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TOPOTECAN STRIDES 4 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

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Package leaflet: Information for the user
Topotecan 4 mg
Powder for Concentrate for Solution for Infusion
topotecan
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 or nurse.
• If you get any side effects, talk to your doctor, or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
What is 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. Contents of the pack and other 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.
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 drug called cisplatin.
Your doctor will decide with you whether
Topotecan therapy is better than further treatment
with your initial chemotherapy.
2. Before you are given Topotecan
You should not receive Topotecan :
• if you are allergic (hypersensitive) to topotecan
or any of the other ingredients of this medicine
(listed in section 6).
• 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.
Warnings and precautions
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.
Topotecan may harm a baby conceived before,
during or soon after treatment. You should use
an effective method of contraception. Ask your
doctor for advice.
→ Tell your doctor if any of these applies to you.
Other medicines and Topotecan
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any other
medicines including herbal products or medicines
obtained without prescription.
Remember to tell your doctor if you start to take any
other medicines while you’re on Topotecan.
Topotecan with food, drink and alcohol
There is no known interaction between Topotecan
and alcohol. However, you should check with your
doctor whether drinking alcohol is advisable for you.
Pregnancy, breast-feeding and fertility
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 squaremetres of body surface area per day.
• For cervical cancer: 0.75 mg per square metres
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.
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 the treatment.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.

The following information is intended for health
care professionals only

Instructions on how to reconstitute, store and
dispose of Topotecan
Reconstitution
Topotecan 4 mg powder for concentrate for
solution for infusion should be reconstituted with 4
ml of water for injections to provide 1 mg per ml of
topotecan.
Further dilution is required. The appropriate
volume of the reconstituted solution 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.
Storage of the prepared solution
The product should be used immediately after
reconstitution and dilution as it contains no
antibacterial preservative.
Chemical and physical in-use stability of the
reconstituted solution and the further diluted
solution has been demonstrated for 24 hours when
stored between 2°C and 25°C.
From a microbiological point of view, the product
should be 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 to 8°C, unless
reconstitution and dilution has taken place in
controlled and validated aseptic conditions.
Handling and disposal
The normal procedures for proper handling and
disposal of anti-tumour medicinal products should
be adopted:
• Staff should be trained to reconstitute the
medicinal product.

• Pregnant staff should be excluded from working
with this medicinal product.
• Staff handling this medicinal product during
reconstitution should wear protective clothing
including mask, goggles and gloves.
• Remnants of the medicinal product as well as the
materials that have been used for reconstitution,
for dilution and administration must be destroyed
according to hospital standard procedures applicable to cytotoxic agents with due regard to current
laws related to the disposal of hazardous waste.
• Any unused medicinal 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.

Serious side effects: tell your doctor
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).
This rare side effect may affect up to 1 in 1000
people treated with Topotecan ).
• Lung inflammation (interstitial lung disease):
You are most at risk if you have existing lung
disease, had radiation treatment to your lungs, or
have previously taken medicines that caused lung
damage. Signs include:
-- difficulty in breathing.
-- cough.
-- fever.
→ Tell your doctor immediately if you get any
symptoms of these conditions, as hospitalisation
may be necessary.
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.
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 1000 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 this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the carton and vial after {EXP}. The
expiry date refers to the last day of that month.
Keep the vial in the outer carton in order to protect
from light.

6. Contents of the pack and other information
What Topotecan contains:
- The active substance is topotecan. Each vial
contains topotecan hydrochloride equivalent to
4 mg of topotecan.
- The other ingredients are tartaric acid (E334),
mannitol (E421), hydrochloric acid (E507) and
sodium hydroxide.
What Topotecan looks like and contents of the
pack.
Topotecan comes as a powder for concentrate for
solution for intravenous infusion.
It is available in packs containing either 1 or 5 vials;
each vial contains 4 mg of topotecan.
The powder needs to be reconstituted and diluted
before infusion.
The powder in the vial provides 1 mg per l of active
substance when reconstituted as recommended.
Marketing Authorisation Holder and
Manufacturer
Marketing authorisation holder
Strides Arcolab International Ltd.
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire WD 189SS
United Kingdom
Manufacturer:
Strides Arcolab Polska Sp.z.o.o.
10, Daniszewska Str
03-230 Warsaw
Poland
This medicinal product is authorized in the
Member States of the EEA under following
names:
This leaflet was last revised in 07/2012.

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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