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Active substance(s): LOMUSTINE

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Lomustine 40 mg capsules · 80695-VPGB · DA · 12.16 · Pharma-Code: 295
Format: 444 x 112 mm · HKS 44 · Corrective action: KV01_osc_15.11.16

medac GmbH


Package leaflet: Information for the user

Lomustine 40 mg capsules
Read all of this leaflet carefully before you
start taking 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.
What is in this leaflet
1. What Lomustine is and what it is used for
2. What you need to know before you take
3. How to take Lomustine
4. Possible side effects
5. How to store Lomustine
6. Contents of the pack and other information


1. What Lomustine is and what it is used for
This medicine contains an active ingredient called

• if you have had a vaccination against yellow fever
or another live vaccine vaccination and suffer
from immunosuppression.
• if you are pregnant or breastfeeding.

Lomustine belongs to a group of medicines
called antineoplastic or cytotoxic agents.
These medicines affect growth and proliferation
of cancer cells.

You and your partner should avoid becoming
pregnant or fathering a child during treatment and
for at least 6 months after your treatment with
lomustine has stopped.

Lomustine capsules are used to treat tumours and
other malignant growths or diseases, for example,
cancer of the lung or skin.

Warnings and precautions
Talk to your doctor or pharmacist before taking

2. What you need to know before you take
Do not take Lomustine
• if you are allergic to lomustine or any of the other
ingredients of this medicine (listed in section 6).
• if you have had a similar medicine before which
you had to stop taking because of side effects or
because it was ineffective.
• if you have any blood disorder.
• if you have severe kidney problems.
• if you have coeliac disease (your body cannot
digest gluten) or wheat allergy.

• Do not take a higher dose of lomustine as
prescribed by your doctor and do not repeat
treatment before the end of 6 weeks.
• Your doctor will check your blood weekly during
your therapy and up to 6 weeks afterwards.
• Lomustine might impair the function of your
blood-building system, and increase the risk of
bleeding and infections. This effect might occur
after a certain time of therapy.
• As the toxic effects of lomustine to your bloodbuilding system are cumulative your doctor might
decide to adjust the dosage of your therapy.
• Tell your doctor if you have any liver problems.
Before you start with lomustine, your doctor will
check the function of your liver and additionally

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of your lung and kidneys. These tests will be
repeated during the time of your therapy.
• Long term use of nitrosoureas has been reported
to be possibly associated with the development
of secondary cancers.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.

Other medicines and Lomustine
No special studies regarding interactions between
lomustine and other medicines have been
performed, but tell your doctor if you are taking any
of the following medicines:
• theophylline – medicine used in the treatment of
respiratory tract diseases, e.g. asthma
• cimetidine – medicine largely used in the
treatment of heartburn and peptic ulcers
• other chemotherapeutic medicines, because
co-administration can lead to complications due
to interactions between the medicines.

Pregnant women should not take this medicine. It is
important to tell your doctor if you are pregnant or
think you might be pregnant, because safe use in
pregnancy has not been established. If you become
pregnant while you are treated with lomustine tell
your doctor immediately, as taking lomustine might
affect your unborn baby detrimentally. If you are
of childbearing age you should avoid becoming

Tell your doctor if you have ever taken
phenobarbital – an anticonvulsant, or any other
antiepileptic medicine.
You should also inform your doctor if you have
recently been vaccinated.
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other

You should not breast-feed your baby while being
treated with this medicine, because lomustine
might pass into your breast milk. As a risk to the
nursing child potentially exists, a decision should be
made whether to discontinue breast-feeding or to
discontinue lomustine therapy taking into account
the benefit of breast-feeding for the child and the
benefit of therapy for the mother.

Men who are treated with lomustine should not
father a child during their therapy and up to 6 month
afterwards. As lomustine may affect your fertility,
ask your doctor to inform you about possible
precautions like sperm conservation before you
start with the treatment.
Driving and using machines
No special studies have been performed, but
Lomustine capsules can impair your ability to drive
and use machines, e.g. because of nausea and
Lomustine contains lactose and wheat starch
This medicine contains lactose. If you have been
told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this
This medicine also contains wheat starch. Patients
with wheat allergy or coeliac disease should
not take this medicine (see above “Do not take

Lomustine 40 mg capsules · 80695-VPGB · DA · 12.16 · Pharma-Code: 295
Format: 444 x 112 mm · HKS 44 · Corrective action: KV01_osc_15.11.16

medac GmbH
3. How to take Lomustine
Care must be taken whenever handling
anticancer products. Caution! Do not break open
the Lomustine capsules. If you accidentally get
the powder on your skin or in your mouth, wash
it off with plenty of water. Wash your hands with
soap and water after handling this product.
Always take this medicine exactly as your doctor
has told you, and in an interval of no less than
6 weeks. Check with your doctor or pharmacist if
you are not sure.
Lomustine capsules are taken by mouth. Swallow
the capsules whole, do not chew or break them.
Use in adults
Your doctor will decide the exact dose to give you
and how often to give it. Usually the dose depends
on your height and weight. You may expect to
receive 200 – 240 mg lomustine. Lomustine
capsules are usually taken once every 6 to 8 weeks
either as a single dose or as a divided dose over
3 days, e.g. 80 mg/day.
The dose you take may be reduced if you are taking
other medicines to treat your condition or if you
have a blood disorder.


Use in children
Lomustine capsules may be used in children
with certain types of tumours. You must only use
Lomustine for children as prescribed by the doctor.
Lomustine capsules are usually taken once every
6 to 8 weeks either as a single dose or as a divided
dose over 3 days, e.g. 40 mg/day.

4. Possible side effects

Other possible side effects:

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

Very common (may affect more than 1 in 10 people)
• Decrease in white blood cells

Please tell your doctor immediately if any of the
following side effects occur:

If you take more Lomustine than you should
Accidental overdose with lomustine has been
reported, including fatal cases.
If you have taken too much medication please
consult your doctor or local casualty department
An overdose might show in abdominal pain,
diarrhoea, regurgitation, lack of appetite, lethargy,
a feeling of dizziness, cough or shortness of breath.

Not known (frequency cannot be estimated from
the available data)
• Various types of effects on the blood, such as too
little red and white blood cells and/or platelets.
This can manifest itself either in the fact that you
bruise more easily than usual or you suffer repeated
infections, e.g. sore throat or cough. You should
contact your doctor immediately if this occurs.
• Nausea, vomiting and loss of appetite. Nausea
and vomiting usually occur approximately
3 – 6 hours after you have taken your dose and
can last for 24 – 48 hours, possibly followed by
reduced appetite for 2 – 3 days. Your doctor may
prescribe other medicines (anti-emetics) which
you can take concurrently to relieve this. It might
also help to take lomustine on an empty stomach.
• Stomatitis (inflammation inside the mouth) and
• Apathy, difficulties in orientation, confusion and
• Hair loss

Not known(frequency cannot be estimated from
the available data)
• Acute leukaemia (blood cancer) and
myelodysplastic syndrome (blood disorder
associated with insufficient production of blood
cells in the bone marrow)
• Pneumonia
• Acute and chronic lung reactions with changes in
lung tissue seen in x-ray, shortness of breath and
dry cough
• Lasting visual impairment (in combination with
radiation treatment)
• Kidney failure, decrease in kidney size and
kidney damage
• Abnormal coordination
• Sleepiness, sluggishness
• Difficulty speaking, unclear speech
• Increase in liver enzymes and bilirubin (breakdown product of the red blood pigment)

If you forget to take Lomustine
It is important to complete the course of medication
exactly as prescribed by your doctor. If you think
you have missed a dose for any reason please
tell your doctor or nurse immediately. Your doctor
will decide how to proceed with the intake of
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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report side effects directly via the Yellow Card
Scheme at:
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Lomustine
Keep this medicine out of the sight and reach of
Do not store above 25 °C.
Keep the box in the outer carton in order to protect
from light and moisture.
Do not use this medicine after the expiry date which
is stated on the carton. The expiry date refers to the
last day of that month.
Do not throw away any medicines via wastewater or
household waste. At the end of treatment return any
leftover medicine to your hospital or pharmacist.

- The other ingredients are lactose, wheat starch,
talc and magnesium stearate.
The capsule is made of gelatine and the colouring
agents titanium dioxide (E171) and indigotine (E132).
What Lomustine looks like and contents
of the pack
Lomustine are blue hard capsules.
Lomustine capsules are packed in a plastic box.
There are 20 capsules in each pack.
Marketing Authorisation Holder and
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Phone: +49 4103 8006-0
Fax: +49 4103 8006-100
PL 11587/0003

6. Contents of the pack and other 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

This leaflet was last revised in December 2016.
What Lomustine contains
- The active substance is lomustine. Each capsule
contains 40 mg lomustine.



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