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TOPOTECAN MYLAN 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): TOPOTECAN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

TOPOTECAN 1 mg/ml
CONCENTRATE FOR SOLUTION
FOR INFUSION
(topotecan)

Read all of this leaflet carefully before you are given this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Topotecan is and what it is used for.
2. Before you are given Topotecan.
3. How to use Topotecan.
4. Possible side effects.
5. How to store Topotecan.
6. Further information.
1. WHAT TOPOTECAN IS AND WHAT IT IS USED FOR
Topotecan helps to destroy tumours. A doctor or a nurse will
give you the medicine as an infusion into a vein (a drip) in
hospital.

This pattern of treatments will normally be repeated every
three weeks, for all cancers. The treatment may vary,
depending on the results of your regular blood tests.
Stopping treatment
Your doctor will decide when to stop treatment.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Topotecan can cause side effects, although
not everybody gets them.
Serious side effects - tell your doctor immediately
These very common side effects may affect more than 1 in 10
people treated with Topotecan:
• Signs of infections: Topotecan may reduce the number of
white blood cells and lower your resistance to infection. This
can even be life threatening. Signs include:
* Fever.
* Serious deterioration of your general condition.
* Local symptoms such as sore throat or urinary problems (for
example, a burning sensation when urinating, which may be
a urinary infection).
• Occasionally severe stomach pain, fever and possibly
diarrhoea (rarely with blood) can be signs of bowel
inflammation (colitis).

Topotecan is used to treat:
• ovarian cancer or small cell lung cancer that has come back
after chemotherapy
• advanced cervical cancer if surgery or radiotherapy
treatment is not possible. When treating cervical cancer,
Topotecan is combined with another medicine called
cisplatin.

This rare side effect may affect up to 1 in 1,000 people
treated with Topotecan:
• Lung inflammation (interstitial lung disease): You are most at
risk if you have a lung disease, had radiation treatment to
your lungs, or have previously taken medicines that caused
lung damage. Signs include:
* Difficulty in breathing.
* Cough.
* Fever.

Your doctor will decide with you whether Topotecan therapy is
better than further treatment with your initial chemotherapy.

Tell your doctor immediately if you get any symptoms of
these conditions, as hospitalisation may be necessary.

2. BEFORE YOU ARE GIVEN TOPOTECAN

Very common side effects
These may affect more than 1 in 10 people treated with
Topotecan:
• Feeling generally weak and tired (temporary anaemia). In
some cases you may need a blood transfusion.
• Unusual bruising or bleeding, caused by a decrease in the
number of clotting cells in the blood. This can lead to severe
bleeding from relatively small injuries such as a small cut.
Rarely, it can lead to more severe bleeding (haemorrhage).
Talk to your doctor for advice on how to minimize the risk of
bleeding.
• Weight loss and loss of appetite (anorexia); tiredness;
weakness; feeling unwell.
• Feeling sick (nausea), being sick (vomiting); diarrhoea;
stomach pain; constipation.
• Inflammation and ulcers of the mouth, tongue, or gums.
• High body temperature (fever).
• Hair loss.

You should not receive Topotecan:
• if you are allergic (hypersensitive) to topotecan or any of the
other ingredients of Topotecan
• if you are breast-feeding
• if your blood cell counts are too low. Your doctor will tell you,
based on the results of your last blood test.
Tell your doctor if any of these applies to you.
Take special care with Topotecan:
Your doctor needs to know before you are given this medicine:
• if you have any kidney or liver problems. Your dose of
Topotecan may need to be adjusted
• if you are pregnant or plan to become pregnant
• if you plan to father a child.
Tell your doctor if any of these applies to you.
Topotecan may harm a baby conceived before, during or soon
after treatment. You must use an effective method of
contraception. Ask your doctor for advice.
Taking other medicines
Please tell your doctor if you are taking or have recently taken
any other medicines, including any herbal products or
medicines obtained without a prescription. Remember to tell
your doctor if you start taking any other medicines while you
are on Topotecan.
Using Topotecan with food and drink
There is no known interaction between Topotecan and
alcohol. However, you should check with your doctor whether
drinking alcohol is advisable for you.
Pregnancy and breast-feeding
Topotecan is not recommended for pregnant women. It may
harm the baby if conceived before, during or soon after
treatment. You should use an effective method of contraception.
Ask your doctor for advice. Do not try and become pregnant/
father a child until a doctor advises you it is safe to do so.
Male patients, who may wish to father a child, should ask their
doctor for family planning advice or treatment. If pregnancy
occurs during treatment, tell your doctor immediately.
Do not breast-feed if you are being treated with Topotecan. Do
not restart breast-feeding until the doctor tells you it is safe to
do so.
Driving and using machines
Topotecan can make people feel tired. If you feel tired or weak,
do not drive and do not use machines.
3. HOW TOPOTECAN IS USED
The dose of Topotecan you are given will be worked out by
your doctor, based on:
• your body size (surface area measured in square metres)
• the results of blood tests carried out before treatment
• the disease being treated.
The usual dose
• for ovarian and small cell lung cancer: 1.5 mg per square
metre of body surface area per day
• for cervical cancer: 0.75 mg per square metre of body surface
area per day.
When treating cervical cancer, Topotecan is combined with
another medicine, called cisplatin. Your doctor will advise you
about the correct dose of cisplatin.
How Topotecan is given
A doctor or nurse will give you a suitable dose of Topotecan as
an infusion (a drip). It is usually dripped into your arm over
about 30 minutes.
• For ovarian and small cell lung cancer, you will have
treatment once a day for 5 days.
• For cervical cancer, you will have treatment once a day for 3
days.

The following information is intended for medical or
healthcare professionals only:
Instructions on how to dilute, store, and dispose of
Topotecan
Dilution
Further dilution is required. The appropriate volume of the
concentrate should be diluted with either 0.9 % w/v sodium
chloride intravenous infusion or 5 % w/v glucose intravenous
infusion, to a final concentration of between 25 and 50
microgram per ml.
Shelf life after opening the container
Chemical and physical in-use stability has been demonstrated
for 48 hours at 2°C-8°C or at room temperature. From a
microbiological point of view, unless the method of opening
precludes the risk of microbiological contamination, the
product should be used immediately. If not used immediately,
in-use storage times and conditions are the responsibility of
the user.
Shelf life after preparing the solution for infusion ready for
use
Chemical and physical in-use stability has been demonstrated
for 96 hours at 2°C-8°C and for 48 hours at room temperature.
From a microbiological point of view, the product should be

Common side effects
These may affect up to 1 in 10 people treated with Topotecan:
• Allergic or hypersensitivity reactions (including rash).
• Yellow skin.
• Itching sensation.
• Muscle pain.
Rare side effects
These may affect up to 1 in 1,000 people treated with
Topotecan.
• Severe allergic or anaphylactic reactions.
• Swelling caused by fluid build up (angioedema).
• Mild pain and inflammation at the site of injection.
• Itchy rash (or hives).
If you are being treated for cervical cancer, you may get side
effects from the other medicine (cisplatin) that you will be
given along with Topotecan. Those effects are described in the
cisplatin patient information.
If you get side effects
Tell your doctor or pharmacist if any of the side effects become
severe or troublesome, or if you notice any side effects not
listed in this leaflet.
5. HOW TO STORE TOPOTECAN
Keep out of the reach and sight of children. Do not use
Topotecan after the expiry date which is stated on the carton.
Store in a refrigerator (2°C-8°C). Keep the vial in the outer
carton in order to protect from light.
6. FURTHER INFORMATION
What Topotecan contains:
• The active substance is topotecan. Each vial contains
topotecan hydrochloride equivalent to 1 mg, 2 mg or 4 mg of
topotecan.
• The other ingredients are: water for injections, hydrochloric
acid and sodium hydroxide.
What Topotecan looks like and contents of the pack
Topotecan is a concentrate for solution for infusion. It is
available in packs containing either 1, 5 or 10 vials; each vial
contains 1 mg, 2 mg or 4 mg of topotecan. The concentrate
needs to be diluted before infusion. The concentrate in the vial
provides 1mg per ml of active substance.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturers:
Medac Gesellschaft für klinische Spezialpräparate mbH,
Fehlandtstr. 3, 20354 Hamburg, Germany.
Oncotec Pharma Produktion GmbH, Am Pharmapark, 06861
Dessau-Rosslau, Germany.
MYLAN S.A.S, 117 allée des Parcs - 69800 SAINT-PRIEST, France.
This leaflet was last revised in: December 2011

I-117176-A 10003617

used immediately. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of the
user and would normally not be longer than 24 hours at
2°C-8°C, unless dilution has taken place under controlled and
validated aseptic conditions.
Handling and disposal
The normal procedures for proper handling and disposal of
anti tumour medicinal products should be adopted:
• Pregnant staff should be excluded from working with this
medicinal product.
• Staff handling this medicinal product should wear protective
clothing including mask, goggles and gloves.
• All items for administration or cleaning, including gloves,
should be placed in high risk, waste disposal bags for high
temperature incineration.
• Any unused product or waste material should be disposed of
in accordance with local requirements.
• Accidental contact with the skin or eyes should be treated
immediately with copious amounts of water.

This leaflet was last revised in: December 2011

I-117176-A 10003617

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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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