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LOMUSTINE MEDAC 40MG

Active substance(s): LOMUSTINE

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Lomustine 40 mg capsules · 80695-VPGB · CB · 07.16 · Pharma-Code: 295
Format: 444 x 112 mm · HKS 44 · Corrective action: KV01_osc_19.07.16

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Lomustine 40 mg capsules
Lomustine
Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Lomustine is and what it is used for
2. Before you take use Lomustine
3. How to take Lomustine
4. Possible side effects
5. How to store Lomustine
6. Further information

1. WHAT LOMUSTINE IS AND WHAT IT IS
USED FOR
This medicine contains an active ingredient called
lomustine.
Lomustine belongs to a group of medicines called
antineoplastic or cytotoxic agents. These medicines
affect growth and proliferation of cancer cells.
Lomustine capsules are used to treat tumours and
other malignant growths or diseases, for example,
cancer of the lung or skin.
2. BEFORE YOU TAKE LOMUSTINE
Do not take Lomustine if you
• are allergic (hypersensitive) to lomustine or any
of the other ingredients of Lomustine.
• have had a similar medicine before which you had
to stop taking because of side effects or because
it was ineffective.
• have any blood disorder.
• have severe kidney problems.
• have coeliac disease (your body cannot digest
gluten) or wheat allergy.
• have had a vaccination against yellow fever or
another live vaccine vaccination and suffer from
immunosuppression.
• are pregnant or breastfeeding.

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.
Take special care with Lomustine
• 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 bloodbuilding 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 of
your lung and kidney. 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 malignancies.
Taking other medicines
No special studies regarding interactions between
lomustine and other drugs 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 drugs, because
co-administration can lead to complications
secondary to pharmacokinetic interactions
between the drugs.
Tell your doctor if you have ever taken
phenobarbital – an anticonvulsant or another
antiepileptic drug.
You should also inform your doctor if you recently
have been vaccinated.
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Fertility, pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Pregnancy
Pregnant women should not receive 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 in
the childbearing age you should avoid becoming
pregnant.

Important information about some of the
ingredients of Lomustine
This medicinal product contains lactose. If you have
been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking
this medicinal product.

Breast-feeding
You should not breast-feed your baby while being
treated with this medicine, because lomustine might
be excreted in 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.

This medicinal product also contains wheat starch.
Patients with wheat allergy or coeliac disease should
not take this medicine (see above “Do not take
Lomustine”).

Fertility
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
vomiting.

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 Lomustine exactly as your doctor has
told you, and in an interval not less than 6 weeks.
You should 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.

Lomustine 40 mg capsules · 80695-VPGB · CB · 07.16 · Pharma-Code: 295
Format: 444 x 112 mm · HKS 44 · Corrective action: KV01_osc_19.07.16

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 drugs to treat your condition or if you have a
blood disorder.
Children
Lomustine capsules may be used in children
with certain types of tumour. 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.
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
immediately.
An overdose might express in abdominal pain,
diarrhea, regurgitation, lack of appetite, lethargy,
a feeling of dizziness, cough or shortness of breath.

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 Lomustine.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lomustine can cause side effects,
although not everybody gets them.
The unwanted effects could include:
Gastrointestinal disorders
• Nausea and vomiting usually occur about
3 – 6 hours after taking a full single dose and lasts
for 24 – 48 hours. This is followed by 2 – 3 days
loss of appetite. Your doctor may prescribe another
type of medicine (antiemetics) for you to take at the
same time to help with these side effects.
Nausea, vomiting and loss of appetite may be less
troublesome if you take Lomustine capsules as
a divided dose over 3 days. It might also help to
take lomustine on an empty stomach.
• Stomatitis (inflammation inside the mouth) and
diarrhoea have occurred rarely.

Blood and liver disorders
• If you are affected by blood and liver disorders you
may, for example, find you bruise more easily, or
you may repeatedly get infections such as sore
throat or cough. If this occurs report immediately
to your doctor. Your doctor will probably carry out
regular blood tests while you are on Lomustine
capsules therapy to monitor these side effects.
• Lomustine may produce cumulative
myelosuppression, manifested by more depressed
indices or longer duration of suppression after
repeated doses.
• Acute leukaemia (blood cancer), and
myelodysplastic syndrome (blood-related medical
conditions that involve ineffective production
of the myeloid class of blood cells) have been
reported in patients following long term nitrosurea
therapy, but frequency can not be estimated from
the available data.
• A reversible type of liver toxicity, manifested
by increased liver parameters (transaminases,
alkaline phosphatase, and bilirubin levels), has
been reported in a small percentage of patients
receiving lomustine.
Nervous system disorders
• Mild neurological symptoms, like lack of interest
(apathy), lethargy, disorientation, abnormal
coordination, confusion and stuttering or speech
defects can occur.

Lung disorders
• Pneumonia has occurred rarely.
• Lung fibrosis (formation of binding tissue in
the lungs) and lung infiltration (accumulation
of substances or fluid in the lung) might occur;
frequency not known.
• Pulmonary toxicity has been described to occur
after an interval of 6 months or longer from the
start of therapy with high total doses (> than
1,100 mg/m²). There is one report of pulmonary
toxicity with a total dose of 600 mg.
• Delayed onset of pulmonary fibrosis occurring
up to 17 years after treatment has been reported
in patients with intracranial tumors who received
related nitrosoureas during their childhood and
early adolescence.

Eye disorders
• After combined therapy with radiation an irreversible
vision loss has been reported in single cases.
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 LOMUSTINE
Keep out of the reach and sight of children.

Skin disorders
• Loss of hair has been reported infrequently.
Kidney disorders
• Kidney disorders have occurred in single cases.
• Failure of the kidney, azotaemia (increase of
nitrogenous compounds in your blood) and
decrease in kidney size after prolonged treatment
and large total dose has been reported for
lomustine and related nitrosoureas. Kidney
damage has also been reported occasionally in
patients receiving lower total doses.

Do not store above 25 °C.
Keep the box in the outer carton in order to protect
from light and moisture.
Do not use Lomustine after the expiry date which is
stated on the box. The expiry date refers to the last
day of that month.

6. FURTHER INFORMATION
What Lomustine contains
The active substance is lomustine.
Each capsule contains 40 mg lomustine.
The other ingredients are lactose, wheat starch,
talc and magnesium stearate.
The capsule is made of gelatin 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 Manufacturer
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel, Germany
Phone: +49 4103 8006-0
Fax: +49 4103 8006-100
PL 11587/0003

At the end of treatment return any leftover medicine
to your hospital or pharmacist.

This leaflet was last revised in July 2016.
80695-VPGB

CB

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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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