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METEX PEN 10 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN

Active substance(s): METHOTREXATE

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S1797 LEAFLET Metoject 20160607

In the following, please find the other side effects that may occur:

5. How to store Metoject PEN

Very common: may affect more than 1 in 10 people



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Mouth inflammation, indigestion, nausea (feeling sick), loss of
appetite



Do not store above 25°C.





Increase in liver enzymes.

Keep the pre-filled pens in the outer carton in order to protect
from light.



Do not use this medicine after the expiry date stated on the
carton and pre-filled pen after EXP. The expiry date refers to
the last day of that month.

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)

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 antibodies 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
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
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



Package leaflet: Information for the user
Metoject® PEN 10 mg solution for injection in pre-filled pen
Metex® PEN 10 mg solution for injection in pre-filled pen
Methotrexate 10 mg solution for injection in pre-filled pen
(methotrexate)
Your medicine is known as above names but will be referred to as
Metoject PEN throughout the following patient information leaflet.

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.

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

If your pre-filled pen shows any signs of deterioration, consult
your doctor or pharmacist who will tell you what to do.



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.

6. Contents of the pack and other information
What Metoject PEN contains


The active substance is methotrexate.



1 pre-filled pen with 0.2 ml solution contains 10 mg
methotrexate.


The other ingredients are sodium chloride, sodium hydroxide
and hydrochloric acid for pH adjustment and water for
injections.

If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

Instructions for use
Recommendations
 Carefully read the instructions below before starting your
injection.
 Always use the injection technique advised by your doctor,
pharmacist or nurse.
Additional information
The manner of handling and throwing away of the medicine and
pre-filled pen must be in accordance with local requirements.
Pregnant healthcare personnel should not handle and/or administer
Metoject PEN.
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.
What you need in order to administer your injection using the
Metoject PEN pre-filled pen
You need:


What is in this leaflet
1. What Metoject PEN is and what it is used for
2. What you need to know before you use Metoject PEN

What Metoject PEN looks like and contents of the pack

3. How to use Metoject PEN

One pre-filled pen containing a clear, yellow-brown pre-filled glass
syringe with chlorobutyl rubber plunger stopper and embedded
injection needle. Alcohol pads are also included in the package.

4. Possible side effects

Metoject PEN is available in packs of 1 pre-filled pen.

5. How to store Metoject PEN
6. Contents of the pack and other information
1. What Metoject PEN is and what it is used for

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Metoject PEN 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,

Manufacturer
This product is manufactured by medac Gesellschaft für klinische
Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany.
POM

PL: 19488/1797

Leaflet revision date: 07 June 2016
Metoject® is a registered trademark of medac Gesellschaft für
klinische Spezialpräparate mbH.
Metex® is a registered trademark of medac Gesellschaft für
klinische Spezialpräparate mbH.
S1797 LEAFLET Metoject 20160607



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.

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.
Psoriasis is a common chronic skin disease, characterised by red
patches covered by thick, dry, silvery, adherent scales.
Psoriatic arthritis is a kind of arthritis with psoriatric lesions of the
skin and nails, especially at the joints of fingers and toes.

What you need to do before administering your injection
1. Wash your hands very carefully.
2. Remove the system from its packaging.
3. Check the Metoject PEN pre-filled pen before using it:
If the Metoject PEN pre-filled pen appears to
be damaged do not use it. Use another one
and contact your doctor, pharmacist or nurse.
In case a small air bubble is visible through
the transparent control zone, this will not affect
your dose nor will it harm you.
If you are not able to see or to check the
system correctly prior to injection, ask someone around you for
assistance.
4. Set the Metoject PEN pre-filled pen on a clean flat surface (such
as a table).
Where you should administer the injection
The most appropriate zones for your injection are:

Metoject PEN modifies and slows down the progression of the
disease.

Enlargement of lymphatic nodes (lymphoma)

Subcutaneous application of methotrexate is locally well tolerated.
Only mild local skin reactions (such as burning sensations,
erythema, swelling, discolouration, severe itching, pain) were
observed, decreasing during therapy.
Reporting of side effects

1 Metoject PEN pre-filled pen

 1 alcohol pad
Metoject PEN pre-filled pen components:



upper thighs,



abdomen except around the navel.



If someone around you administers the
injection for you, the person may also use
the top of the zone at the back of the arm,
just below the shoulder.

2. What you need to know before you use Metoject PEN
Do not use Metoject PEN if you


are allergic to methotrexate or any of the other ingredients of
this medicine (listed in section 6).



Change the injection area with each injection. This will minimize
any reactions at the injection site.



Never inject into areas where the skin is tender, bruised, red or
hard or where you have scars or stretch marks. If you have
psoriasis, you should not try to inject directly into any raised,
thick, red or scaly skin patches or lesions.



suffer from liver or severe kidney diseases or blood diseases.

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.



regularly drink large amounts of alcohol.



suffer from a severe infection, such as tuberculosis, HIV or
other immunodeficiency syndromes.

By reporting side effects you can help provide more information on
the safety of this medicine.



suffer from stomach ulcer or intestinal ulcer.



are pregnant or breast-feeding.



receive vaccinations with live vaccines at the same time.

How to prepare the injection
5. Clean your skin in the chosen injection
zone using the enclosed alcohol pad.
6. Hold the Metoject PEN pre-filled pen with
one hand in the handling area.


Do not remove the cap before you are
ready to administer the injection.



Theophylline (medicine against bronchial asthma and other
lung diseases).

Pregnant health care personnel should not handle and/or
administer Metoject PEN.

are elderly or if you feel generally unwell and weak.



Proton-pump inhibitors (medicines against stomach trouble).

have problems with the way your liver works.



Hypoglycaemics (medicines that are used to lower the blood
sugar).

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.

7. Use your other hand to pull the cap
straight off. The small needle shield
comes off with the cap automatically. If
not, use another pen and contact your
doctor, pharmacist or nurse.

Warnings and precautions



 suffer from dehydration (water loss).
Recommended follow-up examinations and safety measures:

Do not press the button until you are
ready to inject.



If you are unable to remove the cap, ask
someone around you for assistance.
Note: Once you have removed the cap, perform your injection
without delay.
8. With your free hand, build a skin fold by
gently squeezing the area of the
cleaned skin at the injection site.


The fold must be held pinched until the
Metoject PEN pre-filled pen is removed
from the skin after the injection.

9. Position the uncapped transparent end of
Metoject PEN pre-filled pen perpendicular
to the fold of skin.
10. Without pressing the button, push the
Metoject PEN pre-filled pen firmly onto
your skin in order to unlock the button.
 If you are unable to push the Metoject
PEN pre-filled pen to the stop-point, ask someone around you
for assistance.
How to administer the injection:
11. While holding the Metoject PEN pre-filled
pen firmly against the skin, now press
the button with your thumb.
12. You will hear a click which indicates the
start of the injection. Keep holding the
pen against the raised skin until all of the
medicine is injected. This can take up to 5
seconds.
Note:
Do not remove the Metoject PEN pre-filled pen from the skin before
the end of the injection to avoid incomplete injection.
If the injection is not triggered, release the button, make sure that
the Metoject PEN pre-filled pen is pressed firmly against the skin
and push hard on the button.
If you have troubles with your hearing, count 5 seconds from the
moment you have pressed the button and then lift the Metoject PEN
pre-filled pen from the injection site.
13. Remove the Metoject PEN prefilled pen
from the injection site, perpendicular to
the skin (pull up).
14. The protective shield automatically moves
into place over the needle. The protective
shield is then locked and the needle is
protected.

Talk to your doctor or pharmacist before taking Metoject PEN if you:



Even when Metoject PEN 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 PEN with food, drink and alcohol

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:

Alcohol as well as large amounts of coffee, caffeine-containing soft
drinks and black tea should be avoided during treatment with
Metoject PEN.
Pregnancy, breast-feeding and fertility

You will have the following tests at least once a month during the
first six months and at least every three months thereafter:

Do not take Metoject PEN 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 PEN has
been discontinued.



Examination of the mouth and throat for changes 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 (such as herpes zoster [shingles],
tuberculosis, hepatitis B or C) may flare up. During therapy with
Metoject PEN 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 if this is the
case, therapy must be stopped.
Diarrhoea can be a possible side effect of Metoject PEN and
requires an interruption of therapy. If you suffer from diarrhoea
please speak to your doctor.

Note

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. Please note that this also
applies to medicines that you will take in the future.
The effect of the treatment may be affected if Metoject PEN is
administered at the same time as certain other medicines:


Medicines harming the liver or the blood count, such as
leflunomide.



Antibiotics (medicines to prevent/fight certain infections) such
as: tetracyclines, chloramphenicol, and non-absorbable broadspectrum 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 (such as acetylsalicylic acid, diclofenac and ibuprofen)
and pyrazole (e.g. metamizol for treating pain).



Medicinal products, which may have adverse effects on the
bone marrow, such as 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).

 For any problem or question, contact your doctor, pharmacist or
nurse.
If you or someone around you is injured by the needle, consult your
doctor immediately and throw away the Metoject PEN pre-filled pen.

If you use more Metoject PEN than you should, talk to your doctor
immediately.

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.

In women of child-bearing age, any existing pregnancy must be
excluded with certainty by taking appropriate measures, such as
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. Men should seek advice about
the possibility of sperm preservation before starting therapy.
Stop breast-feeding prior to and during treatment with Metoject
PEN.

Do not take a double dose to make up for a forgotten dose.
If you stop using Metoject PEN
If you stop using Metoject PEN, talk to your doctor immediately.
If you have the impression that the effect of Metoject PEN is too
strong or too weak, 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



The duration of the treatment is determined by the treating
physician. Treatment of rheumatoid arthritis, juvenile idiopathic
arthritis, psoriasis vulgaris and psoriatic arthritis with Metoject PEN
is a long-term treatment.

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



At the start of your therapy, Metoject PEN will be injected by
medical staff. However, your doctor may decide that you are able to
learn how to inject Metoject PEN under the skin yourself. You will
then receive appropriate training.
Under no circumstances should you try to inject Metoject PEN
yourself before you have received such training.

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)

Driving and using machines
Treatment with Metoject PEN may cause adverse reactions
affecting the central nervous system, such as 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 do not drive or use machines.
Metoject PEN contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per
dose; i.e. essentially “sodium-free”.
3. How to use Metoject PEN

Other medicines and Metoject PEN

To avoid any injury, never insert your fingers in the opening of
the protective tube covering the needle. Do not destroy the pen.
Whom should you contact in case of need

If you use more Metoject PEN than you should

If you forget to use Metoject PEN

Before therapy:

15. In case of a slight bleeding use a plaster.
Before throwing away the Metoject PEN pre-filled pen, check
visually that there is no liquid left in the pen, at the bottom of the
transparent control zone. If there is liquid left in the pen, not all of
the medicine has been injected correctly and you should consult
your doctor.

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 must be avoided.

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Your doctor decides on the dosage, which is adjusted individually to
you. Usually it takes 4 – 8 weeks before there is any effect of the
treatment.
Metoject PEN is administered subcutaneously (under the skin) 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.
Use in children and adolescents
The doctor decides on the appropriate dose in children and
adolescents with polyarthritic forms of juvenile idiopathic arthritis.
Metoject PEN 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 PEN is injected once weekly!

You can also find guidance on how to use Metoject PEN in the
section “Instructions for use” at the end of this leaflet. Please note
that all of the contents have to be used.
The manner of handling and throwing away of the medicine and
pre-filled pen must be in accordance with local requirements.

Expand view ⇕

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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