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METEX 50 MG/ML SOLUTION FOR INJECTION

Active substance: METHOTREXATE

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PATIENT INFORMATION LEAFLET

2528
15.05.14[3]

Metoject® 50 mg/ml solution for injection
(methotrexate)
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, please 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.
This medicine is available using above name but will be referred to as
Metoject 50 mg/ml throughout the leaflet.
In this leaflet:
1. What Metoject 50 mg/ml is and what it is used for
2. What you need to know before you use Metoject 50 mg/ml
3. How to use Metoject 50 mg/ml
4. Possible side effects
5. How to store Metoject 50 mg/ml
6. Contents of the pack and other information
1. WHAT METOJECT 50 MG/ML IS AND WHAT IT IS USED FOR
Metoject 50 mg/ml is indicated for the treatment of
 active rheumatoid arthritis in adult patients.
 polyarthritic forms of severe, active juvenile idiopathic arthritis, when the
response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been
inadequate.
 severe recalcitrant disabling psoriasis, which is not adequately
responsive to other forms of therapy such as phototherapy, PUVA, and
retinoids, and severe psoriatic arthritis in adult patients.
 mild to moderate Crohn’s Disease in adult patients when adequate
treatment with other medicines is not possible.
Rheumatoid arthritis (RA) is a chronic collagen disease, characterised by
inflammation of the synovial membranes (joint membranes). These
membranes produce a fluid which acts as a lubricant for many joints. The
inflammation causes thickening of the membrane and swelling of the joint.
Juvenile arthritis concerns children and adolescents less than 16 years.
Polyarthritic forms are indicated if 5 or more joints are affected within the
first 6 months of the disease.
Psoriatic arthritis is a kind of arthritis with psoriatic lesions of the skin and
nails, especially at the joints of fingers and toes.
Psoriasis is a common chronic skin disease, characterised by red patches
covered by thick, dry, silvery, adherent scales.
Metoject 50 mg/ml modifies and slows down the progression of the
disease.
Crohn’s Disease is a type of inflammatory bowel disease that may affect
any part of the gastrointestinal tract causing symptoms such as
abdominal pain, diarrhoea, vomiting or weight loss.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE METOJECT
50 MG/ML
Do not use Metoject 50 mg/ml if you

 are allergic to methotrexate or any of the other ingredients of this
medicine (listed in section 6).
 suffer from liver or severe kidney diseases or blood diseases.
 regularly drink large amounts of alcohol.
 suffer from a severe infection, e.g. tuberculosis, HIV or other
immunodeficiency syndromes.
 suffer from stomach ulcer or intestinal ulcer.
 are pregnant or breast-feeding.
 receive vaccinations with live vaccines at the same time.
Warnings and precautions
Talk to your doctor or pharmacist before taking Metoject 50 mg/ml if:
 you are elderly or if you feel generally unwell and weak.
 you have problems with the way your liver works.
 you suffer from dehydration (water loss).
Recommended follow-up examinations and safety measures:
Even when Metoject 50 mg/ml is administered in low doses, severe side
effects can occur. In order to detect them in time, check-ups and
laboratory tests have to be carried out by your doctor.
Before therapy:
Before starting the treatment, blood samples will be taken in order to
check that you have enough blood cells, tests to check your liver function,
serum albumin (a protein in the blood) and kidney function. Your doctor

will also check if you suffer from tuberculosis (infectious disease in
combination with little nodules in the affected tissue) and a chest X-ray
will be taken.
During therapy:
You will have the following tests at least once a month during the first six
months and at least every three months thereafter:
 Examination of the mouth and throat for alterations of the mucosa
 Blood tests
 Check if your liver is working properly
 Check if your kidneys are working properly
 Check of respiratory system and if necessary lung function test
Methotrexate may affect your immune system and vaccination results. It
may also affect the result of immunological tests. Inactive, chronic
infections (e.g. herpes zoster [shingles], tuberculosis, hepatitis B or C)
may flare up. During therapy with Metoject 50 mg/ml you must not be
vaccinated with live vaccines.
Radiation induced dermatitis and sun-burn can reappear under
methotrexate therapy (recall-reaction). Psoriatic lesions can exacerbate
during UV-irradiation and simultaneous administration of methotrexate.
Enlarged lymph nodes (lymphoma) may occur and therapy must then be
stopped.
Diarrhoea can be a toxic effect of Metoject 50 mg/ml and requires an
interruption of therapy. If you suffer from diarrhoea please speak to your
doctor.
Other medicines and Metoject 50 mg/ml
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
The effect of the treatment may be affected if Metoject 50 mg/ml is
administered at the same time as certain other drugs:
 Medicines harming the liver or the blood count, e.g. leflunomide
 Antibiotics (medicines to prevent/fight certain infections) such as:
tetracyclines, chloramphenicol, and non-absorbable broad-spectrum
antibiotics, penicillines, glycopeptides, sulphonamides (sulphur containing
medicines that prevent/fight certain infections), ciprofloxacin and cefalotin
 Non-steroidal anti-inflammatory drugs or salicylates (medicines against
pain and/or inflammation)
 Probenecid (medicine against gout)
 Weak organic acids like loop diuretics (“water tablets”) or some
medicines used for treatment of pain and inflammatory diseases (e.g.
acetylsalicylic acid, diclofenac and ibuprofen) and pyrazole (e.g.
metamizol for treating pain)
 Medicinal products, which may have adverse effects on the bone
marrow, e.g. trimethoprim-sulphamethoxazole (an antibiotic) and
pyrimethamine
 Sulphasalazine (antirheumatic medicine)
 Azathioprine (an immunosuppressive agent sometimes used in severe
forms of rheumatoid arthritis)
 Mercaptopurine (a cytostatic agent)
 Retinoids (medicine against psoriasis and other dermatological diseases)
 Theophylline (medicine against bronchial asthma and other lung
diseases)
 Proton-pump inhibitors (medicines against stomach trouble)
 Hypoglycaemics (medicines that are used to lower the blood sugar)
Vitamins containing folic acid may impair the effect of your treatment and
should only be taken when advised by your doctor.
Vaccination with live vaccine should be avoided.
Metoject 50 mg/ml 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 Metoject 50 mg/ml.

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.
You must not take Metoject 50 mg/ml during pregnancy. Men and
women should use an effective method of birth control during
treatment and during a further six months after treatment with
Metoject 50 mg/ml 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.

Breast-feeding should be stopped prior to and during treatment with
Metoject 50 mg/ml.
Driving and using machines
Treatment with Metoject 50 mg/ml may cause adverse reactions affecting
the central nervous system, e.g. tiredness and dizziness. Thus the ability
to drive a vehicle and/or to operate machines may, in certain cases, be
compromised. If you feel tired or drowsy you should not drive or use
machines.
Important information about some of the ingredients of Metoject
50 mg/ml
This medicinal product contains less than 1 mmol sodium (23 mg) per
dose, i.e. essentially “sodium-free”.
3. HOW TO USE METOJECT 50 MG/ML
Your doctor decides on the dosage, which is adjusted individually. Usually
it takes 4 – 8 weeks before there is any effect of the treatment.
Metoject 50 mg/ml is administered by or under the supervision of a
physician or healthcare staff as an injection once a week only. Together
with your doctor you decide on a suitable weekday each week on which
you receive your injection. Metoject 50 mg/ml may be injected
intramuscularly (in a muscle), intravenously (in a vein) or subcutaneously
(under the skin).
As there is very little data about giving the medicine intravenously in
children and adolescents, it must only be injected under the skin or into a
muscle.
The doctor decides on the appropriate dose in children and adolescents
with polyarthritic forms of juvenile idiopathic arthritis.
Metoject is not recommended in children less than 3 years of age due to
insufficient experience in this age group.
Method and duration of administration
Metoject is injected once weekly!
The duration of the treatment is determined by the treating physician.
Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis
vulgaris, psoriatic arthritis and Crohn’s disease with Metoject is a longterm treatment.
At the start of your therapy, Metoject may be injected by medical staff.
In certain cases your doctor may decide to instruct you how to inject
Metoject under the skin yourself. You will then receive appropriate
training.
Under no circumstances should you try to inject Metoject yourself before
you have received such training.
Please refer to the instructions for use at the end of the leaflet.
The manner of handling and disposal must be consistent with that of
other cytostatic preparations in accordance with local requirements.
Pregnant health care personnel should not handle and/or administer
Metoject 50 mg/ml.
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 have the impression that the effect of Metoject 50 mg/ml is too
strong or too weak, you should talk to your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The frequency as well as the degree of severity of the side effects
depends on the dosage level and the frequency of administration.
As severe side effects may occur even at low dosage, it is important
that you are monitored regularly by your doctor. Your doctor will do
tests to check for abnormalities developing in the blood (such as low
white blood cells, low platelets, lymphoma) and changes in the
kidneys and the liver.
Tell your doctor immediately if you experience any of the following
symptoms, as these may indicate a serious, potentially life-threatening
side effect, which require urgent specific treatment:
 persistent dry, non-productive cough, shortness of breath and
fever; these may be signs of an inflammation of the lungs (pneumonia)
[common — may affect up to 1 in 10 people]
 symptoms of liver damage such as yellowing of the skin and
whites of the eyes; methotrexate can cause chronic liver damage (liver
cirrhosis), formation of scar tissue of the liver (liver fibrosis), fatty
degeneration of the liver [all uncommon — may affect up to 1 in 100
people], inflammation of the liver (acute hepatitis) [rare - may affect up
to 1 in 1,000 people] and liver failure [very rare - may affect up to 1 in
10,000 people]

 allergy symptoms such as skin rash including red itchy skin,
swelling of the hands, feet, ankles, face, lips, mouth or throat
(which may cause difficulty in swallowing or breathing) and feeling
you are going to faint; these may be signs of severe allergic reactions
or an anaphylactic shock [rare - may affect up to 1 in 1,000 people]
 symptoms of kidney damage such as swelling of the hands,
ankles or feet or changes in frequency of urination or decrease or
absence of urine; these may be signs of kidney failure [rare - may
affect up to 1 in 1,000 people]
 symptoms of infections, e.g. fever, chills, achiness, sore throat;
methotrexate can make you more susceptible to infections. Rarely [may
affect up to 1 in 1,000 people] severe infections like a certain type of
pneumonia (Pneumocystis carinii pneumonia) or blood poisoning
(sepsis) may occur
 severe diarrhoea, vomiting blood and black or tarry stools; these
symptoms may indicate a rare [may affect up to 1 in 1,000 people]
severe complication of the gastrointestinal system caused by
methotrexate e.g. gastrointestinal ulcers
 fever and serious deterioration of your general condition, or
sudden fever accompanied by a sore throat or mouth, or urinary
problems; methotrexate can very rarely [may affect up to 1 in 10,000
people] cause a sharp fall in white blood cells (agranulocytosis) and
severe bone marrow suppression
 unexpected bleeding, e.g. bleeding gums, blood in the urine,
vomiting blood or bruising, these can be signs of a severely reduced
number of blood platelets caused by severe courses of bone marrow
depression [very rare - may affect up to 1 in 10,000 people]
 severe skin rash or blistering of the skin (this can also affect your
mouth, eyes and genitals); these may be signs of the very rare [may
affect up to 1 in 10,000 people] conditions called Stevens Johnson
syndrome or burned skin syndrome (toxic epidermal necrolysis)
In the following, please find the other side effects that may occur:
Very common: may affect more than 1 in 10 people
 Mouth inflammation, indigestion, nausea (feeling sick), loss of appetite
 Increase in liver enzymes
Common: may affect up to 1 in 10 people
 Mouth ulcers, diarrhoea
 Rash, reddening of the skin, itching
 Headache, tiredness, drowsiness
 Reduced blood cell formation with decrease in white and/or red blood
cells and/or platelets (leukopenia, anaemia, thrombocytopenia)
Uncommon: may affect up to 1 in 100 people
 Throat inflammation, inflammation of the bowels, vomiting
 Increased sensitivity to light, loss of hair, increased number of
rheumatic nodules, shingles, inflammation of blood vessels, herpes-like
skin rash, hives
 Onset of diabetes mellitus
 Dizziness, confusion, depression
 Decrease in serum albumin
 Decrease in the number of blood cells and platelets
 Inflammation and ulcer of the urinary bladder or vagina, reduced kidney
function, disturbed urination
 Joint pain, muscle pain, osteoporosis (reduction of bone mass)

 Enlargement of lymphatic nodes (lymphoma)
When methotrexate is given by the intramuscular route, local undesirable
effects (burning sensation) or damage (formation of sterile abscess,
destruction of fatty tissue) at the site of injection can occur commonly.
Subcutaneous application of methotrexate is locally well tolerated.
Only mild local skin reactions were observed, decreasing during therapy.
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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE METOJECT 50 MG/ML
Keep out of the sight and reach of children.
Do not store above 25 °C.
Keep the pre-filled syringes in outer carton in order to protect from light.
Do not use after the expiry date stated on the packaging. The expiry date
refers to the last day of that month.
Medicines should not be disposed via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. The
measures will help to protect the environment
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Metoject 50 mg/ml contains
 The active substance is methotrexate. 1 ml of solution contains
methotrexate disodium corresponding to 50 mg methotrexate.
1 pre-filled syringe of 0.20 ml contains 10 mg methotrexate.
1 pre-filled syringe of 0.25 ml contains 12.5 mg methotrexate.
1 pre-filled syringe of 0.30 ml contains 15 mg methotrexate.
1 pre-filled syringe of 0.35 ml contains 17.5 mg methotrexate.
1 pre-filled syringe of 0.40 ml contains 20 mg methotrexate.
1 pre-filled syringe of 0.45 ml contains 22.5 mg methotrexate.
1 pre-filled syringe of 0.50 ml contains 25 mg methotrexate.
1 pre-filled syringe of 0.60 ml contains 30 mg methotrexate
 The other ingredients are sodium chloride, sodium hydroxide, water for
injections.
What Metoject 50 mg/ml looks like and contents of the pack
A pre-filled colourless glass syringe of 1 ml capacity, filled with a clear,
yellow-brown solution. It is embedded with an injection needle with a
plunger stopper of rubber and plastic rods inserted on the stopper to form
the syringe. Also contains alcohol pads.
The following pack sizes are available:
Pre-filled syringes containing 0.20 ml, 0.25, 0.30 ml, 0.35 ml, 0.40 ml,
0.45 ml, 0.50 ml and 0.60 ml of solution are available in a packsize of
1 syringe with embedded SC needle.
Also Pre-filled syringes containing 0.20 ml, 0.30 ml and 0.40 ml of
solution are available in a packsize of 6 syringes with embedded SC
needle.
Alcohol pads included in the package.

Instructions for use
Carefully read the instructions below before starting your injection, and
always use the injection technique advised by your doctor, pharmacist or
nurse.
For any problem or question, contact your doctor, pharmacist or nurse.
Preparation
Select a clean, well-lit and flat working surface.
Collect necessary items before you begin:
 1 Metoject pre-filled syringe
 1 alcohol pad (provided in the packaging)
Wash your hands carefully. Before use, check the Metoject syringe for
visual defects (or cracks).
Injection site
Areas for subcutaneous injection
The best sites for injection are:
- upper thighs,
- abdomen except around the navel.
 If someone is helping you with the
injection, he/ she may also give the
injection into the back of your arms, just
below the shoulder.
 Change the injection site with each
injection.
This may reduce the risk of developing
irritations at the injection site.
 Never inject into skin that is tender,
bruised, red, hard, scarred or where you
have stretch marks.
If you have psoriasis, you should try not
to inject directly into any raised, thick, red
or scaly skin patches or lesions.
Injecting the solution
1. Unpack the methotrexate pre-filled syringe and read the package
leaflet carefully. Remove the pre-filled syringe from the packaging at room
temperature.
2. Disinfection
Choose an injection site and disinfect it with a
swab soaked in disinfectant.
Allow at least 60 seconds for the disinfectant to
dry.

3. Remove the protective plastic cap
Carefully remove the grey protective plastic cap
by pulling it straight off the syringe. If the cap is
very stiff, turn it slightly with a pulling movement.
Important: Do not touch the needle of the prefilled
syringe!

4. Inserting the cannula
Rare: may affect up to 1 in 1,000 people
 Increased skin pigmentation, acne, blue spots due to vessel bleeding
 Allergic inflammation of blood vessels, fever, red eyes, infection,
wound-healing impairment, decreased number of anti-bodies in the
blood
 Visual disturbances
 Inflammation of the sac around the heart, accumulation of fluid in the
sac around the heart
 Low blood pressure, occlusion of a blood vessel by dislodged blood clot
(thromboembolic events)
 Lung fibrosis, shortness of breath and bronchial asthma, accumulation
of fluid in the sac around the lung
 Electrolyte disturbances

PRODUCT LICENCE HOLDER AND MANUFACTURER
Manufactured by medac Gesellschaft für klinische Spezialpräparate mbH,
Theaterstr. 6, 22880 Wedel, Germany and procured from the EU by
Product Licence holder: Star Pharmaceuticals Ltd., 5 Sandridge Close,
Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.

Very rare: may affect up to 1 in 10,000 people
 Profuse bleeding, toxic megacolon (acute toxic dilatation of the gut)
 Increased pigmentation of the nails, inflammation of the cuticles,
furunculosis (deep infection of hair follicles), visible enlargement of
small blood vessels
 Local damage (formation of sterile abscess, changes in the fatty tissue)
of injection site following administration into a muscle or under the skin
 Impaired vision, pain, loss of strength or sensation of numbness or
tingling in arms and legs, changes in taste (metallic taste), convulsions,
paralysis, severe headache with fever
 Retinopathy (noninflammatory eye disorder)
 Loss of sexual drive, impotence, male breast enlargement
(gynaecomastia), defective sperm formation, menstrual disorder,
 vaginal discharge

This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria, Belgium, Bulgaria, Czech Republic, Finland, Greece,
Hungary, Iceland, Netherlands, Romania, Slovak Republic, Slovenia,
Spain, Sweden, United Kingdom: Metoject
Denmark, Estonia, Latvia, Lithuania, Norway, Poland and Portugal:
Metex
Germany: metex
Italy: Reumaflex

POM

Using two fingers, pinch up a fold of skin and
quickly insert the needle into the skin at a 90degree angle.

PL 20636/2528
5. Injection

Leaflet issue and revision date (Ref): 15.05.14[3]
Metoject is trademark of medac Gesellschaft für klinische
Spezialpräparate mbH.

Insert the needle fully into the fold of skin.
Push the plunger down slowly and inject the liquid
underneath your skin. Hold the skin securely until
the injection is completed.
Carefully pull the needle straight out.

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 or someone around you is injured by the needle, consult your
doctor immediately and do not use this pre-filled syringe.
Disposal and other handling
The manner of handling and throwing away of the medicine and pre-filled
syringe must be in accordance with local requirements. Pregnant
healthcare personnel should not handle and/or administer Metoject.

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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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