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 25 mg/ml solution for injection/infusion, if
you are prescribed another medicine while the treatment is still ongoing.
It is especially important to tell your doctor if you are using:
- other treatments for rheumatoid arthritis or psoriasis such as leflunomide,
sulphasalazine (also used for ulcerative colitis), salicylates such as
acetylsalicylic acid, phenylbutazone, or amidopyrine
- alcohol (should be avoided)
- live vaccinations
- azathioprine (used to prevent rejection after an organ transplant)
- retinoids (used to treat psoriasis and other skin disorders)
- anticonvulsant drugs (prevent fits)
- cancer treatments
- barbiturates (sleeping injection)
- tranquillisers
- oral contraceptives
- probenecid (for gout)
- antibiotics
- pyrimethamine (used to prevent and treat malaria)
- vitamin preparations, which contain folic acid
- proton-pump inhibitors (used to treat severe heartburn or ulcers)

Tell your doctor before you use Methotrexate 25 mg/ml solution for injection/

- theophylline (used to treat asthma).

number of white blood cells)
• breast cancer
• bone cancer (osteosarcoma)
• head and neck cancer
• gynaecologic cancer (choriocarcinoma, trophoblastic disease - tumour
development directly associated with pregnancy)
• cancer of the lymphatic system (Non-Hodgkin´s lymphoma).
2. What you need to know before you use Methotrexate 25 mg/ml
solution for injection/infusion
Do not use Methotrexate 25 mg/ml solution for injection/infusion if:
• you are allergic to methotrexate or any of the other ingredients of this
medicine (listed in section 6)
• you have significant kidney disease
• you have significant liver disease
• you have increased alcohol consumption
• you have disorders of the blood-forming system
• you have severe or existing infections
• you have gastrointestinal ulcers or ulcers of the oral cavity
• you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding
and fertility”)
You should not be given live vaccines during treatment with Methotrexate 25

infusion if you think any of the above applies to you.

Dimension: 380 x 310 mm

Font: Times New Roman ; Font Size: 9 Pt.

Driving and using machines
Tiredness and dizzinesscan occur during treatment. If affected you should not
drive or operate machinery.
Methotrexate 25 mg/ml solution for injection/infusion contains sodium
This medicinal product contains 0.21 mmol (or 4.945 mg) sodium per ml. To
be taken into consideration by patients on a controlled sodium diet.

Methotrexate 25 mg/ml
solution for injection/infusion
may be further diluted with
an appropriate preservativesolution (5 %) or sodium
chloride solution (0.9 %) to an
in-use concentration of
2 mg/ml.
With respect to the handling
the following general
recommendations should be
considered: The product should
be used and administered
only by trained personnel; the
mixing of the solutions should
take place in designated areas,
and the environment (e.g.
safety cabins); protective
clothing should be worn
(including gloves, eye
protection, and masks if
necessary).
The product is for single use
only. Discard any unused
solution immediately after

3. How to use Methotrexate 25 mg/ml solution for injection/infusion
solution for injection/infusion
Treatment with methotrexate should be initiated by or in consultation with a
doctor with considerable experience in cancer treatment. The dose is usually
calculated based on various factors e.g. the patient general health and body
surface area and the type of disease. The overall duration of treatment and
intervals between administrations is decided by the physician.
Methotrexate can be given intramuscularly (in a muscle), intravenously (in a
vein), intra-arterially (in an artery and intra-thecally. Higher doses are usually
given as an infusion over 24 h, either alone or in combination with other
medicinal products used to treat cancer.
Your doctor may instruct you to take sodium bicarbonate or acetazolamide
tablets while receiving your medicine to help make sure that methotrexate is
not concentrated in the kidnes. If you receive methotrexate in high doses, you
will receive calcium folinate as well to lessen the side effects of methotrexate.
Use in children
This medicine should be used with caution in children and in line with standard
therapy.
Methotrexate should not come into contact with the surface of the skin or
mucosa. In the event of contamination, the affected area must be rinsed
immediately with plenty of water.
If you use more Methotrexate 25 mg/ml than you should
Your doctor decides on the dosage, which is given by healthcare staff.
Overdose is therefore unlikely.
An overdose of methotrexate can lead to severe toxic reactions.
Overdose symptoms may include easy bruising or bleeding, unusual weakness,
mouth sores, nausea, vomiting, black or bloody stools. The antidote in case of
an overdose is calcium folinate.

initial use. Waste should
be disposed of carefully in
suitable separate containers,
clearly labelled as to their
contents (as the patient’s body
fluids and excreta may also
contain appreciable amounts
of antineoplastic agents and
it has been suggested that
they, and material such as
bed linen contaminated with
them, should also be treated as
hazardous waste). Any unused
product or waste should be
disposed of in accordance
with local requirements by
incineration. For example,
chemical destruction methods
(oxidation with e.g., potassium
permanganate and sulphuric
acid or aqueous alkaline
potassium permanganate or
sodium hypochlorite) have also
been used.

Front Side

Adequate procedures should
be in place for accidental
contamination due to spillage;
staff exposure to antineoplastic
agents should be recorded and
monitored.

If you forget or stop using Methotrexate 25 mg/ml solution for injection/
infusion

Low blood pressure, blood clots. Sore throat, interruption of breathing, asthma.

Manufacturer:

Inflammation of the digestive tract, bloody stools, inflamed gums, abnormal

Agila Specialties Polska Sp.z.o.o.

You should not interrupt or discontinue Methotrexate 25 mg/ml solution for
injection/infusion treatment, unless you have discussed this with your doctor.
In case you forget your appointment for next dose, contact your doctor as soon
as possible to schedule a new appointment. If you suspect severe side effects,
contact your doctor immediately for advice.

digestion. Changed colour of nails, acne, red or purple spots.

10, Daniszewska Str

Bone fracture. Kidney failure, little or no urine produced, waste products in the

03-230 Warsaw

blood.

Poland

If a cytotoxic drug should

If you have any further questions on the use of this product, ask your doctor or

contaminate the skin it should

pharmacist.

be washed off immediately

Very rare (less than 1 in 10000 and unknown):
Infections. Severe failure of the bone marrow (can be detected by a test carried

This leaflet was last approved in 02/2013

out by a doctor). Swollen glands. Sleeplessness. Pain, muscle weakness, pins
and needles, changes in sense of taste (metallic taste), inflammation of the
lining of the brain causing paralysis or vomiting. Red eyes, damage to the

using copious amounts of

4. Possible Side Effects

running water for at least ten

Like all medicines Methotrexate 25 mg/ml solution for injection/infusion can

the urine (can be detected by a test carried out by a doctor). Loss of sex drive,

minutes. For example, if eyes

cause side effects, although not everybody gets them.

problems having an erection, low sperm production, abnormal periods, vaginal

are sprayed with cytotoxic

Tell your doctor straight away if you get any sudden wheeziness, difficulty

discharge, infertility. Infection around a fingernail, severe complication of the

material they should be rinsed

in breathing, swelling of the eyelids, face or lips, rash or itching (especially

digestive tract, fungal infections, boils, dilated small blood vessels in the skin,

immediately with copious

affecting your whole body).

damage to the blood vessels of the skin. Lumps in the armpit or groin. Slow

amounts of water and bathed

Serious side effects

wound healing.

with sterile sodium chloride

If you develop any of the following side effects, contact your doctor

Other: After injection into a muscle, there may be a burning sensation or

solution for at least ten

immediately:

damage at the injection site.

minutes.

• lung complaints (symptoms may be general illness; dry, irritating cough;

If you get any side effects, talk to your doctor. This includes any side effects

Pregnant staff should avoid
handling antineoplastic agents.

shortness of breath, breathlessness at rest, chest pain, or fever)

retina of the eye. Fluid on the lungs. Vomiting blood. Cold sores. Protein in

not listed in this leaflet.

• severe peeling or blistering of the skin
• unusual bleeding (including vomiting blood) or bruising

5. How to store Methotrexate 25 mg/ml solution for injection/infusion

• severe diarrhoea

Keep the medicine out of sight and reach of children.

• ulcers in mouth

Keep the vial in the outer carton in order to protect from light.

• black or tarry stools

Do not store above 25°C.

• blood in the urine or stools

For single dose use only. Discard any unused solution immediately and safely
after initial use.

• tiny red spots on the skin
• fever
• yellowing of the skin (jaundice)
• pain or difficulty in passing urine
• thirst and/or frequent urination

This medicine should only be administered by a medically qualified person,
e.g. a doctor.
Do not use Methotrexate 25 mg/ml solution for injection/infusion if there are
any visible signs of deterioration.

• fits (convulsions)

Do not use Methotrexate 25 mg/ml solution for injection/infusion after the
expiry date which is printed on the carton and vial after EXP.

• loss of consciousness

The expiry date refers to the last day of that month.

• blurred or decreased vision.

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.

The following side effects have also been reported.
Very common (more than 1 in 10):
Inflammation of the mouth, indigestion, loss of appetite, nausea (feeling sick),
vomiting, tummy pain, inflammation and ulcers in the mouth and throat.
Increase in liver enzymes (can be detected by a test carried out by a doctor).

6. Contents of the pack and other information
What Methotrexate 25 mg/ml solution for injection/infusion contains
The active substance is: methotrexate.

Common (between 1 in 100 and 1 in 10):

Each 1 ml of this sterile solution for injection/infusion contains 25 milligrams

Changes in the number of blood cells and platelets (can be detected by a test

methotrexate.

carried out by a doctor).

The other ingredients are: sodium chloride, hydrochloric acid, sodium

Headache, tiredness, sleepiness. Diarrhoea. Measles-like rash (alone), redness,

hydroxide, water for injections.

and itching.

What Methotrexate 25 mg/ml solution for injection/infusion looks like and
contents of the pack

Spinning sensation, confusion, depression, fits. Brain disorder

Methotrexate 25 mg/ml solution for injection/infusion is a yellow and sterile

(leukoencephalopathy/enchepalopathy). Lung damage. Ulcers and bleeding

solution in clear glass vials.

in the digestive tract. Liver disorders (can be detected by a test carried out by

Each pack contains 5 vials of 2 ml, 4 ml or 10 ml solution.

a doctor), diabetes, decreased blood protein (can be detected by a test carried

Each pack contains 1 vial of 40 ml solution.

out by a doctor). Nettle rash (alone), light sensitivity, brown skin, hair loss,

Not all pack sizes may be marketed.

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

101xxxx

Uncommon (between 1 in 1000 and 1 in 100):

Strides Arcolab International Ltd.
Unit 4, Metro Centre, Tolpits Lane,

Rare (between 1 in 1000 and 1 in 10000):

Watford, Hertfordshire WD18 9SS

Inflammation of the lining of the heart, fluid around the heart. Severely visual

United Kingdom

disturbance, mood alterations.

Dimension: 380 x 310 mm

Font: Times New Roman ; Font Size: 9 Pt.

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