CYCLOPHOSPHAMIDE TABLETS 50MG

Active substance: CYCLOPHOSPHAMIDE MONOHYDRATE

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Patient Information Leaflet

Cyclophosphamide 50 mg Tablets
Cyclophosphamide monohydrate
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, please 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 Cyclophosphamide is and what
it is used for
2. Before you are given Cyclophosphamide
3. How you will be given Cyclophosphamide
4. Possible side effects
5. How to store Cyclophosphamide
6. Further information

1. What Cyclophosphamide
is and what it is used for
• Cyclophosphamide is used to treat a wide
range of tumours. It belongs to a group of
medicines called cytotoxics which are used to
kill cells in tumours.
• Cyclophosphamide can be given alone or in
combination with other medicines.
• Your doctor will be able to explain how
Cyclophosphamide might help in your
particular condition.

2. Before you are given
Cyclophosphamide
Do not take Cyclophosphamide if you:

These potentially life-threatening skin rashes are
often accompanied by flu-like symptoms. The rash
may progress to widespread blistering or peeling
of the skin.
The highest risk for occurrence of serious skin
reactions is within the first weeks of treatment.
If you have developed Stevens-Johnson syndrome
or toxic epidermal necrolysis with the use of
Cyclophosphamide you must not be re-started on
Cyclophosphamide at any time, ie. You must not
take Cyclophosphamide in the future.
If you develop a rash or these skin symptoms, stop
taking Cyclophosphamide, seek immediate advice
from a doctor and tell him that you are taking this
medicine.

Taking other medicines:
Please tell your doctor or pharmacist if you are
taking:
• any sulphonylurea-type hypoglycaemics
(used to treat diabetes)
• doxorubicin (another cytotoxic drug used to
kill tumours)
• allopurinol (used to treat painful joint swelling
and reduce levels of uric acid)
• suxamethonium (a muscle relaxant used
in surgery).
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without
a prescription.

Taking Cyclophosphamide with
food & drink
Cyclophosphamide should be taken on an empty
stomach. If you suffer from severe stomach
irritation, you may take Cyclophosphamide with a
meal.

Pregnancy and Breast-feeding

• are allergic (hypersensitive) to Cyclophosphamide
or any of the other ingredients of this medicine.
• have severe kidney disease, i.e inflammation of
the bladder.

If you are pregnant or planning to become pregnant
it is important to tell your doctor this before you are
given Cyclophosphamide.
You should not breast-feed while taking
Cyclophosphamide.

Take special care with Cyclophosphamide:

Driving and using machinery

If you have:
• lowering of the levels of blood cells
• severe infections
• any kidney or liver disease
• received or are receiving radiotherapy
• received in the past any anti-tumour drugs or
x-rays
• any other illnesses.
Potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported with the use of
Cyclophosphamide, appearing initially as reddish
target-like spots or circular patches often with
central blisters on the trunk.
Additional signs to look for include ulcers in the
mouth, throat, nose and genitals and conjunctivitis
(red and swollen eyes).

There are no special precautions, and you can
drive or operate machinery as long as you feel fully
recovered following your treatment.

Important information about some of the
ingredients of Cyclophosphamide
Cyclophosphamide contains lactose and sucrose,
these are types of sugar. If you have been told by
your doctor that you have an intolerance to some
sugars, contact your doctor before taking this
medicinal product.

3. How you will be given
Cyclophosphamide
Always take Cyclophosphamide exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.

110920-9

Your doctor will advise you of how much and how
often you will need to take your medicine. Your
dosage is calculated from the ratio of your weight
and total body surface area (in square metres); this
is necessary because the dose is usually calculated
as ‘milligrams per square metre’ (mg/m2).
You will find more about CYCLOPHOSPHAMIDE on
the back of this leaflet

• your medicine must be taken under the
supervision of specialists
• much higher doses may be used if the specialist
thinks it is necessary
• your medicine is to be swallowed whole;
preferably on an empty stomach but if you suffer
from severe stomach irritation, then you may
take Cyclophosphamide with a meal
• you should be given Cyclophosphamide early in
the day
• you should drink plenty of fluids
• Your doctor may also give you another drug
called Mesna (Uromitexan) to try to prevent
some of the side effects of treatment with
Cyclophosphamide.

4. Possible side effects
Like all medicines, Cyclophosphamide can
cause side effects, although not everybody
gets them.
Tell your doctor immediately if you experience:
• An allergic reaction such as sudden
wheeziness, difficulty in breathing,
increased heart rate, decreased blood
pressure or swelling to the face.
Cyclophosphamide can also cause the following
side effects:
• Effects on your blood cells: Platelets (these
are cells that help the blood to clot) can be
affected which could make you bruise or bleed
more easily. It is important to seek medical
advice if this happens.
Thromoboembolism (blood clots usually in the
leg, which causes pain, swelling or redness).
Anaemia (a low red blood cell count) that can
leave you feeling tired and drowsy. White blood
cell counts (which fight infections) can also drop
which might increase the chance of infections.
• Effects on your kidneys, bladder and liver:
Burning sensations during urination and frequent
need to urinate (cystitis). Appearance of blood in
the urine (haematuria). Blood tests will be done
by your doctor to monitor any abnormal effects.
• Effects on your heart and circulation:
Alterations in blood sugar levels, heart damage.
• Effects on your respiratory system:
Thickening of the lining of the lungs will lead to
shortness of breath.
• Effects on your hair and skin: Hair loss,
flushing and colouration of skin.
Potentially life-threatening skin rashes (StevensJohnson syndrome, toxic epidermal necrolysis)
have been reported (see section 2) very rarely.
• Effects on your mouth, stomach and
intestines: Sore mouth, feeling sick (nausea),
being sick (vomiting), ulcers and loss of appetite
(anorexia).
• Effects on your nervous system: Headaches.
• Effects on your endocrine system:
Inflammation of the pancreas.

• Effect on your reproductive system: Lack of
menstruation (periods) in females and infertility
in men. Both of which are reversible in most
cases. It may leave children permanently sterile.
• Other effects
There is an increased risk of cancer of the white
blood cells and some other cancers and tumours
following Cyclophosphamide therapy.
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.

5. How to store
Cyclophosphamide
• Keep out of the reach and sight of children.
• Cyclophosphamide should not be used after
the expiry date stated on the carton and on the
container. The expiry date refers to the last day
of the month.
• Do not store above 25°C
• Store in the original container in order to protect
from moisture.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

6. Further Information
What Cyclophosphamide contains
The active ingredient is Cyclophosphamide
monohydrate 50mg
The other ingredients are: maize starch,
pregelatinised starch, lactose, gelatin,
microcrystalline cellulose, sodium stearyl fumarate,
magnesium stearate,
Coating: polyethylene glycol, sucrose, maize starch,
calcium carbonate, povidone, opalux AS-9486
(sucrose, titanium dioxide, purified water, red iron
oxide, yellow iron oxide, polyvinylpyrrolidone, sodium
benzoate (E211)) and carnauba wax.

What Cyclophosphamide looks like
and contents of the pack
Cyclophosphamide 50 mg tablets are sugar coated
and brown in colour. They are presented in a white
plastic container.
Cyclophosphamide is available in a pack size of
100 tablets.

Marketing Authorisation Holder
Pharmacia Limited,
Ramsgate Road,
Sandwich,
Kent,
CT13 9NJ,
United Kingdom.

Manufacturer
Orion Corporation,
PO Box 425,
FIN 20101,
Turku,
Finland.
This leaflet was revised in
03/2012



Ref: CP7_2

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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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