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TOPOTECAN MEDAC 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): TOPOTECAN HYDROCHLORIDE

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Topotecan medac 1 mg/ml · 82000-VPGB · BB · 01.16 · Pharma-Code: 490
Format: 444 x 112 mm · HKS 44 · Corrective action: KV01_osc_06.01.16

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Topotecan medac 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 medac is and what it is
used for
2. Before you are given Topotecan medac
3. How to use Topotecan medac
4. Possible side effects
5. How to store Topotecan medac
6. Further information

1. WHAT TOPOTECAN MEDAC IS AND
WHAT IT IS USED FOR
Topotecan medac 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 medac 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
medac is combined with another
medicine called cisplatin.
Your doctor will decide with you whether
Topotecan medac therapy is better
than further treatment with your initial
chemotherapy.

• 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 medac
Your doctor needs to know before you are
given this medicine
• if you have any kidney or liver problems.
Your dose of Topotecan medac 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.

2. BEFORE YOU ARE GIVEN
TOPOTECAN MEDAC

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.

You should not receive Topotecan medac
• if you are allergic (hypersensitive) to
topotecan or any of the other ingredients
of Topotecan medac.
• if you are breast-feeding.

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 medac.
Using Topotecan medac with food
and drink
There is no known interaction between
Topotecan medac and alcohol. However,
you should check with your doctor whether
drinking alcohol is advisable for you.
Pregnancy and breast-feeding
Topotecan medac 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 medac. Do not restart

breast-feeding until the doctor tells you it is
safe to do so.
Driving and using machines
Topotecan medac can make people feel
tired. If you feel tired or weak, do not drive
and do not use machines.
3. HOW TOPOTECAN MEDAC IS USED
The dose of Topotecan medac 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
medac is combined with another medicine,
called cisplatin. Your doctor will advise you
about the correct dose of cisplatin.

How Topotecan medac is given
A doctor or nurse will give you a suitable
dose of Topotecan medac 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
treatment.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Topotecan medac 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 medac:
• Signs of infections: Topotecan medac
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 1,000 people treated with Topotecan
medac:
• 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.

Topotecan medac 1 mg/ml · 82000-VPGB · BB · 01.16 · Pharma-Code: 490
Format: 444 x 112 mm · HKS 44 · Corrective action: KV01_osc_06.01.16

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 medac:
• 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 medac:
• 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 medac:
• 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 medac. Those
effects are described in the cisplatin patient
information.

Reporting of side effects
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
By reporting side effects you can help
provide more information on the safety of
this medicine.
5. HOW TO STORE TOPOTECAN MEDAC
Keep out of the reach and sight of children.
Do not use Topotecan medac 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 medac 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 medac looks like and
contents of the pack
Topotecan medac is a concentrate for
solution for infusion.
It is available in packs containing either
1 or 5 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
1 mg per ml of active substance.

Marketing Authorisation Holder
and Manufacturer
medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Tel.: +49 4103 8006-0
Fax: +49 4103 8006-100
This leaflet was last approved in 01/2016.

The following information is intended for
medical or healthcare professionals only:
Instructions on how to dilute, store, and
dispose of Topotecan medac
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 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.

82000-VPGB
BB

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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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