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METOJECT 10 MG/MLL SOLUTION FOR INJECTION PRE-FILLED SYRINGE

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Format 370 x 150 mm / Laetus-Code 626

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Metoject 10 mg/ml

Metoject modifies and slows down the progression of
the disease.
2. BEFORE YOU USE METOJECT

solution for injection, pre-filled syringe
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.

Do not use Metoject, if you
• are allergic (hypersensitive) to methotrexate or any of
the other ingredients of Metoject.
• suffer from severe liver or severe kidney disease or
blood disease.
• regularly drink large amounts of alcohol.
• suffer from a severe infection, e.g. tuberculosis or
HIV.
• suffer from mouth ulcers, stomach ulcers or intestinal
ulcers.
• are pregnant or breast-feeding.
• receive vaccinations with live vaccines at the same
time.
• suffer from diseases which compromise your immune
defence.

In this leaflet:
1. What Metoject is and what it is used for
2. Before you use Metoject
3. How to use Metoject
4. Possible side effects
5. How to store Metoject
6. Further information

Take special care with Metoject, if you
• are elderly or if you feel generally unwell and weak.
• have liver or kidney problems.
• are dehydrated (for example if you have suffered
diarrhoea or vomiting).

1. WHAT METOJECT IS AND WHAT IT IS USED
FOR

Recommended follow-up examinations and safety
measures:
Even when Metoject 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.

Metoject is indicated for the treatment of:
• Severe, active rheumatoid arthritis in adult patients
where treatment with so-called disease modifying
antirheumatic drugs (DMARD) is needed.
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.

During therapy:
You will have the following tests at least once a month
during the first 6 months and at least every 3 months
thereafter:

Before therapy:
Before starting the treatment, blood samples will be
taken in order to carry out certain tests to check that
you have enough blood cells, tests to check your liver
function, serum albumin (a protein in the blood) and
your 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 also be taken.

• 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 tract and if necessary lung
function test
Methotrexate may affect your immune system and
influence vaccination results. It may also affect the result
of tests that examine the function of your immune
system. Inactive, chronic infections (e.g. herpes zoster
[shingles], tuberculosis, hepatitis B or C) may flare up.
During therapy with Metoject you must not be
vaccinated with live vaccines.

penicillines, glycopeptides, sulphonamides,
ciprofloxacin and cefalotin

Medicinal products, which may have adverse effects
on the bone marrow, e.g. trimethoprimsulphamethoxazole (an antibiotic) and pyrimethamine

Driving and using machines
During treatment with Metoject side effects may occur
which may cause you to feel tired and dizzy. Thus the
ability to drive a car or to operate machines maybe
impaired. If you feel tired or dizzy do not drive or use
machines. You alone are responsible to decide if you
are in fit condition to drive a motor vehicle or perform
other tasks that demand increased concentration.
Because of their effects or undesirable effects, one of
the factors that can reduce your ability to do these
things safely is your use of medicines. A list of potential
side effects can be found in section 4 of this package
leaflet. Discuss with your doctor or pharmacist if you are
unsure about anything.

Sulphasalazine (antirheumatic medicine)

3. HOW TO USE METOJECT

Proton-pump inhibitors (medicines to reduce
stomach acid secretion)

Metoject is administered as an injection once a week
only by your doctor or your nurse. Together with your
doctor you decide on a suitable weekday each week for
the injection. Metoject may be injected intramuscularly
(in a muscle), intravenously (in a vein) or subcutaneously
(under the skin).

Non-steroidal anti-inflammatory drugs or salicylates
(medicines against pain and/or inflammation)
Probenecid (medicine against gout)
Weak organic acids such as loop diuretics (“water
tablets”) and pyrazole

Enlarged lymph nodes (lymphoma) may occur and
therapy must then be stopped.

Vitamins containing folic acid may impair the effect of
your treatment and should only be taken when advised
by your doctor.

Contact your doctor in case you have a persisting
cough or breathlessness.

Vaccination with live vaccine should be avoided.

This medicinal product contains less than 1 mmol
sodium (23 mg) per dose, i.e. essentially “sodium-free”.

Using Metoject with food and drink
Do not drink alcohol or large amounts of coffee,
caffeine-containing soft-drinks and black tea during
treatment with Metoject.

Using other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription. Please note
that this also applies to medicines that you will take in
the future.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before using
any medicine.

The effect of the treatment may be affected if Metoject
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,

You must not use Metoject if you are pregnant. There is
a risk that your unborn child may be damaged and you
may have a miscarriage.
Men and women must use an effective method of birth
control during treatment with Metoject and at least 6
months thereafter.
Stop breast-feeding prior to and during treatment with
Metoject.

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.
Methotrexate must 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 ample amount of water.
Your doctor decides on the dosage, which is adapted
individually to you. Usually it takes 4 – 8 weeks before
there is any effect of the treatment. The duration of the
treatment is decided by your doctor.
If you have the impression that the effect of Metoject is
too strong or too weak, please talk to your doctor or
pharmacist about your dose.
If you use more Metoject than you should
The dosage recommendations must be followed. Do
not change the dosage by yourself.

If you suspect that you have received too much
Metoject, contact your doctor immediately. He will
decide on the adequate treatment depending on the
severity of the intoxication.
If you forget to use Metoject
If you miss a dose speak to your doctor. Do not use a
double dose to make up for a forgotten individual dose.
The prescribed dose should be used as soon as
possible and each week thereafter.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Metoject 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 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.
The most relevant side effects are effects on the blood
forming system and the gastrointestinal tract.
The following categories are used in order to organise
the adverse effects in order of frequency:
Very common (occurs in more than 1 in 10 patients),
common (occurs in more than 1 in 100 patients),
uncommon (occurs in less than 1 in 100 patients), rare
(occurs in less than 1 in 1,000 patients) and very rare
(occurs in less than 1 in 10,000 patients).
The following side effects may occur:
Gastrointestinal tract
Very common: Mouth inflammation, indigestion, feeling
sick, reduced appetite.
Common: Mouth ulcers, diarrhoea.
Uncommon: Throat inflammation, inflammation of the
bowel, vomiting.
Rare: Gastrointestinal ulcers, inability to absorb
nutrients through the gut lining into the bloodstream
(malabsorption).
Very rare: Vomiting of blood, bleeding from your bowel,
a very dilated colon which maybe accompanied by
bloating and abdominal pain.

Skin
Common: Rash, reddening of the skin, itching.
Uncommon: Your skin may become very sensitive to
light, loss of hair, increased number of rheumatic
nodules, shingles, inflammation of blood vessels,
herpes-like skin rash, hives.
Rare: Increased skin pigmentation, acne, blue spots
due to vessel bleeding.
Very rare: Stevens-Johnson Syndrome (a systemic
reaction with rash involving the skin and mucous
membranes, potentially life threatening), syndrome of
“burnt skin” (Lyell’s syndrome), increased pigmentation
of the nails, inflammation of the cuticle, deep infection of
hair follicles, visible enlargement of small blood vessels.
General symptoms and/or symptoms at the
administration site
Very common: Local skin reactions (burning sensation,
redness) at the site of injection. Most of these reactions
are of mild degree.
Rare: Allergic reactions, allergic shock, allergic
inflammation of blood vessels, fever, conjunctivitis
(which may be recognised as red eyes), infection, blood
poisoning, wound-healing problems, reduced antibody
formation.
Very rare: Local damage (abscess, changes in the fatty
tissue) at the site of injection.
Metabolism
Uncommon: Onset of diabetes mellitus.
Nervous system
Common: Headache, tiredness, drowsiness.
Uncommon: Dizziness, confusion, feeling very sad or
unable to do your normal activities (depression), having
difficulty in your ability to pay attention, remember,
process and act upon information (cognitive
dysfunction).
Very rare: Impaired vision, pain, loss of muscular
strength or sensation of numbness or tingling in arms
and legs, changes in taste (metallic taste), convulsions,
severe headache with fever, loss of muscle function
(paralysis).

Eye
Rare: Visual disturbances.
Very rare: Disease of the retina of the eye (retinopathy).
Liver and gall bladder
Very common: Increase in specific liver enzymes.
Uncommon: Chronic liver damage (cirrhosis), a wasting
away of liver tissue (liver atrophy), formation of liver scar
tissue (liver fibrosis), fatty degeneration of the liver (i.e.
accumulation of excess fat in the liver).
Heart and vascular system
Rare: 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).
Lungs and respiratory system
Common: Inflammation of the lungs, allergic pulmonary
reaction often associated with elevated count of white
blood cells. (Symptoms are: dry, non-productive cough,
shortness of breath and fever).
Rare: Lung fibrosis (thickening and scarring of lung
connective tissue), shortness of breath and bronchial
asthma, accumulation of fluid in the sac around the
lung.
Blood
Common: Reduced blood cell formation with decrease
in the amount of white and/or red blood cells and/or
platelets (leucopenia, anaemia, thrombocytopenia).
Uncommon: Decrease of all blood cells (pancytopenia).
Very rare: Severely decreased number of white blood
cells (e.g. agranulocytosis, see below), severe bone
marrow depression (decreased ability of the bone
marrow to produce red blood cells, white blood cells or
platelets).
Kidney and urinary system
Uncommon: Inflammation and ulcers of the urinary
bladder or vagina, kidney problems, disturbed urination.
Rare: Kidney failure, decreased or absent production of
urine, electrolyte disturbances (imbalance of certain
salts in the blood).
Very rare: Loss of sexual drive, impotence, reduced
sperm count, defective egg formation, defective sperm

formation, infertility, menstrual disorders, vaginal
discharge.
Muscular/skeletal
Uncommon: Joint pain, muscle pain, osteoporosis
(brittle bones).
Other
Very rare: There have been reports of individual cases of
lymphoma (enlarged lymph nodes) which subsided in a
number of cases once treatment with Metoject had
been discontinued.
Metoject can in very rare cases influence the white
blood cells so that the immune defence is
compromised. In case you suffer from an infection
associated with symptoms such as fever and feeling
generally unwell and weak, or fever with symptoms of
local infections such as throat or mouth pain or difficulty
urinating, you should immediately contact your doctor
so that a blood sample can rule out a lack of white
blood cells (agranulocytosis). It is important that you
inform him about your medication.
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.
5. HOW TO STORE METOJECT
Keep out of the reach and sight of children.
Store below 25 °C.
Keep the pre-filled syringes in the 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.

What Metoject looks like and contents of the pack
Metoject pre-filled syringes contain a clear, yellow
solution.
The following pack sizes are available: 0.75 ml, 1 ml,
1.5 ml, 2 ml and 2.5 ml solution for injection in packs of
1, 5, 10 and 30 pre-filled syringes with graduation, with
or without injection needle. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation
holder:
medac
Gesellschaft für klinische
Spezialpräparate mbH
Fehlandtstr. 3
20354 Hamburg
Germany
Tel.: +49 4103 8006-0
Fax: +49 4103 8006-100

Manufacturer:
medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Tel.: +49 4103 8006-0
Fax: +49 4103 8006-100

For further information please contact:
medac UK
Scion House
Stirling University
Stirling
FK94NF
Tel.: 01786458086
Fax: 01786458032
This leaflet was last approved 2007-05-09.

6. FURTHER INFORMATION
What Metoject contains
• The active substance is methotrexate. 1 ml of
solution contains methotrexate disodium
corresponding to 10 mg methotrexate.
• The other ingredients are sodium chloride, sodium
hydroxide, water for injections.

90230-VPGB
BA

Expand Transcript

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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