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METHOTREXATE 17.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN

Active substance(s): METHOTREXATE / METHOTREXATE / METHOTREXATE

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Uncommon: may affect up to 1 in 100 people

6. Contents of the pack and other information



What Metoject PEN contains

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



Package leaflet: Information for the user

The active substance is methotrexate.
1 pre-filled pen with 0.35 ml solution contains 17.5 mg
methotrexate.
The other ingredients are sodium chloride, sodium hydroxide
(E 524) and hydrochloric acid (E507) (for pH adjustment) and
water for injections.

What Metoject PEN looks like and contents of the pack

Rare: may affect up to 1 in 1,000 people

Pre-filled pen containing a clear, yellow-brown solution in pre-filled
colourless glass syringe with a plunger stopper of rubber and
embedded injection needle. The syringe is externally equipped with
the device for self-administration. Alcohol pads are included in the
package.



Increased skin pigmentation, acne, blue spots due to vessel
bleeding

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

Allergic inflammation of blood vessels, fever, red eyes,
infection, wound-healing impairment, decreased number of antibodies in the blood

Product Licence holder





Joint pain, muscle pain, osteoporosis (reduction of bone mass)

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



Visual disturbances



Inflammation of the sac around the heart, accumulation of fluid
in the sac around the heart

Manufacturer



Low blood pressure, occlusion of a blood vessel by dislodged
blood clot (thromboembolic events)

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



Lung fibrosis, shortness of breath and bronchial asthma,
accumulation of fluid in the sac around the lung



POM





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



Metoject PEN 17.5 mg solution for injection in pre-filled
pen
®
Metex PEN 17.5 mg solution for injection in pre-filled
pen
Methotrexate 17.5 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.
This medicine is also available in other strengths.
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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

Metoject® is a registered trademark of medac Gesellschaft für
klinische Spezialpräparate mbH.

4. Possible side effects

Metex® is a registered trademark of medac Gesellschaft für
klinische Spezialpräparate mbH.

6. Contents of the pack and other information

S1800 LEAFLET Metoject 20160922



1 Metoject PEN pre-filled pen

 1 alcohol pad
Metoject PEN pre-filled pen components:
Injection button
Handling area
Transparent control zone
Cap

a) With cap before injection
b) After cap removal before
injection

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,



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.

5. How to store Metoject PEN

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



You need:

c) After injection

Psoriatic arthritis is a kind of arthritis with psoriatric lesions of the
skin and nails, especially at the joints of fingers and toes.



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

1. What Metoject PEN is and what it is used for

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



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.

5. How to store Metoject PEN

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.



 Always use the injection technique advised by your doctor,
pharmacist or nurse.
Additional information

3. How to use Metoject PEN

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.

Reporting of side effects

 Carefully read the instructions below before starting your
injection.

2. What you need to know before you use Metoject PEN

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.

Recommendations

1. What Metoject PEN is and what it is used for

PL: 19488/1800

Leaflet revision date: 22 September 2016


®

Instructions for use

What is in this leaflet

Electrolyte disturbances

Very rare: may affect up to 1 in 10,000 people

S1800 LEAFLET Metoject 20160922

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:


upper thighs,

Do not store above 25°C.

2. What you need to know before you use Metoject PEN



abdomen except around the navel.

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

Do not use Metoject PEN if you



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.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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.



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.

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.



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



suffer from stomach ulcer or intestinal ulcer.



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



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 PEN if you:


are elderly or if you feel generally unwell and weak.



have problems with the way your liver works.



suffer from dehydration (water loss).



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.

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.

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.


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 prefilled 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).

Recommended follow-up examinations and safety measures:

Metoject PEN with food, drink and alcohol

If you forget to use Metoject PEN

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.

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

Do not take a double dose to make up for a forgotten dose.

Before therapy:

Pregnancy, breast-feeding and fertility

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.

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.

During therapy:

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.

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 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.
Other medicines and Metoject PEN
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:

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.

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.

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)

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
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.

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

Use in children and adolescents



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.

Metoject PEN is not recommended in children less than 3
years of age due to insufficient experience in this age group.

The doctor decides on the appropriate dose in children and
adolescents with polyarthritic forms of juvenile idiopathic arthritis.

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).

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.



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).

Whom should you contact in case of need



 For any problem or question, contact your doctor, pharmacist or
nurse.

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).

 If you or someone around you is injured by the needle, consult
your doctor immediately and throw away the Metoject PEN prefilled pen.
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.
Leaflet revision date: 16 August 2016

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.





To avoid any injury, never insert your fingers in the opening of
the protective tube covering the needle. Do not destroy the pen.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

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.

Method and duration of administration

Note

4. Possible side effects

Driving and using machines

Non-steroidal anti-inflammatory drugs or salicylates
(medicines against pain and/or inflammation).

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.

If you have the impression that the effect of Metoject PEN is too
strong or too weak, talk to your doctor or pharmacist.

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:



15. In case of a slight bleeding use a
plaster.

If you stop using Metoject PEN, talk to your doctor immediately.

Stop breast-feeding prior to and during treatment with Metoject
PEN.



14. The protective shield automatically
moves into place over the needle.
The protective shield is then locked
and the needle is protected.

If you stop using Metoject PEN

Metoject PEN is injected once weekly!

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.
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.
Pregnant health care 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.

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

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

If you use more Metoject PEN than you should



Headache, tiredness, drowsiness

Vaccination with live vaccine must be avoided.

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



Reduced blood cell formation with decrease in white and/or red
blood cells and/or platelets (leukopenia, anaemia,
thrombocytopenia)

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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