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EPOSIN CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML

Active substance(s): ETOPOSIDE

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Eposin 20 mg/ml · 81450-VBGB · CA · 07.15 · Pharma-Code: 37
Format: 486 x 252 mm · HKS 44 · Corrective action: KV01_jte_09.04.15 / KV02_jte_10.04.15 / KV03_jte_10.04.15 / KV04_osc_27.07.15

Package leaflet: Information for the user

Eposin,
concentrate for solution for infusion 20 mg/ml
etoposide
Read all of this leaflet carefully before you are
given your 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,
pharmacist or nurse.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

Eposin, 20 mg/ml
81450-VBGB
CA

What is in this leaflet
1. What Eposin is and what it is used for
2. What you need to know before you are given Eposin
3. How to use Eposin
4. Possible side effects
5. How to store Eposin
6. Contents of the pack and other information

1. What Eposin is and what it is used for

Eposin, 20 mg/ml
81450-VBGB
CA

Medicinal product group
Eposin contains the active ingredient of etoposide,
which is a cancer chemotherapy drug which slows the
process of cell division. Eposin belongs to a class of
drugs known as podophyllotoxin derivatives; it slows or
stops the growth of cancer cells in your body.
Use for
This medicinal product is used for:
• Tumours of the testis in combination with other
products against cancer.
• A certain form of lung cancer (small cell lung cancer),
in combination with other products against cancer.
• Certain types of cancer of the blood (acute
myelomonocytic and monocytic leukaemia; in
combination with other products against cancer.)

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are
given Eposin.
Eposin is only used under strict supervision of a doctor
experienced with the use of cytostatics.
Tell your doctor if you have previously been treated
with products against cancer or if you have received
radiation therapy.
Eposin should be only administered in a vein. If you have
a stinging or burning sensation at the place where you
have been injected with Eposin, it may be due to leaking
of Eposin out of the vein. If this happens please tell your
doctor as they will start treatment from a different vein
and will monitor the affected area carefully.
Your doctor will regularly check your blood and the
functioning of your liver during the use of Eposin.
If you have bone marrow depression caused by radiation
therapy or chemotherapy, your doctor will not restart the
treatment until your blood tests shows that this is justified.
Also tell your doctor if you think that you have infections.
If you think that you might have an allergic reaction
causing flushing, fast heartbeat, difficulty in breathing
and a severe reduction in blood pressure (anaphylactic
reaction). Tell your doctor immediately of these
symptoms, you may need urgent medical attention.
During and for 6 months after the use of Eposin
both men and women must use products to prevent
pregnancy. Because Eposin can cause infertility, men
can have their sperm frozen at the sperm bank before
the treatment with Eposin starts.
A bottle with Eposin contains 24 % m/v alcohol.
This may be harmful to alcoholics, children, pregnant
women and patients with liver diseases, epilepsy
or diseases of the brains. Alcohol can influence or
increase the effect of other medicinal products.
This product contains benzyl alcohol. May cause toxic
reactions and allergic reactions in infants
and children up to 3 years old.
Eposin and anthracyclines can negatively affect each
other’s action.

2. What you need to know before you are given
Eposin

Consult your doctor if one of the above warnings is
applicable to you, or has been in the past.

Do not use Eposin
• if you are allergic to etoposide, or one of the other
ingredients of this medicine (listed in section 6)
• if you have severely reduced function of the liver
• if you have severe suppression of the functioning of
the bone marrow, unless when this is caused by your
disease
• if you are breast-feeding
• if you will receive yellow fever vaccine or other
live vaccines. Live vaccines should not be used in
patients whose immune system is less functional.
• This product contains benzyl alcohol. Must not be
given to premature babies or neonates.

Other medicines and Eposin
Tell your doctor, pharmacist or nurse if you are taking,
have recently taken or might take any other medicines.
Note: the following remarks may also be applicable to
the use of medicinal products in the past or their use in
the near future.
The medicines mentioned in this section may be known
to you under a different name, often the brand name.
In this section only the active ingredient of the
medicinal product is mentioned, not the brand name!
Therefore always carefully read on the package or in
the patient leaflet what the active ingredient is of the
medicines you are using.

An interaction means that (medicinal) products that are
used together can influence each other’s effect and/ or
side effect. An interaction can occur with the concomitant
use of this concentrate for injection fluid and:
• Cisplatin can reduce the rate of elimination of Eposin.
• Phenytoin (a product used in the treatment of
epilepsy). The concomitant use of Eposin and
phenytoin can reduce the effect of Eposin.
• products that counteract coagulation of the blood
(coumarines like warfarin, acenocoumarol or
phenprocoumon), Eposin may increase the effect of
these products.
• Eposin may reduce the effectiveness of the immune
system, therefore yellow fever vaccine or other live
vaccines should not be used in immunosuppressed
patients.
• certain painkillers (phenylbutazone, sodium
salicylate, salicylic acid), the effect and adverse
effects of Eposin may increase.
• cyclosporin (immune system suppressing product);
the dose of Eposin should be reduced.
• bone marrow suppressing products (such as
for instance cyclophosphamide, BCNU, CCNU,
5-fluorouracil, vinblastin, doxorubicin, cisplatin);
the effect of Eposin and/ or of the concomitantly
administered bone marrow suppressing medicine
can be increased.
• anthracyclines (products against cancer); Eposin
and anthracyclines can negatively affect each
other’s action.
• other products against cancer (such as for instance
bleomycin, cisplatin, ifosfamide, methotrexate); the
occurrence of acute leukaemia has been reported.
Pregnancy and breast-feeding
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 you are given
this medicine.
Pregnancy
Eposin is not recommended during pregnancy. Women
should not get pregnant and men should not father a
baby until at the earliest 6 months after the therapy with
Eposin. See section “Take special care with Eposin”.
Breast-feeding
Because many drugs are excreted in human milk and
because of the potential for serious adverse reactions
in nursing infants from Eposin, a decision should be
made whether to discontinue nursing or to discontinue
the drug, taking into account the importance of the
drug to the mother.
Driving and using machines
The use of this medicinal product can cause nausea
and vomiting. Therefore be cautious with activities
that require your full attention, such as participating
in traffic, operating machines and working at heights.
Keep a close eye on children who are using this
medicine, when they are playing outside.

3. How to use Eposin

Other side effects include:

Eposin is an infusion concentrate. This means that
it should not be injected into the veins the way it is.
It must first be diluted with a physiological salt or
glucose solution. Eposin is administered by your
doctor in the hospital as an infusion into the veins.
The usual dose of Eposin in combination with other
chemo-therapeutic drugs is 100 –120 mg/m2 per day.
The administration takes at least 30 minutes.
A treatment cycle may exist of one administration per
day (=24 hours) for 3 to 5 days, followed by 10 to
20 days of rest. Usually three or four treatment cycles
are given, however, the length of the treatment and
the number of treatment cycles are determined by the
doctor and may be different for each patient.
A dose adjustment should take place with an
abnormal renal function.

Very common (may affect more than 1 in 10 people)
• Decreased production of blood cells and platelets
(myelosuppression)
• Few white blood cells (leucopenia)
• Decreased platelet count (thrombocytopenia)
• Low number of neutrophils (neutropenia)
• Reduction of haemoglobin (anaemia)
• Feeling (nausea) or being sick (vomiting)
• Loss of appetite, abdominal pain and constipation
• Hair loss
• Liver toxicity
• Pigmentation
• Weakness, sleepiness and feeling discomfort

If you notice that the effects of Eposin are too strong
or too weak, consult your doctor or pharmacist.
If you are given more Eposin than you should
If you suspect a severe overdose, you should notify
a doctor immediately. Symptoms that may occur are
severe bruising and/ or bleeding and inflammation of
the mucous membranes. You may be treated
with antibiotics or blood transfusions. In case of
a hypersensitivity reaction, you will be treated with
certain medicinal products (antihistamines and
corticosteroids).
If you forget to use Eposin or if you stop using
Eposin
Contact your doctor if you think a dose of etoposide
has been forgotten.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them. Some side
effects only occur after some time.
Tell your doctor or nurse immediately if you notice
any of the following:
• Severe allergic reactions such as fever, loss of heat,
rapid heartbeat, abnormal contraction of muscles
of bronchioles, shortness of breathing, stopping of
breathing, low muscles tone and low blood pressure
• Itching, reddish or purple patches on skin, infection
and bleeding.
• Serious illness with severe peeling and swelling of
the skin, blistering of the skin, mouth, eyes genitals
and fever
• Skin rash with pink-red blotches especially on palms
of hands or soles of feet which may blister (handfoot syndrome).

Common (may affect up to 1 in 10 people)
• Acute leukaemia (severe blood cancer)
• Irregular heart rhythm and heart attack
• Dizziness
• High blood pressure
• Inflammation of the gastric and oesophageal mucous
membrane (mucositis, oesophagitis)
• Inflammation of the mouth and lips (stomatitis)
• Diarrhoea
• Skin irritation and rash
• Inflammation of vein (phlebitis)
• Leakage of the fluid outside the vessel (extravasation)
Uncommon (may affect up to 1 in 100 people)
• Numbness or weakness of limbs
• Cough
Rare (may affect up to 1 in 1,000 people)
• Seizures
• Transitory loss of vision
• Inflammation of optic nerve
• Lung inflammation
• Scarring of the lung which causes shortness of
breath (pulmonary fibrosis)
• Changes in taste
• Swallowing difficulties
• Radiation recall dermatitis (i.e. skin redness, swelling
and/or blistering of skin at the site of previous
radiation)
Not known (frequency cannot be estimated from the
available data)
• Acute promyelocytic leukemia (a type of blood
cancer)
• Increase in some liver enzymes and bilirubin in the
blood
Paediatric population
Anaphylactoid reactions were more often reported in
children who received doses that were higher than
recommended.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side

Eposin 20 mg/ml · 81450-VBGB · CA · 07.15 · Pharma-Code: 37
Format: 486 x 252 mm · HKS 44 · Corrective action: KV01_jte_09.04.15 / KV02_jte_10.04.15 / KV03_jte_10.04.15 / KV04_osc_27.07.15

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 Eposin
Keep this medicine out of the sight and reach of
children.
Do not use Eposin after the expiry date which is stated
on the packaging after “do not use after” or “exp.”
The first 2 numbers indicate the month, the last
numbers indicate the year.
The expiry date refers to the last day of that month.
Store unopened bottles below 25 °C in the tightly
closed package. Do not freeze. If stored like this then
the medicinal product can be used up to the date
mentioned on the package.
After dilution the solution must be administered
immediately. If this is not possible the diluted solution
may be stored at room temperature (15 –25 °C) for
a maximum of 12 hours. The solution may not be
stored in the refrigerator (2 –8 °C) as deposits could
be formed. Remainders of used solutions should be
discarded. Solutions must be clear. Cloudy solutions
must not be used.
Prevent unnecessary contact with the solution.
Immediately wash the skin after contact with Eposin.
Have your doctor or nurse take the bottles, needles
and syringes in order to dispose of them according
to the regulations.
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.

6. Contents of the pack and other information
What Eposin contains
• The active substance is 20 mg of etoposide per ml
of concentrate for solution for infusion.
• The other ingredients are macrogol 300, polysorbate
80 (E433), benzyl alcohol (30 mg per ml), ethanol,
citric acid anhydrate (E330).
What Eposin looks like and contents of the pack
Eposin is a yellowish viscous liquid in a clear glass
bottle with a rubber stopper with an aluminium closing
and a plastic snap-cap.
1 bottle with 5 ml of concentrate for solution for
infusion contains 100 mg of etoposide.
1 bottle with 25 ml of concentrate for solution for
infusion contains 500 mg of etoposide.

A package contains 1 bottle or 10 bottles of Eposin.
Not all mentioned package sizes are marketed.
Marketing Authorisation Holder
Pharmachemie B.V.
Swensweg 5
Postbus 552
2003 RN Haarlem
Netherlands
Manufacturer
medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
This medicinal product is authorised in the Member
States of the EEA under the following names:
The Netherlands Eposin, concentraat voor oplossing
voor infusie 20 mg/ml
Finland
Eposin, infuusiokonsentraatti,
liuosta varten 20 mg/ml
Germany
Etomedac, Konzentrat zur
Herstellung einer Infusionslösung
20 mg/ml
Spain
Etopósido Tevagen 20 mg/ml
concentrado para solución para
perfusión
United Kingdom
Eposin, Concentrate for Solution for
Infusion 20 mg/ml
This leaflet has last been revised in 07/2015.

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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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